The 20e is an enhancement of the LIFEPAK 20 defibrillator/monitor, which has become the standard of care in many hospitals worldwide since its introduction in 2002. It offers all the capabilities of the LIFEPAK 20 device, along with a more powerful Lithium-ion battery that doubles ECG monitoring time and the run time of other parameters such as noninvasive pacing and pulse oximetry, a noninvasive way to monitor the oxygenation of a patient’s hemoglobin. Additionally, a new on-screen “fuel gauge” displays the real-time status of available battery capacity so clinicians can monitor remaining use time.

The 20e also was developed to be easily transported, helping hospitals meet the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) standard for having resuscitation services readily available in all facility areas.

“We are very pleased to have received 510(k) clearance from the FDA on the LIFEPAK 20e defibrillator/monitor. Physio-Control has a long history of providing products for the hospital marketplace and the 20e will fit well into the line of reliable, quality products customers have come to expect from us,” said Brian Webster, president of Physio-Control. “It is an exciting time for our company as we continue to provide our customers with new generations of LIFEPAK products.”

Physio-Control is currently under a consent decree with the FDA, which restricts the amount of products that can be delivered to customers until certain improvements in the company’s quality system have been completed. However, the company is permitted to manufacture and ship a limited selection of product under certain conditions to meet the critical needs of emergency response customers. Hospital staff should call their local Physio-Control representative to learn more about the specific conditions under which Physio-Control can deliver LIFEPAK 20 and LIFEPAK 20e products to U.S. hospital customers.
About Physio-Control

Physio-Control, a division of Medtronic, is located in Redmond, Wash. Physio-Control pioneered defibrillation technology more than 50 years ago. With nearly 700,000 LIFEPAK® defibrillators distributed worldwide, the company is the world’s leading provider of external defibrillators for the treatment of sudden cardiac arrest. To find out more about Physio-Control, go to http://www.physio-control.com or call 1-800-442-1142.

About Medtronic

Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.

Medical experts told lawmakers Wednesday that new television advertisements for medical devices pose even greater risks to patients than ads for drugs, which have been scrutinized for years.

The Senate Aging Committee hearing was focused on whether new restrictions are needed on consumer-directed advertisements for artificial knees, heart devices and other medical implants.

Magazine and TV spots have been a staple of pharmaceutical marketing for over a decade, with the industry spending over $5 billion on such efforts last year. While spending by the device industry is minuscule by comparison, several of the biggest players are adapting similar high-profile tactics.

Johnson & Johnson currently promotes its orthopedic hips with a TV advertisement featuring Duke University basketball coach Mike Krzyzewski. Biomet has promoted its competing products with spokeswoman Mary Lou Retton, an Olympic gymnastics champion.

Unlike ads from pharmaceutical companies, medical device spots are not required to give equal balance to risks and benefits of their products. Because of that, they can “create unrealistic expectations among patients and lead to overutilization of inappropriate and costly, unproven technologies,” said Kevin Bozic, a board director of the American Association of Orthopedic Surgeons.

AdvaMed, which represents industry leaders like Medtronic and Boston Scientific Corp., disagreed, arguing that marketing “is a powerful education tool” that helps patients learn about important new treatment options.

Committee Chairman Sen. Herb Kohl, D-Wis., asked AdvaMed President Stephen Ubl whether some advertisements overstate the benefits of devices.

After playing the J&J advertisement featuring Krzyzewski — which shows a number of people playing various sports — Kohl asked, “Is it typical for hip replacement patients to be able to jump rope, surf and swim?”

Ubl declined to comment on the advertisement.

Other experts told lawmakers that device advertisements are more deserving of restrictions than those for drugs because the implants often involve greater risks.

While all drugs have side effects, taking a pill for insomnia or impotence is nowhere near as risky as having a medical device surgically implanted, according to Dr. William Boden, a professor at the University of Buffalo.

Boden pointed to a recent ad for Johnson & Johnson’s Cypher stent, which he said “crossed the line” in touting the benefits of a device to millions without mentioning the sometimes fatal complications of surgery. Stents are mesh-wire tubes used to prop open arteries after they have been cleared of fatty plaque deposits.

Boden recommended a ban on advertisements for medical devices for at least two years after they are approved. Democrats have pushed for similar restrictions on the drug industry, but without much success.

Kohl said he may consider proposing similar restrictions for medical device makers, and on Wednesday he pressed a Food and Drug Administration official on whether the agency needs more resources and authority to oversee device marketing.

Daniel Schultz, who runs the FDA’s device center, said only that he hoped actions by Congress would improve public health and not just create more regulations.

“There are a lot of things that could be done, the question is what should be done to get the ultimate outcome of improved public health,” Schultz said.

FDA 510(k)s

• General Information
• Federal Register Notices
• Search the Releasable 510(k) Database
• Listing of CDRH Substantially Equivalent (SE) 510(k) Summaries or 510(k) Statements, for Final Decisions Rendered
• Downloadable 510(k) Files

General Info

510(k) Overview
Class I 510(k) Exemptions, FDA Talk Paper - February 6, 1996
The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications
Screening Checklist for all Premarket Notification 510(k) Submissions
Reclassification Letters
FDA Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices

Notices

Medical Devices; Exemptions From Premarket Notification and Reserved Devices; Class I (2/2/98)
Medical Devices; Exemptions from Premarket Notification; Class II Devices (1/21/98)

Search the 510(k) database

You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following format :

Device Classification Name:
Regulation Number:
510(k) Number:
Device Name:
Applicant:
Contact:
Product Code:
Date Received:
Decision Date:
Decision:
Classification Advisory Committee:
Review Advisory Committee:
Summary or Statement

• SUMMARY indicates that a summary of safety and effectiveness information is available from FDA
• STATEMENT indicates that safety and effectiveness information may be obtained from the 510(k) applicant

Clearance Requirements

These requirements apply to medical devices classified as Class II or Class III, a 510K clearance is necessary in order to market the product in the US. The clearance requires compliance to the CFR, Part 820 Quality System Regulations (QSRs), Good Manufacturing Practices (GMP) and the other applicable CFRs for the product type and indications for use. 510k Assessments can assist in the preparation and filing the 510K clearance application, provide training on the GMPs, and the implementation of a quality management system in compliance with the QSRs and applicable CFRs.

NOTE: Registrars and notified bodies sometimes offer a different service called “FDA 510k Reviews”. This service is limited to a review of the final draft of the submittal to the FDA. They in NO WAY are allowed to assist or advise you on the how to prepare your submittal, nor provide training or consulting. Our services include assistance in establishing AND final review of the 510k submittal, along with any training or implementation consulting that may be necessary.

Process for Submission

Here are some important facts about this process:

1/ Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration. Registration provides FDA with the location of medical device manufacturing facilities and importers. A registration fee is under consideration by Congress.

2/ A 510k is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.

3/ A 510k requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.

4/ The holder of a 510k must have design control documentation available for FDA review during a site inspection. In addition, any changes to the device specifications or manufacturing processes must be made in accordance with the Quality System regulation (21 CFR 820) and may be subject to a new 510k.

5/ Please note that the FDA does not perform 510k pre-clearance facility inspections. The submitter may market the device immediately after 510k clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510k

6/ The SE determination is usually made within 90 days and is made based on the information submitted by the submitter.

7/ The FDA charges a one-time fee to review your 510k application. This FDA fee was$4,158 through September 30, 2007. There is a discount available to US companies with under $100,000,000 in sales.

Good Manufacturing Practice Regulations (GMP)

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters  A, B, C, D, and Efor drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors.  This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

For more details on GMP, please visit: What is GMP?

Regulatory Compliance

The following is an excerpt from a treatise on the subject; It’s mostly academic, but a very helpful read.

FDA Regulatory Compliance Reconsidered

Many observers consider the Food and Drug Administration (FDA) vital for the protection of consumer health and safety. One hundred years ago, Congress established the entity that would become the FDA and authorized it to regulate foods and drugs, critical responsibilities that the agency has long discharged carefully. Throughout the past century, the FDA’s regulatory power has expanded systematically, albeit gradually, while legislatures and courts in the fifty American jurisdictions broadened liability exposure for manufacturers that sold defective products that injured consumers. Observers have recently criticized the agency for overseeing pharmaceuticals too leniently, even as states increasingly narrowed manufacturers’ liability exposure. For instance, numerous jurisdictions have elevated burdens of proof and circumscribed damage awards.

Substantially less clear is the relationship between FDA regulation and the products liability cause of action. Conventional wisdom holds that agency mandates and common law suits occupy distinct, albeit intersecting, universes. Comparatively few legislative and judicial bodies in the states assign great relevance to defendants’ conformity with regulation, and only a small number expressly apply a “regulatory compliance defense.” However, scrutiny reveals that more jurisdictions address conformity in ways that profoundly, yet subtly, affect the cause of action. Because compliance and the defense have significant effects on personal injury litigation, they require evaluation, which this Article undertakes.

Part I provides an overview of this Article’s scope. Part II then descriptively analyzes the origins and expansion of FDA regulation. Part III details the weight legislatures and courts have traditionally accorded compliance and the increasing relevance that both assign to the concept, ascertaining that a growing number of states make conformity a factor that limits defendants’ liability exposure. Part IV next reviews whether the disadvantages of this phenomenon outweigh the benefits and finds that they do. This Article concludes by proffering suggestions that recognize the compelling societal value of drugs, the importance of uniform manufacturer regulation, and the acute need for the essentially individualized patient consideration that common law suits afford.

For the complete disertation on this subject, please vist: FDA Regulatory Compliance Reconsidered

Certification

PMA Approval, Certification, and other requirements are too involved to share here.  For FDA Guidelines, please visit: Guidance for Industry and FDA - Regulation of Medical Devices, or for an earlier article on our sight on the subject of Certification and Approval, please visit: PMA Approval.

When you make a new material on a nanoscale how can you see what you have made? A team lead by a Biotechnology and Biological Sciences research Council (BBSRC) fellow has made a significant step toward overcoming this major challenge faced by nanotechnology scientists. With new research published in ChemBioChem, the team from the University of Liverpool, The School of Pharmacy (University of London) and the University of Leeds, show that they have developed a technique to examine tiny protein molecules called peptides on the surface of a gold nanoparticle. This is the first time scientists have been able to build a detailed picture of self-assembled peptides on a nanoparticle and it offers the promise of new ways to design and manufacture novel materials on the tiniest scale - one of the key aims of nanoscience.

Engineering new materials through assembly of complex, but tiny, components is difficult for scientists. However, nature has become adept at engineering nanoscale building blocks, e.g. proteins and RNA. These are able to form dynamic and efficient nanomachines such as the cell’s protein assembly machine (the ribosome) and minute motors used for swimming by bacteria. The BBSRC-funded team, led by Dr Raphaël Lévy, has borrowed from nature, developing a way of constructing complex nanoscale building blocks through initiating self-assembly of peptides on the surface of a metal nanoparticle. Whilst this approach can provide a massive number and diversity of new materials relatively easily, the challenge is to be able to examine the structure of the material.

Using a chemistry-based approach and computer modelling, Dr Lévy has been able to measure the distance between the peptides where they sit assembled on the gold nanoparticle. The technique exploits the ability to distinguish between two types of connection or ‘cross-link’ - one that joins different parts of the same molecule (intramolecular), and another that joins together two separate molecules (intermolecular). As two peptides get closer together there is a transition between the two different types of connection. Computer simulations allow the scientists to measure the distance at which this transition occurs, and therefore to apply it as a sort of molecular ruler. Information obtained through this combination of chemistry and computer molecular dynamics shows that the interactions between peptides leads to a nanoparticle that is relatively organized, but not uniform. This is the first time it has been possible to measure distances between peptides on a nanoparticle and the first time computer simulations have been used to model a single layer of self-assembled peptides.

Dr Lévy said: “As nanotechnology scientists we face a challenge similar to the one faced by structural biologists half a century ago: determining the structure with atomic scale precision of a whole range of nanoscale materials. By using a combination of chemistry and computer simulation we have been able to demonstrate a method by which we can start to see what is going on at the nanoscale.

“If we can understand how peptides self-assemble at the surface of a nanoparticle, we can open up a route towards the design and synthesis of nanoparticles that have complex surfaces. These particles could find applications in the biomedical sciences, for example to deliver drugs to a particular target in the body, or to design sensitive diagnostic tests. In the longer term, these particles could also find applications in new generations of electronic components.”

Professor Nigel Brown, BBSRC Director of Science and Technology, said: “Bionanotechnology holds great promise for the future. We may be able to create stronger, lighter and more durable materials, or new medical applications. Basic science and techniques for working at the nanoscale are providing the understanding that will permit future such applications of bionanotechnology.”

Biotechnology and Biological Sciences Research Council

Article Source: Medical News Today

Product Name: CONTAK RENEWAL® 3 AVT® Cardiac Resynchronization Defibrillator (CRT-D), Models M150, M155, M157, and M159
PMA Applicant:Guidant Corporation, a Boston Scientific Company
Address: 4100 Hamline Ave North , St. Paul, MN 55112
Approval Date: March 13, 2008

What is it? The CONTAK RENEWAL® 3 AVT CRT-D® is an implantable cardioverter defibrillator (ICD) that also delivers cardiac resynchronization therapy (CRT) and atrial therapies.

How does it work? The CONTAK RENEWAL® 3 AVT CRT-D® consists of an implantable pulse generator (IPG), made up of a battery and electronic circuitry connected to three independent leads (insulated wires). The IPG is usually implanted below the collarbone, just beneath the skin. The leads are placed in three different areas:

• One in an upper heart chamber (the right atrium)
• A second lead in a lower heart chamber (the right ventricle), and
• A third lead in a vein that overlies the left ventricle.

When the device is functioning as an ICD, it senses dangerous abnormal heart rhythms and shocks the heart back into a normal rhythm. The CRT portion of the device uses small electrical impulses to coordinate the beating of the left and right ventricles so that they work together more effectively to pump blood throughout the body. The atrial therapy portion of the device detects and treats rapid heart rates in the atrium with antitachycardia pacing or shock therapy.

When is it used? CONTAK RENEWAL® 3 AVT® is used in certain patients who have:

• symptoms of advanced heart failure despite taking heart failure medication, and
• a heart rhythm problem (arrhythmia) that may cause the lower chambers (ventricles) of the heart to beat in an uncoordinated manner
• and may have a history of or may develop heart rhythm problems in the upper chambers (atria) of the heart.

CONTAK RENEWAL® 3 AVT® CRT-Ds are indicated for patients with moderated to severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF </= 35%) and QRS duration >/= 120 ms.

CONTAK RENEWAL® 3 AVT® provides atrial antitachycardia pacing and atrial defibrillation treatment for patients with a history of, or who are at risk of developing atrial arrhythmias.

What will it accomplish? CONTAK RENEWAL® 3 AVT® will deliver:

• CRT to help coordinate the beating of the heart, and
• A life-saving shock to attempt to return the heart to normal heart rhythm.

Together, these two therapies may reduce the combined risk of death or first hospitalization as well as the risk of death alone. It may also relieve some of the symptoms associated with heart failure, including shortness of breath and fatigue during exercise, which may result in a better quality of life.

CONTAK RENEWAL® 3 AVT® will also deliver:

• Atrial antitachycardia pacing and atrial defibrillation to terminate atrial arrhythmias.

When should it not be used? There is no contraindication for this device.

Article Source - FDA’s Approval To Market Site

Product Name: FreeStyle Navigator® Continuous Glucose Monitoring System
PMA Applicant:Abbott Diabetes Care
Address: 1360 South Loop Road, Alameda, CA 94502
Approval Date: March 12, 2008

What is it? The FreeStyle Navigator Glucose Monitoring System is a glucose sensor that reports glucose values continuously for up to 120 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults, age 18 and over, with diabetes.

How does it work? The sensor is inserted in either the abdomen or the back of the upper arm. After a 10 hour start-up period, the FreeStyle Navigator Continuous Glucose Monitoring System is calibrated with a fingerstick measurement taken by a built-in glucose meter. After calibration, the FreeStyle Navigator System provides continuous glucose readings and updated glucose trend information for viewing. The FreeStyle Navigator Continuous Glucose Monitoring System also contains a built-in alarm that can be programmed to alert the user when results fall below pre-set low and pre-set high levels, and another alarm to alert users before their results reach pre-set levels.

When is it used? The FreeStyle Navigator Continuous Glucose Monitoring System is used with fingerstick measurements to provide additional glucose information to adults with diabetes, age 18 and over, and their healthcare practitioners. The Indications for Use are:

The FreeStyle Navigator Continuous Glucose Monitoring System is indicated for continually recording interstitial fluid glucose levels in people (ages 18 and older) with diabetes mellitus for the purpose of improving diabetes management. Readings and alarms about glucose levels from the FreeStyle Navigator Continuous Glucose Monitoring System are not intended to replace traditional blood glucose monitoring. Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator Continuous Glucose Monitoring System, traditional blood glucose tests must be performed. The FreeStyle Navigator Continuous Glucose Monitoring System provides a built-in blood glucose meter to confirm the continuous glucose result.

The FreeStyle Navigator Continuous Glucose Monitoring System provides real-time readings, graphs, trends and glucose alarms directly to the user. The FreeStyle Navigator Continuous Glucose Monitoring System is intended to be used in home settings to aid people with diabetes in predicting and detecting episodes of hypoglycemia and hyperglycemia and in clinical settings to aid healthcare professionals in evaluating glucose control. The FreeStyle Navigator Continuous Glucose Monitoring System is available only by prescription.

What will it accomplish? Additional glucose information may help people with diabetes and their healthcare practitioners to better manage their disease by providing more information on glucose trends and patterns than can be obtained with fingerstick glucose measurements alone.

When should it not be used?

• Results from this device are not designed to replace blood glucose meter measurements.
• Treatment decisions should not be based solely on results from the FreeStyle Navigator Continuous Glucose Monitoring System. You must confirm with a blood glucose meter measurement before making therapeutic adjustments.
• Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, use your blood glucose meter to check the FreeStayle Navigator System results.

Article Source - FDA’s Market Approval Site

FDA CDRH Third Party Review Training Certificate was awarded to Bob Walton in 1996.