Archive for the ‘510k Approvals’ Category
Physio-Control Receives FDA 510(k) Clearance For LIFEPAK(R) 20e Defibrillator/Monitor
Physio-Control, Inc., a wholly owned subsidiary of Medtronic, Inc., (NYSE: MDT) announced today that it has received clearance by the U.S. Food and Drug Administration (FDA) to market the LIFEPAK 20e defibrillator/monitor within the United States.
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.
Tags: defibrillator, monitor
FDA 510k Web Info
FDA’s website information:
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
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Notices
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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
Tags: fda 510k
FDA 510k Clearance
For those who may have some confusion on the matter of obtaining FDA 510(k) Clearance, please review the following:
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.
Tags: fda 510k clearance
510k Approval - CONTAK RENEWAL® 3 AVT® Models M150, M155, M157 and M159
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
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
Tags: 510k approval
510k Approval - FreeStyle Navigator® Continuous Glucose Monitoring System - P050020
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
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
Tags: 510k approval, Add new tag
510k Approval
510k Approval is FDA Premarket Approval
“510k Approval” is more properly termed FDA Premarket Approval, or PMA. Technically, the FDA does not “approve” Class 1 and 2 medical devices for sale in the US they give “clearance” for them to be sold. Most people use the term “FDA approval” for simplicity. To be cleared for sale by the FDA, the first step is to identify a Predicate Device(s), a device similar to the one for which FDA approval is being sought.
CDRH Clearance
If you want to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k)to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act).
Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order “clears” the device for commercial distribution.
PMA Consultant
Due to the complexity of requirements, many companies turn to Third Parties for consulting and review of their products and application paperwork prior to submitting medical devices for “510k Approval”. Third-party review can slash months off the total 510(k) clearance (approval) time in getting products to market.
Medical Device Review
We at 510k Assessment want to be your consultant & advocate. Our services provide the much sought after buffer between our clients and the, oft perceived, adversarial FDA bureaucracy government contacts can convey.
* Identify a predicate device(s) or verify that the predicate device(s) used in your submission meets FDA criteria.
* Write the “substantial equivalence” section of the 510 (k) that compares your device to the predicate device(s).
* Determine if FDA Guidance Documents are applicable to your medical device.
* Contact the FDA Office of Device Evaluation to determine any special requirements for their review of this product, if necessary.
* Prepare and submit the FDA 510 (k) application to the FDA in electronic and hard copy format.
* Write the Executive Summary section of the 510 (k).
* Coordinate with you and the FDA reviewer, and assist with the preparation of a response if the FDA has questions or requires additional information.
* Monitor the progress of the FDA 510 (k) Pre Market Notification through the FDA review process and supply you with periodic updates as they become available.
Compliance
Contact us today to see how we can help you shave months off obtaining your “510k Approval”. Our pledge is service, and our aim is helping your achieve PMA compliance with your 510k Application.
Tags: 510k approval