Archive for July, 2008
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
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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
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Third Party Review Training Recieved From The FDA
FDA CDRH Third Party Review Training Certificate was awarded to Bob Walton in 1996.
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A Healthy Listing
DirectoryInternational.com
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.
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Intel’s in-home health device gets FDA Approval
The new Intel Health Guide–which collects vital signs and allows for remote interactions between patient and doctor–may soon make its way into the homes of consumers with chronic health conditions such as diabetes and congestive heart failure.
The Food and Drug Administration approved the medical device, Intel announced Thursday.
The 8-pound in-home gadget connects caregivers and patients outside of hospitals or clinic settings. It manages vital-sign collection, patient reminders, educational content, and motivational messages. The device has a 40GB hard drive.
Information collected by the device is sent to the health care professional, and from there, physician and doctor can engage in video conferencing to discuss health issues. Doctors monitor and remotely care for their patients via an online interface using software called the Intel Health Care Management Suite. It currently runs on Windows XP only.
With the ability to hook up to wired and wireless monitors, such as glucose or blood pressure gauges, a caregiver can schedule times to remotely measure vital signs, or patients can check their own. The encrypted information is sent to a remote database, as long as the device connected to the Internet via broadband.
“This is an important product that will improve the state and cost of health care around the world,” Louis Burns, vice president and general manager of Intel’s Digital Health Group, said in a statement. “We envision a wide range of usage models, not only chronic conditions such as CHF and diabetes, but also programs for health and wellness management at home.”
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Tags: medical devices
Growing Orthopedic Implant Market in India
India is positioned to become the largest market for knee and hip implants over the upcoming five years; the Indian market is growing at a rate of over 30% annually. The total number of joint replacements in India is currently estimated to be around 40,000–50,000 and is doubling every year. In particular, knee replacement surgeries are growing faster than any other category, due in part to the availability of gender-specific devices developed specifically for the Asian population. It is estimated that two out of every ten people in India over 65 years of age currently have osteoarthritic knees. Additional information is available at http://www.devicelink.com/newsedge.
Sponsor Fits Prostheses Without FDA Approval
A sponsor-investigator in a device clinical trial failed to get FDA approval before fitting patients with experimental prostheses, according to the agency. The FDA sent a warning letter to Charles Hamlin based on an inspection conducted Jan. 30 through Feb. 21 at the Denver offices of Hand Surgery Associates.
According to the letter, Hamlin enrolled 47 patients before getting FDA approval for an investigational device exemption. The institutional review board (IRB) had given him approval to enroll 12 subjects at most, according to the letter, which was posted recently to the agency’s website.
Many of the case report forms “were completed several months to more than a year after the patient visit” instead of at the time of the visit, the letter said. Hamlin also did not do required follow-up visits within the specified time window.
The letter cited Hamlin for failure to prepare and submit complete, accurate and timely reports of unanticipated adverse device effects. These are supposed to be sent to the IRB as soon as possible but no later than 10 working days after the sponsor or investigator first learns of them.
He also failed to obtain and document informed consent in that he provided no written documentation for three subjects, consented another two using unapproved documents and had three more sign after they received the prostheses, the FDA said.
The warning letter can be accessed at www.fda.gov/foi/warning_letters/s6803c.htm.