(76 days)
The JUMP START is intended to be used to treat patients in cardiopulmonary arrest. It is intended for use in either in-hospital or out-of-hospital arrests.
It is intended for use by personnel who are authorized by a physician/medical director, and who have the following training and skills:
- American Heart Association Heartsaver course, American Red Cross CPR / AED course, or equivalent
- Training in the use of the MRL JUMP START
It should only be used on patients who are unconscious, pulseless, and not breathing spontaneously. The biphasic waveform employed by the JUMP START has not been clinically tested on pediatric patients The device has not been evaluated for cardioversion of atrial fibrillation or direct (internal) cardiac defibrillation. It should not be used on pediatric patients less than 8 years old.
Not Found
This document is a 510(k) clearance letter from the FDA for the "Jump Start" Automated External Defibrillator (AED). It states that the device is substantially equivalent to a legally marketed predicate device.
Unfortunately, this document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
Here's why:
- 510(k) Clearance: A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a comprehensive study with detailed acceptance criteria and performance data for the specific device being cleared.
- Lack of Specific Study Details: The letter refers to a "premarket notification" but does not include the actual study design, results, or statistical analysis.
Therefore, I cannot extract the requested information from this document. The document only provides the basic details of the clearance process, such as the device name, regulation number, product code, and the date of clearance. It also includes the intended use statement.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2002
Medical Research Laboratories, Inc. c/o Mr. Joel Orlinsky 1000 Asbury Drive Buffalo Grove, IL 60089
Re: K021168
Jump Start (Model 970300) Regulation Number: 870.1025 Regulation Name: Automated External Defibrillator Regulatory Class: III (three) Product Code: 74 MKJ Dated: April 10, 2002 Received: April 11, 2002
Dear Mr. Orlinsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Joel Orlinsky
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment III
.510(k) Number (if Known): ____________________________________________________________________________ 68
Device Name: JUMP START
Indications For Use:
The JUMP START is intended to be used to treat patients in cardiopulmonary arrest. It is intended for use in either in-hospital or out-of-hospital arrests.
It is intended for use by personnel who are authorized by a physician/medical director, and who have the following training and skills:
- American Heart Association Heartsaver course, American Red Cross CPR / � AED course, or equivalent
- Training in the use of the MRL JUMP START +
It should only be used on patients who are unconscious, pulseless, and not breathing spontaneously. The biphasic waveform employed by the JUMP START has not been clinically tested on pediatric patients The device has not been evaluated for cardioversion of atrial fibrillation or direct (internal) cardiac defibrillation. It should not be used on pediatric patients less than 8 years old.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODR)
ん
Division of Cardiovascular & Respiratory Devices
510(k) Number Ko 21168
scular &
Prescription Use (Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.