(206 days)
Ambu Paediatic Multi-Function Defibrillation Electrodes are used for defibrillation, pacing, monitoring ECG applications and synchronized cardioversion.
The Paediatic Multi-Function Defibrillation Electrodes may be used with Class III type of external defibrillators (automated external defibrillators) or class II type of transcutaneous external pacemakers (pulse amplitude not to exceed 200mA in pulse duration not to exceed 200 m sec.
The electrode can be used with mono- and biphasic defibriliators.
The electrode is intended for use on pediatric patients whose weight is less than 10kg (22lbs).
Disposable electrode, for single use, only,
The electrode is intended for use on defibrillators who's output is maximum 100 Joule.
Individual catalogue numbers are labeled for specific use primarily based on the interface connector and cable system which defines the host external device.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device: "Ambu Pediatric Multi-Function Defibrillation Electrodes." It does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory classifications, general controls, and responsibilities under the Federal Food, Drug, and Cosmetic Act.
The "Indications for Use" section (page 2) describes what the electrodes are designed for (defibrillation, pacing, monitoring ECG, synchronized cardioversion) and specific patient/device parameters (pediatric patients < 10kg, external defibrillators or pacemakers, mono/biphasic defibrillators, max 100 Joule output). However, these are use specifications, not performance acceptance criteria or study results.
Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria, device performance, or details of a study.
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Public Health Service
FEB 27 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ambu, Inc. c/o Mr. Sanjay Parikh Technical and Regulatory Affairs Manager 611 North Hammonds Ferry Road Linthicum, MD 21090-1356
Re: K032421
Trade Name: Ambu Pediatric Multi-Function Defibrillation Electrodes Regulation Number: 21 CFR 870.1025 Regulation Name: Arrythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: 74 MKJ, MLN Dated: December 01, 2003 Received: December 02, 2003
Dear Mr. Parikh:
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. Sanjay Parikh
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), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Dara R. Jackner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Ambu Paediatric Multi-function Defibrillation Electrode
Indications For Use:
Ambu Paediatic Multi-Function Defibrillation Electrodes are used for defibrillation, pacing, monitoring ECG applications and synchronized cardioversion.
The Paediatric Multi-Function Defibrillation Electrodes may be used with Class III type of external defibrillators (automated external defibrillators) or class II type of transcutaneous external pacemakers (pulse amplitude not to exceed 200mA in pulse duration not to exceed 200 m sec.
The electrode can be used with mono- and biphasic defibriliators.
The electrode is intended for use on pediatric patients whose weight is less than 10kg (22lbs).
Disposable electrode, for single use, only,
The electrode is intended for use on defibrillators who's output is maximum 100 Joule.
Individual catalogue numbers are labeled for specific use primarily based on the interface connector and cable system which defines the host external device.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Jones
Division Sign-Off)
Division Cardiovascular Devices
Owlsion . Cardiovascular Devices
510(k) Number K03242
Page 1 of
§ 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.