(441 days)
The Merlin Resuscitators are manual resuscitators incorporating a bag and valve. They are intended for use in providing artificial respiration to patients suffering from respiratory distress. The infant model is intended for patients weighing between 5 and 12 kg, the child model for patients weighing between 12 and 30 kg, and the adult model is intended for patients weighing more than 30 kg. The Merlin Resuscitator is available in reusable and in disposable models.
Manual resuscitators incorporating a bag and valve.
This document is a 510(k) premarket notification letter for the Merlin Resuscitator. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. It confirms the FDA's determination of substantial equivalence to a predicate device. Therefore, I cannot provide the requested information based on this input.
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Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. Inside the circle is an emblem of an eagle with three stripes across its body.
Public Health Service
JUL 1 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Steele Director of Technical Development and Quality Merlin Medical Limited The Whitbread Centre Rhymney Gwent NP22 5BF United Kingdom
Re: K031395
Trade/Device Name: Merlin Resuscitator Regulation Number: 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: June 25, 2004 Received: July 12, 2004
Dear Mr. Steele:
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. Steele
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) 594-4646. 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 vours,
Kee Mly
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K031395
Device Name: Merlin Resuscitator
Indications for use:
The Merlin Resuscitators are manual resuscitators incorporating a bag and valve. They are intended The Merini Kesuschators are manadi rosselfering from respiratory distress. The infant model is intended for patients weighing between 5 and 12 kg, the child model for patients weighing between Intended for patients worgining out is intended for patients weighing more than 30 kg.
The Merlin Resuscitator is available in reusable and in disposable models.
X Prescription Use______________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use_
(Part 21 CAR 801 Subpart D)
(21 CAR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
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J. Y. Hino
Anesthesiology, General Hospital, Infection Control, De
510(k) Number: K031395
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).