(47 days)
The Ambu SPUR II Adult Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg).
Not Found
This document is a 510(k) premarket notification from the FDA for a medical device called the "Ambu® SPUR® II Adult Single Patient Use Resuscitator." This type of document is a regulatory approval, not a scientific study report describing the performance of an AI/ML device against acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in this document.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. This substantial equivalence is assessed based on design, materials, and intended use, rather than a detailed performance study with acceptance criteria and ground truth as would be reported for an AI/ML diagnostic device.
Therefore, I cannot provide the requested table and information based on the provided text.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 5 2004
Ms. Sanjay Parikh Technical and Regulatory Affairs Ambu. Incorporated 611 North Hammonds Ferry Road Linthicum, Maryland 21090-1356
Re: K042682
Trade/Device Name: Ambu® SPUR® II Adult Single Patient Use Resuscitator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: September 28, 2004 Received: September 29, 2004
Dear Ms. 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 - Ms. 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 (240) 276-0120. 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,
Chaves
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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Indications for Use
510(k) Number (if known):
Device Name: Ambu® SPUR® II. Adult Single Patient Use Resuscitator.
Indications For Use:
.
The Ambu SPUR II Adult Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg).
AND/OR Over-The-Counter Use ... . . . . . . . . . . . . . . . . X Prescription Use (Part 21 CFR 801 Subpart D) (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)
Ceeer Suliom
1 of
(Division Sign-Okt) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number K042682
§ 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).