The Ambu SPUR II Infant Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight up to 22lbs (10kg).

The Ambu SPUR II Pediatric Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of infants and children with a body weight up to 66lbs (30kg), approx. 9 years of age.

Device Description

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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Ambu, Inc. regarding their Ambu® SPUR® II resuscitators. This document primarily focuses on regulatory approval and indications for use.

It does not contain any information about:

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Results from any studies proving criteria are met.
Sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot fulfill your request for this specific information based on the text provided.

Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 12 2004

Ms. Sanjay Parikh Technical and Regulatory Affairs Ambu, Incorporated 611 North Hammonds Ferry Road Linthicum, Maryland 21090-1356

Re: K042843

Trade/Device Name: Ambu® SPUR® II. Pediatric Single Patient Use Resuscitator and Ambu® SPUR® II. Infant Single Patient Use Resuscitator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: October 13, 2004 Received: October 14, 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 Please be advised that I Dr 3 issualled on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal sales and regisments, including, but not limited to: registration You must comply with an the Hecker of to CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), lasting (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 18, Cal requirents as set form in the quality by oversions (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) I his letter will anow you to other of substantial equivalence of your device to a premarket notification. The PDF 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), If you desire specific at 120 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Dristor (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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. Infant Single Patient Use Resuscitator.

Indications For Use:

The Ambu SPUR II Infant Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight up to 22lbs (10kg).

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)

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(Division Sigh Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices

510(k) Number: K042843

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Indications for Use

510(k) Number (if known):

Device Name: Ambu® SPUR® II. Pediatric Single Patient Use Resuscitator.

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sigh-Off Division of Anesthesiology, General Hospital, Infection Control, Dental D 510(k) Number

Regulation Number and Section

§ 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).