AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR

K042682 · Ambu, Inc. · BTM · Nov 15, 2004 · Anesthesiology

Device Facts

• Record ID: K042682
• Device Name: AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
• Applicant: Ambu, Inc.
• Product Code: BTM · Anesthesiology
• Decision Date: Nov 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

Ambu SPUR II is a manual resuscitator (bag-valve-mask) for pulmonary resuscitation and emergency respiratory support. Operated by clinicians or trained personnel in emergency settings; device delivers manual breaths to patients weighing >30kg. Device consists of a self-inflating bag, patient valve, and mask; manual compression of the bag forces air/oxygen into the patient's airway. Provides immediate respiratory support during respiratory failure or arrest; benefits patient by maintaining ventilation and oxygenation until advanced airway management or spontaneous breathing is restored. Single-patient use design reduces cross-contamination risk.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual resuscitator; self-inflating bag design; single-patient use; non-powered; mechanical operation; intended for adult patients >30kg.

Indications for Use

Indicated for pulmonary resuscitation and emergency respiratory support of adult patients weighing >66lbs (30kg).

Regulatory Classification

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.

Submission Summary (Full 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 [phone]. 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 [phone] or [phone] 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:

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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)

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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