AMBU NEONATE SILICONE RESUSCITATOR

K993278 · Ambu, Inc. · BTM · May 17, 2000 · Anesthesiology

Device Facts

• Record ID: K993278
• Device Name: AMBU NEONATE SILICONE RESUSCITATOR
• Applicant: Ambu, Inc.
• Product Code: BTM · Anesthesiology
• Decision Date: May 17, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Ambu Neonate Sillcone Resuscitator is intended for ventilation of neonates and infants with a body weight up to 22 lb (10 kg).

Device Story

Manual resuscitator for neonates and infants; provides positive pressure ventilation. Device consists of silicone bag-valve-mask system; operated manually by clinician or trained personnel in clinical settings. Input is manual compression of silicone bag by operator; output is delivery of air/oxygen to patient airway. Facilitates respiratory support; assists in resuscitation or ventilation of patients weighing up to 10 kg.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual resuscitator; materials include silicone; form factor is bag-valve-mask; non-powered; manual operation.

Indications for Use

Indicated for ventilation of neonates and infants with body weight up to 22 lb (10 kg).

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

MAY 1 7 2000

Mr. Sanjay Parikh Ambu, Inc. 611 North Hammonds Ferry Road Linthicum, MD 21090-1356

Re: K993278 Ambu Neonate Silicone Resuscitator Regulatory Class: II (two) Product Code: 73 BTM Dated: March 9, 2000 March 10, 2000 Received:

Dear Mr. Parikh:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Sanjay Parikh

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours

sincerely yours,

Mark n Melkum

James E. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K993278 510(k) Number (if known):

Dovice Namo: Ambu Neonate Silicone Resuscitator

Indications For Use:

The Ambu Neonate Sillcone Resuscitator is intended for ventilation of neonates and infants with a body weight up to 22 lb (10 kg).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark M. Melkerson

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

(Optior al Format 3-10-98)

PRESCRIPTION USE

510(k) Number .

OVER - THE- COUNTER USE