AVIATOR TRANSPORT INCUBATOR

K081399 · International Biomedical, Ltd. · FPL · Jun 6, 2008 · General Hospital

Device Facts

• Record ID: K081399
• Device Name: AVIATOR TRANSPORT INCUBATOR
• Applicant: International Biomedical, Ltd.
• Product Code: FPL · General Hospital
• Decision Date: Jun 6, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5410
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The transport incubator is intended to be used to transport neonatal infants including transport in ambulances or aircraft and to be used by personnel trained in neonatal care.

Device Story

Aviator Transport Incubator provides controlled environment for neonatal infants during transport in ambulances or aircraft. Device maintains thermal regulation and protection for neonates. Operated by trained neonatal care personnel. Output consists of stable microenvironment for patient. Benefits include maintaining physiological stability during transit.

Clinical Evidence

No clinical data provided; substantial equivalence based on device modification review.

Technological Characteristics

Neonatal transport incubator designed for mobile use in ambulances and aircraft. Provides thermal control and environmental protection for neonates. Class II device under 21 CFR 880.5410.

Indications for Use

Indicated for neonatal infants requiring transport via ambulance or aircraft. Intended for use by personnel trained in neonatal care.

Regulatory Classification

Identification

A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2008

Ms. Amy Pieper Director of Regulatory Affairs International Biomedical, Limited 8508 Cross Park Drive Austin, Texas 78754

Rc: K081399

Trade/Device Name: Aviator Transport Incubator Regulation Number: 21 CFR 880.5410 Regulation Name: Neonatal Transport Incubator Regulatory Class: II Product Code: FPL Dated: May 14, 2008 Received: May 19, 2008

Dear Ms. Pieper:

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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Pagc 2 - Ms. Pieper

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 vour 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/industry/support/index.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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# Special 510(k): Device Modification Aviator Transport Incubator May 14, 2008

## INDICATIONS FOR USE STATEMENT

# Applicant's Name:

International Biomedical, Ltd.

## 510(k) Number:

### Device Name:

Aviator Transport Incubator

### Indications for Use:

The transport incubator is intended to be used to transport neonatal infants including transport in ambulances or aircraft and to be used by personnel trained in neonatal care.

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Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K481399 510(k) Number: