MODIFICATION TO TRANSPORT INCUBATOR 185

K031096 · International Biomedics, Inc. · FPL · Jun 24, 2003 · General Hospital

Device Facts

• Record ID: K031096
• Device Name: MODIFICATION TO TRANSPORT INCUBATOR 185
• Applicant: International Biomedics, Inc.
• Product Code: FPL · General Hospital
• Decision Date: Jun 24, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5410
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The "Transport Incubator 185A" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment.. The system is to be operated by trained medical technical personnel. Intended use of the modified and predicate device (K850496A) are identical.

Device Story

Transport Incubator 185A provides controlled thermal environment for neonates during transport. Device circulates warmed air into transparent chamber at operator-selected temperature. Designed for ground and air transport; structural integrity supports mobile use. Operated by trained medical technical personnel. Does not include integrated airway management or vital signs monitoring equipment. Benefits patient by maintaining stable body temperature during transit.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Neonatal transport incubator; transparent chamber; forced air heating system; operator-controlled temperature regulation. Designed for ground and air transport portability. No software or electronic algorithm components described.

Indications for Use

Indicated for neonatal transport. Used for infants requiring a controlled, warmed environment during ground or air transport. Operated by trained medical technical personnel.

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.

Predicate Devices

• K850496A

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 & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 4 2003

Mr. Gerald Manning Director of Engineering International Biomedical, Incorporated 8508 Cross Park Drive Austin, Texas 78754

Re: K031096

Trade/Device Name: Transport Incubator 185A Regulation Number: 880.5410 Regulation Name: Neonatal Transport Incubator Regulatory Class: II Product Code: FPL Dated: March 6, 2003 Received: April 29, 2003

Dear Mr. Manning:

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 - Mr. Manning

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.

Susan Ruoss

Susan Runner, DDS, MA Interim 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 Statement

510(k) number - K031096

# Device name: Transport Incubator 185A

#### Indications for Use:

The "Transport Incubator 185A" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment.. The system is to be operated by trained medical technical personnel. Intended use of the modified and predicate device (K850496A) are identical.

**Name**

**Title** Director of Engineering

Date March 6, 2003

Patricio Cuenca

510(k) Number: K031096