K Number
K022876
Device Name
MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
Date Cleared
2002-09-11

(12 days)

Product Code
Regulation Number
880.5410
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The "Infant Life Support Module - 20" 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 is usually present. The system is to be operated by trained medical technical personnel. Intended use of the modified (K022876) and predicate device ( K854065) are identical.
Device Description
The "Infant Life Support Module - 20" 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 is usually present.
More Information

Not Found

No
The description focuses on basic temperature control and structural features of a transport incubator, with no mention of AI/ML terms or functionalities.

Yes
The device is described as an infant life support module and a neonatal transport incubator that circulates warmed air at a controlled temperature, providing essential environmental support for infants, which is a therapeutic function.

No
The device is described as a neonatal transport incubator that circulates warmed air to an infant. While it mentions the presence of auxiliary equipment for vital signs monitoring, the incubator itself is not described as performing diagnostic functions such as identifying a disease or condition. Its primary function is to provide life support and transport.

No

The device description explicitly states it is a "neonatal transport incubator," which is a physical hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Device Function: The "Infant Life Support Module - 20" is a neonatal transport incubator. Its function is to provide a controlled environment (warmed air) for an infant during transport. It does not perform any tests on biological samples.
  • Intended Use: The intended use is to support an infant's life during transport, not to diagnose or monitor a condition through analysis of biological samples.

Therefore, the device described is a life support device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The "Infant Life Support Module - 20" 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 is usually present. The system is to be operated by trained medical technical personnel. Intended use of the modified (K022876) and predicate device ( K854065) are identical.

Product codes

FPL

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Infant / Neonatal

Intended User / Care Setting

trained medical technical personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K854065

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 880.5410 Neonatal transport incubator.

(a)
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.(b)
Classification. Class II (performance standards).

0

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles or faces stacked on top of each other, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 11 2002

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

Re: K022876

Trade/Device Name: Infant Life Support Module-20 Regulation Number: 880.5410 Regulation Name: Neonatal Transport Incubator Regulatory Class: II Product Code: FPL Dated: August 26, 2002 Received: August 30, 2002

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.

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.

1

Page 2 - Mr. Manning

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Tim Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use Statement (ref. K022876)

510(k) number - K854065 ( modified device)

Device name: Infant Life Support Module - 20

Indications for Use:

The "Infant Life Support Module - 20" 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 is usually present. The system is to be operated by trained medical technical personnel. Intended use of the modified (K022876) and predicate device ( K854065) are identical.

Name

Gerald Manning

Director of Engineering Title

Date September 9, 2002

Patricio Ciccenti

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K022874