BABYTHERM 8000 LDR

K980886 · Draeger Medical, Inc. · FMZ · May 29, 1998 · General Hospital

Device Facts

• Record ID: K980886
• Device Name: BABYTHERM 8000 LDR
• Applicant: Draeger Medical, Inc.
• Product Code: FMZ · General Hospital
• Decision Date: May 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Babytherm 8000 LDR is intended for use as a warming bed in labor and delivery suites, neonatal wards, neonatal intensive care units, and for short transports inside the hospital

Device Story

Infant warming bed providing therapeutic heat to neonates and infants; used in labor and delivery, neonatal wards, NICUs, and for short hospital transports. Device maintains thermal environment for premature and full-term infants. Operated by clinical staff. Provides warmth via warming bed surface; optional canopy usage. Benefits include thermal regulation for vulnerable patient populations.

Clinical Evidence

No clinical data. Evidence consists of hazard analysis, system-level qualification testing, and environmental testing.

Technological Characteristics

Infant warming bed. Principle of operation: therapeutic warming. Form factor: bed with optional canopy. No software or electronic algorithm details provided.

Indications for Use

Indicated for providing therapeutic warmth to premature and full-term neonates and infants up to 16 lbs, with or without a canopy.

Regulatory Classification

Identification

A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

Predicate Devices

• Babytherm 8000 WB (K94567)

Submission Summary (Full Text)

{0}------------------------------------------------

K980886

# Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

| Proprietary Name: | Babytherm 8000 LDR |
|----------------------|--------------------------------------------------------------------------|
| Classification Name: | Water Circulating Hot or Cold Pack 89ILO |
| Device Class: | Class II |
| Manufacturer: | North American Dräger<br>3135 Quarry Road<br>Telford, Pennsylvania 18969 |

Establishment Registration Number: 2517967

Devices to which substantial equivalence is claimed: Babytherm 8000 WB K94567

### Device Description:

The Babytherm 8000 LDR is an infant warming bed which provides therapeutic warmth for premature and full-term neonates, and infants.

#### Intended Use:

The Babytherm 8000 LDR is intended for use as a warming bed in labor and delivery suites, neonatal wards, neonatal intensive care units, and for short transports inside the hospital

#### Substantial Equivalence:

The Babytherm 8000 LDR is substantially equivalent to the Babytherm 8000 WB.

The Babytherm 8000 LDR and the Babytherm 8000 WB have the same intended use and principal of operation and are substantially equivalent.

Qualification of the Babytherm 8000 LDR included a hazard analysis, system level qualification testing, and environmental testing.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized image of three human profiles facing right, layered on top of each other. The profiles are abstract and flowing, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 1998

Mr. James J. Brennan · Director Requlatory Affairs North American Drager 3135 Quarry Road Telford, Pennsylvania 18969

Re : K980886 Trade Name: Babytherm 8000 LDR Requlatory Class: II Product Code: FMZ Dated: March 6, 1998 Received: March 9, 1998

Dear Mr. Brennan:

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 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in 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

{2}------------------------------------------------

Page 2 - Mr. Brennan

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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.fdal.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

{3}------------------------------------------------

Page 1 of of l

510(k) Number (if known):

Device Name: Babytherm 8000 LDR

Indications for Use:

The Babytherm 8000 LDR is indicated as a therapeutic device for providing warmth with or without the use of a canopy for premature and full-term neonates and infants up to 16 lbs.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use レ (Per 21 CFR 801.109) OR

Over-The-Counter Use_

Patricia Caccavale
(Division Sign-Off)

(Optional Format 1-2-96)

Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K980886

l Hospital Devices
Number K980886