(81 days)
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.
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.
The Babytherm 8000 LDR is an infant warming bed which provides therapeutic warmth for premature and full-term neonates, and infants.
The provided texts do not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The texts are a summary of safety and effectiveness data for the Babytherm 8000 LDR, including its intended use, a claim of substantial equivalence to a predicate device (Babytherm 8000 WB), and a letter from the FDA stating that the device is substantially equivalent and can be marketed.
Specifically, the document states:
- "Qualification of the Babytherm 8000 LDR included a hazard analysis, system level qualification testing, and environmental testing." However, no details about the acceptance criteria for these tests, the results of the tests, or how these results demonstrate the device meets those criteria are provided.
- There is no mention of a clinical study, a test set, ground truth establishment, expert adjudication, or sample sizes for testing or training sets. There is also no mention of standalone algorithm performance or MRMC studies, as the device is a medical warming bed, not an AI or imaging device.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies, as the provided text does not contain this type of data.
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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 Dräger3135 Quarry RoadTelford, 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.
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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
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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 (301) 594-4692. 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" (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 (800) 638-2041 or (301) 443-6597 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
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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
§ 880.5400 Neonatal incubator.
(a)
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.(b)
Classification. Class II (performance standards).