BABYTHERM 8000 LDR

• K Number: K980886
• Device Name: BABYTHERM 8000 LDR
• Manufacturer: DRAEGER MEDICAL, INC.
• Date Cleared: 1998-05-29 ( 81 days)
• Product Code: FMZ
• Regulation Number: 880.5400
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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.

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.

Device Description

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

AI/ML Overview

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.

Regulation Number and Section

§ 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).