(65 days)
The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.
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The provided text is a 510(k) premarket notification letter from the FDA to Belmont Instrument Corporation for their device, The Belmont® buddy lite™ Fluid Warmer. This type of document does not contain the detailed information requested regarding acceptance criteria, study design parameters (sample sizes, data provenance, expert details, adjudication methods), multi-reader multi-case studies, standalone performance, or ground truth establishment for AI/ML-based medical devices.
The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (warming blood, blood products, and intravenous solutions prior to administration to prevent hypothermia). It discusses regulatory compliance and general controls but does not present clinical study results or technical performance data in the format requested for an AI/ML device.
Therefore, I cannot extract the requested information from the provided text.
§ 864.9205 Blood and plasma warming device.
(a)
Nonelectromagnetic blood or plasma warming device —(1)Identification. A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration.(2)
Classification. Class II (performance standards).(b)
Electromagnetic blood and plasma warming device —(1)Identification. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.(2)
Classfication. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See § 864.3.