(28 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 document is a 510(k) clearance letter from the FDA for a medical device called "The Belmont® buddy lite™ Fluid Warmer." This document does not describe or include information about a study that proves the device meets acceptance criteria in the manner requested, which typically refers to performance studies for software, AI, or diagnostic devices.
Instead, this letter is a regulatory approval based on the device's "substantial equivalence" to a predicate device. It confirms that the device meets certain regulatory requirements for marketing.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth as those elements are not part of this type of FDA clearance document for a medical fluid warming device.
The information on this document focuses on:
- Device Name: The Belmont® buddy lite™ Fluid Warmer
- Regulation Number/Name: 21 CFR 864.9205, Blood and Plasma Warming Device
- Regulatory Class: II
- Product Code: BSB
- Indications For Use: To warm blood, blood products, and intravenous solution prior to administration by healthcare professionals in clinical environments to prevent hypothermia.
- Basis of Approval: Substantial equivalence to legally marketed predicate devices.
The questions in the prompt are more relevant to the evaluation of AI/ML-based medical devices or diagnostic tools, which involve detailed performance studies with quantitative metrics, ground truth establishment, and often human reader studies. This document pertains to a physical fluid warming device.
§ 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.