(56 days)
Indications for Use:
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- Warming transfusions, infusions, fluids.
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- Warming blood infusions and return blood flow.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "ASTOFLO," a blood and infusion warmer. It outlines the FDA's determination of substantial equivalence to a predicate device and provides information on regulatory responsibilities.
The document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies. Therefore, I cannot extract the requested information from this 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.