(86 days)
The HemoDraw™ Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.
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I am sorry, but the provided context does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is a 510(k) clearance letter from the FDA for the HemoDraw™ Arterial Blood Sampling Set, indicating that the device has been found substantially equivalent to a predicate device. It defines the indications for use of the device but does not include any performance data or study design details.
§ 868.1100 Arterial blood sampling kit.
(a)
Identification. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.