(18 days)
The V-Cath® PICC is indicated for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 3.8FR or larger catheter is recommended.
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I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.
The text is a 510(k) clearance letter from the FDA for the V-Cath® PICC. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed. It discusses regulatory matters, product classification, and general controls, but it does not contain any data, results, or details of studies regarding the device's performance against specific acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions you've posed as the necessary information is not present in the provided document. The document only states the "Indications for Use" of the device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).