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The V-Cath® Poly 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 4FR or larger catheter is recommended.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the V-Cath® Poly PICC (K033853) does not contain the specific information required to answer your request regarding acceptance criteria and a study proving device performance.

The letter primarily:

• Identifies the device: V-Cath® Poly PICC
• States the clearance: Substantially equivalent to legally marketed predicate devices.
• Specifies the Regulation Number and Product Code: 880.5200, FOZ
• Lists the Indications for Use: "for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 4FR or larger catheter is recommended."
• Outlines general regulatory compliance directives for the manufacturer.

It does not include:

• A table of acceptance criteria and reported device performance.
• Details about a specific study (sample size, data provenance, ground truth, adjudicated methods, MRMC study, standalone performance, training set details).

To obtain this information, you would typically need to consult the original 510(k) submission document itself, which would contain the preclinical and clinical data submitted to the FDA to demonstrate substantial equivalence. The clearance letter only summarizes the FDA's decision based on that submission.

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