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Indications: The system is indicated for the relief of pain in patients following surgery by the continuous administration of medication into the incision site.

AVIA Pain Medication Delivery System

This document is a 510(k) clearance letter from the FDA for the "AVIA Pain Medication Delivery System." It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study as might be required for a PMA (Premarket Approval) or de novo submission for novel devices.

Therefore, I cannot provide the requested information based on the provided text. The document primarily outlines:

• Device: AVIA Pain Medication Delivery System
• Applicant: AMTEC Medical, Incorporated
• Regulatory Class: II
• Product Code: MEA
• Date of Clearance: April 22, 1999
• Indications for Use: Relief of pain in patients following surgery by the continuous administration of medication into the incision site.
• Contraindications: Not intended for intravenous or intra-vascular infusion.
• Warnings: Disposable, do not refill or resterilize, do not overfill, follow drug manufacturer's instructions.
• Caution: Federal (USA) Law restricts this device to use or sale only by or on the order of a physician.

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