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Medline Catheterization Laboratory Trays/Kits/Packs are intended for use by licensed physicians. The intended use of the medical products assembled in these kits will not be changed from the manufacturer's original intended use.

Medline Catheterization Laboratory Trays/Kits/Packs are an assemblage of medical materials to be used by medical professionals during cardiac catheterization, angiography, or arteriorgram procedures. These procedures may include actual catheterization, implantation of pacemakers, or other procedures that are specific to the Catheterization Laboratory. The trays will be assembled using Medline and other manufacturer's materials, medical devices and/or drugs. The devices are custom to our customers who specify the contents, quantity and placement of the individual items in the tray, kit, or pack.

This document is a 510(k) premarket notification for Medline Catheterization Laboratory Trays/Kits/Packs. It is a regulatory submission to the FDA, not a study demonstrating device performance against acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not present in this document.

The document discusses:

• Device Description: An assemblage of medical materials for cardiac catheterization, angiography, or arteriogram procedures.
• Intended Use/Indications for Use: For use by licensed physicians, with the intended use of individual components unchanged from their original manufacturers.
• Substantial Equivalence: The key argument for clearance, stating that components were on the market prior to May 28, 1976, or are substantially equivalent to pre-amendment devices, or are exempt. It also references similar kits marketed by other companies.
• Regulatory Classification: The individual components are Class I or Class II medical devices, drugs, or non-medical materials. The FDA letter classifies the overall device as Class II.
• Manufacturing and Sterilization: Kits will be assembled in a Class 10,000 clean room and sterilized using EtO or gamma radiation.
• FDA Response: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market, subject to general controls and specific conditions regarding drug components and suture handling.

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