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The Medline Cardiovascular Procedure Kit contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing the operating environment for, and performing cardiovascular procedures and surgeries. The intended use of the medical products assembled in these kits will not be changed from the manufacturer's original intended use.

The Medline Cardiovascular Procedure Kit is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits are assembled for customer convenience using Medline and other manufacturer's currently manufactured/marketed components. Customers specify the kit contents, quantity, and placement of individual components in the kit. A component listing is provided within this submission, which includes the name and regulatory status of components that can be selected for placement in various configurations of the final Medline Cardiovascular Kits. The BOM provides the corresponding FDA product codes, and reference to respective marketing clearances (as applicable). These included components are standard for cardiovascular procedures.

The intended use of the products assembled in the final Medline Cardiovascular Procedure Kit will not be changed. These components are all legally marketed drug products, and/or medical devices that are either: (1) pre-amendment devices; (2) 510(k)-cleared devices; or (3) 510(k) exempt devices. Commodity products, not regulated by FDA, are additionally included in the proposed kit. The customer may also specify a certain brand of similar items or minor variations of items. If additional components and/or manufacturers must be added to this list, we certify the regulatory compliance of the added components and maintain the information in our internal Device Master Record.

This document is a 510(k) Premarket Notification for a Medline Cardiovascular Procedure Kit. It is a regulatory submission to the FDA, and as such, it does not contain a study that proves the device meets acceptance criteria in the way described in the request (e.g., performance metrics, sample sizes for test sets, expert adjudication methods).

Instead, this submission is built on the principle of Substantial Equivalence (SE) to a legally marketed predicate device. The core argument is that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.

Here's a breakdown based on your request, explicitly stating when the information is not present in the document:

1. A table of acceptance criteria and the reported device performance

   • Not applicable in the provided document for this type of device. This document is for a "convenience kit" which is essentially a collection of existing, already-cleared medical devices (and some non-regulated items) bundled together for convenience. The performance of the individual components is assumed to be established by their original clearances or regulatory status (e.g., pre-amendment devices).
   • The "acceptance criteria" for a 510(k) for a convenience kit revolve around demonstrating that the kit itself does not alter the intended use or safety/effectiveness of its components, and that the chosen sterilization method is appropriate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable. No test set with patient data (e.g., images for AI) was used or described. The "testing" primarily refers to non-clinical evaluations related to biocompatibility and sterilization of the kit assembly.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable. No external experts were used to establish ground truth in the context of device performance testing in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. No test set with adjudication was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable. This device is a surgical procedure kit, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This is not an algorithm-based or AI device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • Not applicable in the context of performance testing. The "ground truth" for this submission concerns the regulatory status and intended use of the individual components within the kit, and the validation of the sterilization process.

8. The sample size for the training set

   • Not applicable. There is no training set mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established

   • Not applicable.

Information that is present in the document relevant to a regulatory acceptance:

• Predicate Device: K962826 - Medline Radiology-Diagnostic Kits. This is the primary "proof" for substantial equivalence.
• Non-Clinical Testing: The safety and performance evaluation was conducted based on a risk assessment and evaluated in accordance with applicable recognized standards and FDA guidance documents. These include:
  • ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process
  • AAMI/ANSI/ISO 10993-7, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals.
  • FDA's Convenience Kits, Interim Regulatory Guidance: 20 May 1997
  • FDA's Sterilized Convenience Kits for Clinical and Surgical Use: 7 January 2002
• Sterilization: The kit is terminally sterilized by ethylene oxide (EO) to deliver a minimum sterility assurance level of 10-6. Medline ensures sterility of components and no adverse impact from sterilization on functionality.
• Components: The device consists of legally marketed drug products and/or medical devices that are either pre-amendment, 510(k)-cleared, or 510(k) exempt devices, along with commodity products not regulated by FDA. The intended use of these products is not changed.

In summary, this document is a regulatory submission for a convenience kit, not a performance study for a novel diagnostic or therapeutic device. The "acceptance criteria" are interpreted by the FDA as meeting the requirements for Substantial Equivalence to the predicate device, primarily through demonstrating similar intended use, technological characteristics, and compliance with relevant non-clinical and sterilization standards.

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