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The Stockert S3 Cardioplegia Control Module is an accessory module to the Stockert S3 (cardiopulmonary bypass) Perfusion System, and is intended to control and monitor the use of cardioplegia solutions during the bypass procedure.

The Stockert S3 Cardioplegia Control Module is an accessory module to the Stockert S3 (cardiopulmonary bypass) Perfusion System, and is intended to control and monitor the use of cardioplegia solutions during the bypass procedure. The predicate and predecessor device to the S3 Cardioplegia Control Module is the Stockert CAPS Cardioplegia Control unit. Similar devices have been used for many years for this same intended purpose. The newly modified Cardioplegia Control Module from Stockert (the S3 Cardioplegia Control Module) is a simple upgrade of the technological aspects of the device, e.g., the software controls have been updated and the control and display panels have been updated for user convenience in operating the system.

This K963300 submission for the Stöckert S3 Perfusion System Cardioplegia Control Module does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria.

The provided text only includes:

• A 510(k) summary for the device.
• Device description and comparison to predicate products.
• A general statement about "extensive testing results characterizing device performance, including electrical testing, functional testing, and software verification and validation testing."
• Mention of conformance to IEC 601, IEC 62a, and UL 544, and holding the CE mark.

There is no detailed information provided on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any testing.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This submission is from 1997, and the level of detail regarding testing and validation, especially for software-controlled medical devices, was generally less extensive in public summaries compared to what might be expected from more recent submissions or detailed technical documentation.

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