(97 days)
The Stöckert Centrifugal Pump Plus System (SCP Plus) is a cardiopulmonary bypass speed control device (21 CFR 870.4380) that is indicated for use with the COBE Revolution Pump Head/Dideco Synergy/ECC.O for speed-controlled pumping through a cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP Plus is intended to be used with the S3 or S5 System and the Stöckert Air Purge Control (APC) System.
The SCP Plus has been qualified only for typical durations of six hours or less, appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies for long-term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.
The modified Stöckert Centrifugal Pump System (referred to as the SCP Plus) is an optional accessory to the S3 or S5 System, a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.
This is a 510(k) summary for a medical device called the "Stöckert Centrifugal Pump Plus System (SCP Plus)". This document describes a medical device and its intended use, but it does not contain the kind of detailed information about acceptance criteria and a study proving those criteria that you've requested.
Specifically, the document states:
- "Testing of the Stöckert Centrifugal Pump Plus System has demonstrated that the System continues to fulfill prospectively defined performance criteria and that the modified System meets user needs."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods for establishing ground truth.
- Details on an MRMC comparative effectiveness study or any effect size.
- Information on a standalone (algorithm only) study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device ("Stöckert Centrifugal Pump System") rather than providing a detailed performance study with specific acceptance criteria and results. For such detailed information, one would typically need to refer to the full 510(k) submission, which is not publicly available in this summarized form.
§ 870.4380 Cardiopulmonary bypass pump speed control.
(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).