S3 CARDIOPLEGIA CONTROL

K962320 · Stoeckert Instrumente · DTR · Jan 10, 1997 · Cardiovascular

Device Facts

• Record ID: K962320
• Device Name: S3 CARDIOPLEGIA CONTROL
• Applicant: Stoeckert Instrumente
• Product Code: DTR · Cardiovascular
• Decision Date: Jan 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4240
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Accessory module for Stöckert S3 cardiopulmonary bypass perfusion system; controls and monitors cardioplegia solution delivery during bypass surgery. Operates via updated software controls and user interface panels. Used in clinical settings (OR) by perfusionists/surgeons. Provides real-time monitoring and control of cardioplegia flow; assists in myocardial protection during cardiac procedures. Device represents an upgrade to the Stöckert CAPS Cardioplegia Control unit.

Clinical Evidence

Bench testing only. Evidence includes electrical testing, functional testing, and software verification and validation testing. Compliance with IEC 601, IEC 62a, and UL 544 standards.

Technological Characteristics

Accessory module for cardiopulmonary bypass console. Features updated software controls and display panels. Conforms to IEC 601, IEC 62a, and UL 544 standards.

Indications for Use

Indicated for use during cardiopulmonary bypass procedures to control and monitor the delivery of cardioplegia solutions.

Regulatory Classification

Identification

A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

Predicate Devices

• Stöckert CAPS Cardioplegia Control unit

Submission Summary (Full Text)

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K962320
JAN 10 1997

# Appendix F

## 510(k) Summary

Stöckert S3 Cardioplegia Control Module 510(k) 6/14/96

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# 510(k) SUMMARY

## STÖCKERT S3 PERFUSION SYSTEM CARDIOPLEGIA CONTROL MODULE

1. **Date Prepared:** June 14, 1996

2. **Submitter:** Stöckert Instrumente, GmbH
Lilienthalallee 5-7
D-80939 Munich, Germany

3. **Contact:** Helmut Höfl
011-49-89-32301-0

4. **Device Name:** Stöckert S3 Perfusion System
Cardioplegia Control Module

5. **Device Classification:** Cardiopulmonary bypass consoles and their accessories have been classified as Class II devices in 21 CFR 870.4370 (Product Code: 74 DWB).

6. **Device Description and Comparison to Predicate Products:**

The Stöckert S3 Cardioplegia Control Module is an accessory module to the Stöckert 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 Stöckert CAPS Cardioplegia Control unit. Similar devices have been used for many years for this same intended purpose. The newly modified Cardioplegia Control Module from Stöckert (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.

Information supplied in this premarket notification to support a determination of Substantial Equivalence for this device included descriptive information about the design, materials, and intended use of the device, as well as extensive testing

Stöckert S3 Cardioplegia Control Module 510(k)
6/14/96

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results characterizing device performance, including electrical testing, functional testing, and software verification and validation testing. The Stöckert S3 Perfusion System console and modular components (including the Cardioplegia Control Module) conform with the applicable requirements of IEC 601, IEC 62a, and UL 544. The device holds the CE mark in the European Union.

Stöckert S3 Cardioplegia Control Module 510(k)
6/14/96