(207 days)
Not Found
No K/DEN numbers were found.
No
The description focuses on updated software controls and user interface, not AI/ML capabilities. There is no mention of AI, DNN, or ML, nor any description of training or test sets which are typical for AI/ML devices.
No
The device aids in controlling and monitoring solutions during a bypass procedure, but it does not directly treat a medical condition or disease.
No
The device is described as controlling and monitoring the use of cardioplegia solutions during a bypass procedure, not diagnosing a medical condition.
No
The device description explicitly states it is an "accessory module" to a larger system and mentions "electrical testing" and "functional testing" in addition to software testing, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "control and monitor the use of cardioplegia solutions during the bypass procedure." This describes a device used during a medical procedure to manage the delivery of a substance to the patient.
- Device Description: The description reinforces this by stating it's an "accessory module to the Stockert S3 (cardiopulmonary bypass) Perfusion System" and is used to "control and monitor the use of cardioplegia solutions during the bypass procedure."
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on specimens.
The device is a component of a cardiopulmonary bypass system, which is used to support a patient's circulation and oxygenation during surgery. It directly interacts with the patient's circulatory system by controlling the delivery of cardioplegia solution. This falls under the category of a medical device used in vivo (within the body) or in direct support of a procedure involving the body.
N/A
Intended Use / Indications for Use
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.
Product codes
74 DWB
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
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.(b)
Classification. Class II (performance standards).
0
JAN | 0 |997
Appendix F
510(k) Summary
1
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 Comnarison to Predicate Products:
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.
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
2
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.