(138 days)
The Stöckert S3 Cyclic RPM Control Module is an accessory to the S3 Cardiopulmonary Bypass System Console which allows for the cyclicapm control offan;S3:pump.
The Stöckert S3 Cyclic RPM Control Module is an accessory module to the Stöckert S3 (cardiopulmonary bypass) Perfusion System, and is intended to allow the roller pump or double head pump to operate in the pulsed flow mode. The predicate and predecessor device to the S3 Cyclic RPM Control Module is the Stöckert-Shiley CAPS PFC 100 S Control unit (K883456). Similar devices have been used for many years for this same intended purpose. The new S3 Cyclic RPM Control Module is a simple upgrade of the technological aspects of the predicate device, e.g., the software controls and have been updated and the control and display panels have been updated for user convenience in operating the system.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Stöckert S3 Cyclic RPM Control Module:
Limitations of the Provided Information:
It's important to note that the provided document is a 510(k) summary, which is a high-level overview. It describes the device, its intended use, and states that testing was performed to support substantial equivalence. However, it does not provide detailed acceptance criteria, specific reported performance data, or the methodologies of the studies in the granularity typically requested.
Therefore, many sections of your request will be answered by stating that the information is either not provided or not applicable based on the context of this specific document.
Description of Acceptance Criteria and Study for Stöckert S3 Cyclic RPM Control Module
The Stöckert S3 Cyclic RPM Control Module is an accessory to the Stöckert S3 Perfusion System, designed to enable pulsed flow operation for the roller pump or double head pump during cardiopulmonary bypass. The device is a technological upgrade of a predicate device, the Stöckert-Shiley CAPS PFC 100 S Control unit (K883456).
The provided 510(k) summary indicates that the device underwent testing to demonstrate substantial equivalence to its predicate. The testing conducted included:
- Electrical testing: To ensure compliance with electrical safety standards.
- Functional acceptance testing: To verify that the device performs its intended functions correctly.
- Software verification and validation testing: To ensure the software controls operate as designed and meet specified requirements.
The device also conforms to applicable international standards: IEC 601 and IEC 62a.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | Conforms with IEC 601. |
| Functional Performance | Functional acceptance testing was performed. (Specific success criteria or quantitative results not provided in this summary.) |
| Software Functionality | Software verification and validation testing was performed. (Specific success criteria or quantitative results not provided in this summary.) |
| International Standards Compliance | Conforms with IEC 62a. |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the 510(k) summary. The document states "extensive testing results characterizing device performance" but does not detail the sample sizes for any test sets or the provenance (e.g., country of origin, retrospective/prospective nature) of data. Given that this is a hardware and software control module, the "test set" would typically refer to the number of units tested or specific scenarios run, rather than patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided and is largely not applicable in the context of this type of device (a control module for a perfusion system). Ground truth, in this case, would be established by engineering specifications and objective measurements, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not provided and is generally not applicable for the type of testing described (electrical, functional, software V&V for a control module). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review where subjective interpretation is involved.
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
An MRMC study was not done and is not applicable for this device. This device is a control module for a perfusion system, not an AI-assisted diagnostic or clinical decision support system that involves human readers interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The device itself (the Cyclic RPM Control Module) is essentially a standalone control algorithm that modulates the pump's RPM. The "standalone" performance testing would be categorized under the "functional acceptance testing" and "software verification and validation testing" mentioned. The document states these tests were performed, but does not provide details on the specific performance metrics or results of these standalone tests.
7. The Type of Ground Truth Used
The ground truth for the testing of this device would be based on:
- Engineering specifications and design requirements: For electrical performance, functional parameters like RPM control accuracy, and software logic.
- Established international standards: IEC 601 and IEC 62a.
It would not involve expert consensus, pathology, or outcomes data in the typical sense for a medical device.
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this device. The Stöckert S3 Cyclic RPM Control Module is described as possessing updated software controls, implying traditional software engineering and validation rather than a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no indication that a "training set" for a machine learning model was used. The software controls would have been developed and validated against engineering specifications and functional requirements.
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SEP 1 0 1997
Appendix F
510(k) Summary
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510(k) Summary
STÖCKERT S3 PERFUSION SYSTEM CYCLIC RPM CONTROL MODULE
| 1. | Date Prepared: | April 24, 1997 |
|---|---|---|
| 2. | Submitter: | Stöckert Instrumente, GmbHLilienthalallee 5-7D-80939 Munich, Germany |
| 3. | Contact: | Helmut Höfl011-49-89-32301-0 |
| 4. | Device Name: | Stöckert S3 Perfusion SystemCyclic RPM Control Module |
| 5. | Device Classification: | Class II, 21 CFR 870.4370 |
Device Description and Comparison to Predicate Products: 6.
The Stöckert S3 Cyclic RPM Control Module is an accessory module to the Stöckert S3 (cardiopulmonary bypass) Perfusion System, and is intended to allow the roller pump or double head pump to operate in the pulsed flow mode. The predicate and predecessor device to the S3 Cyclic RPM Control Module is the Stöckert-Shiley CAPS PFC 100 S Control unit (K883456). Similar devices have been used for many years for this same intended purpose. The new S3 Cyclic RPM Control Module is a simple upgrade of the technological aspects of the predicate device, e.g., the software controls and have been updated and the control and display panels have been updated for user convenience in operating the system.
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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. Testing included electrical testing, functional acceptance testing, and software verification and validation testing. The Stöckert S3 Perfusion System, including the Cyclic RPM Control Module, conforms with the applicable requirements of IEC 601, and IEC 62a. The manufacturing facility is ISO 9001 certified, and the device holds the CE mark in the European Union.
Page F-2
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Stöckert Instrumente GmbH SEP 1 0 1997 c/o Ms. Rosina Robinson Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K971520 Stöckert S3 Cyclic RPM Control Module Requlatory Class: II (Two) Product Code: 74 DWB Dated: August 6, 1997 Received: August 8, 1997
Dear Ms. Robinson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act
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Page 2 - Ms. Rosina Robinson
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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k 97 1520 510(k) Number (if known): _
Device Name: Stöckert S3 Bypass System Cyclic RPM Control Module_
Indications For Use:
The Stöckert S3 Cyclic RPM Control Module is an accessory to the S3 Cardiopulmonary Bypass System Console which allows for the cyclicapm control offan;S3:pump.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bette R. Semperele
Division Sign-Off) Wision of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Stöckert S3 Cyclic RPM Control Module 510(k)
4/24/97
Page vi
§ 870.4370 Roller-type cardiopulmonary bypass blood pump.
(a)
Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.(b)
Classification. Class II (performance standards).