(43 days)
The Stöckert S5 System is intended to be used during cardiopulmonary bypass surgery lasting six (6) hours or less.
The modified Stöckert S5 System, like the parent S5 System, is a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.
This submission describes a device modification to an existing system, rather than a new standalone device, and focuses on demonstrating substantial equivalence to the predicate device. Therefore, the information provided does not fully align with all the requested categories for a typical medical device performance study proving a new device meets acceptance criteria.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states: "Testing of the modified Stöckert S5 System (hardware and software) has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs."
However, specific numerical acceptance criteria (e.g., accuracy percentages, specific thresholds for flow rates, pressure, etc.) and the detailed reported performance values are not explicitly provided in the given text. The submission focuses on demonstrating substantial equivalence rather than presenting a detailed performance study against specific, quantified acceptance metrics.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. The submission does not detail specific "test sets" or data used in the conventional sense of a clinical or performance study for a new device. The testing was likely internal V&V for the modified system.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the given text. The concept of "ground truth" established by experts, as typically found in diagnostic device studies, is not applicable here. The device is a heart-lung machine, and its performance is validated through engineering and functional testing.
4. Adjudication Method
This information is not provided and is not applicable to the type of device and submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
This information is not provided and is not applicable. MRMC studies are typically used for diagnostic imaging or screening devices to assess human reader performance with and without AI assistance. This device is a cardiopulmonary bypass system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not provided. While the device has "software," the submission describes "hardware and software" testing of a system, implying integrated performance, not an isolated "algorithm only" study.
7. Type of Ground Truth Used
The concept of "ground truth" as typically understood (e.g., pathology, expert consensus for diagnosis) is not applicable here. For a heart-lung machine, the "ground truth" for performance would be its ability to consistently and accurately control physiological parameters (flow, pressure, temperature) according to engineering specifications and clinical requirements. This would be established through engineering tests, calibration, and functional verification.
8. Sample Size for the Training Set
This information is not provided and is likely not applicable. The device is a modified heart-lung machine, not an AI/ML-driven diagnostic or predictive algorithm that typically requires a "training set" for model development. The "software" mentioned likely refers to operational control software, not machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the reasons stated in point 8.
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SEP 2 8 2006
APPENDIX C
"
510(k) Summary
:
Sorin Group Deutschland GmbH August 15, 2006 Special 510(k): Device Modification - Stöckert S5 System
APPENDIX C
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510(k) Summary Sorin Group Deutschland GmbH Stöckert S5 System (per 21 CFR 807.92)
1. SPONSOR
Sorin Group Deutschland GmbH Lindberghstrasse 25 80939 Munich Germany Contact Person: Helmut Höfl Telephone: 011 49 89 323 010
Date Prepared: August 15, 2006
2. DEVICE NAME
Proprietary Name: Stöckert S5 System Common/Usual Name: Heart lung machine Classification Name: Multiple
3. PREDICATE DEVICES
Stöckert S5 System
4. DEVICE DESCRIPTION
The modified Stöckert S5 System, like the parent S5 System, is a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.
5. INTENDED USE
The Stöckert S5 System is intended to be used during cardiopulmonary bypass surgery lasting six (6) hours or less.
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6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The modified Stöckert S5 System is an upgrade of the parent Stöckert S5 System. The modified Stöckert S5 System is substantially equivalent to the parent Stöckert S5 System based on intended use, indication for use, operational characteristics, and fundamental technological characteristics.
PERFORMANCE TESTING 7.
Testing of the modified Stöckert S5 System (hardware and software) has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2006
Medical Device Consultants, Inc. c/o Ms. Rosina Robinson Principal Consultant, Regulatory Services 49 Plain Street North Attleboro, MA 02760
Re: K062396 Stöckert S5 System Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart Lung Machine Console Regulatory Class: Class II (two) Product Code: DTQ Dated: September 18, 2006 Received: September 19, 2006
Dear Ms. Robinson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Rosina Robinson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) promation 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anna R. Vachner
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A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K062396
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
:
The Stöckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k 662396
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).