(127 days)
The modified Stöckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
The Stöckert Gas Blender is an optional accessory to and designed to be operated with the Stöckert S5 System. It cannot be operated independently from the heart lung machine console.
The provided text describes a 510(k) summary for a medical device (Stöckert S5 System Gas Blender) and a letter from the FDA regarding its substantial equivalence. This document focuses on regulatory approval based on demonstrating equivalence to an existing device, rather than presenting a performance study with detailed acceptance criteria and results as typically seen for novel AI/ML medical devices.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not available in this type of regulatory submission. The information provided is primarily related to design verification and validation, ensuring the device meets its own specifications and is safe and effective when compared to a predicate device.
Here's an attempt to answer the questions based only on the provided text, acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document states that "Design verification and validation information provided in this Special 510(k): Device Modification demonstrates that the product meets prospectively defined design and performance specifications." However, no specific quantitative acceptance criteria or their corresponding performance results are detailed in the provided text. The statement is a general declaration of compliance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission mentions "testing" but does not elaborate on the sample sizes or provenance of any data used for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable in the context of this device's regulatory pathway. The Stöckert S5 System Gas Blender is an accessory to a heart-lung machine, and its performance evaluation would likely involve engineering and functional testing against specifications, rather than expert-adjudicated ground truth data sets in the way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated in question 3.
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
This information is not applicable. The device is not an AI/ML diagnostic or assistive tool, but rather a physical component (gas blender) for a heart-lung machine. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical hardware component and does not operate as a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. For a device like a gas blender, ground truth would typically relate to known physical properties, engineering specifications, and validated measurement techniques, rather than expert-derived medical diagnoses or outcomes data. Its functionality would be verified based on its ability to accurately blend gases according to set parameters.
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. This is not an AI/ML device that requires a training set.
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108832
JUL 30 2008
510(k) Summary Sorin Group Deutschland GmbH Stöckert S5 System Gas Blender (per 21 CFR 807.92)
SPONSOR 1.
| Sorin Group Deutschland GmbH | |
|---|---|
| Lindberghstrasse 25 | |
| 80939 Munich | |
| Germany | |
| Contact Person: | Helmut Höfl |
| Telephone: | 011 49 89 323 010 |
Date Prepared: May 14, 2008
2. DEVICE NAME
| Proprietary Names: | Stöckert S5 System |
|---|---|
| Common/Usual Names: | Heart Lung Machine |
| Classification Names: | Cardiopulmonary bypass heart lung machine console and accessories |
| Proprietary Name: | Stöckert S5 System |
3. PREDICATE DEVICES
Stöckert S5 System (Parent Device) Terumo® Advanced Perfusion System 1, K022947
DEVICE DESCRIPTION 4.
The Stöckert Gas Blender is an optional accessory to and designed to be operated with the Stöckert S5 System. It cannot be operated independently from the heart lung machine console.
เก่ INTENDED USE
The modified Stöckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
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6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Sorin Group Deutschland GmbH bases the claim of substantial equivalence of the Stöckert Gas Blender to the cited predicate devices based on equivalence in intended use, fundamental technological and operational characteristics. Information and testing submitted in this Special 510(k): Device Modification demonstrates that the Stöckert Gas Blender integrated with the S5 System Stöckert Gas Blender with the S5 System do not raise new issues of safety or effectiveness.
7. PERFORMANCE INFORMATION
Design verification and validation information provided in this Special 510(k): Device Modification demonstrates that the product meets prospectively defined design and performance specifications.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 2008
Sorin Group Deutscland c/o Ms. Rosina Robinson, RN, Med, RAC Principal Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K080832
Stockert S5 System Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart-Lung Machine Console Regulatory Class: Class II (two) Product Code: DTQ, DWB, DTR, KRI, DTW, DXS, DWA, KRL, DTX Dated: June 13, 2008 Received: June 19, 2008
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 vour 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 sct forth in the quality systems (QS) 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) premarket notification. The FDA finding of substantial cquivalence 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Dmen R. hohner
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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Indication for Use
510(k) Number (if known): K080832
Stöckert S5 System Device Name:
Indications for Use:
The modified 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)
Dina R. Vollmer
ivision Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices
510(k) Number K080832
§ 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).