(22 days)
The Stockert Air Purge Control (APC) detects air in the venous line and removes air from the venous bubble trap of the Synergy System tubing circuit that is intended to be used with the Stockert S3 Perfusion System. The S3 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S3 System.
The Stöckert Air Purge Control is a modification of the cleared S3 Level Control/Bubble Detector with the new Air Purge Control module replacing the Bubble Detector. The APC System uses the same Level Control module, Level Control sensor as the predicate device above. The modifications being made to the parent Stöckert S3 Level Control and Bubble Detector consist of three changes: (1) a change to the artwork of the display panel to show "APC" rather than "Bubble Detector," (2) replacement of the "Alarm Clear" key with the "Purge Control" key, and (3) firmware and software modifications. No modifications are being made to the hardware or electronics of any of the components.
The provided text is a 510(k) summary for a medical device modification, specifically the Stöckert Air Purge Control (APC) System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to fill out all the aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Missing | Missing |
The document states: "Stöckert Instrumente GmbH has verified and validated the device modifications and has demonstrated, through the testing provided in the 510(k) that the APC System complies with specifications, meets user requirements, and the differences between the parent and the proposed device do not raise new issues of safety or effectiveness."
However, the specific "specifications" (acceptance criteria) and the quantitative results from the "testing provided in the 510(k)" (reported device performance) are not included in this summary. This document is a high-level summary and doesn't delve into the detailed test report.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The summary mentions "testing provided in the 510(k)," but doesn't detail the nature or origin of the data. Given it's a device modification and verification/validation, it's likely internal testing by the manufacturer, but specifics are absent.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not applicable and not provided. The device (Air Purge Control) is a bubble detector and air removal system. Its "ground truth" would likely be established through physical tests with known air volumes or conditions, rather than expert interpretation of images or observations.
4. Adjudication Method for the Test Set
- Not applicable and not provided. See point 3 above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool for human readers. It's an automated control system.
6. Standalone Performance Study
- Was it done? Yes, implicitly. The summary states: "Stöckert Instrumente GmbH has verified and validated the device modifications and has demonstrated, through the testing provided in the 510(k) that the APC System complies with specifications, meets user requirements..." This refers to the device's performance in its intended function (detecting and removing air), which is a standalone performance validation. However, the specific results of this standalone testing are not detailed in the summary.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated but inferred to be based on engineering specifications and physical measurements. For a bubble detector and air purge system, the ground truth would involve controlled introduction of air into the system and verification of the device's ability to detect and remove it according to predetermined thresholds and operational parameters. It would likely involve instrument-based measurements rather than expert consensus or pathology.
8. Sample Size for the Training Set
- Not applicable and not provided. This device is a control system with firmware/software modifications, not a machine learning or AI model that requires a training set in the typical sense. The "firmware and software modifications" would have been developed and tested against established engineering requirements.
9. How the Ground Truth for the Training Set Was Established
- Not applicable and not provided. See point 8.
In summary:
The provided text serves as a regulatory submission summary, focusing on demonstrating substantial equivalence for a device modification. It mentions "testing" and "verification/validation" were performed to show the device meets "specifications" and "user requirements," but it does not disclose the specific acceptance criteria, the detailed results, or the methodologies (like sample sizes, ground truth establishment for AI/diagnostic devices, or MRMC studies) that you've requested. These details would typically be found in the actual test reports and validation documents submitted with the 510(k), which are not part of this public summary.
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K041558 Special 510(k): Device Modification 510(k) Summary for Stöckert Air Purge Control
1. SPONSOR
Stöckert Instrumente GmbH Lindberghstrasse 25 80939 Munich Germany
Contact: Helmut Hofl, Director, Quality Assurance and Regulatory Affairs Telephone: 011 49 89 323 010 Facsimile: 011 49 89 323 01100
Date Prepared: June 30, 2004
DEVICE NAME 2.
Proprietary Name: Stöckert Air Purge Control (APC) System Common/Usual Name: Cardiopulmonary bypass bubble detector and sensor Classification Name: Cardiopulmonary bypass bubble detector
3. PREDICATE DEVICE
Stöckert S3 Level Control and Bubble Detector (K955152)
4. DEVICE DESCRIPTION
The Stöckert Air Purge Control is a modification of the cleared S3 Level Control/Bubble Detector with the new Air Purge Control module replacing the Bubble Detector. The APC System uses the same Level Control module, Level Control sensor as the predicate device above. The modifications being made to the parent Stöckert S3 Level Control and Bubble Detector consist of three changes: (1) a change to the artwork of the display panel to show "APC" rather than "Bubble Detector," (2) replacement of the "Alarm Clear" key with the "Purge Control" key,
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and (3) firmware and software modifications. No modifications are being made to the hardware or electronics of any of the components.
5. INTENDED USE
The Stockert Air Purge Control (APC) detects air in the venous line and removes air from the venous bubble trap of the Synergy System tubing circuit that is intended to be used with the Stockert S3 Perfusion System. The S3 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S3 System.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The proposed APC is identical in intended use and fundamental scientific technology to the parent Stöckert S3 Level Control and Bubble Detector. The differences between the proposed and parent device is limited to the display panel and firmware/software. Stöckert Instrumente GmbH has verified and validated the device modifications and has demonstrated, through the testing provided in the 510(k) that the APC System complies with specifications, meets user requirements, and the differences between the parent and the proposed device do not raise new issues of safety or effectiveness.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, representing the department's focus on people and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 2 2004
Stöckert Instrumente GmbH c/o Ms. Rosina Robinson Senior Staff Consultant Medical Devices Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K041558 Stöckert Air Purge Control Dated: June 9, 2004 Received: June 10, 2004
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 (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 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 (301) 594-4646. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Duna D. Lochner
( 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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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K041558
Device Name: Stöckert Air Purge Control
Indications for Use:
The Stockert Air Purge Control (APC) detects air in the venous line and removes air from The Stocker An Furge Oontrol ( = 3) System tubing circuit that is intended to be used the vehous oubote thip of the System. The S3 System is indicated for speed-controlled whill the Stocker US Forfastor Dystems
pumping of blood through the cardiopulmonary bypass circuit for durations of six hours pulliping of violou arrowenting, cardiotomy suction, and administration of cardioplegia of tess, for ventreatir valuages and serfusionist who is experienced in the operation of the S3 System.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna P. Vochner
Ision Sign-Off) (Division of Cardiovascular Device
510(k) Number K041558
§ 870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
(a)
Identification. A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.