(84 days)
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No
The document does not mention AI, ML, or related terms, and the device description focuses on standard medical device components and functions.
No
The device is part of a cardiopulmonary bypass circuit, and its functions (detecting and removing air, pumping blood, ventricular venting, cardiotomy suction, administering cardioplegia) are supportive of life functions during surgery or critical care, which qualifies it as a therapeutic device.
No
The device is described as an "Air Purge Control System" that detects and removes air from a tubing circuit used in cardiopulmonary bypass. Its function is to perform a control action (removing air) based on a detection (of air), which falls under therapeutic/interventional rather than diagnostic. It does not provide information to diagnose a patient's medical condition.
No
The device description explicitly states it is a "modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces," indicating it includes hardware components. The performance studies also mention testing of both "hardware and software."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function in detecting and removing air from a blood circuit during cardiopulmonary bypass. This is a direct interaction with the patient's blood within the body's circulatory system (albeit outside the heart and lungs temporarily), not an analysis of a sample in vitro (outside the body).
- Device Description: The description focuses on the system's components for pumping blood and managing the bypass circuit.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
The device is clearly intended for use in a surgical setting by a qualified perfusionist to manage blood flow during cardiopulmonary bypass, which is a life support procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Stöckert Air Purge Control System detects air in the venous line and removes air from the venous bubble trap of the Synergy/ECC.O System tubing circuit. The Synergy/ECC.O shall only be used in conjunction with the Stöckert S5 System and SCP Plus (Stöckert Centrifugal Pump Plus) System and the S5 System.
The Stöckert S5 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) 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 S5 System.
Product codes (comma separated list FDA assigned to the subject device)
DTQ
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
qualified perfusionist who is experienced in the operation of the S5 System.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
KC091007
JUL - 2 2009
510(k) Summary (Per 21 CFR 807.92) Addition of the Stöckert Air Purge Control System to the Stöckert S5 System
1. SPONSOR
| Sorin Group Deutschland GmbH | |
|---|---|
| Lindberghstrasse 25 | |
| 80939 Munich | |
| Germany | |
| Contact Person: | Helmut H\u00f6fl |
| Telephone: | 011 49 89 323 010 |
Date Prepared: April 8, 2009
2. DEVICE NAME
Proprietary Name: -Stöckert S5 System, Stöckert Air Purge Control System Common/Usual Name: Heart lung machine and accessories Classification Name: Multiple
3. PREDICATE DEVICES
- Stöckert S5 System .
- . Stöckert Air Purge Control System
DEVICE DESCRIPTION 4.
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/INDICATIONS FOR USE
The Stöckert Air Purge Control System detects air in the venous line and removes air from the venous bubble trap of the Synergy/ECC.O System tubing circuit that is intended to be used with the Stöckert S5 System.
1
The (integrated) S5 Stöckert is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) 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 S5 System.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The modified Stöckert S5 System is an upgrade of the parent Stöckert S5 System and APC 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.
7. PERFORMANCE TESTING
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem of an eagle with outstretched wings, symbolizing protection and service. The eagle is stylized with three distinct lines forming its body and wings.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 2 2009
Sorin Group Deutschland Gmbh c/o Ms. Rosina Robinson Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K091007
Air Purge Control System for S5 System Model 23-45-05 Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary bypass heart-lung machine console Regulatory Class: Class II (two) Product Code: DTQ Dated: May 28, 2009 Received: June 2, 2009
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 (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,
Ashley B. Barr
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): K091007
Device Name: Stöckert Air Purge Control System (Model Number 23-45-05)
Indications for Use:
The Stockert Air Purge Control System detects air in the venous line and removes air from the venous bubble trap of the Synergy/ECC.O System tubing circuit. The Synergy/ECC.O shall only be used in conjunction with the Stöckert S5 System and SCP Plus (Stöckert Centrifugal Pump Plus) System and the S5 System.
The Stöckert S5 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) 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 S5 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aulley Boann for BDZ
rdiovascular Devices
510(k) Number K091007