(147 days)
Stöckert S3 System (multiple 510(k) numbers)
Not Found
No
The summary describes a modular system for cardiopulmonary bypass surgery and does not mention any AI or ML components or capabilities.
No
The device is used during surgery, which implies it assists a medical procedure rather than directly treating a disease or condition. Therapeutic devices typically administer treatment.
No
The provided text does not indicate that the Stöckert S5 System is used to diagnose medical conditions, but rather "during cardiopulmonary bypass surgery."
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 significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "during cardiopulmonary bypass surgery lasting six (6) hours or less." This describes a surgical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description mentions a "modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces." This aligns with equipment used in a surgical setting to support a patient's circulation and oxygenation during heart surgery.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro (in a lab setting), or providing diagnostic information based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Stöckert S5 System's function is to support a patient's physiological functions during surgery, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The Stöckert S5 System is intended to be used during cardiopulmonary bypass surgery lasting six (6) hours or less.
Product codes
DTQ
Device Description
The Stöckert S5 System, like the parent S3 System, is a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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 Stöckert S5 System demonstrated that the System fulfills prospectively defined performance criteria and included electrical safety, electromagnetic compatibility, software validation, and functional testing.
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.
Stöckert S3 System (multiple 510(k) numbers)
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k) Summary Stöckert S5 System
K0600053
1. SPONSOR
Sorin Group Deutschland GmbH Lindberghstrasse 25 80939 Munich Germany Contact Person: Helmut Höfl Telephone: 011 49 89 323 010
Date Prepared: January 4, 2006
2. DEVICE NAME
Proprietary Name: Stöckert S5 System Common/Usual Name: Heart lung machine Classification Name: Multiple
3. PREDICATE DEVICES
Stöckert S3 System (multiple 510(k) numbers)
4. DEVICE DESCRIPTION
The Stöckert S5 System, like the parent S3 System, is a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.
ડ. 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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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Stöckert S5 System is an upgrade of the Stöckert S3 System. The Stöckert S5 System is substantially equivalent to the Stöckert S3 System based on intended use, indication for use, operational characteristics, and fundamental technological characteristics.
7. PERFORMANCE TESTING
Testing of the Stöckert S5 System demonstrated that the System fulfills prospectively defined performance criteria and included electrical safety, electromagnetic compatibility, software validation, and functional testing.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN = 2 2006
Medical Device Consultants, Inc. c/o Ms. Rosina Robinson Senior Staff Consultant 49 Plain Street North Attleboro, MA 02760
Re: K060053 Stöckert S5 System Regulation Number: 21 CFR 870.4220 Regulation Name: Heart Lung Machine Console Regulatory Class: Class II Product Code: DTQ Dated: May 22, 2006 Received: May 23, 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) 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,
Brimmer for
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):
Stöckert S5 System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications för 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)
Bhumima
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