(57 days)
The modified S5 and the Pulse Mode Control for the SCP/S5 are used with the SCP Rhythm System in conjunction with the Stöckert S5 System during cardiopulmonary bypass for procedures 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.
The provided 510(k) summary for the Stöckert S5 System does not contain the detailed information requested regarding specific acceptance criteria, device performance, and study methodology (sample sizes, ground truth establishment, expert qualifications, etc.).
The summary states:
"Testing of the modified Stöckert S5 System (hardware and software) has demonstrated that the System fulfills prospectively defined performance specifications and that the modified System meets user needs."
This is a general statement. To provide the requested table and details, a more comprehensive performance study report or verification and validation documentation would be needed.
Based on the available text, I can only state that:
- Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed. The document only generically states that the system "fulfills prospectively defined performance specifications."
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth Type, Training Set Size/Ground Truth): None of these specific details are provided in the given 510(k) summary. The document is a regulatory submission for substantial equivalence, focusing on comparative technological characteristics rather than a detailed breakdown of a clinical or performance study.
Therefore, I cannot populate the table or provide the detailed study information as requested from the provided input. The document serves as an overview of the device and its regulatory status, not a detailed performance study report.
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K07/3/8
510(k) Summary Stöckert S5 System (per 21 CFR 807.92)
JUL -6 2007
SPONSOR 1.
Sorin Group Deutschland GmbH Lindberghstrasse 25 80939 Munich Germany Contact Person: Helmut Höfl Telephone: 011 49 89 323 010
May 9, 2007 Date Prepared:
DEVICE NAME 2.
Stöckert S5 System Proprietary Name: Heart lung machine Common/Usual Name: Cardiopulmonary bypass heart-lung machine console and Classification Name: accessories
3. PREDICATE DEVICES
- Stöckert S5 System (K062396) .
- . Stöckert S3 Roller Pump Module and Console (K950990)
- . Stöckert SCP Rhythm Module (K042374)
- Stöckert S3 Cyclic RPM Control (K971520) .
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.
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5. INTENDED USE
The modified S5 and Pulse Mode Control for the SCP/S5 are used with the SCP Rhythm System in conjunction with the Stöckert S5 System during cardiopulmonary bypass for procedures lasting six (6) hours or less.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
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 specifications and that the modified System meets user needs.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three curved lines representing the snakes and the staff, and the text is in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL -6 2007
Medical Device Consultant, Inc. c/o Ms. Rosina Robinson Principal Consultant, Regulatory Devices 49 Plain Street North Attleboro, MA 02760
Re: K071318
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: June 21, 2007 Received: June 22, 2007
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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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 vours.
Ashley B. Boane
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 for Use:
The modified S5 and the Pulse Mode Control for the SCP/S5 are used with the SCP Rhythm System in conjunction with the Stöckert S5 System 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)
Ahlee B. Evans for BDZ
of Cardiovascular Devices
510(k) Number K071318
§ 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).