(97 days)
The Stöckert Centrifugal Pump Plus System (SCP Plus) is a cardiopulmonary bypass speed control device (21 CFR 870.4380) that is indicated for use with the COBE Revolution Pump Head/Dideco Synergy/ECC.O for speed-controlled pumping through a cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP Plus is intended to be used with the S3 or S5 System and the Stöckert Air Purge Control (APC) System.
The SCP Plus has been qualified only for typical durations of six hours or less, appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies for long-term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.
The modified Stöckert Centrifugal Pump System (referred to as the SCP Plus) is an optional accessory to the S3 or S5 System, a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.
This is a 510(k) summary for a medical device called the "Stöckert Centrifugal Pump Plus System (SCP Plus)". This document describes a medical device and its intended use, but it does not contain the kind of detailed information about acceptance criteria and a study proving those criteria that you've requested.
Specifically, the document states:
- "Testing of the Stöckert Centrifugal Pump Plus System has demonstrated that the System continues to fulfill prospectively defined performance criteria and that the modified System meets user needs."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods for establishing ground truth.
- Details on an MRMC comparative effectiveness study or any effect size.
- Information on a standalone (algorithm only) study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device ("Stöckert Centrifugal Pump System") rather than providing a detailed performance study with specific acceptance criteria and results. For such detailed information, one would typically need to refer to the full 510(k) submission, which is not publicly available in this summarized form.
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JUL 1 5 2009
510(k) Summary (Per 21 CFR 807.92) Stöckert Centrifugal Pump System
1. SPONSOR
Sorin Group Deutschland GmbH Lindberghstrasse 25 80939 Munich Germany Contact Person: Helmut Höfl 011 49 89 323 010 Telephone:
Date Prepared: July 7, 2009
2. DEVICE NAME
| Proprietary Name: | Stöckert Centrifugal Pump Plus System (SCP Plus) |
|---|---|
| Common/Usual Name: | Centrifugal pump system |
| Classification Name: | Cardiopulmonary bypass speed control device |
3. PREDICATE DEVICES
Stöckert Centrifugal Pump System
4. DEVICE DESCRIPTION
The modified Stöckert Centrifugal Pump System (referred to as the SCP Plus) is an optional accessory to the S3 or S5 System, a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.
5. INTENDED USE/INDICATIONS FOR USE
The Stöckert Centrifugal Pump Plus System (SCP Plus) is a cardiopulmonary bypass speed control device (21 CFR 870.4380) that is indicated for use with the COBE Revolution Pump Head/Dideco Synergy/ECC.O for speed-controlled pumping through a cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP Plus is intended to be used with the S3 or S5 System and the Stöckert Air Purge Control (APC) System.
510(k) Summary Page 1 of 2
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The SCP Plus has been qualified only for typical durations of six hours or less, appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies for long-term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The modified Stöckert Centrifugal Pump System (referred to as the SCP Plus) is an upgrade of the parent SCP System. The modified SCP System is substantially equivalent to the parent SCP System based on intended use, indication for use, operational characteristics, and fundamental technological characteristics.
7. PERFORMANCE TESTING
Testing of the Stöckert Centrifugal Pump Plus System has demonstrated that the System continues to fulfill prospectively defined performance criteria and that the modified System meets user needs.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2009
Sorin Group Deutschland Gmbh c/o Ms. Rosina Robinson Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K091008
Stockert Centrifugal Pump Plus System (SCP Plus), models 60-00-10, 60-00-55 Regulation Number: 21 CFR 870.4380 Regulation Name: Control, pump speed, cardiopulmonary bypass Regulatory Class: Class II (two) Product Code: DWA Dated: July 7, 2009 Received: July 8, 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 (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,
R. Vahner
Image /page/3/Picture/5 description: The image shows a signature on the left and the letters B, D, and D on the right. The signature is illegible, but it appears to be written in cursive. The letters B, D, and D are written in a simple, sans-serif font. The image is likely a scan or photograph of a document.
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): Kog1008
Stöckert Centrifugal Pump Plus System Device Name:
Indications for Use:
The Stöckert Centrifugal Pump Plus System (SCP Plus) is ದ cardiopulmonary bypass speed control device (21 CFR 870.4380) that is indicated for use with the COBE Revolution Pump Head/Dideco Synergy/ECC.O for speed-controlled pumping through a cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP Plus is intended to be used with the S3 or S5 System and the Stöckert Air Purge Control (APC) System.
The SCP Plus has been qualified only for typical durations of six hours or less, appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies for long-term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.
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)
Duma R Vchmer
ion of Cardiovascular Devices
limber 2091008
Sorin Group Deutschland GmbH July 7, 2009 FDA Request for Additional Information for K091008 Stockert Centrifugal Pump Plus System (SCP Plus)
Indications for Use Statement Page 1 of 1
§ 870.4380 Cardiopulmonary bypass pump speed control.
(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).