(249 days)
The Stockert S3 Mast Pump is a modular component of the Stockert S3 Perfusion System. The S3 Mast Pump is intended to provide speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of normally six hours or less, left ventricular venting, cardiotomy suction, or the administration of cardioplegia solution, when used by a qualified perfusionsist who is experienced in the operation of the S3 System.
The Stockert S3 (cardiopulmonary bypass) Mast Pump Module is intended for use during cardiopulmonary bypass surgery. The S3 Mast Pump Module is a component of the Stockert S3 Perfusion System, and is intended to provide speed controlled pumping of fluid through the cardiopulmonary bypass circuit, left ventricular venting, cardiotomy suction, or the administration of cardioplegia solution. The predicate and predecessor device to the S3 Mast Pump Module is the S3 Double Head Pump Module. The S3 Mast Pump has the same double head pump design and intended use as the S3 Double Head Pump Module(K955038). The basic difference between these two double head pumps is that for the Mast Pump, the pump heads are mounted on the mast of an S3 Mast Pump Extension Unit, and the control/operating unit is placed on a swivel plate on the console, whereas for the standard 69 double head pump module, the control unit is mounted directly over the pump theads and the entire module is installed on the S3 Console Base. The Mast Pump configuration enables the perfusionist to position the pump heads in close proximity to the patient, thus reducing the length of tubing required for the extracorporeal blood circuit and the associated priming volume required. This option is useful in clinical situations where it is important to minimize the amount of tubing in the circuit, e.g. infant perfusion.
The provided 510(k) summary for the Stöckert S3 Perfusion System Mast Pump Module does not include acceptance criteria or a study demonstrating device performance against such criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device (S3 Double Head Pump Module) and outlines the device's description, intended use, and conformity to general safety standards (IEC 601, IEC 62a, and UL 544).
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance from the provided text.
Here's why the requested information isn't present:
- No Acceptance Criteria: The document does not define specific performance metrics, thresholds, or pass/fail criteria for the device.
- No Performance Study Details: While it mentions "extensive testing results characterizing device performance and software verification and validation," it does not provide any details about these studies, such as:
- The specific tests performed.
- The results of those tests.
- The methodologies used.
- Any comparison to acceptance criteria.
- Sample sizes, ground truth establishment, or expert involvement.
In summary, the provided text describes the device and its regulatory status, but lacks the detailed performance study information required to answer your specific questions.
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510(k) Summary STÖCKERT S3 PERFUSION SYSTEM MAST PUMP MODULE
FEB 2 7 1998
| 1. | Date Prepared: | June 20, 1997 |
|---|---|---|
| 2. | Submitter: | Stöckert Instrumente, GmbHLilienthalallee 5-7D-80939 Munich, Germany |
| 3. | Contact: | Helmut Höfl011-49-89-32301-0 |
| 4. | Device Name: | Stöckert S3 Perfusion SystemMast Pump Module |
| 5. | Device Classification: | Cardiopulmonary bypass roller-type pumps havebeen classified as Class II devices in21 CFR 870.4370 (Product Code: 74 DWB). |
. 6. Device Description and Comnarison to Predicate Products:
The Stockert S3 (cardiopulmonary bypass) Mast Pump Module is intended for use during cardiopulmonary bypass surgery. The S3 Mast Pump Module is a component of the Stockert S3 Perfusion System, and is intended to provide speed controlled pumping of fluid through the cardiopulmonary bypass circuit, left ventricular venting, cardiotomy suction, or the administration of cardioplegia solution. The predicate and predecessor device to the S3 Mast Pump Module is the S3 Double Head Pump Module. The S3 Mast Pump has the same double head pump design and intended use as the S3 Double Head Pump Module(K955038). The basic difference between these two double head pumps is that for the Mast Pump, the pump heads are mounted on the mast of an S3 Mast Pump Extension Unit, and the control/operating unit is placed on a swivel plate on the console, whereas for the standard 69 double head pump module, the control unit is mounted directly over the pump theads and the entire module is installed on the S3 Console Base. The Mast Pump configuration
Stöckert S3 Mast Pump 510(k)
- 如上一
June 20, 1997
Page F-1
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enables the perfusionist to position the pump heads in close proximity to the patient, thus reducing the length of tubing required for the extracorporeal blood circuit and the associated priming volume required. This option is useful in clinical situations where it is important to minimize the amount of tubing in the circuit, e.g. infant perfusion.
Information supplied in this premarket notification to support a determination of substantial equivalence for this device included descriptive information about the design, materials, and intended use of the device, as well as extensive testing results characterizing device performance and software verification and validation.
The Stöckert S3 Perfusion System console and modular components (including the Mast Pump Module) conform with the applicable requirements of IEC 601, IEC 62a, and UL 544.
Stöckert S3 Mast Pump 510(k)
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Image /page/2/Picture/2 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus-like symbol with three wavy lines emanating from a central point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 27 1990
Stöckert Instrumente GmbH c/o Ms. Rosina Robinson Senior Staff Consultant Medical Device Consultant, Inc. 49 Plain Street North Attleboro, MA 02760
K972321 Re: Stöckert S3 Mast Pump Regulatory Class: II (Two) Product Code: 74 DWB Dated: January 22, 1998 Received: January 23, 1998
Dear Ms. Robinson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: ------General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Rosina Robinson
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): __ K972321
Device Name: __ Stöckert S3 Mast Pump Module
Indications For Use:
The Stockert S3 Mast Pump is a modular component of the Stockert S3 Perfusion System. The S3 Mast Pump is intended to provide speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of normally six hours or less, left ventricular venting, cardiotomy suction, or the administration of cardioplegia solution, when used by a qualified perfusionsist who is experienced in the operation of the S3 System.
(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NECESSARY)
Conourronoc of CDRH, Office of Device Evaluation (ODE)
Aexa R. Lamperle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
K 442321 510(k) Number __
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 870.4370 Roller-type cardiopulmonary bypass blood pump.
(a)
Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.(b)
Classification. Class II (performance standards).