(88 days)
The Stöckert Compact System is an integrated heart-lung machine consisting of pumps, monitoring, and control elements on a single chassis. It is indicated for speed controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less, left ventricular venting, cardiotomy suction, administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the SC System.
The SC System has been qualified only for durations 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 Stöckert Compact System is a modification of the Stöckert S3 System, which integrates its components into a single chassis. There is no change to the indications for use or the fundamental technological characteristics.
The provided document, K982014, describes a Special 510(k) for a device modification of the Stöckert Compact System (SC System). A Special 510(k) is used when a modification to a legally marketed device does not alter the fundamental technology or intended use, and therefore the determination of substantial equivalence relies heavily on the equivalence to the predicate device and the validation of the modifications according to design control procedures. This type of submission typically does not involve a traditional "study" in the sense of a clinical trial or performance study with acceptance criteria being met by reported device performance against a ground truth.
Instead, the "acceptance criteria" for a Special 510(k) are typically the demonstration that the modified device remains substantially equivalent to the predicate device in terms of intended use, technological characteristics, safety, and effectiveness. The "study" proving this usually involves design validation and verification activities.
Based on the provided text, here's an analysis against your requested information:
1. Table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with reported device performance in the manner requested for a new device submission. Instead, the "acceptance criteria" are implied by the nature of a Special 510(k) and the claim of substantial equivalence.
| Acceptance Criteria (Implied for Special 510(k)) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence: The modified device (SC System) must have the same intended use as the predicate device (Stöckert S3 System). | Met: "There is no change to the indications for use..." |
| Technological Characteristics Equivalence: The modified device must have fundamentally similar technological characteristics (design and operation) to the predicate. | Met: "...no change to... the fundamental technological characteristics." and "This determination is based on equivalence in intended use and technological characteristics (design and operation)." |
| Safety and Effectiveness Equivalence: Any differences between the modified and predicate device must not raise new issues of safety or effectiveness. | Met: Stöckert Instrumente GmbH "believes that any differences between the SC and S3 Systems are minor and raise no new issues of System safety or effectiveness." |
| Design Control Validation: System modifications must be validated according to Stöckert Instrumente Design Control procedures. | Met: "System modifications have been validated according to Stöckert Instrumente Design Control procedures, in compliance with the Quality Systems Regulations." |
2. Sample size used for the test set and the data provenance
The document does not mention a "test set" in the context of a performance study with a specific sample size. The validation performed focused on the modifications to the existing S3 system. There is no information about data provenance like country of origin or retrospective/prospective nature because it's not a performance study on a new clinical dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "test set" or "ground truth" was established by experts in the context of a new performance study. The validation relates to engineering and design control processes.
4. Adjudication method for the test set
Not applicable. There was no test set requiring adjudication in the context of a performance study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a heart-lung machine, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a heart-lung machine, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate S3 System, and the demonstration that the modifications to create the SC System do not alter this. This is validated through design, engineering, and quality system procedures, not comparison to a clinical "ground truth" dataset.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
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- SEP 4 1998
510(k) Summary Special 510(k): Device Modification Stöckert Compact System (per 21 CFR 807.92)
SPONSOR/APPLICANT 1.
Stöckert Instrumente GmbH Lilienthalallee 5-7 D-80939 Munich 45, Germany
| Contact: | Helmut Höfl,Manager, Quality Assurance |
|---|---|
| Telephone: | 011 49 89 323 010 |
| Facsimile: | 011 49 89 323 4238 |
2. DEVICE NAME
| Proprietary Name: | Stöckert Compact System (SC System) |
|---|---|
| Common/Usual Name: | Heart Lung Machine |
| Classification Names: | Multiple (See Table E-1) |
Table E-1. SC System Classifications
| Classification Name | 21 CFR | ProCode |
|---|---|---|
| Cardiopulmonary bypass heart-lung console | 870.4220 | 74DTQ |
| Roller type cardiopulmonary bypass blood pump | 870.4370 | 74DWB |
| Cardiopulmonary bypass pump speed control | 870.4380 | 74DWA |
| Cardiopulmonary bypass bubble detector | 870.4205 | 74KRL |
| Cardiopulmonary bypass level sensing monitor/control | 870.4340 | 74DTW |
| Accessory to the cardiopulmonary bypass console: Temperature Monitor | 870.4220 | 74DTQ |
| Accessory to the cardiopulmonary bypass console: Timer | 870.4220 | 74DTQ |
| Cardiopulmonary bypass coronary pressure gauge | 870.4310 | 74DXS |
| Optional SC System Accessories | ||
| Venous Line Clamp (Class I and Exempt) | 870.4200 | 74KRI |
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PREDICATE DEVICES 3.
Stöckert S3 System Modules: Multiple 510(k) Numbers
INTENDED USE 4.
The Stöckert Compact System is an integrated heart-lung machine consisting of pumps, monitoring, and control elements on a single chassis. It is indicated for speed controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less, left ventricular venting, cardiotomy suction, administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the SC System.
The SC System has been qualified only for durations 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.
DEVICE DESCRIPTION 5.
The Stöckert Compact System is a modification of the Stöckert S3 System, which integrates its components into a single chassis. There is no change to the indications for use or the fundamental technological characteristics.
BASIS FOR DETERMINATION OF EQUIVALENCE 6.
The Stöckert Compact System is a modification of the Stöckert S3 System and is therefore substantially equivalent to the S3 System. This determination is based on equivalence in intended use and technological characteristics (design and operation). System modifications have been validated according to Stöckert Instrumente Design Control procedures, in compliance with the Quality Systems Stöckert Instrumente GmbH also believes that any differences Regulations. between the SC and S3 Systems are minor and raise no new issues of System safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized profiles facing to the right.
SEP 4 1998
STÖCKERT INSTRUMINTE c/o Ms. Rosina Robinson Senior Staff Consultant Medical Device Consultant, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K982014 Stöckert Compact System Requlatory Class: II Product Code: DTQ Dated: August 4, 1998 Auqust 5, 1998 Received:
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 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). 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 requlation 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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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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/dsma/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
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510(k) Number (if known): K982014
Device Name: Stöckert Compact System
Indications For Use:
The SC System is an integrated heart lung machine consisting of pumps and monitoring and control elements on a single chassis. It is indicated for speed controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less, left ventricular venting, cardiotomy suction, administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the SC System.
The SC System has been qualified only for durations 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bera L. Campbell
Division Sign-Off
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
Stöckert Instrumente GmbH ୧/૨/૭૪ CONFIDENTIAL Stöckert Compact System Special 510(k): Device Modification Page vi
§ 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).