(214 days)
No
The summary describes a software-controlled pump console that monitors standard physiological parameters. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a "cardiopulmonary bypass device" used for "pumping through the cardiopulmonary bypass circuit." While it assists in a medical procedure, its primary role is to manage blood flow during surgery, not to directly treat a disease or condition itself.
No
The device is described as a "cardiopulmonary bypass device" designed for "speed-controlled pumping" and "monitoring the cardiopulmonary bypass circuit." While it monitors parameters like pressure and temperature, its primary function is therapeutic (pumping blood during bypass), not diagnostic (identifying or characterizing disease).
No
The device description explicitly states it contains an uninterruptable power supply (UPS) and S3 Sensor Modules, which are hardware components. It also mentions providing electrical power and setting operational parameters for a control panel and drive unit. The performance studies section also mentions hardware testing.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "software-controlled cardiopulmonary bypass device" designed for "speed-controlled pumping through the cardiopulmonary bypass circuit." This describes a device used during a medical procedure to support physiological function, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description focuses on providing power, setting operational parameters for a pump, and monitoring physiological parameters (pressure, temperature, level, time) within the cardiopulmonary bypass circuit. These are all functions related to supporting the patient during surgery, not performing diagnostic tests on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
Therefore, the Stöckert Centrifugal Pump Console (SCPC System) is a medical device used for cardiopulmonary bypass, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SCPC System is a software-controlled cardiopulmonary bypass device containing an uninterruptable power supply (UPS) and S3 Sensor Modules that is designed for operation of the Stöckert Centrifugal Pump and monitoring the cardiopulmonary bypass circuit. The SCPC System, in combination with the Stöckert Centrifugal Pump and the COBE Revolution Pump Head, is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.
The SCPC 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.
Product codes (comma separated list FDA assigned to the subject device)
74DTQ, 74KRL, 74DTW, 74DXS
Device Description
The SCPC System provides electrical power and sets specific operational parameters for the Stöckert Centrifugal Pump Control Panel and Drive Unit described in K011838. The SCPC System also monitors the following parameters of the cardiopulmonary bypass circuit:
. Pressure
Temperature.
Level monitoring/bubble detection.
Elapsed time.
The SCPC System provides procedural flexibility for use of the Stöckert Centrifugal Pump, allowing the pump to be used as a component of other legally marketed heartlung machine consoles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiopulmonary bypass circuit
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety and electromagnetic compatibility testing was performed to demonstrate conformance with the appropriate standards. Functional acceptance testing, hardware and software testing, and validation testing was performed to confirm that the proposed SCPC System performed as designed and met user requirements, including compatibility with the Stöckert CAPS (K863541), Stöckert S3, and COBE® Century™ (K960974) heart-lung machine (HLM) consoles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Medtronic Bio-Console 540/550, RotaFlow Centrifugal Pump System (K991864), Himex Centriflow Centrifugal Perfusion Pump System (K972740), Stöckert Compact System (K982014)
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP 2 3 2002
510(k) Summary for Stöckert Centrifugal Pump Console
1. SPONSOR
Stöckert Instrumente GmbH Lindberghstrasse 25 80939 Munich, Germany
Contact: Helmut Hofl, Director, Quality Assurance and Regulatory Affairs 011 49 89 323 010 Telephone: 011 49 89 323 01100 Facsimile:
Date Prepared: July 9, 2002
2. Device Name
Proprietary Name: Stöckert Centrifugal Pump Console Common/Usual Name: Cardiopulmonary bypass device Classification Name: Multiple (see Table 1)
Table G-1. SCPC System Classifications
| Classification Name | 21 CFR | ProCode | Classification |
|---|---|---|---|
| Cardiopulmonary bypass heart-lung console | 870.4220 | 74DTQ | Class II |
| Cardiopulmonary bypass bubble detector | 870.4205 | 74KRL | Class II |
| Cardiopulmonary bypass level sensing monitor/control | 870.4340 | 74DTW | Class II |
| Accessory to the cardiopulmonary bypass console: | |||
| Temperature Monitor | 870.4220 | 74DTQ | Class II |
| Accessory to the cardiopulmonary bypass console: Timer | 870.4220 | 74DTQ | Class II |
| Cardiopulmonary bypass coronary pressure gauge | 870.4310 | 74DXS | Class II |
Predicate Devices 3.
- . Medtronic Bio-Console 540/550 (Multiple)
- RotaFlow Centrifugal Pump System (K991864) ●
- Himex Centriflow Centrifugal Perfusion Pump System (K972740) ●
- Stöckert Compact System (K982014) ●
1
Device Description 4.
The SCPC System provides electrical power and sets specific operational parameters for the Stöckert Centrifugal Pump Control Panel and Drive Unit described in K011838. The SCPC System also monitors the following parameters of the cardiopulmonary bypass circuit:
- . Pressure
- Temperature .
- Level monitoring/bubble detection .
- Elapsed time .
The SCPC System provides procedural flexibility for use of the Stöckert Centrifugal Pump, allowing the pump to be used as a component of other legally marketed heartlung machine consoles.
న. INTENDED USE
The SCPC System is a software-controlled cardiopulmonary bypass device containing an uninterruptable power supply (UPS) and S3 Sensor Modules that is designed for operation of the Stöckert Centrifugal Pump and monitoring the cardiopulmonary bypass circuit. The SCPC System, in combination with the Stöckert Centrifugal Pump and the COBE Revolution Pump Head, is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.
The SCPC 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.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The proposed SCPC System is identical in intended use and fundamental scientific technology to the cited predicate devices. Both the proposed SCPC System and the predicate devices provide electrical power and set operational parameters of connected pump(s) and monitor critical parameters of the cardiopulmonary bypass procedure. The differences between the proposed and predicate devices are limited to features that raise no new issues of safety or effectiveness.
2
7. PERFORMANCE TESTING
Electrical safety and electromagnetic compatibility testing was performed to demonstrate conformance with the appropriate standards. Functional acceptance testing, hardware and software testing, and validation testing was performed to confirm that the proposed SCPC System performed as designed and met user requirements, including compatibility with the Stöckert CAPS (K863541), Stöckert S3, and COBE® Century™ (K960974) heart-lung machine (HLM) consoles.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird in flight, composed of three curved lines that also suggest human profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 2002
Stöckert Instrumente GmbH Cynthia J. M. Nolte, Ph.D., RAC Staff Consultant c/o Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K020571 Stöckert Centrifugal Pump Console Regulation Number: 870.4360 Regulation Name: Nonroller-type cardiopulmonary bypass blood pump Regulatory Class: Class II (two) Product Code: DTQ Dated: July 9, 2002 Received: July 11, 2002
Dear Ms. Nolte:
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.
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
4
Page 2 - Cynthia J. M. Nolte, Ph.D., RAC
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Bram D/ Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: Stöckert Centrifugal Pump Console
Indications for Use:
The Stöckert Centrifugal Pump Console (SCPC System) is a software-controlled cardiopulmonary bypass device containing an uninterruptable power supply (UPS) and S3 Sensor Modules that is designed for operation of the Stöckert Centrifugal Pump (SCP) and monitoring the cardiopulmonary bypass circuit. The SCPC System, in combination with the SCP and the COBE Revolution Pump Head, is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.
The SCPC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through 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)
Division of Cardiovascular & Resr
510(k) Number K02057 devices
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use -------
(Optional Format 1-2-96)
February 20, 2002