(238 days)
Not Found
No
The document describes a speed control device for a centrifugal pump used in cardiopulmonary bypass. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The testing focuses on functional, safety, and software verification/validation, not on AI/ML model performance.
Yes
The device is a cardiopulmonary bypass speed control device, designed to assist the circulatory system during heart-lung procedures, which is a therapeutic intervention.
No
The device is a cardiopulmonary bypass speed control device, used for pumping blood during open-heart surgery, and does not perform diagnostic functions.
No
The device description explicitly lists multiple hardware components (Control Panel, Drive Unit, Flow Probe, Emergency Drive Unit) and mentions connections to other hardware systems (COBE Revolution Pump Head, Stöckert S3 and SC Systems). The performance studies also include electrical/mechanical safety testing, indicating hardware is a significant part of the device.
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 "cardiopulmonary bypass speed control device" used for "speed-controlled pumping through the cardiopulmonary bypass circuit". This describes a device used in vivo (within the body) during a surgical procedure, not a device used in vitro (outside the body) to examine specimens like blood or tissue.
- Device Description: The description details components like a control panel, drive unit, and flow probe, all consistent with a device used to manage blood flow during bypass surgery. It also mentions being used with a "disposable pump head" and connected to "S3 and SC Systems," which are part of a cardiopulmonary bypass setup.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Stöckert Centrifugal Pump is a medical device used for a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stockert Centrifugal Pump (SCP) is a cardiopulmonary bypass speed control device is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP 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.
The Stöckert Centrifugal Pump (SCP) is a cardiopulmonary bypass speed control device (21 CFR 870.4380) indicated for use exclusively with the COBE Revolution Pump Head, for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.
The SCP 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.
Product codes (comma separated list FDA assigned to the subject device)
DWA
Device Description
The Stöckert Centrifugal Pump, developed to address the needs of the health care marketplace, consists of the following components:
- SCP Control Panel .
- SCP Drive Unit .
- Flow Probe .
- Emergency Drive Unit .
The SCP is designed to be used exclusively with the COBE® Revolution Disposable Pump Head and in connection with Stöckert S3 and SC Systems. The power supply voltage (24 V DC) as well as the CAN Bus connection is provided through a connection cable. The SCP utilizes the battery backup power from the S3/SC System Uninterruptible Power Supply in case of mains power failure.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing submitted in this premarket notification consists of functional acceptance testing, electrical/mechanical safety (IEC60601-1), and electromagnetic compatibility (IEC60601-1-2), software verification and validation, ship testing, and battery life. Test results demonstrate that the SCP and associated software perform as intended.
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.
K991864, Medtronic Bio-Medicus BioConsole 540/550 (Multiple)
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.
Not Found
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
§ 870.4380 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).
0
FEB 0 5 2002
510(k) Summary for the Stöckert Instrumente GmbH Centrifugal Pump (SCP) K011838
1. SPONSOR
Stöckert Instrumente GmbH Lindberghstrasse 25 D80939 München Germany
Helmut Hofl, Director, Quality Assurance and Regulatory Affairs Contact: Telephone: 011 49 89 323 010 011 49 89 323 4238 Facsimile:
Date Prepared: November14, 2001
DEVICE NAME 2.
Stöckert Centrifugal Pump Proprietary Name: Common/Usual Name: Centrifugal Pump Cardiopulmonary bypass speed control device Classification Name:
PREDICATE DEVICES 3.
- Jostra RotaFlow (K991864) .
- Medtronic Bio-Medicus BioConsole 540/550 (Multiple) .
4. DEVICE DESCRIPTION
The Stöckert Centrifugal Pump, developed to address the needs of the health care marketplace, consists of the following components:
- SCP Control Panel .
- SCP Drive Unit .
- Flow Probe .
- Emergency Drive Unit .
The SCP is designed to be used exclusively with the COBE® Revolution Disposable Pump Head and in connection with Stöckert S3 and SC Systems. The power supply voltage (24 V DC) as well as the CAN Bus connection is provided through a
1
connection cable. The SCP utilizes the battery backup power from the S3/SC System Uninterruptible Power Supply in case of mains power failure.
క. INTENDED USE
The Stockert Centrifugal Pump (SCP) is a cardiopulmonary bypass speed control device is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP 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.
6. PERFORMANCE TESTING
Testing submitted in this premarket notification consists of functional acceptance testing, electrical/mechanical safety (IEC60601-1), and electromagnetic compatibility (IEC60601-1-2), software verification and validation, ship testing, and battery life. Test results demonstrate that the SCP and associated software perform as intended.
7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Stöckert Instrumente GmbH claims equivalence to cited predicate devices based on equivalence in indications for use, operational characteristics, and technological characteristics. A side-by-side comparison of the SCP to the predicate devices is provided in the table below.
| Characteristic | Stöckert
Centrifugal
Pump | Medtronic
BIO-MEDICUS
540/550 | Jostra
RotaFlow | | |
|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-------------------------------------|--------------------|--|--|
| Indications for Use: Speed controlled pumping
through the cardiopulmonary bypass circuit for
durations of six hours or less | Yes | Yes | Yes | | |
| Design | | | | | |
| Mounting System | Mast | Console | Console | | |
| Magnetic Pump Head Coupling | Yes | Yes | Yes | | |
| Communication with heart lung machine | Yes | No | Yes | | |
| Battery | Uses Battery in
HLM console | Yes | Yes | | |
| Data Output | via HLM | serial port | serial port | | |
Side-by-Side Comparison of the SCP with Cited Predicate Devices
2
| Characteristic | Stöckert
Centrifugal
Pump | Medtronic
BIO-MEDICUS
540/550 | Jostra
RotaFlow |
|-----------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------|
| Operational Specifications | | | |
| RPM Range | 0-3500 RPM | 0-4500 RPM | 0-5000 RPM |
| RPM Accuracy | $ \pm 10% $ | Not specified | $ \pm 20 RPM $ |
| RPM Display Resolution | 1 RPM | Not specified | 10 RPM |
| LPM Range | -10 LPM to +10.0
LPM | -2 to 9.99 LPM | 0 to 9.9 LPM |
| LPM Accuracy | $ \pm 10% or 0.1 $
LPM, whichever
is greater | Not specified | 0.1 LPM |
| LPM Resolution | 0.01 LPM
(Flow > 0)
0.1 LPM
(Flow Trade Name: Stöckert Centrifugal Pump Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary bypass pump speed control Regulatory Class: Class II (two) Product Code: DWA Dated: November 27, 2001 Received: November 28, 2001
Dear Mr. Höfl:
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 - Mr. Helmut Höfl
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.
Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K011838
Device Name: Stöckert Centrifugal Pump (SCP)
Indications for Use:
The Stöckert Centrifugal Pump (SCP) is a cardiopulmonary bypass speed control device (21 CFR 870.4380) indicated for use exclusively with the COBE Revolution Pump Head, for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.
The SCP 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K011838
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use