(22 days)
Not Found
No
The summary describes firmware and software modifications for cyclic control of blood delivery, but there is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML.
No
The device is described as an accessory to the S3 Cardiopulmonary Bypass Console, which delivers blood during cardiopulmonary bypass. While cardiopulmonary bypass itself is a therapeutic procedure, the SCP Rhythm is an accessory that controls the delivery of blood rather than directly performing a therapeutic function on the patient. It's a control module for an existing therapeutic system, not a therapeutic device in itself.
No
This device is an accessory to a cardiopulmonary bypass console, used for cyclically controlled delivery of blood. It does not perform any diagnostic functions like measuring, analyzing, or interpreting physiological data to identify a disease or condition. Its purpose is to assist in a treatment procedure.
No
The device is described as a modification to an existing hardware module (S3 Cyclic RPM Control Module) and is intended for use with a hardware console (S3 Cardiopulmonary Bypass Console). While it includes software and firmware modifications, it is not solely software; it is an accessory to a hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory to a cardiopulmonary bypass console for delivering blood during bypass. This is a direct interaction with the patient's circulatory system during a surgical procedure, not an in vitro test performed on a sample outside the body.
- Device Description: The description reinforces its role as a modification to a component of a cardiopulmonary bypass system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical control of blood flow.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Stöckert SCP Rhythm is an accessory to the S3 Cardiopulmonary Bypass Console that allows for cyclically controlled delivery of blood with the Stöckert SCP during cardiopulmonary bypass for periods of up to six hours.
Product codes (comma separated list FDA assigned to the subject device)
DWA
Device Description
The Stöckert SCP Rhythm is a modification of the S3 Cyclic RPM Control Module. The modifications consist of two changes: ( 1 ) a change to the artwork of the display panel to show SCP Rhythm rather than Cyclic RPM Control and (2) firmware and software modifications. No modifications are being made to the hardware or electronics of any of the components. The Stöckert SCP Rhythm is intended for use with the SCP System as mounted on an S3 Cardiopulmonary Bypass Console.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Stöckert Instrumente GmbH has verified and validated the device modifications and has demonstrated, through the testing provided in the 510(k), that the Stöckert SCP Rhythm complies with specifications, meets user requirements, and the differences between the parent and the proposed device do not raise new issues of safety or effectiveness.
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.
Stöckert S3 Cyclic RPM Control Module (K971520)
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
SEP 2 3 2004
04237
Special 510(k): Device Modification 510(k) Summary for Stöckert SCP Rhythm
1. SPONSOR
Stöckert Instrumente GmbH Lindberghstrasse 25 80939 Munich Germany
Helmut Hofl, Director, Quality Assurance and Regulatory Affairs Contact: Telephone: 011 49 89 323 010 011 49 89 323 01100 Facsimile:
Date Prepared: August 31, 2004
2. DEVICE NAME
Stöckert SCP Rhythm Proprietary Name: Common/Usual Name: Cyclic RPM Control Accessory to cardiopulmonary bypass console Classification Name:
3. PREDICATE DEVICE
Stöckert S3 Cyclic RPM Control Module (K971520)
4. DEVICE DESCRIPTION
The Stöckert SCP Rhythm is a modification of the S3 Cyclic RPM Control Module. The modifications consist of two changes: ( 1 ) a change to the artwork of the display panel to show SCP Rhythm rather than Cyclic RPM Control and (2) firmware and software modifications. No modifications are being made to the hardware or electronics of any of the components. The Stöckert SCP Rhythm is intended for use with the SCP System as mounted on an S3 Cardiopulmonary Bypass Console.
1
న. INTENDED USE
The Stockert SCP Rhythm is an accessory to the S3 Cardiopulmonary Bypass Console that allows for cyclically controlled delivery of blood with the Stöckert SCP during cardiopulmonary bypass for periods of up to six hours.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The proposed Stöckert SCP Rhythm is identical in intended use and fundamental scientific technology to the parent Stöckert S3 Cyclic RPM Control. The differences between the proposed and parent device are limited to the display panel and firmware/software. Stöckert Instrumente GmbH has verified and validated the device modifications and has demonstrated, through the testing provided in the 510(k), that the Stöckert SCP Rhythm complies with specifications, meets user requirements, and the differences between the parent and the proposed device do not raise new issues of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/10 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 that resembles three stylized human figures or waves.
Public Health Service
SEP 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Device Consultants, Inc. c/o Ms. Rosina Robinson Senior Staff Consultant 49 Plain Street North Attleborn, MA 02760
Re: K042374 Stöckett SCP Rhythm Regulation Number: 21 CFR 870.9380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: Class II (two) Product Code: DWA Dated: August 31, 2004 Received: September 1, 2004
Dear Ms. Robinson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosule) to trgans actment date of the Medical Device Amendments, or to commerce pror to thay 2017 3, in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains of the Act include requirements for annual registration, listing of general controlly proficions or actice, 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 If your device is classified (600 a00 rols. Existing major regulations affecting your device can may be subject to back adder and Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
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 (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), 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) you may obtain. 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,
onner R. Vochner
Image /page/3/Picture/5 description: The image shows a signature. The signature is illegible, but it appears to be written in cursive. The signature is black and is on a white background. The signature is small and compact.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Ko 42 3 7 4
Device Name: Stöckert SCP Rhythm
Indications for Use:
The Stöckert SCP Rhythm is an accessory to the S3 Cardiopulmonary Bypass Console that allows for cyclically controlled delivery of blood with the Stöckert SCP during cardiopulmonary bypass for periods of up to six hours.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Wchines
(Division Sign-Off) (Division Sign-on)
Division of Cardiovascular Devices
510(K) Number Kodz 274