(258 days)
Not Found
No
The document describes a standard medical device for temperature control during surgery and does not mention any AI or ML components or functionalities.
Yes
The device is intended to warm or cool a patient during medical procedures, directly affecting their physiological state for therapeutic purposes.
No
The device is a heater-cooler system used to warm or cool a patient during cardiopulmonary bypass procedures; it does not diagnose a condition or disease.
No
The device description clearly lists hardware components such as the heater-cooler base unit, water connectors, and cables, indicating it is a physical system, not software only.
Based on the provided information, the Stöckert Heater-Cooler System 3T is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to provide temperature-controlled water to heat exchanger devices to warm or cool a patient during cardiopulmonary bypass procedures. This is a direct interaction with the patient's body (indirectly through heat exchangers and blankets), not the analysis of samples taken from the body.
- Device Description: The description details a system that circulates temperature-controlled water. There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Stöckert Heater-Cooler System 3T's function is to regulate patient temperature during a medical procedure, which falls under the category of therapeutic or supportive medical devices, not diagnostics.
N/A
Intended Use / Indications for Use
The Stöckert Heater-Cooler System 3T is intended to provide temperature-controlled water to heat exchanger devices (cardiopulmonary bypass heat exchangers, cardioplegia heat exchangers, and thermal regulating blankets) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less.
The Stöckert Heater-Cooler System 3T is used with a Stöckert S3 heart-lung machine and/or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
Product codes (comma separated list FDA assigned to the subject device)
DWC
Device Description
The Sorin Group Deutschland GmbH Stöckert Heater-Cooler System 3T consists of standard and optional components. The standard components comprise the heater-cooler base unit, water connectors, CAN-connecting cable for the S3 System, potential equalization cable, and Operating Instructions. Patient blankets used with the System are already legally marketed in the United States.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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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 demonstrates that the Stockert Heater-Cooler System 3T complies with specifications, meets user requirements, and the differences between the proposed device and cited predicate devices do not raise new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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
§ 870.4250 Cardiopulmonary bypass temperature controller.
(a)
Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.(b)
Classification. Class II (performance standards).
0
L052601
Traditional 510(k) Premarket Notification 510(k) Summary Sorin Group Deutschland GmbH, Stöckert Heater-Cooler System 3T
1. SUBMITTER/HOLDER
Sorin Group Deutschland GmbH Lindberghstrasse 25 80939 Munich Germany
Contact: Helmut Hofl, Director, Quality Assurance and Regulatory Affairs Telephone: 011 49 89 323 010
Date Prepared: September 19, 2005
2. DEVICE NAME
Proprietary Name: Stöckert Heater-Cooler System 3T Common/Usual Name: Heater-Cooler Classification Name: Cardiopulmonary bypass temperature controller
3. PREDICATE DEVICE
- . Cincinnati Subzero Hemotherm (CSZ Hemotherm) (K811742)
- . Alpha Omega, Inc. Dual2 Cooler-Heater (K.001520)
- . Jostra AB Heater-Cooler Unit 30 (K031544)
4. DEVICE DESCRIPTION
The Sorin Group Deutschland GmbH Stöckert Heater-Cooler System 3T consists of standard and optional components. The standard components comprise the heater-cooler base unit, water connectors, CAN-connecting cable for the S3 System, potential equalization cable, and Operating Instructions. Patient blankets used with the System are already legally marketed in the United States.
1
5. INTENDED USE
The Stöckert Heater-Cooler System 3T is intended to provide temperature-controlled water to heat exchanger devices (cardiopulmonary bypass heat exchangers, cardioplegia heat exchangers, and thermal regulating blankets) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Sorin Group Deutschland GmbH bases the claim of substantial equivalence of the Stöckert Heater-Cooler System 3T to the cited predicate devices based on equivalence in intended use, fundamental technological and operational characteristics. Testing submitted in this premarket notification demonstrates that the Stockert Heater-Cooler System 3T complies with specifications, meets user requirements, and the differences between the proposed device and cited predicate devices do not raise new issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2006
Sorin Group Deutschland GmbH c/o Ms. Rosina Robinson Principal Consultant, Regulatory Services 49 Plain Street North Attleboro, MA 02760
Re: K052601 Stockert Heater-Cooler System 3T Regulation Number: 21 CFR 870.4250 Regulation Name: Cardiopulmonary Bypass Temperature Controller Regulatory Class: Class II Product Code: DWC Dated: May 15, 2006 Received: May 16, 2006
Dear Ms. Robinson:
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.
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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 (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
.. : :
Sincerely yours,
ina R. Holmes
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K052601 510(k) Number:
Stöckert Heater-Cooler System 3T Device Name:
Indications for Use:
The Stöckert Heater-Cooler System 3T is used with a Stöckert S3 heart-lung machine and/or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 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)
uma R. Varlmer
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K052601