(86 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard monitoring of physiological parameters.
No.
The device is described as an "accessory" used for "monitoring oxygen saturation, hematocrit, and temperature." It does not provide treatment or directly affect physiological function, which are characteristics of a therapeutic device.
Yes
Explanation: The device is used to "monitor oxygen saturation, hematocrit, and temperature in the venous blood circuit during cardiopulmonary bypass," and it is "exclusively for determining oxygen saturation, hematocrit value, and temperature in the venous blood circuit." This indicates it gathers information about the patient's physiological state to aid in diagnosis or monitoring.
No
The device is described as an "optional accessory" and a "component part" of the Stöckert S5 System, which is a modular system consisting of hardware components like a console, pumps, monitors, and displays. The description of testing includes "hardware, software, and performance," indicating the B-Cares is not solely software.
Based on the provided information, the Sorin B-Cares is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The B-Cares is described as monitoring parameters in the venous blood circuit during cardiopulmonary bypass. While it interacts with blood, it's doing so within a closed extracorporeal circuit, not analyzing a collected specimen for diagnostic purposes in the traditional sense of an IVD.
- The intended use is monitoring during a medical procedure. The primary purpose is to provide real-time data about the blood's condition within the bypass circuit to the perfusionist, aiding in the management of the procedure. This is distinct from using a sample to diagnose a disease or condition.
- It's an accessory to a cardiopulmonary bypass system. The Stöckert S5 System is a device used for supporting circulation during surgery. The B-Cares is an integrated component of this system, not a standalone device for analyzing samples.
While the B-Cares measures parameters like oxygen saturation and hematocrit, which are also measured by some IVDs, the context of its use within the cardiopulmonary bypass circuit and its function as a monitoring tool during a procedure places it outside the typical definition of an IVD.
N/A
Intended Use / Indications for Use
The Sorin B-Cares is an optional accessory to the Stöckert S5 System and is intended to be used to monitor oxygen saturation, hematocrit, and temperature in the venous blood circuit during cardiopulmonary bypass. The Sorin B-Cares cannot be used independently and shall only be used with the Stöckert S5 System Console. The Stöckert S5 is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S5 System.
The B-Cares is intended for use as a component part of the Stöckert S5 System during cardiopulmonary bypass for procedures up to six hours. B-Cares is used exclusively for determining oxygen saturation, hematocrit value, and temperature in the venous blood circuit.
Product codes
DTQ
Device Description
The Stöckert S5 System is a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces. This premarket notification adds the B-Cares. The B-Cares is used for determining oxygen saturation, hematocrit, and temperature in the venous blood circuit.
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
qualified perfusionist who is experienced in the operation of the S5 System.
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)
Testing of the modified Stöckert S5 System (hardware, software, and performance) has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K092Y63
NOV - 5 2009
510(k) Summary (per 21 CFR 807.92) Addition of the Sorin B-Cares to the Stockert S5 System
1. SPONSOR
Sorin Group Deutschland GmbH Lindberghstrasse 25 80939 Munich Germany Contact Person: Renate Goebert Telephone: 011 49 89 323 010
Date Prepared: August 10, 2009
2. DEVICE NAME
| Proprietary Name: | Stöckert S5 System, Sorin B-Care₅ |
|---|---|
| Common/Usual Name: | Heart lung machine, on-line venous blood gas monitor |
| Classification Name: | Multiple |
3. PREDICATE DEVICES
Parent Device: S5 System Predicate Device (for monitoring of saturation, hematocrit, and temperature): Dideco Data Master (K001388)
4. DEVICE DESCRIPTION
The Stöckert S5 System is a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces. This premarket notification adds the B-Cares. The B-Cares is used for determining oxygen saturation, hematocrit, and temperature in the venous blood circuit.
5. INTENDED USE/INDICATIONS FOR USE
The Sorin B-Cares is an optional accessory to the Stöckert S5 System and is intended to be used to monitor oxygen saturation, hematocrit, and temperature in the venous blood circuit during cardiopulmonary bypass. The Sorin B-Cares cannot be used independently and shall only be used with the Stöckert S5 System Console. The Stöckert S5 is indicated
1
for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S5 System.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The modified Stöckert S5 System is an upgrade of the parent Stöckert S5 System with the addition of the optional Sorin B-Cares. The modified Stockert S5 System is substantially equivalent to the parent Stöckert S5 System based on intended use, indication for use, operational characteristics, and fundamental technological characteristics. The performance specifications for the measurements performed by the Stöckert B-Cares are substantially equivalent to those of the Dideco Data Master.
7. PERFORMANCE TESTING
Testing of the modified Stöckert S5 System (hardware, software, and performance) has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 5 2009
Sorin Group Deutschland Gmbh c/o Medical Device Consultants, Inc. Ms. Rosina Robinson 49 Plain St. North Attleboro, MA 02760
Re: K092463
Trade/Device Name: Sorin B-Care5 for the Stockert S5 System Regulation Number: 21 CFR 870.4220 Regulation Name: Console, Heart-Lung Machine, Cardiopulmonary bypass Regulatory Class: Class II Product Code: DTQ Dated: August 10, 2009 Received: August 11, 2009
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.
3
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Dona R. Ladner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Sorin B-Cares for the Stockert S5 System Device Name:
Indications for Use:
The B-Cares is intended for use as a component part of the Stöckert S5 System during cardiopulmonary bypass for procedures up to six hours. B-Cares is used exclusively for determining oxygen saturation, hematocrit value, and temperature in the venous blood circuit.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dmah D. Varner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K0924 6.3
CONFIDENTIAL