The B-Cares is intended for use as a component part of or optional accessory to the Stöckert S5 system (or any compatible system using the S5 firmware versions of 3.0 or greater), during cardiopulmonary bypass for procedures up to six hours. The B-Cares is used exclusively for determining oxygen saturation, hematocrit value and temperature in the venous blood circuit.

Device Description

The Sorin B-Cares described in this 510(k) Premarket Notification is identical to the device that was cleared under K092463 and uses the same in-line sensors cleared under K001388. When switched on, the Sorin B-Cares progresses from warm-through initialization . self test while resting on the holder. When self test is successful, Sat- (venous saturation) and Hct- (hematocrit) values are displayed. The sensor is then mounted on the disposable connector in the extra-corporal circuit. The B-Cares alerts (alarms or warns) the user if laboratory reference values have not been stored for venous O2 saturation and hematocrit. The Sorin B-Cares monitors blood values via the sensor head with two LED sources and a receiver in contact with the optical window integrated into the venous connectors. Temperatures are monitored using thermistors in the venous probes. The technology of the Sorin B-Cares is based on the technology of the Dideco Data Master (Sorin Group Italia is the parent company of Sorin Group Deutschland GmbH and was formerly known as Dideco). The B-Cares is used for determining oxygen saturation, hematocrit, and temperature in the venous blood circuit.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Sorin B-Cares device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide a direct table of specific, quantitative acceptance criteria for parameters like accuracy or resolution of oxygen saturation, hematocrit, and temperature. Instead, it refers to the device meeting "prospectively defined performance criteria" and being "within clinically relevant ranges."

However, it does compare some specifications to the predicate device (Dideco Data Master). While not explicit acceptance criteria, these comparisons highlight the device's performance characteristics.

Performance Characteristic	Acceptance Criteria (Implied/Compared)	Reported Device Performance (Sorin B-Cares)
Saturation Resolution	Identical to Dideco Data Master	Identical to Dideco Data Master
Saturation Accuracy	Identical to Dideco Data Master	Identical to Dideco Data Master
Hematocrit Resolution	Identical to Dideco Data Master	Identical to Dideco Data Master
Temperature Resolution	Identical to Dideco Data Master	Identical to Dideco Data Master
Saturation Range	Wide enough for perfusionist to operate and detect parameters at lower and higher levels (wider than Dideco Data Master's 40%-100%)	0%-100% (Wider than predicate)
Hematocrit Range	Wide enough for perfusionist to operate and detect parameters at lower and higher levels (wider than Dideco Data Master's 15%-50%)	0% to 100% (Wider than predicate)
Temperature Range	Wide enough for perfusionist to operate and detect parameters at lower and higher levels (wider than Dideco Data Master's 10°C to 45°C)	0°C to 50°C (Wider than predicate)
Safety	Compliance with IEC60601-1 (with National Deviations)	Demonstrated compliance with IEC60601-1 (with National Deviations)
EMC	Compliance with IEC60601-1-2	Demonstrated compliance with IEC60601-1-2
Functional Performance	Fulfills "prospectively defined performance criteria" and "meets user needs" based on a formal prospectively defined functional acceptance test. Performance should be "identical" to the B-Cares integrated with the C5 (as cleared under K092463) when integrated with the Stöckert S5 system.	Demonstrated fulfillment of prospectively defined performance criteria and user needs. Performed in an "identical manner" as the B-Cares integrated with the C5 when integrated with the Stöckert S5, thus demonstrating no differences and substantial equivalence to prior clearance and performance in accordance with specifications.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a numerical sample size for the "test set." It refers to "Testing of the Sorin B-Cares (hardware, firmware, and performance)" as having demonstrated that the system "fulfills prospectively defined performance criteria."
Data Provenance: The testing was "non-clinical" and appears to be internal performance testing conducted by the manufacturer. No details are provided regarding the country of origin of the data or whether it was retrospective or prospective, other than the mention of a "formal prospectively defined functional acceptance test."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. The study was non-clinical performance testing, not a clinical study involving experts establishing ground truth on patient data.

4. Adjudication Method for the Test Set

This information is not provided. As it was non-clinical performance testing, an adjudication method for ground truth would not typically be applicable in the same way as a clinical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Formal clinical testing of the Sorin B-Cares has not been performed. Therefore, this section does not apply."

6. If a Standalone (Algorithm only without human-in-the-loop performance) was done

Yes, the testing described appears to be standalone performance testing of the device itself (hardware, firmware, and its ability to monitor blood values). The device's function is to display data digitally and alert the user, which is a standalone function, though it is used by a human in a clinical setting. The "non-clinical performance testing" focuses on the device's technical specifications and functionality independent of human interpretation or assistance for its core measurements.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance testing would be the actual, measured values from calibrated laboratory equipment or reference standards against which the device's readings (oxygen saturation, hematocrit, temperature) were compared. The text mentions that "Venous saturation and hematocrit values are calibrated to reference (laboratory) values," indicating that laboratory reference values serve as the ground truth.

8. The Sample Size for the Training Set

This information is not provided. The document describes a medical device for monitoring, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The device's technology is based on the Dideco Data Master, and its performance relies on physical principles (LED sources, receivers, thermistors) and firmware, not a learned model from a data training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device does not employ a "training set" in the context of machine learning or AI that would require establishing ground truth in that manner. The device's core functionality is based on established scientific principles for measuring blood gases and hematocrit. Its calibration would involve comparison to laboratory reference measurements.

Summary

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1. SPONSOR/APPLICANT

Sorin Group Deutschland GmbH
Lindberghstrasse 25
80939 Munich
Germany

Telephone:	011-49 (0)89 323 01 153
Facsimile:	011- 49(0)89 323 01 333
Contact:	Renate Goebert

Date Prepared: January 4, 2010

2. DEVICE NAME

Proprietary Name:	Sorin B-Care5
Common/Usual Name:	Venous blood gas module for heart lung machine; perfusion monitoring device
Classification Name:	Cardiopulmonary bypass, on-line blood gas monitor (21 CFR 870.4330; Product code: DRY)

3. PREDICATE DEVICE/S

· Dideco Data Master, K001388
· Sorin B-Cares (Addition of an Optional Modular Accessory to the Stöckert S5 System), K092463)

4. DEVICE DESCRIPTION

· Physical description

The Sorin B-Cares described in this 510(k) Premarket Notification is identical to the device that was cleared under K092463 and uses the same in-line sensors cleared under K001388.

· How the device functions

When switched on, the Sorin B-Cares progresses from warm-through initialization . self test while resting on the holder. When self test is successful, Sat- (venous

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saturation) and Hct- (hematocrit) values are displayed. The sensor is then mounted on the disposable connector in the extra-corporal circuit. The B-Cares alerts (alarms or warns) the user if laboratory reference values have not been stored for venous O2 saturation and hematocrit.

· Scientific concepts that form the basis for the device
The Sorin B-Cares monitors blood values via the sensor head with two LED sources and a receiver in contact with the optical window integrated into the venous connectors. Temperatures are monitored using thermistors in the venous probes. The technology of the Sorin B-Cares is based on the technology of the Dideco Data Master (Sorin Group Italia is the parent company of Sorin Group Deutschland GmbH and was formerly known as Dideco).

· Significant physical and performance characteristics of the device, such as device design, material used, and physical properties

The B-Cares is used for determining oxygen saturation, hematocrit, and temperature in the venous blood circuit. Specifications are provided in B-Cares Operating Instructions.

5. INTENDED USE/INDICATION FOR USE

6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE/S

The technological characteristics of the B-Cares are identical to those reported to the FDA in K092463 and substantially equivalent to those of the Dideco Data Master (K001388). All are firmware-controlled systems using the same in-line connectors with integral sensor probes. All devices read the data external to the blood circulation and display data digitally; all are controlled via touchscreen. Venous saturation and hematocrit values are calibrated to reference (laboratory) values. All provide trending of values and allow the user to program alarm limits. However, the Dideco Data Master can be used independently of a heart lung machine console, whereas the B-Cares cannot be used independently and must be used connected to a Sorin/Stöckert heart lung machine console.

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Sorin B-Cares and Data Master specifications for the following are identical: saturation resolution, saturation accuracy, hematocrit resolution, and temperature resolution.

There are some minor differences in the operational specifications but all are within clinically relevant ranges. For example, the saturation range for the B-Cares has a wider range (0%-100%) than the Data Master (40%-100%); the B-Cares hematocrit range is 0% to 100% while the Data Master hematocrit range is 15% to 50%; the B-Care, temperature range is 0°C to 50°C while the Data Master temperature range is 10℃ to 45℃. These wider ranges allow the perfusionist to operate and detect the specified parameters at lower and higher levels.

7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

The Sorin B-Cares was tested in conjunction with the heart lung machine for safety in accordance with IEC60601-1 (with National Deviations), for electromagnetic compatibility in accordance with IEC60601-1-2, and performance according to a formal prospectively defined functional acceptance test. Testing of the Sorin B-Cares (hardware, firmware, and performance) has demonstrated that the Sorin B-Cares fulfills prospectively defined performance criteria and that the System meets user needs.

8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Formal clinical testing of the Sorin B-Cares has not been performed. Therefore, this section does not apply.

9. SUMMARY OF OTHER INFORMATION

No information other than that described was provided.

· 10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Based on the non-clinical testing provided in this premarket notification, the Sorin B-Cares integrated with the Stöckert SS performs in an identical manner as the B-Cares integrated with the C5, thus demonstrating that there are no differences and that the devices are substantially equivalent and perform in accordance with specifications.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized emblem with three curved lines, resembling a human figure, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the emblem. The emblem is black, and the text is also in black.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Sorin Group Deutschland GmbH c/o Ms. Rosina Robinson Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K103168

Trade/Device Name: Sorin B-Cares Regulation Number: 21 CFR 870.4330 Regulation Name: Cardiopulmonary bypass on-line blood gas monitor Regulatory Class: II Product Code: DRY Dated: October 26, 2010 Received: October 27, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

JAN - 6 200

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Page 2 – Ms. Rosina Robinson

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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm 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,

inver R. bihner

Image /page/4/Picture/7 description: The image shows a signature on the left side and the words "Br" and "Di" on the right side. The signature appears to be handwritten in black ink. The letters "Br" and "Di" are printed in a simple, sans-serif font. The overall image has a clean and straightforward appearance.

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 STATEMENT

JAN - 6 2011

K103168 510(k) Number (if known):

Device Name:

Sorin B-Cares

Indications for Use:

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. Vachnes

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K103168

Regulation Number and Section

§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.

(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).