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.

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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study details for the Sorin B-Cares:

The provided 510(k) summary for K092Y63, the Sorin B-Cares addition to the Stöckert S5 System, is quite high-level regarding performance testing. It states that "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." However, it does not provide specific details on the acceptance criteria themselves, nor does it describe a detailed study that proves the device meets specific criteria.

The document emphasizes substantial equivalence to the Dideco Data Master (K001388) for monitoring saturation, hematocrit, and temperature, suggesting that the performance specifications for these measurements are considered substantially equivalent. This implies that the B-Cares' performance aligns with what was previously accepted for the predicate device.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, specific numerical acceptance criteria and corresponding reported device performance values are NOT explicitly stated. The submission only generically claims that "the System fulfills prospectively defined performance criteria."

Measurement Parameter	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Not Explicitly Stated)
Oxygen Saturation	(Implied to be substantially equivalent to Dideco Data Master)	(Implied to be substantially equivalent to Dideco Data Master)
Hematocrit	(Implied to be substantially equivalent to Dideco Data Master)	(Implied to be substantially equivalent to Dideco Data Master)
Temperature	(Implied to be substantially equivalent to Dideco Data Master)	(Implied to be substantially equivalent to Dideco Data Master)

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

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions "Testing of the modified Stöckert S5 System."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth for a test set, nor does it provide details on the qualifications of such experts. This type of expert assessment is less common for devices measuring physiological parameters directly unless the validation involves clinical interpretation of the measurements.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This is generally not relevant for direct physiological measurement devices like this, which measure objective values rather than requiring subjective interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted. Such studies are typically performed for diagnostic imaging devices where human interpretation is a key component, to assess how AI assistance impacts reader performance. This device is an on-line monitor of physiological parameters, not an interpretive diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

The document does not provide details specifically on a "standalone" or algorithm-only performance study in the way it might be discussed for a diagnostic AI algorithm. However, any "performance testing" of the B-Cares system itself, given its function, would inherently be assessing its "standalone" measurement capabilities (i.e., its ability to accurately measure saturation, hematocrit, and temperature). The submission states "The performance specifications for the measurements performed by the Stöckert B-Cares are substantially equivalent to those of the Dideco Data Master," implying an assessment of its measurement accuracy.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. For devices measuring physiological parameters like oxygen saturation, hematocrit, and temperature, the ground truth would typically be established using:

Reference laboratory methods: Such as co-oximetry for oxygen saturation, standard hematology analyzers for hematocrit, and calibrated thermometers for temperature. These are considered highly accurate and serve as the "gold standard" for comparison.
Another validated device: For example, comparing against an existing, widely accepted, and accurate blood gas analyzer or co-oximeter.

Given the substantial equivalence claim, it's highly probable that comparisons were made against a reference method or the predicate device that itself had been validated against reference methods.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is an online monitor based on established principles (likely spectrophotometry for saturation and hematocrit, and thermistors for temperature). Its functionality doesn't typically involve a machine learning model that requires a "training set" in the conventional sense. Therefore, this question is not directly applicable to the information provided.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a "training set" for a machine learning model, the question of how its ground truth was established is not applicable based on the provided document.

In summary: The 510(k) summary for the Sorin B-Cares focuses on the concept of "substantial equivalence" to a predicate device (Dideco Data Master) rather than presenting detailed, specific acceptance criteria and the comprehensive data from a study explicitly proving adherence to those criteria for the measurements of oxygen saturation, hematocrit, and temperature. The document is very high-level regarding performance testing specifics. For more detailed information on acceptance criteria and performance data, one would typically need to review the full 510(k) submission, including any referenced test reports.

Summary

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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

5. INTENDED USE/INDICATIONS FOR USE

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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.

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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.

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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

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510(k) Number (if known):

Sorin B-Cares for the Stockert S5 System Device Name:

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 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

Regulation Number and Section

§ 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).