SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM

K092463 · Sorin Group Deutschland GmbH · DTQ · Nov 5, 2009 · Cardiovascular

Device Facts

• Record ID: K092463
• Device Name: SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM
• Applicant: Sorin Group Deutschland GmbH
• Product Code: DTQ · Cardiovascular
• Decision Date: Nov 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4220
• Device Class: Class 2

Intended 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.

Device Story

Sorin B-Cares is an optional accessory module for the Stöckert S5 heart-lung machine. It monitors venous blood oxygen saturation, hematocrit, and temperature during cardiopulmonary bypass. The device integrates into the S5 console, which provides speed-controlled blood pumping, venting, and cardioplegia delivery. Operated by qualified perfusionists in clinical settings (e.g., OR), the B-Cares provides real-time physiological data to the perfusionist via the S5 system interface. This monitoring assists the perfusionist in managing the bypass circuit, potentially improving patient safety by ensuring blood parameters remain within desired ranges during surgery.

Clinical Evidence

Bench testing only. Testing of hardware, software, and performance demonstrated that the system fulfills prospectively defined performance criteria and meets user needs.

Technological Characteristics

Modular accessory for Stöckert S5 console. Measures venous blood oxygen saturation, hematocrit, and temperature. Integrated into the cardiopulmonary bypass circuit. System includes console, pumps, monitors, and user interfaces. Software-controlled monitoring.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures up to six hours. Used by qualified perfusionists to monitor venous blood oxygen saturation, hematocrit, and temperature.

Regulatory Classification

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.

Predicate Devices

• S5 System (Parent Device)
• Dideco Data Master (K001388)

Submission Summary (Full Text)

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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: [phone]

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

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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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#### 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 [phone] or [phone] 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:

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