SORIN C5 SYSTEM MODEL 58-00-00

K093882 · Sorin Group Deutschland GmbH · DTQ · Jan 15, 2010 · Cardiovascular

Device Facts

• Record ID: K093882
• Device Name: SORIN C5 SYSTEM MODEL 58-00-00
• Applicant: Sorin Group Deutschland GmbH
• Product Code: DTQ · Cardiovascular
• Decision Date: Jan 15, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sorin C5 System 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 System.

Device Story

The Sorin C5 System is a modular heart-lung machine console with integrated roller pumps; it functions as a modification of the Stöckert S5 System. The device is used in clinical settings (e.g., OR) by qualified perfusionists to manage extracorporeal circulation. It provides speed-controlled pumping of blood through cardiopulmonary bypass circuits, facilitates left ventricular venting, performs cardiotomy suction, and administers cardioplegia solutions. The system supports patient physiological needs during cardiac surgery by maintaining circulation and oxygenation for up to six hours. The perfusionist monitors system performance and adjusts pump speeds to manage blood flow and pressure, directly influencing clinical decision-making during bypass procedures.

Clinical Evidence

Bench testing only. The system fulfilled prospectively defined performance criteria and met user needs.

Technological Characteristics

Modular heart-lung machine console with integrated roller-type cardiopulmonary bypass pumps. Operates as a speed-controlled pumping system. Compatible with existing Stöckert S5 System components and accessories.

Indications for Use

Indicated for patients requiring cardiopulmonary bypass support for durations of 6 hours or less. Used for speed-controlled blood pumping, left ventricular venting, cardiotomy suction, and cardioplegia solution administration. Must be operated by a qualified, experienced perfusionist.

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

• Stöckert S5 System

Submission Summary (Full Text)

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K093882

# 510(k) Summary (per 21 CFR 807.92) Sorin C5 System

#### 1. SPONSOR

JAN 1 5 2010

Sorin Group Deutschland GmbH Lindberghstrasse 25 80939 Munich Germany Contact Person: Renate Goebert Telephone: [phone]

Date Prepared: December 1, 2009

### 2. DEVICE NAME

| Proprietary Name: | Sorin C5 System |
|----------------------|----------------------------------------------------------------------------------------------|
| Common/Usual Name: | Heart lung machine console and integrated roller pumps |
| Classification Name: | Cardiopulmonary bypass console, (with integrated roller-type<br>cardiopulmonary bypass pumps |

#### 3. PREDICATE DEVICES

Parent Device: Stöckert S5 System

#### 4. DEVICE DESCRIPTION

The Sorin C5 System is a modification of the modular S5 System that comprises basic components and optional components. Optional components/accessories that have been cleared by the FDA for use as part of the S5 System are also compatible with the C5 · System.

#### 5. INTENDED USE/INDICATIONS FOR USE

The Sorin C5 System 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 System.

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## 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Sorin C5 System is a modification of the Stockert S5 System. The modified Stöckert S5 System is substantially equivalent to the parent Stöckert S5 System based on intended use, indication for use, operational characteristics, fundamental technological characteristics and performance specifications.

#### 7. PERFORMANCE TESTING

Testing of the Sorin CS System 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - 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

JAN 1 5 2010

Re: K093882

Trade/Device Name: Sorin C5 System, Model 58-00-00 Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart Lung Machine Console Regulatory Class: II Product Code: DTQ Dated: December 15, 2009 Received: December 18, 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. 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

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Page 2 - Ms. Rosina Robinson

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 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/ucml 15809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

D.nna R. Valine

Image /page/3/Picture/7 description: The image contains a handwritten signature on the left and the letters 'B' and 'D' on the right. The signature is illegible, but it appears to be written in cursive. The letters 'B' and 'D' are in a simple, sans-serif font. The image is black and white.

C 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):

Device Name: Sorin C5 System

Indications for Use:

The Sorin C5 System 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 C5 System.

Ko93882

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)

Duna P. Watkins

n of Cardiovascular Devices

510(k) Number_Ko93882