Sorin Connect

K170460 · Sorin Group Deutschland GmbH · DXJ · Jun 8, 2017 · Cardiovascular

Device Facts

• Record ID: K170460
• Device Name: Sorin Connect
• Applicant: Sorin Group Deutschland GmbH
• Product Code: DXJ · Cardiovascular
• Decision Date: Jun 8, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2450
• Device Class: Class 2

Intended Use

The device is a modularly structured program package that is exclusively used with Sorin/Stockert heart lung machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually.

Device Story

Sorin CONNECT is a data management system for cardiopulmonary bypass surgery; interfaces with Sorin/Stockert heart-lung machines to capture perfusion data. System components include Datapad display monitor, CONNECT Recorder software (data capture), CONNECT Manager PC software (data review/manual entry), RFID card reader for Heartlink card data transfer, and pole mounting system. Used in clinical settings by perfusionists/clinicians to monitor bypass parameters. Output displayed on Datapad; allows clinicians to review perfusion data and add comments. Facilitates real-time data recording and post-procedure evaluation to support clinical decision-making during bypass.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including verification and validation activities to demonstrate compliance with product specifications and safety/effectiveness requirements. Electrical safety and electromagnetic compatibility testing performed per IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

Modular data management system. Hardware includes CPU board, SSD, WIFI module, CFAST memory, and soft-keyboard control panel. Connectivity via RFID card reader and WIFI. Software includes CONNECT Recorder and CONNECT Manager. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. System is pole-mounted.

Indications for Use

Indicated for use with Sorin/Stockert heart lung machines to record, process, and evaluate perfusion data during cardiopulmonary bypass procedures.

Regulatory Classification

Identification

A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.

Predicate Devices

• Sorin CONNECT (K131816)

Submission Summary (Full Text)

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

June 8, 2017

Sorin Group Deutschland GmbH % Scott Light Regulatory Affairs Manager Sorin Group USA, Inc. 14401 W 65th Way Arvada, Colorado 80004

Re: K170460

Trade/Device Name: Sorin CONNECT Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II Product Code: DXJ Dated: May 10, 2017 Received: May 11, 2017

Dear Scott Light:

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 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Hillemann

for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K170460

Device Name Sorin CONNECT

Indications for Use (Describe)

The device is a modularly structured program package that is exclusively used with Sorin/Stockert heart lung machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually.

| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
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| SUBMITTER: | Sorin Group Deutschland GmbH<br>Lindberghstrasse, 25<br>D-80939 München<br>Germany |
|-----------------------|------------------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | February 13, 2017 |
| DEVICE TRADE NAME: | Sorin CONNECT |
| COMMON NAME: | Data Management System |
| CLASSIFICATION NAME: | Display, cathode-ray tube, medical |
| UNMODIFIED DEVICE(S): | Sorin CONNECT (K131816) |

# 510(k) SUMMARY

### DEVICE DESCRIPTION:

The Sorin CONNECT is used to collect and view data generated during cardiopulmonary bypass surgery. It interfaces with Sorin Heart-Lung machines to capture this data.

The Sorin CONNECT includes the following main components:

- The Datapad display monitor. It's used to display the collected data.
- The data recording software installed on the Datapad; known as "CONNECT Recorder". . lt's used to save the collected data.
- The PC software for reviewing data; known as "CONNECT Manager". It's used to view ● the recorded data and manually enter additional data including clinician's comments.
- . An RFID card reader used to transfer the data from the Heartlink card to the Datapad.
- . A pole mounting system (holder) to attach the Datapad to an IV pole.

### INDICATION FOR USE:

The device is a modularly structured program package that is exclusively for use with Sorin/Stockert heart lung machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass as well as the processing and evaluation of this data. Data may be recorded automatically or entered manually.

### TECHNOLOGICAL CHARACTERISTICS:

The modified Sorin CONNECT has the same fundamental technological characteristics, principles of operation, and control mechanisms as the unmodified device modifications are described below.

The hardware was updated to replace obsolete components with readily available ones; CPUboard, Solid State Drive (SSD) and WIFI module. A removable CFAST memory was added and

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the PS/2 port was removed. The control panel was also changed to a soft-keyboard which includes buttons for brightness control.

The CONNECT Recorder and CONNECT Manager software were upgraded to accommodate the hardware changes, to provide Unique Device Identifier (UDI) information, to avoid the possibility of removing the encryption of patient data in the CONNECT Recorder database, to fix a bug and to provide a notification if a Windows update is available.

No change to the intended use has been made as a result of these modifications.

#### NON CLINICAL TEST RESULTS:

The electrical safety of Sorin CONNECT was determined by testing the unit against the IEC 60601-1 electrical safety standard.

The electromagnetic compatibility was also determined by testing the device aqainst the applicable electromagnetic compatibility IEC 60601-1-2 safety standards.

#### IN VITRO TEST RESULTS:

Verification, validation, and testing activities, were conducted to demonstrate compliance to the product's specifications and compliance to safety and effectiveness requirements.

#### CONCLUSIONS:

The modified device has the same intended use, principles of operation and technological characteristics as the unmodified device. The testing performed demonstrates substantial equivalence.