(113 days)
Not Found
No
The description focuses on data collection, recording, and viewing, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as a program package and system for recording, processing, and evaluating perfusion data during cardiopulmonary bypass. It collects and displays data from heart-lung machines and allows for manual entry of additional data. It does not directly provide therapy or treatment.
No
The device is described as a system for recording, processing, and evaluating perfusion data during cardiopulmonary bypass. It collects and views data generated during surgery, but there is no indication that it is used to diagnose a medical condition or disease.
No
The device description explicitly lists hardware components like the "Datapad display monitor," "An RFID card reader," and "A pole mounting system (holder)," in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to record, process, and evaluate perfusion data during cardiopulmonary bypass. This data is related to the operation of a heart-lung machine and the physiological parameters of the patient during surgery. It does not involve testing samples taken from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease.
- Device Description: The device collects and views data generated during the surgical procedure, interfacing with the heart-lung machine. It's a data management system for the surgical process itself, not a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
In vitro diagnostics are tests performed on samples taken from the human body to detect diseases, conditions, or infections. This device's function is centered around monitoring and managing data related to a surgical procedure.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DXJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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.
Verification, validation, and testing activities, were conducted to demonstrate compliance to the product's specifications and compliance to safety and effectiveness requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Sorin CONNECT (K131816)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2450 Medical cathode-ray tube display.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/2 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of three human profiles facing right, stacked on top of each other, symbolizing health and human services.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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| SUBMITTER: | Sorin Group Deutschland GmbH
Lindberghstrasse, 25
D-80939 München
Germany |
|-----------------------|------------------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi
Phone: 39 0535 29811
Fax: 39 0535 25229 |
| 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
4
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.