Who is the manufacturer of SORIN CONNECT DATA MANAGEMENT SYSTEM?

Sorin Group Deutschland GmbH filed the 510(k) submission for SORIN CONNECT DATA MANAGEMENT SYSTEM (K131816).

What is the FDA product code for SORIN CONNECT DATA MANAGEMENT SYSTEM?

DXJ. It is classified under 21 CFR 870.2450 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for SORIN CONNECT DATA MANAGEMENT SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SORIN CONNECT DATA MANAGEMENT SYSTEM?

IntelliVue Clinical Information Portfolio (K100272); TLink Data Management System (K113214).

Who can help prepare an FDA 510(k) submission like SORIN CONNECT DATA MANAGEMENT SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SORIN CONNECT DATA MANAGEMENT SYSTEM

K131816 · Sorin Group Deutschland GmbH · DXJ · Jul 23, 2013 · Cardiovascular

Device Facts

Record ID	K131816
Device Name	SORIN CONNECT DATA MANAGEMENT SYSTEM
Applicant	Sorin Group Deutschland GmbH
Product Code	DXJ · Cardiovascular
Decision Date	Jul 23, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2450
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended Use

Sorin CONNECT is a modularly structured program package that is exclusively used with Sorin/Stöckert 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. It captures numerical/perfusion data from Stöckert/Sorin heart-lung machines (HLM) via serial cable or RFID, and accepts manual user inputs. The system comprises a hardware unit (Datapad II PC, Heartlink RFID reader) and software (Connect Recorder for online data collection; Connect Manager for central database/reporting). Perfusionists use the system in the OR to monitor patient physiological conditions via tabular trends and measurement graphs. Data is stored in relational databases (ONLINE32.DBS for current cases; HLM32.DBS for closed cases). The system facilitates documentation, reporting, and post-procedural analysis. It benefits patients by providing comprehensive, accurate perfusion records and enabling clinicians to identify physiological changes during surgery.

Clinical Evidence

Bench testing only. Performance testing verified PC server/client specifications and simulated real-world hospital deployment scenarios. Testing confirmed system performance with compatible measuring devices and local infrastructure. No clinical data presented.

Technological Characteristics

Software-only product installed on PC/server; client-server architecture. Hardware: PC (Datapad II), RFID reader. Connectivity: Hospital LAN, serial cable interface to HLM, WLAN. OS: Microsoft Windows XP. Database: Relational. Standards: IEC 62304 (software), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ANSI HL7 V2.5 (HIT), ISO 14971 (risk management).

Indications for Use

Indicated for use by perfusionists during cardiopulmonary bypass procedures to record, process, and evaluate perfusion data from Sorin/Stöckert heart lung machines.

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

IntelliVue Clinical Information Portfolio (K100272)
TLink Data Management System (K113214)

Related Devices

K170460 — Sorin Connect · Sorin Group Deutschland GmbH · Jun 8, 2017
K212003 — ESSENZ Patient Monitor · Livanova Deutschland, GmbH · Nov 10, 2021
K113214 — TLINK DATA MANAGEMENT SYSTEM (DMS) · Terumo Cardiovascular Systems Corp. · Feb 7, 2012
K052555 — MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB · Rand S.R.L. · Mar 15, 2006
K060053 — STOCKERT S5 SYSTEM · Sorin Group Deutschland GmbH · Jun 2, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ | | Sorin CONNECT Data Management System Traditional 510(k) | | | |------------------------------|---------------------------------------------------------|--------------|--| | Sorin Group Deutschland GmbH | | June 7, 2013 | | | | K131816 | | | | | | P 1/7 | | | | 510(k) SUMMARY | JUL 2 3 2013 | | | SUBMITTER: | Sorin Group Deutschland GmbH | | | | | 25, Lindberghstrasse | | | | | D-80939 Munich, Germany | | | | CONTACT PERSON: | Renate Göbert | | | | | Phone: + 49 (0)89 323-153 | | | | | Fax: + 49 (0)89 32301333 | | | | DATE PREPARED: | June 7, 2013 | | | | DEVICETRADE NAME: | Sorin CONNECT | | | | COMMON NAME: | Data Management System | | | | CLASSIFICATION NAME: | Display, Cathode-ray Tube, Medical | | | | PREDICATE DEVICE: | IntelliVue Clinical Information Portfolio | K100272 | | | | TLink Data Mangement System | K113214 | | ## DEVICE DESCRIPTION: The Sorin CONNECT is aiming to capture, display and store numerical or other perfusion related information entered by the user or captured from Stocket/Sorin Heart Lung Machine and from any compatible external device via a serial cable connection to the HLM interface. The capture of the data is performed automatically from the HLM via a serial cable communication or via RFID while simultaneously allowing for simple, manual user inputs The Sorin CONNECT Data Management System includes a hardware unit (the Personal Computer, hereinafter referred to as Datapad II, and the RFID card/reader hereinafter identified as Heartlink) and the software only product. The Sorin CONNECT software can be embedded into Datapad II (Online version hereinafter identified as {1}------------------------------------------------ | Sorin Group Deutschland GmbH | June | |------------------------------|------| |------------------------------|------| 7, 2013 K131816 P 2/7 Connect recorder) or available also on a server computer (server version hereinafter identified as Connect Manager). The Datapad II with embedded Connect Recorder allows for collection of all data that occur during an operation in order to generate a complete case record; its database store data in trend, event, calculation and it is possible to display on the monitor tabular trends or to view measurement trend graphs, with different measurements combined in each graph, to help the perfusionist in identify changes in the patient's physiological condition. The Connect Manager is a central database application in which all case records are stored and processed; in this case it is possible to consolidate data from different Connect Recorders on one central server computer. The application stores and manages data for documentation, reporting, analysis and export after the clinical case has been done: data are stored in a specific database and it is possible to display on the server workstation tabular trends, measurement trend graphs as well as statistical analysis and document them on a printer. The two different Sorin CONNECT applications have access to their own, independent database and data transfer among the databases takes place using either an USB memory stick or a network (Ethernet) connection: - HLM32.DBS is the database on the server computer. This database contains all case records that are already closed. - ONLINE32.DBS is the database on each of the online computers. This database contains the current case record(s) data. The Sorin CONNECT, through actuators, software and control mechanisms, performs the data collection, storage and management as requested by the operator through the user interface. Operating modes include automatic collection of data and manual insertion of data via keyboard The supported medical devices for Sorin CONNECT are the Stöckert/Sorin Heartlung machines SC (K982014), S3 (950990), S5 (K071318) and C5 (K093882). ### INDICATIONS FOR USE: Sorin CONNECT is a modularly structured program package that is exclusively used with Sorin/Stöckert heart lunq 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. {2}------------------------------------------------ K131816 P 3/7 ## TECHNOLOGICAL CHARACTERISTICS: Sorin makes the claim of substantial equivalence to cited predicates based on intended use, indications for use, technological characteristics, and operational characteristics. Sorin CONNECT and the predicates are software only products intended to be installed on a PC or on a server. They have a client server architecture and are compliant with the up to date Micrsosoft® Operating System and databases. The related software supports a standard hospital LAN interface and Sorin device interface for connection to the compatible measuring devices. Sorin Group Deutschland GmbH believes that the Sorin CONNECT is substantially equivalent to the IntelliVue family of Patient Data Management solutions, to TLink DMS and to other currently marketed data management devices, that any differences are minor, and raise no new issues of safety and effectiveness. The summary of equivalences regarding general features and performance characteristics of the Sorin CONNECT and the predicate devices is presented below | Parameters | Sorin CONNECT | INTELLIVUE | TLink DMS | Equivalence | |------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | Sorin CONNECT is a modularly structured program package that is used together with Sorin heart lung machines. The system allows detailed recording of systemic perfusion data during cardio- surgical interventions; as well as the processing and evaluation of these data afterwards. The recording of the data is performed automatically or via RFID while simultaneously allowing for simple, manual user inputs. | The INTELLIVUE is intended for use in the data collection, storage, and management with independent bedside devices and ancillary systems that are connected either directly or through networks. This device is indicate for use by the health care providers whenever there is a need for generation of a patient record and computation drug usage | The TLink DMS is an electronic clinical record keeping and reporting system indicated for use in collecting, displaying, storing and managing data from external medical devices. The system facilitates the creation of electronic patient records and enables post- procedural case reviews. Data and records can be viewed in local workstations or transferred to a central computer or hospital network for storage and post- case analysis/reporting | Equivalent to TLink as both system are tailored for use in both OR and afterwards by perfusionists Equivalent to INTELLIVUE but limited to data management of cardiac surgery intervention (IntelliVue can be used also for bedside data management) and not intended for the scope of computation drug usage but only for generation of patient record | | Modules division | Connect (central application - based on both and/or PC-) Connect recorder (online application - PC based-) | IntelliVue application (central database application - based on both server and/or PC-) IntelliVue monitors (online application - PC based-) | XDS TLink management system (central database application -based on both server and/or PC-) TLink management system (On line application based on a touch screen PC) | Data Equivalent to both INTELLIVUE and TLink : all system have a SW application which can be loaded on a PC or on a server and an online application loaded on the monitor where data are collected ( which. is actually a PC as well) | | Parameters | Sorin CONNECT | INTELLIVUE | TLink DMS | Equivalence | | User interface | Touch screen without additional input devices (Connect Recorder) Standard keyboard and mouse of commercial PC (Connect Manager) | Touch screen; additional input devices like mouse, remote control or trackball can be used (IntelliVue monitors) Standard keyboard and mouse of commercial PC (XDS application) | Touch screen computer Standard keyboard and mouse of commercial PC (TLink DMS) | Equivalent to both INTELLIVUE and TLink | | Data source | Manually, Automatically captured by compatible measuring devices, RFID card reader, calculations | Manually, Automatically captured by compatible measuring devices, RFID card reader, calculations | Manually, Automatically captured by compatible measuring devices, bar code scanner, calculations | Equivalent to INTELLIVUE. Only difference with TLink is that ; it is not using a RFID card reader but a bar code reader | | Data managemen t | The operator can at any moment overrule the data entry in any mode and manually enter or modify each single parameter and save the modified data | The operator can at any moment overrule the data entry in any mode and manually enter or modify each single parameter and save the modified data | The operator can at any moment overrule the data entry in any mode and manually enter or modify each single parameter and save the modified data | identical to both INTELLIVUE and TLink | | Data storage | Relational database PC embedded (Connect recorder) Relational database PC and/or central database server embedded (Connect manager) | Relational database PC embedded (IntelliVue monitors) Relational database PC and/or central database server embedded (XDS application) | Relational database PC embedded (TLink DMS embedded into the touch screen computer) Relational database PC and/or central database server embedded (TLINK DMS | Equivalent to both INTELLIVUE and TLink | | Parameters | Sorin CONNECT | INTELLIVUE | TLink DMS | Equivalence | | Data transfer/ backup | Data can be transferred to/from: connect manager connect recorder via: - portable storage medium - network connection - WLAN connection | Data can be transferred to/from: IntelliVue monitors to XDS application: - portable storage medium - network connection - WLAN connection - Telemetry | Data can be transferred via: - portable storage medium - network connection - WLAN connection | Equivalent to TLink. Only difference with INTELLIVUE is that ; it allows transfer of data also using telemetry ( not possible in Connect and Tlink) | | Data Output | Numerical, graphical, statistical, | Numerical, graphical, waves, statistical, | Numerical, graphical, statistical, | Equivalent to TLink. Only difference with INTELLIVUE is that ; it allows data output also in form of wave pulse (not possible in Connect and Tlink) | | Fundamental scientific technology | Microsoft.NET framework together with WLAN module | Microsoft.NET framework together with WLAN module | Microsoft.NET framework together with WLAN module | Equivalent to INTELLIVUE and TLink | | Availability | Availability as a standalone SW embedded into a PC or into a LAN Network | Availability as a standalone SW embedded into a PC or into a LAN Network | Availability as a standalone SW embedded into a PC or into a LAN Network | Identical to INTELLIVUE and TLink | | Materials | Hardware: PC Firmware: Microsoft Windows XP | Hardware: PC Firmware: Microsoft Windows XP | Hardware: PC Firmware: Microsoft Windows ( version Not available) | Equivalent to INTELLIVUE and TLink | | Sterilization /Shelf Life | Not sterile | Not sterile | Not sterile | Identical to INTELLIVUE and TLINK | | Biocompatibi lity | No blood contacting parts | No blood contacting parts | No blood contacting parts | Identical to INTELLIVUE and TLINK | | EMC (emissions) | Group 1 Class A ( CISPR 11) | Group 1 Class A ( CISPR 11) | Data not available | Identical to INTELLIVUE | | Parameters | Sorin CONNECT | INTELLIVUE | TLink DMS | Equivalence | | Electromagn etic compatibility and electrical safety | UL 60601-1 (IEC 60601-1, A1, A2) and IEC 60601-1-2 testing | UL 60601-1 (IEC 60601-1, A1, A2) and IEC 60601-1-2 testing | Data not available | Identical to INTELLIVUE | {3}------------------------------------------------ Sorin Group Deutschland GmbH June 7, 2013 {4}------------------------------------------------ Sorin Group Deutschland GmbH June 7, 2013 {5}------------------------------------------------ Sorin Group Deutschland GmbH June 7, 2013 ## IN VITRO TEST RESULTS: Testing supplied in the 510(k) premarket notification for the Sorin CONNECT includes electrical testing, electromagnetic compatibility testing, and performance testing that demonstrate compliance with performance specifications. The purpose of the performance testing was to ensure the performance of the device by verifying and stressing the PC server and client specifications and simulating various scenarios of real customer deployment in the hospital, The conducted performance tests have confirmed performances of the Sorin CONNECT software together with the compatible measuring devices and the local infrastructures under conditions simulating real environment of use. The results of the study showed the device characteristics between Sorin CONNECT and IntelliVue were comparable. The list of tests performed to fulfill compliance with the nonclinical tests is presented below with the relevant standard followed {6}------------------------------------------------ Sorin CONNECT Data Management System Traditional 510(k) | | Sorin Group Deutschland GmbH | | |--------------------------------------------------------------|------------------------------|--| | A market and the comments of the comments of the comments of | | | ## K131816 P 7/7 | TEST | STANDARD | |-------------------------------|---------------------------------------------------------------------------------------------------------| | Vibration test | ASTM D999, version 6, Aug 1st, 2008 | | Drop test | ASTM D5276 version 9, March 1st, 2009 | | Software | IEC 62304 version 1, May1st, 2006 | | Off the shelf Software | FDA Guidance for the compliance on Off-the-Shelf software used in medical devices, September 9, 1999 | | Cybersecurity | FDA Guidance for networked Medical devices containing Off-the-Shelf software January 14, 2005 | | Usability | IEC 62366: 2007 | | Health information technology | ANSI HL 7 V2.5-2003 | | Electromagnetic compatibility | IEC 60601-1-2, version 3, March 1st, 2007 | | Electrical safety | IEC 60601-1:2005, 3rd ed. | | Risk management | ISO14971, version 3, July 1st, 2009 | | Wireless technology | FDA guidance for radio frequency Wireless technology in medical devices, Jan 3, 2007 | · ## CONCLUSIONS: The results of in vitro studies demonstrate that the Sorin CONNECT is substantially equivalent to the predicate device in terms of safety and effectiveness. {7}------------------------------------------------ Image /page/7/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. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 23, 2013 Sorin Group Deutschland GmbH c/o Mr. Olaf Tiechert Responsible Third Party Official TUV SUD America, Inc. 1775 Old Highway 8 NW New Brighton, MN 55112 Re: K131816 Trade/Device Name: Sorin "CONNECT Data Management System" Regulatory Number: 21 CFR 870.2450 Regulation Name: Display, Cathode-Ray tube, Medical Regulatory Class: Il (two) Product Code: 74 DXJ Dated: July 2, 2013 Received: July 11, 2013 Dear Mr. Tiechert: 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 {8}------------------------------------------------ Page 2 - Mr. Olaf Tiechert 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. # Owen P. Faris -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ Sorin CONNECT Data Management System Traditional 510(k) Sorin Group Deutschland GmbH June 7, 2013 K131816 #### Indications for Use Device Name: Sorin CONNECT Data Management System Indications for Use: Sorin CONNECT is a modularly structured program package that is exclusively used with Sorin/Stöckert 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. Prescription Use X (Part 21 CFR 801 Subpart D) C) | Over-the-Counter Use | | |----------------------|------------------------------------------------------------------------------| | | ---------------------------------------------------------------------------- | ( AND/OR (21 CFR 807 Subpart (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Digitally signed by Owen P. Faris -S Date: 2013.07.23 12:49:36-04'00' "

SORIN CONNECT DATA MANAGEMENT SYSTEM

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Intended Use

Device Story

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SORIN CONNECT DATA MANAGEMENT SYSTEM

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Predicate Devices

Related Devices

Submission Summary (Full Text)

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