Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on data collection, storage, display, and basic statistical analysis. There is no mention of algorithms that learn from data or make predictions.

Therapeutic

No
The device is a data management system that records, processes, and displays perfusion data. It does not directly provide therapy or therapeutic benefit to a patient.

Diagnostic

No

The device is described as a "Data Management System" that records, processes, and evaluates perfusion data. Its primary function is to capture, display, and store numerical or other perfusion-related information. While it aims to help the perfusionist in "identify changes in the patient's physiological condition" by displaying trends and graphs, it is presented as a tool for data management and documentation, not for independently diagnosing a disease or condition. It supports the health care providers in generating patient records and computing drug usage.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Sorin CONNECT Data Management System includes a hardware unit (Datapad II and Heartlink) in addition to the software-only product.

IVD (In Vitro Diagnostic)

Based on the provided information, the Sorin CONNECT is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to record, process, and evaluate perfusion data during cardiopulmonary bypass. This involves monitoring physiological parameters and drug usage during a medical procedure performed on a patient.
Device Description: The device captures, displays, and stores numerical and other perfusion-related information from heart-lung machines and external devices. It is a data management system for clinical use.
Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Sorin CONNECT does not perform such examinations of biological specimens. It is focused on managing data related to a medical procedure.

The device is clearly intended for use in a clinical setting to support healthcare providers during and after cardiopulmonary bypass procedures by managing patient data. This aligns with the function of a clinical information or data management system, as indicated by the predicate devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

74 DXJ

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 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).

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)

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.

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.

K100272, K113214

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.

Not Found

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

Regulation Number and Section

§ 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).

Summary

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)

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'
"