The Sorin FlexTherm Heater-Cooler System is used with a Stöckert S3 heart-lung machine and / or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

Device Description

Sorin FlexTherm is designed to provide temperature control during extracorporeal procedures. The device can be used in conjunction with heat exchangers tubing sets and heating/cooling blankets present on the market with an intended use in ECC (cardiopulmonary bypass heat exchangers, cardioplegia heat exchangers) and able to withstand a pressure of at least 2 bar. The device is used to warm or cool a patient during cardiopulmonary bypass procedures lasting up to six (6) hours.

As the unmodified device, the Sorin FlexTherm is a software-controlled device provided with hardware elements.

The main components for both devices are the housing provided with wheels, compressor, condenser unit, evaporator, expansion valves, water tanks, heaters, pumps, valves, sensors and a user interface/display.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Sorin FlexTherm device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

TEST CLASSIFICATION	TEST TYPE	ACCEPTANCE CRITERIA	REPORTED DEVICE PERFORMANCE
Functional/Performance	Functional performances without patient simulatorin terms of system capacity to reach the targettemperature, precision of the temperature controland pump capacity.	Not explicitly stated, but implied to be defined by internal methods and specifications, ensuring the device can reach target temperatures with precision and adequate pump capacity.	"The Sorin FlexTherm successfully met all acceptance criteria for each test."
Functional/Performance	Functional performances with patient simulator interms of cooling/warming a patient andadministration of cold/warm cardioplegia.	Not explicitly stated, but implied to be defined by internal methods to demonstrate effective cooling/warming of a simulated patient and delivery of cardioplegia.	"The Sorin FlexTherm successfully met all acceptance criteria for each test."
Electrical Safety	Assessment against IEC 60601-1 electrical safety standard.	Compliance with IEC 60601-1.	"The electrical safety of Sorin FlexTherm was verified by testing the unit against the IEC 60601-1 electrical safety standard."
Electromagnetic Compatibility	Assessment against IEC 60601-1-2 safety standard.	Compliance with IEC 60601-1-2.	"The electromagnetic compatibility was also verified by testing the device against the applicable electromagnetic compatibility IEC 60601-1-2 safety standard."
Software Validation	Functional validation of the entire system software.	Compliance with internal procedures, recognized standards for software life cycle processes and quality assurance, and FDA Guidance for software in medical devices.	"The SW provided with Sorin FlexTherm was also fully validated." and "The software documentation was developed according to the requirements of the FDA Guidance..."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document does not specify a numerical sample size for the in-vitro performance tests. It only states that "Comparative tests were performed according to internal methods developed by the manufacturer."
Data Provenance: The document does not provide information on the country of origin of the data or whether the tests were retrospective or prospective. It only mentions in vitro testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

Not Applicable: This information is not provided. The study conducted was in vitro testing, not a clinical study involving expert assessment of patient data for ground truth establishment. The ground truth for these tests would likely be the known physical properties and expected performance of the device and simulators.

4. Adjudication Method for the Test Set:

Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations of data (e.g., image readings). Since this was an in vitro performance study, such adjudication methods would not be relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC study was NOT done. The document primarily describes in vitro testing and compliance with safety standards, and software validation. There is no mention of human readers, comparative effectiveness with or without AI assistance, or any effect sizes related to human performance improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes (implicitly). The in vitro tests described ("Functional performances without patient simulator" and "Functional performances with patient simulator") are solely focused on the device's inherent performance. The software validation also indicates an assessment of the algorithm's functionality independently. There is no human intervention in the device's operational performance being evaluated in these tests, making them standalone assessments of the device's capabilities.

7. Type of Ground Truth Used:

The ground truth for the in vitro tests would be based on known physical parameters, engineering specifications, and established performance benchmarks for temperature control, precision, and pump capacity. For example, if a target temperature is 37°C, the ground truth is simply 37°C, and the device's output is measured against that. For electrical safety and EMC, the ground truth is compliance with the specified IEC standards.

8. Sample Size for the Training Set:

Not Applicable / Not Provided: This device is a hardware heater-cooler system with embedded software. While the software was developed and validated, the document does not indicate that it uses machine learning or AI models that require a "training set" in the conventional sense (i.e., a large dataset for model training). The software development followed standard life cycle processes, which involves design, coding, and validation, rather than data-driven machine learning training.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable / Not Provided: As noted above, the concept of a "training set" and associated ground truth establishment for machine learning models does not appear to apply to this device's software development as described in the document. The software validation relied on established software engineering principles and FDA guidance.

Summary

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Sorin Group Deutschland GmbH Sorin FlexTherm

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510(k) SUMMARY

SUBMITTER:	Sorin Group Deutschland GmbHLindberghstrasse, 25D-80939 MünchenGermany	JAN 31 2014
CONTACT PERSON:	Luigi VecchiPhone: 39 0535 29811Fax: 39 0535 25229
DATE PREPARED:	December 20, 2013
DEVICE TRADE NAME:	Sorin FlexTherm
COMMON NAME:	Heater-Cooler
CLASSIFICATION NAME:	Controller, temperature, cardiopulmonary bypass
CLASSIFICATION CODE:	DWC
REGULATION NUMBER:	870.4250
UNMODIFIED DEVICE(S):	Stöckert Heater-Cooler System 3T (K052601)

DEVICE DESCRIPTION:

As the unmodified device, the Sorin FlexTherm is a software-controlled device provided with hardware elements.

INDICATION FOR USE:

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TECHNOLOGICAL CHARACTERISTICS:

The modified device Sorin FlexTherm has the same fundamental scientific technology, operating principles and intended use as the unmodified device.

The changes introduced improve usability and enhance user interface.

The main modifications are the introduction of a newly designed user interface/display, the change of device software and hardware components, change materials of construction (console, hood, tanks, cooling circuit), change of the dimensions, change in power supply. The Sorin FlexTherm will be offered with a wide range power supply suitable to different voltages (i.e. from 100 - 240 VAC and 50 - 60 Hz).

The labeling and the instructions for use have been updated to reflect the modifications.

There are no significant differences in the packaging scheme.

The basic device function is the same for both the Stöckert Heater-Cooler System 3T and Sorin FlexTherm.

Sorin Group Deutschland GmbH believes that the Sorin FlexTherm is substantially equivalent to the unmodified device and to other currently marketed heater/cooler devices, and raise no new issues of safety and effectiveness.

NON CLINICAL TEST RESULTS:

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

The electromagnetic compatibility was also verified by testing the device against the applicable electromagnetic compatibility IEC 60601-1-2 safety standard.

IN VITRO TEST RESULTS:

In vitro testing was performed in order to provide the data necessary to demonstrate both the substantial equivalence with the unmodified device and also to comply with safety and effectiveness requirements.

Comparative tests were performed according to internal methods developed by the manufacturer.

The following table lists the performance tests conducted to demonstrate compliance to the product's performance specifications. The Sorin FlexTherm successfully met all acceptance criteria for each test.

TEST	TEST CLASSIFICATION	TEST TYPE
1	Functional/Performance	Functional performances without patient simulatorin terms of system capacity to reach the targettemperature, precision of the temperature controland pump capacity.
2	Functional/Performance	Functional performances with patient simulator interms of cooling/warming a patient andadministration of cold/warm cardioplegia.

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The SW provided with Sorin FlexTherm was also fully validated.

A functional validation of the software of the entire system was conducted and the software was developed in accordance with Sorin Group Deutschland internal procedures and with consideration of commonly recognized standards of software life cycle processes and quality assurance.

The software documentation was developed according to the requirements of the FDA Guidance for the content of premarket submissions for software contained in medical devices (May 2005) as well as according to the Level of Concern of the device.

CONCLUSIONS:

Based on the information submitted in this 510(k) premarket notification, the Sorin FlexTherm is substantially equivalent to the unmodified device. The Sorin FlexTherm has the same intended use and fundamental scientific technology. The results of in vitro studies demonstrate that the Sorin FlexTherm is substantially equivalent to the unmodified device in terms of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 figures.

Public Health Service

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

January 31, 2014

Sorin Group Deutschland GmbH Scott Light Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004

Re: K140012

Trade/Device Name: Sorin FlexTherm Regulation Number: 21 CFR 870.4250 Regulation Name: Cardiopulmonary bypass temperature controller Regulatory Class: Class II Product Code: DWC Dated: December 31, 2013 Received: January 2, 2014

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. Ilsting 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 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

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Page 2 - Scott Light

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.

for

Sincerely yours.

M. A. Stilleman

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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Indications for Use:

510(k) Number (if known): _ K140012

Device Name: Sorin FlexTherm

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-the-Counter Use_

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Hillerman

Regulation Number and Section

§ 870.4250 Cardiopulmonary bypass temperature controller.

(a)
Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.(b)
Classification. Class II (performance standards).