The Heater-Cooler System 3T is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

Device Description

The 3T System is an independent (i.e., independent of the water supply) 3-circuit heating/cooling base unit that includes three water circuits (two circuits for the patient supplied by one tank (for the heating/cooling blanket, the oxygenator) and one interchangeable heating/cooling circuit for cardioplegia. If required, patient and cardioplegia circuits can be switched off separately, in order to increase the activated functional group's heating and/or cooling performance.

The following optional components and accessories are also available for the 3T System:

1. Heating-cooling blankets;
1. Water circuit tubing; and
1. Various cables.
  The 3T System includes a disposable aerosol collection set that consists of a canister connected to the 3T System and the user facility's vacuum source that captures emissions that are drawn from the tank using negative pressure created by the user facility's vacuum.

AI/ML Overview

The Heater-Cooler System 3T is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Aspect	Reported Device Performance
Reduction in Emission (Aerosolized Mycobacteria)	- Microbiological and orthogonal assay testing during all phases of device operation to evaluate device emissions verified reduction. - Microbiological testing verified the hydrophobic filter of the disposable aerosol collection set's canister adequately prevents contamination of the user facility's vacuum source. - Microbiological and orthogonal assay testing verified the seven-day use period of the disposable aerosol collection set.
Aerosol Collection Set Integrity and Efficacy	Testing verified the chemical resistance of materials, integrity, and efficacy of the disposable Aerosol Collection Set, as well as the integrity of its packaging design.
Heating and Cooling Functions	Testing verified the performance of the heating and cooling functions of the 3T System using a patient simulator circuit.
Corrosion and Erosion Resistance	Testing evaluated the chemical resistance of the metallic and plastic components and materials of the 3T System.
Cleaning, Disinfection, and Preservation of Water Circuit (Intermediate Level)	Validation testing demonstrated an intermediate level of disinfection. Long-term testing (58 weeks) verified that the instructions adequately prevent contamination of the device.
Cleaning and Disinfection of 3T System Surfaces	Validation testing of the 3T System surface cleaning instructions was performed.
Transportation and Storage Packaging	Testing of the transportation and shipping packaging of the 3T System was performed.
Production Disinfection and Drying Process Qualification	Process validation testing of the production disinfection and drying processes was conducted.
Human Factors	Human factors validation testing of the 3T System Operating Instructions was performed.
Substantial Equivalence to Predicate Device (Stöckert Heater-Cooler System 3T)	The Final Configuration 3T System has very similar indications for use, the same fundamental scientific technology, and similar technological characteristics. Performance and validation testing demonstrate that the modified 3T System is as safe and effective as the predicate device.

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

The provided text does not explicitly state the specific, quantitative sample sizes for each of the performance tests. It describes the types of testing performed (e.g., microbiological, orthogonal assay testing, long-term testing for 58 weeks).

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective. The testing appears to be laboratory-based performance testing conducted by the company.

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

This information is not provided in the document. The studies appear to be laboratory performance tests rather than clinical studies requiring expert ground truth for interpretation. For example, microbiological testing determines contamination levels, and heating/cooling tests measure temperature changes against predefined specifications.

4. Adjudication Method for the Test Set

This information is not applicable and thus not provided. Since the tests are described as performance and validation testing (e.g., measuring emissions, verifying filter efficacy, testing heating/cooling functions), there isn't a "ground truth" established by multiple experts that would require an adjudication method. The results are likely binary (pass/fail) or quantitative measurements compared against specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not conducted. This device is a medical apparatus (heater-cooler system) and not an AI-powered diagnostic or assistive technology that would involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This concept is not applicable to the Heater-Cooler System 3T. It is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the various performance tests appears to be based on:

Established industry standards/specifications: For performance aspects like heating/cooling efficiency, corrosion resistance, transportation, and surface cleaning.
Microbiological control principles: For assessing the reduction in emissions, filter efficacy, and prevention of contamination. This involves measuring microbial counts against acceptable limits.
Chemical and material science principles: For testing chemical resistance and material integrity.
FDA guidance: Specifically referenced for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" for cleaning, disinfection, and water preservation.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI. The performance testing focuses on the physical and functional aspects of the hardware and associated procedures.

9. How the Ground Truth for the Training Set was Established

As there is no training set for this device, this question is not applicable.

Summary

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February 25, 2020

LivaNova Deutschland GmbH % Scott Light Senior Manager, Regulatory Affairs LivaNova USA, Inc. 14491 West 65th Way Arvada. Colorado 80004

Re: K191402

Trade/Device Name: Heater-Cooler System 3T Regulation Number: 21 CFR 870.4250 Regulation Name: Cardiopulmonary Bypass Temperature Controller Regulatory Class: Class II Product Code: DWC Dated: January 17, 2020 Received: January 17, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Fernando Aguel Assistant Director Division of Circulatory Support, Structural and Vascular Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page

510(k) Number (if known)

K191402

Device Name

Heater-Cooler System 3T

Indications for Use (Describe)

The Heater-Cooler System 3T is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY

LivaNova's Heater-Cooler System 3T

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

LivaNova Deutschland GmbH Lindberghstrasse 25 D-80939 München, Germany

Contact Person:

Bryan Olin, Ph.D. Senior Vice President, Clinical, Quality, and Regulatory Affairs

Date Prepared: February 20, 2020

Name of Device and Name/Address of Sponsor:

Heater-Cooler System 3T LivaNova Deutschland GmbH Lindberghstrasse 25 D-80939 München, Germany

Common or Usual Name:

Cardiopulmonary bypass temperature controller

Classification Name:

21 CFR 870.4250; Product Code DWC

Predicate Device:

Stöckert Heater-Cooler System 3T (K052601)

Intended Use / Indications for Use

The Heater-Cooler 3T System (3T System) is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

Device Description

The following optional components and accessories are also available for the 3T System:

1. Heating-cooling blankets;
1. Water circuit tubing; and

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1. Various cables.
  The 3T System includes a disposable aerosol collection set that consists of a canister connected to the 3T System and the user facility's vacuum source that captures emissions that are drawn from the tank using negative pressure created by the user facility's vacuum.

Technological Characteristics

The technological characteristics of the Final Configuration 3T System are similar to the cleared 3T System (K052601), with a number of minor modifications to the hardware, software and labeling of the device. Both devices employ an independent (i.e., independent of the water supply) heating/cooling base unit that includes three water circuits (two circuits for the patient supplied by one tank (for the heating/cooling blanket, the oxygenator) and one interchangeable heating/cooling circuit for cardioplegia. Both devices can also be used with the same types of optional components and accessories, including heating-cooling blankets and various cables and tubing.

Performance Data

The Company conducted performance testing that verified the modifications made to the 3T System reduced the risk of transmission of aerosolized mycobacteria. Testing including the following:

Testing to VerifyReduction in Emission	Microbiological and orthogonal assay testing during all phases of device operation to evaluate device emissions; Microbiological testing to verify that the hydrophobic filter of the disposable aerosol collection set's canister adequately prevents contamination of the user facility's vacuum source; and Microbiological and orthogonal assay testing to verify the seven-day use period of the disposable aerosol collection set.
Aerosol Collection SetTesting	Testing to verify the chemical resistance of the materials in this disposable Aerosol Collection Set, the integrity and efficacy of the disposable Aerosol Collection Set, and the integrity of the packaging design of the disposable Aerosol Collection Set
Heating and CoolingTesting	Testing to verify the performance of the heating and cooling functions of the 3T System using a patient simulator circuit.
Corrosion and ErosionTesting	Testing to evaluate the chemical resistance of the metallic and plastic component and materials of the 3T System.
Cleaning, Disinfection,and Preservation of theWater Circuit	Validation testing of the cleaning, disinfection, and water preservation instructions provided in the 3T System Operating Instructions per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" demonstrated an intermediate level of disinfection. Long-term testing (58 weeks) of the cleaning, disinfection, and water preservation instructions verified that the instructions adequately prevent contamination of the device.
Cleaning andDisinfection of 3TSystem Surfaces	Validation testing of the 3T System surface cleaning instructions provided in the 3T System Operating Instructions.
Transportation andStorage	Testing of the transportation and shipping packaging of the 3T System.
Qualification of theDisinfection and Drying	Process validation testing of the production disinfection and drying processes

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Process used in Production
Human Factors Testing	• Human factors validation testing of the 3T System Operating Instructions.

Substantial Equivalence

The Final Configuration 3T System has very similar indications for use as the cleared 3T System. In addition, the Final Configuration and cleared 3T Systems have the same fundamental scientific technology, and similar technological characteristics. As explained in the attached 510(k) notice, the minor differences discussed do not raise new or different questions of safety or effectiveness. Furthermore, performance and validation testing demonstrate that the modified 3T System is as safe and effective as the predicate device. Thus, the Company maintains that the Final Configuration 3T System is substantially equivalent to its predicate device.

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).