The subject of this 510(k) is the new surface feature which makes minor modifications to the existing IVTM Start-Up Kits (SUKs) to enable connection of a Thermogard console to the STx™ Vest provides for circulation of thermally conditioned fluid supplied by the Thermogard console (either Thermogard HQ™ or Thermogard XP®). Transfer of heat between the patient and the circulating fluid results in modification of patient core temperature for the purpose of therapeutic patient temperature modulation.

The existing, commercialized Thermogard Systems (Thermogard HQTM and Thermogard XP®) are used in conjunction with catheters placed in the vasculature to support intravascular cooling. The TGHQ-SURF accessory is a modification of the model TGHQ-500D accessory which was verified, validated, and commercialized. The CG-SURF accessory is a modification of the model CG-500D accessory which was verified, validated, and commercialized. These Surface SUK models are identical to their predecessors with the exception of longer inflow and outflow tubing lengths and replacing the Luers for catheters with 0.25inch hose barb valved connectors for the STx™ Vest. The Surface SUK also has a label on the fluid spike to indicate the size of bag of fluid (3000ml) to use and to mark it as non-sterile. The Surface SUKs are otherwise identical to their predecessors in terms of materials that contact the heat exchange fluid (i.e., saline), manufacturing process, and packaging materials.

There are no changes to the commercially available Thermogard XP® (K213031) and Thermogard HO™ (K220008) consoles.

There are no changes to the commercially available STxTM Vest.

AI/ML Overview

The provided document is an FDA 510(k) summary for a medical device called the "Thermogard HQ™ Temperature Management System" and "Thermogard XP® Temperature Management System." These devices are thermal regulating systems used for temperature reduction in adult hyperthermic patients.

The document does not describe:

Acceptance criteria for an AI/ML powered device. This device is a hardware system, not an AI/ML product.
Performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML diagnostic tools.
Any information regarding training sets, test sets, ground truth establishment by experts, or MRMC studies.

Therefore, the requested information cannot be extracted from this document, as it pertains to a different type of medical device lacking AI/ML components and the typical studies associated with them.

To directly answer your request based on the lack of relevant information in the provided text:

1. A table of acceptance criteria and the reported device performance:
Not applicable. The document describes a physical temperature management system, not a device with acceptance criteria based on AI/ML performance metrics like sensitivity or specificity. Performance testing mentioned is related to dimensional verification, functional testing, temperature behavior, shipping and handling, and electrical/EMC standards, not diagnostic accuracy.

2. Sample size used for the test set and the data provenance:
Not applicable. There is no mention of a "test set" in the context of an AI/ML algorithm's performance evaluation. The document refers to "performance testing" of the hardware system, but provides no sample sizes or data provenance (country of origin, retrospective/prospective) for such tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment by experts is relevant for AI/ML diagnostic devices, not for this hardware temperature management system.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are used in studies involving human interpretation or AI/ML model output validation, which is not described here.

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:
Not applicable. This device is not an AI-assisted diagnostic tool, so an MRMC study is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no AI algorithm in this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. Ground truth as typically understood in AI/ML validation is not relevant for this device. The "ground truth" for a temperature management system would be its ability to accurately and safely control patient temperature, which is assessed through engineering and functional testing, not diagnostic ground truth methods.

8. The sample size for the training set:
Not applicable. There is no AI/ML component that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. As above, there is no AI/ML component or training set.

In summary, the provided FDA 510(k) summary is for a traditional medical device (hardware for temperature management) and does not contain the information requested regarding acceptance criteria and studies for an AI/ML powered device. The document explicitly states "Clinical performance data to demonstrate substantial equivalence was not required." meaning the evaluation was based on non-clinical (engineering and functional) tests.

Summary

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November 3, 2023

ZOLL Circulation, Inc Sean Manning Senior Manager, Regulatory Affairs 2000 Ringwood Avenue San Jose, California 91531

Re: K231182

Trade/Device Name: Thermogard HQTM Temperature Management System, Thermogard XP® Temperature Management System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: NZE Dated: October 12, 2023 Received: October 12, 2023

Dear Sean Manning:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-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 Advice (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,

Nicole M. Gillette -S

Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K231182

Device Name

Thermogard HQ Temperature Management System Thermogard XP Temperature Management System

Indications for Use (Describe)

Thermogard HO™ Temperature Management System Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients.

Thermogard XP® Temperature Management System Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients.

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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510(K) SUMMARY

I. GENERAL INFORMATION

Date Prepared:	October 31, 2023
Submitter:	ZOLL Circulation, Inc.
Address:	2000 Ringwood AvenueSan Jose, CA 95131
Phone:	707-696-6666
Fax:	408-541-1030
Contact Person:	Sean Manning, Senior Manager Regulatory Affairs
Secondary Contact:	Nazma Chaudhry, Director Regulatory Affairs
Trade Name:	Thermogard HQ™ Temperature Management SystemThermogard XP® Temperature Management System
Common Name:	Thermal Regulating System
Classification/Name:	Class II; System, Thermal Regulating
Regulation:	21 CFR 870.5900, Thermal Regulating System
Product Code:	NZE
Primary Predicate Device:	K100071 EMCOOLSpad
Secondary Predicate Device:	K162523 The IQool™ System

II. DEVICE DESCRIPTION

There are no changes to the commercially available Thermogard XP® (K213031) and Thermogard HO™ (K220008) consoles.

There are no changes to the commercially available STxTM Vest.

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INDICATIONS FOR USE III.

Thermogard HQ™ Temperature Management System

Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients.

Thermogard XP® Temperature Management System

Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients.

SUBSTANTIAL EQUIVALENCE DISCUSSION IV.

Thermogard Temperature Management System Non-Confidential 510(k) Summary
Comparison of Subject to Predicate Device:
Description	Subject Device	Predicate Device	Secondary PredicateDevice
Proprietary Name	Thermogard HQ andXP TemperatureManagement System	EMCOOLSpad	IQool™ System
Common Name	Thermal RegulatingSystem	Thermal RegulatingSystem	Thermal RegulatingSystem
ProductClassification Code	NZE	NZE	NZE
Product RegulationNumber & Name	21 CFR 870.5900,Thermal RegulatingSystem	21 CFR 870.5900,Thermal RegulatingSystem	21 CFR 870.5900,Thermal RegulatingSystem
Device Class	Class II	Class II	Class II
Device Description	System, ThermalRegulating	System, ThermalRegulating	System, ThermalRegulating
Indications For Use	Temperature reductionin adult patients whereclinically indicated,e.g., in hyperthermicpatients.	Temperature reductionin adult patients whereclinically indicated,e.g., in hyperthermicpatients.	Temperature reductionin adult patients whereclinically indicated,e.g., in hyperthermicpatients.
TechnicalSpecifications	Achieves cooling withpatient contactingCooling Pads throughwhich coolant (saline)is circulated. Cooling iscontrolled by thesettings on the device.Consistent temperaturereduction is maintainedand controlled by thesystem pushing moreor less coolant throughthe pads as neededachieve or maintaindesired cooling.	Achieves coolingthrough patientcontacting CoolingPads which are filledwith a high thermalconductivity material.Pads must be pre-cooled before use. Tocontrol cooling, padsare removed from thepatient's skin to slowcooling or to stopcooling. The pads arere-applied to thepatient's skin torecommence thecooling process.	Achieves cooling withpatient contactingCooling Pads throughwhich coolant iscirculated. Cooling iscontrolled by thesettings on the device.Consistent temperaturereduction is maintainedand controlled by thesystem pushing more orless coolant through thepads as needed achieveor maintain desiredcooling.

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The subject device is identical to the predicates in the indications for use. The mechanism of action to achieve the intended use is equivalent between the subject and predicate devices.

V. SUMMARY OF THE NONCLINICAL TESTS PERFORMED

Testing was completed for the Thermogard Temperature Management System used with the Surface Start-Up Kit and STx™ Vest which demonstrated intended, labeled device performance. Performance testing included dimensional verification, functional testing, temperature, shipping and handling, and standards testing included electrical safety, electromagnetic compatibility, and usability. All testing confirmed that the Thermogard Temperature Management System used with the Surface Start-Up Kit and STx™ Vest operates as described and is substantially equivalent to the predicate devices.

SUMMARY OF THE CLINICAL TESTS PERFORMED VI.

Clinical performance data to demonstrate substantial equivalence was not required.

VII. CONCLUSION

The Thermogard HQTM Temperature Management System and the Thermogard XP® Temperature Management System used with the Surface Start-Up Kit and STx™ Vest meet the design, performance, and safety specifications when used in accordance with the labeling. It was demonstrated through performance testing, design and features, and non-clinical testing that the proposed devices are substantially equivalent to those of the predicate devices.

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).