K Number

Device Name

Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System

Manufacturer

ZOLL Circulation, Inc

Date Cleared

2023-11-03

(191 days)

Product Code

NZE

Regulation Number

870.5900

Intended Use

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.

Device Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K100071, K162523

Reference Devices

K213031,K220008

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a temperature management system that circulates fluid for heat exchange. There is no mention of AI, ML, or any computational analysis of data for decision-making or prediction. The changes described are purely mechanical and related to tubing and connectors.

Therapeutic

Yes.
The device's intended use is "Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients," and its description explicitly states "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." These statements indicate a direct therapeutic effect on the patient's condition.

Diagnostic

This device is a temperature management system designed for therapeutic patient temperature modulation (cooling) rather than for diagnosing a condition.

SaMD (Software as a Medical Device)

The device description explicitly details hardware components, including tubing, connectors, and modifications to existing hardware kits, all of which are integral to the device's function of circulating thermally conditioned fluid. The submission focuses on modifications to these physical components, not solely on software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients." This describes a therapeutic intervention applied directly to the patient to modify their core temperature.
Device Description: The device description details a system that circulates thermally conditioned fluid to transfer heat between the patient and the fluid, resulting in temperature modulation. This is a physical process for therapeutic purposes.
Lack of IVD Characteristics: The text does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in vitro (outside the living body).

The device is clearly designed for direct patient treatment and temperature management, which falls under the category of therapeutic medical devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

NZE

Device Description

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.

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

adult patients

Intended User / Care Setting

Prescription Use

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 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. Clinical performance data to demonstrate substantial equivalence was not required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K100071, K162523

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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).

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

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 Avenue
San 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 System
Thermogard 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.

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 Predicate
Device
Proprietary Name	Thermogard HQ and
XP Temperature
Management System	EMCOOLSpad	IQool™ System
Common Name	Thermal Regulating
System	Thermal Regulating
System	Thermal Regulating
System
Product
Classification Code	NZE	NZE	NZE
Product Regulation
Number & Name	21 CFR 870.5900,
Thermal Regulating
System	21 CFR 870.5900,
Thermal Regulating
System	21 CFR 870.5900,
Thermal Regulating
System
Device Class	Class II	Class II	Class II
Device Description	System, Thermal
Regulating	System, Thermal
Regulating	System, Thermal
Regulating
Indications For Use	Temperature reduction
in adult patients where
clinically indicated,
e.g., in hyperthermic
patients.	Temperature reduction
in adult patients where
clinically indicated,
e.g., in hyperthermic
patients.	Temperature reduction
in adult patients where
clinically indicated,
e.g., in hyperthermic
patients.
Technical
Specifications	Achieves cooling with
patient contacting
Cooling Pads through
which coolant (saline)
is circulated. Cooling is
controlled by the
settings on the device.
Consistent temperature
reduction is maintained
and controlled by the
system pushing more
or less coolant through
the pads as needed
achieve or maintain
desired cooling.	Achieves cooling
through patient
contacting Cooling
Pads which are filled
with a high thermal
conductivity material.
Pads must be pre-
cooled before use. To
control cooling, pads
are removed from the
patient's skin to slow
cooling or to stop
cooling. The pads are
re-applied to the
patient's skin to
recommence the
cooling process.	Achieves cooling with
patient contacting
Cooling Pads through
which coolant is
circulated. Cooling is
controlled by the
settings on the device.
Consistent temperature
reduction is maintained
and controlled by the
system pushing more or
less coolant through the
pads as needed achieve
or maintain desired
cooling.

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

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.