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

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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). {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | | |---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | <span style="font-size: 10px;"> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10px;"> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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GENERAL INFORMATION | Date Prepared: | October 31, 2023 | |-----------------------------|----------------------------------------------------------------------------------------------| | Submitter: | ZOLL Circulation, Inc. | | Address: | 2000 Ringwood Avenue<br>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<br>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 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. {4}------------------------------------------------ #### 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<br>Device | | | | | Proprietary Name | Thermogard HQ and<br>XP Temperature<br>Management System | EMCOOLSpad | IQool™ System | | | | | Common Name | Thermal Regulating<br>System | Thermal Regulating<br>System | Thermal Regulating<br>System | | | | | Product<br>Classification Code | NZE | NZE | NZE | | | | | Product Regulation<br>Number & Name | 21 CFR 870.5900,<br>Thermal Regulating<br>System | 21 CFR 870.5900,<br>Thermal Regulating<br>System | 21 CFR 870.5900,<br>Thermal Regulating<br>System | | | | | Device Class | Class II | Class II | Class II | | | | | Device Description | System, Thermal<br>Regulating | System, Thermal<br>Regulating | System, Thermal<br>Regulating | | | | | Indications For Use | Temperature reduction<br>in adult patients where<br>clinically indicated,<br>e.g., in hyperthermic<br>patients. | Temperature reduction<br>in adult patients where<br>clinically indicated,<br>e.g., in hyperthermic<br>patients. | Temperature reduction<br>in adult patients where<br>clinically indicated,<br>e.g., in hyperthermic<br>patients. | | | | | Technical<br>Specifications | Achieves cooling with<br>patient contacting<br>Cooling Pads through<br>which coolant (saline)<br>is circulated. Cooling is<br>controlled by the<br>settings on the device.<br>Consistent temperature<br>reduction is maintained<br>and controlled by the<br>system pushing more<br>or less coolant through<br>the pads as needed<br>achieve or maintain<br>desired cooling. | Achieves cooling<br>through patient<br>contacting Cooling<br>Pads which are filled<br>with a high thermal<br>conductivity material.<br>Pads must be pre-<br>cooled before use. To<br>control cooling, pads<br>are removed from the<br>patient's skin to slow<br>cooling or to stop<br>cooling. The pads are<br>re-applied to the<br>patient's skin to<br>recommence the<br>cooling process. | Achieves cooling with<br>patient contacting<br>Cooling Pads through<br>which coolant is<br>circulated. Cooling is<br>controlled by the<br>settings on the device.<br>Consistent temperature<br>reduction is maintained<br>and controlled by the<br>system pushing more or<br>less coolant through the<br>pads as needed achieve<br>or maintain desired<br>cooling. | | | | {5}------------------------------------------------ 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.