· In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period: 7 days)

The Cool Line Catheter Model CL-2295A, when used with the ZOLL Thermal Regulation System, is indicated for use in fever reduction, as an adjunct to antipyretic therapy. in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893A, connected to the ZOLL Coolgard/Thermogard Thermal Regulation System, is indicated for use:

• In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and

· To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.
The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use:

• In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and

· To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.

Device Description

The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQ™ Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the Thermogard HQ™ Console, Thermogard HQ™ Start-Up Kit and Thermogard HQTM Start-Up Kit EX. The Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, and Quattro Intravascular Heat Exchange Catheter are also included as part of the system but are unchanged compared to the predicate device.

AI/ML Overview

This is a medical device submission, meaning that the device's performance is compared to a predicate device to prove substantial equivalence, rather than establishing new acceptance criteria against a clinical outcome.

Here's a breakdown of the information provided, focused on the device's performance and studies:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, "acceptance criteria" are implied by the successful "Pass" conclusions from all non-clinical performance and safety tests. The reported device performance is that it met all tested requirements and standards, leading to a "Pass" for each test. The document doesn't define explicit numerical acceptance criteria in the way one might for a new device's clinical efficacy, but rather relies on established test methods and standards for medical device safety and performance.

Test Category	Test Method Summary	Conclusion
Console & Start-Up Kit
Air Trap Insertion / Removal	Test method verifies that the Thermogard HQTM Start-Up Kit Air Trap may be inserted into and removed from the Thermogard HQTM Console as intended.	Pass
Console Warming and Cooling	Test method verifies that the system cools and warms as intended.	Pass
Electrical Safety	Test methods verify that the system meets electrical safety standards.	Pass
Electromagnetic Compatibility	Test method verifies that the system meets electrical immunity and emissions standards.	Pass
Human Factors / Usability	Test methods validate the device for human factors per the intended use.	Pass
Software Verification	Test methods verify that the software meets software requirements.	Pass
Console Specific
Data Module Functionality	Test methods verify that the Data Module meets applicable requirements.	Pass
Reliability	Test methods verify that the system meets the service life requirements.	Pass
Transit Testing	Test methods verify that the system meets the shipping and transit requirements.	Pass
Start-Up Kit Specific
Use Duration (Life) & Durability	Test methods verify that the Thermogard HQTM Start-Up Kits meet the duration of use requirements.	Pass
Leak Testing	Test methods verify that the Thermogard HQTM Start-Up Kits meet the leak requirements.	Pass
Tensile Testing	Test methods verify that the Thermogard HQTM Start-Up Kits meet the tensile strength requirements.	Pass
Transit and Environmental	Test methods verify that the Thermogard HQTM Start-Up Kits meet the shipping and transit requirements.	Pass

The document also includes a table of mortality results from a randomized controlled trial (RCT) involving the Cool Line Intravascular Heat Exchange Catheter for fever reduction in different patient cohorts (CI, ICH, PTBI, SAH) to highlight a specific warning regarding safety in SAH and PTBI patients. This is not about the acceptance criteria for the new device but rather a critical safety warning based on prior clinical data for a related product line.

		Cool Line				Control
	n	N	%	n	N	%	p*
CI	3	16	18.8	3	14	21.4	0.74
ICH	8	33	24.2	7	27	25.9	1.00
PTBI	10	44	22.7	4	38	10.5	0.24
SAH	13	61	21.3	7	63	11.1	0.15
*Fischer's exact test

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

The document explicitly states: "No clinical performance data were determined to be necessary to demonstrate substantial equivalence." This means the device was cleared based on non-clinical (laboratory and engineering) testing and comparison to a predicate device. Therefore, there is no "test set" in the sense of patient data for this specific submission.

The clinical trial mentioned for the Cool Line Intravascular Heat Exchange Catheter (related but not the subject of this 510(k)) involved 296 patients in a randomized controlled trial. The provenance of this data (country of origin, retrospective/prospective) is not specified in this document, other than it being a "randomized controlled trial."

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

Since no clinical test set was used for this 510(k) submission to establish substantial equivalence, this information is not applicable. The non-clinical tests were evaluated against established engineering, safety, and performance standards.

4. Adjudication Method for the Test Set

As there was no clinical test set for this 510(k) submission, an adjudication method is not applicable.

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

No MRMC comparative effectiveness study was mentioned or performed for this 510(k) submission. MRMC studies are typically for image analysis or diagnostic aid devices where human readers interpret results. This device is a thermal regulating system.

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

This device is a hardware system (thermal regulating console and catheters) rather than an AI algorithm. Therefore, a standalone study for an algorithm is not applicable. The "algorithm" here refers to the console's internal control logic, which was verified through software verification and console warming/cooling tests.

7. Type of Ground Truth Used

For the 510(k) submission of the Thermogard HQ system, the "ground truth" for the non-clinical tests was established by recognized industry standards, device specifications, and engineering requirements. This means the device either met or did not meet the predefined criteria for electrical safety, EMI, software functionality, durability, etc.

For the Cool Line Catheter's clinical trial data (mentioned as a warning, not part of this 510(k)'s clearance criteria), the ground truth for outcomes (mortality) would have been patient outcomes data collected during the randomized controlled trial.

8. Sample Size for the Training Set

Since this is not an AI/ML algorithm submission and no clinical data was required for this 510(k) clearance, a "training set" in the context of machine learning is not applicable. The device's design was developed based on established engineering principles and prior device models.

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

As there is no training set mentioned in the context of an AI/ML model for this submission, this information is not applicable.

Summary

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June 2, 2022

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized human figure. The U.S. Food & Drug Administration logo is on the right and features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

ZOLL Circulation, Inc. Elizabeth Haines Senior Director, Regulatory Affairs 2000 Ringwood Avenue San Jose, California 95131

Re: K220008

Trade/Device Name: Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console, Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II

Product Code: NCX Dated: April 29, 2022 Received: May 2, 2022

Dear Elizabeth Haines:

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 and the limitations described below. 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 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.

The OHTS: Office of Neurological and Physical Medicine Devices has determined that there is a reasonable likelihood that the Solex 7 Intravascular Heat Exchange Catheter will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the box warning immediately following the indications for use statement of the device's labeling:

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Warning - Fever Reduction

The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury. A randomized controlled trial of endovascular cooling in patients with fever associated with subarachnoid hemorrhage and primary traumatic brain injury has shown increased mortality as compared to patients receiving standard of care.

The OHT5: Office of Neurological and Physical Medicine Devices has determined that there is a reasonable likelihood that the Cool Line Intravascular Heat Exchange Catheter will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the box warning immediately following the indications for use statement of the device's labeling:

Warning - Fever Reduction

The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was examined in a randomized controlled trial of 296 patients. The mortality results reported in this trial, for the four patient cohorts enrolled, are presented in the table below (CI - cerebral infarction, ICH - intracerebral hemorrhage, PTBI - primary traumatic brain injury, SAH subarachnoid hemorrhage).

		Cool Line				Control
	n	N	%	n	N	%	p*
CI	3	16	18.8	3	14	21.4	0.74
ICH	8	33	24.2	7	27	25.9	1.00
PTBI	10	44	22.7	4	38	10.5	0.24
SAH	13	61	21.3	7	63	11.1	0.15

*Fischer's exact test

For more details on the clinical trial results, refer to the Physician's Manual - "Normothermia for the Neurocritically Ill stroke patient."

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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.

{2}------------------------------------------------

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 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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.

Christopher M. Loftus M.D. Acting Director OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220008

Device Name

Indications for Use (Describe)

The Solex 7 Intravascular Heat Exchange Catheter connected to the Coolgard/Thermogard Thermal Regulation System is indicated for use:

· In cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care. (Maximum use period: 4 days)

· To induce, maintain and reverse mild hypothermia in neurosurgery and recovery/intensive care.

(Maximum use period: 4 days)

Warning - Fever Reduction

			WARNING - Fever ReductionThe safety of this device has not been demonstrated for feverreduction in patients presenting with subarachnoid hemorrhageor primary traumatic brain injury. The safety and effectiveness ofthis device was examined in a randomized controlled trial of 296patients. The mortality results reported in this trial, for the fourpatient cohorts enrolled, are presented in the table below (CI -cerebral infarction, ICH - intracerebral hemorrhage, PTBI - pri-mary traumatic brain injury, SAH - subarachnoid hemorrhage).

		Cool Line			Control
	n	N	%	n	N	%	D*
Cl	ਤੋ	16	18.8	ਤ	14	21.4	0.74
ICH	8	33	24.2	7	27	25.9	1.00
РТВІ	10	44	22.7	4	38	10.5	0.24

For more details on the clinical trial results, refer to the Physician's Manual - "Normothermia for the Neuro- critically III stroke patient"

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The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893A, connected to the ZOLL Coolgard/Thermogard Thermal Regulation System, is indicated for use:

• In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and

· To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.
The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use:

• In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and

· To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.
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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K220008 510(k) SUMMARY

Date Prepared:	May 31, 2022
Submitter:	ZOLL Circulation, Inc.
Address:	2000 Ringwood AvenueSan Jose, CA 95131
Phone:	978-421-9291
Fax:	408-541-1030
Contact Person:	Elizabeth Haines, Senior Director Regulatory Affairs
Submission Author:	Melissa Paffenroth, Manager Regulatory Affairs
Trade Name:	Solex 7 Intravascular Heat Exchange CatheterCool Line Intravascular Heat Exchange CatheterICY Intravascular Heat Exchange CatheterQuattro Intravascular Heat Exchange CatheterThermogard HQTM Start-Up KitThermogard HQTM Start-Up Kit EXThermogard HQTM Console
Common Name:	Central Venous Catheter (short term) and Thermal Regulating System
Classification/Name:	Class II; System, Hypothermia, Intravenous, Cooling
Regulation:	21 CFR 870.5900, Thermal Regulating System
Product Code:	NCX
Predicate Device:	K213031, Solex 7® Intravascular Heat Exchange Catheter, CoolLine® Intravascular Heat Exchange Catheter, ICY® IntravascularHeat Exchange Catheter, Quattro® Intravascular Heat ExchangeCatheter, Start-Up Kit, Coolgard 3000® Console, Thermogard XP®Console

I. DEVICE DESCRIPTION

II. INDICATIONS FOR USE

The Thermogard HQ™ Console and Thermogard HQ™ Start-Up Kit (EX) are not intended to be used separately from the heat exchange catheters and do not have specific indications for use. The indications for use of the Solex 7® Intravascular Heat Exchange Catheter, Cool Line® Intravascular Heat Exchange Catheter, ICY® Intravascular Heat Exchange Catheter, Quattro® Intravascular Heat Exchange Catheter are identical to the indications for use of the predicate device.

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Indications for Use

Solex 7® Intravascular Heat Exchange Catheter

The Solex 7® Intravascular Heat Exchange Catheter connected to the CoolgardThermal Regulation System is indicated for use:

. In cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care. (Maximum use period: 4 days)
To induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and . recovery/intensive care. (Maximum use period: 4 days)
. In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period: 7 days)

Warning - Fever Reduction

Cool Line® Intravascular Heat Exchange Catheter

The Cool Line® Catheter Model CL-2295A, when used with the ZOLL® Thermal Regulation System, is indicated for use in fever reduction, as an adjunct to antipyretic therapy, in adult patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

Warning - Fever Reduction

infarction, ICH - intracerebral hemorrhage, PTBI - primary traumatic brain injury, SAH subarachnoid hemorrhage).

	Cool Line®			Control
	n	N	%	n	N	%	p*
CI	3	16	18.8	3	14	21.4	0.74
ICH	8	33	24.2	7	27	25.9	1.00
PTBI	10	44	22.7	4	38	10.5	0.24
SAH	13	61	21.3	7	63	11.1	0.15

*Fischer's exact test

For more details on the clinical trial results, refer to the Physician's Manual – "Normothermia for the Neuro-critically Ill stroke patient."

{7}------------------------------------------------

ICY® Intravascular Heat Exchange Catheter

The ZOLL® ICY® Intravascular Heat Exchange Catheter Model IC-3893A, connected to the ZOLL® Coolgard/Thermogard Thermal Regulation System, is indicated for use:

. In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and
. To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.

Quattro® Intravascular Heat Exchange Catheter

The ZOLL® Quattro® Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use:

In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery . and recovery/intensive care, and
. To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.

III. TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICES COMPARED TO THE PREDICATE DEVICES

There were no changes to the intravascular heat exchange catheters as shown through comparison of the technological characteristics in Table 1 and 2. The comparison with the predicate Start-Up Kit and Start-Up Kit EX shows the technological characteristics of the proposed HOM Start-Up Kit and Thermogard HQTM Start-Up Kit EX to be substantially equivalent in Table 3. The comparison with the predicate Thermogard XP® Console shows the technological characteristics of the proposed Thermogard HOTM Console to be substantially equivalent in Table 4.

Feature	PREDICATE DEVICES	SUBJECT DEVICES
Device Name	Quattro® Intravascular HeatExchange Catheter, Cool Line®Intravascular Heat ExchangeCatheter, ICY® IntravascularHeat Exchange Catheter	Quattro® Intravascular HeatExchange Catheter, Cool Line®Intravascular Heat ExchangeCatheter, ICY® IntravascularHeat Exchange Catheter
510(k) Number	K213031	K220008
Class	II	Same
Classification/RegulationName	System, Hypothermia, Intravenous,Cooling/Thermal RegulatingSystem	Same
Regulation Number	21 CFR 870.5900	Same
Product Code	NCX	Same
Feature	PREDICATE DEVICES	SUBJECT DEVICES
Insertion Site	Cool Line® - Femoral vein,jugular vein, subclavian veinICY® – Femoral veinQuattro® - Femoral vein	Same
Heparin Coating	SurModics ApplauseHeparin Coating	Same
Luer Designs	Inflow and outflow Luers:ZOLL® Custom LuersInfusion Luers: ZOLL®Standard LuersVent Caps: ZOLL® CustomVent Caps	Same
Luer Materials	Base material is polyurethane(for all Luers except for ventcaps)	Same
	Inflow and outflow Luers:Polyurethane: TecoplastOP-770-164 Orange
	Distal infusion Luer:Polyurethane:Tecoplast OP-770-477Brown(pad printing white ink)
	Medial Infusion Luer:Polyurethane:Tecoplast OP-770-White
	Proximal infusion Luer:Polyurethane: TecoplastOP-770-541 Dark Blue(pad printing white ink)
	Male vent cap: ABS: IneosLustran (P/N 348-012002)
	Female vent cap: ABS: IneosLustran (P/N 348-012002)
	Catheter Working Length(tip to manifold)		Cool Line® – 22 cmICY® - 38 cmQuattro® - 45 cm	Same
	Shaft Diameter		9.3 Fr	Same
	Number of Lumens		5 lumens: 2 infusion, 1 guidewire(plus infusion), 1 inflow, 1 outflow	Same
Guidewire Compatibility	0.032 in.	Same
Feature	PREDICATE DEVICES	SUBJECT DEVICES
Heat Exchange Balloons	Cool Line® - 2 (straight/coaxial)ICY®- 3 (straight/coaxial)Quattro® - 4 (straight/coaxial)	Same
Flow Rate (by lumen)	Cool Line®Distal - 2100 mL/hrMedial - 1200 mL/hrProximal – 1400 mL/hrICY®Distal – 1700 mL/hrMedial – 900 mL/hrProximal - 1200 mL/hrQuattro®Distal – 1300 mL/hrMedial – 800 mL/hrProximal - 1100 mL/hr	Same
Approx. Inflated Balloon OD(Cross-sectional Area)	Cool Line®: ~5 mm (20 mm2)ICY® and Quattro®: ~8 mm (50 mm2)	Same
Heat Exchange Power	Cool Line® – 65 Watts nominalICY®- 140 Watts nominalQuattro® – 190 Watts nominal	Same
Materials:Shaft	PolyurethanePET and Polyurethane (ICY® and Quattro®)	Same
Balloon	Polyurethane (Cool Line®)	Same
Sterilization Method andSterility Assurance Level(SAL)	Ethylene Oxide (EO) and SAL 10-6	Same

Table 1: Comparison of Subject and Predicate Catheters

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{9}------------------------------------------------

Table 2: Comparison of Subject Solex 7® Intravascular Heat Exchange Catheter with

Predicate

Feature	PREDICATE DEVICE	SUBJECT DEVICE
Device Name	Solex 7® IntravascularHeat Exchange Catheter	Solex 7® IntravascularHeat Exchange Catheter
510(k) Number	K213031	K220008
Class	II	Same
Classification/RegulationName	System, Hypothermia,Intravenous, Cooling/ThermalRegulating System	Same
Regulation Number	21 CFR 870.5900	Same
Product Code	NCX	Same
Heparin Coating	SurModics Applause HeparinCoating	Same
Feature	PREDICATE DEVICE	SUBJECT DEVICE
Luer Designs	Inflow and Outflow Luers:ZOLL® Custom LuersInfusion Luers: Standard LuersVent Caps: ZOLL® Custom VentCaps	Same
Luer Materials	Luer Base: Polyurethane (for allLuers except for vent caps)Inflow and outflow Luers:Polyurethane: Tecoplast OrangeDistal infusion Luer:Polyurethane: Tecoplast Brown(pad printing white ink)Medial infusion Luer:Polyurethane: Tecoplast WhiteProximal infusion Luer:Polyurethane: Tecoplast DarkBlue (pad printing white ink)Male vent cap: ABSFemale vent cap: ABS	Same
Catheter Working Length (tipto manifold)	20 cm	Same
Shaft Diameter	9.3 Fr	Same
Number of Lumens	5 lumens:2 infusion1 guidewire (also infusion)1 inflow1 outflow	Same
Guidewire Compatibility	0.032 in.	Same
Flow Rate (by lumen)	Distal - 1900 mL/hrMedial – 1300 L/hrProximal - 1300 mL/hr	Same
Heat Exchange Balloons	1 (serpentine)	Same
Inflated Balloon OD(Cross- Sectional Area)	Balloon OD: N/ACross-sectional Area: 54 mm2	Same
Cross Sectional Area (approx.inflated outer diameter)	54 mm2 (12.2 mm OD)	Same
Insertion Site	Jugular and Subclavian Veins	Same
Max. Use Period	7 Days	Same
Materials	Shaft: PolyurethaneHeat Exchange Balloon: PET	Same
Feature	PREDICATE DEVICE	SUBJECT DEVICE
Sterilization Method and SAL	EO and SAL 10-6	Same

{10}------------------------------------------------

{11}------------------------------------------------

Table 3: Comparison of the subject Thermogard HQ™ Start-Up Kit with predicate Start-Up Kit
--------------------------------------------------------------------------------------------	--	--	--	--

Feature	PREDICATE DEVICE	SUBJECT DEVICE
Device Name	Start-Up KitStart-Up Kit EX	Thermogard HQTM Start-Up KitThermogard HQTM Start-Up Kit EX
510(k) number	K213031	K220008
Model	CG-500DCG-500D EX	TGHQ-500DTGHQ-500D EX
Class	II	Same
Classification/Regulation Name	System, Hypothermia,Intravenous, Cooling/ThermalRegulating System	Same
Regulation Number	21 CFR 870.5900	Same
Product Code	NCX	Same
Patient Contact	Indirect Patient Contact	Same
Luer Function	Join the SUK to theInFlow/OutFlow Lumens of thecatheters, and allow saline tocirculate through thecatheter/start-up kit fluid path	Same
Supplied 20 ml SterileDeflation (Slip-Fit)Syringe	Syringe provided with SUK foroptional removal of saline fromcatheter heat exchange balloonsprior to catheter removal	Same
Sterilization Method andSAL	Gamma sterilization SAL 10-6	Same
Shelf Life	2 years	Same
IV Spike design	Bonded into a short section oflarger tubing at the end of thetubing set.	New component with integratedpockets into which the inlet andoutlet tubing are bonded.Revised spike geometry for ease ofinsertion.
Materials:
Start-up Kit tubing	Polyvinyl chloride	Same
Luer	Polyvinyl chloride	Same
Spike	Acrylonitrile butadiene styrene	Same

Table 4: Comparison of the subject Thermogard HQ™ Console and predicate Thermogard XP® Console

Feature	PREDICATE DEVICE	SUBJECT DEVICE
Device Name	Thermogard XP® Console	Thermogard HQ TM Console
510(k) number	K213031	K220008
Principle of Operation	It automatically adjusts the temperature of aheater/chiller glycol bath to achieve thepatient target temperature that has previously	Same
Feature	PREDICATE DEVICE	SUBJECT DEVICE
	been set by the attending physician. Atemperature probe is used to monitor thepatient temperature, a catheter is used toexchange heat to and from the patient, andthe delta between the target temperature andpatient temperature defines the temperatureof the saline pumped through the catheter. Aheat exchanger placed within the glycol bathheats and cools the saline in the catheter.
	Class		Class II	Same
	Classification/RegulationName		System, Hypothermia, Intravenous, Cooling	Same
	Regulation Number		21 CFR 870.5900	Same
	Product Code		NCX	Same
	Patient Contact		No direct patient contact	Same
	Physical:
	1. Dimensions		Height: 45 in. (114 cm)Width: 17 in. (43 cm)Depth: 30 in. (76 cm)	Same
	2. Weight		107 lb. (49 kg)
Electrical:
1. Configuration	100-120 VAC, 50/60 Hz, 5 A220-240 VAC, 50/60 Hz, 2.25 A	Same
2. Voltage	115 V - 230 V
3. Fuse protection	T6.3A (slow blow) 5 x 20mmLag: 60ms@60A BreakingCapacity: 63A @ 250VAC
Environmental:		Same
1. Operatingtemperatures	10° C – 27° C (50° F – 81° F)
2. Operating humidity	30% to 75% noncondensing70 kPa to 106 kPa
3. Atmospheric pressure:
Chiller and Heater:
1. Reservoir volume	2.0 liters (0.5 gal.)	Same
2. Pump capacity	7 lpm at 0 m head (0 ft.)	Same
3. Temperature range	0° C - 42° C	Same
4. Coolant	1:1 mixture of propylene glycol and distilledwater	1:1 mixture of propyleneglycol and deionized water
5. Refrigerant	RFC 134a	Same
Feature	PREDICATE DEVICE	SUBJECT DEVICE
6. Nominal Power (mustbe greater than)	190 watts	Same
Controller and Display
1. Screen display	6.4 in. (16.25 cm) LCD color VGA	Same
2. Controls	Pushbuttons and knob	Same
3. Temperature input	Thermistor, YSI 400 series	Same
4. Articulation	180° swivel, 45° tilt	Same
5. Data interface	Serial RS-232C, 9-pin sub-D connector	USB, Wi-Fi, Digital EMRoutput (IOIOI), Patienttemperature output (T1Out)
6. Alarms	Audible tones and displayed text messages	Same
7. Displayed temperaturerange	26° C–42° С	Same
8. Displayed temperatureaccuracy	± 0.2° C	Same
Saline Coolant Circuit
1. Priming volume	200 ml	Same
2. Heat exchanger	Disposable stainless steel coil	Same
3. Priming source	Sterile saline solution (hospital-provided)	Same
4. Patient connection	Directional Luer connections on72 in. (183 cm) lines	Same
5. Pump tubing	Roller pump compatible with directionalfittings	Same
6. Sterility	Gamma sterilized	Same
7. Saline alarm	Reservoir level detection & alarm system	Same
8. Coolant circuitoperating life	Replace disposable components after seven(7) days of continuous use	Same
EquipmentClassifications:
1. Type of protectionagainst moisture	Ordinary	Same
2. 60601 Safety Class	Type BF for temperature inputs	Same
Feature	PREDICATE DEVICE	SUBJECT DEVICE
	Type B for catheter connections
3. Protection class	1
4. Mode of operation	Continuous
Start-Up Kit Accessory	Model CG-500D	TGHQ-500D
	Model CG-500D EX	TGHQ-500D EX

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IV. SUMMARY OF THE NONCLINICAL TESTS PERFORMED

Non-clinical performance testing was conducted to verify the performance of the Thermogard HQ™ Console, Thermogard HQ™ Start-Up Kit and Thermogard HQ™ Start-Up Kit EX. The following performance data were provided in support of substantial equivalence determination between the subject and predicate devices.

Test	Test Method Summary	Conclusion
Air Trap Insertion / Removal	Test method verifies that the Thermogard HQTM Start-Up Kit Air Trap may be inserted into and removed from the Thermogard HQTM Console as intended.	Pass
Console Warming and Cooling	Test method verifies that the system cools and warms as intended.	Pass
Electrical Safety	Test methods verify that the system meets electrical safety standards.	Pass
Electromagnetic Compatibility	Test method verifies that the system meets electrical immunity and emissions standards.	Pass
Human Factors / Usability	Test methods validate the device for human factors per the intended use.	Pass
Software Verification	Test methods verify that the software meets software	Pass

Table 5: Performance testing for the Thermogard HOTM Console and Thermogard HOTM Start-Up
Kits

Table 6: Performance testing specific only to the Thermogard HQTM Console

requirements.

Test	Test Method Summary	Conclusion
Data Module Functionality	Test methods verify that the Data Module meets applicable requirements.	Pass
Reliability	Test methods verify that the system meets the service life requirements.	Pass

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Test	Test Method Summary	Conclusion
Transit Testing	Test methods verify that the system meets the shipping and transit requirements.	Pass

					Table 7: Performance testing specific only to the Thermogard HQTM Start-Up Kits
--	--	--	--	--	---------------------------------------------------------------------------------	--

Test	Test Method Summary	Conclusion
Use Duration (Life) andDurability Testing	Test methods verify that theThermogard HQTM Start-Up Kitsmeet the duration of userequirements.	Pass
Leak Testing	Test methods verify that theThermogard HQTM Start-Up Kitsmeet the leak requirements.	Pass
Tensile Testing	Test methods verify that theThermogard HQTM Start-Up Kitsmeet the tensile strengthrequirements.	Pass
Transit and Environmental	Test methods verify that theThermogard HQTM Start-Up Kitsmeet the shipping and transitrequirements.	Pass

Safety testing per the international recognized standards

The proposed Thermogard HQ™ Console, Thermogard HQ™ Start-Up Kit, and Thermogard HQ™ Start-Up Kit EX were tested and all requirements were met from each applicable FDA recognized consensus standard.

Table 8: Thermogard HQTM Console, Thermogard HQTM Start-Up Kit, Thermogard HQTM Start-
Up Kit EX Standards

FDA Consensus Number	Standard	Year
5-125	ISO 14971	2019
5-117	ISO 15223	2016
19-8	IEC 60601-1-2	2014
19-4	IEC 60601-1	2005/A1:2012
5-89	IEC 60601-1-6	2010+ A1:2013
5-76	IEC 60601-1-8	2006+ A1:2012
19-9	IEC 60601-1-10	2007+A1:2013
6-421	ISO 80601-2-56	2017
13-79	IEC 62304:2006/Amd1	2015
5-129	IEC 62366-1	2015/Cor1:2016
5-57	ANSI/AAMI HE 75	2009/(R)2013
5-89	EN 60601-1-6 Edition 3.1	2013-10
14-499	ASTM D4169	2016
2-245	ISO 10993-5	1999
2-191	ISO 10993-12	2002
14-514	ISO 11737-1	2018

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FDA Consensus Number	Standard	Year
14-540	ISO 11737-2	2019

V. SUMMARY OF THE CLINICAL TESTS PERFORMED

No clinical performance data were determined to be necessary to demonstrate substantial equivalence.

VI. CONCLUSION

The Thermogard HQ™ Console, Thermogard HQ™ Start-Up Kit and Thermogard HQ™ Start-Up Kit EX meet their design, performance, and safety specifications when used in accordance with the labeling. The differences between the subject and predicate devices do not raise new questions of safety and effectiveness. It was demonstrated through performance testing, and comparison of design features that the proposed devices are substantially equivalent to 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).