Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description mentions "feedback control" but does not include any terms or descriptions indicative of AI or ML, such as algorithms, training data, or specific AI/ML techniques. The performance studies focus on standard engineering and safety tests.

Therapeutic

Yes
The device is indicated for medical conditions such as achieving/maintaining normothermia in cardiac surgery patients, inducing/maintaining/reversing mild hypothermia in neurosurgery patients, and fever reduction in specific adult patients, all of which are therapeutic interventions.

Diagnostic

No

The device is indicated for therapeutic purposes, such as achieving/maintaining normothermia, inducing/maintaining/reversing hypothermia, and fever reduction, rather than for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states the system is comprised of an external heat exchange console and intravascular heat exchange catheter, which are hardware components. The submission also includes performance testing for hardware aspects like electrical safety, electromagnetic compatibility, and durability.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly describes a system for regulating patient body temperature through intravascular heat exchange. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
Device Description: The description details an external console and intravascular catheters that directly interact with the patient's circulatory system to manage temperature. This is consistent with a therapeutic device.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.

Therefore, this device falls under the category of a therapeutic medical device, specifically for temperature management, rather than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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)

· 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.

Product codes (comma separated list FDA assigned to the subject device)

NCX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Central venous circulation, Femoral vein, jugular vein, subclavian vein

Indicated Patient Age Range

Adult patients

Intended User / Care Setting

Attending physician / Recovery/intensive care; Surgery

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)

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.
Tests conducted included: Air Trap Insertion / Removal (Pass), Console Warming and Cooling (Pass), Electrical Safety (Pass), Electromagnetic Compatibility (Pass), Human Factors / Usability (Pass), Software Verification (Pass), Data Module Functionality (Pass), Reliability (Pass), Transit Testing (Pass), Use Duration (Life) and Durability Testing (Pass), Leak Testing (Pass), Tensile Testing (Pass), Transit and Environmental (Pass).
No clinical performance data were determined to be necessary.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K213031

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

0

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:

1

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

3

Indications for Use

510(k) Number (if known) K220008

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 HO Console

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)

· 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)

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 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.

| | | | 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 - 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"

4

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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5

K220008 510(k) SUMMARY

Date Prepared:	May 31, 2022
Submitter:	ZOLL Circulation, Inc.
Address:	2000 Ringwood Avenue
San 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 Catheter
Cool Line Intravascular Heat Exchange Catheter
ICY Intravascular Heat Exchange Catheter
Quattro Intravascular Heat Exchange Catheter
Thermogard HQTM Start-Up Kit
Thermogard HQTM Start-Up Kit EX
Thermogard 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, Cool
Line® Intravascular Heat Exchange Catheter, ICY® Intravascular
Heat Exchange Catheter, Quattro® Intravascular Heat Exchange
Catheter, Start-Up Kit, Coolgard 3000® Console, Thermogard XP®
Console

I. 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.

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.

6

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

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.

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

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 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 Heat
Exchange Catheter, Cool Line®
Intravascular Heat Exchange
Catheter, ICY® Intravascular
Heat Exchange Catheter	Quattro® Intravascular Heat
Exchange Catheter, Cool Line®
Intravascular Heat Exchange
Catheter, ICY® Intravascular
Heat Exchange Catheter
510(k) Number	K213031	K220008
Class	II	Same
Classification/Regulation
Name	System, Hypothermia, Intravenous,
Cooling/Thermal Regulating
System	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 vein
ICY® – Femoral vein
Quattro® - Femoral vein	Same
Heparin Coating	SurModics Applause
Heparin Coating	Same
Luer Designs	Inflow and outflow Luers:
ZOLL® Custom Luers
Infusion Luers: ZOLL®
Standard Luers
Vent Caps: ZOLL® Custom
Vent Caps	Same
Luer Materials	Base material is polyurethane
(for all Luers except for vent
caps)	Same
	Inflow and outflow Luers:
Polyurethane: Tecoplast
OP-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: Tecoplast
OP-770-541 Dark Blue
(pad printing white ink)
	Male vent cap: ABS: Ineos
Lustran (P/N 348-012002)
	Female vent cap: ABS: Ineos
Lustran (P/N 348-012002)
	Catheter Working Length
(tip to manifold)		Cool Line® – 22 cm
ICY® - 38 cm
Quattro® - 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/hr
Medial - 1200 mL/hr
Proximal – 1400 mL/hr

ICY®
Distal – 1700 mL/hr
Medial – 900 mL/hr
Proximal - 1200 mL/hr

Table 1: Comparison of Subject and Predicate Catheters

8

9

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

Predicate

Feature	PREDICATE DEVICE	SUBJECT DEVICE
Device Name	Solex 7® Intravascular
Heat Exchange Catheter	Solex 7® Intravascular
Heat Exchange Catheter
510(k) Number	K213031	K220008
Class	II	Same
Classification/Regulation
Name	System, Hypothermia,
Intravenous, Cooling/Thermal
Regulating System	Same
Regulation Number	21 CFR 870.5900	Same
Product Code	NCX	Same
Heparin Coating	SurModics Applause Heparin
Coating	Same
Feature	PREDICATE DEVICE	SUBJECT DEVICE
Luer Designs	Inflow and Outflow Luers:
ZOLL® Custom Luers
Infusion Luers: Standard Luers
Vent Caps: ZOLL® Custom Vent
Caps	Same
Luer Materials	Luer Base: Polyurethane (for all
Luers except for vent caps)

Inflow and outflow Luers:
Polyurethane: Tecoplast Orange

Distal infusion Luer:
Polyurethane: Tecoplast Brown
(pad printing white ink)

Medial infusion Luer:
Polyurethane: Tecoplast White

Proximal infusion Luer:
Polyurethane: Tecoplast Dark
Blue (pad printing white ink)

Male vent cap: ABS

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 Kit
Start-Up Kit EX	Thermogard HQTM Start-Up Kit
Thermogard HQTM Start-Up Kit EX
510(k) number	K213031	K220008
Model	CG-500D
CG-500D EX	TGHQ-500D
TGHQ-500D EX
Class	II	Same
Classification/Regulation Name	System, Hypothermia,
Intravenous, Cooling/Thermal
Regulating 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 the
InFlow/OutFlow Lumens of the
catheters, and allow saline to
circulate through the
catheter/start-up kit fluid path	Same
Supplied 20 ml Sterile
Deflation (Slip-Fit)
Syringe	Syringe provided with SUK for
optional removal of saline from
catheter heat exchange balloons
prior to catheter removal	Same
Sterilization Method and
SAL	Gamma sterilization SAL 10-6	Same
Shelf Life	2 years	Same
IV Spike design	Bonded into a short section of
larger tubing at the end of the
tubing set.	New component with integrated
pockets into which the inlet and
outlet tubing are bonded.
Revised spike geometry for ease of
insertion.
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 a
heater/chiller glycol bath to achieve the
patient target temperature that has previously	Same
Feature	PREDICATE DEVICE	SUBJECT DEVICE
	been set by the attending physician. A
temperature probe is used to monitor the
patient temperature, a catheter is used to
exchange heat to and from the patient, and
the delta between the target temperature and
patient temperature defines the temperature
of the saline pumped through the catheter. A
heat exchanger placed within the glycol bath
heats and cools the saline in the catheter.
	Class		Class II	Same
	Classification/Regulation
Name		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 A
220-240 VAC, 50/60 Hz, 2.25 A	Same
2. Voltage	115 V - 230 V
3. Fuse protection	T6.3A (slow blow) 5 x 20mm
Lag: 60ms@60A Breaking
Capacity: 63A @ 250VAC
Environmental:		Same
1. Operating
temperatures	10° C – 27° C (50° F – 81° F)
2. Operating humidity	30% to 75% noncondensing
70 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 distilled
water	1:1 mixture of propylene
glycol and deionized water
5. Refrigerant	RFC 134a	Same
Feature	PREDICATE DEVICE	SUBJECT DEVICE
6. Nominal Power (must
be 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 EMR
output (IOIOI), Patient
temperature output (T1
Out)
6. Alarms	Audible tones and displayed text messages	Same
7. Displayed temperature
range	26° C–42° С	Same
8. Displayed temperature
accuracy	± 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 on
72 in. (183 cm) lines	Same
5. Pump tubing	Roller pump compatible with directional
fittings	Same
6. Sterility	Gamma sterilized	Same
7. Saline alarm	Reservoir level detection & alarm system	Same
8. Coolant circuit
operating life	Replace disposable components after seven
(7) days of continuous use	Same
Equipment
Classifications:
1. Type of protection
against 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

12

13

14

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

15

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) and
Durability Testing	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

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

16

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.