Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the mechanical and thermal exchange aspects of the catheter and system, with no mention of AI or ML for control, analysis, or prediction. The performance studies are related to MR compatibility, not algorithmic performance.

Therapeutic

Yes
The device is indicated for medical purposes such as maintaining normothermia, inducing/maintaining/reversing hypothermia, and fever reduction, which directly treat or manage physiological conditions.

Diagnostic

No

The device is a heat exchange catheter system used to regulate body temperature (maintain normothermia, induce/maintain/reverse hypothermia, or reduce fever). It is a therapeutic device, not a diagnostic one, as it does not gather or interpret data to identify a medical condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly details multiple hardware components including catheters, a Start-Up Kit (SUK), and consoles (Coolgard 3000 and Thermogard XP). The system relies on the physical circulation of saline for heat exchange, which is a hardware-dependent function.

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 clearly describes a device used within the body (intravascular) to directly regulate body temperature. This is a therapeutic or physiological intervention, not a diagnostic test performed on samples taken from the body.
Device Description: The description details a catheter inserted into veins to circulate temperature-controlled saline for heat exchange. This mechanism is for directly altering the patient's body temperature, not for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is entirely focused on physical heat exchange within the circulatory system.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

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

NCX

Device Description

The ZOLL Intravascular Heat Exchange Catheters (Quattro® Intravascular Heat Exchange Catheter Kit, Quattro® Intravascular Heat Exchange Catheter Premium Access Kit, Cool Line® Intravascular Heat Exchange Catheter, ICY® Intravascular Heat Exchange Catheter) are sterile, single use heparin coated flexible catheters designed for placement in the femoral, jugular, or subclavian veins. The Solex 78 Intravascular Heat Exchange Catheter Premium Access Kit is a sterile, single use 9.3F flexible catheter designed for placement in the superior vena cava from an insection site in the jugular and subclayian veins. The Cool Line catheter contains two heat exchange balloons, the ICY catheter contains three heat exchange balloons, the Quattro catheter contains four heat exchange balloons and the Solex 7® catheter consists of a serpentine balloon. The ZOLL catheters are connected to a single use, disposable Start-Up Kit (SUK), the Coolgard 3000® Console and Thermogard XP® Console. The catheters connect to the console coolant well via tubing integral to the SUK. The catheter is connected to the SUK by connecting the male outflow Luer of the SUK to the female inflow Luer of the catheter and the female inflow Luer of the SUK to the male outflow Luer of the catheter. Both SUK Luers, in turn, are connected via tubing to a heat exchange coil through which saline circulates. The coil is placed in a coolant well located in the console. The controlled temperature saline is circulated through the closed-loop circuit of the SUK and catheter using the console pump, after which the saline is then returned within the SUK to the console heater and chiller coolant well via the catheter's outflow lumen. The catheters, SUK, the Coolgard 3000® Console and the Thermogard XP® Console are supplied separately. The ZOLL Intravascular Heat Exchange System is also designed for use with an off-the-shelf temperature probe, which is supplied separately and not manufactured by ZOLL.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Femoral vein, jugular vein, subclavian vein, superior vena cava

Indicated Patient Age Range

Adult patients

Intended User / Care Setting

Not Found

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)

Clinical evaluations were not performed for this change. The document includes a table from a randomized controlled trial that examined the safety and effectiveness of the Cool Line Intravascular Heat Exchange Catheter in 296 patients, reporting mortality results for four patient cohorts (CI, ICH, PTBI, SAH). This trial showed increased mortality in patients with fever associated with subarachnoid hemorrhage and primary traumatic brain injury when cooled endovascularly, compared to standard of care.

Nonclinical testing was performed to support 'MR Conditional' labeling for the Cool Line® Intravascular Heat Exchange Catheter, Solex 7® Intravascular Heat Exchange Catheter Premium Access Kit, Quattro® Intravascular Heat Exchange Catheter Premium Access Kit, and Quattro® Intravascular Heat Exchange Catheter Kit. Testing included magnetic field interactions, MRI-related heating, and artifact tests. All devices were found to be MR Conditional in 1.5 T/64 MHz or 3 T/128 MHz MR systems.

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

Mortality results from a randomized controlled trial for Cool Line Catheter:
CI: Cool Line n=3 N=16 (18.8%), Control n=3 N=14 (21.4%), p*=0.74
ICH: Cool Line n=8 N=33 (24.2%), Control n=7 N=27 (25.9%), p*=1.00
PTBI: Cool Line n=10 N=44 (22.7%), Control n=4 N=38 (10.5%), p*=0.24
SAH: Cool Line n=13 N=61 (21.3%), Control n=7 N=63 (11.1%), p*=0.15

Predicate Device(s)

K072234, K060308, K150046, K153226

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

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

December 20, 2021

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

Re: K213031

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, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console

Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: NCX Dated: September 20, 2021 Received: September 21, 2021

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 OHT5: 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

1

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. 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 Neuro-critically III stroke natient."

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

2

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 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) K213031

Device Name

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

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 | ਤ | 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 |
| 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 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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K213031 510(K) SUMMARY

Date Prepared:	December 16, 2021
Submitter:	ZOLL Circulation, Inc.
Address:	2000 Ringwood Avenue
San Jose, CA 95131
Phone:	408-419-2950
Fax:	408-541-1030
Contact Person:	Elizabeth Haines, Senior Director 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
Start-Up Kit
Coolgard 3000 Console
Thermogard XP 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 Devices:

Device Name	510(k) Number
Alsius THERMOGARD XP and Catheter Thermal
Regulation System	K072234
Alsius CoolGard 3000 and Catheter Thermal Regulation
System	K060308
Cool Line Intravascular Heat Exchange Catheter, ICY
Intravascular Heat Exchange Catheter, Quattro
Intravascular Heat Exchange Catheter, Start-Up Kit
(SUK)	K150046
Solex 7 Intravascular Heat Exchange Catheter and Start-
Up Kit	K153226

I. DEVICE DESCRIPTION

The ZOLL Intravascular Heat Exchange Catheters (Quattro® Intravascular Heat Exchange Catheter Kit, Quattro® Intravascular Heat Exchange Catheter Premium Access Kit, Cool Line® Intravascular Heat Exchange Catheter, ICY® Intravascular Heat Exchange Catheter) are sterile, single use heparin coated flexible catheters designed for placement in the femoral, jugular, or subclavian veins. The

6

Solex 78 Intravascular Heat Exchange Catheter Premium Access Kit is a sterile, single use 9.3F flexible catheter designed for placement in the superior vena cava from an insection site in the jugular and subclayian veins. The Cool Line catheter contains two heat exchange balloons, the ICY catheter contains three heat exchange balloons, the Quattro catheter contains four heat exchange balloons and the Solex 7® catheter consists of a serpentine balloon. The ZOLL catheters are connected to a single use, disposable Start-Up Kit (SUK), the Coolgard 3000® Console and Thermogard XP® Console. The catheters connect to the console coolant well via tubing integral to the SUK. The catheter is connected to the SUK by connecting the male outflow Luer of the SUK to the female inflow Luer of the catheter and the female inflow Luer of the SUK to the male outflow Luer of the catheter. Both SUK Luers, in turn, are connected via tubing to a heat exchange coil through which saline circulates. The coil is placed in a coolant well located in the console. The controlled temperature saline is circulated through the closed-loop circuit of the SUK and catheter using the console pump, after which the saline is then returned within the SUK to the console heater and chiller coolant well via the catheter's outflow lumen. The catheters, SUK, the Coolgard 3000® Console and the Thermogard XP® Console are supplied separately. The ZOLL Intravascular Heat Exchange System is also designed for use with an off-the-shelf temperature probe, which is supplied separately and not manufactured by ZOLL.

II. Indications for Use

The intended use / Indications for Use of the Cool Line® Intravascular Heat Exchange Catheter, Icy® Intravascular Heat Exchange Catheter, Solex 7® Intravascular Heat Exchange Catheter Premium Access Kit, Quattro® Intravascular Heat Exchange Catheter Kit. Quattro® Intravascular Heat Exchange Premium Access Kit, Start-Up Kit (SUK), Coolgard 3000® Console, and the Thermogard XP® Console are identical to the intended use and Indications for Use of the predicate Cool Line® Intravascular Heat Exchange Catheter, ICY® Intravascular Heat Exchange Catheter, Solex 7 Intravascular Heat Exchange Catheter, Quattros Intravascular Heat Exchange Catheter, Start-Up Kit. Alsius THERMOGARD XP and Catheter Thermal Regulation System, and Alsius CoolGard 3000 and Catheter Thermal Regulation System.

Indications for Use

The Solex 7® Intravascular Heat Exchange Catheter

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 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.

7

The 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".

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.

8

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

This Traditional 510(k) submission is an update to the Instructions for Use based on a request from the Food and Drug Administration (FDA) related to a recall.

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	K150046	K213031
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
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	Same
Feature	PREDICATE DEVICES	SUBJECT DEVICES
Luer Materials	Vent Caps: ZOLL Custom Vent Caps
Base material is polyurethane (for all Luers except for vent caps)
Inflow and outflow Luers: Polyurethane:
Tecoplast OP-770-164 Orange
Distal infusion Luer:
Polyurethane:
Tecoplast OP-770-477 Brown
(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)	Same
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
Heat Exchange Balloons	Cool Line® – 2 (straight/coaxial)
ICY® – 3 (straight/coaxial)
Quattro® – 4 (straight/coaxial)	Same
Feature	PREDICATE DEVICES	SUBJECT DEVICES
Flow Rate (by lumen)	Cool Line®
Distal – 2100 mL/hr
Medial – 1200 mL/hr
Proximal – 1400 mL/hr	Same
			ICY®
Distal – 1700 mL/hr
Medial – 900 mL/hr
Proximal – 1200 mL/hr
				Quattro®
Distal – 1300 mL/hr
Medial – 800 mL/hr
Proximal – 1100 mL/hr
				Approx. Inflated Balloon OD
(Cross-sectional Area)	Cool Line®: ~5 mm (20 mm²)	Same
					ICY® and Quattro®: ~8 mm (50 mm²)
Heat Exchange Power	Cool Line® – 65 Watts nominal	Same
	ICY® – 140 Watts nominal
	Quattro® – 190 Watts nominal
Materials:
Shaft
Balloon	Polyurethane	Same
	PET and Polyurethane (ICY®
and Quattro®)
	Polyurethane (Cool Line®)
Sterilization Method and Sterility
Assurance Level (SAL)	Ethylene Oxide (EO) and SAL 10-6	Same

Table 1: Comparison of Subject and Predicate Catheters

9

10

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	K153226	K213031
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
Luer Designs	Inflow and Outflow Luers: ZOLL
Custom Luers
Infusion Luers: Standard Luers
Vent Caps: ZOLL Custom Vent
Caps	Same
Feature	PREDICATE DEVICE	SUBJECT DEVICE
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)

11

12

Table 3: Comparison of Subject Start-Up Kit with Predicate

Table 4: Comparison of Subject Coolgard® 3000 Console and Thermogard® XP Console with Predicate

Feature	PREDICATE DEVICE	PREDICATE DEVICE	SUBJECT DEVICES
Device Name	Alsius CoolGard 3000	Alsius
THERMOGARD XP	Coolgard 3000®
Console
Thermogard XP®
Console
510(k) number	K060308	K072234	K213031
Principle of
Operation	It automatically adjusts the
temperature of a heater/chiller
glycol bath to achieve the patient
target temperature that has
previously 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	Same	Same
Feature	PREDICATE DEVICE	PREDICATE DEVICE	SUBJECT DEVICES
	bath heats and cools the saline in the catheter.
Class	Class II	Same	Same
Classification/
Regulation Name	System, Hypothermia,
Intravenous, Cooling	Same	Same
Regulation
Number	21 CFR 870.5900	Same	Same
Product Code	NCX	Same	Same
Patient Contact	No direct patient contact	Same	Same
Physical:

Dimensions | Height: 45 in. (114 cm)
Width: 17 in. (43 cm)
Depth: 30 in. (76 cm) | Same | Same |
| 2.Weight | 115 lb. (52 kg) | Same | 107 lb. (49 kg) |
| Electrical:
Configuration | 100-120 VAC, 50/60 Hz, 5 A
220-240 VAC, 50/60 Hz, 2.25 A | Same | Same |
| 2. Voltage
selector setting | 115 V - 230 V | Same | Same |
| 3. Fuse
protection | T6.3A (slow blow) 5 x 20 mm
T6.3A (slow blow) 5 x 20 mm | Same | Same |
| Environmental:
Operating
temperatures | 10° C - 27° C (50° F – 81° F) | Same | Same |
| 2. Operating
humidity | 30% to 75% noncondensing | Same | Same |
| 3. Atmospheric
pressure: | 70 kPa to 106 kPa | Same | Same |
| Chiller and
Heater:
1.Reservoir
volume | 2.0 liters (0.5 gal.) | Same | Same |
| 2. Pump capacity | 7 lpm at 0 m head (0 ft.) | Same | Same |
| 3. Temperature
range | 0° C - 42° C | Same | Same |
| 4. Coolant | 1:1 mixture of propylene glycol
and distilled water | Same | Same |
| 5. Refrigerant | HFC 134a | Same | RFC 134a |
| 6. Nominal Power
(must be greater
than) | 115 watts | 190 watts | Coolgard 3000®:
115 watts
Thermogard XP®:
190 watts |
| Feature | PREDICATE DEVICE | PREDICATE
DEVICE | SUBJECT
DEVICES |
| Controller and
Display
Screen
display | 6.4 in. (16.25 cm) LCD color VGA | Same | Same |
| 2. Controls | Pushbuttons and knob | Same | Same |
| 3. Temperature
input | Thermistor, YSI 400 series | Same | Same |
| 4. Articulation | 180° swivel, 45° tilt | Same | Same |
| 4. Data interface | Serial RS-232C, 9-pin sub-D
connector | Same | Same |
| 6. Alarms | Audible tones and displayed text
messages | Same | Same |
| 7. Displayed
temperature
range | 26° C - 42° C | Same | Same |
| 8. Displayed
temperature
accuracy | ± 0.2° C | Same | Same |
| Saline Coolant
Circuit
Priming
volume | 200 ml | Same | Same |
| 2. Heat exchanger | Disposable stainless steel coil | Same | Same |
| 3. Priming source | Sterile saline solution (hospital-
provided) | Same | Same |
| 4. Patient
connection | Directional Luer connections on
72 in. (183 cm) lines | Same | Same |
| 5. Pump tubing | Roller pump compatible with
directional fittings | Same | Same |
| 6. Sterility | Gamma sterilized | Same | Same |
| 7. Saline alarm | Reservoir level detection & alarm
system | Same | Same |
| 8. Coolant circuit
operating life | Replace disposable components
after seven (7) days of
continuous use | Same | Same |
| Feature | PREDICATE DEVICE | PREDICATE DEVICE | SUBJECT DEVICES |
| Equipment Classifications:
Type of protection against moisture | Ordinary | Same | Same |
| 2. 60601 Safety Class | Type BF for temperature inputs
Type B for catheter connections | Same | Same |
| 3. Protection class | 1 | Same | Same |
| 4. Mode of operation | Continuous | Same | Same |
| Alsius Start-up Kit: Start-up Kit Accessory | Model CG-500D
Model CG-500D EX | Same | Same |

13

14

15

IV. SUMMARY OF THE NONCLINICAL TESTS PERFORMED

This Traditional 510(k) submission is for an update to the Instructions for Use based on a recall related to an FDA request. Technological characteristics of the devices remain similar to the predicate devices. Nonclinical testing was performed to support 'MR Conditional' labelling. Tables 5-7 below summarize the nonclinical testing for the Cool Line® Intravascular Heat Exchange Catheter, Solex 7® Intravascular Heat Exchange Catheter Premium Access Kit, Quattro® Intravascular Heat Exchange Catheter Premium Access Kit and Quattro® Intravascular Heat Exchange Catheter Kit. Nonclinical testing demonstrated that the Cool Line® Intravascular Heat Exchange Catheter, Solex 7º Intravascular Heat Exchange Catheter Premium Access Kit, Quattro® Intravascular Heat Exchange Catheter Premium Access Kit and Quattro® Intravascular Heat Exchange Catheter Kit are MR Conditional. MR testing of the Quattro® Intravascular Heat Exchange Catheter Kit was used to support the 'MR Conditional' labeling for the ICY® Intravascular Heat Exchange Catheter.

Test Name	Test Method Summary	Results
Magnetic Field
Interactions	Testing for magnetic field interactions involved
evaluations of translational attraction and torque for the
Cool Line® Intravascular Heat Exchange Catheter using a
3 Tesla (T) MR system.	Testing showed the
Cool Line®
Intravascular Heat
Exchange Catheter
is MR Conditional
in 3 T MR systems.
MRI-Related
Heating	This device was tested for MRI-related heating according
to recommendations in the ASTM F2182-19e2: Standard
Test Method for Measurement of Radio Frequency
Induced Heating On or Near Passive Implants During
Magnetic Resonance Imaging.	Testing showed the
Cool Line®
Intravascular Heat
Exchange Catheter
is MR Conditional
in 1.5 T/64 MHz

Table 5: Cool Line® Intravascular Heat Exchange Catheter

16

Test Name	Test Method Summary	Results
Artifact Test	MR imaging artifacts were assessed for the Cool Line®
Intravascular Heat Exchange Catheter, emphasizing the
part of the catheter that would be implanted in the patient,
in association with the use of a 3 T MR system. This test
was accomplished by performing MR imaging with the
device placed inside of a gadolinium-doped, saline filled
plastic phantom following aspects of the ASTM F2119-
07 (2013): Standard Test Method for Evaluation of MR
Image Artifacts from Passive Implants.	and 3 T/128 MHz
MR systems.
Testing showed the
Cool Line®
Intravascular Heat
Exchange Catheter
is MR Conditional
in 3 T MR systems.

	Table 6: Solex 7® Intravascular Heat Exchange Catheter Premium Access Kit

Test Name	Test Method Summary	Results
Magnetic Field
Interactions	Testing for magnetic field interactions involved
evaluations of translational attraction and torque for the
Solex 7® Intravascular Heat Exchange Catheter Premium
Access Kit using a 3 T MR system. The Solex 7®
Intravascular Heat Exchange Catheter Premium Access
Kit that was evaluated was representative of the
manufactured or "finished" version of this device. A
single sample of this device was tested and deemed
appropriate since there are insignificant variations due to
manufacturing differences.	Testing showed the
Solex 7®
Intravascular Heat
Exchange Catheter
Premium Access
Kit is MR
Conditional in 3 T
MR systems.
MRI- Related
Heating	This device was tested for MRI-related heating according
to recommendations in the ASTM F2182-19e2: Standard
Test Method for Measurement of Radio Frequency
Induced Heating On or Near Passive Implants During
Magnetic Resonance Imaging.	Testing showed the
Solex 7®
Intravascular Heat
Exchange Catheter
Premium Access
Kit is MR
Conditional in 1.5
T/64 MHz and 3
T/128 MHz MR
Systems.
Artifact Test	MR imaging artifacts were assessed for the Solex 7®
Intravascular Heat Exchange Catheter Premium Access
Kit, emphasizing the part of the catheter that would be
implanted in the patient, in association with the use of a 3
T MR system. This test was accomplished by performing
MR imaging with the device placed inside of a
gadolinium-doped, saline filled plastic phantom following
aspects of the ASTM F2119-07 (2013): Standard Test
Method for Evaluation of MR Image Artifacts from
Passive Implants.	Testing showed the
Solex 7®
Intravascular Heat
Exchange Catheter
Premium Access
Kit is MR
Conditional in 3 T
MR systems.

17

Test Name	Test Method Summary	Results
Magnetic Field
Interactions	Testing for magnetic field interactions involved
evaluations of translational attraction and torque for the
Quattro® Intravascular Heat Exchange Catheter Kit and
Quattro® Intravascular Heat Exchange Catheter Premium
Access Kit using a 3 T MR system. The Quattro
Intravascular Heat Exchange Catheter Kit that was
evaluated was representative of the manufactured or
"finished" version of this device. A single sample of this
device was tested and deemed appropriate since there are
insignificant variations due to manufacturing differences.	Testing showed the
Quattro®
Intravascular Heat
Exchange Catheter
Kit and Quattro®
Intravascular Heat
Exchange Catheter
Premium Access
Kit are MR
Conditional in 3 T
MR systems.
MRI-Related
Heating	The Quattro Intravascular Heat Exchange Catheter Kit
was tested for MRI-related heating according to
recommendations in the ASTM F2182-19e2: Standard
Test Method for Measurement of Radio Frequency
Induced Heating on or Near Passive Implants During
Magnetic Resonance Imaging.	Testing showed the
Quattro®
Intravascular Heat
Exchange Catheter
Kit and Quattro®
Intravascular Heat
Exchange Catheter
Premium Access
Kit are MR
Conditional in 1.5
T/64 MHz and 3 T/
128 MHz MR
systems.
Artifact Test	MR imaging artifacts were assessed for the Quattro
Intravascular Heat Exchange Catheter Kit, emphasizing
the part of the catheter that would be implanted in the
patient's vasculature, in association with the use of a 3 T
MR system. This test was accomplished by performing
MR imaging with the device placed inside a gadolinium-
doped, saline filled plastic phantom following the ASTM
F2119-07 (2013): Standard Test Method for Evaluation
of MR Image Artifacts from Passive Implants.	Testing showed the
Quattro®
Intravascular Heat
Exchange Catheter
Kit and Quattro®
Intravascular Heat
Exchange Catheter
Premium Access
Kit are MR
Conditional in 3 T
MR systems.

Table 7: Quattro® Intravascular Heat Exchange Catheter Kit and Quattro® Intravascular Heat Exchange Catheter Premium Access Kit

Biocompatibility: The changes in this submission do not impact biocompatibility.

V. SUMMARY OF CLINICAL TESTS PERFORMED

Clinical evaluations were not performed for this change.

18

VI. CONCLUSIONS

This Traditional 510(k) submission is for an update to the Instructions for Use. The difference in the Instructions for Use between the subject and predicate devices do not raise any new questions of safety and effectiveness. New warnings, precautions, and instructions were added to the Instructions for Use for the subject devices.

ZOLL Circulation, Inc., concludes that based on the above discussion the Cool Line® Intravascular Heat Exchange Catheter, ICY® Intravascular Heat Exchange Catheter, Solex 7% Intravascular Heat Exchange Catheter Premium Access Kit, Quattro® Intravascular Heat Exchange Catheter, Quattro® Intravascular Heat Exchange Premium Access Kit, Start-Up Kit, the Coolgard 3000® Console and the Thermogard XP® Console with updated Instructions for Use are substantially equivalent to the predicate devices.