In cardiac surgery patients to achieve and or maintain normothermia during surgery and . recovery/intensive care, and
To induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care.
Maximum use period: 48 hours

Device Description

The ZOLL Solex Intravascular Heat Exchange Catheter (Solex Catheter) is a sterile, single use 9.3F flexible catheter designed for placement in the superior vena cava from an insertion site in the jugular vein. The Solex Catheter is connected to a single use, disposable CoolGard 3000" or Thermogard XP® Start-Up Kit (SUK) and the CoolGard 3000" or Thermogard XP® Console, all of which comprise the ZOLL Intravascular Heat Exchange System. The Start-Up Kit (SUK) and the CoolGard 3000 or Thermogard XP Console are supplied separately. The ZOLL Heat Exchange System is also designed for use with an off-the-shelf temperature probe. The Solex Catheter is comprised of a polyurethane shaft and a serpentine shaped PET balloon at the distal end. The blood contact surfaces of the catheter incorporate a hydrophilic heparin coating as an anti-thrombogenic agent.
The catheter has five lumens, two of which when connected to the Start-Up Kit, are used to circulate sterile saline in a closed loop circuit for heat exchange with the blood in the central venous system. Heated or chilled saline is pumped through the heat exchange lumens, inflating the diameter of the PET balloon that interfaces with the patient's blood system to warm or cool circulating blood. The inflow/outflow lumens form a closed-loop system through which the heated or chilled saline circulates. The heated or chilled saline is not infused into the patient. Additional lumens of the Solex Catheter consist of a 0.032" guidewire compatible lumen that can also be used as a primary infusion lumen, and two additional infusion lumens within the catheter shaft.

AI/ML Overview

The provided document is a 510(k) premarket notification for the ZOLL Solex Intravascular Heat Exchange Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where specific acceptance criteria are defined for a new medical device's performance against clinical outcomes.

This document primarily describes non-clinical testing (bench performance, biocompatibility, and shelf life) to support a minor modification (change in heparin coating) to an already cleared device. Therefore, a table of acceptance criteria and reported device performance related to clinical efficacy or a multi-reader, multi-case comparative effectiveness study are not applicable to the information provided.

Based on the provided text, here’s a breakdown of the available information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't provide a table of acceptance criteria with specific numerical targets for clinical performance measures (e.g., accuracy, sensitivity, specificity). Instead, it states that "Nonclinical testing was performed to ensure that the modified ZOLL Solex Catheter meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate devices."

The non-clinical tests performed and their general outcomes are summarized as follows:

Acceptance Criteria Category	Reported Device Performance (Summary)
Bench Performance	Met product design specifications at T=0 and at its labeled expiration date.
Biocompatibility	Biocompatible for its intended use.
Shelf Life Testing	Supports the labeled expiration date.

Specific details for each bench performance test and their acceptance criteria are not explicitly listed in a table format but are described narratively as "meeting design specifications." Examples of these tests include: catheter visual inspection, dimensional measurements, life testing, flow rate and pressure monitoring, heat exchange testing, air/liquid leakage testing, burst testing, flex and fatigue testing, and tensile strength testing, performed in accordance with ISO 10555-1:2013 where applicable.

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

Test Set Sample Size: Not applicable. The document describes non-clinical bench testing, not clinical studies involving patient data. For bench testing, samples of the modified catheter were used. The number of units tested for each specific bench test is not provided in detail.
Data Provenance: Not applicable. The data is generated from laboratory bench tests, not from patient populations or clinical settings.

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

Not applicable. This information pertains to medical imaging or diagnostic devices where expert review establishes ground truth for a test set. The current document describes a physical medical device (catheter) and its non-clinical performance.

4. Adjudication Method for the Test Set:

Not applicable, as a clinical test set with adjudicated ground truth is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices evaluating human performance improvement with AI assistance, which is not the subject of this 510(k) submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

No. This is not an algorithm or AI device. The testing described is for a physical medical device.

7. The Type of Ground Truth Used:

For the non-clinical testing, the "ground truth" refers to the pre-determined design and performance specifications of the device, and compliance with recognized standards (e.g., ISO 10555-1:2013 for catheter performance, ISO 10993-1:2009 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of this non-clinical testing.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable, as there is no training set for an AI/machine learning device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines extending from the bottom profile.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 3, 2014

ZOLL Circulation, Inc. Ms. Susan Noriega Director of Regulatory Affairs 2000 Ringwood Avenue San Jose, California 95131

Re: K141139

Trade/Device Name: Solex Intravascular Heat Exchange Catheter Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: NCX Dated: September 2, 2014 Received: September 4, 2014

Dear Ms. Susan Noriega,

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -SA

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141139

Device Name

Solex Intravascular Heat Exchange Catheter

Indications for Use (Describe)

The Solex Intravascular Heat Exchange Catheter connected to the CoolGuard 3000/Thermogard XP Thermal Regulation System is indicated for use:

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

Maximum use period: 48 hours.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. Pena - S

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PREMARKET NOTIFICATION 510(K) SUMMARY

Date Prepared:	April 23, 2014
Submitter:	ZOLL Circulation, Inc.
Address:	2000 Ringwood AvenueSan Jose, CA 95131
Phone:	408-541-2140
Fax:	408-541-1030
Contact Person:	Susan Noriega, Director Regulatory Affairs
Trade Name/ProprietaryName:	Solex® Intravascular Heat Exchange Catheter
Common Name:	Central Venous Catheter (short term) and Thermal RegulatingSystem
Classification/Name:	Class II; System, Hypothermia, Intravenous, Cooling
Regulation:	21 CFR 870.5900, Thermal Regulatory System
Product Code:	NCX
Legally marketed devices towhich substantialequivalence is claimed:	ZOLL Solex Catheter, Kit Model 510(k) K081936ZOLL Cool Line Catheter Kit Model CL-2295A, Icy Catheter KiModel IC-3893A, Quattro Catheter Kit Model IC-4593 510(k)K101987

I. Device Description:

The catheter has five lumens, two of which when connected to the Start-Up Kit, are used to circulate sterile saline in a closed loop circuit for heat exchange with the blood in the central venous system. Heated or chilled saline is pumped through the heat exchange lumens, inflating the diameter of the PET balloon that interfaces with the patient's blood system to warm or cool circulating blood. The inflow/outflow lumens form a closed-loop system through which the heated or chilled saline circulates. The heated or chilled saline is not infused into the patient. Additional lumens of the Solex Catheter consist of a 0.032" guidewire compatible lumen that can also be used as a primary infusion lumen, and two additional infusion lumens within the catheter shaft.

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II. Indications for Use:

The intended use / indications for use of the modified Solex Catheter is identical to that of the 510(k) cleared Solex Catheter (K081936).

The Solex® Intravascular Heat Exchange Catheter connected to the CoolGard 3000®/Thermogard XP® Thermal Regulation System, is indicated for use:

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

Maximum use period: 48 hours

III. Technological Characteristics of the Device Compared to the Predicate Device:

The modified Solex Catheter is substantially equivalent to the 510(k) cleared Solex Catheter (K081936), as well as the other cleared ZOLL Catheters (K101987), with regard to intended use / indications for use, technological characteristics, and principles of operation. Table 1 provides a comparison of the similarities and differences in technological characteristics between the modified Solex Catheter, the cleared Solex Catheter, and other cleared ZOLL Catheters (Cool Line, ICY and Quattro).

	ZOLL Intravascular Heat Exchange Catheters
Feature	SUBJECT DEVICEModified Solex Catheterwith SurModics ApplauseHeparin Coating	PREDICATE DEVICESolex Catheter withEdwards LifeSciencesDuraFlo Heparin Coating	ADDITIONALPREDICATE DEVICESCool Line, ICY and QuattroCatheters
510(k)Number	TBD	K081936	K101987
Device	Solex Intravascular HeatExchange Catheter -Model SL-2593	Solex Intravascular HeatExchange Catheter -Model SL-2593	Cool Line Catheter Kit-Model CL-2295A,Icy Catheter Kit -Model IC-3893A,Quattro Catheter Kit -Model IC-4593
Indicationsfor Use	The Solex Catheterconnected to the CoolGard3000/Thermogard XPThermal Regulation Systemis indicated for use:●In cardiac surgerypatients to achieveand/or maintainnormothermia duringsurgery and	The Solex Catheterconnected to the CoolGard3000/Thermogard XPThermal Regulation Systemis indicated for use:●In cardiac surgerypatients to achieveand/or maintainnormothermia duringsurgery and	The Quattro Catheter and ICYCatheter connected to a ZOLLThermal Regulation System areindicated for use:●In cardiac surgery adultpatients to achieve and/ormaintain normothermiaduring surgery andrecovery/intensive care, and●To induce, maintain and
	recovery/intensive care,and●To induce, maintain andreverse mild	recovery/intensive care,and●To induce, maintain andreverse mild	reverse mild hypothermia inneurosurgery patients insurgery andrecovery/intensive care.
	ZOLL Intravascular Heat Exchange Catheters
Feature	SUBJECT DEVICEModified Solex Catheterwith SurModics ApplauseHeparin Coating	PREDICATE DEVICESolex Catheter withEdwards LifeSciencesDuraFlo Heparin Coating	ADDITIONALPREDICATE DEVICESCool Line, ICY and QuattroCatheters
	hypothermia inneurosurgery patients insurgery andrecovery/intensive care.Maximum use period: 48hours.	hypothermia inneurosurgery patients insurgery andrecovery/intensive care.Maximum use period: 48hours.	The Cool Line Catheter whenused with the ZOLL ThermalRegulation System is indicatedfor use in fever reduction, as anadjunct to antipyretic therapy, inadult patients with cerebralinfarction and intracerebralhemorrhage who require access tothe central venous circulation andwho are intubated and sedated. **
HeparinCoating	SurModics ApplauseHeparin Coating	Edwards LifeSciencesDuraflo Heparin Coating	SurModics Applause HeparinCoating
Max. UsePeriod	2 days	2 days	7 days - Cool Line4 days - ICY4 days - Quattro
Number oflumens	5 lumens:2 infusion1 guidewire (also infusion)1 inflow1 outflow	5 lumens:2 infusion1 guidewire (also infusion)1 inflow1 outflow	5 lumens:2 infusion1 guidewire (also infusion)1 inflow1 outflow
Catheterworkinglength(maximum)	26cm	26cm	22 cm - Cool Line39 cm - ICY48 cm - Quattro
Heatexchangeballoons	1 (serpentine)	1 (serpentine)	2 (straight/coaxial) Cool Line3 (straight/coaxial) ICY4 (straight/coaxial) Quattro
CrossSectionalArea(approx.inflatedouterdiameter)	54mm² (12.2 mm OD)	54mm² (12.2 mm OD)	Cool Line: 20mm² (5 mm)ICY / Quattro: 50mm² (8 mm)
Shaftdiameter	9.3 Fr	9.3 Fr	9.3 Fr
InsertionSite	Jugular Vein	Jugular Vein	Quattro - Femoral VeinICY - Femoral VeinCool Line - Femoral, Jugular,Subclavian Veins
Materials	Shaft: PolyurethaneHeat Exchange Balloon: PET	Shaft: PolyurethaneHeat Exchange Balloon: PET	Shaft: PolyurethaneHeat Exchange Balloon: PET/Polyurethane
Feature	ZOLL Intravascular Heat Exchange Catheters
	SUBJECT DEVICEModified Solex Catheterwith SurModics ApplauseHeparin Coating	PREDICATE DEVICESolex Catheter withEdwards LifeSciencesDuraFlo Heparin Coating	ADDITIONALPREDICATE DEVICESCool Line, ICY and QuattroCatheters
Sterilizationmethod andSAL	EO, SAL 10-6	EO, SAL 10-6	EO, SAL 10-6

Table 1. Comparison of Proposed Solex Catheter with Predicates

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** The Indication for Use for the Cool Line Catheter also includes the following warning:

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			p*
	n	N	%	n	N	%
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

Mortality by Diagnosis (ITT analysis)

*Fischer's exact test

For more details on the clinical trial results please refer to Physician's Manual - "Normothermia for the Neuro-critically III stroke patient" #101416-001.

IV. Summary of the Nonclinical Tests Performed:

Nonclinical testing was performed to ensure that the modified ZOLL Solex Catheter meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate devices (K081936 and K101987).

The modified Solex Catheter is identical to the 510(k) cleared Solex Catheter in terms of intended use/indications for use and principles of operation, and has equivalent technological characteristics. Minor design modifications have been incorporated into the catheter design to improve manufacturability of the device. Nonclinical testing completed includes Bench Performance, Biocompatibility, and Shelf Life Testing to support the labeled expiration date. The non-clinical test results demonstrate that the modified Solex Catheter continues to meet product design specifications.

Bench Performance

Bench performance testing of the modified Solex Catheter was performed to verify that product design specifications were met at T=0 and after real time aging to support the labeled expiration date. Testing completed includes the following: catheter visual inspection, dimensional measurements, life testing, flow rate and pressure monitoring, heat exchange testing, air/liquid leakage testing, burst testing, flex and fatigue testing, and tensile strength testing. Where applicable, testing was performed in accordance with the catheter performance requirements of

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ISO 10555-1:2013. The results of the design verification testing demonstrate that the modified Solex Catheter meets its design performance specifications at T=0 and at its labeled expiration date.

Biocompatibility

The modified Solex Catheter is fabricated with similar materials and components as the predicate Solex Catheter and other cleared ZOLL Catheters. In addition, the Solex Catheter utilizes the identical SurModics Heparin Coating as the predicate ZOLL Cool Line, ICY and Quattro Catheters 510(k) cleared in K101987, using the same material substrates. According to ISO 10993-1:2009, Biological Evaluation of Medical Devices – Part 1: Guidance on Selection of Tests, the Solex Catheter is categorized as an "external communicating, blood contact device with prolonged exposure (>24 hours to 30 days)". Based on this categorization, the Solex Catheter was tested for Cytotoxicity, Sensitization, Acute Systemic Toxicity, Subacute Toxicity, Genotoxicity, Implantation, and Hemocompatibility. The results of the testing demonstrate that the Solex Catheter is biocompatible for its intended use.

V. Summary of Clinical Tests Performed:

Clinical evaluations were not performed for the modified Solex Catheter and were not necessary to demonstrate substantial equivalence of the modified Solex Catheter to the predicate devices (K081936 and K101987).

VI. Substantial Equivalence:

The modified Solex Catheter has the same intended use / indications for use as the 510(k) cleared Solex Catheter (K081936). The modified Solex Catheter utilizes the identical SurModics Applause Heparin Coating as other currently cleared ZOLL Catheters (Cool Line, ICY and Quattro - K101987) and has similar technological characteristics as the currently cleared Solex Catheter. The results of the bench performance, biocompatibility and shelf life testing demonstrate that the modifications do not affect the performance or function of the device. The minor differences in the design between the modified and cleared Solex Catheters, as well as other ZOLL predicate Catheters, do not raise any new types of safety or effectiveness questions as confirmed by design verification testing. Therefore, the modified Solex Catheter is substantially equivalent to the previously cleared predicate devices.

VII. Conclusions:

ZOLL concludes that based on the results of the bench performance, biocompatibility and shelf life testing, that the Solex Catheter is 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).