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

Device Description

The Solex 7 Intravascular Heat Exchange Catheter (Solex 7 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 and Subclavian Veins. The Solex 7 Catheter is connected to a single use, disposable CoolGard 3000 or Thermogard XP® Start-Up Kit (SUK) and the CoolGard 30000 or Thermogard XP® Console, all of which comprise the ZOLL Intravascular Heat Exchange The Start-Up Kit (SUK) and the CoolGard 3000 or Thermogard XP Console are System. supplied separately. The ZOLL Heat Exchange System is also designed for use with an off-theshelf temperature probe. The Solex 7 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.

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. Warmed or chilled saline is pumped through the heat exchange lumens, inflating the diameter of the serpentine balloon that interfaces with the patient's blood to warm or cool circulating blood. The inflow/outflow lumens form a closed-loop system through which the warmed or chilled saline circulates. The warmed or chilled saline is not infused into the patient.

Additional lumens of the Solex 7 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 document provided describes the Solex 7™ Intravascular Heat Exchange Catheter and Start-Up Kit and its substantial equivalence to predicate devices, based on nonclinical testing. This is a 510(k) premarket notification, which demonstrates a device is at least as safe and effective as a legally marketed predicate device, rather than proving effectiveness through clinical trials required for a PMA.

Therefore, the study described here is primarily a set of nonclinical tests to show that the modified device performs similarly to its predicate devices and meets its own design specifications.

Here's an analysis of the acceptance criteria and the "study" (nonclinical testing) that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document provides multiple tables (Table 3, Table 4, Table 5, Table 6, Table 7) detailing various tests, their methods, and results. These tables effectively serve as the acceptance criteria and reported device performance. I will consolidate key examples below.

Test Category	Acceptance Criteria (Test Method Summary)	Reported Device Performance (Results)
Solex 7 Catheter Bench Performance
Visual Inspection	Ensure catheter is smooth without major pits.	Catheter samples met the acceptance criterion for smooth appearance with no pits.
Catheter Indwell Life (7 days)	Verify no saline leakage during simulated use for seven days.	Catheter samples met the acceptance criterion for normal function for seven days without leakage.
Particulate Testing	Determine catheter coating integrity following simulated indwell and flow rate conditions.	Solex 7 samples and Cool Line samples tested demonstrated levels of particulate below that required in USP <788>.
Heat Exchange Testing	Determine heat exchange capability of catheter.	Catheter samples met the acceptance criterion for a heat exchange power of 125 Watts minimum.
In Vitro Thrombogenicity Testing	Measurement of thrombogenic behavior of catheter following 7 day simulated use by radioactive platelet quantification and visual inspection.	Coated catheter samples showed statistically significant decreases (p < 0.05) in thrombogenicity when compared to normalized thrombogenic behavior of uncoated catheters.
Start-Up Kit (SUK) Packaging Testing
SUK Package Seal Peel Test	Ensure seal peel data is not less than specified acceptance criteria.	SUK package seals met the acceptance criterion for peel strength.
Start-Up Kit Performance Testing
SUK Flow Test	Verify that air flows through the SUK system.	SUK systems met the acceptance criterion for air flow.
Modified SUK Indwell Life Test	Verify that Custom Luers and SUK Tubing are able to function normally at specified temperatures for the labeled indwell period.	Custom Luers and SUK tubing met the acceptance criterion for normal function for 7 days at the specified temperature.
Custom Luer Catheter Bench Performance
Guidewire Passage	Verify ability to frontload, backload, and remove J-tip 0.032" guidewire from catheter.	Catheters met the acceptance criterion for the J-tip 0.032" guidewire to be frontloaded, backloaded, and removed from the catheters.
Balloon Deflation Using Deflation Syringe (20 mL Slip-Fit)	Verify that balloons collapse upon aspiration at specified temperature using supplied slip-fit syringe.	Catheter balloons met the acceptance criterion of collapse upon aspiration using the supplied slip fit syringe.
Luer Standards Performance Testing
Water/Liquid Leakage	Tested using test method similar to test specified in ISO594-1&2 (§4.2.1).	All samples met the requirements of the test method used.
Stress Cracking	Tested using test method similar to that specified in ISO594-2 (§4.7).	All samples met the requirements of the test method used.
Biocompatibility Testing
Cytotoxicity	MEM Elution Test.	The reactivity grade of all test article extract samples was “0”.
Hemocompatibility (ASTM Hemolysis)	ASTM Hemolysis (Extract Method) Test.	The difference between the hemolytic indexes of the test article and the negative control equals 0.00 percent. This places the test article in the non-hemolytic range.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document generally refers to "samples" or "catheter samples" without specifying precise numerical sample sizes for most bench tests. However, for "Particulate Testing," it mentions "Solex 7 samples and Cool Line samples."

Sample Size: Not explicitly stated numerically for most tests. It refers to "catheter samples," "SUK systems," "all samples," etc.
Data Provenance: This is a nonclinical study conducted by ZOLL Circulation, Inc. (submitter). The tests are laboratory-based and simulated, rather than involving human subjects or real-world clinical data. Therefore, concepts like country of origin for data or retrospective/prospective don't directly apply in the same way they would for a clinical study. The tests were performed to verify performance against international standards (ISO, EN ISO, ASTM, USP).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable (N/A). The "ground truth" for these tests is defined by established engineering and medical device standards (e.g., ISO, ASTM, USP criteria for tensile strength, leakage, biocompatibility, etc.) and the device's own design specifications. Expert consensus in the traditional sense (like for medical image interpretation) is not directly involved in setting the pass/fail criteria for these bench tests. The human factors testing involved "users" but not experts establishing ground truth for objective performance metrics in the same way.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This section is N/A. Adjudication methods like 2+1 or 3+1 are used in clinical studies where subjective expert review is required (e.g., for ambiguous medical findings). For these nonclinical bench tests, results are typically objective measurements or observations against predefined pass/fail criteria outlined in the test methods.

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

This section is N/A. The document describes a medical device (intravascular heat exchange catheter and start-up kit), not an AI diagnostic or assistance system. Therefore, an MRMC comparative effectiveness study or assessment of human reader improvement with AI assistance is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is N/A. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on a combination of:

International Standards: ISO 10555-1, ISO 594-1, ISO 594-2, EN ISO 10555-1, USP <788>, ASTM Hemolysis standards.
Device Design Specifications: Specific dimensional tolerances, flow rates, heat exchange power, tensile strength, burst/leak resistance, indwell life, and biocompatibility criteria defined by the manufacturer for the device.
Human Factors Test Scenarios: User tasks designed to assess the ease and correctness of device usage as per the Instructions for Use (IFU).

8. The sample size for the training set

This section is N/A. This is not a machine learning or AI device, so there is no "training set" in the context of algorithm development.

9. How the ground truth for the training set was established

This section is N/A for the same reason as above.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.

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

March 24, 2016

ZOLL Circulation, Inc. Mr. Sam Nanavati Vice President, Quality & Regulatory Affairs 2000 Ringwood Avenue San Jose, California 95131

Re: K153226

Trade/Device Name: Solex 7™ Intravascular Heat Exchange Catheter and Start-Up Kit Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: NCX Dated: February 23, 2016 Received: February 25, 2016

Dear Mr. Sam Nanavati:

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. 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 Office of Device Evaluation has determined that there is a reasonable likelihood that this device 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 Warnings section of the device's labeling as a box warning immediately following the Indications for Use (IFU) statement:

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

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and primary traumatic brain injury showed increased mortality as compared to patients receiving standard of care.

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.

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 the quality systems (QS) 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.

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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,

William H. Maisel - S

William H. Maisel, MD, MPH Director (Acting) Office of Device Evaluation Deputy Center Director for Science Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153226

Device Name

Solex 7TM Intravascular Heat Exchange Catheter and Start-Up Kit

Indications for Use (Describe)

The Solex 7™ Intravascular Heat Exchange Catheter connected to the CoolGard 3000®/Thermal Regulation System is indicated for use:

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

· To induce, maintain and reverse mild hypothermia in neurosurgery and recovery/intensive care. (Maximum use period = 4 days)

Warning - Fever Reduction

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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PREMARKET NOTIFICATION 510(K) SUMMARY K153226

Date Prepared:	March 9, 2016
Submitter:	ZOLL Circulation, Inc.
Address:	2000 Ringwood AvenueSan Jose, CA 95131
Phone:	408-419-2950
Fax:	408-541-1030
Contact Person:	Sam Nanavati, VP, Quality and Regulatory Affairs
Trade Name/ProprietaryName:	Solex 7™ Intravascular Heat Exchange Catheter andStart-Up Kit
Common Name:	Central Venous Catheter (short term) and Thermal RegulatingSystem
Classification/Name:	Class II; System, Hypothermia, Intravenous, Cooling
Regulation:	21 CFR 870.5900, Thermal Regulating System
Product Code:	NCX
Legally marketed devices towhich substantialequivalence is claimed:	Solex Intravascular Heat Exchange Catheter Kit, 510(k) K141139Cool Line Intravascular Heat Exchange Catheter Kit, 510(k)K101987 and K150046Start-Up Kit Model CG-500D and Model CG-500D EX, 510(k)K014241 and K150046

I. Device Description:

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II. Indications for Use:

The intended use/indications for use of the modified Solex Catheter (Solex 7 Catheter) is as follows:

The Solex 7™ 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. (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

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

The Solex 7 Catheter

The modified Solex Catheter (Solex 7 Catheter) is substantially equivalent to the 510(k) cleared Solex Catheter (K141139) and the ZOLL Cool Line Catheter (K101987) with regard to intended use / indications for use, technological characteristics, and principles of operation. With the exception of the Custom Luers, the modified Solex Catheter (Solex 7 Catheter) is identical to the cleared Solex Catheter with respect to design and materials. Table 1 provides a comparison of the similarities and differences between the modified Solex Catheter (Solex 7 Catheter), the cleared Solex Catheter, and the cleared ZOLL Cool Line Catheter (comparisons are relative to the subject device).

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Table 1. Comparison of Solex 7 Catheter with Custom Luers to Predicates
-------------------------------------------------------------------------	--	--

	ZOLL Intravascular Heat Exchange Catheters
Feature	SUBJECT DEVICESolex 7 IntravascularHeat Exchange Catheter	PRIMARY PREDICATEDEVICECool Line IntravascularHeat Exchange Catheter	REFERENCEPREDICATEDEVICESolex IntravascularHeat ExchangeCatheter	REFERENCEPREDICATE DEVICEQuattro IntravascularHeat ExchangeCatheter
510(k)Number	K153226	K101987 and K150046	K141139	K150046
Class	II	Same	Same	Same
Classification/RegulationName	System, Hypothermia,Intravenous.Cooling/ThermalRegulating System	Same	Same	Same
RegulationNumber	21 CFR 870.5900	Same	Same	Same
Product Code	NCX	Same	Same	Same
HeparinCoating	SurModics ApplauseHeparin Coating	Same	Same	Same
Luer Designs	Inflow and Outflow Luers:ZOLL Custom Luers*Infusion Luers: StandardLuersVent Caps: ZOLL CustomVent Caps	Same	Inflow and OutflowLuers: Standard LuersInfusion Luers: SameVent Caps: StandardVent Caps	Same as Subject Device
Catheterworkinglength (tip tomanifold)	26cm	22 cm	Same as SubjectDevice	48 cm
Shaftdiameter	9.3 Fr	Same	Same	Same
Number oflumens	5 lumens:2 infusion	Same	Same	Same
Feature	ZOLL Intravascular Heat Exchange Catheters
	SUBJECT DEVICESolex 7 IntravascularHeat Exchange Catheter	PRIMARY PREDICATEDEVICECool Line IntravascularHeat Exchange Catheter	REFERENCEPREDICATEDEVICESolex IntravascularHeat ExchangeCatheter	REFERENCEPREDICATE DEVICEQuattro IntravascularHeat ExchangeCatheter
GuidewireCompatibility	1 guidewire (also infusion)1 inflow1 outflow0.032"	Same	Same	Same
Flow Rate (bylumen)	Distal - 1900 mL/hrMedial - 1300 mL/hrProximal - 1300 mL/hr	Distal - 2100 mL/hrMedial - 1200 mL/hrProximal - 1400 mL/hr	Distal - Same asSubject DeviceMedial - Same asSubject DeviceProximal - Same asSubject Device	Distal - 1300 mL/hrMedial - 800 mL/hrProximal - 1100 mL/hr
Heatexchangeballoons	1 (serpentine)	2 (straight/coaxial)	Same as SubjectDevice	4 (straight/coaxial)
InflatedBalloon OD(Cross-sectional Area)	Balloon OD: N/ACross-sectional Area:54mm2	Balloon OD: 5mmCross-sectional area: N/A	Same as SubjectDevice	Balloon OD: 8mmCross-sectional area:N/A
CrossSectionalArea (approx.inflated outerdiameter)	54mm2 (12.2 mm OD)	20mm2 (5 mm)	Same as SubjectDevice	50mm2 (8 mm)
Insertion Site	Jugular andSubclavian Veins	Femoral, Jugular, SubclavianVeins	Jugular Vein	Femoral
Max. UsePeriod	7 days	7 days	2 days	4 days
	ZOLL Intravascular Heat Exchange Catheters
Feature	SUBJECT DEVICESolex 7 IntravascularHeat Exchange Catheter	PRIMARY PREDICATEDEVICECool Line IntravascularHeat Exchange Catheter	REFERENCEPREDICATEDEVICESolex IntravascularHeat ExchangeCatheter	REFERENCEPREDICATE DEVICEQuattro IntravascularHeat ExchangeCatheter
Materials	Shaft: PolyurethaneHeat Exchange Balloon:PET	Shaft: Same2 Heat Exchange Balloons:Polyurethane	Shaft: SameHeat ExchangeBalloon:Same as SubjectDevice	Shaft: SameHeat ExchangeBalloons: Same asSubject Device
Sterilizationmethod andSAL	EO, SAL 10-6	Same	Same	Same

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*The ZOLL Custom Luers on the ZOLL Cool Line, ICY, and Quattro Catheters were cleared via K150046 on October 30, 2015

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The Modified Start-Up Kit with Custom Luers

The modified Start-Up Kit (SUK) with Custom Luers is substantially equivalent to the 510(k) cleared SUK (K014241) with regard to intended use, technological characteristics, and principles of operation. Table 2 provides a comparison of the similarities and differences between the modified SUK and the predicate SUK.

Characteristic	SUBJECT DEVICEZOLL Start-up Kit with ZOLL CustomLuers	PREDICATE DEVICEZOLL Start-up Kit with ZOLL StandardLuers
	(modified)K150046
510(k) Number	TBD	K014241
Intended Use	To control patient core temperature usingheat exchange fluid in conjunction with theCoolGard 3000 or Thermogard XP systemand ZOLL Heat Exchange Catheters	Same
Class	II	Same
Classification/Regulation Name	System, Hypothermia, Intravenous,Cooling/Thermal Regulating System	Same
RegulationNumber	21 CFR 870.5900	Same
Product Code	NCX	Same
Patient Contact	Indirect patient contact	Same
Luer Function	Join the SUK to the Inflow/Outflow Lumensof the catheters, and allow saline to circulatethrough the catheter/SUK fluid path	Same
Supplied 20 mlSterile Deflation(Slip-Fit) Syringe	Syringe, compatible with new Custom Luerlocks, provided with SUK for removal ofsaline from catheter heat exchange balloonprior to catheter removal	Syringe not provided with SUK
Sterilization	Provided sterile (Gamma sterilization)	Same

Table 2. Comparison of Modified Start-up Kit with Custom Luers to Predicate

IV. Summary of the Nonclinical Tests Performed:

Nonclinical testing was performed to ensure that the modified Solex Catheter (Solex 7 Catheter) and modified SUK meet their design performance specifications and that the product is substantially equivalent to the predicate devices (Catheters: K141139, K101987; SUK: K014241). Nonclinical testing performed includes: Bench Performance. Packaging Validation (SUK only), Biocompatibility, and Usability Testing. The nonclinical test results demonstrate that the modified devices continue to meet product design specifications.

1. 7-Day Indwell Testing

Bench Performance testing of the modified Solex Catheter (Solex 7 Catheter) was performed to support the proposed modification to the 7 day indwell time.

Where applicable, testing was performed in accordance with the following standards:

. ISO 10555-1:2013 - Sterile, single-use intravascular catheters Part 1. General requirements

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ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and . certain other medical equipment Part 1: General requirements
ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and ● certain other medical equipment Part 2: Lock fittings

The modified Solex Catheter (Solex 7 Catheter) was functionally tested after being subjected to 7 days of simulated use conditions to verify that the catheter continues to perform as intended. Testing completed is shown in Table 3.

Test Name	Test Method Summary	Results
Visual Inspection	Visual inspection to ensure catheteris smooth without major pits.	Catheter samples met theacceptance criterion for smoothappearance with no pits.
Catheter Indwell Life (7 days)	Verification that the catheter doesnot leak saline from the heatexchange path during simulated usefor seven days.	Catheter samples met theacceptance criterion for normalfunction for seven days withoutleakage.
Dimensional Measurement	Measurement of catheterdimensional aspects	Catheter samples met theacceptance criteria for dimensionalrequirements per the productspecification.
Toluidine Blue Staining	Dye staining of catheter and visualinspection to ensure consistentcoverage of blue purple color andthat stained portion covers all depthmarkers.	Catheter samples met theacceptance criteria for consistentblue purple color and stainedportion covered all depth markers.
Particulate Testing	Determination of catheter coatingintegrity following simulatedindwell and flow rate conditions.	Solex 7 samples and Cool Linesamples tested demonstrated levelsof particulate below that required inUSP <788>.
Tensile Testing	Strength testing of various catheterjoints. Must conform to EN ISO10555-1:2013.	Catheter joints met the acceptancecriteria for tensile strengthrequirements of EN ISO 10555-1:2013.
Burst/Leak Testing	Determination of catheter burst/leakresistance. Must conform to ENISO 10555-1:2013.	Catheter samples met theacceptance criteria to withstand aminimum of 100 psi static pressureat 37°C without embolic failure.
Flow Resistance Testing	Measurement of catheter backpressure.	Catheter samples met theacceptance criterion for a backpressure of less than 7 psi at a flowrate of 2000 ml/hr.
Flow Rate Testing	Measurement of catheter infusionlumen flow rates. Must conform toEN ISO 10555-1:2013.	Catheter samples met theacceptance criteria for flow raterequirements of EN ISO 10555-1:2013
Heat Exchange Testing	Determination of heat exchangecapability of catheter.	Catheter samples met theacceptance criterion for a heatexchange power of 125 Wattsminimum.
Flexural Fatigue/Tip Flex Testing	Determination of catheter tipstrength and flexure.	Catheter samples met theacceptance criteria to withstand 100
Test Name	Test Method Summary	Results
Infusion Lumen Aspiration Rate Testing	Determination of catheter blood sampling rate	cycles of tip flexure.Catheter samples met theacceptance criterion of a bloodsampling rate of 10cc in 15 secondsor less.
Torsional Integrity Testing	Determination of catheter (tip tomanifold) ability to withstandtwisting.	Catheter samples met theacceptance criterion to withstandone complete twist without failure
In Vitro Thrombogenicity Testing	Measurement of thrombogenicbehavior of catheter following 7day simulated use by radioactiveplatelet quantification and visualinspection.	Coated catheter samples showedstatistically significant decreases ( $p$< 0.05) in thrombogenicity whencompared to normalizedthrombogenic behavior of uncoatedcatheters.

Table 3. Solex 7 Catheter Bench Performance Testing

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2. Solex Catheter and Modified SUK with Custom Luers

Nonclinical testing was performed to ensure that the Solex Catheter and modified SUK with Custom Luers meet their design and performance specifications and that the product is substantially equivalent to the predicate devices.

a. Packaging Validation (SUK only)
Packaging performance testing of the modified SUK was performed to verify that following exposure to simulated shipping conditions, the addition of the sterile packaged 20 mL Deflation (Slip-Fit) syringe to the outside of the sterilized SUK packaging does not impact the integrity of the SUK sterile packaging. Packaging testing completed is shown in Table 3.

Test Name	Test Method Summary	Results
Visual Inspection	Visual inspection to inspect shipping boxes and trays for damage.	Shipping boxes and trays met the acceptance criteria with respect to visible damage.
SUK Package Seal Visual Integrity	Visual inspection to inspect the package seal in the area where the syringe bag is attached.	Package seals and trays met the acceptance criteria with respect to visible damage.
Syringe Pouch Seal Visual Integrity & Adhesion to Tyvek	Visual inspection of the affected area to inspect the package seal area of the syringe bag.	Syringe pouch seals and the film and Tyvek portion of the pouches met the acceptance criteria with respect to visible damage.
SUK Package Seal Peel Test	Peel testing of the affected area to ensure that seal peel data is not less than specified acceptance criteria	SUK package seals met the acceptance criterion for peel strength.

Table 3. Start-Up Kit Packaging Testing

In addition, testing was performed (following exposure to simulated shipping conditions and packaging testing) to verify that product design specifications were met. Bench performance testing completed is shown in Table 4.

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Test Name	Test Method Summary	Results
SUK Flow Test	To verify that air flows through theSUK system.	C SUK systems met the acceptancecriterion for air flow.
SUK High Pressure Leak Test	To verify no leaks below specifiedacceptance criteria.	SUK systems met the acceptancecriterion for no leaks below thespecified pressure.
Modified SUK Indwell Life Test	To verify that Custom Luers andSUK Tubing are able to functionnormally at specified temperaturesfor the labeled indwell period.	Custom Luers and SUK tubing metthe acceptance criterion for normalfunction for 7 days at the specifiedtemperature.
SUK Tubing to Luer Tensile	To verify that SUK Tubing andCustom Luers conform to EN ISO10555-1:2013 and minimumspecified acceptance criteria.	The SUK tubing meet theacceptance criterion for the tensilestrength of all inflow and outflowtubes to Luers with respect to therequirements of ISO 10555-1:2013.

Table 4. Start-Up Kit Performance Testing

The packaging of the Solex catheter remains unchanged; therefore, re-validation of the catheter packaging was not warranted.

b. Bench Performance
Bench Performance Testing was conducted on samples of the Cool Line Intravascular Heat Exchange Catheter (as a representative model for the Solex Catheter subject to the same modifications) to verify that product design specifications were met. The Luers and Extension tubings are identical in all models. Testing completed is shown in Table 5.

Table 5. Custom Luer Catheter Bench Performance Testing

Test Name	Test Method Summary	Results
Visual Inspection	Visual inspection to inspect for Luers, caps, and extension tubes for correct colors.	Luers colors met the acceptance criteria based on the requirements of associated drawings.
Dimensional Measurement ofExtension Tube Lengths	Verify dimensions of extension tube lengths.	Extension tubes met the acceptance criteria for specific dimensional specifications.
Guidewire Passage	Verify ability to frontload, backload, and remove J-tip 0.032" guidewire from catheter.	Catheters met the acceptance criterion for the J-tip 0.032" guidewire to be frontloaded, backloaded, and removed from the catheters.
Ink Stability	Verify that pad printed ink does not smudge or come off when tested in accordance with specified acceptance criteria.	The pad printed ink on all infusion Luers met the acceptance criterion of remaining legible after rubbing with alcohol.
Alcohol Resistance	Verify that Luers do not craze or crack when tested in accordance with specified acceptance criteria.	Luers met the acceptance criterion of no evidence of crazing or cracking after being soaked in alcohol.
Balloon Deflation Using DeflationSyringe (20 mL Slip-Fit)	Verify that balloons collapse upon aspiration at specified temperature using supplied slip-fit syringe.	Catheter balloons met the acceptance criterion of collapse upon aspiration using the supplied slip fit syringe.
Balloons Leakage Upon Aspiration	To verify that catheter balloons	Catheters met the acceptance

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Test Name	Test Method Summary	Results
@ 37°C Using the SuppliedDeflation (20 mL Slip-Fit) Syringe	conform to EN ISO 10555-1:2013(must not show air leakage duringaspiration).	criterion for no air leakage from thecatheter balloons during aspirationusing the supplied slip fit syringe
Heat Exchange Power	To verify that the modifiedcatheters meet specified acceptancecriteria.	Catheters met the acceptancecriterion for heat transferperformance.
Ultimate Burst/Leak (All Luers -Custom and Infusion Luers) -Embolic Failure	To verify that catheter Luersconform to EN ISO 10555-1:2013(must meet minimum staticpressure at specified temperaturewithout embolic failure).	Catheters met the acceptancecriterion to withstand 100-110 psistatic pressure at 37°C withoutembolic failure.
Catheter Inflow/Outflow CustomLuers connected to SUK CustomInflow/Outflow Pressure Test	To verify that catheterinflow/outflow Luers andextensions withstand minimumstatic pressure for specified periodof time.	Luers and extension tubes met theacceptance criterion to withstand aminimum static pressure whileconnected to an SUK for a specifiedperiod of time.
Catheter with Modified Luers -Indwell Life	To verify that catheters Luers andextensions are able to functionnormally for the labeled indwellperiod.	Luers and extension tubes met theacceptance criterion to be able tofunction normally for seven days.
Extension Tubing to Luer Tensile.	To verify that extensiuon tubing toLuer joints conform to EN ISO10555-1:2013 (must meet minimumstrength).	Catheter joints met the acceptancecriteria for minimum tensilestrength in accordance with therequirements of EN ISO 10555-1:2013

Where applicable, testing was performed in accordance with the following standards:

ISO 10555-1:2013 Sterile, single-use intravascular catheters Part 1. General . requirements
The results of design verification testing performed demonstrate that the modified Catheter and SUK with Custom Luers meet their design performance specifications at T=0.
c. Testing to Luer Standards
Additional testing was conducted as part of Testing to Luer Standards on the injection molded components used to manufacture the modified SUK and Catheter with Custom Luers. Results of testing verifies compliance to the following applicable standards:
ISO 594-1:1986 - Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
. ISO 594-2:1998 - Conical fittings with a 6% (Luer) taper for syringes. needles and certain other medical equipment Part 2: Lock fittings

The testing completed are shown in Table 6.

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Test Name	Test Method Summary	Results
Critical Dimensions Inspection	Critical dimensions must meet the dimensional tolerances for the Critical dimensions, of the respective drawing	Samples met the acceptance criteria for dimensional tolerances for the critical dimensions.
Gauging	Tested using test method similar to test specified in ISO594-1&2 (§4.1)	All samples met the requirements of the test method used.
Water/Liquid Leakage	Tested using test method similar to test specified in ISO594-1&2 (§4.2.1)	All samples met the requirements of the test method used.
Air Leakage	Tested using test method similar to test specified in ISO594-2 (§4.2.2)	All samples met the requirements of the test method used.
Separation Force	Tested using test method similar to that specified in ISO594-2 (§4.3)	All samples met the requirements of the test method used.
Unscrewing Torque	Tested using test method similar to that specified in ISO594-2 (§4.4)	All samples met the requirements of the test method used.
Ease of Assembly	Tested using test method similar to that specified in ISO594-2 (§4.5 b)	All samples met the requirements of the test method used.
Resistance to Overriding	Tested using test method similar to that specified in ISO594-2 (§4.6)	All samples met the requirements of the test method used.
Stress Cracking	Tested using test method similar to that specified in ISO594-2 (§4.7)	All samples met the requirements of the test method used.
Test Category	Test Method Summary	Results
Cytotoxicity	MEM Elution Test	The reactivity grade of all testarticle extract samples was “0”.
Sensitization	ISO 10993 Part 10 Guinea PigMaximization Sensitization Test(GLP)	The test article extracts did notcause sensitization reactions underthe conditions of the assay.
Irritation	ISO/USP Intracutaneous ReactivityIrritation Test in Rabbits(GLP)	The data indicated that the testarticle extracts did not cause a skinirritation reaction.
Acute Systemic Toxicity	ISO/USP Medical Device AcuteSystemic Toxicity Test in Mice(GLP)	Based on the clinical observationsand body weight evaluations, thetest article (device) extracts did notshow significantly greaterbiological reaction than the controlarticle extracts.
Material Mediated Pyrogen	ISO/USP Materials MediatedPyrogen Test in Rabbits(GLP)	None of the animals in the studyshowed abnormal clinical signsprior to dose administration andduring the observation period. Noanimals showed a temperatureincrease of 0.5°C or greater duringthe study period.
Hemocompatibility	ASTM Hemolysis (Extract Method)Test (GLP)	The difference between thehemolytic indexes of the test articleand the negative control equals 0.00percent. This places the test articlein the non-hemolytic range. All testmethod acceptance criteria weremet.
Hemocompatibility	Complement Activation Test(GLP)	C3a: The P value was >0.050when the test article was comparedto the predicate at the 30, 60, and90 minute time points; the testarticle and predicate are statisticallysimilar at these time points.The P value was >0.050 when thetest article was compared to thenegative control at the 30, 60, and90 minute time points; the testarticle and predicate are statisticallysimilar at these time points.SC5b-9: The P value was >0.050when the test article was comparedto the predicate at the 30, 60, and90 minute time points; the testarticle and predicate are statisticallysimilar at these time points.The P value was >0.050 when thetest article was compared to the
Test Category	Test Method Summary	Results
		minute time points; the test articleand negative control are statisticallysimilar at these time points. The Pvalue was ≤0.050 when the testarticle was compared to thenegative control at the 90 minutetime point; the test article isstatistically lower than the negativecontrol at this time point

Table 6. Luer Standards Performance Testing

Based on the test results obtained, it can be concluded that all of the standard and custom catheter Luers, custom SUK Luers, and custom catheter vented caps are qualified for use in the assemblies used to manufacture the modified SUK and Solex Catheter with Custom Luers.

d. Biocompatibility

The only material change for the Solex Catheter and SUK has been to the Custom Luers. To verify the biocompatibility of the new materials of the Custom Luers for the Solex Catheter, ZOLL conducted biocompatibility testing on the proximal (modified) portion of the catheter only. Similarly, to verify the biocompatibility of the modified SUK, ZOLL conducted biocompatibility testing on the SUK Custom Luers only. Biocompatibility testing was conducted in accordance with GLP regulations.

Because the Custom Luer components located on the SUK and on the proximal end of the catheter have indirect blood contact and prolonged exposure. ZOLL conducted testing based on the classification of an externally communicating device, blood path indirect for prolonged exposure (>24hrs and ≤30 days). Based on this classification, the following categories of biocompatibility tests were performed: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity and Hemocompatibility.

The biocompatibility test results are shown in Table 7.

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Table 7. Biocompatibility Testing

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The results of the testing demonstrate that the modified SUK and the modified Solex Catheter with Custom Luers are biocompatible for their intended use and the modifications made to the subject devices do not adversely affect the established biocompatibility of the predicate devices.

e. Usability/Human Factors

Pursuant to FDA's guidance document entitled, "Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design" Human Factors testing was conducted as follows:

1. Summary of Formative Testing

Human factors formative testing was performed to determine if users trained according to the IFU can properly perform the following:

Identify infusion lumens, (proximal, medial, and distal) ●
Properly connect the IN and OUT Luers to the Start-Up Kit (SUK) ●
Identify the saline IN and OUT Luers
. Identify any lumen that is appropriate for pharmacological infusate.
. Disconnect the Saline IN and OUT track (SUK Luers) including evacuating the saline from the catheter using a syringe.

User tasks were based on identifying and (or) making proper connections as documented in the Formative Human Factors Protocol for ZOLL Custom Luers. The test session ran over the course of two days.

Four scenarios were presented, and participants were evaluated based on 14 predefined success metrics. All participants correctly executed each scenario, with no failures. All participants who received representative level of training and had access to the IFU successfully completed all of the tasks. This indicates that the device design, training content and the IFU adequately mitigate the risk of misconnections. No device design, training or IFU modifications were indicated based on this formative test.

2. Summary of Summative Testing

Human factors summative testing was performed to evaluate if users trained according to the ZOLL Custom Luer Training Program and IFU can properly perform the following:

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Match the new catheter and new Start-Up Kit (SUK) with Custom Luers
Place 20 cc syringe on saline hook on Thermogard XP (TGXP) console ●
Connect the IN and OUT Luers on the catheter to its counterpart on the SUK .
Select an infusion lumen for an IV infusion
. Use 20 cc syringe for aspiration of saline after a catheter is used as a CVC after temperature management therapy ends
Aspirate saline prior to catheter removal ●

A total of five scenarios were presented, and each participant had to correctly answer questions 9-13 to achieve a passing score. All other questions (1-8, 14-15) required a minimum of an 80% passing score. The acceptance criteria were met with 100% of the users passing the critical tests (9-13). All of the non-critical items (1-8 and 14-15) were passed with at least 12 participants passing (80%).

All participants who received training and followed the IFU successfully met the acceptance criteria. This testing confirms that the custom Luer design, training, and IFU facilitate appropriate catheter and SUK connections. No device design, training or IFU modifications were indicated based on the summative evaluation.

V. Summary of Clinical Tests Performed:

Clinical evaluations were not necessary to evaluate the modifications incorporated in the Solex Catheter and SUK to demonstrate substantial equivalence to the predicate devices.

VI. Substantial Equivalence:

Based on the results of the Bench Performance, Packaging Validation (SUK only), Biocompatibility, and Usability testing, the modified Solex Catheter (Solex 7 Catheter) and modified SUK are substantially equivalent to the currently cleared Solex Catheter (K141139), Cool Line Catheter (K101987), and SUK (K014241) with respect to intended use/indication for use, technological characteristics, and principles of operation and that the modifications do not affect the performance or function of the devices. The minor differences in the design between the modified and cleared devices, do not raise any new types of safety or effectiveness questions as confirmed by design verification testing. Therefore, the modified Solex Catheter (Solex 7 Catheter) and modified SUK are substantially equivalent to the previously cleared predicate devices.

VII. Conclusions:

ZOLL concludes that based on the results of the Bench Performance. Packaging Validation (SUK only). Biocompatibility, and Usability testing, that the modified Solex Catheter (Solex 7 Catheter) and modified SUK are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).