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

{0}------------------------------------------------ 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<br>The safety of this device has not been demonstrated for fever<br>reduction in patients presenting with subarachnoid hemorrhage<br>or primary traumatic brain injury. The safety and effectiveness of<br>this device was examined in a randomized controlled trial of 296<br>patients. The mortality results reported in this trial, for the four | | | | | |------|--------------------------------------------------------------------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|----|------|------| | | | | patient cohorts enrolled, are presented in the table below (CI -<br>cerebral infarction, ICH - intracerebral hemorrhage, PTBI - pri- | | | | | | | mary traumatic brain injury, SAH - subarachnoid hemorrhage).<br>Cool Line<br>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) | <span></span> | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |---------------|----------------------------------------------------------------------------------| | <span></span> | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ # K213031 510(K) SUMMARY | Date Prepared: | December 16, 2021 | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | ZOLL Circulation, Inc. | | Address: | 2000 Ringwood Avenue<br>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<br>Cool Line Intravascular Heat Exchange Catheter<br>ICY Intravascular Heat Exchange Catheter<br>Quattro Intravascular Heat Exchange Catheter<br>Start-Up Kit<br>Coolgard 3000 Console<br>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<br>Regulation System | K072234 | | Alsius CoolGard 3000 and Catheter Thermal Regulation<br>System | K060308 | | Cool Line Intravascular Heat Exchange Catheter, ICY<br>Intravascular Heat Exchange Catheter, Quattro<br>Intravascular Heat Exchange Catheter, Start-Up Kit<br>(SUK) | K150046 | | Solex 7 Intravascular Heat Exchange Catheter and Start-<br>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<br>The safety of this device has not been demonstrated for fever<br>reduction in patients presenting with subarachnoid hemorrhage<br>or primary traumatic brain injury. The safety and effectiveness of<br>this device was examined in a randomized controlled trial of 296<br>patients. The mortality results reported in this trial, for the four<br>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<br>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<br>Exchange Catheter, Cool Line®<br>Intravascular Heat Exchange<br>Catheter, ICY Intravascular Heat<br>Exchange Catheter | Quattro Intravascular<br>Heat Exchange Catheter,<br>Cool Line Intravascular<br>Heat Exchange Catheter,<br>ICY Intravascular Heat<br>Exchange Catheter | | | | | | 510(k) Number | K150046 | K213031 | | | | | | Class | II | Same | | | | | | Classification/Regulation Name | System, Hypothermia, Intravenous,<br>Cooling/Thermal Regulating System | Same | | | | | | Regulation Number | 21 CFR 870.5900 | Same | | | | | | Product Code | NCX | Same | | | | | | Insertion Site | Cool Line® - Femoral vein, jugular<br>vein, subclavian vein<br>ICY® – Femoral vein<br>Quattro® - Femoral vein | Same | | | | | | Heparin Coating | SurModics Applause Heparin<br>Coating | Same | | | | | | Luer Designs | Inflow and outflow Luers: ZOLL<br>Custom Luers<br>Infusion Luers: ZOLL Standard<br>Luers | Same | | | | | | Feature | PREDICATE DEVICES | SUBJECT DEVICES | | | | | | Luer Materials | Vent Caps: ZOLL Custom Vent Caps<br>Base material is polyurethane (for all Luers except for vent caps)<br>Inflow and outflow Luers: Polyurethane:<br>Tecoplast OP-770-164 Orange<br>Distal infusion Luer:<br>Polyurethane:<br>Tecoplast OP-770-477 Brown<br>(pad printing white ink)<br>Medial Infusion Luer:<br>Polyurethane:<br>Tecoplast OP-770-White<br>Proximal infusion Luer:<br>Polyurethane: Tecoplast<br>OP-770-541 Dark Blue<br>(pad printing white ink)<br>Male vent cap: ABS: Ineos Lustran<br>(P/N 348-012002)<br>Female vent cap: ABS: Ineos<br>Lustran (P/N 348-012002) | Same | | | | | | Catheter Working Length (tip to manifold) | Cool Line® – 22 cm<br>ICY® – 38 cm<br>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)<br>ICY® – 3 (straight/coaxial)<br>Quattro® – 4 (straight/coaxial) | Same | | | | | | Feature | PREDICATE DEVICES | SUBJECT DEVICES | | | | | | Flow Rate (by lumen) | Cool Line®<br>Distal – 2100 mL/hr<br>Medial – 1200 mL/hr<br>Proximal – 1400 mL/hr | Same | | | | | | | | | ICY®<br>Distal – 1700 mL/hr<br>Medial – 900 mL/hr<br>Proximal – 1200 mL/hr | | | | | | | | | Quattro®<br>Distal – 1300 mL/hr<br>Medial – 800 mL/hr<br>Proximal – 1100 mL/hr | | | | | | | | Approx. Inflated Balloon OD<br>(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:<br>Shaft<br>Balloon | Polyurethane | Same | | | | | | | PET and Polyurethane (ICY®<br>and Quattro®) | | | | | | | | Polyurethane (Cool Line®) | | | | | | | Sterilization Method and Sterility<br>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<br>Exchange Catheter | Solex 7® Intravascular<br>Heat Exchange Catheter | | 510(k) Number | K153226 | K213031 | | Class | II | Same | | Classification/Regulation Name | System, Hypothermia, Intravenous,<br>Cooling/Thermal Regulating System | Same | | Regulation Number | 21 CFR 870.5900 | Same | | Product Code | NCX | Same | | Heparin Coating | SurModics Applause Heparin<br>Coating | Same | | Luer Designs | Inflow and Outflow Luers: ZOLL<br>Custom Luers<br>Infusion Luers: Standard Luers<br>Vent Caps: ZOLL Custom Vent<br>Caps | Same | | Feature | PREDICATE DEVICE | SUBJECT DEVICE | | Luer Materials | Luer Base: Polyurethane (for all<br>Luers except for vent caps)<br><br>Inflow and outflow Luers:<br>Polyurethane: Tecoplast Orange<br><br>Distal infusion Luer:<br>Polyurethane: Tecoplast Brown (pad<br>printing white ink)<br><br>Medial infusion Luer:<br>Polyurethane: Tecoplast White<br><br>Proximal infusion Luer:<br>Polyurethane: Tecoplast Dark Blue<br>(pad printing white ink)<br><br>Male vent cap: ABS<br>Female vent cap: ABS | Same | | Catheter Working Length (tip to<br>manifold) | 26 cm | 20 cm | | Shaft Diameter | 9.3 Fr | Same | | Number of Lumens | 5 lumens:<br>2 infusion<br>1 guidewire (also infusion)<br>1 inflow<br>1 outflow | Same | | Guidewire Compatibility | 0.032 in. | Same | | Flow Rate (by lumen) | Distal - 1900 mL/hr<br>Medial - 1300 mL/hr<br>Proximal - 1300 mL/hr | Same | | Heat Exchange Balloons | 1 (serpentine) | Same | | Inflated Balloon OD (Cross-<br>Sectional Area) | Balloon OD: N/A<br>Cross-sectional Area: 54 mm² | Same | | Cross Sectional Area (approx.<br>inflated outer diameter) | 54 mm² (12.2 mm OD) | Same | | Insertion Site | Jugular and Subclavian Veins | Same | | Max. Use Period | 7 Days | Same | | Materials | Shaft: Polyurethane<br>Heat Exchange Balloon: PET | Same | | Sterilization Method and SAL | EO and SAL 10-6 | Same | | Feature | PREDICATE DEVICE | SUBJECT DEVICE | | Device Name | Start-Up Kit | Start-Up Kit | | 510(k) number | K153226 | K213031 | | Model | CG-500D<br>CG-500D EX | Same | | Principle of Operation | To control patient core temperature<br>using heat exchange fluid in<br>conjunction with Coolgard 3000® or<br>Thermogard XP® Consoles and<br>ZOLL Heat Exchange Catheters | Same | | Class | II | Same | | Classification/Regulation Name | System, Hypothermia, Intravenous,<br>Cooling/Thermal Regulating System | Same | | Regulation Number | 21 CFR 870.5900 | Same | | Product Code | NCX | Same | | Patient Contact | Indirect Patient Contact…