(90 days)
The Solex 7 Intravascular Heat Exchange Catheter connected to the Coolgard/Thermogard Thermal Regulation System is indicated for use:
· In cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care. (Maximum use period: 4 days)
· To induce, maintain and reverse mild hypothermia in neurosurgery and recovery/intensive care.
(Maximum use period: 4 days)
· In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period: 7 days)
The Cool Line Catheter Model CL-2295A, when used with the ZOLL Thermal Regulation System, is indicated for use in fever reduction, as an adjunct to antipyretic therapy. in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893A, connected to the ZOLL Coolgard/Thermogard Thermal Regulation System, is indicated for use:
• In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and
- · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.
The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use:
• In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and
- · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.
The ZOLL Intravascular Heat Exchange Catheters (Quattro® Intravascular Heat Exchange Catheter Kit, Quattro® Intravascular Heat Exchange Catheter Premium Access Kit, Cool Line® Intravascular Heat Exchange Catheter, ICY® Intravascular Heat Exchange Catheter) are sterile, single use heparin coated flexible catheters designed for placement in the femoral, jugular, or subclavian veins. The Solex 78 Intravascular Heat Exchange Catheter Premium Access Kit is a sterile, single use 9.3F flexible catheter designed for placement in the superior vena cava from an insection site in the jugular and subclayian veins. The Cool Line catheter contains two heat exchange balloons, the ICY catheter contains three heat exchange balloons, the Quattro catheter contains four heat exchange balloons and the Solex 7® catheter consists of a serpentine balloon. The ZOLL catheters are connected to a single use, disposable Start-Up Kit (SUK), the Coolgard 3000® Console and Thermogard XP® Console. The catheters connect to the console coolant well via tubing integral to the SUK. The catheter is connected to the SUK by connecting the male outflow Luer of the SUK to the female inflow Luer of the catheter and the female inflow Luer of the SUK to the male outflow Luer of the catheter. Both SUK Luers, in turn, are connected via tubing to a heat exchange coil through which saline circulates. The coil is placed in a coolant well located in the console. The controlled temperature saline is circulated through the closed-loop circuit of the SUK and catheter using the console pump, after which the saline is then returned within the SUK to the console heater and chiller coolant well via the catheter's outflow lumen. The catheters, SUK, the Coolgard 3000® Console and the Thermogard XP® Console are supplied separately. The ZOLL Intravascular Heat Exchange System is also designed for use with an off-the-shelf temperature probe, which is supplied separately and not manufactured by ZOLL.
The provided text is a 510(k) summary for a medical device (intravascular heat exchange catheters and associated consoles). It describes the device, its intended use, a comparison to predicate devices, and nonclinical testing that was performed. However, it explicitly states that clinical evaluations were NOT performed for this change (see section V. SUMMARY OF CLINICAL TESTS PERFORMED on page 18).
Therefore, it is not possible to extract the requested information regarding acceptance criteria and studies that prove the device meets these criteria, as the submission focuses on demonstrating substantial equivalence through nonclinical testing and comparison to predicate devices, rather than a de novo clinical study with specific performance acceptance criteria.
The clinical trial information presented in the document (the table with CI, ICH, PTBI, SAH patient cohorts, and mortality percentages) is not a study performed to prove the acceptance criteria of this specific device, but rather a reference to a randomized controlled trial that influenced the FDA's decision to add a "Warning - Fever Reduction" limitation to the device's labeling. This trial evaluated the safety and effectiveness of the Cool Line Intravascular Heat Exchange Catheter generally, and its results (increased mortality in certain cohorts compared to standard of care) led to the specific warning about its use for fever reduction in patients with subarachnoid hemorrhage or primary traumatic brain injury. It does not represent a study designed to meet pre-defined acceptance criteria for the device in this 510(k) submission.
Given this, I cannot fill the table or answer the specific questions about "proving the device meets acceptance criteria" as no such study is presented in the provided document for this 510(k) submission. The submission relies on substantial equivalence to predicate devices and nonclinical testing for "MR Conditional" labeling.
If you had a document describing a clinical study undertaken specifically to demonstrate the performance characteristics of this device against defined acceptance criteria, I would be able to provide the requested information.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
December 20, 2021
ZOLL Circulation, Inc. Elizabeth Haines Senior Director, Regulatory Affairs 2000 Ringwood Avenue San Jose, California 95131
Re: K213031
Trade/Device Name: Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: NCX Dated: September 20, 2021 Received: September 21, 2021
Dear Elizabeth Haines:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
The OHT5: Office of Neurological and Physical Medicine Devices has determined that there is a reasonable likelihood that the Solex 7 Intravascular Heat Exchange Catheter will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with
{1}------------------------------------------------
Section 513(i)(1)(E) of the Act, the following limitation must appear in the box warning immediately following the indications for use statement of the device's labeling:
Warning - Fever Reduction
The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury. A randomized controlled trial of endovascular cooling in patients with fever associated with subarachnoid hemorrhage and primary traumatic brain injury has shown increased mortality as compared to patients receiving standard of care.
The OHT5: Office of Neurological and Physical Medicine Devices has determined that there is a reasonable likelihood that the Cool Line Intravascular Heat Exchange Catheter will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the box warning immediately following the indications for use statement of the device's labeling:
Warning - Fever Reduction
The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was examined in a randomized controlled trial of 296 patients. The mortality results reported in this trial, for the four patient cohorts enrolled, are presented in the table below (CI - cerebral infarction, ICH - intracerebral hemorrhage, PTBI - primary traumatic brain injury, SAH subarachnoid hemorrhage).
| Cool Line | Control | ||||||
|---|---|---|---|---|---|---|---|
| n | N | % | n | N | % | $p*$ | |
| CI | 3 | 16 | 18.8 | 3 | 14 | 21.4 | 0.74 |
| ICH | 8 | 33 | 24.2 | 7 | 27 | 25.9 | 1.00 |
| PTBI | 10 | 44 | 22.7 | 4 | 38 | 10.5 | 0.24 |
| SAH | 13 | 61 | 21.3 | 7 | 63 | 11.1 | 0.15 |
*Fischer's exact test
For more details on the clinical trial results, refer to the Physician's Manual – "Normothermia for the Neuro-critically III stroke natient."
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
{2}------------------------------------------------
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Christopher Loftus, M.D. Acting Director OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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 ReductionThe safety of this device has not been demonstrated for feverreduction in patients presenting with subarachnoid hemorrhageor primary traumatic brain injury. The safety and effectiveness ofthis device was examined in a randomized controlled trial of 296patients. The mortality results reported in this trial, for the four | |||||||
|---|---|---|---|---|---|---|---|
| patient cohorts enrolled, are presented in the table below (CI -cerebral infarction, ICH - intracerebral hemorrhage, PTBI - pri- | |||||||
| mary traumatic brain injury, SAH - subarachnoid hemorrhage).Cool LineControl | |||||||
| 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"
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The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893A, connected to the ZOLL Coolgard/Thermogard Thermal Regulation System, is indicated for use:
• In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and
- · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.
The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use:
• In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and
- · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K213031 510(K) SUMMARY
| Date Prepared: | December 16, 2021 |
|---|---|
| Submitter: | ZOLL Circulation, Inc. |
| Address: | 2000 Ringwood AvenueSan 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 CatheterCool Line Intravascular Heat Exchange CatheterICY Intravascular Heat Exchange CatheterQuattro Intravascular Heat Exchange CatheterStart-Up KitCoolgard 3000 ConsoleThermogard 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 ThermalRegulation System | K072234 |
| Alsius CoolGard 3000 and Catheter Thermal RegulationSystem | K060308 |
| Cool Line Intravascular Heat Exchange Catheter, ICYIntravascular Heat Exchange Catheter, QuattroIntravascular Heat Exchange Catheter, Start-Up Kit(SUK) | K150046 |
| Solex 7 Intravascular Heat Exchange Catheter and Start-Up Kit | K153226 |
I. DEVICE DESCRIPTION
The ZOLL Intravascular Heat Exchange Catheters (Quattro® Intravascular Heat Exchange Catheter Kit, Quattro® Intravascular Heat Exchange Catheter Premium Access Kit, Cool Line® Intravascular Heat Exchange Catheter, ICY® Intravascular Heat Exchange Catheter) are sterile, single use heparin coated flexible catheters designed for placement in the femoral, jugular, or subclavian veins. The
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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.
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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 ReductionThe safety of this device has not been demonstrated for feverreduction in patients presenting with subarachnoid hemorrhageor primary traumatic brain injury. The safety and effectiveness ofthis device was examined in a randomized controlled trial of 296patients. The mortality results reported in this trial, for the fourpatient 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 testFor 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.
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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 HeatExchange Catheter, Cool Line®Intravascular Heat ExchangeCatheter, ICY Intravascular HeatExchange Catheter | Quattro IntravascularHeat Exchange Catheter,Cool Line IntravascularHeat Exchange Catheter,ICY Intravascular HeatExchange Catheter | ||||
| 510(k) Number | K150046 | K213031 | ||||
| Class | II | Same | ||||
| Classification/Regulation Name | System, Hypothermia, Intravenous,Cooling/Thermal Regulating System | Same | ||||
| Regulation Number | 21 CFR 870.5900 | Same | ||||
| Product Code | NCX | Same | ||||
| Insertion Site | Cool Line® - Femoral vein, jugularvein, subclavian veinICY® – Femoral veinQuattro® - Femoral vein | Same | ||||
| Heparin Coating | SurModics Applause HeparinCoating | Same | ||||
| Luer Designs | Inflow and outflow Luers: ZOLLCustom LuersInfusion Luers: ZOLL StandardLuers | Same | ||||
| Feature | PREDICATE DEVICES | SUBJECT DEVICES | ||||
| Luer Materials | Vent Caps: ZOLL Custom Vent CapsBase material is polyurethane (for all Luers except for vent caps)Inflow and outflow Luers: Polyurethane:Tecoplast OP-770-164 OrangeDistal infusion Luer:Polyurethane:Tecoplast OP-770-477 Brown(pad printing white ink)Medial Infusion Luer:Polyurethane:Tecoplast OP-770-WhiteProximal infusion Luer:Polyurethane: TecoplastOP-770-541 Dark Blue(pad printing white ink)Male vent cap: ABS: Ineos Lustran(P/N 348-012002)Female vent cap: ABS: IneosLustran (P/N 348-012002) | Same | ||||
| Catheter Working Length (tip to manifold) | Cool Line® – 22 cmICY® – 38 cmQuattro® – 45 cm | Same | ||||
| Shaft Diameter | 9.3 Fr | Same | ||||
| Number of Lumens | 5 lumens: 2 infusion, 1 guidewire (plus infusion), 1 inflow, 1 outflow | Same | ||||
| Guidewire Compatibility | 0.032 in. | Same | ||||
| Heat Exchange Balloons | Cool Line® – 2 (straight/coaxial)ICY® – 3 (straight/coaxial)Quattro® – 4 (straight/coaxial) | Same | ||||
| Feature | PREDICATE DEVICES | SUBJECT DEVICES | ||||
| Flow Rate (by lumen) | Cool Line®Distal – 2100 mL/hrMedial – 1200 mL/hrProximal – 1400 mL/hr | Same | ||||
| ICY®Distal – 1700 mL/hrMedial – 900 mL/hrProximal – 1200 mL/hr | ||||||
| Quattro®Distal – 1300 mL/hrMedial – 800 mL/hrProximal – 1100 mL/hr | ||||||
| Approx. Inflated Balloon OD(Cross-sectional Area) | Cool Line®: ~5 mm (20 mm²) | Same | ||||
| ICY® and Quattro®: ~8 mm (50 mm²) | ||||||
| Heat Exchange Power | Cool Line® – 65 Watts nominal | Same | ||||
| ICY® – 140 Watts nominal | ||||||
| Quattro® – 190 Watts nominal | ||||||
| Materials:ShaftBalloon | Polyurethane | Same | ||||
| PET and Polyurethane (ICY®and Quattro®) | ||||||
| Polyurethane (Cool Line®) | ||||||
| Sterilization Method and SterilityAssurance Level (SAL) | Ethylene Oxide (EO) and SAL 10-6 | Same |
Table 1: Comparison of Subject and Predicate Catheters
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Table 2: Comparison of Subject Solex 7® Intravascular Heat Exchange Catheter with Predicate
| Feature | PREDICATE DEVICE | SUBJECT DEVICE |
|---|---|---|
| Device Name | Solex 7™ Intravascular HeatExchange Catheter | Solex 7® IntravascularHeat Exchange Catheter |
| 510(k) Number | K153226 | K213031 |
| Class | II | Same |
| Classification/Regulation Name | System, Hypothermia, Intravenous,Cooling/Thermal Regulating System | Same |
| Regulation Number | 21 CFR 870.5900 | Same |
| Product Code | NCX | Same |
| Heparin Coating | SurModics Applause HeparinCoating | Same |
| Luer Designs | Inflow and Outflow Luers: ZOLLCustom LuersInfusion Luers: Standard LuersVent Caps: ZOLL Custom VentCaps | Same |
| Feature | PREDICATE DEVICE | SUBJECT DEVICE |
| Luer Materials | Luer Base: Polyurethane (for allLuers except for vent caps)Inflow and outflow Luers:Polyurethane: Tecoplast OrangeDistal infusion Luer:Polyurethane: Tecoplast Brown (padprinting white ink)Medial infusion Luer:Polyurethane: Tecoplast WhiteProximal infusion Luer:Polyurethane: Tecoplast Dark Blue(pad printing white ink)Male vent cap: ABSFemale vent cap: ABS | Same |
| Catheter Working Length (tip tomanifold) | 26 cm | 20 cm |
| Shaft Diameter | 9.3 Fr | Same |
| Number of Lumens | 5 lumens:2 infusion1 guidewire (also infusion)1 inflow1 outflow | Same |
| Guidewire Compatibility | 0.032 in. | Same |
| Flow Rate (by lumen) | Distal - 1900 mL/hrMedial - 1300 mL/hrProximal - 1300 mL/hr | Same |
| Heat Exchange Balloons | 1 (serpentine) | Same |
| Inflated Balloon OD (Cross-Sectional Area) | Balloon OD: N/ACross-sectional Area: 54 mm² | Same |
| Cross Sectional Area (approx.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: PolyurethaneHeat 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-500DCG-500D EX | Same |
| Principle of Operation | To control patient core temperatureusing heat exchange fluid inconjunction with Coolgard 3000® orThermogard XP® Consoles andZOLL Heat Exchange Catheters | Same |
| Class | II | Same |
| Classification/Regulation Name | System, Hypothermia, Intravenous,Cooling/Thermal Regulating System | Same |
| Regulation Number | 21 CFR 870.5900 | Same |
| Product Code | NCX | Same |
| Patient Contact | Indirect Patient Contact | Same |
| Luer Function | Join the SUK to the InFlow/OutFlowLumens of the catheters, and allowsaline to circulate through thecatheter/SUK fluid path | Same |
| Supplied 20 ml Sterile Deflation(Slip-Fit) Syringe | Syringe provided with SUK foroptional removal of saline fromcatheter heat exchange balloons priorto catheter removal | Same |
| Sterilization Method and SAL | Gamma sterilization, SAL 10-6 | Same |
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Table 3: Comparison of Subject Start-Up Kit with Predicate
Table 4: Comparison of Subject Coolgard® 3000 Console and Thermogard® XP Console with Predicate
| Feature | PREDICATE DEVICE | PREDICATE DEVICE | SUBJECT DEVICES |
|---|---|---|---|
| Device Name | Alsius CoolGard 3000 | AlsiusTHERMOGARD XP | Coolgard 3000®ConsoleThermogard XP®Console |
| 510(k) number | K060308 | K072234 | K213031 |
| Principle ofOperation | It automatically adjusts thetemperature of a heater/chillerglycol bath to achieve the patienttarget temperature that haspreviously been set by theattending physician. A temperatureprobe is used to monitor thepatient temperature, a catheter isused to exchange heat to and fromthe patient, and the delta betweenthe target temperature and patienttemperature defines thetemperature of the saline pumpedthrough the catheter. A heatexchanger placed within the glycol | Same | Same |
| Feature | PREDICATE DEVICE | PREDICATE DEVICE | SUBJECT DEVICES |
| bath heats and cools the saline in the catheter. | |||
| Class | Class II | Same | Same |
| Classification/Regulation Name | System, Hypothermia,Intravenous, Cooling | Same | Same |
| RegulationNumber | 21 CFR 870.5900 | Same | Same |
| Product Code | NCX | Same | Same |
| Patient Contact | No direct patient contact | Same | Same |
| Physical:1. Dimensions | Height: 45 in. (114 cm)Width: 17 in. (43 cm)Depth: 30 in. (76 cm) | Same | Same |
| 2.Weight | 115 lb. (52 kg) | Same | 107 lb. (49 kg) |
| Electrical:1. Configuration | 100-120 VAC, 50/60 Hz, 5 A220-240 VAC, 50/60 Hz, 2.25 A | Same | Same |
| 2. Voltageselector setting | 115 V - 230 V | Same | Same |
| 3. Fuseprotection | T6.3A (slow blow) 5 x 20 mmT6.3A (slow blow) 5 x 20 mm | Same | Same |
| Environmental:1. Operatingtemperatures | 10° C - 27° C (50° F – 81° F) | Same | Same |
| 2. Operatinghumidity | 30% to 75% noncondensing | Same | Same |
| 3. Atmosphericpressure: | 70 kPa to 106 kPa | Same | Same |
| Chiller andHeater:1.Reservoirvolume | 2.0 liters (0.5 gal.) | Same | Same |
| 2. Pump capacity | 7 lpm at 0 m head (0 ft.) | Same | Same |
| 3. Temperaturerange | 0° C - 42° C | Same | Same |
| 4. Coolant | 1:1 mixture of propylene glycoland distilled water | Same | Same |
| 5. Refrigerant | HFC 134a | Same | RFC 134a |
| 6. Nominal Power(must be greaterthan) | 115 watts | 190 watts | Coolgard 3000®:115 wattsThermogard XP®:190 watts |
| Feature | PREDICATE DEVICE | PREDICATEDEVICE | SUBJECTDEVICES |
| Controller andDisplay1. Screendisplay | 6.4 in. (16.25 cm) LCD color VGA | Same | Same |
| 2. Controls | Pushbuttons and knob | Same | Same |
| 3. Temperatureinput | Thermistor, YSI 400 series | Same | Same |
| 4. Articulation | 180° swivel, 45° tilt | Same | Same |
| 4. Data interface | Serial RS-232C, 9-pin sub-Dconnector | Same | Same |
| 6. Alarms | Audible tones and displayed textmessages | Same | Same |
| 7. Displayedtemperaturerange | 26° C - 42° C | Same | Same |
| 8. Displayedtemperatureaccuracy | ± 0.2° C | Same | Same |
| Saline CoolantCircuit1. Primingvolume | 200 ml | Same | Same |
| 2. Heat exchanger | Disposable stainless steel coil | Same | Same |
| 3. Priming source | Sterile saline solution (hospital-provided) | Same | Same |
| 4. Patientconnection | Directional Luer connections on72 in. (183 cm) lines | Same | Same |
| 5. Pump tubing | Roller pump compatible withdirectional fittings | Same | Same |
| 6. Sterility | Gamma sterilized | Same | Same |
| 7. Saline alarm | Reservoir level detection & alarmsystem | Same | Same |
| 8. Coolant circuitoperating life | Replace disposable componentsafter seven (7) days ofcontinuous use | Same | Same |
| Feature | PREDICATE DEVICE | PREDICATE DEVICE | SUBJECT DEVICES |
| Equipment Classifications:1. Type of protection against moisture | Ordinary | Same | Same |
| 2. 60601 Safety Class | Type BF for temperature inputsType B for catheter connections | Same | Same |
| 3. Protection class | 1 | Same | Same |
| 4. Mode of operation | Continuous | Same | Same |
| Alsius Start-up Kit: Start-up Kit Accessory | Model CG-500DModel CG-500D EX | Same | Same |
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IV. SUMMARY OF THE NONCLINICAL TESTS PERFORMED
This Traditional 510(k) submission is for an update to the Instructions for Use based on a recall related to an FDA request. Technological characteristics of the devices remain similar to the predicate devices. Nonclinical testing was performed to support 'MR Conditional' labelling. Tables 5-7 below summarize the nonclinical testing for the Cool Line® Intravascular Heat Exchange Catheter, Solex 7® Intravascular Heat Exchange Catheter Premium Access Kit, Quattro® Intravascular Heat Exchange Catheter Premium Access Kit and Quattro® Intravascular Heat Exchange Catheter Kit. Nonclinical testing demonstrated that the Cool Line® Intravascular Heat Exchange Catheter, Solex 7º Intravascular Heat Exchange Catheter Premium Access Kit, Quattro® Intravascular Heat Exchange Catheter Premium Access Kit and Quattro® Intravascular Heat Exchange Catheter Kit are MR Conditional. MR testing of the Quattro® Intravascular Heat Exchange Catheter Kit was used to support the 'MR Conditional' labeling for the ICY® Intravascular Heat Exchange Catheter.
| Test Name | Test Method Summary | Results |
|---|---|---|
| Magnetic FieldInteractions | Testing for magnetic field interactions involvedevaluations of translational attraction and torque for theCool Line® Intravascular Heat Exchange Catheter using a3 Tesla (T) MR system. | Testing showed theCool Line®Intravascular HeatExchange Catheteris MR Conditionalin 3 T MR systems. |
| MRI-RelatedHeating | This device was tested for MRI-related heating accordingto recommendations in the ASTM F2182-19e2: StandardTest Method for Measurement of Radio FrequencyInduced Heating On or Near Passive Implants DuringMagnetic Resonance Imaging. | Testing showed theCool Line®Intravascular HeatExchange Catheteris MR Conditionalin 1.5 T/64 MHz |
Table 5: Cool Line® Intravascular Heat Exchange Catheter
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| Test Name | Test Method Summary | Results |
|---|---|---|
| Artifact Test | MR imaging artifacts were assessed for the Cool Line®Intravascular Heat Exchange Catheter, emphasizing thepart of the catheter that would be implanted in the patient,in association with the use of a 3 T MR system. This testwas accomplished by performing MR imaging with thedevice placed inside of a gadolinium-doped, saline filledplastic phantom following aspects of the ASTM F2119-07 (2013): Standard Test Method for Evaluation of MRImage Artifacts from Passive Implants. | and 3 T/128 MHzMR systems.Testing showed theCool Line®Intravascular HeatExchange Catheteris MR Conditionalin 3 T MR systems. |
| Table 6: Solex 7® Intravascular Heat Exchange Catheter Premium Access Kit | ||
|---|---|---|
| Test Name | Test Method Summary | Results |
|---|---|---|
| Magnetic FieldInteractions | Testing for magnetic field interactions involvedevaluations of translational attraction and torque for theSolex 7® Intravascular Heat Exchange Catheter PremiumAccess Kit using a 3 T MR system. The Solex 7®Intravascular Heat Exchange Catheter Premium AccessKit that was evaluated was representative of themanufactured or "finished" version of this device. Asingle sample of this device was tested and deemedappropriate since there are insignificant variations due tomanufacturing differences. | Testing showed theSolex 7®Intravascular HeatExchange CatheterPremium AccessKit is MRConditional in 3 TMR systems. |
| MRI- RelatedHeating | This device was tested for MRI-related heating accordingto recommendations in the ASTM F2182-19e2: StandardTest Method for Measurement of Radio FrequencyInduced Heating On or Near Passive Implants DuringMagnetic Resonance Imaging. | Testing showed theSolex 7®Intravascular HeatExchange CatheterPremium AccessKit is MRConditional in 1.5T/64 MHz and 3T/128 MHz MRSystems. |
| Artifact Test | MR imaging artifacts were assessed for the Solex 7®Intravascular Heat Exchange Catheter Premium AccessKit, emphasizing the part of the catheter that would beimplanted in the patient, in association with the use of a 3T MR system. This test was accomplished by performingMR imaging with the device placed inside of agadolinium-doped, saline filled plastic phantom followingaspects of the ASTM F2119-07 (2013): Standard TestMethod for Evaluation of MR Image Artifacts fromPassive Implants. | Testing showed theSolex 7®Intravascular HeatExchange CatheterPremium AccessKit is MRConditional in 3 TMR systems. |
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| Test Name | Test Method Summary | Results |
|---|---|---|
| Magnetic FieldInteractions | Testing for magnetic field interactions involvedevaluations of translational attraction and torque for theQuattro® Intravascular Heat Exchange Catheter Kit andQuattro® Intravascular Heat Exchange Catheter PremiumAccess Kit using a 3 T MR system. The QuattroIntravascular Heat Exchange Catheter Kit that wasevaluated was representative of the manufactured or"finished" version of this device. A single sample of thisdevice was tested and deemed appropriate since there areinsignificant variations due to manufacturing differences. | Testing showed theQuattro®Intravascular HeatExchange CatheterKit and Quattro®Intravascular HeatExchange CatheterPremium AccessKit are MRConditional in 3 TMR systems. |
| MRI-RelatedHeating | The Quattro Intravascular Heat Exchange Catheter Kitwas tested for MRI-related heating according torecommendations in the ASTM F2182-19e2: StandardTest Method for Measurement of Radio FrequencyInduced Heating on or Near Passive Implants DuringMagnetic Resonance Imaging. | Testing showed theQuattro®Intravascular HeatExchange CatheterKit and Quattro®Intravascular HeatExchange CatheterPremium AccessKit are MRConditional in 1.5T/64 MHz and 3 T/128 MHz MRsystems. |
| Artifact Test | MR imaging artifacts were assessed for the QuattroIntravascular Heat Exchange Catheter Kit, emphasizingthe part of the catheter that would be implanted in thepatient's vasculature, in association with the use of a 3 TMR system. This test was accomplished by performingMR imaging with the device placed inside a gadolinium-doped, saline filled plastic phantom following the ASTMF2119-07 (2013): Standard Test Method for Evaluationof MR Image Artifacts from Passive Implants. | Testing showed theQuattro®Intravascular HeatExchange CatheterKit and Quattro®Intravascular HeatExchange CatheterPremium AccessKit are MRConditional in 3 TMR systems. |
Table 7: Quattro® Intravascular Heat Exchange Catheter Kit and Quattro® Intravascular Heat Exchange Catheter Premium Access Kit
Biocompatibility: The changes in this submission do not impact biocompatibility.
V. SUMMARY OF CLINICAL TESTS PERFORMED
Clinical evaluations were not performed for this change.
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VI. CONCLUSIONS
This Traditional 510(k) submission is for an update to the Instructions for Use. The difference in the Instructions for Use between the subject and predicate devices do not raise any new questions of safety and effectiveness. New warnings, precautions, and instructions were added to the Instructions for Use for the subject devices.
ZOLL Circulation, Inc., concludes that based on the above discussion the Cool Line® Intravascular Heat Exchange Catheter, ICY® Intravascular Heat Exchange Catheter, Solex 7% Intravascular Heat Exchange Catheter Premium Access Kit, Quattro® Intravascular Heat Exchange Catheter, Quattro® Intravascular Heat Exchange Premium Access Kit, Start-Up Kit, the Coolgard 3000® Console and the Thermogard XP® Console with updated Instructions for Use are substantially equivalent to the predicate devices.
§ 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).