(30 days)
The Solex 7 Intravascular Heat Exchange Catheter connected to the CoolgardThermal Requlation 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 recoverylintensive care. (Maximum use period: 4 days)
- · In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral infaction and intracerebral 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 neurosurqery 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 recoverylintensive care, and
- · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.
The ZOLL Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (either the Thermogard HQ™ Console or the Thermogard XP® Console) and intravascular heat exchange catheters connected via a sterile heat exchanger and tubing circuit. These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the Thermogard HQ™ Console (TGHQ) and the Thermogard XP® Console (TGXP) for software changes due to the addition of the TrakLo functionality to both consoles.
Here's a breakdown of the requested information based on the provided text, regarding the "TrakLo" feature of the Thermogard XP Console and Thermogard HQ Console:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Human Factors / Usability | Passed - "Test methods validate the device for human factors per the intended use with the TrakLo feature." |
| Software Verification | Passed - "Test methods verify that the software meets software requirements." |
| Device operates as intended | Passed - "The Thermogard HQ™ Console and Thermogard XP® Console with the TrakLo feature meet the design, performance, and safety specifications when used in accordance with the labeling." and "The difference between the subject and predicate devices does not raise new questions of safety and effectiveness." |
| Substantial Equivalence | Achieved - "It was demonstrated through performance testing and comparison of design features that the proposed devices are substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance
The document does not specify a numerical sample size for the test set for the TrakLo feature's non-clinical testing. It only states "Test methods validate the device for human factors per the intended use with the TrakLo feature" and "Test methods verify that the software meets software requirements." This suggests internal testing without a specified sample size for "human factors" or "software verification" in the context of clinical trials.
The data provenance for the non-clinical testing is implied to be internal testing conducted by ZOLL Circulation, Inc. The document does not mention details about country of origin or whether it was retrospective or prospective data in the context of this specific regulatory submission for the TrakLo feature.
It is important to note that the broader warnings regarding the "Cool Line Intravascular Heat Exchange Catheter" refer to a randomized controlled trial of 296 patients, but this clinical trial data is not related to the TrakLo feature, but rather to the initial clearance of the Cool Line device and its limitations for certain fever reduction indications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information about the number or qualifications of experts used to establish ground truth for the non-clinical tests (Human Factors/Usability and Software Verification) related to the TrakLo feature.
4. Adjudication method for the test set
The document does not describe any adjudication method for the test set. For software and human factors testing, "adjudication" in the sense of expert consensus on clinical outcomes is typically not applicable. The testing would have followed internal protocols to assess functionality and usability.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done for the TrakLo feature. The TrakLo feature is a software enhancement to an existing thermal regulation console, primarily affecting alarm behavior, not an AI-assisted diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance of the TrakLo feature itself, as a software algorithm, was evaluated in standalone non-clinical testing. The "Software Verification" and aspects of "Human Factors / Usability" tests evaluate the algorithm's functionality and its interaction with the user interface, independent of a clinical human-in-the-loop scenario for diagnostic purposes. It's a control algorithm enhancement, not an AI for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the TrakLo feature:
- Software Verification: The ground truth would be the defined software requirements and specifications. The tests verify that the code implements these requirements correctly.
- Human Factors / Usability: The ground truth would involve established human factors engineering principles and usability goals, likely assessed through user observation, task analysis, and error analysis against predetermined acceptance criteria related to usability.
8. The sample size for the training set
This information is not provided. The TrakLo feature is described as a software modification for improved utility in warming applications, preventing a "Lo alarm" under specific conditions. It doesn't appear to be an AI/machine learning model that would require a distinct "training set" in the conventional sense. It's an algorithmic change.
9. How the ground truth for the training set was established
As described above, the concept of a "training set" and associated "ground truth" for training an AI model does not apply here based on the information provided. The TrakLo feature is an algorithmic change for alarm management under specific temperature conditions.
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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 13, 2023
ZOLL Circulation, Inc. Brian Robey Vice President. Advanced Development and Design Quality Assurance 2000 Ringwood Avenue San Jose, California 95131
Re: K223746
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, Thermogard XP Console, Thermogard HQ Console
Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: NCX Dated: December 12, 2022 Received: December 14, 2022
Dear Brian Robey:
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 Neurocritically Ill stroke patient."
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 medical devices and radiation-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,
David P. Mc Mullen -S
David McMullen, M.D. 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) K223746
Device Name
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
Indications for Use (Describe)
The Solex 7 Intravascular Heat Exchange Catheter connected to the CoolgardThermal Requlation 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 recoverylintensive care. (Maximum use period: 4 days)
- · In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral infaction 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.
The Cool Line Catheter Model CL-2295A, when used with the ZOLL Thermal Regulation System, is indicated for use in fever reduction, as an adjunct to antipyretic therapy, in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
Warning - Fever Reduction
The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was examined in a randomized controlled trial of 296 patients. The mortality results reported in this trial, for the four patient cohorts enrolled, are presented in the table below (CI - cerebral infarction, ICH - intracerebral hemorrhage, PTBI - 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 Neurocritically Ill stroke patient.3
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The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893A, connected to the ZOLL Coolgard/Thermogard Thermal Requlation 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 neurosurqery 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 recoverylintensive 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K223746 510(k) SUMMARY
| Date Prepared: | January 6, 2023 |
|---|---|
| Submitter:Address: | ZOLL Circulation, Inc.2000 Ringwood AvenueSan Jose, CA 95131 |
| Phone:Fax:Contact Person: | 978-805-9015408-541-1030Brian Robey, Vice President, Advanced Development and Design QualityAssurance |
| Trade Name: | Solex 7® Intravascular Heat Exchange CatheterCool Line® Intravascular Heat Exchange CatheterICY® Intravascular Heat Exchange CatheterQuattro® Intravascular Heat Exchange CatheterThermogard XP® ConsoleThermogard HQ™ Console |
| Common Name:Classification/Name:Regulation:Product Code: | Central Venous Catheter (short term) and Thermal Regulating SystemClass II; System, Hypothermia, Intravenous, Cooling21 CFR 870.5900, Thermal Regulating SystemNCX |
| Predicate Devices: | K220008: Solex 7® Intravascular Heat Exchange Catheter, Cool Line®Intravascular Heat Exchange Catheter, ICY® Intravascular HeatExchange Catheter, Quattro® Intravascular Heat Exchange Catheter,Thermogard HQ™ Start-Up Kit, Thermogard HQ™ Start-Up Kit EX,Thermogard HQ™ Console |
| K213031: Solex 7® Intravascular Heat Exchange Catheter, Cool Line®Intravascular Heat Exchange Catheter, ICY® Intravascular HeatExchange Catheter, Quattro® Intravascular Heat Exchange Catheter,Start-Up Kit, Coolgard® 3000 Console, Thermogard XP® Console |
I. DEVICE DESCRIPTION
The ZOLL Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (either the Thermogard HQ™ Console or the Thermogard XP® Console) and intravascular heat exchange catheters connected via a sterile heat exchanger and tubing circuit. These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the Thermogard HQ™ Console (TGHQ) and the Thermogard XP® Console (TGXP) for software changes due to the addition of the TrakLo functionality to both consoles.
II. INDICATIONS FOR USE
The Thermogard HQ™ Console and Thermogard XP® Console are not intended to be used separately from the heat exchange catheters and do not have specific indications for use. The indications for use of the Solex 7® Intravascular Heat Exchange Catheter, Cool Line® Intravascular Heat Exchange Catheter, ICY® Intravascular Heat Exchange Catheter, and Quattro® Intravascular Heat Exchange Catheter are identical to the indications for use of the predicate devices.
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Indications for Use:
Solex 7 Intravascular Heat Exchange Catheter
The Solex 7 Intravascular Heat Exchange Catheter connected to the CoolgardThermal 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.
Cool Line Intravascular Heat Exchange Catheter
The Cool Line Catheter Model CL-2295A, when used with the ZOLL Thermal Regulation System, is indicated for use in fever reduction, as an adjunct to antipyretic therapy, in adult patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
Warning - Fever Reduction
The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was examined in a randomized controlled trial of 296 patients. The mortality results reported in this trial, for the four patient cohorts enrolled, are presented in the table below (CI - cerebral infarction, ICH - intracerebral hemorrhage, PTBI - primary traumatic brain injury, SAH -
| DUUUUUUUUUUU TIATIMITTUAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA | |||||||
|---|---|---|---|---|---|---|---|
| Cool Line | |||||||
| n | N | % | n | N | % | p* | |
| CI | ನ | 16 | 18.8 | 3 | 14 | 21.4 | 0.74 |
| ICH | 80 | 33 | 24.2 | 7 | 27 | 25.9 | 1.00 |
| PTBI | 10 | 44 | 22.7 | ব | 38 | 10.5 | 0.24 |
| SAH | 13 | 61 | 21.3 | 7 | ર્ભ્ડ | 11.1 | 0.15 |
subarachnoid hemorrhage)
*Fischer's exact test
For more details on the clinical trial results, refer to the Physician's Manual – "Normothermia for Neuro-critically Ill stroke patient."
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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.
III. TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICES COMPARED TO THE PREDICATE DEVICES
There were no changes to the intravascular heat exchange catheters. The comparison with the predicates Thermogard XP® Console and Thermogard HQ™ Console shows the technological characteristics of the proposed Thermogard XP® Console and Thermogard HQ™ Console with TrakLo functionality to be substantially equivalent in Table 1.1.
| Feature | Predicate Devices | Subject Devices |
|---|---|---|
| Device Name | Thermogard XP® Console (K213031)Thermogard HQ™ Console (K220008) | Thermogard XP® ConsoleThermogard HQ™ Console |
| 510(k) Number | K213031K220008 | K223746 |
| Principle of Operation | Automatically adjusts the temperature of aheater/chiller glycol bath to achieve the patienttarget temperature that has previously been set bythe attending physician. A temperature probe isused to monitor the patient temperature, a catheteris used to exchange heat to and from the patient,and the delta between the target temperature andpatient temperature defines the temperature of thesaline pumped through the catheter. A heatexchanger placed within the glycol bath heats andcools the saline in the catheter. | Same |
| Class | Class II | Same |
| Table 1.1: Comparison of the subject Thermogard HQ™ Console and Thermogard XP® Console |
|---|
| and predicate Thermogard HQ™ Console and Thermogard XP® Console |
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| Feature | Predicate Devices | Subject Devices |
|---|---|---|
| Classification/Regulation Name | System, Hypothermia, Intravenous, Cooling | Same |
| Regulation Number | 21 CFR 870.5900 | Same |
| Product Code | NCX | Same |
| Patient Contact | No direct patient contact | Same |
| Physical:1. Dimensions | Height: 45 in. (114 cm)Width: 17 in. (43 cm)Depth: 30 in. (76 cm) | Same |
| 2.Weight | 107 lb (49 kg) | |
| Electrical:1. Configuration | 100-120 VAC, 50/60 Hz, 5 A220-240 VAC, 50/60 Hz, 2.25 A | Same |
| 2. Voltage | 115 V - 230 V | |
| 3. Fuse protection | T6.3A (slow blow) 5 x 20 mmLag: 60 ms @ 60A BreakingCapacity: 63A @ 250VAC | |
| Environmental:1. Operating temperatures | 10 °C - 27 °C (50 °F - 81 °F) | Same |
| 2. Operating humidity | 30% to 75% noncondensing | |
| 3. Atmospheric pressure | 70 kPa to 106 kPa | |
| Chiller and Heater:1. Reservoir volume | 2.0 liters (0.5 gal) | Same |
| 2. Pump capacity | 7 lpm at 0 m head (0 ft) | |
| 3. Temperature range | 0 °C - 42 °C | |
| 4. Coolant | 1:1 mixture of propylene glycol and deionized water | |
| 5. Refrigerant | RFC 134a | |
| 6. Nominal Power (must begreater than) | 190 watts | |
| Controller and Display1. Screen display | 6.4 in. (16.25 cm) LCD color VGA | Same |
| 2. Controls | Push buttons and knob | Same |
| 3. Temperature input | Thermistor, YSI 400 series | Same |
| 4. Articulation | 180° swivel, 45° tilt | Same |
| 5. Data interface | TGXP: Serial RS-232C, 9-pin sub-D connectorTGHQ: USB, Wi-Fi, Digital EMR output (IOIOI),Patient temperature output (T1 Out) | Same |
| Feature | Predicate Devices | Subject Devices |
| 6. Alarms | Audible tones and displayed text messages | Same |
| Temperature Alarms:Hi Alarm,Lo Alarm | Temperature Alarms:Hi Alarm (Same),Lo Alarm (Same),TrakLo Alarm (New) | |
| 7. Displayed temperaturerange | 26 °C – 42 °C | Same |
| 8. Displayed temperatureaccuracy | ± 0.2 °C | Same |
| Saline Coolant Circuit1. Priming volume | 200 ml | Same |
| 2. Heat exchanger | Disposable stainless steel coil | Same |
| 3. Priming source | Sterile saline solution (hospital-provided) | |
| 4. Patient connection | Directional Luer connections on72 in. (183 cm) lines | |
| 5. Pump tubing | Roller pump compatible with directional fittings | |
| 6. Sterility | Gamma sterilized | |
| 7. Saline alarm | Reservoir level detection & alarm system | |
| 8. Coolant circuitoperating life | Replace disposable components after seven (7)days of continuous use | |
| Equipment Classifications: | ||
| 1. Type of protectionagainst moisture | Ordinary | Same |
| 2. 60601 Safety Class | Type BF for temperature inputsType B for catheter connections | |
| 3. Protection class | 1 | |
| 4. Mode of operation | Continuous |
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TrakLo is a software feature for the Thermogard XP and Thermogard HQ Consoles that improves the utility for warming applications where the patient is at a presenting temperature below 28 ℃. When TrakLo is enabled on a patient whose temperature is < 28 ℃, the feature prevents the Lo alarm from being triggered so long as the patient temperature remains stable or continues to increase. The TrakLo alarm will trigger if the patient temperature decreases by 1 °C relative to the highest patient temperature the system has detected.
The TrakLo Alarm requires an update to the Thermogard console software only. The console hardware was not modified in this 510(k). In addition, there were no changes to the existing alarm features, control algorithm, principles of operation, or any other technological aspects of the subject devices. Furthermore, this change does not impact the Start-Up Kit or the IVTM catheters.
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IV. SUMMARY OF THE NON-CLINICAL TESTS PERFORMED
Non-clinical performance testing for the Thermogard HQ™ Console and Thermogard XP® Console with TrakLo feature was conducted, to ensure that the device performs as intended, included in Table 1.2:
| Test | Test Method Summary | Conclusion |
|---|---|---|
| Human Factors / Usability | Test methods validate the device forhuman factors per the intended usewith the TrakLo feature. | Pass |
| Software Verification | Test methods verify that the softwaremeets software requirements. | Pass |
Table 1.2: Performance testing for the Thermogard HQ™ Console and Thermogard XP® Console
V. SUMMARY OF THE CLINICAL TESTS PERFORMED
No clinical performance data were determined to be necessary to demonstrate substantial equivalence.
VI. CONCLUSION
The Thermogard HQ™ Console and Thermogard XP® Console with the TrakLo feature meet the design, performance, and safety specifications when used in accordance with the labeling. The difference between the subject and predicate devices does not raise new questions of safety and effectiveness. It was demonstrated through performance testing and comparison of design features that the proposed devices 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).