(149 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 Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQ™ Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the Thermogard HQ™ Console, Thermogard HQ™ Start-Up Kit and Thermogard HQTM Start-Up Kit EX. 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 also included as part of the system but are unchanged compared to the predicate device.
This is a medical device submission, meaning that the device's performance is compared to a predicate device to prove substantial equivalence, rather than establishing new acceptance criteria against a clinical outcome.
Here's a breakdown of the information provided, focused on the device's performance and studies:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, "acceptance criteria" are implied by the successful "Pass" conclusions from all non-clinical performance and safety tests. The reported device performance is that it met all tested requirements and standards, leading to a "Pass" for each test. The document doesn't define explicit numerical acceptance criteria in the way one might for a new device's clinical efficacy, but rather relies on established test methods and standards for medical device safety and performance.
| Test Category | Test Method Summary | Conclusion |
|---|---|---|
| Console & Start-Up Kit | ||
| Air Trap Insertion / Removal | Test method verifies that the Thermogard HQTM Start-Up Kit Air Trap may be inserted into and removed from the Thermogard HQTM Console as intended. | Pass |
| Console Warming and Cooling | Test method verifies that the system cools and warms as intended. | Pass |
| Electrical Safety | Test methods verify that the system meets electrical safety standards. | Pass |
| Electromagnetic Compatibility | Test method verifies that the system meets electrical immunity and emissions standards. | Pass |
| Human Factors / Usability | Test methods validate the device for human factors per the intended use. | Pass |
| Software Verification | Test methods verify that the software meets software requirements. | Pass |
| Console Specific | ||
| Data Module Functionality | Test methods verify that the Data Module meets applicable requirements. | Pass |
| Reliability | Test methods verify that the system meets the service life requirements. | Pass |
| Transit Testing | Test methods verify that the system meets the shipping and transit requirements. | Pass |
| Start-Up Kit Specific | ||
| Use Duration (Life) & Durability | Test methods verify that the Thermogard HQTM Start-Up Kits meet the duration of use requirements. | Pass |
| Leak Testing | Test methods verify that the Thermogard HQTM Start-Up Kits meet the leak requirements. | Pass |
| Tensile Testing | Test methods verify that the Thermogard HQTM Start-Up Kits meet the tensile strength requirements. | Pass |
| Transit and Environmental | Test methods verify that the Thermogard HQTM Start-Up Kits meet the shipping and transit requirements. | Pass |
The document also includes a table of mortality results from a randomized controlled trial (RCT) involving the Cool Line Intravascular Heat Exchange Catheter for fever reduction in different patient cohorts (CI, ICH, PTBI, SAH) to highlight a specific warning regarding safety in SAH and PTBI patients. This is not about the acceptance criteria for the new device but rather a critical safety warning based on prior clinical data for a related product line.
| 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 |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical performance data were determined to be necessary to demonstrate substantial equivalence." This means the device was cleared based on non-clinical (laboratory and engineering) testing and comparison to a predicate device. Therefore, there is no "test set" in the sense of patient data for this specific submission.
The clinical trial mentioned for the Cool Line Intravascular Heat Exchange Catheter (related but not the subject of this 510(k)) involved 296 patients in a randomized controlled trial. The provenance of this data (country of origin, retrospective/prospective) is not specified in this document, other than it being a "randomized controlled trial."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical test set was used for this 510(k) submission to establish substantial equivalence, this information is not applicable. The non-clinical tests were evaluated against established engineering, safety, and performance standards.
4. Adjudication Method for the Test Set
As there was no clinical test set for this 510(k) submission, an adjudication method is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed for this 510(k) submission. MRMC studies are typically for image analysis or diagnostic aid devices where human readers interpret results. This device is a thermal regulating system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is a hardware system (thermal regulating console and catheters) rather than an AI algorithm. Therefore, a standalone study for an algorithm is not applicable. The "algorithm" here refers to the console's internal control logic, which was verified through software verification and console warming/cooling tests.
7. Type of Ground Truth Used
For the 510(k) submission of the Thermogard HQ system, the "ground truth" for the non-clinical tests was established by recognized industry standards, device specifications, and engineering requirements. This means the device either met or did not meet the predefined criteria for electrical safety, EMI, software functionality, durability, etc.
For the Cool Line Catheter's clinical trial data (mentioned as a warning, not part of this 510(k)'s clearance criteria), the ground truth for outcomes (mortality) would have been patient outcomes data collected during the randomized controlled trial.
8. Sample Size for the Training Set
Since this is not an AI/ML algorithm submission and no clinical data was required for this 510(k) clearance, a "training set" in the context of machine learning is not applicable. The device's design was developed based on established engineering principles and prior device models.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned in the context of an AI/ML model for this submission, this information is not applicable.
§ 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).