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Thermogard HO™ Temperature Management System Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients.

Thermogard XP® Temperature Management System Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients.

The subject of this 510(k) is the new surface feature which makes minor modifications to the existing IVTM Start-Up Kits (SUKs) to enable connection of a Thermogard console to the STx™ Vest provides for circulation of thermally conditioned fluid supplied by the Thermogard console (either Thermogard HQ™ or Thermogard XP®). Transfer of heat between the patient and the circulating fluid results in modification of patient core temperature for the purpose of therapeutic patient temperature modulation.

The existing, commercialized Thermogard Systems (Thermogard HQTM and Thermogard XP®) are used in conjunction with catheters placed in the vasculature to support intravascular cooling. The TGHQ-SURF accessory is a modification of the model TGHQ-500D accessory which was verified, validated, and commercialized. The CG-SURF accessory is a modification of the model CG-500D accessory which was verified, validated, and commercialized. These Surface SUK models are identical to their predecessors with the exception of longer inflow and outflow tubing lengths and replacing the Luers for catheters with 0.25inch hose barb valved connectors for the STx™ Vest. The Surface SUK also has a label on the fluid spike to indicate the size of bag of fluid (3000ml) to use and to mark it as non-sterile. The Surface SUKs are otherwise identical to their predecessors in terms of materials that contact the heat exchange fluid (i.e., saline), manufacturing process, and packaging materials.

There are no changes to the commercially available Thermogard XP® (K213031) and Thermogard HO™ (K220008) consoles.

There are no changes to the commercially available STxTM Vest.

The provided document is an FDA 510(k) summary for a medical device called the "Thermogard HQ™ Temperature Management System" and "Thermogard XP® Temperature Management System." These devices are thermal regulating systems used for temperature reduction in adult hyperthermic patients.

The document does not describe:

• Acceptance criteria for an AI/ML powered device. This device is a hardware system, not an AI/ML product.
• Performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML diagnostic tools.
• Any information regarding training sets, test sets, ground truth establishment by experts, or MRMC studies.

Therefore, the requested information cannot be extracted from this document, as it pertains to a different type of medical device lacking AI/ML components and the typical studies associated with them.

To directly answer your request based on the lack of relevant information in the provided text:

1. A table of acceptance criteria and the reported device performance:
Not applicable. The document describes a physical temperature management system, not a device with acceptance criteria based on AI/ML performance metrics like sensitivity or specificity. Performance testing mentioned is related to dimensional verification, functional testing, temperature behavior, shipping and handling, and electrical/EMC standards, not diagnostic accuracy.

2. Sample size used for the test set and the data provenance:
Not applicable. There is no mention of a "test set" in the context of an AI/ML algorithm's performance evaluation. The document refers to "performance testing" of the hardware system, but provides no sample sizes or data provenance (country of origin, retrospective/prospective) for such tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment by experts is relevant for AI/ML diagnostic devices, not for this hardware temperature management system.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are used in studies involving human interpretation or AI/ML model output validation, which is not described here.

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:
Not applicable. This device is not an AI-assisted diagnostic tool, so an MRMC study is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no AI algorithm in this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. Ground truth as typically understood in AI/ML validation is not relevant for this device. The "ground truth" for a temperature management system would be its ability to accurately and safely control patient temperature, which is assessed through engineering and functional testing, not diagnostic ground truth methods.

8. The sample size for the training set:
Not applicable. There is no AI/ML component that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. As above, there is no AI/ML component or training set.

In summary, the provided FDA 510(k) summary is for a traditional medical device (hardware for temperature management) and does not contain the information requested regarding acceptance criteria and studies for an AI/ML powered device. The document explicitly states "Clinical performance data to demonstrate substantial equivalence was not required." meaning the evaluation was based on non-clinical (engineering and functional) tests.

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The AutoPulse NXT Resuscitation System is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by a lack of spontaneous breathing and pulse. The AutoPulse NXT System must be used only in cases where chest compressions are likely to help the patient.

The AutoPulse NXT System is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

The AutoPulse® NXT Resuscitation System (also referred to as the AutoPulse® Model 200 or AP 200 System) is an automatic, portable, battery-powered chest compressor, which provides chest compressions as an adjunct to performing manual cardiopulmonary resuscitation (CPR). The system can adjust to different patient sizes and can operate in environments with limited space, such as moving vehicles.

The system may be a reasonable alternative to conventional CPR in specific settings where the delivery of high-quality manual compressions may be challenging or dangerous for the provider (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

The AutoPulse® NXT Resuscitation System (hereinafter referred to as AutoPulse® NXT System) consists of four (4) primary components: a reusable platform (AutoPulse® NXT Platform), a single-use chest compression assembly (AutoPulse® NXT Band), a rechargeable battery (AutoPulse® NXT Battery), and a reusable battery charger (AutoPulse® NXT Battery Charger).

The AutoPulse® NXT Platform contains the mechanical drive mechanism, control system, software, and electronics necessary to generate and control the motion required to perform mechanical chest compressions. User controls and indicators are contained in two (2) identical User Control Panels provided for ease-of-use.

The AutoPulse® NXT Band is a chest compression assembly which consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. Attached to the AutoPulse® NXT Platform, the NXT Band is automatically adjusted to the patient and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. The band is a single-use component that is attached to the AutoPulse® NXT Platform before each use.

The Lithium-ion (Li-ion) Battery is a removable component that supplies power for operation of the AutoPulse® NXT Platform. It also includes a printed circuit assembly to provide "smart battery" features including cell balancing, state of charge (SOC) reporting, a history archive, and safety circuits.

The AutoPulse® NXT Battery Charger is a reusable, stand-alone unit intended to charge and test-cycle AutoPulse® NXT Batteries. The battery charger has two (2) charging bays, each with its own indicators, and is used to charge and test-cycle up to two (2) AutoPulse® NXT batteries simultaneously. When in use, the battery charger continuously tests itself and any compatible batteries in its ways.

The AutoPulse® NXT System comprises the subject devices included in this 510(k).

The provided document is a 510(k) premarket notification for the AutoPulse NXT Resuscitation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data (such as an MRMC study or detailed analysis of ground truth establishment for AI models). The document primarily presents non-clinical evidence related to software verification and validation, safety testing against recognized standards, and usability testing.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance (especially for AI/ML based devices), and ground truth establishment methods for large datasets is largely not applicable or not detailed in this document, as the device is a mechanical chest compressor and not an AI/ML diagnostic tool.

However, I can extract the information that is present and indicate where the requested details are not provided by this document:

Acceptance Criteria and Device Performance for AutoPulse NXT Resuscitation System

The provided document describes the AutoPulse NXT Resuscitation System, a mechanical chest compressor. The "acceptance criteria" in this context refer to the device's adherence to its design specifications, safety standards, and functional requirements, rather than performance metrics typically associated with AI/ML diagnostic tools (like sensitivity, specificity, or AUC). The study proving the device meets these criteria primarily involves non-clinical testing (software verification, safety standard compliance, and usability testing) rather than clinical trials with patient outcomes or large-scale data analysis for diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The document details a comparison of technological characteristics between the proposed device (AutoPulse NXT System) and its predicate (AutoPulse Resuscitation System Model 100). The "performance" here refers to operational parameters rather than diagnostic accuracy.

Intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective or consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR). | Yes |
| Target Patient Population | Clinically dead adults as defined by a lack of spontaneous breathing and pulse. | Same | Yes |
| Min. Patient Chest Width | 9.8" | Same | Yes |
| Patient Chest Circumference | Minimum: 30", Maximum: 51.2" | Minimum: Same (30"), Maximum: 56" | Yes (Improved) |
| Maximum Patient Weight | 300 lbs. | 400 lbs. | Yes (Improved) |
| Operating Temperature | 0 – 40° C, 5 – 95% non-condensing relative humidity | 0 – 45° C, 15 – 95% non-condensing relative humidity | Yes (Improved range) |
| Compression Frequency | 80 ± 5 compressions per minute | Same | Yes |
| Compression Depth | Chest displacement equal to 20% reduction in anterior-posterior chest depth, +0.25/-0.5 inches. | Chest displacement equal to 20%, up to 2.1 +0.25/-0.5 inches reduction in anterior-posterior chest depth for each patient. | Yes (Clarified/Slightly adjusted limit) |
| Compression Modes | 30:2; 15:2; Continuous | 30:2; Continuous | Yes (Modified to 2 modes) |
| Physiologic Duty Cycle | 50 ± 5% | Same | Yes |
| Patient Basline/Depth Control | Determined and controlled via load cell. | Determined and controlled via motor current. | Yes (Different mechanism) |
| User Control Panel | One (1) LCD screen with buttons on the side. | Two (2) identical simple non-LCD user interfaces on both sides for glanceability, intuitiveness, and minimizing physical, cognitive, and visual workload. | Yes (Improved design) |
| Band change (patient position)| Patient must be off the platform. | Patient can be either on or off the platform. | Yes (Improved flexibility) |

Note: The "Acceptance Criteria Met?" column is inferred based on the FDA's clearance of the device, indicating that the differences were deemed acceptable and did not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a medical device (mechanical chest compressor), not an AI/ML algorithm. Therefore, the concept of a "test set" in the sense of a data pipeline for AI validation does not directly apply. The "testing" involved here is primarily:

• Software Verification and Validation: Conducted internally by the manufacturer. No specific sample sizes (e.g., number of cases/patients) are mentioned as it relates to software functionality testing, not diagnostic performance on a dataset.
• Safety Testing: Compliance with international standards (e.g., ISO, IEC). This involves device testing under various conditions, not patient data sets.
• Usability Testing: Formalized human factors analyses. While a "Summative Usability Test" was conducted, the document does not specify the number of participants (sample size) or their provenance. The testing was simulated use conditions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This device is a mechanical therapeutic device, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as there isn't a "test set" as defined for AI/ML diagnostic purposes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic imaging AI. This document does not mention such a study, and it's not typically required for a mechanical chest compressor in a 510(k) submission, especially one relying on substantial equivalence to a predicate device. The document explicitly states: "Clinical evidence was not necessary to show substantial equivalence."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an AI algorithm but a mechanical device. Its performance is inherent to its mechanical and software operation.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic AI. The "ground truth" for this device's performance would be its ability to mechanically deliver compressions according to its specifications and safely interact with users/patients, as verified by engineering tests, compliance with standards, and usability studies.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that undergoes a training phase with a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is involved for this type of device.

In summary, the provided document is a regulatory submission for a mechanical medical device, not an AI/ML-driven diagnostic tool. Therefore, many of the questions asked, which are highly relevant to AI/ML device validation, are not applicable or detailed in this context. The "acceptance criteria" are met through adherence to design specifications, safety standards, and documented performance comparison to a predicate device, as demonstrated through engineering tests, software verification, and usability studies rather than clinical data from human subjects or AI model performance metrics.

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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

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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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.

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.

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.

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

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

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

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

The Solex 7 Intravascular Heat Exchange Catheter (Solex 7 Catheter) is a sterile, single use 9.3F flexible catheter designed for placement in the Superior Vena Cava from an insertion site in the Jugular and Subclavian Veins. The Solex 7 Catheter is connected to a single use, disposable CoolGard 3000 or Thermogard XP® Start-Up Kit (SUK) and the CoolGard 30000 or Thermogard XP® Console, all of which comprise the ZOLL Intravascular Heat Exchange The Start-Up Kit (SUK) and the CoolGard 3000 or Thermogard XP Console are System. supplied separately. The ZOLL Heat Exchange System is also designed for use with an off-theshelf temperature probe. The Solex 7 Catheter is comprised of a polyurethane shaft and a serpentine shaped PET balloon at the distal end. The blood contact surfaces of the catheter incorporate a hydrophilic heparin coating.

The catheter has five lumens, two of which when connected to the Start-Up Kit, are used to circulate sterile saline in a closed loop circuit for heat exchange with the blood in the central venous system. Warmed or chilled saline is pumped through the heat exchange lumens, inflating the diameter of the serpentine balloon that interfaces with the patient's blood to warm or cool circulating blood. The inflow/outflow lumens form a closed-loop system through which the warmed or chilled saline circulates. The warmed or chilled saline is not infused into the patient.

Additional lumens of the Solex 7 Catheter consist of a 0.032" guidewire compatible lumen that can also be used as a primary infusion lumen, and two additional infusion lumens within the catheter shaft.

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

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

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

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

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

• Device Design Specifications: Specific dimensional tolerances, flow rates, heat exchange power, tensile strength, burst/leak resistance, indwell life, and biocompatibility criteria defined by the manufacturer for the device.
• Human Factors Test Scenarios: User tasks designed to assess the ease and correctness of device usage as per the Instructions for Use (IFU).

8. The sample size for the training set

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

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

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

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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.

The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893-A, connected to the ZOLL CoolCard 3000/ Thermogard XP 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 Start-Up Kit (SUK) is intended to control patient core temperature using heat exchange fluid in conjunction with CoolGard 3000 or Thermogard XP system and ZOLL Heat Exchange Catheters, but does not have a specific independent indications for use.

The ZOLL Intravascular Heat Exchange Catheters (Cool Line, ICY, and Quattro - ZOLL Catheters) are sterile, single use heparin coated flexible catheters designed for placement in the femoral, jugular, or subclavian veins. The Cool Line Catheter contains two heat exchange balloons, the ICY Catheter contains three heat exchange balloons, and the Quattro Catheter contains four heat exchange balloons.

The ZOLL Catheters are connected to a single use, disposable Start-Up Kit (SUK) and the CoolGard 3000® or 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 and the CoolGard 3000 or 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.

This document is a 510(k) premarket notification for a medical device (ZOLL Intravascular Heat Exchange Catheters and Start-Up Kit). It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices after minor modifications (specifically, changes to Luer designs and materials, and the addition of a deflation syringe to the SUK).

The FDA's review letter (pages 1-3) does mention a historical randomized controlled trial (RCT) for the Cool Line Intravascular Heat Exchange Catheter to support a specific warning label regarding its use for fever reduction in certain patient populations. However, this study was not conducted specifically to validate the modified devices described in this 510(k) submission, but rather to establish safety and effectiveness of the original Cool Line Catheter's indications for use. The current 510(k) submission states that "Clinical evaluations were not performed for the modified SUK and the modified Cool Line, ICY, and Quattro Intravascular Heat Exchange Catheters because such evaluations were not necessary to demonstrate substantial equivalence of the modified devices to the predicate devices."

Therefore, for the current submission's modified devices, there is no acceptance criteria or study that proves the modified device meets new such criteria, as the submission claims substantial equivalence to predicate devices based on non-clinical testing. The provided tables are for non-clinical performance tests (packaging, bench performance, biocompatibility, usability) to ensure the modifications do not negatively impact the device's original performance.

However, since the initial request asks for acceptance criteria and a study that proves the device (referring to the Cool Line Catheter in general, based on the warning label content) meets acceptance criteria, I will address the randomized controlled trial mentioned in the FDA letter for the Cool Line Intravascular Heat Exchange Catheter's general performance as it relates to the specified warning.

Acceptance Criteria and Study for the Cool Line Intravascular Heat Exchange Catheter (as presented in the FDA warning and 510(k) summary)

It's important to clarify that the provided document outlines the process for demonstrating substantial equivalence of modified devices (Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit) to their predicate versions. The extensive details about "acceptance criteria" and "study results" within the 510(k) application itself (like in Tables 3-7) refer to non-clinical tests (packaging, bench performance, biocompatibility, and usability/human factors) conducted to confirm that the modifications do not adversely affect the device's established safety and effectiveness.

The only "study" mentioned that relates to clinical effectiveness for the Cool Line Catheter is a randomized controlled trial (RCT), which is cited to support a Warning label on the device regarding specific patient populations. This RCT examined the safety and effectiveness of the Cool Line Catheter for fever reduction, but the results led to a limitation on its indications for use rather than specific "acceptance criteria" being met for those populations. The effectiveness of the device for fever reduction in Cerebral Infarction (CI) and Intracerebral Hemorrhage (ICH) patients is implied by its indication for use in these groups, but the detailed acceptance criteria for this specific clinical efficacy are not provided in this document. Instead, the document provides mortality data from a historical trial.

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

For the Cool Line Intravascular Heat Exchange Catheter as it relates to the FDA's warning:

Control Group:
CI: 21.4% (3/14)
ICH: 25.9% (7/27)
PTBI: 10.5% (4/38)
SAH: 11.1% (7/63) |
| Statistical Significance | P-value for mortality differences between Cool Line and Control groups should ideally show non-inferiority or superiority for indicated uses, and lack thereof for non-indicated uses. | P-values (Fischer's exact test):
CI: 0.74
ICH: 1.00
PTBI: 0.24
SAH: 0.15

(Note: P-values > 0.05 generally indicate no statistically significant difference, which in this context means the Cool Line did not show a statistically significant benefit in mortality compared to standard care for any of the tested populations, and for PTBI and SAH, mortality was numerically higher, leading to the warning.) |

For the modified devices in this 510(k) submission, the "acceptance criteria" are product design specifications met through non-clinical testing. Examples include:

Regarding the Randomized Controlled Trial for the Cool Line Catheter (cited for the warning):

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

• Sample Size: 296 patients
• Data Provenance: The document does not specify the country of origin of the data. It was a prospective randomized controlled trial.

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

• This information is not provided in the document. The trial focused on mortality outcomes, which are typically objectively measured without expert consensus on diagnostic classifications for the "ground truth" of the test set itself, though diagnoses for patient inclusion (CI, ICH, PTBI, SAH) would have been established clinically by treating physicians.

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

• This information is not provided in the document.

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 conducted, nor is the device an AI device. This study was a clinical trial comparing patient outcomes (mortality) between a device treatment arm and a control arm, not an imaging interpretation study.

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

• No, this device is a physical catheter for thermal regulation, not an algorithm.

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

• The ground truth in the randomized controlled trial was outcomes data, specifically mortality. Patient diagnoses (CI, ICH, PTBI, SAH) were also used for stratification and analysis.

8. The sample size for the training set

• Since this was a randomized controlled trial for clinical outcomes, it does not have a "training set" in the context of machine learning or AI. The 296 patients constituted the study population for evaluating the device's effects.

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

• Not applicable, as there was no "training set" in the machine learning sense. Clinical diagnoses for patient enrollment and the objective outcome of mortality were used.

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