Search Results
Found 26 results
510(k) Data Aggregation
(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.
Ask a specific question about this device
(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.
Ask a specific question about this device
(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.
Ask a specific question about this device
(345 days)
The Seiratherm GmbH tempedy 5000 is intended to deliver cooled or warmed sterile intravenous solutions which may be used to alter the body temperature of adult patients.
The Seiratherm tempedy System is an adjunct to normalizing the body temperature of adults. It is intended to be used in situations when the patient is hypothermic and requires warming or when the patient is hyperthermic and requires cooling.
- It is an intravenous fluid cooling system
- It is an intravenous fluid warming system
- It is a thermal regulating system with feedback of patient's temperature
The tempedy System does not deliver drugs. It is not a drug infusion device.
The tempedy System does not deliver colloids (blood products, plasma, lipids, etc.) It is only for delivery of crystalloids (normal saline, Ringers, etc.).
The tempedy System includes the following accessories: Power cord, Tubg Set, and Temperature Probe. A list of accessories is on Page 50 of the Instructions for Use Manual.
Patient contacting parts: The sterile "Tubing Set T0" is a patient contacting part of the system. The Tubing Set TO is a single use part in the tempedy System.
The GE Healthcare, K051873, M1024231 GP Temperature Probe, Adult YS1 400 compatible temperature probe is also a patient contacting part of the system. It is a manufacturer sterilized, single use part.
This document outlines the acceptance criteria and study proving the Seiratherm GmbH tempedy 5000 system meets these criteria.
The Seiratherm GmbH tempedy 5000 is a thermal regulating system intended to deliver cooled or warmed sterile intravenous solutions to alter the body temperature of adult patients. It was found substantially equivalent to predicate devices in terms of technology, function, and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criterion (a.c.) | Reported Device Performance |
|---|---|---|
| Spillage testing (IEC 60529 - IPX2 Clause 201.11.6.3 and 5) | IPX2 compliant | Pass |
| Unintended bolus testing (Clause 201.12.4.4.104) | Time to occlusion alarm < 2.5 s; measurement of surplus bolus < 5 ml | Time to occlusion alarm < 2.5s; No measurable unintended bolus. Pass. |
| Reverse delivery testing (Clause 201.12.4.4.105) | No instance of reverse flow | No instance of reverse flow. Pass. |
| Fitting of tubing, alarms (Clause 201.15.101 and 102) | 100% function for alarm at incorrect positioning of tubing, bubble detection, traction to patient | Pass |
| Use errors / alarms (Clause 201.15.103) | 2 actions required before flow after alarm or a start up | Pass |
| Infusion Accuracy - Bolus Accuracy (Clause 201.12.1.106) | < 6% deviation for delivered boluses | All boluses (n=25) were delivered with acceptance criterion of <6%. Pass |
| Infusion Accuracy - Flow Accuracy (Clause 201.12.1.107) | < 6% deviation for all flow rates | All Flow Rates within acceptance criterion of <6%. Pass |
| Temperature Sensing Accuracy (DIN EN ISO 80601-2-56) | Tprobe = Tdisplay = Tservice connection (+/- 0.2°C) | Pass |
| Performance Cooling (038_20160725_performance cooling) | Appropriate responses to cooling when in Temperature Management Mode | Appropriate responses to cooling. |
| Performance Warming (039_20160727_performance warming) | Appropriate responses to warming when in Temperature Management Mode | Appropriate responses to warming. |
| Hemocompatibility (ISO 10993-4 Hemolysis) | Test material does not release substances in hemolytic concentrations during 24h contact of 4.5 cm2 surface area to 1ml of physiological fluid | Tubing set does not cause hemolysis. |
| Cytotoxicity, L929-Proliferation (ISO 10993-5, -12) | Test material does not release substances in cytotoxic concentrations during 24h contact of 4.5 cm2 surface area to 1ml physiological fluid | Tubing set is not cytotoxic. |
| Chemical analysis, characterization of organic leachables / extractables (ISO 10993-12, -18) | Extractable substances are not released in toxicologically relevant concentrations during clinical application | The extractable substances are not released in toxicologically relevant concentrations during clinical application. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state a comprehensive sample size for the test set across all performance tests. Here are the details provided:
- Infusion Accuracy - Bolus Accuracy: n=25 boluses.
- Other tests: For most other tests, the sample size is not explicitly stated but implied to be sufficient for a "Pass" result according to the specific standards.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It mentions "Third Party Testing to EN 60601-2-24:2012-10" and adherence to ISO standards, suggesting testing was conducted in a controlled environment.
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 tests described are primarily bench performance and biocompatibility tests conducted according to defined engineering and medical device standards. There is no indication of expert assessment used to establish ground truth in the context of diagnostic interpretation or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests performed are objective performance and safety tests against predetermined technical standards, not subjective assessments requiring expert adjudication.
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. The "tempedy 5000 system" is a thermal regulating device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical device for thermal regulation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the testing described is based on established engineering standards and regulatory requirements for medical devices (e.g., EN 60601-2-24, IEC 60529, ISO 80601-2-56, ISO 10993 series). The device's performance is measured against objective, quantifiable parameters defined by these standards.
8. The sample size for the training set
Not applicable. This device is not an AI/Machine Learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As this device is not an AI/Machine Learning algorithm, there is no training set or ground truth in that context.
Ask a specific question about this device
(204 days)
Hypocore™ is a single-use device intended to cool sterile saline, lactated ringers and other comparable low viscosity inert fluids during intravenous administration where clinically indicated for reduction of patient temperature.
The Hypocore device is an inline chiller for IV (Intravenous) solutions that uses an endothermic reaction for cooling. The IV fluids enter the device through a Luer-lock connector on a standard IV tube, is cooled inside the device and exits through another Luerlock connector on a longer section of IV tube. During expected use, the device inlet is connected to an IV solution bag via an IV administration set, and its outlet is connected to an intravenous access port. It is powered by an internal non-rechargeable battery. The device has a handle to turn the device on and off. The entire device is disposable, single use and is provided pre-sterilized.
The provided text describes the acceptance criteria and a series of performance tests for the Novocor Medical Systems, Inc. Hypocore device.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 10 Minute Standard Device Performance - Level of cooling, fast flow | To cool 1 liter of fluid to an average temperature of <11ºC | All samples met the average output temperature acceptance criteria (range = 6.9-7.8 °C) |
| 30 Minute Standard Device Performance - Level of cooling, slow flow | To cool 1 liter of fluid to an average temperature of <11ºC | All samples met the average output temperature acceptance criteria (range = 6.1-8.5 °C) |
| 30 Minute Standard Device Performance - Time to achieve required cooling level | Time required to achieve the stated temperature threshold is less than 2 minutes | All samples met the acceptance criteria (range = 46-60 seconds) |
| Elevated Environmental Temperature Test | To cool IV fluids to less than 11ºC when flowed at 48 ml/min in a 32°C environment | All samples met the acceptance criteria. The average temperature of the exiting fluid ranged from 8.8-10.5 ℃ inside a 32°C chamber. |
| Flow Rate Test - Comparative flow rate of standard IV set with and without the Hypocore device in line | Flow rate reduction be less than 25% of the standard flow rate | All samples met the acceptance criteria (flow rate reduction ranged from 10.35-15.87%) |
| Tilt Test | The temperature of the exit fluid be less than that of the initial fluid | All samples met the acceptance criteria. The average environmental temperature ranged from 22.5-22.8°C. The output temperatures during the test ranged from 8.6-9.2°C at +45 degrees and 9.1-10.1°C at -45 degrees. |
| Activation Handle Force Test | Activation handle must withstand 20.36 lbs | All samples withstood the applied force and no sample devices broke. |
| Strap Performance Test - Device attachment | Devices must stay attached to the limb | All samples met the acceptance criteria. |
| Strap Performance Test - Pressure on limb | Pressure of the strap must not exceed 200 mmHg | All samples met the acceptance criteria (pressures ranged from 50-80 mmHg). |
| Strap Performance Test - Force on outlet tubing upon drop | Force of the device be less than 52.9 N (force required to pull out a taped IV catheter) | All test iterations met the acceptance criteria (forces ranged from 14.0-27.0 N). |
| Biocompatibility (Cytotoxicity) - Fluid Path | Non-cytotoxic with scores of 0, 1, or 2 per ISO 10993-5 (grade less than 2) | The test article extract showed no evidence of causing cell lysis or toxicity. The test article extract met the requirements of the test, since the grade was less than a grade 2 (mild reactivity). |
| Biocompatibility (Cytotoxicity) - Skin Contact | Non-cytotoxic with scores of 0, 1, or 2 per ISO 10993-5 (grade less than 2) | The test article extract showed evidence of causing slight cell lysis or toxicity; however, the test article extract met the requirements of the test, since the grade was less than a grade 2. |
| Biocompatibility (Irritation) - Fluid Path | Non-irritant with scores of 0-1 comparison between control and test sample reaction (ISO 10993-10) | The test article met the requirements, since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 for sodium chloride (SC) and sesame oil (SO) extracts. |
| Biocompatibility (Irritation) - Skin Contact | Non-irritant with scores of 0-1 comparison between control and test sample reaction (ISO 10993-10) | The test article met the requirements, since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.1 for the SC and SO test article extracts, respectively. |
| Biocompatibility (Sensitization) - Fluid Path | Non-sensitizer or mild sensitizer with a score of 0 (non-sensitizer) or 1 (mild sensitizer), based on comparison between control and test sample (ISO 10993-10) | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer. |
| Biocompatibility (Sensitization) - Skin Contact | Non-sensitizer or mild sensitizer with a score of 0 (non-sensitizer) or 1 (mild sensitizer), based on comparison between control and test sample (ISO 10993-10) | The test article extracts showed no evidence of causing delayed dermal contact sensitization. (Result truncated in document, but implies acceptance criteria met for non-sensitization). |
| Biocompatibility (Pyrogenicity) | No single animal temperature rise of 0.5°C or more above its baseline temperature. | No single animal showed a temperature rise of 0.5°C or more above its baseline temperature. The total rise of the rabbits' temperature during 3 hours was 0.0°C. The test article was judged as non-pyrogenic. |
| Biocompatibility (Ethylene Oxide and Ethylene Chlorohydrin Testing) - EO and ECH residuals | EO residuals <= 4mg and ECH residuals <= 9mg. | EO and ECH levels were acceptable on Day 1. |
| Biocompatibility (Ethylene Oxide and Ethylene Chlorohydrin Testing) - Tolerable Contact Limits (TCL) | TCL for EO and ECH shall not exceed 10 μg/cm2 and 5 mg/cm2, respectively, or the device shall have negligible irritation as specified in ISO 10993-10. | The Hypocore device exhibited no irritation as demonstrated within biocompatibility irritation testing. |
| Biocompatibility (Partial Thromboplastin Time) | Test result clotting time > 50% of the negative control per ASTM F2382. | The plasma exposed to the test article had an overall average clotting time of 235.9 seconds, which represented 79.9% of the negative control. The test article was considered a minimal activator, and therefore, met the requirements of the test. |
| Biocompatibility (Acute Systemic Toxicity) | Reference ISO 10993-11 (Section 5.3) - no mortality or evidence of systemic toxicity. | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. |
| Biocompatibility (Hemocompatibility) | Reference ISO 10993-4 - criteria for non-hemolytic/slightly hemolytic. | The hemolytic index for the test article in direct contact with blood was 2.0%, and the hemolytic index for the test article extract was 0.8%. The test article in direct contact with blood was slightly hemolytic and the test article extract was non-hemolytic. |
| Sterilization | Suitable to pass the acceptance criteria of ISO 11135 for a 1x10-6 SAL. | Testing demonstrated that the Hypocore device is suitable to pass the acceptance criteria of ISO 11135 therefore demonstrating substantial equivalence for sterilization compared to the predicate device. |
| Medical Electrical Safety | Meets the acceptance criteria of IEC 60601-1 and IEC 60601-1-2. | Testing demonstrated that the Hypocore device meets the acceptance criteria of IEC 60601-1 and IEC 60601-1-2 therefore demonstrating substantial equivalence to the predicate device with regard to electrical safety. |
| Human Factors Design Validation | All users safely complete all use tasks successfully. | All users safely completed all use tasks successfully. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific number of samples used for each test beyond indicating "All samples" met criteria. For some tests like "Strap Performance Test", it implies multiple tests were performed (e.g., three tests performed, "all samples met"). For the Biocompatibility tests, it refers to "test article extract" and "test article" but doesn't quantify the number of devices or extracts tested.
The data provenance (country of origin, retrospective/prospective) is not mentioned in the provided text. The tests appear to be laboratory-based performance and safety evaluations rather than clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this study. The study focuses on the physical and chemical performance, safety, and usability of a medical device, which are evaluated against predefined engineering specifications, international standards (ISO, IEC, ASTM, USP), and human factors guidance. There is no mention of expert consensus or interpretation required to establish a "ground truth" in the way it would be for diagnostic imaging or clinical assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints where agreement among observers is critical. This study involves objective measurements and adherence to engineering and safety standards.
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
This information is not applicable. The device (Hypocore) is a thermal regulating system, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study or assessment of AI's effect on human readers is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The Hypocore is a physical device, not an algorithm. Its "standalone" performance is assessed throughout the various performance and safety tests, which evaluate the device's ability to meet its specifications independently of human intervention during the measurement process. However, Human Factors Design Validation did evaluate user interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance tests (cooling level, time to cool, flow rate, environmental conditions, tilt, handle force, strap performance), the "ground truth" or reference was predefined engineering specifications and benchmark values, often based on "known published literature regarding IV fluid cooling" or "standard of care" (e.g., refrigerated IV fluid bag temperature, strength limits for a human wrist).
For the biocompatibility tests, the "ground truth" or reference was international standards such as ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ASTM F756, ASTM F2382, and USP General Chapter <151>.
For sterilization, it was ANSI/AAMI/ISO 11135.
For electrical safety, it was IEC 60601-1 and IEC 60601-1-2.
For Human Factors, it was FDA Draft Guidance "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" and standards IEC 62366: 2007 + A1: 2014, IEC 60601-1-6: 2007 (3rd Ed.).
8. The sample size for the training set
This information is not applicable. This is a medical device performance and safety study, not an AI model development study that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for an AI model.
Ask a specific question about this device
(139 days)
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.
| Test Category | Acceptance Criteria (Test Method Summary) | Reported Device Performance (Results) |
|---|---|---|
| Solex 7 Catheter Bench Performance | ||
| Visual Inspection | Ensure catheter is smooth without major pits. | Catheter samples met the acceptance criterion for smooth appearance with no pits. |
| Catheter Indwell Life (7 days) | Verify no saline leakage during simulated use for seven days. | Catheter samples met the acceptance criterion for normal function for seven days without leakage. |
| Particulate Testing | Determine catheter coating integrity following simulated indwell and flow rate conditions. | Solex 7 samples and Cool Line samples tested demonstrated levels of particulate below that required in USP <788>. |
| Heat Exchange Testing | Determine heat exchange capability of catheter. | Catheter samples met the acceptance criterion for a heat exchange power of 125 Watts minimum. |
| In Vitro Thrombogenicity Testing | Measurement of thrombogenic behavior of catheter following 7 day simulated use by radioactive platelet quantification and visual inspection. | Coated catheter samples showed statistically significant decreases (p < 0.05) in thrombogenicity when compared to normalized thrombogenic behavior of uncoated catheters. |
| Start-Up Kit (SUK) Packaging Testing | ||
| SUK Package Seal Peel Test | Ensure seal peel data is not less than specified acceptance criteria. | SUK package seals met the acceptance criterion for peel strength. |
| Start-Up Kit Performance Testing | ||
| SUK Flow Test | Verify that air flows through the SUK system. | SUK systems met the acceptance criterion for air flow. |
| Modified SUK Indwell Life Test | Verify that Custom Luers and SUK Tubing are able to function normally at specified temperatures for the labeled indwell period. | Custom Luers and SUK tubing met the acceptance criterion for normal function for 7 days at the specified temperature. |
| Custom Luer Catheter Bench Performance | ||
| Guidewire Passage | Verify ability to frontload, backload, and remove J-tip 0.032" guidewire from catheter. | Catheters met the acceptance criterion for the J-tip 0.032" guidewire to be frontloaded, backloaded, and removed from the catheters. |
| Balloon Deflation Using Deflation Syringe (20 mL Slip-Fit) | Verify that balloons collapse upon aspiration at specified temperature using supplied slip-fit syringe. | Catheter balloons met the acceptance criterion of collapse upon aspiration using the supplied slip fit syringe. |
| Luer Standards Performance Testing | ||
| Water/Liquid Leakage | Tested using test method similar to test specified in ISO594-1&2 (§4.2.1). | All samples met the requirements of the test method used. |
| Stress Cracking | Tested using test method similar to that specified in ISO594-2 (§4.7). | All samples met the requirements of the test method used. |
| Biocompatibility Testing | ||
| Cytotoxicity | MEM Elution Test. | The reactivity grade of all test article extract samples was “0”. |
| Hemocompatibility (ASTM Hemolysis) | ASTM Hemolysis (Extract Method) Test. | The difference between the hemolytic indexes of the test article and the negative control equals 0.00 percent. This places the test article in the non-hemolytic range. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document generally refers to "samples" or "catheter samples" without specifying precise numerical sample sizes for most bench tests. However, for "Particulate Testing," it mentions "Solex 7 samples and Cool Line samples."
- Sample Size: Not explicitly stated numerically for most tests. It refers to "catheter samples," "SUK systems," "all samples," etc.
- Data Provenance: This is a nonclinical study conducted by ZOLL Circulation, Inc. (submitter). The tests are laboratory-based and simulated, rather than involving human subjects or real-world clinical data. Therefore, concepts like country of origin for data or retrospective/prospective don't directly apply in the same way they would for a clinical study. The tests were performed to verify performance against international standards (ISO, EN ISO, ASTM, USP).
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 section is not applicable (N/A). The "ground truth" for these tests is defined by established engineering and medical device standards (e.g., ISO, ASTM, USP criteria for tensile strength, leakage, biocompatibility, etc.) and the device's own design specifications. Expert consensus in the traditional sense (like for medical image interpretation) is not directly involved in setting the pass/fail criteria for these bench tests. The human factors testing involved "users" but not experts establishing ground truth for objective performance metrics in the same way.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is N/A. Adjudication methods like 2+1 or 3+1 are used in clinical studies where subjective expert review is required (e.g., for ambiguous medical findings). For these nonclinical bench tests, results are typically objective measurements or observations against predefined pass/fail criteria outlined in the test methods.
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
This section is N/A. The document describes a medical device (intravascular heat exchange catheter and start-up kit), not an AI diagnostic or assistance system. Therefore, an MRMC comparative effectiveness study or assessment of human reader improvement with AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is N/A. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on a combination of:
- International Standards: ISO 10555-1, ISO 594-1, ISO 594-2, EN ISO 10555-1, USP <788>, ASTM Hemolysis standards.
- 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.
Ask a specific question about this device
(291 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 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:
| Acceptance Criteria Category | Specific Criteria (Implicit from FDA Warning) | Reported Device Performance (Mortality Rates from RCT) |
|---|---|---|
| Clinical Effectiveness | No demonstrated safety for fever reduction in patients with subarachnoid hemorrhage (SAH) or primary traumatic brain injury (PTBI), specifically concerning mortality. | Cool Line Group:CI: 18.8% (3/16)ICH: 24.2% (8/33)PTBI: 22.7% (10/44)SAH: 21.3% (13/61)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: 0.74ICH: 1.00PTBI: 0.24SAH: 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:
| Acceptance Criteria Category | Specific Criteria (Example from Non-Clinical Tests) | Reported Device Performance (Example from Non-Clinical Tests) |
|---|---|---|
| Packaging Validation (SUK) | All package seals and tray seals are undamaged. | All package seals and tray seals were undamaged (Table 3). |
| Bench Performance (SUK) | No leaks below specified acceptance criteria during high pressure leak test. | No leaks were noted below the specified pressure (Table 4). |
| Bench Performance (Catheter) | All Luers meet requirements after alcohol resistance test (no crazing/cracking). | No Luers showed evidence of crazing or cracking after being soaked in alcohol (Table 5). |
| Biocompatibility | No cytotoxicity (reactivity grade "0"). | Reactivity grade of all test article extract samples was "0" (Table 7). |
| Biocompatibility | No sensitization reactions caused by test article extracts. | The test article extracts did not cause sensitization reactions under the conditions of the assay (Table 7). |
| Usability/Human Factors (Summative) | 100% of users pass critical tests regarding device connection and saline aspiration. | All participants passed critical tests (100% successful completion rate) (page 16). |
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.
Ask a specific question about this device
(154 days)
The Solex® Intravascular Heat Exchange Catheter connected to the CoolGard 3000®/Thermogard XP® Thermal Regulation System, is indicated for use:
- In cardiac surgery patients to achieve and or maintain normothermia during surgery and . recovery/intensive care, and
- To induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care.
Maximum use period: 48 hours
The ZOLL Solex Intravascular Heat Exchange Catheter (Solex 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 vein. The Solex Catheter is connected to a single use, disposable CoolGard 3000" or Thermogard XP® Start-Up Kit (SUK) and the CoolGard 3000" or Thermogard XP® Console, all of which comprise the ZOLL Intravascular Heat Exchange System. The Start-Up Kit (SUK) and the CoolGard 3000 or Thermogard XP Console are supplied separately. The ZOLL Heat Exchange System is also designed for use with an off-the-shelf temperature probe. The Solex 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 as an anti-thrombogenic agent.
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. Heated or chilled saline is pumped through the heat exchange lumens, inflating the diameter of the PET balloon that interfaces with the patient's blood system to warm or cool circulating blood. The inflow/outflow lumens form a closed-loop system through which the heated or chilled saline circulates. The heated or chilled saline is not infused into the patient. Additional lumens of the Solex 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 provided document is a 510(k) premarket notification for the ZOLL Solex Intravascular Heat Exchange Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where specific acceptance criteria are defined for a new medical device's performance against clinical outcomes.
This document primarily describes non-clinical testing (bench performance, biocompatibility, and shelf life) to support a minor modification (change in heparin coating) to an already cleared device. Therefore, a table of acceptance criteria and reported device performance related to clinical efficacy or a multi-reader, multi-case comparative effectiveness study are not applicable to the information provided.
Based on the provided text, here’s a breakdown of the available information:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't provide a table of acceptance criteria with specific numerical targets for clinical performance measures (e.g., accuracy, sensitivity, specificity). Instead, it states that "Nonclinical testing was performed to ensure that the modified ZOLL Solex Catheter meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate devices."
The non-clinical tests performed and their general outcomes are summarized as follows:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Bench Performance | Met product design specifications at T=0 and at its labeled expiration date. |
| Biocompatibility | Biocompatible for its intended use. |
| Shelf Life Testing | Supports the labeled expiration date. |
Specific details for each bench performance test and their acceptance criteria are not explicitly listed in a table format but are described narratively as "meeting design specifications." Examples of these tests include: catheter visual inspection, dimensional measurements, life testing, flow rate and pressure monitoring, heat exchange testing, air/liquid leakage testing, burst testing, flex and fatigue testing, and tensile strength testing, performed in accordance with ISO 10555-1:2013 where applicable.
2. Sample Size Used for the Test Set and the Data Provenance:
- Test Set Sample Size: Not applicable. The document describes non-clinical bench testing, not clinical studies involving patient data. For bench testing, samples of the modified catheter were used. The number of units tested for each specific bench test is not provided in detail.
- Data Provenance: Not applicable. The data is generated from laboratory bench tests, not from patient populations or clinical settings.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. This information pertains to medical imaging or diagnostic devices where expert review establishes ground truth for a test set. The current document describes a physical medical device (catheter) and its non-clinical performance.
4. Adjudication Method for the Test Set:
Not applicable, as a clinical test set with adjudicated ground truth is not described.
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. An MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices evaluating human performance improvement with AI assistance, which is not the subject of this 510(k) submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
No. This is not an algorithm or AI device. The testing described is for a physical medical device.
7. The Type of Ground Truth Used:
For the non-clinical testing, the "ground truth" refers to the pre-determined design and performance specifications of the device, and compliance with recognized standards (e.g., ISO 10555-1:2013 for catheter performance, ISO 10993-1:2009 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of this non-clinical testing.
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/machine learning device.
Ask a specific question about this device
(90 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 infaccerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
The ZOLL ICY Catheter Model IC-3893A, connected to the 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 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 recoveryintensive care.
ZOLL IVTM Cool Line. ICY and Quattro catheters are multi lumen intravascular catheters with balloons as heat exchange units. Each of these three catheter models has two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. The inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The thermal regulation system chills/warms the saline and pumps it through the inflow lumen of the catheter. The chilled/warmed saline travels to the balloons, whose surface facilitates heat exchange between the patient's circulating blood and the saline returns to the system via the outflow lumen. The chilled/warmed saline is not infused into the patient. Two additional lumens provide infusion channels. The fifth lumen serves as a guide wire lumen which can also be used as an infusion lumen. The basic difference between these three models of catheters is size and number of balloons which provides different heat exchange capacity.
The catheters are supplied sterile for single-use only.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds that the device must meet for approval. Instead, it presents the results of a randomized controlled trial and uses this data to inform a warning to be included in the device labeling. The performance is reported in terms of mortality rates for different patient cohorts.
| Cohort (Diagnosis) | Cool Line n (count) | Cool Line N (total) | Cool Line % (mortality) | Control n (count) | Control N (total) | Control % (mortality) | p-value* |
|---|---|---|---|---|---|---|---|
| CI (Cerebral Infarction) | 3 | 16 | 18.8 | 3 | 14 | 21.4% | 0.74 |
| ICH (Intracerebral Hemorrhage) | 8 | 33 | 24.2 | 7 | 27 | 25.9% | 1.00 |
| PTBI (Primary Traumatic Brain Injury) | 10 | 44 | 22.7 | 4 | 38 | 10.5% | 0.24 |
| SAH (Subarachnoid Hemorrhage) | 13 | 61 | 21.3 | 7 | 63 | 11.1% | 0.15 |
Note: The p-value is from Fischer's exact test.
The conclusion drawn from this study is that "The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury." This indicates that for these specific conditions, the observed mortality rates were either higher in the Cool Line group or not statistically different enough to confirm safety, leading to a labeling warning rather than a clear "acceptance" for those indications. The device is indicated for fever reduction in adult patients with cerebral infarction and intracerebral hemorrhage, implying that its performance for these conditions was considered acceptable despite the lack of explicit "acceptance criteria" in this document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 296 patients.
- Data Provenance: The document states "a randomized controlled trial." While the country of origin is not explicitly mentioned, FDA review documents typically pertain to devices intended for the US market, and the listed address for ZOLL Circulation, Inc. is Sunnyvale, California, USA. The trial type is prospective as it's a randomized controlled trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document describes a randomized controlled clinical trial measuring mortality. No information is provided about experts establishing a "ground truth" for the test set in the context of diagnostic performance. The "ground truth" in this context is the actual clinical outcome (mortality), which is a direct observation.
4. Adjudication Method for the Test Set
No information is provided about an adjudication method. The trial measured mortality, which is a definitive outcome and typically doesn't require adjudication in the way diagnostic interpretations might.
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
This document describes a clinical trial for a thermal regulating catheter, not an AI-powered diagnostic device. Therefore, no MRMC comparative effectiveness study was done and the concept of "human readers improve with AI" is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Again, this is a physical medical device (catheter) for thermal regulation, not an algorithm or AI. Therefore, no standalone performance study was done in the context of an algorithm.
7. The Type of Ground Truth Used
The ground truth used in the clinical trial was outcomes data, specifically mortality by diagnosis.
8. The Sample Size for the Training Set
No information is provided about a "training set." The study described is a clinical trial, which typically has a single patient cohort (divided into treatment and control groups) rather than separate training and test sets in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" described in the context of this device and study. The ground truth (mortality) for the clinical trial was established through direct observation of patient outcomes.
Ask a specific question about this device
(199 days)
The RapidBlue™ System is a thermal regulating system intended to induce, maintain and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care, to achieve and/or maintain normothermia in cardiac surgery patients in surgery and in recovery/ intensive care, and for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who required access to the central venous circulation and who are intubated and sedated.
The subject device is a thermal regulating system consisting of three (3) parts:
-
- A console containing refrigeration/heating elements, a heat exchanger to cool and warm the circulating fluid, a pump to circulate that fluid, and controls and software necessary to operate the system.
-
- A sterile cassette to connect the console to the catheter, and through which the heat transfer fluid is circulated to and from the catheter in a closed-loop manner.
-
- An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which is available in various diameters from 10.7 french to 14 french.
The modified system offers a mode, which uses conventional, off-the-shelf temperature probes such as YSI-400 esophageal probes, to monitor patient temperature and control system operation, and one mode that uses an integrated temperature sensor in the catheter.
- An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which is available in various diameters from 10.7 french to 14 french.
The provided text is a 510(k) summary for the RapidBlue™ System, a thermal regulating system. It describes the device, its intended use, and its comparison to predicate devices. However, this document does not contain explicit acceptance criteria or a study detailing device performance against such criteria.
The 510(k) summary is a premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, rather than a detailed report of a new clinical trial proving specific performance metrics with acceptance criteria.
Therefore, the requested information cannot be extracted from the provided text for the following reasons:
- A table of acceptance criteria and the reported device performance: This information is not present. The document states that the device "has equivalent performance in inducing and reversing hypothermia, and in maintaining normothermia, as do other thermal regulating systems commercially available in the U.S." but does not provide specific metrics or acceptance thresholds.
- Sample size used for the test set and the data provenance: No test set is described or analyzed in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no described test set requiring ground truth establishment by experts.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physical thermal regulating system, not an AI-assisted diagnostic or therapeutic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document focuses on demonstrating substantial equivalence based on indications for use, design characteristics, biocompatible materials, and general performance equivalence to existing predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed study parameters.
Ask a specific question about this device
Page 1 of 3