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510(k) Data Aggregation
(37 days)
The Solex Catheter Model SL2593, connected to an Alsius External 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.
The SOLEX catheter is a multi lumen intravascular catheter. The catheter has two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. When the heat exchange feature of the catheter is in use, heated/chilled saline is pumped through the heat exchange lumen, expanding the diameter of the distal portion of the catheter to a nominal 12.2 mm where the heating/cooling membranes interface with the patient's circulating blood. The inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The chilled saline is not infused into the patient. Additional lumens of the Alsius Solex Catheter Model SL2593 consist of a standard guide wire lumen that can be used as a primary infusion lumen, and two additional infusion lumens within the shaft.
The provided document is a 510(k) summary for the Alsius Solex Catheter Model SL2593, which is a submission to the FDA for market clearance based on substantial equivalence to a predicate device. This type of submission generally does not include a detailed study proving the device meets acceptance criteria in the same way a clinical trial for a novel drug or a high-risk device might. Instead, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Therefore, many of the requested categories (e.g., sample size for the test set, number of experts, adjudication method, MRMC study, standalone performance) are not applicable in this context, as this document is not a report of a new clinical study with acceptance criteria being met in a statistically powered trial.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of "acceptance criteria" with measured performance for the Solex Catheter in the way it would for a clinical trial endpoint. Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device (Alsius Fortius Catheter Kit Model FR-5093, K030421) by comparing technical characteristics and intended use.
The "performance" is implicitly considered equivalent if the technical changes do not raise new questions of safety and effectiveness, and the basic operating principle and indications for use are the same.
| Characteristic/Comparison Point | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|---|
| Indications for Use | Identical to predicate device | Identical to predicate device |
| Principle of Operation | Same as predicate device | Same as predicate device |
| Technical Characteristics | Very similar to predicate device; differences should not raise new safety/effectiveness concerns | Differences noted (shorter balloon, shorter length, additional infusion lumens, different insertion site label, different PET construction OD). These differences were deemed not to raise new safety/effectiveness concerns. |
| Materials Used | Very similar to predicate device | Very similar (e.g., same heat exchange balloon material, Duraflo® Treatment heparin coating) |
| Clinical Performance (Cooling/Heating) | Not explicitly stated as a numerical criterion; assumed to be acceptable given similarity in principle and material. Shorter balloon results in reduced heat exchange power, but this is not presented as a failure to meet a criterion, but rather a characteristic. | The shorter length balloon "results in reduced heat exchange power." The document implies this is acceptable given the overall substantial equivalence determination. |
| Safety | No new questions of safety | No new questions of safety raised. |
| Effectiveness | No new questions of effectiveness | No new questions of effectiveness raised. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. This is not a study with a test set in the conventional sense. The submission relies on comparative analysis with a predicate device.
- Data Provenance: Not applicable. The data primarily consists of engineering and design specifications for the new device and a comparison to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. Ground truth as typically established by medical experts for clinical endpoints is not part of this 510(k) submission for substantial equivalence based on technical comparison.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. There was no test set 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:
- MRMC Study: Not applicable. This device is a catheter for thermal regulation, not an AI-assisted diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a physical medical device (catheter) and associated system, not an algorithm. Its operation involves human medical professionals.
7. The Type of Ground Truth Used:
- Type of Ground Truth: The "ground truth" implicitly used for this 510(k) submission is the established safety and effectiveness of the predicate device. The new device is compared against the predicate's characteristics and performance to demonstrate that it is "substantially equivalent." There isn't a separate, independently established ground truth for the new device's performance in a clinical setting presented in this document.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This is a medical device submission, not an AI/machine learning model submission that would require a "training set."
9. How the Ground Truth for the Training Set was Established:
- How Ground Truth for Training Set was Established: Not applicable. This is a medical device submission, not an AI/machine learning model submission.
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(13 days)
The THERMOGARD XP can be used with any of the Alsius Catheters. The indications for use are specific to the catheter. Please refer to the Indications for Use statement in the catheter specific Instructions for Use.
The THERMOGARD XP/Alsius Catheter Thermal Regulation System, using either the Icy™ or Fortius™ model catheter, 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.
The Alsius THERMOGARD XP™ and Cool Line™ Catheter Thermal Requlation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
The THERMOGARD XP and Catheter Thermal Regulation System consists of the THERMOGARD XP, a disposable Start Up Kit used to interface between the cooling bath of the THERMOGARD XP and the intravascular Catheter. The THERMOGARD XP is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller primo. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
The technical characteristics of the Catheter are identical to the predicate device.
The Alsius THERMOGARD XP and Catheter Thermal Regulation System is indicated for fever reduction in patients with cerebral infarction and intracerebral hemorrhage who require central venous access, intubation, and sedation. It is also indicated for use in cardiac surgery patients to achieve and 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fever Reduction | |
| Mortality rates not significantly inferior to control for: | |
| Cerebral Infarction (CI) | Cool Line: 18.8% (3/16), Control: 21.4% (3/14). p-value: 0.74 (No significant difference) |
| Intracerebral Hemorrhage (ICH) | Cool Line: 24.2% (8/33), Control: 25.9% (7/27). p-value: 1.00 (No significant difference) |
| Primary Traumatic Brain Injury (PTBI) | Cool Line: 22.7% (10/44), Control: 10.5% (4/38). p-value: 0.24 (No significant difference, but note higher mortality in Cool Line group; device safety not demonstrated for PTBI.) |
| Subarachnoid Hemorrhage (SAH) | Cool Line: 21.3% (13/61), Control: 11.1% (7/63). p-value: 0.15 (No significant difference, but note higher mortality in Cool Line group; device safety not demonstrated for SAH.) |
| Normothermia/Hypothermia in Cardiac/Neurosurgery | The acceptance criteria for these indications are not explicitly detailed in the provided text. The document states that the system is "safe and effective when used in accordance with the Directions For Use and substantially equivalent to the predicate device" (Alsius CoolGard 3000™/Alsius THERMOGARD™ thermal regulation system). This implies the device meets the performance standards of the predicate for these indications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): A total of 296 patients were enrolled in the randomized controlled trial for fever reduction. The breakdown per cohort is:
- Cerebral Infarction (CI): 16 (Cool Line) + 14 (Control) = 30 patients
- Intracerebral Hemorrhage (ICH): 33 (Cool Line) + 27 (Control) = 60 patients
- Primary Traumatic Brain Injury (PTBI): 44 (Cool Line) + 38 (Control) = 82 patients
- Subarachnoid Hemorrhage (SAH): 61 (Cool Line) + 63 (Control) = 124 patients
- Data Provenance: The text does not explicitly state the country of origin. The study was a "randomized controlled trial," indicating it was prospective in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not specify the number or qualifications of experts used to establish ground truth for morbidity/mortality outcomes in the randomized controlled trial. Mortality data appears to be objective (number of deaths).
4. Adjudication Method for the Test Set
The provided text does not specify any adjudication method for the test set outcomes. Given that the primary outcome described is mortality, it's typically an objective measure that may not require complex 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
This device is a thermal regulation system, not an AI-powered diagnostic or interpretive device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study with human readers (or "AI assistance") is not applicable to this product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a physical medical device (an integrated electro-mechanical heater/cooler and catheter system) that directly modifies patient temperature. It is operated by medical professionals. The concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this type of device. Its performance is intrinsically linked to its physical function in a patient setting under human supervision.
7. The Type of Ground Truth Used
For the fever reduction indication, the ground truth used was mortality data (i.e., patient outcomes).
8. The Sample Size for the Training Set
The document describes a randomized controlled trial for evaluating safety and effectiveness for fever reduction. In such a trial, the entire patient cohort (296 patients) generally serves as the "test set" to evaluate the device's performance against a control group. The concept of a separate "training set" is typically associated with machine learning or artificial intelligence models, which is not relevant here as this is a physical medical device. Therefore, there is no distinct training set as would be understood in an AI context. The study population is the performance evaluation set.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, there isn't a separate "training set" in the context of this device and study design. The ground truth (mortality) for the study population was established by observing and recording patient outcomes (death) in both the device-treated group and the control group of the randomized controlled trial.
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(27 days)
The THERMOGARD can be used with any of the Alsius Catheters. The indications for use are specific to the catheter. Please refer to the Indications for Use statement in the catheter specific Instructions for Use.
The THERMOGARD/Alsius Catheter Thermal Regulation System, using either the Icy™ or Fortius™ model catheter, 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.
The Alsius THERMOGARD™ and Cool Line™ Catheter Thermal Regulation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
The THERMOGARD and Catheter Thermal Regulation System consists of the THERMOGARD, a disposable Start Up Kit used to interface between the cooling bath of the THERMOGARD and the intravascular Catheter. The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
The technical characteristics of the Catheter are identical to the predicate device with the exception of revisions to the software that controls the device.
All models of Alsius Intravascular catheters are available for use with the THERMOGARD.
The provided text describes a 510(k) summary for the ALSIUS CORPORATION'S THERMOGARD and Catheter Thermal Regulation System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting acceptance criteria and a study proving a device meets those criteria for a novel technology.
However, the document does contain information about a clinical trial related to the device's use in fever reduction and outlines certain limitations on its use based on the trial results. This information can be re-purposed to infer a type of "acceptance criteria" based on the observed safety and effectiveness, and the study details are provided.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in the typical sense for a new device's performance metrics (e.g., sensitivity, specificity, accuracy thresholds). Instead, it presents mortality rates from a clinical trial that led to a warning and limitation on the device's indications for use.
The "acceptance criteria" here are effectively inferred limits on where the device's performance was considered safe and effective enough for its intended use, particularly for fever reduction, based on its performance relative to a control group. For the conditions where the device was not shown to be safe and effective, the mortality rates in the Cool Line group were not significantly better (and in some cases numerically worse) than the control group.
| Acceptance Criteria (Inferred from FDA Warning) | Reported Device Performance (Mortality % with Cool Line System) | Control Group Performance (Mortality % without Cool Line System) | p-value | Indication/Patient Cohort |
|---|---|---|---|---|
| Acceptable for Fever Reduction: Device demonstrated safety and effectiveness as an adjunct to other antipyretic therapy. (Implies non-inferiority or better outcomes compared to control, though not explicitly stated as a statistical threshold for improvement.) | CI: 18.8% (n=3/N=16) | CI: 21.4% (n=3/N=14) | 0.74 | Cerebral Infarction (CI) |
| ICH: 24.2% (n=8/N=33) | ICH: 25.9% (n=7/N=27) | 1.00 | Intracerebral Hemorrhage (ICH) | |
| NOT Acceptable for Fever Reduction: Safety and effectiveness not demonstrated in these populations, leading to a warning. (Implies outcomes were not sufficiently better or were worse than control, or demonstrated a safety concern.) | PTBI: 22.7% (n=10/N=44) | PTBI: 10.5% (n=4/N=38) | 0.24 | Primary Traumatic Brain Injury (PTBI) |
| SAH: 21.3% (n=13/N=61) | SAH: 11.1% (n=7/N=63) | 0.15 | Subarachnoid Hemorrhage (SAH) |
Note: The p-values indicate a lack of statistically significant difference between the Cool Line and Control groups in mortality for all cohorts in this specific trial. However, for PTBI and SAH, the Cool Line group numerically had higher mortality, which contributed to the FDA's warning about lack of demonstrated safety and effectiveness for those indications for fever reduction.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: A randomized controlled trial of 296 patients was conducted.
- Cool Line group: (16 CI + 33 ICH + 44 PTBI + 61 SAH) = 154 patients
- Control group: (14 CI + 27 ICH + 38 PTBI + 63 SAH) = 142 patients
- Data Provenance: The document does not explicitly state the country of origin. It is a prospective randomized controlled trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of information is generally not applicable to a clinical trial involving patient outcomes like mortality. The "ground truth" here is the actual patient outcome (mortality), which is a definitive clinical event, not an expert interpretation of an image or a condition. Therefore, no experts were "establishing ground truth" in that sense.
4. Adjudication Method for the Test Set
Not applicable in the context of a clinical trial where the primary endpoint is mortality. Mortality is typically recorded as a factual event, not subject to adjudication in the same way, for example, an imaging diagnosis or a pathological finding might be.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, this was not an MRMC study. An MRMC study typically involves multiple human readers interpreting cases (e.g., medical images) to assess diagnostic performance, often with and without AI assistance, and then analyzing the variability and agreement among readers. This study was a randomized controlled trial comparing a medical device with an active control group based on patient survival outcomes.
- Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as this was not an imaging diagnostic study involving human readers and AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- No, this was a study of a medical device (THERMOGARD Thermal Regulation System) used in patients, with human medical staff operating and managing the system. It is not an algorithm designed for diagnostic or predictive tasks that could operate "standalone" in the medical sense of an AI model only.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Outcomes Data: The ground truth was mortality, which is a definitive clinical outcome.
8. Sample Size for the Training Set
The document describes a clinical trial (a "test set" or pivotal study) evaluating the device in humans. It does not mention a "training set" in the context of machine learning or AI model development. The device itself is electro-mechanical, not an AI algorithm that would typically require a training set in that sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a machine learning "training set" for an AI algorithm.
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(78 days)
The COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the IcyTM or Fortius™ model catheter, 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.
The Alsius CoolGard® 3000 and Cool Line™ Catheter Thermal Regulation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
The CoolGard and Catheter Thermal Regulation System consists of the CoolGard™ 3000, a disposable Start Up Kit used in the CoolGard™ for interface with the cooling bath and patient catheter and the Intravascular Catheter. The Alsius CoolGard™ 3000 is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
The provided document is a 510(k) Summary and an FDA 510(k) clearance letter for the Alsius CoolGard 3000 and Catheter Thermal Regulation System. This submission is for modifications to the software of an existing device, and the device acts as its own predicate.
As such, acceptance criteria and device performance in the traditional sense of a new medical device showing clinical efficacy or diagnostic accuracy are not explicitly outlined as a pass/fail threshold. Instead, the study aims to demonstrate that the software modifications do not raise new questions of safety or effectiveness and that the updated system is substantially equivalent to its existing predicate (itself).
The document details a randomized controlled trial that was previously conducted, which is relevant to a specific warning for the device, rather than being the primary study proving the current software modification meets acceptance criteria.
Let's break down the information based on your request, focusing on what is available and noting where details are not provided due to the nature of this 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this 510(k) is for a software modification to an existing device, the "acceptance criteria" are not reported as specific performance metrics against a threshold for new clinical efficacy. Instead, the acceptance criteria are implicitly that the software modifications do not negatively impact the device's safety or effectiveness as established by its previous clearances. The reported device performance relates to a clinical trial mentioned in a warning on its labeling.
| Acceptance Criteria (Implicit for Software Modification) | Reported Device Performance (from cited clinical trial relevant to a warning) |
|---|---|
| No new questions of safety or effectiveness | Trial results for mortality by diagnosis are provided. The "device performance" in this context is the observed mortality rates in different cohorts with and without the device (Cool Line) for fever reduction, to inform a warning about specific uses. The p-values indicate no statistically significant difference in mortality across the groups for the specified conditions (CI, ICH, PTBI, SAH) in this particular study. This study is not proving efficacy for the current software modification, but providing data for a device warning. |
| Substantial equivalence to predicate device (itself) | "descriptive information and performance data demonstrate that the Alsius CoolGard and Catheter Thermal Regulation System characteristics do not raise new questions of safety and effectiveness. Where appropriate, performance data demonstrate equivalence." - The specific technical performance data supporting this claim for the software modification are summarized but not detailed in this 510(k) summary. |
2. Sample Size Used for the Test Set and Data Provenance
The primary "test set" discussed in relation to clinical outcomes is from a randomized controlled trial of 296 patients. This study's data informs a warning related to fever reduction with the Cool Line Catheter.
- Sample Size (for the referenced clinical trial): 296 patients
- Cool Line group: (16 CI + 33 ICH + 44 PTBI + 61 SAH) = 154 patients
- Control group: (14 CI + 27 ICH + 38 PTBI + 63 SAH) = 142 patients
- Data Provenance: The document does not specify the country of origin. It is a retrospective analysis of previously collected data, forming the basis of a clinical trial used to establish a warning rather than being a prospective trial for the current software modification. The trial itself would have been prospective to collect the data, but the analysis presented here is of already completed data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The clinical trial generated patient outcomes (mortality), which served as the "ground truth" for evaluating the safety concern, rather than requiring expert consensus on a subjective measure.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given that the outcome measured was mortality, which is an objective endpoint, a formal adjudication method for interpretation might not have been
explicitly required in the same way it would be for subjective diagnostic evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study typically assesses the performance of human readers, sometimes with and without AI assistance, especially in diagnostic imaging. The device in question is a thermal regulation system, not an imaging or diagnostic AI device. The study cited is a randomized controlled trial assessing mortality outcomes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
No, a standalone algorithm-only study was not done in the context of diagnostic performance. The device is a physical thermal regulation system with software control. The "algorithm" here refers to the software controlling the device's function. The 510(k) submission for the software modification indicates that software revisions were made and "supportive evidence is provided to establish that there are no new questions of safety or efficacy." The details of this "supportive evidence" are not fully elaborated in the summary but would likely involve verification and validation testing of the software changes to ensure it performs as intended and does not introduce hazards (e.g., in a standalone testing environment for the software, but not in the sense of a standalone clinical performance study).
7. The Type of Ground Truth Used (for the described clinical trial)
The ground truth for the clinical trial was outcomes data, specifically mortality. Mortality is an objective and directly observable outcome.
8. The Sample Size for the Training Set
The document is for a 510(k) submission for a software modification to an existing medical device. It does not describe a machine learning algorithm or an AI model that would require a "training set" in the conventional sense. The "software revisions" mentioned would have been developed and tested, but the term "training set" doesn't apply here.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" in the context of this 510(k) submission. The software modifications would have undergone software validation and verification according to established engineering and regulatory practices, rather than being "trained" on data.
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