Search Results

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:

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