(85 days)
The Reverse Medical ReFlex™ Guide Catheter is indicated for the introduction of interventional devices into the peripheral, and neuro vasculature.
The ReFlex™ Guide Catheter is a single lumen, flexible, variable stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The ReFlex™ Guide Catheter shaft is visible under fluoroscopy. The ReFlex™ Guide Catheter dimensions are included on the individual device label. The ReFlex™ Guide Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The proximal end of the ReFlex™ Guide Catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The ReFlex™ Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.
The ReFlex™ Guide Catheter's acceptance criteria and the study proving it meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| In vitro Tests | Acceptance Criteria | Reported Performance |
|---|---|---|
| Dimensional and Visual Inspection | Met established criteria | Met established criteria |
| Guidewire Compatibility | Met established criteria | Met established criteria |
| Torque Response | Met established criteria | Met established criteria |
| Torque Strength | Met established criteria | Met established criteria |
| Kink Resistance | Met established criteria | Met established criteria |
| Flexibility Test | Met established criteria | Met established criteria |
| Tensile Strength | Met established criteria | Met established criteria |
| Catheter Leak Test (Liquid Leakage) | Met established criteria | Met established criteria |
| Catheter Leak Test (Air Leakage) | Met established criteria | Met established criteria |
| Dynamic Pressure Test | Met established criteria | Met established criteria |
| Static Burst Test | Met established criteria | Met established criteria |
| Aspiration Test | Met established criteria | Met established criteria |
| Hub Gauging | Met established criteria | Met established criteria |
| Corrosion Resistance | Met established criteria | Met established criteria |
| USP Particulate Test | Met established criteria | Met established criteria |
| Navigation and Accessibility Capabilities in vitro | Met established criteria | Met established criteria |
| In vivo Tests | ||
| System Deliverability, Compatibility, Visibility and Aspiration Performance | Met established criteria | Met established criteria |
| Acute histopathology of treated vessels | Met established criteria | Met established criteria |
| Biocompatibility testing | Met established criteria | Met established criteria |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample size for each individual test. However, it mentions that "All testing was performed on units which were sterilized and met all inspection criteria."
The data provenance is from bench-top (in vitro) and in vivo testing conducted by Reverse Medical Corporation, the device sponsor. The document does not specify the country of origin for the in vivo testing, but considering the sponsor is based in Irvine, CA, USA, it's likely conducted in the US. The studies are prospective in nature, as they involve testing of newly manufactured devices under controlled conditions to evaluate their performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are primarily engineering and biological performance tests, not diagnostic tests requiring human expert interpretation in the context of ground truth establishment for a test set. The "ground truth" for these tests is based on established engineering standards, biological compatibility requirements, and functional specifications, not expert consensus on medical images or patient outcomes.
4. Adjudication method for the test set:
This information is not applicable as the tests are objective measurements and evaluations against established criteria, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that rely on human interpretation of images or data, often with AI assistance, to measure the impact of the AI on human performance. The ReFlex™ Guide Catheter is an interventional device, and its evaluation focuses on its physical, mechanical, and biological performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the testing described is primarily focused on the standalone performance of the device itself. The "Design Verification (Bench-Top Testing)" and "In vivo Tests" assess the intrinsic characteristics and functionality of the ReFlex™ Guide Catheter without human interaction being a variable in the performance evaluation.
7. The type of ground truth used:
The "ground truth" for the tests is based on:
- Established engineering standards and specifications: For dimensional, mechanical (torque, kink resistance, tensile strength, leak, burst, aspiration), and material (corrosion, particulate) tests.
- Biological compatibility standards: For biocompatibility tests (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, hemocompatibility, pyrogenicity) in accordance with ISO 10993-1 guidelines.
- Functional performance criteria: For guidewire compatibility, navigation and accessibility capabilities, and system deliverability/compatibility/visibility/aspiration.
- Histopathological evaluation: For acute histopathology of treated vessels, likely performed by a qualified pathologist, to assess tissue reaction.
8. The sample size for the training set:
There is no mention of a training set as this product is a physical medical device, not an AI/machine learning algorithm that requires training data.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).