(86 days)
The Reverse Medical ReFlex™ Balloon Guide Catheter is indicated for use in facilitating and guidance of intravascular catheters into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
The ReFlex™ Balloon Guide Catheter is a flexible, variable stiffness composite catheter shaft has a hydrophilic coating to reduce friction during use. A compliant balloon is mounted on the distal end of the catheter. The ReFlex™ Balloon Guide Catheter dimensions are included on the individual device labels. The ReFlex™ Balloon 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™ Balloon Guide Catheter has a bifurcated luer fitting to allow attachment of accessories and infusion of liquids through the system. The ReFlex™ Balloon Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. The catheter is provided sterile, non-pyrogenic, and is intended for single use only.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: ReFlex™ Balloon Guide Catheter
K Number: K112262
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes various in vitro and in vivo tests conducted to demonstrate the substantial equivalence of the ReFlex™ Balloon Guide Catheter. The "acceptance criteria" are implied by the statement "Met established criteria" for each test. The reported device performance is that it successfully met these criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dimensional and Visual Inspection | Met established criteria |
| Guidewire Compatibility | Met established criteria |
| Microcatheter Compatibility | Met established criteria |
| Torque Strength | Met established criteria |
| Kink Resistance | Met established criteria |
| Tip Buckling Test | Met established criteria |
| Flexibility Test (including tip flexibility) | Met established criteria |
| Tensile Strength | Met established criteria |
| Catheter Leak Test (Liquid Leakage) | Met established criteria |
| Catheter Leak Test (Air Leakage) | Met established criteria |
| Dynamic Pressure Test | Met established criteria |
| Static Burst Test | Met established criteria |
| Aspiration Test | Met established criteria |
| Hub Gauging | Met established criteria |
| Corrosion Resistance | Met established criteria |
| USP Particulate Test | Met established criteria |
| Navigation, Accessibility, & Simulated Vascular Occlusion Capabilities in vitro | Met established criteria |
| Balloon Inflation/Deflation Times | Met established criteria |
| Balloon Cycle Fatigue | Met established criteria |
| Balloon Rated Volume (informational purposes) | Met established criteria |
| Balloon Compliance (informational purposes) | Met established criteria |
| System Deliverability, Compatibility, Visibility, and Temporary Vascular Occlusion Performance (in vivo) | Met established criteria |
| Acute Histopathology of Treated Vessels (in vivo) | Met established criteria |
| Biocompatibility Testing | Met established criteria |
Note on Biocompatibility: The document also lists specific biocompatibility tests and states that the blood-contacting materials "successfully passed all of the following biocompatibility tests:"
- Cytotoxicity (L929 MEM Elution Test)
- Sensitization (Kligman Maximization)
- Intracutaneous Reactivity (Irritation) (Intracutaneous Injection Test)
- Systemic Toxicity (Acute) (ISO Acute Systemic Injection Test)
- Hemocompatibility (Complement Activation, Hemolysis, Inactivated Partial Thromboplastin Time Test, In vivo thrombogenicity)
- Pyrogenicity (USP Material Mediated Rabbit Pyrogen Test)
- EtO Residuals (Ethylene oxide and Ethylene chlorohydrins residuals)
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test within the "Design Verification (Bench-Top Testing)" or "In vivo Tests" sections. It only states that "All testing was performed on units that were sterilized and met all inspection criteria."
The data provenance is not specified regarding country of origin, but the tests are described generally as "non-clinical data" and "bench-top testing" and "in vivo tests," implying laboratory and potentially animal studies, not human clinical trials. The data is thus prospective, as it was generated specifically for this device's submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The studies described are primarily product performance and safety tests (mechanical, physical, biocompatibility, in vivo performance) rather than studies requiring expert consensus on a 'ground truth' in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically relevant for studies where human interpretation or judgment is involved, such as in clinical image reading or diagnosis. These are not applicable to the bench-top and animal (in vivo) performance studies described for this medical device. The "ground truth" for these tests would be objective measurements against established engineering, biological, or regulatory standards.
5. 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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a physical medical instrument (a balloon guide catheter), not an AI-powered diagnostic or assistive technology for human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device is a physical medical instrument and does not involve an algorithm.
7. The Type of Ground Truth Used
For the various tests:
- Physical and Mechanical Tests (Bench-Top): The ground truth is based on established engineering specifications, industry standards, and internal design criteria. The results were compared against these predefined criteria (e.g., "Met established criteria").
- Biocompatibility Tests: The ground truth is based on recognized international standards and guidelines, specifically FDA General Program Memorandum #G95-1 and ISO 10993-1 guidelines, which specify acceptable biological responses to materials.
- Sterilization: Ground truth is based on ANSI / AAMI / ISO 11135 standards for achieving a Sterility Assurance Level (SAL) of 10^-6^ (stated as 10^-8^ in the document, which is stricter than common).
- In vivo Tests: The ground truth would be based on observed physiological responses, device functionality in a relevant biological model, and histopathological assessment against predefined safety and performance parameters in the animal model.
8. The Sample Size for the Training Set
Not applicable. This submission describes the testing of a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.
§ 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).