(304 days)
The Columbus Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Columbus Guidewire is intended to facilitate the selective placement of therapeutic catheters. This device is not intended for use in coronary arteries.
The Columbus guidewire is a 0.014" diameter steerable guidewire with a deflectable tip to aid in accessing vasculature. The guidewire is supplied sterile (ETO sterilization) and is for single use only. The Columbus guide wire is comprised of a Nitinol braided flexible distal cable, a proximal shaft, an inner core wire and a handle. The braided cable is attached to the proximal shaft via inner connector. The inner core wire runs inside the shaft and the cable from the distal end of the cable to the handle. The distal end of the inner core wire is flattened, looped around and joined to the tip of the distal cable, forming a deflectable tip. In order to actuate the tip deflection in two directions, the Columbus guidewire handle contains a tube assembly section which enables continuous stroke by a self-locking feature. The handle is assembled to the proximal end of the core wire and controls the movement of the distal tip by pulling/pushing the inner moveable core wire, allowing the bending of the distal tip in two directions. Two models are available, Columbus LR (large radius) PN: GWPP4464 which has radius curvature of 4mm and Columbus SR (small radius) PN: GWPP4463 which has radius curvature of 2mm. The Columbus guidewire is provided with a torque accessory to facilitate use of the guidewire and is not intended to contact the patient's body.
The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed in the document provided, specifically for the Columbus Guidewire (K200374).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria (Non-Clinical Performance Tests) and Reported Device Performance:
The document lists various performance bench tests that the Columbus Guidewire underwent, along with the standards they followed and the results. The acceptance criteria for these tests are implied by the "Pass" result, indicating that the device met the requirements outlined in the specified FDA Guidance or ISO standards.
| Test | Standards / Description | Reported Performance (Result) |
|---|---|---|
| Visual and Dimensions Verification | FDA Guidance for Industry and Food and Drug Administration Staff: Coronary, Peripheral, and Neurovascular Guidewires Performance Tests and Recommended Labeling, October 2019 ("FDA Guidewire Guidance"), Section G-3 | Pass |
| Tip Flexibility | FDA Guidewire Guidance, Section G-15 | Pass |
| Simulated Use - Delivery and Retrieval Force | FDA Guidewire Guidance, Section G-5 | Pass |
| Simulated Use Model Testing and Product Compatibility | FDA Guidewire Guidance, Section G-5 | Pass |
| Torqueability | FDA Guidewire Guidance, Section G-9 | Pass |
| Kink Resistance | FDA Guidewire Guidance, Section G-14 | Pass |
| Fracture Test | ISO11070 section 8.4 | Pass |
| Flexing Test | ISO11070 section 8.5 | Pass |
| Tensile Force | FDA Guidewire Guidance, Section G-6 | Pass |
| Torque Strength | FDA Guidewire Guidance, Section G-8 | Pass |
| Particulate | FDA Guidewire Guidance, Section G-11 | Pass |
| Corrosion | FDA Guidewire Guidance, Section G-13 | Pass |
| Tip deflection force | The maximum tip deflection force was measured during complete deflection in a simulated vessel diameter range of 0.5-5.5mm to verify it is within justifiable safe range. | Pass |
| Deflectable tip cyclic fatigue testing | Testing was conducted to determine the tip deflection mechanism durability to 30 full handle actuations. | Pass |
2. Sample Size Used for the Test Set and the Data Provenance:
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Animal Testing (Pre-Clinical GLP Studies):
- Sample Size: "a total of 5 swine" were used across two controlled GLP studies.
- Data Provenance: The studies were conducted in "domestic swine," which implies prospective animal studies. The country of origin is not explicitly stated but is likely where Rapid-Medical Ltd. or its contract research organization operates, given that the company is based in Israel. The studies are described as "controlled GLP studies," indicating a high standard of preclinical research.
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Bench Tests: The document does not specify the exact sample sizes (e.g., number of guidewires tested for each parameter). The data provenance is laboratory-based non-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
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Animal Testing: The document states "assessments by well qualified experts in accordance with recognized methods, standards, and guidelines." While the exact number of experts is not specified, their qualification is noted as "well qualified experts." This likely refers to veterinary professionals, pathologists, or interventional specialists involved in the animal studies. Specific experience levels (e.g., "10 years of experience") are not provided.
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Bench Tests: The "ground truth" for bench tests is established by adherence to specified engineering standards and internal requirements, not typically by human expert consensus in the same way as clinical or image-based studies. The "experts" involved would be the engineers and quality assurance personnel conducting and interpreting the tests.
4. Adjudication Method for the Test Set:
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Animal Testing: The document does not explicitly state an adjudication method (e.g., 2+1, 3+1) for the expert assessments in the animal studies. It implies a direct assessment by "well qualified experts" following recognized methods, which inherently requires agreement on the observed outcomes (e.g., presence/absence of perforations, thrombus).
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Bench Tests: Adjudication is not typically applicable in the classical sense for bench tests. The "ground truth" is determined by measured physical properties against predefined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not conducted. This type of study (comparing human readers with and without AI assistance on various cases) is generally relevant for AI/imaging devices. The Columbus Guidewire is a mechanical medical device, and its evaluation focuses on physical performance, safety, and functional equivalence rather than diagnostic performance aided by AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:
This question is not applicable to the Columbus Guidewire. This device is a physical, mechanical medical guidewire, not an algorithm or AI system. Its "performance" is inherently human-in-the-loop, as it requires a physician to operate it. The bench tests evaluated the device's inherent mechanical properties and functionality.
7. The Type of Ground Truth Used:
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Animal Testing: The ground truth was established through direct observation and assessment by "well qualified experts" during and after the animal procedures. This included angiographic assessment for perforations/dissections/thrombus, and macroscopic assessment of internal organs for thrombi. This can be considered a form of outcomes data (in vivo biological response) from a controlled study.
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Bench Tests: The "ground truth" for bench tests was based on engineering specifications, physical measurements, and adherence to established national and international standards (e.g., FDA Guidewire Guidance, ISO 11070).
8. The Sample Size for the Training Set:
This information is not applicable and not provided in the document. The Columbus Guidewire is a physical medical device, not an AI/machine learning model 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 a physical medical device like the Columbus Guidewire.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.