(30 days)
The Cordis AVIATOR Peripheral Dilatation catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The AVIATOR Peripheral Dilatation Catheter has an integrated shaft system and a balloon near the distal tip. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The second lumen, located only in the distal shaft, permits the use of a .014" diameter guidewire to facilitate the advancement of the catheter to and through the stenosis to be dilated. The catheter shaft has a distal port (hole) near the distal end that accesses the guidewire lumen. The guidewire lumen begins at the distal port and ends at the distal tip. This "rapid exchange" design allows insertion and removal of the catheter without extension of the guidewire.
The balloon has radiopaque marker(s) to aid in positioning the balloon. The balloon is further designed to provide an expandable segment of known diameter and length at a specific pressure.
The design of this catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
A flushing needle accessory is also provided with the device to facilitate flushing/lubricating the catheter's inner guidewire lumen prior to use.
The AVIATOR Peripheral Dilatation Catheter is provided sterile and is intended for single use only.
The provided text describes a 510(k) premarket notification for a medical device, the Cordis AVIATOR Peripheral Dilatation Catheter. This document primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices through non-clinical performance data. It does not contain information about clinical studies with "acceptance criteria" in the typical sense of measuring a device's effectiveness through patient outcomes or comparative clinical performance against a benchmark.
Here's a breakdown based on your request, highlighting the information that is present and absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What the device was tested for) | Reported Device Performance (Implied by substantial equivalence) |
|---|---|
| Biocompatibility | Demonstrated to be substantially equivalent to predicate devices. |
| Balloon minimum burst strength | Met specifications equivalent to predicate devices. |
| Balloon compliance (distensibility) | Met specifications equivalent to predicate devices. |
| Balloon inflation/deflation performance | Met specifications equivalent to predicate devices. |
| Balloon fatigue (repeated balloon inflation) endurance | Met specifications equivalent to predicate devices. |
| Bond strengths | Met specifications equivalent to predicate devices. |
| Catheter diameter and balloon profile | Matched specifications of predicate devices. |
| Catheter body minimum burst strength | Met specifications equivalent to predicate devices. |
| General | Safety and effectiveness demonstrated via non-clinical tests and analyses, as determined necessary per applicable risk analyses. |
Important Note: The document explicitly states, "The safety and effectiveness of the Cordis AVIATOR Peripheral Dilatation Catheter have been demonstrated via data collected from non-clinical tests and analyses..." It does not provide specific numerical acceptance criteria or detailed numerical performance results for these tests, but rather asserts that the device met the necessary standards to be "substantially equivalent" to its predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text refers to "non-clinical tests and analyses" but does not detail sample sizes, data provenance (e.g., country of origin), or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and therefore not provided. The assessment was based on non-clinical engineering and material performance tests, not clinical evaluations requiring expert consensus on ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. As the testing was non-clinical, there wouldn't be an adjudication method for interpreting clinical test results.
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
An MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter), not an AI diagnostic tool, so this type of study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical catheter, not an algorithm, so "standalone" performance in the context of an algorithm is not relevant. The device itself is designed to be used by a human operator (physician).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be established by engineering standards and specifications for medical devices (e.g., ASTM standards, internal company specifications for burst strength, compliance, etc.). There is no mention of expert consensus, pathology, or outcomes data, as these are typically associated with clinical studies.
8. The sample size for the training set
This information is not provided and not applicable in the context of this device. A "training set" typically refers to data used to train an AI algorithm, which is not what this device is. For non-clinical device testing, there might be "test sets" for various engineering experiments, but they are not referred to as training sets.
9. How the ground truth for the training set was established
This information is not provided and not applicable, as there is no "training set" for this physical 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).