(76 days)
The EverCross 0.035" OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
The EverCross Peripheral Dilatation Catheter is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip to aid in crossing tight stenoses. The distal catheter, proximal to the balloon, is covered with a hydrophilic coating. The catheter manifold includes two lumens. The lumen marked "THRU" is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.035 inches. The lumen, marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis.
The provided document is a 510(k) Summary for the EverCross™ .035" OTW PTA Dilatation Catheter. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on bench testing and biocompatibility testing. The document does not contain information about a study proving the device meets specific acceptance criteria in the context of device performance as one might expect for an AI/ML or diagnostic device.
This is a medical device submission for a physical dilatation catheter, not a software device or diagnostic tool. The "acceptance criteria" here refer to the performance standards met through bench testing and biocompatibility. There is no mention of a clinical study with human subjects, ground truth, or expert review in the way would be described for an AI/ML or diagnostic device.
Therefore, many of the requested fields cannot be filled.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
It does not provide specific quantitative acceptance criteria (e.g., burst pressure tolerance, flexural strength, etc.) nor specific quantitative results. It broadly refers to "conformance to the requirements for its intended use."
Therefore, a table of specific acceptance criteria and reported performance cannot be generated from the given text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The "test set" for this type of medical device refers to the physical units tested in bench and biocompatibility assays. No information is provided about the sample sizes for these tests, nor their provenance.
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)
Not applicable. The concept of "experts establishing ground truth" as it applies to diagnostic or AI/ML devices is not relevant for this physical medical device. Performance is assessed through engineering and biological testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is typically related to expert review of data for diagnostic or AI/ML devices.
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. This is a physical medical device (dilatation catheter), not an AI/ML or diagnostic device. An MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a physical medical device like this, performance is validated through bench testing (e.g., mechanical properties, fluid dynamics) and biocompatibility testing (e.g., cytotoxicity, irritation). The "ground truth" would be established by engineering specifications and industry standards for material and device performance.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this physical medical device submission.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this physical medical 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).