(347 days)
The Filao NC RX PTCA Dilatation Catheters are indicated for:
Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.
Balloon dilatation of a stent after implantation (balloon models 2.00mm - 4.50mm)
The Filao NC RX PTCA Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a non-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing the tight stenosis. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating improves pushability of the catheter.
The Filao NC PTCA RX Catheter is available in balloon diameters ranging from 2.00 mm to 4.50 mm, and balloon lengths ranging from 8mm to 30 mm in step of 1 mm. The maximum recommended guide wire diameter is 0.014"
This document is a 510(k) summary for the Filao NC RX PTCA Dilatation Catheter (K141933). It describes the device, its intended use, and a comparison to predicate devices, along with performance data.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria with corresponding performance results. Instead, it lists various non-clinical tests conducted, implying that the device met internal acceptance criteria for each test to demonstrate substantial equivalence. The performance data is summarized in a qualitative manner.
| Test Category | Reported Device Performance |
|---|---|
| Material & Design | |
| Catheter dimensions and balloon profile | "Substantial Equivalence has been demonstrated based on the results of non-clinical testing on the Filao NC RX PTCA Dilatation Catheter which addressed the following considerations:" (implied satisfactory performance, but no specific values given). |
| Balloon preparation, deployment and retraction | "Substantial Equivalence has been demonstrated based on the results of non-clinical testing on the Filao NC RX PTCA Dilatation Catheter which addressed the following considerations:" (implied satisfactory performance, but no specific values given). |
| Balloon rated burst pressure (within a stent) | "Substantial Equivalence has been demonstrated based on the results of non-clinical testing on the Filao NC RX PTCA Dilatation Catheter which addressed the following considerations:" (implied satisfactory performance, but no specific values given). |
| Balloon compliance | "Substantial Equivalence has been demonstrated based on the results of non-clinical testing on the Filao NC RX PTCA Dilatation Catheter which addressed the following considerations:" (implied satisfactory performance, but no specific values given). |
| Balloon fatigue (within a stent) | "Substantial Equivalence has been demonstrated based on the results of non-clinical testing on the Filao NC RX PTCA Dilatation Catheter which addressed the following considerations:" (implied satisfactory performance, but no specific values given). |
| Balloon inflation and deflation time | "Substantial Equivalence has been demonstrated based on the results of non-clinical testing on the Filao NC RX PTCA Dilatation Catheter which addressed the following considerations:" (implied satisfactory performance, but no specific values given). |
| Bond strengths | "Substantial Equivalence has been demonstrated based on the results of non-clinical testing on the Filao NC RX PTCA Dilatation Catheter which addressed the following considerations:" (implied satisfactory performance, but no specific values given). |
| Tip pull test | "Substantial Equivalence has been demonstrated based on the results of non-clinical testing on the Filao NC RX PTCA Dilatation Catheter which addressed the following considerations:" (implied satisfactory performance, but no specific values given). |
| Flexibility and kink test | "Substantial Equivalence has been demonstrated based on the results of non-clinical testing on the Filao NC RX PTCA Dilatation Catheter which addressed the following considerations:" (implied satisfactory performance, but no specific values given). |
| Torque strength test | "Substantial Equivalence has been demonstrated based on the results of non-clinical testing on the Filao NC RX PTCA Dilatation Catheter which addressed the following considerations:" (implied satisfactory performance, but no specific values given). |
| Coating integrity test | "Substantial Equivalence has been demonstrated based on the results of non-clinical testing on the Filao NC RX PTCA Dilatation Catheter which addressed the following considerations:" (implied satisfactory performance, but no specific values given). |
| Particulate Evaluation test | "Substantial Equivalence has been demonstrated based on the results of non-clinical testing on the Filao NC RX PTCA Dilatation Catheter which addressed the following considerations:" (implied satisfactory performance, but no specific values given). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "non-clinical testing" but does not specify the sample sizes for these tests. It also does not provide information on the country of origin of the data or whether the tests were retrospective or prospective. Given it's non-clinical testing, it would typically be laboratory-based rather than patient data.
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 study detailed is non-clinical performance testing of a medical device (dilatation catheter), not a diagnostic study requiring expert ground truth for interpretation of medical images or patient conditions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. The study involves non-clinical performance testing of a physical device, not a diagnostic study with human observers requiring adjudication.
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, an MRMC comparative effectiveness study was not done. This document is for a physical medical device (catheter), not an AI/software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable here. The device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical medical device like a PTCA catheter, "ground truth" for performance testing typically refers to:
- Engineering standards and specifications: The device's performance is compared against pre-defined engineering requirements and industry standards (e.g., ISO standards for medical devices).
- Reference measurements: Using calibrated equipment to measure physical properties like dimensions, burst pressure, inflation/deflation times, bond strengths, etc., and comparing these measurements to the specified design parameters.
- Predicate device comparison: Performance data is also often compared to that of a legally marketed predicate device to demonstrate substantial equivalence.
The document implicitly states that the non-clinical testing addressed various considerations to demonstrate substantial equivalence, meaning the device met its design specifications and performed comparably to predicate devices.
8. The sample size for the training set
This information is not applicable and therefore not provided. This is not an AI/machine learning study, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided. This is not an AI/machine learning study.
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.