(40 days)
The Fortrex 0.035" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
The Fortrex™ 0.035" PTA Balloon Catheter (Fortrex 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. The manifold includes a lumen marked "THRU". This 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 diameter of 0.035". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the balloon with a mixture of contrast medium and saline solution. The balloon has two radiopague markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon.
The Fortrex Catheter is available with balloon diameters 4.0 mm to 12.00 mm, balloon lengths 20 mm, 40 mm, 80 mm, and 100 mm and with shaft lengths of 40 cm, 80 cm, and 135 cm.
This document is a 510(k) summary for the Fortrex™ 0.035" OTW PTA Balloon Catheter, which is a medical device intended to dilate stenoses in various arteries and for stent post-dilatation in the peripheral vasculature. The summary outlines the device's characteristics, its similarities to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.
Here's an analysis of the provided text in response to your questions:
1. A table of acceptance criteria and the reported device performance
The document states: "The Fortrex catheter met all acceptance criteria for the performance testing. The results from these tests demonstrate that the technological characteristics and performance criteria of the Fortrex Catheter are comparable to the predicate EverCross Catheter and that the Fortrex Catheter performs in a manner equivalent to the predicate EverCross device currently on the market."
However, specific quantitative acceptance criteria values are not provided, nor are the numerical results for each test. The table below lists the performance tests conducted, but without the specific criteria or reported performance data.
| Performance Test | Acceptance Criteria (Not specified) | Reported Device Performance (Not specified quantitatively) |
|---|---|---|
| Balloon Dimensional Verification | Met acceptance criteria | Met all acceptance criteria |
| Balloon Rated Burst Pressure | Met acceptance criteria | Met all acceptance criteria |
| Minimum Balloon Burst Strength | Met acceptance criteria | Met all acceptance criteria |
| Balloon Fatigue | Met acceptance criteria | Met all acceptance criteria |
| Balloon Compliance | Met acceptance criteria | Met all acceptance criteria |
| Catheter Dimensional Verification | Met acceptance criteria | Met all acceptance criteria |
| Inflation / Deflation Time | Met acceptance criteria | Met all acceptance criteria |
| Wire Movement | Met acceptance criteria | Met all acceptance criteria |
| Radiopacity | Met acceptance criteria | Met all acceptance criteria |
| Device Tracking | Met acceptance criteria | Met all acceptance criteria |
| Insertion Force | Met acceptance criteria | Met all acceptance criteria |
| Balloon Pull-back Force | Met acceptance criteria | Met all acceptance criteria |
| Reinsertion Force | Met acceptance criteria | Met all acceptance criteria |
| Torque Strength | Met acceptance criteria | Met all acceptance criteria |
| Tensile Strength | Met acceptance criteria | Met all acceptance criteria |
| Kink | Met acceptance criteria | Met all acceptance criteria |
| Marker Band to Balloon Body | Met acceptance criteria | Met all acceptance criteria |
| Biocompatibility (ISO 10993-1) | Met acceptance criteria | Met all acceptance criteria |
| - Cytotoxicity | Met acceptance criteria | Met all acceptance criteria |
| - Sensitization | Met acceptance criteria | Met all acceptance criteria |
| - Intracutaneous reactivity | Met acceptance criteria | Met all acceptance criteria |
| - Acute systemic toxicity | Met acceptance criteria | Met all acceptance criteria |
| - Hemolysis | Met acceptance criteria | Met all acceptance criteria |
| - Pyrogen | Met acceptance criteria | Met all acceptance criteria |
| - Complement activation | Met acceptance criteria | Met all acceptance criteria |
| - Thromboresistance | Met acceptance criteria | Met all acceptance criteria |
| - Partial thromboplastin time | Met acceptance criteria | Met all acceptance criteria |
| - Platelet/leukocyte counts | Met acceptance criteria | Met all acceptance criteria |
| - Mutagenicity | Met acceptance criteria | Met all acceptance criteria |
| - Lymphoma | Met acceptance criteria | Met all acceptance criteria |
| - Micronucleus assay | Met acceptance criteria | Met all acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists performance tests but does not specify the sample sizes used for each test. It also does not provide information on the data provenance in terms of country of origin or whether the study was retrospective or prospective. The study appears to be an internal bench testing and biocompatibility testing conducted by the manufacturer, Covidien llc.
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 document describes performance testing of a medical device (PTA balloon catheter), not a diagnostic algorithm that requires expert-established ground truth from medical images or clinical data. Therefore, this question is not applicable to the type of study presented here. The "ground truth" for these tests would be established by validated test methods and reference standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is bench and biocompatibility testing of a physical device, not an assessment requiring human adjudication of 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
Not applicable. This document pertains to the 510(k) clearance of a physical medical device (balloon 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
Not applicable. This document is about a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests:
- Bench Testing: The "ground truth" is established by the specifications and validated test methods for a medical device (e.g., burst pressure measured by a pressure gauge, dimensions measured by calibrated instruments).
- Biocompatibility Testing: The "ground truth" is established by the accepted standards and protocols defined in ISO 10993-1, using biological assays and analytical methods.
8. The sample size for the training set
Not applicable. 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
Not applicable. There is no training set for this type of device study.
§ 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).