(43 days)
The Sleek® OTW PTA Catheters are intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
The subject device, the Sleek® OTW PTA Catheter LE, is a balloon dilation catheter for angioplasty. A double lumen coaxial shaft features an inflatable balloon at its distal end. The proximal end provides a double hub connector, whose first port allows the attachment of an inflation device which is used to inflate and deflate the balloon through the outer lumen. A second hub port allows the advance of a guidewire throughout the whole length of the catheter using the distally open inner lumen. The outer shaft lumen and the balloon are made of Polyamide, enclosing the inner High Density Polyethylene (HDPE) / Plexar / PolyEther Block Amide shaft. A Polycarbonate hub is connected to the outer and inner shaft proximally together with a PolyEther Block Amide strain relief tube.
Acceptance Criteria and Study for Sleek® OTW PTA Catheters (K130786)
This submission describes the Sleek® OTW PTA Catheter LE, which is a balloon dilation catheter for angioplasty, substantially equivalent to the predicate device, the Sleek® OTW PTA Catheter (K102035).
A. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes that the device met all predetermined acceptance criteria but does not explicitly list the specific quantitative acceptance criteria for each test. Instead, it states that the results demonstrated comparability to the predicate device. Therefore, the "Reported Device Performance" column reflects this general statement of comparability.
| Acceptance Criteria (Not explicitly stated, inferred as "comparable to predicate") | Reported Device Performance |
|---|---|
| Balloon Working Length (comparable to predicate) | Comparable to predicate |
| Marker Band Alignment (comparable to predicate) | Comparable to predicate |
| Burst Strength (Rated Burst Pressure) (comparable to predicate) | Comparable to predicate |
| Burst Mode (comparable to predicate) | Comparable to predicate |
| Proximal Tensile (comparable to predicate) | Comparable to predicate |
| Sheath Compatibility (comparable to predicate) | Comparable to predicate |
| Reinsertion (comparable to predicate) | Comparable to predicate |
| Inflation Time (comparable to predicate) | Comparable to predicate |
| Deflation Time (comparable to predicate) | Comparable to predicate |
| Fatigue (comparable to predicate) | Comparable to predicate |
| Balloon Outer Diameter (comparable to predicate) | Comparable to predicate |
| Compliance (comparable to predicate) | Comparable to predicate |
B. Sample sizes used for the test set and data provenance:
The document states that the evaluation involved "additional in vitro tests" using FDA Guidance Documents and internal Risk Assessment procedures. However, the specific sample sizes used for each of the listed in vitro tests are not provided in the summary. The data provenance is also not explicitly stated in terms of country of origin or retrospective/prospective, but given they are "in vitro tests," they were likely conducted in a laboratory setting.
C. Number of experts used to establish the ground truth for the test set and their qualifications:
This information is not applicable as the evaluation involved in vitro non-clinical testing of device characteristics, not human clinical data requiring expert review for ground truth establishment.
D. Adjudication method for the test set:
This information is not applicable as the evaluation involved in vitro non-clinical testing of device characteristics, not human clinical data requiring adjudication.
E. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not performed. This submission pertains to the substantial equivalence of a medical device based on non-clinical performance data, not a study evaluating human reader performance.
F. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical medical device (catheter), not an algorithm or AI system.
G. The type of ground truth used:
The ground truth for the in vitro performance tests would be the physical and mechanical properties of the device as measured against established engineering specifications and design requirements, and critically, comparability to the predicate device's performance characteristics. This implicitly relies on the predicate device meeting acceptable standards.
H. The sample size for the training set:
This information is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning or AI.
I. How the ground truth for the training set was established:
This information is not applicable for the same reason as in H.
§ 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).