Search Results

SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, poplited, infra poplited and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and selfexpanding stents in the peripheral vasculature.

The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon, which is the same device as its predicate, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333), with an additional indication. The device has identical technological characteristics as the predicate, SABER™ .035 PTA Dilatation Catheter (K201333). SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate crossing of tight stenoses. SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is compatible with standard .035" guide wires and 5Fr, 6Fr and 7Fr catheter sheath introducers (CSI).

The SABER™ .035" PTA Dilatation Catheter has identical device/component constructions as the predicate, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333). Same as the predicate, the balloon of the SABER™ .035 PTA Dilatation Catheter has radiopaque markers at the distal and proximal ends of the balloon working length to aid in balloon placement when under fluoroscopy. The SABER™ .035 PTA Dilatation Catheter has a proximal hub assembly that contains a luer locking connector with a balloon inflation port and a quide wire port. The balloon is inflated by injecting diluted contrast medium through the inflation port of the hub and the inflation lumen connected to the balloon.

The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended for single use only and is provided sterile.

This document describes the submission of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K210626) to the FDA for a 510(k) premarket notification. The submission aims to demonstrate substantial equivalence to its predicate device (K201333) with an additional indication for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Here's an analysis based on the provided text, addressing your specific points:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of explicit acceptance criteria with numerical targets. Instead, it states that "Design Verification and Validation (DV&V) testing was performed to verify that the proposed SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter meets the pre-determined safety and performance requirements." It also mentions that testing "completed with favorable test results, meeting the applicable ISO standards and FDA's recognized consensus standards pertaining to evaluations of PTA Catheters."

The reported device performance is that all listed tests had "favorable test results" and demonstrated "conformance to the FDA's recognized standards."

Here's a summary of the performance testing categories:

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 does not explicitly state the numerical sample size for individual tests within the "Design Verification Performance Testing" or the "Biocompatibility Assessment." It mentions "samples" for accelerated aging and packaging validation.

For Biocompatibility Assessment, it states the testing "has been conducted at a US testing laboratory."
For Sterilization Adoption Validation and Microbiology Validation, the document points to external reports ("eCopy 002") and mentions "Confluent Medical Technologies" as the physical manufacturer and "Synergy Health" (for sterilization cycle 2.0) and "Steris AST" for sterilization.

This suggests the data provenance is primarily from US testing laboratories and manufacturing/sterilization facilities. The nature of these tests (e.g., material testing, mechanical testing) implies they are prospective tests performed on newly manufactured devices.

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 provided in the document. The tests performed are primarily engineering, chemical, and biological evaluations, not clinical studies requiring expert interpretation of patient data to establish 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. The tests described are objective measurements (e.g., burst pressure, material compatibility, sterility) and do not involve subjective interpretation or a need for adjudication among multiple experts to establish a "ground truth."

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the document. This type of study is typically conducted for diagnostic devices (especially imaging-based AI) where human interpretation is involved. The SABER™ .035 PTA Dilatation Catheter is an interventional medical device, and its safety and efficacy are evaluated through performance testing, biocompatibility, and substantial equivalence to a predicate device, not through human reader performance with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is a physical medical device (dilatation catheter), not an AI algorithm or software. Therefore, there is no "standalone" algorithm performance to assess.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., expert consensus for image interpretation, pathology for disease diagnosis) is not directly applicable to the type of device and testing described. For this device, the "ground truth" for performance is established by objective measurements against pre-defined engineering specifications, international standards (e.g., ISO), and FDA recognized consensus standards.

For example:

• Biocompatibility: Conformance to ISO 10993-1 standards (e.g., passing cytotoxicity, sensitization tests).
• Mechanical Properties: Achieving specific values for burst pressure, tensile strength, inflation/deflation times, kink diameter, etc., as defined by design specifications and relevant standards for PTA catheters.
• Sterilization: Demonstrated sterility assurance level (SAL) according to established sterilization validation protocols.

8. The sample size for the training set

This information is not applicable as the device is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

Ask a specific question about this device