(190 days)
The UltraScore Focused Force PTA Balloon 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 recommended for post dilatation of balloon expanding stents, and stent grafts in the peripheral vasculature.
The ULTRASCORE ™ Focused Force PTA Balloon consists of a flexible, over-the-wire (OTW) catheter shaft with a semi-compliant balloon fixed at the distal end. For all balloon lengths, radiopaque markers delineate the working length of the balloon and aid in balloon placement. For balloon lengths of 100 mm and greater, two radiopaque markers are positioned on the distal portion of the balloon and one radiopaque marker is positioned on the proximal portion of the balloon to differentiate between the distal and proximal ends of the balloon. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. Two scoring wires, oriented 180° apart, provide focused force upon dilatation. The ULTRASCORE ™ Focused Force PTA Balloon is compatible with .014" or .035" quidewires, as denoted by the product labeling. The distal portion of the .014" guidewire compatible catheters is hydrophilically coated. The proximal portion of the catheter includes a female luer lock hub connected to the catheter with a guidewire lumen and an inflation lumen. Packaged with every product is a protective sheath that is positioned over the balloon and must be removed prior to use. A stylet is placed into the tip of the catheter. These products are not made with natural rubber latex.
The provided document describes the Bard Peripheral Vascular, Inc.'s UltraScore Focused Force PTA Balloon and its substantial equivalence to a predicate device, the VASCUTRAK® PTA Dilatation Catheter (K103459). The document focuses on demonstrating that the new device meets performance criteria similar to the predicate device and does not raise new safety or effectiveness issues.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists numerous in vitro tests performed to demonstrate substantial equivalence, implying that acceptance criteria were met for each. However, specific numerical acceptance criteria or detailed performance results (e.g., a specific pressure rating, a defined trackability score) are not provided in this summary. The summary states, "The subject device, the ULTRASCORE™ Focused Force PTA Balloon, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Dimensional Characteristics | Met specifications for Balloon Outer Diameter, Balloon Working Length, Catheter Shaft Length. |
| Balloon Performance | Met specifications for Balloon Compliance, Inflation Time, Deflation Time, Rated Burst Pressure, Balloon Burst Mode, Balloon Fatigue (with and without stent/stent graft), Balloon Removal from Stent/Stent Graft. |
| Marker Performance | Met specifications for GEOALIGN® Gradient Marking Position, Legibility, Durability, Marker Band Radiopacity, Marker Band Alignment. |
| Catheter Functionality | Met specifications for Trackability, Sheath Compatibility, Guidewire Compatibility, Flushability, Reinsertion, Tip Taper, Device Compatibility. |
| Material/Assembly Integrity | Met specifications for Hub Stress, Hub Torque, Balloon to Shaft Tensile, Tip to Wire Tensile, Catheter Elongation, Proximal Assembly Tensile. |
| Biocompatibility | Met specifications for Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility, Material Mediated Pyrogenicity (in accordance with ISO 10993-1: 2009). |
| Packaging Integrity | Met specifications for Packaging Pouch Tensile, Packaging Visual Inspection, Packaging Bubble Emission. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "in vitro tests" performed. There is no information provided about the sample sizes for these tests, the country of origin of the data, or whether it was retrospective or prospective. Given they are in vitro tests, the concept of "prospective" or "retrospective" data provenance typically applies more to human clinical studies rather than bench testing.
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)
The document describes in vitro (bench) testing. Therefore, the concept of "ground truth established by experts" in the clinical sense (e.g., radiologists, pathologists) is not applicable to the data presented. Ground truth for these tests would be derived from engineering specifications and standardized measurement techniques.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since the tests are in vitro bench tests, clinical adjudication methods like "2+1" or "3+1" are not applicable. The "adjudication" would be based on comparison against predefined engineering acceptance criteria by qualified technicians or engineers performing the tests. No specific adjudication method for discrepancies in measurement is described.
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, nor any discussion of human readers or AI assistance. This document describes the a medical device (a PTA balloon catheter), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the document describes a physical medical device (a balloon catheter), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in vitro tests conducted, the "ground truth" would be established by engineering specifications, standardized test methods, and measurement accuracy. For biocompatibility, it would be established by reference to international standards like ISO 10993-1:2009. The document does not refer to expert consensus, pathology, or outcomes data for establishing ground truth for these tests.
8. The sample size for the training set
This question is not applicable as the document describes a physical medical device and its predicate equivalence through bench testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set mentioned or relevant to the device described.
§ 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).