(34 days)
Ultraverse® RX PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the renal, femoral, popliteal, infrapopliteal, tibial, and peroneal arteries. This catheter is not for use in coronary arteries.
The Ultraverse® RX PTA Dilatation Catheter is a small vessel balloon catheter consisting of a rapid exchange catheter and a balloon fixed at the distal tip. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The device will come in 80, 150. and 200 cm catheter shaft lengths. On the 150 and 200 cm catheter shaft lengths, two non-radiopaque markers are located 90 cm and 100 cm from the balloon catheter tip to help confirm when the balloon catheter tip exits the introducer sheaths or guide catheters. The catheter includes a radiopaque atraumatic tip and the Ultra-Cross™ Dual Layer Hydrophilic Coating (as used on Ultraverse 014/018) on the distal segment of the catheter shaft and balloon to facilitate advancement of the catheter to and through the stenosis. Ultraverse® RX Catheters are compatible with .014" guidewires. The proximal portion of the catheter includes a female luer lock hub connected to the catheter. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. A flushing needle is provided for catheter prep. These products are not made with any natural rubber latex.
Here's a breakdown of the acceptance criteria and study information for the Ultraverse® RX PTA Dilatation Catheter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary lists numerous performance tests but does not explicitly present a table of "acceptance criteria" alongside specific quantitative performance results for each criterion. Instead, it generally states that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Ultraverse® RX PTA Dilatation Catheter is comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market with the same intended use."
However, we can infer some of the performance criteria from the list of in vitro tests performed:
| Acceptance Criterion (Inferred from Test Name) | Reported Device Performance |
|---|---|
| Dimensional Verification (Outer Diameter, Lengths) | Comparable to predicate devices |
| Flushability | Comparable to predicate devices |
| Tip Taper | Comparable to predicate devices |
| Hub Torque | Comparable to predicate devices |
| Hub Stress | Comparable to predicate devices |
| Sheath Compatibility | Comparable to predicate devices |
| Reinsertion/Stylet/Refold | Comparable to predicate devices |
| Rated Burst Pressure | Comparable to predicate devices |
| Balloon Burst Mode | Comparable to predicate devices |
| Catheter Shaft Leaks | Comparable to predicate devices |
| Fatigue | Comparable to predicate devices |
| Balloon Distensibility | Comparable to predicate devices |
| Inflation Time | Comparable to predicate devices |
| Deflation Time | Comparable to predicate devices |
| Balloon to Shaft Tensile | Comparable to predicate devices |
| RX Junction Tensile | Comparable to predicate devices |
| Hub to Hypotube Tensile | Comparable to predicate devices |
| Trackability (Flexibility and Kink) | Comparable to predicate devices |
| Tip Radiopacity | Comparable to predicate devices |
| Marker Band Alignment | Comparable to predicate devices |
| Flushing Needle Stress | Comparable to predicate devices |
| Flushing Needle Torque | Comparable to predicate devices |
| Packaging Visual Inspection | Comparable to predicate devices |
| Dye Penetration | Comparable to predicate devices |
| Biocompatibility (ISO 10993-1:2010 based) | |
| - Cytotoxicity | Biocompatible for intended use |
| - Irritation/Intracutaneous Reactivity | Biocompatible for intended use |
| - Sensitization | Biocompatible for intended use |
| - Acute Systemic Toxicity | Biocompatible for intended use |
| - Material Mediated Pyrogenicity | Biocompatible for intended use |
| - Hemocompatibility (Hemolysis & Thrombogenicity) | Biocompatible for intended use |
The study proving these criteria are met consists of the execution of the listed "Performance Data" (in vitro tests) and "Biocompatibility" tests. The 510(k) summary explicitly states: "The subject device, the Ultraverse® RX PTA Dilatation Catheter, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each individual in vitro test or biocompatibility test. It only lists the types of tests performed.
- Data Provenance: The studies are described as "in vitro tests" and "biocompatibility testing." This indicates the data is derived from laboratory testing of the device itself, rather than human clinical data. Therefore, there is no country of origin for human data or retrospective/prospective classification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a physical medical device (catheter) and the tests described are primarily engineering performance and material biocompatibility tests. There is no 'ground truth' in the context of expert visual interpretation or diagnosis required for these types of tests. The "ground truth" for these tests would be the established scientific and engineering principles, and the protocols defined in standards like ISO 10993-1.
4. Adjudication Method for the Test Set
This information is not applicable, as the tests are objective physical and chemical assessments rather than subjective assessments 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
This information is not applicable. This 510(k) submission is for a physical medical device (dilatation catheter), not an AI/imaging device, so no MRMC study or AI-assisted interpretation is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This information is not applicable, as this is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for the performance and biocompatibility studies conducted is based on:
- Established scientific and engineering principles: Used to define the expected performance metrics (e.g., burst pressure, tensile strength).
- FDA Guidance Documents on non-clinical testing of medical devices: These documents provide a framework for the types of tests and expected methodologies.
- Internal Risk Assessment procedures: Used to identify critical performance parameters.
- International Standards: Specifically, ISO 10993-1:2010 for biocompatibility, and likely other relevant ISO or ASTM standards for the mechanical and physical tests, although not explicitly named.
- Test protocols and/or customer inputs: Defining the specific methods and acceptance limits for each test.
8. The Sample Size for the Training Set
This information is not applicable. There is no 'training set' as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no 'training set'.
§ 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).