(57 days)
The UHP Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Surmodics™ Arise™ UHP Dilatation Catheter is a coaxial Over the Wire (OTW) 0.035' PTA Balloon Dilatation Catheter with a distal inflatable balloon intended to be used for the treatment of peripheral arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The UHP Dilatation Catheter obtains a low compliance at high pressure over a large working range. The proximal portion of the catheter has a bifurcated manifold which includes a balloon lumen marked "BAL" and a guidewire lumen. Two radiopaque marker bands indicate the dilatating section of the balloon and aid in the balloon placement. The catheter is designed so that a specific balloon diameter can be reached depending on the balloon size and defined pressure.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the Arise™ UHP Dilatation Catheter. This document details the regulatory approval process for a new medical device and focuses on establishing "substantial equivalence" to a predicate device, rather than proving a device's performance against specific clinical acceptance criteria in the manner one might see for an AI/ML diagnostic or prognostic device.
Therefore, many of the requested criteria, such as those related to AI model performance, expert ground truth establishment, MRMC studies, and training/test set details, are not applicable to this type of device and submission.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document states that "All test results met documented acceptance criteria and/or included justification of values." However, it does not provide a table with specific quantitative acceptance criteria or the reported performance values for each test. Instead, it lists the types of tests performed:
| Category | Tests Performed | Acceptance Criteria / Performance |
|---|---|---|
| Performance Bench Testing | - Rated Burst Pressure (RBP) |
- Balloon Diameter at Nominal Pressure
- Inflation & Deflation Time
- Balloon Length & Marker Band Position
- Radiopacity
- Ancillary Tool Compatibility (Guidewire)
- Catheter Effective Length
- Tip Profile (Geometry of the catheter most distal tip)
- Simulated Use
- Crossing Profile
- Multiple Inflation/Fatigue & Leak Test
- Tensile Strength (strength of the catheter shafts, bonds, and tip)
- Flexibility & Kink | "All test results met documented acceptance criteria and/or included justification of values." (Specific values not provided in this document). Testing demonstrated that "technological differences identified do not raise new questions of safety or effectiveness." |
| Biocompatibility | - Cytotoxicity - Irritation / Intracutaneous Reactivity
- Sensitization
- Acute Systemic Toxicity
- Pyrogenicity
- Hemocompatibility (Hemolysis ASTM Method (Direct and Indirect), C3a Complement Activation Assay, O SC5b Complement Activation Assay, In Vivo Thrombogenicity)
- Genotoxicity
- Bacterial Reverse Mutation
- Chemical Characterization | "All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness." (Specific values not provided). Biocompatibility evaluated per ISO 10993-1 and FDA Guidance. |
| Sterilization | Product testing for Ethylene Oxide (EtO) sterilization | "Sterilization method... meets the requirements of ISO 11135, and that the sterility of the device will be maintained over the entirety of shelf life." |
2. Sample sizes used for the test set and the data provenance
For the bench testing, the specific sample sizes for each test are not detailed in this summary. The data provenance is laboratory-based testing on the device components and the assembled device itself (e.g., testing the mechanical properties of the catheter, balloon, etc.). There is no patient data or clinical data utilized for testing in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device relying on expert-labeled ground truth from medical images or clinical data. The "ground truth" for this device's performance is established through engineering specifications, material science, and established test methodologies (e.g., ISO standards, ASTM methods).
4. Adjudication method for the test set
Not applicable. There is no human interpretation or adjudication involved in the bench testing 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
Not applicable. This is not an AI-assisted diagnostic or imaging device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm; it is a physical medical device (catheter). Standalone performance refers to the device's mechanical, material, and functional properties as tested in the lab.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's safety and effectiveness is primarily based on:
- Engineering specifications and design requirements: Whether the device meets its intended physical and mechanical properties.
- Established international standards (ISO, ASTM): Compliance with recognized standards for medical device performance, biocompatibility, and sterilization.
- Comparison to a predicate device: Establishing substantial equivalence by demonstrating similar performance characteristics to a legally marketed device.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of an AI/ML model for this type of device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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).