Search Results
Found 1 results
510(k) Data Aggregation
(442 days)
ProTrack Pigtail Wire
The ProTrack™ Pigtail Wires are intended for use to introduce and position catheters and other interventional devices within the chambers of the heart, including those used within transcatheter aortic valve procedures (TAVR).
The ProTrack™ Pigtail Wire is a single used for the patients requiring diagnostic and interventional procedures like transcatheter aortic valve replacement (TAVR). It is used to facilitate the introduction and placement of devices in catheterization procedures primarily by Electrophysiologists and Interventional Cardiologists. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy and echocardiography under sterile technique.
The device consists of a stainless-steel core wire with a flexible, spiral shaped stainless steel distal coil. A green PTFE coating is present on the entire length of the device and provides a lubricious surface for smooth tracking through accessory devices and vasculature. The Wire has a radiopaque coil (304V Stainless Steel) around the distal curve to allow visualization under appropriate imaging guidance during procedures. The device is offered in multiple models with two different lengths (230 cm and 275 cm), diameters (0.032″ and 0.035″), and distal curve shapes (regular and small). The device is provided sterilized).
The wire is classified as an external communicating device, contacting circulating blood, with limited exposure and contact up to a maximum of 24 hours. The patient contacting materials are PTFE coating, stainless steel and adhesive.
The provided FDA 510(k) summary (K213898) for the ProTrack™ Pigtail Wire does not contain information about the acceptance criteria or results from a study that typically applies to AI/ML software as a medical device (SaMD). This document is for a physical medical device (guidewire), and the performance testing described focuses on mechanical, physical, biocompatibility, sterilization, pyrogen, and packaging verification, as well as bench-top validation for user needs.
Therefore, the requested information about acceptance criteria for AI/ML performance, sample sizes for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone algorithm performance, ground truth types, and training set details are not applicable to the content of this document.
The document describes the following types of performance testing and their general outcomes:
1. Table of Acceptance Criteria and Reported Device Performance (as interpreted for a physical device):
| Acceptance Criteria Category | Specific Tests Performed by Baylis Medical Company Inc. | Reported Device Performance |
|---|---|---|
| Mechanical Performance | - Corrosion Resistance (per 11070:2014/Amd:2018) | All test requirements met |
| - Flex Test (per 11070:2014/Amd:2018) | All test requirements met | |
| - Fracture test (per 11070:2014/Amd:2018) | All test requirements met | |
| - Peak tensile force (per 11070:2014/Amd:2018) | All test requirements met | |
| - Tensile strength (per 11070:2014/Amd:2018) | All test requirements met | |
| - Tip Pull (per 11070:2014/Amd:2018) | All test requirements met | |
| - Dimensional verification (per FDA guidance) | All test requirements met | |
| - Visual inspection (per FDA guidance) | All test requirements met | |
| - Repeated Simulated Use (per FDA guidance) | All test requirements met | |
| - Torque Strength (per FDA guidance) | All test requirements met | |
| - Coating integrity (per FDA guidance) | All test requirements met | |
| - Particulate testing (per FDA guidance) | All test requirements met | |
| - Lubricity/Friction testing (per FDA guidance) | All test requirements met | |
| - Kink resistance (per FDA guidance) | All test requirements met | |
| - Tip flexibility (per FDA guidance) | All test requirements met | |
| - Radiopacity (per FDA guidance) | All test requirements met | |
| General Physical Performance | - Curve Retention (per self-enforced requirements) | All test requirements met |
| - Flexural rigidity (per self-enforced requirements) | All test requirements met | |
| Biocompatibility | - ISO Cytotoxicity study | All test requirements met |
| - ISO Maximization Sensitization Study | All test requirements met | |
| - ISO Intracutaneous Reactivity Study | All test requirements met | |
| - ISO/USP Material Mediated Pyrogenicity | All test requirements met | |
| - ISO Hemocompatibility Study | All test requirements met | |
| - ISO Acute Systemic Toxicity Study | All test requirements met | |
| Sterilization | - EO Sterilization to SAL 10-6 (per ISO 11134-1:2014) | All test requirements met |
| - Residual limits (per ISO 10993-7:2008) | All test requirements met | |
| Pyrogenicity | - LAL testing (Kinetic Chromogenic method) (per ANSI/AAMI ST72:2019 and FDA guidance) | Meets current FDA and USP pyrogen limit specifications |
| Packaging | - Ship testing | Integrity verified |
| - Seal strength | Compliance with ISO 11607-1:2020 and ISO 11607-2:2017 verified | |
| - Sterile barrier integrity | Compliance with ISO 11607-1:2020 and ISO 11607-2:2017 verified | |
| User Needs/Usability | - Bench-top Validation with users familiar with catheter-based interventional procedures | Meets intended use, supporting substantial equivalence |
The following information is not present in the provided document, as it pertains specifically to AI/ML software performance studies and not to a physical medical device like the ProTrack™ Pigtail Wire:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
Ask a specific question about this device
Page 1 of 1