(57 days)
The TightRail Sub-C Rotating Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects.
The TightRail Sub-C Rotating Dilator Sheaths are mechanical, intra-operative devices. The devices consist of a proximal handle drive mechanism with a distal dilation catheter. The sheaths are packaged with an optional outer support sheath. The dilator sheath is advanced, withdrawn, and rotated about the lead, catheter or foreign object to be removed. Actuating the trigger on the proximal handle activates a rotary dilation mechanism sheathed at the distal terminus of the catheter. Rotation of the inner shaft is translated to axial actuation of the dilation mechanism via a cam path contained within the distal components. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the object targeted for removal, thereby facilitating removal of said object. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail Sub-C is 15.5 cm.
The provided text describes a medical device, the "TightRail Sub-C Rotating Dilator Sheath," and its premarket notification (510(k)) to the FDA. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that defines and meets specific acceptance criteria for a new, standalone device performance claim. Therefore, much of the requested information regarding algorithm performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment is not available in this document because it pertains to the evaluation of a software algorithm or AI, which is not the subject of this medical device submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document lists various design verification and validation tests performed to ensure the subject device met specifications and was substantially equivalent to its predicate. These are not acceptance criteria in the sense of a clinical trial's primary endpoints and statistical measures, but rather engineering and safety parameters.
| Acceptance Criteria (Test) | Reported Device Performance (Outcome) |
|---|---|
| Dimensional Verification | Met specifications (implied by "demonstrated that the subject device is as safe and clinically effective") |
| Tensile Test | Met specifications |
| Torque to Deform Test | Met specifications |
| Axial Load Test | Met specifications |
| Weld Integrity Test | Met specifications |
| Outer Sheath Axial Load Test | Met specifications |
| Radio-Detectability Test | Met specifications |
| Corrosion Resistance Characterization | Met specifications |
| Simulated Use Testing | Met specifications |
| Dimensional Verification at 2 years | Met specifications |
| Outer Sheath Axial Load Test at 2 years | Met specifications |
| Simulated Use Test at 2 years | Met specifications |
| Sterilization: | |
| Product adoption equivalency per AAMI TIR:28-2009 | Met specifications |
| Biocompatibility: | |
| Cytotoxicity | Met specifications |
| Sensitization | Met specifications |
| Intracutaneous Reactivity | Met specifications |
| Acute Systemic Toxicity | Met specifications |
| C3a Complement Activation | Met specifications |
| SC5b-9 Complement Activation | Met specifications |
| Direct Hemolysis | Met specifications |
| Indirect Hemolysis | Met specifications |
| Thrombosis Partial Thromboplastin Time (PTT) | Met specifications |
| Material Mediated Pyrogenicity | Met specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This document describes engineering and biocompatibility testing for a physical device, not an algorithm being tested on a "test set" of data. No clinical studies were required or performed to demonstrate substantial equivalence for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
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:
- No. This is a physical medical device, not an AI or software algorithm requiring an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For the engineering tests, "ground truth" would be established by validated measurement techniques, standards, and established laboratory protocols, rather than expert consensus on medical images or pathology.
8. The sample size for the training set:
- Not Applicable. This document describes a traditional 510(k) submission for a physical device, not an AI or machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).