(83 days)
The Torquer is indicated for use in manipulating a guide wire in order to access discreet regions of the vasculature.
The IntraLuminal Therapeutics Torquer is a plastic device that allows for manipulating and directional control of a guide wire. The Torquer will accommodate commercially available quide wires ranging in size from 0.014" to 0.035". The Torquer can be sideloaded onto the quide wire after the wire is in place within the catheter. When the finger tabs of the ILT Torquer are squeezed and the iaws of the ILT Torquer open, the quide wire can be placed inside. Releasing the finger tabs allows the jaws to close, capturing and firmly gripping the guide wire.
The ILT Torquer is packaged in a Tyvek®/mylar pouch that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", and is intended for single use only.
The provided text describes a 510(k) premarket notification for a medical device called the "ILT Torquer." This document focuses on demonstrating that the device is substantially equivalent to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the way a clinical trial for an AI/ML device would.
Therefore, many of the requested categories for AI/ML device studies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission. This 510(k) is for a mechanical medical device, not an AI/ML diagnostic or prognostic tool.
However, I can extract the relevant information regarding performance and acceptance criteria as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance Requirements | In vitro bench studies were conducted to evaluate the performance characteristics. Performance test results indicate the device satisfies functional performance requirements when used as indicated. |
| Accommodate Guide Wires | The Torquer will accommodate commercially available guide wires ranging in size from 0.014" to 0.035". |
| Ability to Sideload | The Torquer can be sideloaded onto the guide wire after the wire is in place within the catheter. |
| Grip Guide Wire | Releasing the finger tabs allows the jaws to close, capturing and firmly gripping the guide wire. |
| Sterility | The device is provided "STERILE" and sterilized with ethylene oxide gas. |
| Biocompatibility | Not required as there is no patient contact. |
| Substantial Equivalence | The results of testing demonstrate that the ILT Torquer is substantially equivalent to the predicate device [Boston Scientific Corporation wireClip™ cleared under 510(k) K003398]. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document only mentions "In vitro bench studies" were conducted.
- Data Provenance: Not applicable/specified. Bench testing is typically performed in a laboratory setting, not with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a mechanical device, and ground truth in the context of expert review for diagnostic accuracy is not relevant here. Performance was assessed via bench tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable directly. The "ground truth" for this mechanical device's performance would be engineering specifications and successful operation during in vitro bench testing (e.g., ability to grip wires of specified sizes, withstand torque, maintain sterility).
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device.
Study That Proves the Device Meets Acceptance Criteria:
The document states:
"In vitro bench studies were conducted to evaluate the performance characteristics of the ILT Torquer. Performance test results indicate that the device satisfies functional performance requirements when used as indicated."
And concludes:
"The results of testing demonstrate that the ILT Torquer is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use."
While the specific details of the bench studies (e.g., number of tests, specific parameters measured, statistical analysis) are not provided in this summary, the submission relies on these in vitro bench studies as the evidence that the device meets its functional performance requirements and is substantially equivalent to the predicate device. The FDA's 510(k) clearance indicates they found this evidence sufficient for substantial equivalence.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.