(28 days)
The Torque Device is used for guidewire manipulation during general intravascular procedures.
The Torque Device is an accessory device used to apply torsional and/or axial force to the guidewire to manipulate its distal end in the vasculature. It is designed to accommodate guidewires with diameters from 0.010 to 0.018 inches and is composed of three main components: 1.) a tubular collet contained within the body and cap assembly; 2.) a cap and 3.) a tubular body.
A guidewire is inserted through the Torque Device from the distal (cap) end. The Torque Device is positioned optimally on the guidewire at the desired location, and then secured by rotation of the cap. Once tightened, the torque device is used to apply torsional and axial force to the guidewire to manipulate its distal end in the vasculature.
The provided text in K123624 is a 510(k) summary and an FDA clearance letter for a medical device called "Torque Device." This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that fits the rigorous criteria outlined in the request. Therefore, most of the requested information regarding acceptance criteria, specific study design, and performance metrics will not be available in this type of submission.
Here's a breakdown based on the provided text, highlighting the absence of certain information:
Acceptance Criteria and Reported Device Performance
The submission states that "Design verification was performed to verify the performance and usability of the Torque Device remains substantially equivalent to the predicate device." It then lists the following tests:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Torque Slip Force | Verified to be substantially equivalent to predicate device |
| Pull Slip Force | Verified to be substantially equivalent to predicate device |
| Guidewire Deformation | Verified to be substantially equivalent to predicate device |
| Collet Release | Verified to be substantially equivalent to predicate device |
| Biocompatibility Testing: Latex | Verified to be substantially equivalent to predicate device |
Note: The document does not provide specific quantitative acceptance criteria (e.g., "Torque Slip Force must be > X N-cm") or explicit numerical results for the device performance. The performance is broadly stated as "substantially equivalent" to the predicate.
Study Information Missing from the Provided Text:
The provided 510(k) summary explicitly states: "Clinical Evaluation was not required for this device." This means that the following information, which is typically associated with clinical or efficacy studies, is not present in this submission:
- Sample size used for the test set and the data provenance: Not applicable as a clinical test set was not used. The design verification likely used physical samples of the device and guidewires.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth was established.
- Adjudication method for the test set: Not applicable.
- 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 a non-AI medical device; MRMC studies are for evaluating AI's impact on human performance in diagnostic tasks.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the design verification tests (Torque Slip Force, Pull Slip Force, etc.), the "ground truth" would be the engineering specifications and performance characteristics of the predicate device, against which the new device was compared.
- The sample size for the training set: Not applicable. There is no AI model to train.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study (Design Verification):
The "study" described is a non-clinical design verification aimed at demonstrating substantial equivalence. It involved:
- Testing areas: Torque Slip Force, Pull Slip Force, Guidewire Deformation, Collet Release, and Biocompatibility.
- Methodology: The tests were performed to ensure that the Torque Device's performance and usability are "substantially equivalent" to two predicate devices: SCIMED® Sideliner™ Torque Device (K922706) and Encore 26 Advantage Kit (K120694).
- Ground Truth (implicit): The performance characteristics of the predicate devices.
- Conclusion: The results of these non-clinical tests, along with material and manufacturing process comparisons, supported the claim of substantial equivalence.
In essence, this 510(k) describes engineering and materials testing, not a clinical study involving human subjects or AI performance metrics.
§ 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.