(266 days)
The Double Flexible Tipped Wire Guides are used to facilitate the placement of devices during diagnostic and interventional procedures.
The Double Flexible Tipped Wire Guides are Class II devices according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The Double Flexible Tipped Wire Guides are wire guides with a flexible distal and proximal end. Double Flexible Tipped Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.
The Double Flexible Tipped Wire Guides, subject of this submission, have been modified from the predicate device, Heavy Double Flexible Tipped Wire Guide (K150802), to include additional lengths ranging from 30 to 260 centimeters, additional outside diameters ranging from 0.018 to 0.038 inches, and additional curve radii ranging from 0 to 3 millimeters.
The Double Flexible Tipped Wire Guides are manufactured using a stainless steel core wire, and stainless steel coils. Some configurations include an exterior coating on the coils.
The modifications to the Double Flexible Tipped Wire Guides have been created to provide additional options for physicians in selecting the appropriate wire guide during diagnostic and interventional procedures.
The Double Flexible Tipped Wire Guides are packaged, sterile devices intended for single use.
The provided text describes the Double Flexible Tipped Wire Guides. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Fracture Testing | Met pre-determined acceptance criteria (in accordance with Annex F of BS EN ISO 11070:2014). |
| Tensile Testing | Met pre-determined acceptance criteria (in accordance with Annex H of BS EN ISO 11070:2014). |
| Flexing Test | Met pre-determined acceptance criteria (in accordance with Annex G of BS EN ISO 11070:2014). |
| Coating Integrity | Device evaluated for flaking of the coating using magnification to 40X. (No explicit "met" statement, but implied acceptable based on overall conclusion). |
| Torque Strength Testing | Characterization testing performed (in accordance with FDA Coronary and Cerebrovascular Guidewire Guidance (1995)). (No explicit "met" statement, but implied acceptable based on overall conclusion). |
| Tip Flexibility (Tip Deflection) Testing | Characterization testing performed (in accordance with FDA Coronary and Cerebrovascular Guidewire Guidance (1995)). (No explicit "met" statement, but implied acceptable based on overall conclusion). |
| Corrosion Testing | Revealed no signs of corrosion that would affect functional performance. Met pre-determined acceptance criteria (in accordance with Annex B of BS EN ISO 11070:2014). |
| Catheter Compatibility Testing | Met pre-determined acceptance criteria (in accordance with BS EN ISO 11070:2014). |
| Biocompatibility Testing | Materials and methods used to manufacture the device are non-toxic and met pre-determined acceptance criteria for their intended use (in accordance with BS EN ISO 10993-1:2009). |
| Performance Testing on Aged Devices | Met pre-determined acceptance criteria (in accordance with BS EN ISO 11070:2014). |
| Acute Performance Evaluation (Animal Model) | All test articles evaluated met the pre-determined acceptance criteria for all performance parameters. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test mentioned (e.g., number of wire guides tested for fracture, tensile, etc.). It only states that the various tests were "performed" and that "all test articles evaluated" met acceptance criteria for the animal model.
Data provenance is not explicitly stated as retrospective or prospective, nor are countries of origin for the data. The tests are described as being performed "to demonstrate that the Double Flexible Tipped Wire Guides met applicable design and performance requirements."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document does not describe a study involving human experts establishing ground truth for a test set. The evaluation is focused on the physical and biological performance of the medical device itself through standardized engineering and biocompatibility tests, and an animal model.
4. Adjudication method for the test set
Not applicable. This was not a study involving human interpretation or adjudication of results. The acceptance criteria were met based on direct measurements and observations during testing.
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 a medical device (wire guides) for diagnostic and interventional procedures, not an AI-assisted diagnostic tool. Therefore, no MRMC comparative effectiveness study involving human readers and AI assistance was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance of the device was established by:
- Standardized Test Methods: Adherence to established international standards (BS EN ISO 11070:2014, BS EN ISO 10993-1:2009) and FDA guidance documents (FDA Coronary and Cerebrovascular Guidewire Guidance (1995)).
- Pre-determined Acceptance Criteria: Specific criteria were set for each test, and the device's performance was compared against these criteria.
- Acute Performance Evaluation in an Animal Model: This constitutes a form of "ground truth" reflecting real-world physiological conditions for device functionality.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
§ 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.