(29 days)
The Spectre guidewire is intended for use in percutaneous procedures to introduce and position cather interventional devices within the coronary and/or peripheral vasculature.
The Spectre guidewire is a straight tip guidewire with a maximum outer diameter of 0.014" available in 190 cm and 300 cm lengths. The Spectre guidewire consists of a bi-metal stainless steel and nitinol core wire covered on the distal end by a radiopaque coil at the distal tip. The distal end of the Spectre guidewire has a hydrophilic coating (HPC) and the proximal end is coated with polytetrafluoroethylene (PTFE). The 190 cm length model is compatible with a guidewire extension.
This document is a 510(k) premarket notification for a medical device called the "Spectre Guidewire." It's a review by the FDA determining substantial equivalence to a predicate device, not a study describing AI performance or complex acceptance criteria for an AI device.
Therefore, most of the information requested in your prompt (e.g., sample size for test set, number of experts, MRMC study, training set details, ground truth for training) cannot be found in this document because it is not relevant to a typical 510(k) submission for a non-AI medical device.
However, I can extract the acceptance criteria and study information that is present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance | Study that proves the device meets the acceptance criteria |
|---|---|---|
| Indications for Use | Intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature. | Substantial equivalence to predicate device (Endura Guidewire, K161702) based on comparison of specifications and bench tests. |
| Anatomical Location | Coronary and peripheral vasculature | Substantial equivalence to predicate device. |
| Dimensions | Maximum O.D.: 0.014", Length: 190 cm and 300 cm | Substantial equivalence to predicate device. |
| Core Wire Material | Nitinol and Stainless Steel | Substantial equivalence to predicate device. |
| Distal Tip | 3 cm radiopaque coil | Substantial equivalence to predicate device. |
| Lubricious Coatings | Hydrophilic (distal end) and PTFE (proximal end) | Substantial equivalence to predicate device. |
| Sterility | Ethylene Oxide (EO) – Sterility Assurance Level (SAL) 10-6 | Substantial equivalence to predicate device. |
| Track Force | Met specified acceptance criteria. | Bench tests |
| Guidewire Support Profile | Met specified acceptance criteria. | Bench tests |
Explanation for missing sections:
- 2. Sample size used for the test set and the data provenance: Not applicable. This device is a guidewire, not an AI or diagnostic tool that uses a "test set" in the context of imagery or clinical data. The "test set" here refers to the guidewire samples used in bench testing. The document does not specify the number of guidewires tested for Track Force or Guidewire Support Profile.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a guidewire's physical properties (like track force) is established through physical measurement, not expert consensus.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for physical bench 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 not an AI-powered device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical tests like track force and guidewire support profile, the ground truth is based on engineering specifications and physical measurements.
- 8. The sample size for the training set: Not applicable. This is not an AI-powered device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.
§ 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.