(73 days)
The SCIMED ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
The ChoICE PT, ChoICE PT Plus, and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are steerable guide wires available in nominal diameters of 0.014 inches and nominal lengths of 190, 182 and 300 centimeters. The magnetic proximal section of the 182 cm length is designed to facilitate exchange of devices when used with SCIMED's Magnet Exchange Device. The 300 cm length allows exchange of therapeutic devices without the use of other exchange devices, e.g., docking systems or extension wires. The distal 35 centimeters on the entire ChoICE PT family of guide wires contains a stainless steel core wire that is jacketed with a radiopaque polymer and coated with ICE™ Hydrophilic Coating. The distal two centimeters of the guide wire are straight shapeable or available in a pre-formed J-Tip. The proximal wire is coated with either polytetrafluoroethylene (PTFE) or fluorinated ethylene propylene (FEP). The distal core wire tapers have increased in thickness or length to differentiate the Extra Support and Extra Support Long Taper models from the ChoICE PT, ChoICE PT Plus, and ChoICE PT Exchange Guide Wires. The Extra Support designates a taper of 2.25 inches proximal to the distal tip, whereas the Extra Support Long Taper designates a taper of 3.5 inches proximal to the distal tip. The ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper Guide Wires will be provided sterile and are intended for one procedure use only (disposable).
This document describes a 510(k) summary for PTCA (Percutaneous Transluminal Coronary Angioplasty) Guide Wires. The primary purpose of this section is to demonstrate substantial equivalence to previously marketed devices, not to present a study with specific acceptance criteria in the manner of an AI/ML device.
Therefore, the requested information elements related to AI/ML device testing (such as a table of acceptance criteria, sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance) are not applicable to this document.
The document discusses non-clinical testing performed to verify the device's conformance to its intended use and design characteristics. Here's a summary of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
This document does not explicitly provide a table of acceptance criteria with numerical thresholds and corresponding device performance values in the context of a clinical study or AI/ML evaluation. Instead, it states that "Test results verified that the ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires met all of the minimum requirements and are adequate for their intended use."
The "minimum requirements" are implied by the types of tests conducted:
- Tip tensile
- Torsion
- Combined load
- Flexibility
- Torque response
- J-Tip curve retention
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. This document refers to "testing and evaluation of the guide wires," but does not provide details on the number of units tested.
- Data Provenance: Not applicable in the context of clinical data. The tests described are "non-clinical" and "in vitro," implying laboratory testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for non-clinical, in vitro testing of a guide wire would be based on engineering specifications and physical measurements, not expert clinical interpretation.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical data labeling, which is not relevant here.
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:
- The "ground truth" for the non-clinical tests would be the established engineering specifications and performance standards for guide wires (e.g., tensile strength requirements, torque response limits, flexibility standards).
8. The sample size for the training set:
- Not applicable. This document does not describe an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: This 510(k) summary focuses on demonstrating the substantial equivalence of a medical device (PTCA guide wires) through non-clinical, in vitro testing, rather than presenting a clinical study or performance evaluation of an AI-powered device. Therefore, many of the requested details related to AI/ML device evaluation are not present in this type of regulatory document.
§ 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.