(37 days)
The Approach Pro ST Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
The Approach Pro ST Wire Guide consists of a stainless steel core wire coated with polytetrafluoroethylene (PTFE). The outside diameter of the Approach Pro ST Wire Guide is 0.014 inches and the device will be available in 135 cm, 190 cm, and 300 cm lengths. It will be supplied sterile and intended for one-time use.
The provided document describes a 510(k) premarket notification for a medical device, the Approach Pro ST Wire Guide. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than clinical efficacy studies with predefined acceptance criteria and performance metrics typically associated with AI/ML devices or novel therapies.
Therefore, many of the requested categories related to acceptance criteria, study design for performance, ground truth establishment, expert adjudication, and AI/MRMC studies are not applicable to this document as it pertains to a traditional medical device demonstrating substantial equivalence through non-clinical bench testing.
Here's an breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable in the sense of clinical performance metrics, accuracy, sensitivity, or specificity. The acceptance criteria are implicit in the success of the various bench tests, demonstrating that the device meets engineering and safety standards. The "reported device performance" is that it successfully passed these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical integrity (bend, torque, tensile, fracture) | Successfully withstood specified mechanical stresses. |
| Biocompatibility | Passed biocompatibility testing. |
| Radiopacity | Demonstrated appropriate radiopacity. |
| Corrosion resistance | Passed corrosion resistance testing. |
| Sterility and safety (pyrogen, bioburden, endotoxin, EtO residuals) | Passed testing for pyrogens, bioburden, endotoxins, and EtO residuals. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified quantitatively in terms of individual device units tested for each test, but standard test methods would dictate appropriate sample sizes for each type of bench test (e.g., n=3, n=5, n=10 per batch, etc., as per ISO or ASTM standards).
- Data Provenance: The tests were performed internally by Cook Incorporated, a US-based company, as part of their premarket notification process. This is retrospective in the sense that the tests were completed before the submission to FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. For traditional medical devices undergoing bench testing for mechanical properties and biocompatibility, "ground truth" is established by adherence to recognized engineering standards, laboratory protocols, and validated analytical methods, not by expert medical consensus in the same way it would be for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" are relevant for clinical trials or diagnostic accuracy studies where there's a need to resolve discrepancies in expert opinions or clinical outcomes. For bench testing, results are typically objective measurements against a defined standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a 510(k) for a traditional medical device (wire guide), not an AI/ML diagnostic tool. Therefore, MRMC studies are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical instrument, not an algorithm or software. Its performance is always in conjunction with a human operator.
7. The Type of Ground Truth Used
For the bench tests: Engineering standards, validated test methods, and material specifications. For example, a "Three Point Bend Test" would have an established maximum deflection or force requirement based on the expected mechanical properties of a functional wire guide. Biocompatibility would be determined against established ISO standards (e.g., ISO 10993).
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is not relevant.
In summary: The provided document is for a traditional medical device seeking 510(k) clearance by demonstrating substantial equivalence through non-clinical bench testing, not through clinical or AI/ML performance studies. Therefore, many of the requested details related to "acceptance criteria" and "ground truth" in the context of diagnostic accuracy or AI performance are not present or applicable. The "study" proving it meets "acceptance criteria" refers to a series of specific, enumerated bench tests that demonstrated the device's physical and biological properties are suitable for its intended use and comparable to the predicate 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.