(72 days)
The Radifocus® Glidewire® Advantage is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures.
The Radifocus Glidewire Advantage consists of a Nickel Titanium alloy core wire. A polyurethane and hydrophilic coating is applied to the distal portion of the wire while a PTFE coating is applied to the proximal portion. The wire distal segment comes in many configurations such as straight, J shaped, and angled. The wire is package in a plastic holder contained within a pouch. A guide wire inserter is contained within the pouch to assist with the insertion of the wire into a needle or catheter.
The provided text describes the 510(k) summary for the Radifocus® Glidewire® Advantage, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in a clinical setting.
Therefore, many of the requested details, such as the sample size for a test set, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and details about training sets, are not applicable and not found within the provided text. This type of premarket notification relies on non-clinical performance testing and comparison to an already cleared device.
Here's a breakdown of the information that can be extracted from the provided text, along with explanations for the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in the typical sense (e.g., a specific percentage of success or a threshold for a metric). Instead, it states that the performance tests "demonstrate the substantial equivalence" and that "None of the data raises any new issues of safety and effectiveness."
| Performance Test | Acceptance Criteria (Implicit) | Reported Device Performance Summary |
|---|---|---|
| Ease of removal from holder | No new issues of safety and effectiveness compared to predicate | Performance demonstrated substantial equivalence to the predicate device. |
| Torque control | No new issues of safety and effectiveness compared to predicate | Performance demonstrated substantial equivalence to the predicate device. |
| Sliding friction | No new issues of safety and effectiveness compared to predicate | Performance demonstrated substantial equivalence to the predicate device. |
| Tip impact | No new issues of safety and effectiveness compared to predicate | Performance demonstrated substantial equivalence to the predicate device. |
| Proximal shaft stiffness | No new issues of safety and effectiveness compared to predicate | Performance demonstrated substantial equivalence to the predicate device. |
| Bend strength | No new issues of safety and effectiveness compared to predicate | Performance demonstrated substantial equivalence to the predicate device. |
| Biocompatibility | Compliance with ISO-10993 (Part-1) | Materials demonstrated biocompatibility as an "Externally Communicating Devices, Circulating Blood, Limited Contact (≤ 24 hrs)". |
| Sterilization | Compliance with ANSI / AAMI / ISO 11135-1994, EN 550, SAL of 10-6 | Validated in accordance with standards to a SAL of 10-6. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "verification tests" but does not give sample sizes for these tests.
- Data Provenance: Not specified, but given the nature of the tests (mechanical and biocompatibility), it would be laboratory-based data, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable to this type of submission. The performance tests are largely objective physical and chemical evaluations.
4. Adjudication method for the test set
- This information is not applicable to this type of submission. The performance tests are objective evaluations against engineering specifications and biocompatibility standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable. This device is a guide wire, not an AI-powered diagnostic tool. No MRMC study was performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This device is a manual medical instrument, not an algorithm.
7. The type of ground truth used
- For the mechanical performance tests (e.g., torque control, bend strength), the "ground truth" would be established engineering specifications or benchmarks derived from empirical data and comparison to the predicate device.
- For biocompatibility, the "ground truth" is compliance with ISO-10993-1.
- For sterilization, the "ground truth" is validation to established standards (ANSI / AAMI / ISO 11135-1994, EN 550) and achieving a Sterility Assurance Level (SAL) of 10-6.
8. The sample size for the training set
- This information is not applicable. This is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
- This information is not applicable. This is a physical medical device, not a machine learning algorithm.
§ 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.