(218 days)
To facilitate the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
The Charlie Guidewire is a steerable guidewire that is compatible with .035" catheters and devices. Lengths are available from 70cm to 280cm. The guidewire is constructed from a Nitinol core wire with a polymer jacket. The jacket is coated with a hydrophilic polymer. The distal tip is atraumatic, and available in straight or various angled configurations. The main body is available in varying stiffness configurations. The device will be provided sterile and intended for one-time use. Product has a 2-year shelf life.
The provided document describes a medical device, the Charlie Guidewire, and its clearance through the 510(k) pathway. However, the document does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the format requested.
The document states that "performance data that demonstrate that the Guidepath Charlie Guidewire family meets all predetermined performance criteria" and "Bench testing per applicable reference documents was completed comparing Charlie Guidewires to the predicates or to known standards for guidewire performance." It lists various performance tests conducted. However, the specific acceptance criteria (i.e., the numerical thresholds or qualitative standards for passing each test) and the actual results obtained for the Charlie Guidewire are not explicitly presented.
Therefore, I cannot populate the table with acceptance criteria and reported device performance, nor can I provide information about sample sizes for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, types of ground truth, or details about the training set. This information is typically found in detailed study reports or technical specifications, which are not part of this 510(k) summary.
Based on the provided text, here is what can be inferred and what cannot:
1. Table of acceptance criteria and the reported device performance:
| Performance Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resistance to flexure | Not Specified | Not Specified |
| Tip resistance to fracture | Not Specified | Not Specified |
| Radiopacity | Not Specified | Not Specified |
| Catheter compatibility | Not Specified | Not Specified |
| Coating adherence | Not Specified | Not Specified |
| Torque strength | Not Specified | Not Specified |
| Torque response | Not Specified | Not Specified |
| Coating lubricity | Not Specified | Not Specified |
| Tip stiffness | Not Specified | Not Specified |
| Tensile | Not Specified | Not Specified |
| Cytotoxicity | Not Specified | Biocompatible |
| Sensitization | Not Specified | Biocompatible |
| Irritation/Intracutaneous | Not Specified | Biocompatible |
| Pyrogenicity | Not Specified | Biocompatible |
| Systemic Injection | Not Specified | Biocompatible |
| Thrombosis | Not Specified | Biocompatible |
| PTT | Not Specified | Biocompatible |
| Hemolysis | Not Specified | Biocompatible |
| Complement Activation | Not Specified | Biocompatible |
| Coating/Volatile Residue | Not Specified | Biocompatible |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "bench testing" and "applicable biocompatibility testing performed on finished, sterile devices" but does not detail sample sizes, data provenance (e.g., country of origin), or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not specified. This device is a guidewire, and the performance tests described are mechanical and biocompatibility tests, not diagnostic imaging or clinical evaluation requiring expert ground truth establishment in the typical sense (e.g., for AI algorithms). The "ground truth" for these tests would be the established scientific standards and methods for assessing material properties and biological interactions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This typically refers to the resolution of disagreements among experts in a clinical study. The tests described are laboratory/bench tests and biocompatibility tests, which have objective endpoints according to defined protocols, not requiring expert adjudication in this manner.
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:
- No. This type of study is for diagnostic or interpretative AI devices that assist human readers. The Charlie Guidewire is a physical medical device (guidewire), not an AI algorithm for image interpretation or diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The Charlie Guidewire is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical and functional tests: The "ground truth" would be established by known standards for guidewire performance and comparison to predicate devices using objective measurements and established protocols.
- For biocompatibility tests: The "ground truth" would be established by adherence to internationally recognized standards for biocompatibility testing (e.g., ISO 10993 series) which determine if materials are acceptable for medical device use based on cellular, systemic, and local responses.
8. The sample size for the training set:
- Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As stated above, this is a physical medical device, not an AI 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.