(81 days)
The Asahi Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.
The Asahi Guide Wire Extension accessory is used to elongate the working length of compatible Asahi PTCA and Peripheral extendable wires. The stainless-steel Asahi Guide Wire Extension has an outer diameter of 0.014" (0.36mm) and a length of 150cm. Its distal end bears preformed elastic connecting tube. The product is specially designed to use with Asahi PTCA and Peripheral extendable guide wires. This product is a non-invasive medical device, and it is not contact with tissue and body fluids.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Asahi Guide Wire Extension.
Based on the provided 510(k) summary, the device is a simple mechanical accessory used to extend the working length of guide wires. The submission focuses on substantial equivalence to predicate devices rather than a complex performance study with quantitative acceptance criteria typically seen for AI/ML devices or diagnostic tools.
Therefore, many of the requested fields (e.g., sample sizes for test/training sets, expert consensus, MRMC studies) are not applicable or not provided in this type of submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Material Equivalence: Made of same materials as predicate devices for similar indications. | "The Asahi Guide Wire Extension accessory is made of the same materials that have been used in other predicate devices that are labeled for the similar indications." (Page 1) |
| Dimensional Equivalence: Dimensional specifications equivalent to predicate devices. | "The dimensional specifications are equivalent to those listed for the currently cleared predicate devices." (Page 1) |
| Functional Equivalence: Meets predetermined performance criteria for its intended use (extending guide wire working length during angioplasty).** | "Enclosed within this submission is performance data that demonstrates that the Asahi Guide Wire Extension accessory meets all predetermined performance criteria." (Page 1) |
| (Note: Specific, quantifiable criteria are not detailed in this summary.) | |
| Substantial Equivalence to Predicate Devices: Overall characteristics are substantially equivalent to specified predicate and other marketed devices. | "The Asahi Guide Wire Extension accessory characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use." (Page 1) |
| Safety and Effectiveness: Demonstrated safety and effectiveness for its intended use. | The FDA's 510(k) clearance implies that the device has been determined to be substantially equivalent to a legally marketed predicate device, thereby demonstrating its safety and effectiveness for the stated indications. (Pages 2-3) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This device is a mechanical accessory. The "performance data" mentioned would typically involve engineering tests (e.g., tensile strength, fatigue, material compatibility) rather than a clinical "test set" with patient data. The summary does not specify any clinical study sample sizes or data provenance.
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 Provided: For a mechanical accessory seeking 510(k) clearance based on substantial equivalence, clinical ground truth established by experts is not typically required in the same way it would be for a diagnostic or AI/ML device. The "ground truth" here is the physical and functional performance of the device itself, assessed through engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: As no clinical test set with patient data is described, an adjudication method for expert review is irrelevant.
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: No MRMC study was done. This device is a mechanical medical accessory, not an AI/ML-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Performance Standards/Specifications: The "ground truth" for this device would be its ability to meet predetermined physical and mechanical performance criteria (e.g., strength, durability, compatibility with specified guide wires, reliable extension function) as demonstrated through bench testing and material characterization. This is established against industry standards and internal specifications, and its equivalence to predicate devices.
8. The sample size for the training set
- Not Applicable / Not Provided: No training set is relevant for a mechanical medical device in this context.
9. How the ground truth for the training set was established
- Not Applicable: No training set is relevant.
§ 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.