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510(k) Data Aggregation
(270 days)
ASAHI Gladius Mongo18 PV ES
This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
The ASAHI Gladius Mongo18 PV ES is a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) and available in 190cm. 235cm and 300cm length. The distal end of the coil part is available straight and is made soft to easily bend with the vessel curve, or available pre shaped. The guide wire is constructed from a stainless-steel core wire with platinum-nickel coil. The coil is soldered to the core wire. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The solder of distal end is Au-Sn and other solder is Ag-Sn. The distal end of the quide wire has a radiopaque tip to achieve visibility. For the models covered by this submission, a hydrophilic coating is applied to the quide wire along the distal structure. The proximal section of the guide wire is coated with PTFE. The purpose of these surface coatings is to provide lubricity when guide wire is passed through percutaneous catheters. The basic structure, construction, and coating of the ASAHI Gladius Mongo18 PV ES are unchanged from that previously described in the predicate ASAHI Gladius (K150445).
This document describes the premarket notification (510(k)) for the ASAHI Gladius Mongo18 PV ES, a catheter guide wire for peripheral vascular use. The submission argues for substantial equivalence to a predicate device (ASAHI Gladius, K150445) and several reference devices.
Here's a breakdown of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the ASAHI Gladius Mongo18 PV ES "met all acceptance criteria and performed similarly to the predicate device" in bench testing. However, it does not explicitly list the quantitative acceptance criteria for each test. Instead, it lists the types of tests performed.
| Test Type | Acceptance Criteria (Not explicitly stated quantitatively, but implied "met all acceptance criteria") | Reported Device Performance (Implied "met all acceptance criteria" and "performed similarly to the predicate device") |
|---|---|---|
| Tensile Strength | Met defined strength requirements | Performed similarly to predicate |
| Torque Strength | Met defined torque limits | Performed similarly to predicate |
| Torqueability | Maintained steerability and control | Performed similarly to predicate |
| Tip Flexibility | Maintained intended flexibility and shape | Performed similarly to predicate |
| Coating Integrity | Maintained intact and functional coating | Performed similarly to predicate |
| Catheter Compatibility | Ensured smooth passage through catheters | Performed similarly to predicate |
| Visual Inspection | No visible defects | Performed similarly to predicate |
| Corrosion Resistance | Resisted corrosion under test conditions | Performed similarly to predicate |
| Kink Resistance | Resisted kinking under test conditions | Performed similarly to predicate |
| Radiopacity | Visible under fluoroscopy | Performed similarly to predicate |
| Dimensional Verification | Met specified dimensions | Performed similarly to predicate |
| Particulate | Met particulate limits | Performed similarly to predicate |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Test Set: The document does not specify the exact sample size for the non-clinical bench tests (e.g., how many guidewires were tested for tensile strength).
- Data Provenance: The studies were bench tests conducted following FDA guidance. The manufacturing company is ASAHI INTECC CO., LTD., located at 3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan, implying the testing likely occurred in or under the purview of the company's R&D facilities. This is a pre-market, prospective evaluation of the device's physical and mechanical properties.
3. Number of Experts and Qualifications for Test Set Ground Truth
This submission is for a medical device (guide wire) and primarily relies on non-clinical bench testing rather than interpretation of diagnostic images or patient outcomes. Therefore, the concept of "ground truth" established by human experts in the way it applies to AI/software performance (e.g., radiologists for imaging studies) is not applicable here. The "ground truth" for these tests is the objective physical and mechanical properties measured on the device itself against established engineering specifications and performance criteria derived from the predicate device and FDA guidance.
4. Adjudication Method for Test Set
As the "ground truth" is established through objective bench testing measurements against pre-defined criteria, an adjudication method (like 2+1, 3+1 for human disagreements) is not applicable. The results are quantitative measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This is a physical medical device (guidewire), not a diagnostic imaging AI or software. Therefore, an MRMC study involving human readers with and without AI assistance is not applicable.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? This question typically applies to AI algorithms. For this physical medical device, the "standalone" performance refers to the device's inherent physical and mechanical properties as measured in bench tests, independent of its use by a human operator for the specific tests mentioned. The non-clinical bench testing effectively represents this "standalone" performance against established engineering criteria.
7. Type of Ground Truth Used
The ground truth for the non-clinical testing was based on objective engineering specifications, physical and mechanical measurements, and performance criteria derived from the predicate device's validated performance and FDA guidance documents.
8. Sample Size for the Training Set
- Sample Size: This device did not undergo a "training" process in the sense of a machine learning algorithm. The "training" for such a device would be its design, manufacturing processes, and quality control. There isn't a "training set" of data in the AI sense for this device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As mentioned above, there is no "training set" for this type of device in the context of an FDA 510(k) submission for substantial equivalence based on bench testing. The design and manufacturing processes are validated to produce devices meeting pre-defined specifications.
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