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510(k) Data Aggregation
(104 days)
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
The ASAHI PTCA Guide Wire ASAHI Gaia Next (hereafter "ASAHI Gaia Next") is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 190cm length. The extension wire may be connected to the end of the guide wire outside the body. The guide wire is constructed from a stainless-steel core wire with a platinum-nickel and stainless-steel coils. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The distal end of the quide wire has a radiopaque outer coil and inner coil to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The coil assembly construction is similar to predicate device.
The provided text describes the 510(k) premarket notification for the ASAHI PTCA Guide Wire ASAHI Gaia Next. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting results from a study proving device performance against specific acceptance criteria for a new, novel technology. Therefore, many of the requested categories (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or not available from this regulatory submission. This document details non-clinical bench testing to show the device performs similarly to a predicate.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a table of precise quantitative acceptance criteria (e.g., "tensile strength must be >X Newtons") or specific numerical performance results for each test. Instead, it states that the device "met all acceptance criteria" and "performed similarly to the predicate devices" in bench testing.
| Acceptance Criteria & Test Category | Reported Device Performance Summary |
|---|---|
| Non-Clinical Bench Testing: | |
| Tensile Strength | Met all acceptance criteria and performed similarly to predicate devices. |
| Torque Strength | Met all acceptance criteria and performed similarly to predicate devices. |
| Torqueability | Met all acceptance criteria and performed similarly to predicate devices. |
| Tip Flexibility | Met all acceptance criteria and performed similarly to predicate devices. |
| Coating Adhesion / Integrity | Met all acceptance criteria and performed similarly to predicate devices. |
| Catheter Compatibility | Met all acceptance criteria and performed similarly to predicate devices. |
| Visual Inspection | Met all acceptance criteria and performed similarly to predicate devices. |
| Corrosion Resistance | Met all acceptance criteria and performed similarly to predicate devices. |
| Kink Resistance | Met all acceptance criteria and performed similarly to predicate devices. |
| Radio-detectability | Met all acceptance criteria and performed similarly to predicate devices. |
| Dimensional Verification | Met all acceptance criteria and performed similarly to predicate devices. |
| Coating Integrity/Particulate | Met all acceptance criteria and performed similarly to predicate devices. |
| Biocompatibility Testing: | |
| Hemocompatibility (due to coil change): | Verified to be the same as predicates/reference devices. |
| - Hemolysis | Verified to be the same as predicates/reference devices. |
| - SC5b-9 Complement Activation | Verified to be the same as predicates/reference devices. |
| - Unactivated Partial Thromboplastin Time | Verified to be the same as predicates/reference devices. |
| - Thrombogenicity | Verified to be the same as predicates/reference devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers generally to "bench testing" without providing the number of units tested for each non-clinical performance test.
- Data Provenance: The tests are described as "in vitro bench tests." This implies tests were conducted in a laboratory setting. The country of origin of the data is not explicitly stated, but the applicant is ASAHI INTECC CO., LTD from Japan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a guide wire, and the evaluation involves non-clinical engineering and biological performance testing, not diagnostic interpretation requiring expert consensus on "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As mentioned above, this is non-clinical bench testing. Adjudication methods are relevant for human-read diagnostic studies.
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
- Not Applicable. This is a medical device (guide wire), not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a medical device (guide wire), not an AI-powered diagnostic tool. No standalone algorithm performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical bench tests, the "ground truth" or reference for acceptance is against established engineering and material science standards and performance specifications for guide wires, and comparison to the predicate device. For biocompatibility, it's against established biological safety standards.
8. The sample size for the training set
- Not Applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for a physical medical guide wire.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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(114 days)
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
The ASAHI® PTCA Guide Wire ASAHI Gladius Mongo consists of a one-piece core wire and a distal coil assembly. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI® PTCA Guide Wire ASAHI Mongo. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE only. The ASAHI® PTCA Guide Wire ASAHI Mongo is available in various lengths. The shorter length device is designed for use with a commercially available ASAHI INTECC extension, wire.
The provided text describes the 510(k) premarket notification for the "ASAHI® PTCA Guide Wire ASAHI Gladius Mongo 14 and ASAHI Gladius Mongo 14 ES." This document pertains to a medical device (a guide wire), not an AI algorithm or a diagnostic tool. Therefore, the questions regarding acceptance criteria and studies for an AI/ML powered device, specifically those requiring information on human readers, ground truth establishment for AI training/test sets, and expert adjudication, are not applicable to this document.
The document focuses on demonstrating substantial equivalence of the new guide wire to a legally marketed predicate device (ASAHI® Fielder XT-A). It primarily relies on non-clinical testing/performance data to show that the new device functions as intended and has a similar safety and effectiveness profile.
Here's a breakdown of the relevant information provided, responding to the spirit of the request where applicable to a traditional medical device:
1. A table of acceptance criteria and the reported device performance:
The document lists the following non-clinical tests performed, implying that internal acceptance criteria were met. However, the specific quantitative acceptance criteria and the exact reported performance results (e.g., specific tensile strength values or torque strength ranges) are not detailed within this public summary. The statement is qualitative: "met all acceptance criteria and performed similarly to the predicate device."
| Test Performed | Implied Acceptance Criteria (Qualitative) | Reported Device Performance (Qualitative) |
|---|---|---|
| Tensile Strength | Met predefined strength requirements | Performed similarly to predicate |
| Torque Strength | Met predefined torque requirements | Performed similarly to predicate |
| Torqueability | Met predefined torqueability standards | Performed similarly to predicate |
| Tip Flexibility | Met predefined flexibility standards | Performed similarly to predicate |
| Coating Adhesion | Met predefined adhesion standards | Performed similarly to predicate |
| Catheter Compatibility | Compatible with standard catheters | Performed similarly to predicate |
| Particulate Testing/ Coating Integrity | Met predefined particulate limits and coating integrity standards | Performed similarly to predicate |
| Lubricity Testing | Met predefined lubricity standards | Performed similarly to predicate |
| Biocompatibility | Materials are biocompatible (similar to predicate/reference devices) | Verified to be the same as predicate/reference devices based on material similarity |
Regarding the other questions, they are not directly applicable to this type of device submission:
- 2. Sample sized used for the test set and the data provenance: This refers to data for an AI model. For this physical device, "sample size" would refer to the number of devices tested for each non-clinical test. This specific number is not provided in the summary. Data provenance is not relevant for a physical device's bench testing.
- 3. Number of experts used to establish the ground truth... and qualifications: This is for AI performance evaluation. Not applicable.
- 4. Adjudication method... for the test set: This is for AI performance evaluation. Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: This is for AI performance evaluation. Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is for AI algorithm performance. Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This is for AI ground truth. For this device, "ground truth" would be established by validated test methods and engineering specifications.
- 8. The sample size for the training set: This is for AI model training. Not applicable.
- 9. How the ground truth for the training set was established: This is for AI model training. Not applicable.
In summary, the provided document is a 510(k) summary for a physical medical device (a guide wire), and the questions posed are primarily designed for the evaluation of AI/ML-powered medical devices. Therefore, most of the specific details requested regarding AI acceptance criteria, ground truth, and study design are not found within this document. The core of this submission is demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical bench testing.
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