(88 days)
The ASAHI Tornus support catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange.
The ASAN Tomas Support Satheton is a device that is intended to provide additional support to a stochable galactine in accessing discrete regions of the coronary and penpheral vasculature. The formas ettempting to cross difficult lesions. The full metal spiral shaft that provides the user with a device that has excllent torqability and pushability during intravascular procedures.
This document describes the safety and effectiveness of the Tornus Support Catheter, a medical device manufactured by Asahi Intecc Co., Ltd. The submission is a 510(k) premarket notification to the FDA, asserting that the Tornus Support Catheter is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
- Table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific, quantifiable acceptance criteria in a table format, nor does it present detailed reported device performance against such criteria. Instead, it relies on a general statement of "substantial equivalence" to predicate devices. The performance data section broadly mentions:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | "long history of use in medical devices and are proven to be biocompatible for use in the vasculature." |
| Mechanical and Functional Performance | "mechanical and functional bench test that demonstrates the Tornus performs as intended." |
| Material equivalence | "made of the same materials that have been used in other Asahi products that are labeled for use in the vasculature." |
| Dimensional equivalence | "dimensional and guidewire compatibility specifications are the equivalent to those listed for the currently cleared predicate devices." |
| Indication for Use equivalence | "substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use." |
- Sample size used for the test set and the data provenance
The document does not specify a sample size for any clinical test set. The studies mentioned are "mechanical and functional bench tests." There is no indication of human subject testing, and therefore no information about data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/not provided. No human-based test set or associated ground truth establishment by experts is mentioned for this device submission. The evaluation is based on bench testing and comparison to predicate devices, not clinical outcomes or expert adjudication of data.
- Adjudication method for the test set
This information is not applicable/not provided as there is no human-based test set that would require adjudication.
- 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
An MRMC comparative effectiveness study was not performed, nor is it relevant to this type of device (a support catheter). This device is not an AI-powered diagnostic tool, but rather a physical interventional device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical catheter, not an algorithm. Therefore, "standalone" algorithm performance is irrelevant.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the "ground truth" implicitly would be engineering specifications and established performance characteristics of the predicate devices, which the Tornus Support Catheter is intended to match. There is no biological or clinical ground truth described.
- The sample size for the training set
This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device. The product development likely involved engineering design and testing, but not in the machine learning sense of a training set.
- How the ground truth for the training set was established
This information is not applicable/not provided as there is no training set in the context of this device's development.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).