(24 days)
The product (Finecross™ MG) is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for the purpose of angiography.
FINECROSS MG consists of a catheter shaft, a hub and an anti-kink protector. The catheter shaft has reinforcing braided mesh, thus achieving the high shaft strength and anti-kink characteristics. The shaft has gradual hardness change from the proximal to the distal portion. This is achieved by joining outer layers of material with different hardness. By using polytetrafluoroethylene (PTFE) as the inner layer, high inner face mobility has been achieved. The outer surface of the catheter is coated with a hydrophilic polymer, therefore, it demonstrates a high lubricity upon moistening.
The provided text describes a 510(k) premarket notification for the FINECROSS™ MG Coronary Micro-Guide catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics typically associated with AI/software as a medical device (SaMD) clearances.
Therefore, many of the requested elements for an AI/SaMD study, such as sample size for test and training sets, expert qualifications, and adjudication methods, are not applicable or explicitly mentioned in this document. The device is a physical medical instrument, not an AI algorithm.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for a physical medical device, specific "acceptance criteria" and "device performance" in the context of an AI algorithm's metrics (e.g., sensitivity, specificity) are not present. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various specifications and bench testing.
| Criterion Type | Description |
|---|---|
| Substantial Equivalence | The FINECROSS™ MG Coronary Micro-Guide catheter is substantially equivalent in intended use, design, principle of operation/technology, materials, and performance to the predicate devices (Rapidtransit and Tornus). |
| Bench Testing | Performance was shown through bench testing, demonstrating equivalence to the predicate devices. The specific tests and their outcomes are not detailed, but they would typically cover aspects like mechanical strength, lubricity, guidewire support, and contrast injection capability. |
| Biocompatibility | Blood contacting materials were tested in accordance with ISO 10993 and found to be biocompatible for "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)". |
| Sterilization | Validated in accordance with EN ISO 11135-1 to provide a Sterility Assurance Level of 10-6. |
| Physical Specifications | - Usable length: 1300 and 1500mm |
- Outer diameter (distal end): 1.8Fr (0.60mm)
- Outer diameter (proximal end): 2.6Fr (0.870mm)
- Inner diameter: 0.018" (0.45mm) to 0.0221" (0.55mm)
- Radiopaque markers: 1 |
| Expiration Dating | 2 years. |
2. Sample size used for the test set and the data provenance
Not applicable for this type of device. The "test set" in this context would refer to physical prototypes undergoing bench testing, not a dataset for an AI algorithm. The document states "bench testing" was performed, but does not specify sample sizes or data provenance for these physical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of AI refers to expert-labeled data. For a physical device, testing is typically against engineering specifications and predicate device performance, not expert-established ground truth in the AI sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a method for resolving discrepancies in expert labeling for AI ground truth.
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 device is a physical catheter, not an AI or software assistant for human readers. Therefore, an MRMC study related to AI assistance would not be performed for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this physical device, the "ground truth" would be established by engineering specifications, validated test methods, and direct comparison to the performance characteristics of the legally marketed predicate devices, rather than expert consensus on medical images or pathology.
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. There is no training set for this physical device.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).