(142 days)
The Asahi Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system.
The Asahi Angiographic Catheter consists, as its basic structure, of a tube to be inserted into vascular, a proximal hub, and strain relief for the joint section of the first 2 parts. The tube is reinforced by stainless steel braid. The distal tip of the catheter is made soft and has variety configuration in order to easily bend in accordance with the vessel curve. The tube is radiopaque in whole length so as to be easily confirmed its position under radioscopy.
The provided text describes a 510(k) premarket notification for the Asahi Angiographic Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria in the manner one would see for novel AI software.
Therefore, the following information is extracted and presented as per the request, but many fields will be marked as "Not Applicable" or "Not Provided" due to the nature of this submission being for a physical medical device demonstrating equivalence, not an AI/software device with specific performance metrics.
Acceptance Criteria and Study Details for Asahi Angiographic Catheter
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Biocompatibility: Compliance with ISO-10993 series | "The contact materials used to fabricate the Asahi Angiographic Catheters pass the testing required by ISO-10993 series." These materials are "currently used in many disposable medical devices." |
| Bench Testing: Performance similar to predicate devices for relevant characteristics (e.g., tube structure, radiopacity, distal tip flexibility, diameter, length) | "[Bench testing was conducted] to demonstrate that the Asahi Angiographic Catheter met the acceptance criteria and performed similarly to the predicate devices." "The Asahi Angiographic Catheters are made of the same materials, available in the same diameters and lengths, have the same design and indications for use as the predicate devices and other currently marketed angiographic catheters." |
| Intended Use: Delivery of radiopaque contrast medium to selected sites in the vascular system. | "The Asahi Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system." (Demonstrated to be the same as predicate devices). |
Note: The submission focuses on demonstrating substantial equivalence to predicate devices (K960975, K970854, K862006) by showing that the new device has the same technological characteristics, materials, and intended use. Specific quantitative acceptance criteria (e.g., "burst pressure > X psi" or "flow rate > Y mL/s") are not explicitly stated in this summary, but rather implied by "met the acceptance criteria and performed similarly to the predicate devices."
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not provided. The submission refers to "bench and biocompatibility testing" without specifying the number of units tested.
- Data Provenance: Not provided. The testing was conducted by Asahi Intecc Co., Ltd. (Japan) but further details on the location or nature of the test subjects (if applicable beyond bench testing) are not given. It is implied to be prospective testing for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. For a physical device like an angiographic catheter, ground truth is typically established through engineering specifications, material standards, and functional bench testing, not expert interpretation of outputs.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Performance is evaluated against engineering standards and comparison to predicate devices, not through expert adjudication of results that would typically apply to interpretative diagnostic devices.
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
- MRMC Study: Not applicable. This is a physical medical device, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used
- Type of Ground Truth: Engineering specifications, material standards (ISO-10993 series for biocompatibility), and performance benchmarks established by legally marketed predicate devices.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is a physical medical device, not an AI software that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. No training set was used.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).