(6 days)
The Radifocus Optitorque Angiographic Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.
The Radifocus Optitorque Angiographic Catheter is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyurethane tip that is permanently welded to the catheter shaft.
The provided text is a 510(k) summary for the Radifocus® Optitorque™ Angiographic Catheter. It states that the device is substantially equivalent to a previously cleared device (K992051) and thus does not contain a typical study with acceptance criteria and performance metrics for a new device. Instead, the justification for substantial equivalence relies on the fact that the device is identical in design, materials, and principle of operation to the predicate device, and a risk/hazard analysis was conducted.
Therefore, many of the requested details about acceptance criteria, performance, sample sizes, expert involvement, and ground truth establishment are not applicable or cannot be extracted from this document, as a new clinical performance study was not required or submitted for this specific 510(k).
Here's an attempt to address the points based on the provided text, indicating where information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical/Physical Specifications | |
| Available Sizes | 4 - 6 Fr. |
| Catheter Length | 650 – 1200 mm |
| Maximum Injection Pressure | 4 Fr.: 750 psi 5, 6 Fr.: 1000 psi |
| Material Biocompatibility | Blood contacting materials are biocompatible (tested in accordance with ISO-10993). |
| Sterilization Efficacy | Sterilized to a SAL of 10^-6 (validated in accordance with EN ISO 11135-1). |
| Overall Performance for New Indication | Justified that the performance is substantially equivalent to the predicate device (K992051). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as a formal performance study on a test set (clinical or otherwise with specific sample sizes) for this new 510(k) was not conducted. The submission relies on substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as a specific clinical performance study requiring expert ground truth establishment for this 510(k) was not conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as a specific clinical performance study requiring adjudication for this 510(k) was not conducted.
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
An MRMC study was not conducted, as this is a medical device (angiographic catheter), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an angiographic catheter and does not involve an algorithm. The "Principle of Operation / Technology" states it "is operated manually or by a manual process."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable to this type of device submission. The performance justification relies on compliance with standards for material safety, sterility, and mechanical/physical specifications rather than a comparative ground truth for diagnostic accuracy.
8. The sample size for the training set
This information is not applicable as this is a medical device (angiographic catheter) and does not involve a "training set" in the context of an algorithm or AI model development.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
§ 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).