(259 days)
The Radifocus Optitorque Angiographic Catheter is indicated for use in 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 comprised of a two-layer construction featuring stainless steel mesh sandwiched between layers of polyurethane and polyamide elastomers. The shaft inner layer and outer layer contain barium sulfate for visibility and contrast under fluoroscopy. A soft tip is attached to the distal portion of some 4 Fr and all 5 Fr and 6 Fr catheters except those with a pigtail design; a soft tube is attached to the distal portion of 5 Fr and 6 Fr catheters with a pigtail design; the 4 Fr products are available with or without a soft tip. Constructed of flexible, supple polyurethane that is permanently welded to the catheter shaft, the soft tip and soft tube are designed to minimize trauma to the vessel wall. There is no change to the design of the device as a result of this submission.
The device is offered in lengths of 65-120 cm. French sizes and shaft inner diameters are as follows:
| French Size | Shaft Inner Diameter |
|---|---|
| 4 | 1.05mm |
| 5 | 1.22mm |
| 6 | 1.32mm |
It is a disposable device intended for single use only. This device is individually packaged and sterilized by ethylene oxide gas.
The provided 510(k) summary describes a medical device, the Radifocus Optitorque Angiographic Catheter, and its performance testing. However, it does not include information about AI/ML device performance, human reader studies, or ground truth establishment relevant to AI/ML. The entire document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing for a material change.
Therefore, many of the requested items related to AI/ML device performance, sample sizes for test/training sets, expert qualifications, and ground truth establishment cannot be extracted from this document.
Here's the information that can be extracted, along with explanations for the missing items:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance/Results |
|---|---|---|
| ISO Standards | Radio-detectability (ISO 10555-1:2013 Section 4.2, ASTM F640-12) | "All samples tested met the standard applicable to each test." |
| Surface (ISO 10555-1:2013 Section 4.4) | "All samples tested met the standard applicable to each test." | |
| Peak tensile force (ISO 10555-1:2013 Section 4.6) | "All samples tested met the standard applicable to each test." | |
| Freedom from leakage (ISO 10555-1:2013 Section 4.7) | "All samples tested met the standard applicable to each test." | |
| Power injection (ISO 10555-1:2013 Section 4.10, Annex F and G) | "All samples tested met the standard applicable to each test." | |
| Distal tip (ISO 10555-1:2013 Section 4.12) | "All samples tested met the standard applicable to each test." | |
| Flow rate (ISO 10555-1:2013 Section 6.3) | "All samples tested met the standard applicable to each test." | |
| Burst pressure (ISO 10555-1:2013 Section 6.3) | "All samples tested met the standard applicable to each test." | |
| Internal Standards | Shaft stiffness (Stiffness of braided-area) | "Meets acceptance criteria" |
| Torque transmission | "Meets acceptance criteria" | |
| Torque strength | "Meets acceptance criteria" | |
| Tensile strength (Shaft) | "Meets acceptance criteria" | |
| Bending strength | "Meets acceptance criteria" | |
| Cleanliness | "Meets acceptance criteria" | |
| Strength of hub junction | "Meets acceptance criteria" | |
| Tensile Strength of soft tip | "Meets acceptance criteria" | |
| Product dimensions (I.D.; O.D.; Tip I.D.; Tip O.D.; Length) | "Meets acceptance criteria" | |
| Embolic cube testing | "Meets acceptance criteria" | |
| Biocompatibility | Cytotoxicity (non-aged and accelerated aged (3 years)) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. A full list of specific acceptance criteria is not provided, but the overall conclusion indicates meeting standards. |
| Sensitization (non-aged) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. | |
| Intracutaneous Reactivity (non-aged) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. | |
| Systemic Toxicity (acute) (non-aged) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. | |
| Pyrogenicity (non-aged) | Certified to be non-pyrogenic in the unopened and undamaged package. Performed in accordance with ISO 10993-11 (2006), ISO 10993-12 (2012), and USP 35, NF 30, 2012 Pyrogen Test (USP Rabbit Test). | |
| Hemolysis (non-aged and accelerated aged (3 years)) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. | |
| Thrombogenicity (non-aged) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. | |
| Complement Activation (Immunology) (non-aged) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. | |
| Chemical Extraction (non-aged and accelerated aged (3 years)) | Results of the testing demonstrate that the device remains biocompatible throughout its shelf life. | |
| Sterilization | Sterility Assurance Level (SAL) | Validated to provide a SAL of 10^-6 per ISO 11135:2014. |
| Ethylene Oxide (EO) Residuals | EO will not exceed 4 mg per device and Ethylene Chlorohydrin (ECH) will not exceed 9 mg per device, meeting requirements for limited exposure devices per ISO 10993-7. | |
| Risk Analysis | ISO 14971 Compliance | "A Product Risk Analysis was conducted... and it was determined that any new risks were adequately captured and mitigated." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical performance and biocompatibility testing for a physical medical device. It does not refer to "test sets" in the context of AI/ML models or clinical data. The testing was performed on "samples" of the device, both non-aged and accelerated aged (3 years). The exact number of samples for each test is not specified, only that "All samples tested met the standard applicable to each test."
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 is not applicable to the information provided. The document concerns a physical medical device and its non-clinical performance, not an AI/ML device that requires expert-established ground truth from clinical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to the information provided. The document concerns a physical medical device and its non-clinical performance, not an AI/ML device that requires adjudication of expert labels.
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 such study was conducted or reported in this document. This filing is for a conventional medical device, not an AI/ML diagnostic aid. The document explicitly states: "This 510(k) does not include data from clinical tests."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device described is not an algorithm or AI/ML product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" or acceptance criteria were derived from recognized consensus standards (ISO, ASTM, USP) and the manufacturer's own internal standards for device functionality and safety. For biocompatibility, it was based on ISO 10993 standards and FDA G95-1 guidance.
8. The sample size for the training set
This is not applicable. There is no AI/ML model or "training set" relevant to this device.
9. How the ground truth for the training set was established
This is not applicable. There is no AI/ML model or "training set" relevant to this device.
§ 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).