(361 days)
The "BIOTEQ" Angiographic Catheter is indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system. The device is for use in the coronary and peripheral vasculature, and not for use in the neurovasculature.
The BIOTEO® ANGIOGRAPHIC CATHETER is with the braided proximal shaft. The distal shaft of the catheter has variety configuration and the tip is made soft to minimize trauma to the vessel wall. It consists of the following major components: Soft Tube, Braiding tube, Screw Cap, F.L.L. Adapter, Adaptor Butterfly.
The provided document pertains to the 510(k) premarket notification for the BIOTEQ® ANGIOGRAPHIC CATHETER. This is a medical device and the document describes performance testing rather than a study typically associated with AI/ML devices that would involve acceptance criteria, sample sizes for test/training sets, ground truth establishment, or expert reviews for diagnostic accuracy.
Therefore, the requested information regarding acceptance criteria and studies typical for AI/ML devices (e.g., sample sizes for test/training sets, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance) cannot be extracted from this document, as it focuses on the physical and biological performance of a catheter.
Here's a breakdown of the performance testing conducted for this device, which serves a similar purpose to acceptance criteria for traditional medical devices:
1. Table of Acceptance Criteria and Reported Device Performance (based on performance testing, not AI/ML metrics):
| Performance Test Category | Specific Test | Acceptance Criteria (Implied by "according to protocols based on international standards and in-house requirements") | Reported Device Performance |
|---|---|---|---|
| Physical Performance | Surface Requirements | Meets established standards for surface finish and integrity. | Achieved |
| Corrosion Resistance | No significant corrosion observed. | Achieved | |
| Strength Test | Withstands specified forces without failure (ee.g., tensile, burst). | Achieved | |
| Leakage Tests (positive pressure, vacuum) | No leakage under specified pressure and vacuum conditions. | Achieved | |
| Flow Rate Test | Achieves specified flow rates for contrast media delivery. | Achieved | |
| Torque Strength Test | Withstands specified torque without failure. | Achieved | |
| Flexibility and Kink Test | Maintains integrity and patency under bending and kinking. | Achieved | |
| Dimensional Verification | Meets specified dimensional tolerances. | Achieved | |
| Particle Test | Within limits for particle shedding. | Achieved | |
| Catheter Twist Transmitting Test | Transmits torque effectively to the distal tip. | Achieved | |
| Catheter Shape Retention | Retains intended shape after use/manipulation. | Achieved | |
| Freedom from leakage and damage under high static pressure conditions | No leakage or damage under specified high static pressure. | Achieved | |
| Aged 3-year Shelf Life Testing | Maintains all performance characteristics after simulated aging (3 years). | Achieved | |
| Packaging Tests | N/A | Maintains sterility and device integrity. | Achieved |
| Biocompatibility Tests | Intracutaneous Reactivity Study | Non-reactive or low reactivity within established limits. | Achieved |
| Guinea Pig Maximization Sensitization Study | Non-sensitizing. | Achieved | |
| Cytotoxicity Testing | Non-cytotoxic. | Achieved | |
| Intramuscular Implant Study (1 week) | Biocompatible; no adverse tissue reaction. | Achieved | |
| Acute Systemic Injection Study | No acute systemic toxicity. | Achieved | |
| Hemolysis (direct and indirect contact) | Non-hemolytic. | Achieved | |
| Thrombogenicity Study ISO | Non-thrombogenic (within limits). | Achieved | |
| Salmonella Typhimurium Reverse Mutation Assay (Ames Test) | Non-mutagenic. | Achieved | |
| Complement Activation Test | Minimal or no complement activation. | Achieved | |
| Material Mediated Pyrogenicity | Non-pyrogenic. | Achieved | |
| Sterilization Validation | ETO Sterilization Validation Study | Achieves sterility assurance level (SAL). | Achieved |
The study supporting these criteria:
The document states: "Performance testing was conducted on the BIOTEO® ANGIOGRAPHIC Catheter to establish substantial equivalence. Testing was conducted according to protocols based on international standards and in-house requirements and included dimensional and functional testing. Additionally, the catheters were subjected to biocompatibility testing per ISO 10993."
Missing Information (as per AI/ML context):
The following points are not applicable or not provided in the context of this traditional medical device submission for an angiographic catheter:
- Sample size used for the test set and the data provenance: Not applicable. Performance testing for physical and biological characteristics does not involve "test sets" in the AI/ML sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and biological testing standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is not an AI/ML diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is defined by established engineering standards, material science properties, biocompatibility guidelines (e.g., ISO 10993), and functional performance specifications.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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).