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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.

Device Description

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.

AI/ML Overview

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.

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