Search Results

The SUPERPIPE Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system.

Angiographic Catheter consists of a catheter hub, a strain relief tubing, catheter shaft (including braided section and non-braided section) and catheter tip. It is comprised of a two-layer construction featuring stainless steel mesh sandwiched between layers of polyamide elastomers of the catheter braided section. The non-braided section is comprised of layers of polyamide elastomers. And the soft catheter tip is comprised of the mixture of polyurethane and polyamide elastomers. The device is offered in lengths of 80cm, 100cm and 110cm.

This is a 510(k) summary for the SUPERPIPE Angiographic Catheter, which is a medical device for delivering radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria in a study involving AI or human readers for diagnostic tasks.

Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them, especially in the context of AI and human reader performance, is not available in this document. This document details the engineering and biocompatibility testing performed to demonstrate that the device is safe and effective for its intended use, mainly comparing it to a predicate device.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

The document lists performance tests conducted, but it does not explicitly state specific quantitative acceptance criteria or the numerical results/performance metrics for each test. Instead, it states that "Performance (bench) testing and biocompatibility testing were performed to demonstrate that the proposed device performs as intended and does not raise new questions of safety or efficacy compared to the predicate devices."

The tests performed include:

• Non-Clinical Performance Testing (per ISO 10555-1):

  • Catheter Sizes
  • Catheter Surface
  • Catheter Color
  • Side Holes
  • Catheter Hub
  • Distal Tip
  • Distal Shape
  • Freedom from Leakage
  • Peak Tensile Force of Catheter
  • Burst Pressure under Static Conditions
  • Radio-detectability
  • Torsion Transmissibility
  • Torque strength
  • Kink test
  • Push and withdrawal Ability
  • Simulated Use
  • Flow rate
  • EO and ECH Residual
  • Sterile
  • Bacterial Endotoxin
  • Visual Inspection test of the inner pouch
  • Sealing-strength of the Inner Pouch
  • Dye Leakage Test of the Inner Pouch

• Biocompatibility Testing:

  • Cytotoxicity study
  • Sensitization study
  • Intracutaneous study
  • Acute systemic toxicity study
  • Pyrogen study
  • Hemolysis study
  • In-vivo thromboresistance study
  • Complement activation assay

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 in the document. The testing described is bench testing and biocompatibility testing, not clinical studies involving patient data or test sets in the context of AI performance evaluation.

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 applicable and not provided. The device is an angiographic catheter, and the evaluation is based on engineering and biocompatibility tests, not diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical imaging context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided.

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

This information is not applicable and not provided. This document does not describe an AI medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. This document does not describe an AI medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable and not provided. The "ground truth" for the performance tests would be the established engineering standards (e.g., ISO 10555-1) and biocompatibility test methods, not clinical outcomes or expert consensus.

8. The sample size for the training set

This information is not applicable and not provided. This document does not describe an AI medical device requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided.

Ask a specific question about this device