MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM

• K Number: K021066
• Device Name: MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM
• Manufacturer: MICRO THERAPEUTICS, INC.
• Date Cleared: 2002-06-18 ( 77 days)
• Product Code: MJN
• Regulation Number: 870.4450
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The MTI HyperGlide™ Occlusion Balloon Catheter is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The MTI Modified Occlusion Balloon Catheter offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow.

Device Description

The HyperGlide™ Occlusion Balloon Catheter is a single lumen balloon catheter with at maximum outer diameter of 2.8F tapering to 2.2F at the distal tip. The distal end of the catheter has a non-detachable low inflation pressure compliant balloon. The catheter is designed to track over the MTI 0.010" guidewire, and requires insertion of the guidewire to occlude the catheter shaft lumen to allow inflation of the balloon. Two platinum markers provide angiographic visualization of the balloon length and facilitate intravascular placement of the balloon prior to inflation. The catheter shaft is hydrophilically coated to assist catheter advancement within the vasculature. The HyperGlide catheter is supplied sterile for single use or as a system, which includes the required 0.010" guidewire.

AI/ML Overview

The provided documentation for the Micro Therapeutics, Inc. HyperGlide™ Occlusion Balloon Catheter does not describe a study involving an AI device or algorithm, and thus does not contain the specific information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 related to AI device performance, sample sizes for test/training sets, expert ground truth, or adjudication methods.

Instead, this document is a 510(k) Summary for a conventional medical device (an occlusion balloon catheter), detailing its substantial equivalence to a predicate device based on performance testing against established standards.

Here's an analysis of what the document does provide regarding acceptance criteria and testing:

Acceptance Criteria and Study for the HyperGlide™ Occlusion Balloon Catheter (Non-AI Device)

The "TESTING" section of the 510(k) Summary states: "Performance testing of the HyperGlide catheter was conducted in accordance with ISO 10555 Sterile, Single Use Intravascular Catheters- Parts 1 and 4 and Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, and Intravascular Stents (Draft May 1995)."

This indicates that the acceptance criteria are implicitly defined by the requirements outlined in these standards and guidance documents. These standards typically cover aspects such as:

• Sterility: Ensuring the device is free from microorganisms.
• Biocompatibility: Showing the device material is safe for contact with the body.
• Physical and Mechanical Performance: This would include criteria related to:
  • Catheter dimensions: Outer diameter, length, balloon dimensions.
  • Inflation/deflation time for the balloon.
  • Burst pressure/integrity of the balloon.
  • Trackability/pushability (how easily it navigates through vessels).
  • Tensile strength (resistance to breaking).
  • Connection strength (e.g., between balloon and catheter shaft).
  • Guidewire compatibility: Ensuring it tracks over the specified guidewire.
  • Hydrophilic coating integrity.
  • Radiopacity of markers.
• Packaging integrity.
• Shelf life.

Study that Proves Device Meets Acceptance Criteria:

The document states that "Performance testing" was conducted. This implies a series of laboratory-based, benchtop, and potentially in vitro (or ex vivo) tests designed to verify adherence to each specific requirement within the cited ISO standards and FDA guidance.

Specific Information Requested (and why it's not present for this document):

1. Table of acceptance criteria and reported device performance:

   • Not provided in the summary. The summary states that performance testing was done according to standards, but does not list the specific numerical criteria or the measured performance values. This level of detail would typically be found in the full 510(k) submission and associated test reports, not a public-facing summary.

2. Sample size used for the test set and data provenance:

   • Not applicable/Not provided for this type of device and study. For mechanical device testing, sample sizes are usually determined by statistical methods for specific tests (e.g., n=5 or n=10 for burst pressure, tensile strength, etc.) to ensure statistical significance for demonstrating reliability. Data provenance would be from internal lab testing.

3. Number of experts used to establish ground truth and qualifications:

   • Not applicable. This pertains to studies where human interpretation (e.g., image reading) is a component of the ground truth. For a physical device like a catheter, "ground truth" is measured repeatedly and objectively by laboratory equipment and calibrated tools.

4. Adjudication method for the test set:

   • Not applicable. Adjudication is relevant for consensus-based ground truth (e.g., expert panel review). Physical performance testing does not involve adjudication.

5. MRMC comparative effectiveness study, effect size of human improvement with AI:

   • Not applicable. This device is not an AI algorithm.

6. Standalone (algorithm-only) performance:

   • Not applicable. This device is not an AI algorithm.

7. Type of ground truth used:

   • Direct physical measurement against established engineering and safety standards. For example, the "ground truth" for balloon burst pressure is the pressure at which the balloon statistically fails, measured by a manometer and pressure test rig. The "ground truth" for trackability might be a subjective assessment by an engineer navigating it through a tortuous path model, or quantifiable metrics like force required.

8. Sample size for the training set:

   • Not applicable. This device is not an AI algorithm that learns from data.

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

   • Not applicable. This device is not an AI algorithm.

In summary: The provided document describes a regulatory submission for a physical medical device. It attests that the device underwent performance testing in accordance with relevant international standards and FDA guidance to demonstrate its substantial equivalence to a predicate device, but it does not involve any AI technology or the associated study design elements relevant to AI validation.

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).