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):

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.
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.
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.
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.
MRMC comparative effectiveness study, effect size of human improvement with AI:
- Not applicable. This device is not an AI algorithm.
Standalone (algorithm-only) performance:
- Not applicable. This device is not an AI algorithm.
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.
Sample size for the training set:
- Not applicable. This device is not an AI algorithm that learns from data.
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.

Summary

{0}------------------------------------------------

Micro Therapeutics, Inc.
Special 510(k): HyperGlide™ Occlusion Balloon Catheter

Attachment 4

K021066

510(k) Summary

Prepared March 28, 2002

TRADE NAME	HyperGlide™ Occlusion Balloon Catheter
GENERIC NAME	Occlusion Balloon Catheter
CLASSIFICATIONSUBMITTED BY	Class II (21 CFR 870.4450)Micro Therapeutics, Inc.2 GoodyearIrvine, CA 92618CONTACT Tom DaughtersRegulatory Affairs(949) 837-3700
PREDICATE DEVICE	MTI Equinox™ Occlusion Balloon Catheter
DEVICE DESCRIPTION	MTI HyperGlide™ Occlusion Balloon CatheterThe HyperGlide™ Occlusion Balloon Catheter is a single lumen ballooncatheter with at maximum outer diameter of 2.8F tapering to 2.2F at thedistal tip. The distal end of the catheter has a non-detachable low inflationpressure compliant balloon. The catheter is designed to track over the MTI0.010" guidewire, and requires insertion of the guidewire to occlude thecatheter shaft lumen to allow inflation of the balloon. Two platinummarkers provide angiographic visualization of the balloon length andfacilitate intravascular placement of the balloon prior to inflation. Thecatheter shaft is hydrophilically coated to assist catheter advancementwithin the vasculature. The HyperGlide catheter is supplied sterile forsingle use or as a system, which includes the required 0.010" guidewire.
INDICATIONS FOR USE	The MTI Occlusion Balloon Catheter is indicated for use in the bloodvessels of the peripheral and neuro vasculature where temporary occlusionis desired. The MTI Occlusion Balloon Catheter offers a vessel selectivetechnique of temporary vascular occlusion, which is useful in selectivelystopping or controlling blood flow.
TESTING	Performance testing of the HyperGlide catheter was conducted inaccordance with ISO 10555 Sterile, Single Use Intravascular Catheters-Parts 1 and 4 and Guidance for the Submission of Research and MarketingApplications for Interventional Cardiology Devices: PTCA Catheters,Atherectomy Catheters , Lasers, and Intravascular Stents (Draft May 1995).
SUMMARY OFSUBSTANTIALEQUIVALENCE	The MTI HyperGlide™ Occlusion Balloon Catheter is substantiallyequivalent to the predicate device in intended use, principles of operationand performance.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 2002

Mr. Tom Daughters Director of Regulatory Affairs Micro Therapeutics, Inc. 2 Goodyear Irvine, CA 92618

Re: K021066

Trade/Device Name: MTI HyperGlide™ Occlusion Balloon Catheter Regulation Number: 870.4450 Regulation Name: Vascular clamp Regulatory Class: II Product Code: MJN Dated: March 28, 2002 Received: April 2, 2002

Dear Mr. Daughters:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

Page 2 - Mr. Tom Daughters

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Micro Therapeutics, Inc.

Special 510(k): HyperGlide™ Occlusion Balloon Catheter

KO21066

Attachment 2

Indications for Use Statement

510(k) Number (if known): ______________

Device Name:

MTI HyperGlide™ Occlusion Balloon Catheter

The MTI HyperGlide™ Occlusion Balloon Catheter is Indications for Use: 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over the Counter Use
------------------	---	----	----------------------	--

(Per 21 CFR 801.109)

(Division Sign-Off)

Division of General, Restorative and Neurological Devices
Page 20 of 24

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).