The HYPERGLIDE Occlusion Balloon System is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The HYPERGLIDE Occlusion Balloon 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 System is a single lumen, open-ended balloon catheter designed for advancement into the vasculature over a 0.010" quidewire. Balloon inflation is accomplished by advancement of the quidewire through the open distal end of the balloon, redirecting inflation media to the balloon through side holes in the catheter wall. The HYPERGLIDE Occlusion Balloon System is currently cleared for commercial distribution in sizes 4x10, 4x15, 4x20, 5x15 and 5x20. The System is packaged with a 0.010" X-pedion™ hydrophilic guidewire, also manufactured by Micro Therapeutics Inc. d/b/a ev3 Neurovascular, and cleared under K982543. The System is packaged in a sterile pouch and is for single use only.

AI/ML Overview

The provided 510(k) summary (K092495) describes a modification to the HYPERGLIDE™ Occlusion Balloon System. This submission pertains to an occlusion balloon catheter, a physical medical device, not an AI/ML or diagnostic software device. Therefore, many of the requested criteria related to AI/ML device studies (such as MRMC studies, training/test sets, ground truth establishment, expert qualifications, adjudication methods, and standalone performance) are not applicable to this type of submission.

The summary focuses on demonstrating substantial equivalence to previously cleared predicate devices through nonclinical bench testing.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the device was subjected to various tests to demonstrate substantial equivalence. The specific acceptance criteria themselves are not numerically detailed in this summary; rather, it implies that the new 3mm balloon size met the same performance specifications as the existing cleared sizes.

Acceptance Criterion Type	Reported Device Performance
Dimensional Verifications	Conforms to specifications (Implied: new 3mm balloon meets dimensional requirements consistent with predicate device and intended use).
Balloon Compliance	Conforms to specifications (Implied: new 3mm balloon expands and conforms as expected, similar to predicate device).
Balloon Fatigue	Conforms to specifications (Implied: new 3mm balloon withstands repeated inflation/deflation cycles without failure, similar to predicate device).
Burst Testing	Conforms to specifications (Implied: new 3mm balloon withstands specified burst pressures, similar to predicate device).
Inflation/Deflation Timing	Conforms to specifications (Implied: new 3mm balloon inflates and deflates within acceptable timeframes, similar to predicate device).

Study Proving Acceptance Criteria Met:

The study proving the device meets its acceptance criteria is referred to as "various testing" or "nonclinical data". This involved a series of bench tests that are standard for evaluating the mechanical and physical performance of medical devices like occlusion balloon catheters.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the summary. For nonclinical bench testing, the sample size would typically refer to the number of devices or components tested for each specific test (e.g., N=10 for burst testing, N=X for fatigue testing). The summary does not provide these specific numbers.
Data Provenance: The data is nonclinical (bench testing), meaning it was generated in a lab setting, not from patients or animals. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies are not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not Applicable. This is not an AI/ML or diagnostic study requiring expert adjudication of data. The "ground truth" for these tests are physical measurements and outcomes based on engineering specifications and test protocols (e.g., a balloon either bursts at a certain pressure or it doesn't; its dimensions are X or Y).

4. Adjudication Method for the Test Set

Not Applicable. As mentioned above, this is nonclinical bench testing. The results are typically objectively measured and verified against predetermined engineering specifications, not subject to expert adjudication in the way clinical diagnostic studies are.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant to diagnostic interpretation by human readers, often with and without AI assistance, using clinical images/cases. This submission is for a physical medical device (balloon catheter), not a diagnostic tool, and involves no human interpretation of data for diagnostic purposes in the context of this submission.
Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not Applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. "Standalone performance" in this context refers to AI algorithm performance. This device is not an algorithm.

7. The Type of Ground Truth Used

Engineering Specifications and Test Protocols: The "ground truth" for the nonclinical tests would be the established engineering specifications for the device (e.g., a minimum burst pressure, maximum inflation/deflation time, specific dimensional tolerances). The actual test results are then compared against these objective criteria.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. There is no "training set" for this type of submission.

Summary

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K092495

SEP & 2 2009

510(k) Summary

Modification to HYPERGLIDE™ Occlusion Balloon System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

1. Submitter Information: Micro Therapeutics d/b/a ev3 Neurovascular 9775 Toledo Wav Irvine. CA 92618
  Contact Person:

Laurie Cartwright Manager, Global Regulatory Affairs

Summary Date: 13 August 2009

II. Device Name

Proprietary: HYPERGLIDE™ Occlusion Balloon System Common: Occlusion Balloon Catheter Classification: li Product Code: MJN CFR Section: 21 CFR 870.4450

III. Predicate Devices

Micro Therapeutics HYPERGLIDE Occlusion Balloon System cleared under 510(k) numbers K011526, K021066 and K090728.

IV. Device Description

Intended Use V.

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VII. Nonclinical Data

The HYPERGLIDE Occlusion Balloon System was subjected to various testing to demonstrate substantial equivalence to the previously cleared balloon sizes. These tests included dimensional verifications, balloon compliance, balloon fatigue, burst testing, and inflation/deflation timing.

VIII. Clinical Data

No clinical or animal data were included in this submission.

IX. Conclusions

The 3 mm HYPERGLIDE Occlusion Balloon System conforms to its performance specifications and is substantially equivalent to the previously cleared Micro Therapeutics HYPERGLIDE Occlusion Balloon System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

SEP 2 2 2009

Micro Therapeutics Inc. d/b/a ev3 Neurovascular c/o Ms. Laurie Cartwright Manager, Global Regulatory Affairs 9775 Toledo Way Irvine, CA 92618

Re: K092495

Trade/Device Name: HyperGlide Occlusion Balloon System -Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: MJN Dated: August 13, 2009 Received: August 14, 2009

Dear Ms. Cartwright:

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 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.

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Page 2 - Ms. Laurie Cartwright

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Duna R. Verner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

1/092495

Device Name:

HYPERGLIDE™ Occlusion Balloon System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna D. Sd. Jones

(Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number_Kog 2495

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).