HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315

K092495 · Ev3 Neurovascular · MJN · Sep 22, 2009 · Cardiovascular

Device Facts

• Record ID: K092495
• Device Name: HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315
• Applicant: Ev3 Neurovascular
• Product Code: MJN · Cardiovascular
• Decision Date: Sep 22, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Single lumen, open-ended balloon catheter; designed for advancement over 0.010" guidewire. Inflation achieved by advancing guidewire through distal end, redirecting inflation media through catheter wall side holes. Used in peripheral and neuro vasculature for temporary blood flow occlusion/control. Packaged with X-pedion™ hydrophilic guidewire. Single use; sterile.

Clinical Evidence

No clinical or animal data included. Substantial equivalence supported by bench testing only.

Technological Characteristics

Single lumen, open-ended balloon catheter. Dimensions include 3 mm size. Inflation via guidewire-directed media flow through side holes. Single use, sterile.

Indications for Use

Indicated for temporary vascular occlusion in peripheral and neuro vasculature to stop or control blood flow.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• HYPERGLIDE Occlusion Balloon System (K011526)
• HYPERGLIDE Occlusion Balloon System (K021066)
• HYPERGLIDE Occlusion Balloon System (K090728)

Reference Devices

• X-pedion™ hydrophilic guidewire (K982543)

Submission Summary (Full Text)

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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

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.

#### Intended Use V.

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.

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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.

ii

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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 [phone] or [phone] 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:

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.

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