HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS

K101570 · Micro Therapeutics Dba Ev3 Neurovascular · MJN · Jul 13, 2010 · Cardiovascular

Device Facts

• Record ID: K101570
• Device Name: HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS
• Applicant: Micro Therapeutics Dba Ev3 Neurovascular
• Product Code: MJN · Cardiovascular
• Decision Date: Jul 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ev3 Occlusion Balloon Catheters are intended for use in the peripheral and neuro vasculature wherever temporary occlusion is desired as well as for balloonassisted embolization of intracranial aneurysms.

Device Story

Single lumen, open-ended balloon catheter; designed for advancement over 0.010" guidewire. Inflation mechanism: guidewire advancement through open distal end redirects inflation media to balloon via side holes in catheter wall. Used in peripheral and neuro vasculature for temporary occlusion and balloon-assisted embolization of intracranial aneurysms. Operated by physicians in clinical settings. Provides temporary vessel occlusion to assist in embolization procedures.

Clinical Evidence

No clinical or animal data were included in this submission. Bench testing only.

Technological Characteristics

Single lumen, open-ended balloon catheter. Diameters: 3-7 mm; lengths: 7-30 mm. Compatible with 0.010" guidewire. Sterile, single-use. Mechanical inflation via guidewire-directed media flow.

Indications for Use

Indicated for temporary vascular occlusion in peripheral and neuro vasculature and for balloon-assisted embolization of intracranial aneurysms.

Regulatory Classification

Identification

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

Predicate Devices

• K990487
• K001237
• K010162
• K011526
• K011656
• K021066
• K090728
• K091458
• K092495
• K100063

Submission Summary (Full Text)

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K101570

### 510(k) Summary

JUL 1 3 2010

### ev3 Occlusion Balloon Catheters

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.

| Submitter Information: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular<br>9775 Toledo Way<br>Irvine, CA 92618 |
|------------------------|-----------------------------------------------------------------------------------------|
| Contact Person: | Laurie Cartwright<br>Manager, Global Regulatory Affairs |

Summary Date: 27 May 2010

#### II. Device Name

| Proprietary: | HYPERGLIDE ^TM and HYPERFORM ^TM |
|-----------------|------------------------------------------------------|
| Common: | Occlusion Balloon Catheter |
| Classification: | II |
| Product Code: | MJN |
| CFR Section: | 21 CFR 870.4450 |

#### III. Predicate Devices

The ev3 Occlusion Balloon Catheters are substantially equivalent to the previously cleared occlusion balloon catheters cleared under 510(k)s K990487, K001237, K010162, K011526, K011656, K021066, K090728, K091458, K092495 and K100063.

#### IV. Device Description

The ev3 Occlusion Balloon Catheters are single lumen, open-ended balloon catheters designed for advancement into the vasculature over a 0.010" guidewire. Balloon inflation is accomplished by advancement of the guidewire through the open distal end of the balloon, redirecting inflation media to the balloon through side holes in the catheter wall.

The Occlusion Balloon Catheters are available in diameters ranging from 3 to 7 mm and lengths ranging from 7 to 30 mm.

The devices are packaged in a sterile pouch and are intended for single use only.

#### V. Intended Use

The ev3 Occlusion Balloon Catheters are intended for use in the peripheral and neuro vasculature wherever temporary occlusion is desired as well as for balloonassisted embolization of intracranial aneurysms.

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#### Nonclinical Data VII.

No nonclinical data was included in this submission.

#### VIII. Clinical Data

No clinical or animal data were included in this submission.

#### Conclusions IX.

The ev3 Occlusion Balloon Catheters are substantially equivalent to the previously The CVS Occludion Balloon Satholor Clearers on Balloon Systems.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

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

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

JUL 1 3 2010

Re: K101570

HyperGlide and HyperForm Occlusion Balloons Regulation Number: 21 CFR§ 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II (Two) Product Code: MJN Dated: May 27, 2010 Received: June 4, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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/ReportalProblem/default.htm for the CDRH's Office of 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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcestoYou/Industry/default.htm.

Sincerely yours.

una R. Varner

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

Enclosure

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# Indications for Use

510(k) Number (if known): K10 | 570

HYPERGLIDE™ and HYPERFORM™ Occlusion Balloon Systems Device Name:

## Indications for Use:

The ev3 Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral The BVS Occusion Balloon Outlotors are indication is desired. These catheters offer a vessely aria neuro vasculature where temporary ooskular is which is useful in selectively stopping
selective technique of temporary vascular occlusion, which is useful in selectively selective lechnique of temporary valocular Catheters may also be used in balloonassisted embolization of intracranial aneurysms.

Prescription Use |X (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Vi line

(Division Sign-Off) Division of Cardiovascular Devices Page 1 of 1

510(k) Number_K_10) 570