MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO

K103780 · Micrus Endovascular Corporation · MJN · Jan 26, 2011 · Cardiovascular

Device Facts

• Record ID: K103780
• Device Name: MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO
• Applicant: Micrus Endovascular Corporation
• Product Code: MJN · Cardiovascular
• Decision Date: Jan 26, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Micrus Ascent Occlusion Balloon Catheters are intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheters are also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.

Device Story

Coaxial dual-lumen balloon catheter; inner lumen for .014" or smaller guidewire; outer lumen for balloon inflation/deflation. Features vent hole for air removal; radiopaque markers for fluoroscopic positioning. Used by physicians in clinical settings for temporary blood flow control or agent delivery. Device deployed over guidewire; balloon inflated to occlude vessel; allows selective flow control. Benefits include precise vessel access and controlled delivery of therapeutic/diagnostic agents. Modifications from predicate include extended balloon coating, tighter PTFE inner liner tolerance, rectangular vent hole, and improved proximal section fusing.

Clinical Evidence

In-vivo study in a porcine model (n=7 devices) demonstrated effective deployment, physician-accepted trackability, and stable balloon positioning. In-vitro bench testing verified balloon cycling, fatigue, burst diameter/volume, pressure, inflation/deflation function, and coating integrity.

Technological Characteristics

Coaxial dual-lumen catheter; PTFE inner liner; radiopaque marker bands. Compatible with .014" guidewires. Features rectangular vent hole for air removal. Sterilized device. No electronic or software components.

Indications for Use

Indicated for patients requiring temporary vascular occlusion or delivery of diagnostic/therapeutic agents (e.g., contrast media, occlusion coils) in peripheral and neuro vasculature.

Regulatory Classification

Identification

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

Predicate Devices

• Micrus Ascent and Summit Occlusion Catheter (K091504)

Submission Summary (Full Text)

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Ascent Occlusion Balloon Catheters 510(k) Premarket Notification

K103780

## 510(k) Summary

(

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JAN 2 6 2011

## Micrus Endovascular Corporation Micrus® Ascent® Occlusion Balloon Catheter

This 510(k) Summary for the Micrus Ascent Occlusion Balloon Catheter is submitted in accordance with the requirements of 21 C.F.R. § 807.92.

#### GENERAL INFORMATION

| Manufacturer: | Micrus Endovascular Corporation<br>821 Fox Lane<br>San Jose, CA 95131<br>Phone: [phone],<br>Est. Registration No. 2954740 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patrick Lee<br>Manager, Regulatory Affairs<br>Phone: [phone]<br>[e-mail] |

Date Prepared: December 21, 2010

### DEVICE CLASSIFICATION

| Classification: | Class II |
|----------------------|--------------------------------------------------------------------|
| Trade Names: | Micrus® Ascent® Occlusion Balloon Catheter |
| Generic/Common Name: | catheter, intravascular occluding, temporary<br>(21CFR § 870.4450) |

# PREDICATE DEVICES

- 510(k) no. K091504, Micrus Ascent and Summit Occlusion Catheter, June 19, 2009 ●
# INDICATIONS FOR USE

The Micrus Ascent Occlusion Balloon Catheters are intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheters are also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.

·

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## DEVICE DESCRIPTION

The Micrus Ascent Occlusion Balloon Catheters are coaxial dual lumen balloon catheters comprised of an inner guidewire lumen and a separate outer lumen to inflate and deflate the balloon. The balloon catheter is designed for use over any .014" or smaller guidewire. The balloon can be inflated and deflated independently of guidewire position. The balloon is equipped with a vent hole for easy preparation and removal of air from the balloon, and with two radiopaque markers for balloon positioning. Certain balloon catheter sizes may have a third radiopaque marker band 3 cm proximal to the tip to facilitate fluoroscopic visualization.

The modification made to the predicate device included: (1) an extended coating to cover the balloon body, (2) a change to a tighter tolerance on the PTFE inner liner, (3) changing the vent hole size from a circular shape to a larger rectangular shape, (4) modifying a manufacturing step to accommodate a better fusing of the proximal sections, (5) revised IFU to clarify the instructions

# SUBSTANTIAL EQUIVALENCE

The modification to the device has not altered the fundamental technology of the predicate devices. The Micrus Ascent Occlusion Balloon Catheters are substantially equivalent to the predicate device in terms of intended use, design, specifications, methods and materials in construction, packaging, and sterilization and materials.

The tests that were conducted to establish substantial equivalence includes:

- · in-vitro tests, verifying that the modified device met acceptance in terms of:
- . balloon cycling and fatigue
- balloon burst diameter and volume changes
- coating integrity of the balloon �
- . pressure at the design diameter of the balloon
- � inflation and deflation functions
- trackability of the device in a simulated tortuous anatomy .
- . the preparation method is adequate and acceptable
- in-vivo study 1 porcine model with 7 devices, demonstrating that �
- the preparation method is adequate and acceptable
- . the device deployed effectively and as expected in a animal model
- . the trackability of the device met physicians' acceptance
- the balloon remained stable in position after placement

### CONCLUSION

As described in this 510(k) Summary, Micrus Endovascular Corporation considers the modified Micrus Ascent Occlusion Balloon Catheters to be as safe, as effective, and performs as well as or better than the legally marketed device.

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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, composed of three curved lines that suggest wings and a head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

Micrus Endovascular Corp. c/o Mr. Patrick Lee Manager of Regulatory Affairs 821 Fox Lane San Jose, CA 95131

JAN 2 6 2011

Re: K103780

Trade/Device Name: Micrus Ascent Occlusion Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp (Catheter, Intravascular Occluding, Temporary) Regulatory Class: Class II Product Code: MJN Dated: December 21, 2010 Received: December 27, 2010

Dear Mr. Lee:

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.

:

. . . . . . .

and the same of the same of

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Page 2 - Mr. Patrick Lee

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 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.

Sincerely yours,

Evelyn Hammond

Malvina B. Eydelman, M Director Division of Ophthalmic. Neurological. and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K103780 510(k) Number (if known): _ _ _ _

Device Name: Micrus Ascent Occlusion Balloon Catheter

## Indications For Use:

The Micrus Ascent Occlusion Balloon Catheters are intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheters are also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.

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)

JOE HUNTER

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K103780 510(k) Number

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