HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104

K091458 · Ev3 Neurovascular · MJN · Oct 15, 2009 · Cardiovascular

Device Facts

• Record ID: K091458
• Device Name: HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104
• Applicant: Ev3 Neurovascular
• Product Code: MJN · Cardiovascular
• Decision Date: Oct 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MTI HyperForm™ Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloon-assisted embolization of intracranial aneurysms. The MTI HyperGlide™ Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloon-assisted embolization of intracranial aneurysms.

Device Story

HyperForm and HyperGlide are single-lumen, tapered occlusion balloon catheters; designed for tracking over 0.010" guidewires. Device features non-detachable, low-inflation-pressure, compliant balloon at distal end; requires guidewire insertion to occlude shaft lumen for balloon inflation. Platinum markers provide angiographic visualization. Used by physicians in clinical settings for vessel-selective temporary blood flow control and balloon-assisted embolization of intracranial aneurysms. Output is physical occlusion of vessel; aids clinical decision-making by enabling controlled embolization procedures; benefits patients by facilitating treatment of complex intracranial aneurysms.

Clinical Evidence

No clinical data or bench testing was performed for this submission. Substantial equivalence is supported by the manufacturer's experience and literature review.

Technological Characteristics

Single-lumen tapered catheter; non-detachable, low-inflation-pressure, compliant balloon; 0.010" guidewire compatibility; platinum markers for radiopacity.

Indications for Use

Indicated for patients requiring temporary vascular occlusion in peripheral and neuro vasculature, including 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

• Equinox Occlusion Balloon Catheter (K001237)
• HyperForm Occlusion Balloon Catheter (K011656)
• HyperGlide Occlusion Balloon Catheter (K011526)
• HyperGlide Occlusion Balloon Catheter (K090728)

Submission Summary (Full Text)

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K091458

## 510(k) Summary

OCT 1 5 2009

## HyperForm™ Occlusion Balloon Catheter HyperGlide™ Occlusion Balloon Catheter

A TO BALL A MARK A BALL A BALL A BALL A BALL A BALL A BALL A BALL A BALL A BALA BALA BALA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA BARA

| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of 21 C.F.R § 807.92. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Micro Therapeutics, Inc. dba ev3 Neurovascular |
| Submitter | Micro Therapeutics, Inc.<br>9775 Toledo Way<br>Irvine, CA 92618<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person | Tom Daughters<br>Director, Regulatory Affairs |
| Date Prepared | May 8, 2009 |
| Device Trade Name | HyperForm™ Occlusion Balloon Catheter<br>HyperGlide™ Occlusion Balloon Catheter |
| Device Common Name | Occlusion Balloon Catheter |
| Classification Name | Catheter, Intravascular Occluding, Temporary (21 CFR 870.4450,<br>Product Code MJN |
| Classification Panel | Cardiovascular |
| Predicate Devices | Equinox Occlusion Balloon Catheter (K001237), HyperForm<br>Occlusion Balloon Catheter (K011656), and HyperGlide Occlusion<br>Balloon Catheter (K011526, K090728). |
| Intended use | The MTI HyperForm™ Occlusion Balloon Catheters are indicated for<br>use in blood vessels of the peripheral and neuro vasculature where<br>temporary occlusion is desired. These catheters offer (1) a vessel<br>selective technique of temporary vascular occlusion, which is useful in<br>selectively stopping or controlling blood flow, and (2) for balloon-<br>assisted embolization of intracranial aneurysms. |
| Intended use | The MTI HyperGlide™ Occlusion Balloon Catheters are indicated for<br>use in blood vessels of the peripheral and neuro vasculature where<br>temporary occlusion is desired. These catheters offer (1) a vessel<br>selective technique of temporary vascular occlusion, which is useful in<br>selectively stopping or controlling blood flow, and (2) for balloon-<br>assisted embolization of intracranial aneurysms. |
| Device Description | The HyperForm™ Occlusion Balloon Catheter is a single lumen<br>tapered catheter with a non-detachable low inflation pressure<br>compliant balloon attached to the distal end of the catheter. The<br>catheter is designed to track over a 0.010" guidewire, and requires<br>insertion of the guidewire to occlude the catheter shaft lumen to allow<br>inflation of the balloon. Two platinum markers provide angiographic |
| Performance data | No bench testing and biocompatibility testing was performed to support a determination of substantial equivalence. Results from submitters experience and literature review provides assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. |
| Summary of Substantial<br>Equivalence | The proposed HyperForm™ and HyperGlide™ Occlusion Balloon Catheters are identical to the predicate devices and use the same basic technology as the predicate devices. The proposed devices share the following similarities to the predicate devices:<br>Same intended use (all predicates) Same balloon technology and specifications (all predicates) Same catheter technology and characteristics (all predicates) Same other product technology and specifications (all predicates) |
| Conclusion | Based on the similar indications for use, technological characteristics and performance testing, ev3 believes the HyperForm™ and HyperGlide™ Occlusion Balloon Catheters are substantially equivalent to the Equinox Occlusion Balloon Catheter (K001237), the HyperForm™ Occlusion Balloon Catheter (K011656), and the HyperGlide™ Occlusion Balloon Catheter (K011526, K090728). |

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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 consists of a stylized eagle with three lines representing its body and wings. To the left of the eagle is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

ev3 Neurovascular ATTN: Tom Daughters Director, Regulatory Affairs 9775 Toledo Way Irvine, CA 92618

OCT 1 5 2009

Re: K091458

Trade/Device Name: Hyperform & Hyperglide Occlusion Balloon Catheters Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: September 18, 2009 Received: September 21, 2009

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. Ilsting 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.

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

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forth in the quality systems (OS) 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,

Duna R. Hohner

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Bram 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 Statement

1091458 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: HyperForm™ Occlusion Balloon Catheters

## HyperGlide™ Occlusion Balloon Catheters

Indications for Use:

The MTI HyperForm™ Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vesscl selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloonassisted embolization of intracranial aneurysms,

The MTI HyperGlide™ Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Lielmes
Division Sign-Off)

ivision of Cardiovascular Devices

510(k) Number K091458