EN SNARE ENDOVASCULAR SNARE SYSTEM

K092343 · Merit Medical Systems, Inc. · MMX · Aug 7, 2009 · Cardiovascular

Device Facts

• Record ID: K092343
• Device Name: EN SNARE ENDOVASCULAR SNARE SYSTEM
• Applicant: Merit Medical Systems, Inc.
• Product Code: MMX · Cardiovascular
• Decision Date: Aug 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EN Snare Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access venipuncture procedure assistance.

Device Story

EN Snare Endovascular Snare System consists of snare, catheter, snare introducer, and torque device. Snare features 3 cable loops secured to shaft wire. Device introduced through catheter; manipulated via external torque device. Snare introducer facilitates back-end loading into pre-placed catheter. Used in cardiovascular system or hollow viscous by clinicians to retrieve/manipulate foreign objects, reposition indwelling venous catheters, strip fibrin sheaths, and assist with central venous access. Mechanical operation; no electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

System comprises snare (3 cable loops on shaft wire), catheter, snare introducer, and torque device. Mechanical design; no energy source, software, or electronic components. Materials and design identical to predicate.

Indications for Use

Indicated for use in the cardiovascular system or hollow viscous for retrieval and manipulation of foreign objects, including indwelling venous catheter repositioning, fibrin sheath stripping, and central venous access venipuncture assistance.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• EN Snare® Endovascular Snare System (K021606)

Submission Summary (Full Text)

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AUG 0`7 2009

Merit Medical Systems, Inc.
EN Snare® Endovascular Snare System Traditional 510(k) Premarket Notification Section 5
510(k) Summary

K097343

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# Section 5

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## 510(k) Summary

| General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date of Preparation:<br>Registration Number: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>[phone]<br>[phone]<br>Glenn Norton<br>July 30, 2009<br>1721504 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject<br>Device | Trade Name:<br>Common/Usual Name:<br>Regulation Name:<br>Manufacturer: | EN Snare® Endovascular Snare System<br>Intravascular snare and catheter<br>Device, Percutaneous Retrieval<br>Merit Medical Systems, Inc |
| Predicate<br>Device | Trade Name:<br>Common/Usual Name:<br>Regulation Name:<br>Manufacturer:<br>Premarket Notification:<br>Decision Date: | EN Snare® Endovascular Snare System<br>Intravascular snare and catheter<br>Device, Percutaneous Retrieval<br>Medical Device Technologies, Inc<br>K021606<br>05/31/2002 |
| Classification | Class II<br>Embolectomy Catheter<br>21 CFR § 870.5150, 74 MMX<br>Division of Cardiovascular Devices | |
| Intended Use | The EN Snare Endovascular Snare and Catheter is intended for use<br>in the cardiovascular system or hollow viscous to retrieve and<br>manipulate foreign objects. Manipulation procedures include<br>indwelling venous catheter repositioning, indwelling venous catheter<br>fibrin sheath stripping, and central venous access venipuncture<br>procedure assistance. | |
| Device<br>Description | The <i>EN Snare</i> ® Endovascular Snare System consists of four<br>individual components: snare; catheter; snare introducer; and torque<br>device. | |
| | The snare is comprised of 3 cable loops which are secured to a shaft<br>wire. The construction of the snare enables it to be introduced<br>through a catheter and manipulated by use of an external torque<br>device. A snare introducer is also included for optional back-end<br>loading of the snare into a pre-placed catheter. | |
| Technological<br>Characteristics | There are no technological differences between the subject and<br>predicate devices. The system is manufactured with identical<br>design, materials and processes as that of the currently marketed<br><i>EN Snare</i> ® Endovascular Snare System. | |
| Safety &<br>Performance<br>Tests | No safety or performance testing is required to establish the safety<br>and efficacy of the subject device. | |
| Summary of<br>Substantial<br>Equivalence | The <i>EN Snare</i> device built by Merit is substantially equivalent to the<br><i>EN Snare</i> device legally marketed by MD Tech via 510(k) K021606,<br>due to identical intended use, design specifications, material<br>specifications, manufacturing specifications and technological<br>characteristics. | |

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K0923413 page 1 of 1

Merit Medical Systems, Inc.
EN Snare® Endovascular Snare System Traditional 510(k) Premarket Notification

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Section 5 510(k) Summary

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-609 Silver Spring, MD 20993-0002

AUG 0 7 2009

Merit Medical Systems, Inc. c/o Glenn Norton 1600 West Merit Pkwy. South Jordan, UT 84095

Re: K092343

Trade/Device Name: EN Snare Endovascular Snare System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: MMX Dated: July 30, 2009 Received: August 3, 2009

## Dear Mr. Norton:

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.

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

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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

uma R. Kirchner

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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K0923343 page lot.1

Merit Medical Systems, Inc. EN Snare® Endovascular Snare System Traditional 510(k) Premarket Notification

Section 4 Indications for Use Statement

### Section 4

#### Indications for Use Statement

KO92343

510(k) Number (if known):

Device Name: EN Snare® Endovascular Snare System

Indications for Use:

The EN Snare Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.

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. V. Aimes

Sign-Off)
Division of Cardiovascular Devices

510(k) Number_

20