MERIT ONE SNARE SYSTEM

K122088 · Merit Medical Systems, Inc. · MMX · Dec 5, 2012 · Cardiovascular

Device Facts

• Record ID: K122088
• Device Name: MERIT ONE SNARE SYSTEM
• Applicant: Merit Medical Systems, Inc.
• Product Code: MMX · Cardiovascular
• Decision Date: Dec 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ONE Snare™ endovascular snare system is intended for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. Retrieval and manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access venipuncture procedure assistance.

Device Story

Percutaneous retrieval system comprising snare, snare catheter, introducer, and torque device. Snare features nitinol cable and gold-plated tungsten loop; super-elastic construction allows introduction through catheters without deformation. Catheter includes Pebax body and platinum/iridium radiopaque marker band. Operated by physicians in clinical settings to retrieve/manipulate foreign objects or reposition indwelling venous catheters. Physician manipulates snare via torque device under imaging guidance; radiopaque markers facilitate visualization. Output is mechanical retrieval/repositioning of objects/catheters. Benefits include minimally invasive foreign body removal and catheter management.

Clinical Evidence

Bench testing only. Testing included surface finish, torque strength, torqueability, compatibility, dimensional inspection, radiodetectability, tensile testing, tip flexibility, fracture/flexing tests, corrosion resistance, and leakage testing. Biocompatibility testing included L929 MEM elution, Kligman maximization, intracutaneous injection, systemic injection, rabbit pyrogen test, genotoxicity (Salmonella/E. Coli), and hemocompatibility (in vitro and in vivo dog thrombogenicity study). Packaging and sterilization validation performed per ISO standards.

Technological Characteristics

Materials: Nitinol (snare cable), gold-plated tungsten (snare loop), Pebax (catheter), platinum/iridium (marker band). Principle: Mechanical retrieval via super-elastic snare loop. Dimensions: Not specified. Connectivity: None. Sterilization: Ethylene oxide (ISO 11135:2007). Standards: ISO 11070, ISO 10555-1, ISO 594-1/2, ASTM F2096, ASTM F1929, ASTM F88, ASTM D4169, ASTM F1980, ISO 10993-1.

Indications for Use

Indicated for patients requiring retrieval or manipulation of foreign objects in the coronary and peripheral vascular system or hollow viscous, including indwelling venous catheter repositioning, fibrin sheath stripping, and central venous access 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

• AMPLATZ GOOSE NECK SNARE KIT/CATHETER (K972511)

Submission Summary (Full Text)

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Merit Medical Systems, Inc.
Merit ONE Snare™ system
Traditional Premarket Notification 510(k)

.

4 Section 10 Executive Summary

| | Section $5$ | | DEC | 5 2012 | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--------|--|
| 510(k) Summary | | | | | |
| General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Registration Number: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>[phone]<br>[phone]<br>Stephanie Erskine<br>1721504 | | | |
| | Correspondent Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date of Preparation:<br>Registration Number: | Merit Medical Ireland Ltd.<br>Parkmore Business Park,<br>Galway, Ireland<br>(353) 91 703 761<br>(353) 91 771 888<br>Mark Mullaney<br>23-Nov-2012<br>9616662 | | | |
| Subject<br>Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | Merit ONE Snare™ System<br>Percutaneous retrieval device<br>device, Percutaneous retrieval | | | |
| Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | AMPLATZ GOOSE NECK SNARE KIT/<br>CATHETER<br>catheter, embolectomy<br>K972511<br>ev3 Inc. | | | |
| Classification | Class II<br>21 CFR § 870.5150<br>Division of Cardiovascular Devices | | | | |
| Intended Use | The ONE Snare™ endovascular snare system is intended for use in the<br>coronary and peripheral vascular system or hollow viscous to retrieve and<br>manipulate foreign objects. | | | | |
| | | Retrieval and manipulation procedures include indwelling venous catheter<br>repositioning, indwelling venous catheter fibrin sheath stripping, and central<br>venous access venipuncture procedure assistance. | | | |

.T.

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K122088
page 2 of 4
Section 10
Executive Summary

ONE Snare™ System contains: (1) Snare, (1) Snare Catheter, (1) Introducer and (1) Torque Device. The snare is constructed of nitinol cable and a gold plated tungsten loop. Device The pre-formed snare loop can be introduced through catheters without risk Description of snare deformation because of the snare's super-elastic construction. The snare catheter is constructed of polyether block amide (Pebax®) and contains a platinum/iridium radiopaque marker band. Technological characteristics of the subject Merit ONE Snare™ system are Technological substantially equivalent to those of the predicate, the currently marketed AMPLATZ GOOSE NECK SNARE KIT/ CATHETER, manufactured by ev3 Characteristics Inc., 510(k) K972511. No performance standards have been established under Section 514 of the Food. Drug and Cosmetic Act for these devices. However, a battery of tests performed on the Merit ONE Snare™ system were designed to demonstrate that the device meets critical design specifications as well as clinical performance attributes for its intended use. Where appropriate, the tests were based on the requirements of the following documents: FDA guidance Coronary and Cerebrovascular Guide Wire . Guidance January 1995. ISO 11070: 1998, Sterile Single-Use Intravascular Catheter . Introducers. ISO 10555-1 1995 Sterile, single-use intravascular catheters, . Part 1 - General Requirements. . ISO 594-1:1996, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part Safety & 1: General requirements Performance ISO 594-2:1998, Conical fittings with 6% (Luer) taper for ● Tests syringes, needles and certain other medical equipment - Part 2: Lock fittings ASTM F 2096-11; Standard Test Method for Detecting Gross . Leaks in Medical Packaging by Internal Pressurization (Bubble Test) . ASTM F 1929-98 (Reapproved 2004); Standard Test Method for Detecting Seal Leaks in porous Medical Packaging by Dye Penetration ASTM F 88-09; Standard Test Method for Seal Strength of . Flexible Barrier Materials. ASTM D4169 - 09 Standard Practice for Performance Testing ● of Shipping Containers and Systems ASTM F1980-07 Standard Guide for Accelerated Aging of . Sterile Barrier Systems for Medical Devices

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## Merit Medical Systems, Inc. Merit ONE Snare™ system Traditional Premarket Notification 510(k)

- ISO 11135:2007 Sterilization of health care products --. Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 10993-1: 2009, Biological Evaluation of medical Devices Part 1: Evaluation and Testing within a risk management process, and the FDA Modified ISO 10993 Test Profile FDA Memo G95-1.

The Merit ONE Snare™ system was compared to the predicate device for various performance attributes that demonstrate substantial equivalence. The following is a list of all significant testing that was successfully completed:

ONE Snare System (Snare device, Catheter, Introducer and Torque Device)

- Surface Finish, Torque Strength, Torqueability, Compatibility of . snare with snare catheter, Snare Catheter to Guiding Catheter compatibility, Snare introducer fit, Introducer Removal Force from Snare and Dimensional Inspection
#### Snare

- Radiodetectability (Snare wire), Size Designation, Tensile Test, � Tip Flexibility, Fracture Test & Flexing Test and Corrosion resistance
## Catheter & Introducer

- Radiodetectability (Snare catheter / marker bands), Catheter Atraumatic Tip Finish. Marker Band Retention. Force at break (at Catheter Tip and Junction between Catheter Hub and Tube), Catheter Pushability (kink or accordion resistance) & Catheter flexibility (buckling resistance), Hub with Female Luer testing, Dimensions, Freedom from leakage, Surface Finish, Force at break (Junction between Introducer Hub and Tube), Corrosion resistance and Snare Torque Strength.
Biocompatibility testing included

- L929 MEM Elution: MEM extraction .
- Kligman Maximization: Saline and cottonseed oil extractions .
- Irritation Intracutaneous Injection Test Intracutaneous Injection: . Saline and cottonseed oil extractions
- . Systemic Injection: Saline and cottonseed oil extractions
- Material Medicated Rabbit Pyrogen Test: Saline extraction .
- Genotoxicity Salonella typhimurium and Escherichia Coli Reverse t Mutation Assay - ISO
- . Hemocompatibility - Rabbit Blood - Indirect
- Hemocompatibility Rabbit Blood direct .
- Hemocompatibility Complement Activation Assay ISO direct . Contact
- . Hemocompatibility - In Vivo Thrombogenicity study in Dogs
- USP Physicochemical Tests for Plastics USP <661> Non-Volatile . Residue

Safety & Performance Tests (continued)

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Merit Medical Systems, Inc.
Merit ONE Snare™ system
Traditional Premarket Notification 510(k)

______________________________________________________________________________________________________________________________________________________________________________

4 Section 10 Executive Summary

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| | Packaging performance before and after exposure to accelerated aging and<br>simulated shipping and handling conditions | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Safety &<br>Performance<br>Tests<br>(continued) | bubble emission dye penetration seal peel tensile strength burst strength visual inspection | |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, design, safety, and performance testing,<br>the subject Merit ONE Snare™ system meets the requirements that are<br>considered essential for its intended use and is substantially equivalent to<br>the predicate device, the currently marketed AMPLATZ GOOSE NECK<br>SNARE KIT/CATHETER, manufactured by ev3 Inc. | |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping human profiles, representing the department's focus on people and health.

#### · Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

> DEC 5 2012

Merit Medical Systems, Inc. Mr. Mark Mullaney Regulatory Affairs Manager 1600 West Merit Parkway South Jordan, UT 4095

Re: K122088

Trade/Device Name: Merit ONE Snare System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: November 22, 2012 Received: November 26, 2012

### Dear Mr. Mullaney:

We have reviewed vour Section 510(k) premarket notification of intent to market the device i 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.

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 (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,

Kenneth J.

# Cavanaugh®

for 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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## Section 4

## Indications for Use Statement

K122088

510(k) Number (if known):

Device Name: Merit ONE Snare™ System

## Indications for Use:

The ONE Snare™ endovascular snare system is intended for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects.

Retrieval and manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access venipuncture procedure assistance

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)

K

vision Sign-Off) vision of Cardiovascular Devices

510(k) Number \$\underline{K*{1} \geq 2*{0} \gamma 8}\$