ONE Snare Endovascular Microsnare System

K142265 · Merit Medical Systems, Inc. · MMX · Nov 13, 2014 · Cardiovascular

Device Facts

• Record ID: K142265
• Device Name: ONE Snare Endovascular Microsnare System
• Applicant: Merit Medical Systems, Inc.
• Product Code: MMX · Cardiovascular
• Decision Date: Nov 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ONE Snare Endovascular Microsnare System is intended for use in adult and pediatric populations for the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial anatomy.

Device Story

The ONE Snare Endovascular Microsnare System is a percutaneous retrieval device used by physicians in clinical settings to remove foreign bodies from the cardiovascular and extracranial systems. The system consists of a nitinol cable snare with a gold-plated tungsten loop, a Pebax snare catheter with a platinum/iridium radiopaque marker, an insertion tool, and a torque device. The device is introduced percutaneously; the super-elastic nitinol construction allows the pre-formed snare loop to pass through catheters without deformation. The physician uses the radiopaque marker to guide the snare to the target site under imaging. Once positioned, the snare is manipulated to capture the foreign body, facilitating its removal. This minimally invasive approach benefits patients by providing a safe method for retrieving misplaced or embolized foreign objects, potentially avoiding more invasive surgical interventions.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included mechanical performance (tensile strength, torque, kink resistance, catheter integrity), biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity, hemolysis, thrombogenicity, complement activation), and packaging/sterilization validation (bubble test, dye penetration, seal strength, accelerated aging).

Technological Characteristics

Materials: Nitinol cable, gold-plated tungsten loop, Pebax catheter, platinum/iridium marker. Features: Super-elastic snare loop, torque device, insertion tool. Standards: ISO 11070:1998, ISO 10555-1:2013, ISO 594-1/2 (Luer), ASTM F2096, F1929, F88, D4169, F1980, ISO 2233, ISO 11135 (EtO sterilization), ISO 10993-1. Connectivity: None (mechanical device).

Indications for Use

Indicated for adult and pediatric patients requiring retrieval and manipulation of atraumatic foreign bodies in coronary, peripheral cardiovascular, and extracranial anatomy.

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

• Amplantz "GOOSE NECK" Microsnare (K970668)

Reference Devices

• Merit Medical ONE Snare System (K122088)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing ribbon-like element connecting them.

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

November 13, 2014

Merit Medical Systems, Inc. Siobhan King RA Specialist II Parkmore Business Park West Galway, Ireland

Re: K142265

> Trade/Device Name: One Snare Endovascular Microsnare System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: August 12, 2014 Received: August 15, 2014

Dear Ms. Siobhan King,

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Melissa A. Torres -S

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142265

Device Name

ONE Snare Endovascular Microsnare System

### Indications for Use (Describe)

The ONE Snare Endovascular Microspare System is intended for use in adult and pediations for the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extracranial anatomy.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

{3}------------------------------------------------

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

______________________________________________________________________________________________________________________________________________________________________________

# 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>Mark Mullaney<br>11-Nov-14<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>[phone]<br>[phone]<br>Siobhan King<br>11-Nov-14<br>9616662 |
| Subject<br>Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | ONE Snare Endovascular Microsnare System<br>Percutaneous Retrieval Device<br>Device, Percutaneous Retrieval |
| Predicate<br>Device | Primary Predicate Device# 1:<br>Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer:<br>Reference Device# 2:<br>Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | Amplantz "GOOSE NECK" Microsnare<br>Catheter, Percutaneous<br>K970668<br>ev3 (Microvena Corp.)<br>Merit ONE Snare System<br>Percutaneous retrieval device<br>K122088<br>Merit Medical Systems, Inc. |
| Classification | Class II<br>21 CFR § 870.5150<br>FDA Product Code: MMX<br>Division of Cardiovascular Devices | |
| Intended Use | | The ONE Snare Endovascular Microsnare System is intended for use in<br>adult and pediatric populations for the retrieval and manipulation of<br>atraumatic foreign bodies located in the coronary and peripheral<br>cardiovascular system and the extra-cranial anatomy. |
| Device<br>Description | ONE Snare Endovascular Microsnare System contains: (1) Snare, (1)<br>Snare Catheter, (1) Insertion Tool and (1) Torque Device. The snare is<br>constructed of nitinol cable and a gold plated tungsten loop. The pre-formed<br>snare loop can be introduced through catheters without risk of snare<br>deformation because of the snare's super-elastic construction. The snare<br>catheter is constructed of polyether block amide (Pebax®) and contains a<br>platinum/iridium radiopaque marker band. | |
| Technological<br>Characteristics | Technological characteristics of the subject Merit ONE Snare Endovascular<br>Microsnare System are substantially equivalent to those of the Primary<br>Predicate#1, the currently marketed Amplantz "GOOSE NECK" Microsnare,<br>manufactured by ev3 Inc., 510(k) K970668 and Reference Device#2, Merit<br>Medical ONE Snare System, 510(k) K122088 for the following performance<br>data - Corrosion Testing, Luer Testing and Packaging Testing. | |
| Safety &<br>Performance<br>Tests | No performance standards have been established under Section 514 of the<br>Food, Drug and Cosmetic Act for these devices. However, a battery of tests<br>performed on the Merit ONE Snare Endovascular Microsnare System were<br>designed to demonstrate that the device meets critical design specifications<br>as well as clinical performance attributes for its intended use. Where<br>appropriate, the tests were based on the requirements of the following<br>documents:<br>FDA guidance Coronary and Cerebrovascular Guide Wire Guidance<br>January 1995. ISO 11070:1998, Sterile Single-Use Intravascular Catheter Introducers ISO 10555-1 2013 Intravascular catheters - Sterile and single use<br>catheters - Part 1: General Requirements. ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes,<br>needles and certain other medical equipment -- Part 1: General<br>requirements ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes,<br>needles and certain other medical equipment - Part 2: Lock fittings ASTM F 2096-11 Standard Test Method for Detecting Gross Leaks in<br>Medical Packaging by Internal Pressurization (Bubble Test) ASTM F 1929-12 Standard Test Method for Detecting Seal Leaks in<br>porous Medical Packaging by Dye Penetration ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible<br>Barrier Materials ASTM D4169-09 Standard Practice for Performance Testing on<br>Shipping Containers and Systems ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile<br>Barrier Systems for Medical Devices ISO 2233:2000 Packaging - Complete, filled transport packages and<br>unit loads - conditioning for testing ISO 11135:2014 – Sterilization of health care products -- Ethylene oxide<br>-- Requirements for the development, validation and routine control of a<br>sterilization process for medical devices ISO 10993-1: 2009, Biological Evaluation of medical Devices Part 1:<br>Evaluation and Testing within a risk management process, and the FDA<br>Modified ISO 10993 Test Profile FDA Memo G95-1. | |

{4}------------------------------------------------

{5}------------------------------------------------

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

## Catheter & Insertion Tool

- Surface Finish ●
- Radiopacity
- Catheter tip atraumatic .
- Marker band placement ●
- Effective Length ●
- ID & OD
- Catheter stiffness .
- Markerband retention
- Tip integrity ●
- Torque Strength ●
- Kink resistance ●
- Buckling force ●
- Freedom from Liquid leakage ●
- Freedom form Air leakage
- Peak tensile force of catheter at hub ●
- Force at break insertion tool at hub ●
- Hub with Female luer testing
- Corrosion Resistance ●

## ONE Snare Endovascular Microsnare System

- Snare Loop Resistance ●
- Guide Catheter resistance ●
- Snare shape integrity
- Insertion Tool Fitment .
- Snare insertion ●
- Insertion Tool tear away force ●
- Snare jacket after insertion tool removal inspection ●
- o Snare loop protruding

## Snare

- Size designation .
- Snare Head Assembly .
- Radio detectability ●
- Surface Finish
- . Tensile strength
- o Torqueability
- Torque Strength ●
- Flexing Test ●
- Fracture Test o
- Tip Flexibility ●
- Corrosion Resistance ●

Biocompatibility testing included

- Cytotoxicity
- Sensitization ●
- . Irritation

Safety & Performance Tests (continued)

{6}------------------------------------------------

| Safety &<br>Performance<br>Tests<br>(continued) | Acute Systemic Toxicity Pyrogenicity Genotoxicity Hemolysis Thrombogenicity Complement Activation Chemical Tests Packaging performance before and after exposure to accelerated aging and<br>simulated shipping and handling conditions 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 Endovascular Microsnare System is<br>substantially equivalent to the Primary Predicate#1 Amplantz “GOOSE<br>NECK” Microsnare, K970668, manufactured by ev3 Inc and the Reference<br>Device#2 Merit Medical ONE Snare System, K122088 for Performance<br>data. |