Merit ONE Snare System

K193507 · Merit Medical Systems, Inc. · MMX · Jan 17, 2020 · Cardiovascular

Device Facts

• Record ID: K193507
• Device Name: Merit ONE Snare System
• Applicant: Merit Medical Systems, Inc.
• Product Code: MMX · Cardiovascular
• Decision Date: Jan 17, 2020
• Decision: SESE
• Submission Type: Special
• 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

Endovascular snare system designed for retrieval and manipulation of foreign objects in coronary/peripheral vascular systems or hollow viscous. System comprises nitinol core wire with tapered distal section, formed nitinol cable, gold-plated tungsten coil, and PTFE polymer sleeve; packaged with introducer, torque device, and guiding catheter. Used by clinicians in clinical settings. Device enables mechanical retrieval/manipulation of objects, repositioning of indwelling venous catheters, and fibrin sheath stripping. Output is physical manipulation of objects within the vasculature. Benefits include minimally invasive removal of foreign bodies and assistance in venous access procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included snare/catheter size designation, surface inspection, dimensional inspection (OD, ID, tip angle), and simulated use design validation. All results met predetermined acceptance criteria and were comparable to the predicate device.

Technological Characteristics

Nitinol core wire, gold-plated tungsten coil, PTFE polymer sleeve. System includes introducer, torque device, and guiding catheter. Dimensions: 4F, 80cm length, 15mm loop diameter; catheter features 15-degree angle 1cm from distal tip. Sterilization via ethylene oxide. Standards: ISO 11070, ISO 11135, EN 556, ISO 10555-1.

Indications for Use

Indicated for use in coronary and peripheral vascular systems 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

• Merit One Snare Endovascular Snare System (K122088)

Submission Summary (Full Text)

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January 17, 2020

Merit Medical Systems, Inc. Michael O'Sullivan Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, IE Galway

Re: K193507

Trade/Device Name: ONE Snare™ endovascular snare system Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: December 13, 2019 Received: December 18, 2019

# Dear Michael O'Sullivan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K193507

#### Device Name

ONE Snare endovascular suare system

## Indications for Use (Describe)

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

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)

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#

| General<br>Provisions | Submitter Name: | Merit Medical Systems, Inc. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| | Address: | 1600 West Merit Parkway<br>South Jordan, UT 84095 |
| | Telephone Number: | ([phone] (3061) |
| | Fax Number: | ([phone] |
| | Contact Person: | Mark Mullaney |
| | Registration Number: | 1721504 |
| | Correspondent Name: | Merit Medical Ireland Ltd. |
| | Address: | Parkmore Business Park West<br>Galway, Ireland |
| | Telephone Number: | ([phone] (3224) |
| | Fax Number: | ([phone] |
| | Contact Person: | Michael O'Sullivan |
| | Date of Preparation: | Jan 17th 2020 |
| | Registration Number: | 9616662 |
| | 510(k) Number: | K193507 |
| Subject<br>Device | Trade Name: | ONE Snare® |
| | Common/Usual Name: | One Snare Endovascular Snare System |
| | Classification Name: | 21 CFR 870.5150<br>Device percutaneous retrieval |
| Predicate<br>Device | | Premarket Notification Predicate: (Primary Predicate) |
| | Trade Name: | Merit One Snare Endovascular Snare System |
| | Classification Name: | 21 CFR 870.5150 |
| | Premarket Notification: | K122088 |
| | Manufacturer: | Merit Medical Systems, Inc. |
| Classification | | Class II |
| | | 21 CFR 870.5150 Device percutaneous retrieval |
| | | FDA Product Code: MMX |
| | | Review Panel: 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<br>indwelling venous catheter repositioning, indwelling venous catheter fibrin<br>sheath stripping, and central venous access venipuncture procedure<br>assistance. | |
| | Special Premarket Notification 510(k) | |
| | sheath stripping, and central venous access venipuncture procedure assistance. | |
| Device<br>Description | The ONE Snare Endovascular Snare System is a snare system that is designed for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. The One Snare wire consists of a Nitinol core with a ground tapered distal section, a formed nitinol cable covered with a gold-plated tungsten coil. The formed cable with coil is attached to the core wire and then covered with a PTFE polymer sleeve. The wires are packaged with an introducer, torque device and guiding catheter – this makes up the “One Snare Endovascular Snare System”. | |
| Comparison<br>to Predicate | The proposed new configuration will consist of the following snare with a 15mm loop diameter which will be 80cm in length. The loop diameter and length fall within the existing approved range for the ONE Snare (Snare loop diameter ranges from 5mm-35mm and Snare length ranges from 65cm-200cm.) Snare dimensions are as follows: 4F, 80cm, 15mm loop. catheter modified with a 15+/-5 degree angle at the catheter tip. The angle will be 1cm from the distal tip. Catheter dimensions: 4F, 65cm, Marker-Banded, with 1cm of the distal tip being angled 15+/- 5 degrees. None of the above changes would be deemed sufficient to affect the technological characteristics of the device and thus the subject One Snare Endovascular Snare System is substantially equivalent to Predicate Device, the Merit ONE Snare Endovascular Snare K122088.<br>The Indications for use of the subject wire are identical to Predicate Device. | |
| | 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 One Snare Endovascular 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: | |
| Safety &<br>Performance<br>Tests | ISO 11070 - Sterile, single-use intravascular catheter introducers ISO 11135 - Sterilization of health care products- Ethylene oxide- Requirements for development, validation and routine control of a sterilization process for medical devices processes EN556 - Sterilization of medical devices - Requirements for terminally sterilized medical devices to be labeled "Sterile" ISO 10555-1 - Intravascular Catheters – Sterile and Single-Use Catheters - Part 1: General Requirements | |
| | The ONE Snare Endovascular Snare System was compared to the predicate device for various performance attributes that support substantial equivalence of the device. The difference in assembly between | |
| | • Snare Size Designation<br>• Catheter Size Designation<br>• Catheter Surface Inspection<br>• Catheter OD Inspection<br>• Catheter Tip Length of Angle<br>• Catheter Angle<br>• Catheter Tip ID Inspection<br>• Simulated Use (design validation) | |
| | All test results were comparable to the predicate devices and the subject<br>One Snare Endovascular Snare System met the predeterminded<br>acceptance criteria. This has demonstrated that the subject device is | |
| Summary of<br>Substantial<br>Equivalence | Based on the Indications for Use, design, safety and performance testing,<br>the subject One Snare Endovascular Snare System is substantially<br>equivalent to the cleared Predicate Device, the Merit One Snare<br>Endovascular Snare System [K1220881]. | |

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Merit Medical Systems, Inc.
Merit One Snare Endovascular Snare System
Special Premarket Notification 510(k)

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the modified device and the cleared device, Merit One Snare Endovascular Snare System [K122088] has raised no new issues with respect to the device.

The following is a list of all testing that was successfully completed: