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.

Device 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”.

AI/ML Overview

The provided text describes the regulatory clearance for the ONE Snare™ endovascular snare system (K193507) and references its substantial equivalence to a predicate device (K122088). However, it does not contain information about a study that proves the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning product.

The document details the physical characteristics and performance testing of a medical device (an endovascular snare system), focused on demonstrating its mechanical and functional equivalence to a previously cleared device. The "acceptance criteria" and "device performance" described are related to physical specifications and mechanical testing, not algorithm performance.

Therefore, many of the requested items (e.g., sample size for test/training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone algorithm performance) are not applicable to the information provided.

Here's the relevant information that can be extracted, interpreted within the context of a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several performance attributes that were tested. The general statement is that "All test results were comparable to the predicate devices and the subject One Snare Endovascular Snare System met the predetermined acceptance criteria." Specific, quantitative acceptance criteria are not explicitly detailed in the provided text.

Acceptance Criterion (General Concept)	Reported Device Performance
Snare Size Designation	Met predetermined acceptance criteria; comparable to predicate device
Catheter Size Designation	Met predetermined acceptance criteria; comparable to predicate device
Catheter Surface Inspection	Met predetermined acceptance criteria; comparable to predicate device
Catheter OD Inspection	Met predetermined acceptance criteria; comparable to predicate device
Catheter Tip Length of Angle	Met predetermined acceptance criteria; comparable to predicate device
Catheter Angle	Met predetermined acceptance criteria; comparable to predicate device
Catheter Tip ID Inspection	Met predetermined acceptance criteria; comparable to predicate device
Simulated Use (design validation)	Met predetermined acceptance criteria; comparable to predicate device

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as the tests are for physical device performance, not AI/ML model performance on data. The tests performed are listed as:

Snare Size Designation
Catheter Size Designation
Catheter Surface Inspection
Catheter OD Inspection
Catheter Tip Length of Angle
Catheter Angle
Catheter Tip ID Inspection
Simulated Use (design validation)

The provenance of this testing data (e.g., country of origin, retrospective/prospective) is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the tests relate to the physical properties and simulated performance of a medical device, not to the interpretation of medical images or data requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the reasons stated in item 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is not applicable as this is not an AI/ML device for diagnostic or assistive interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the physical tests conducted (e.g., Catheter OD Inspection, Catheter Angle), the "ground truth" would be the engineering specifications and tolerances of the device. This is inherent to the manufacturing and design process and not explicitly detailed in terms of "expert consensus," "pathology," or "outcomes data."

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established

This information is not applicable as this is not an AI/ML device.

In summary, the provided document describes a 510(k) clearance for a physical medical device and its performance testing to demonstrate substantial equivalence, not an AI/ML product's validation study. Therefore, most of the requested information related to AI/ML evaluation criteria is not present.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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GeneralProvisions	Submitter Name:	Merit Medical Systems, Inc.
	Address:	1600 West Merit ParkwaySouth Jordan, UT 84095
	Telephone Number:	(+353) 91 703700 (3061)
	Fax Number:	(+353) 91 680 104
	Contact Person:	Mark Mullaney
	Registration Number:	1721504
	Correspondent Name:	Merit Medical Ireland Ltd.
	Address:	Parkmore Business Park WestGalway, Ireland
	Telephone Number:	(+353) 91 703700 (3224)
	Fax Number:	(+353) 91 680 104
	Contact Person:	Michael O'Sullivan
	Date of Preparation:	Jan 17th 2020
	Registration Number:	9616662
	510(k) Number:	K193507
SubjectDevice	Trade Name:	ONE Snare®
	Common/Usual Name:	One Snare Endovascular Snare System
	Classification Name:	21 CFR 870.5150Device percutaneous retrieval
PredicateDevice		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 thecoronary and peripheral vascular system or hollow viscous to retrieve andmanipulate foreign objects. Retrieval and manipulation procedures includeindwelling venous catheter repositioning, indwelling venous catheter fibrinsheath stripping, and central venous access venipuncture procedureassistance.
	Special Premarket Notification 510(k)
	sheath stripping, and central venous access venipuncture procedure assistance.
DeviceDescription	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”.
Comparisonto 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.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 &PerformanceTests	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• Catheter Size Designation• Catheter Surface Inspection• Catheter OD Inspection• Catheter Tip Length of Angle• Catheter Angle• Catheter Tip ID Inspection• Simulated Use (design validation)
	All test results were comparable to the predicate devices and the subjectOne Snare Endovascular Snare System met the predetermindedacceptance criteria. This has demonstrated that the subject device is
Summary ofSubstantialEquivalence	Based on the Indications for Use, design, safety and performance testing,the subject One Snare Endovascular Snare System is substantiallyequivalent to the cleared Predicate Device, the Merit One SnareEndovascular 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:

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
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.(b)
Classification. Class II (performance standards).