The EN 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 veupuncture procedure assistance.

Device Description

The EN Snare Endovascular Snare System consists of four individual components: snare: catheter: insertion tool and torque device. Systems are available in various sizes and lengths. The snare is comprised of 3 interlaced stranded cables of platinum and super-elastic nitinol that form 3 loops and are mechanically secured with a crimp collar to a nitinol shaft wire. The superelastic nitinol construction enables the loops of the snare to be introduced through a catheter without the risk of deformation. The catheter is manufactured with a Pebax outer layer and a PTFE inner layer with an embedded iridium/platinum markerband at the distal end, a Pebax hub and a polycarbonate luer. A snare insertion tool is also included for optional back-end loading of the snare into a preplaced catheter. The snare insertion tool is manufactured from polypropylene. The snare is inserted into an intravascular catheter and manipulated by use of an external torque device. The snare is offered in sizes ranging from 2mm to 45mm, with catheter sizes of 3.2F, 6F, and 7F.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "EN Snare Endovascular Snare System." It focuses on demonstrating substantial equivalence to a predicate device through various performance and safety tests.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that a "battery of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not explicitly list specific numerical acceptance criteria for each test. Instead, it lists the types of tests performed and concludes that the device "met the acceptance criteria applicable to the safety and effectiveness of the device."

Therefore, a table cannot be constructed with specific numerical acceptance criteria. The performance is reported as meeting these (unspecified in detail) criteria.

Note: For medical devices, acceptance criteria are typically well-defined in the test protocols, but these are often considered proprietary and not included in publicly available 510(k) summaries beyond broad statements of compliance.

Acceptance Criteria Category	Reported Device Performance
Material & Design
Corrosion Testing	Met acceptance criteria
Luer Testing	Met acceptance criteria
Packaging Testing	Met acceptance criteria
Catheter and Insertion Tool
Surface (external)	Met acceptance criteria
Radiodetectability	Met acceptance criteria
Dimensions (Markerband)	Met acceptance criteria
Surface (PTFE Liner)	Met acceptance criteria
Dimensions (Tip Angle/Length)	Met acceptance criteria
Dimensions (Length, Diameter)	Met acceptance criteria
Atraumatic Catheter Tip	Met acceptance criteria
Markerband retention	Met acceptance criteria
Torque Strength	Met acceptance criteria
Kink resistance	Met acceptance criteria
Buckling resistance	Met acceptance criteria
Freedom from Liquid Leakage	Met acceptance criteria
Freedom from Air Leakage	Met acceptance criteria
Force at break (Hub-Tube)	Met acceptance criteria
System
Snare Loop Resistance	Met acceptance criteria
Guiding Catheter Resistance	Met acceptance criteria
Snare insertion tool fitment	Met acceptance criteria
Snare insertion	Met acceptance criteria
Insertion Tool tear away force from the snare	Met acceptance criteria
Snare inspection after insertion tool removal	Met acceptance criteria
Snare loop protrusion	Met acceptance criteria
Force at break (Insertion Tool Hub-Tube)	Met acceptance criteria
Catheter hub with female luer	Met acceptance criteria
Corrosion resistance	Met acceptance criteria
Biocompatibility
Cytotoxicity	Met acceptance criteria
Sensitization	Met acceptance criteria
Irritation	Met acceptance criteria
Acute Systemic Toxicity	Met acceptance criteria
Pyrogenicity	Met acceptance criteria
Genotoxicity	Met acceptance criteria
Hemolysis	Met acceptance criteria
Thrombogenicity	Met acceptance criteria
Complement Activation	Met acceptance criteria
Chemical Tests	Met acceptance criteria

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., number of devices tested for kink resistance). It reports a "battery of testing" was conducted.

Moreso, this is a premarket notification for a medical device (EN Snare Endovascular Snare System), and the studies described are engineering and bench testing rather than clinical trials with human subject data. Therefore, concepts like "country of origin of the data" (for human subjects) or "retrospective or prospective" do not directly apply in the typical sense. The data provenance would be from laboratory and bench testing environments, likely performed at the manufacturer's (Merit Medical Systems, Inc.) facilities or certified testing labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to the type of studies described. The "ground truth" for these engineering and biocompatibility tests is established by objective measurements against predefined engineering specifications, international standards (e.g., ISO, ASTM), and regulatory guidance documents, not by expert human consensus (like in diagnostic AI studies). The "experts" involved would be engineers, material scientists, and microbiologists who design and execute the tests and interpret the results against those standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers are making subjective diagnoses or assessments which then need to be reconciled. For device performance testing, the results are objective measurements from instruments or standardized observations which either meet or fail the specified acceptance criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms, often in comparison to human readers, and involves multiple human readers assessing medical cases.

The document describes pre-market testing for a physical medical device (an endovascular snare system), focusing on its mechanical, material, and biological safety characteristics, not its diagnostic or interpretative capabilities.

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

This is not applicable. The device described, the "EN Snare Endovascular Snare System," is a physical medical instrument used for retrieving foreign objects and manipulating catheters. It is not an algorithm, software, or AI system requiring standalone performance evaluation in that context.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed on the EN Snare Endovascular Snare System is constituted by:

Engineering Specifications: Explicit design requirements and performance parameters set by the manufacturer.
International Standards: Compliance with relevant ISO (e.g., ISO 10555-1, ISO 594-1/2, ISO 11135, ISO 10993-1, ISO 2233) and ASTM (e.g., ASTM F1980-07) standards.
FDA Guidance: Adherence to FDA guidance documents (e.g., Coronary and Cerebrovascular Guide Wire Guidance, FDA Modified ISO 10993 Test Profile FDA Memo G95-1).

The tests confirm that the device physically functions as intended, is safe in terms of materials and interactions with the body, and meets required structural integrity, rather than confirming a medical diagnosis.

8. The Sample Size for the Training Set

This question is not applicable. The studies described are physical performance, material, and biocompatibility tests for a medical device. There is no "training set" in the context of machine learning or AI algorithms. The device's design and manufacturing processes are informed by engineering principles, material science, and regulatory requirements, not by training data in the AI sense.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no "training set" for physical device testing in the context of AI. The "ground truth" for the device's design and manufacturing relies on established scientific and engineering principles, verified material properties, and adherence to quality control standards, rather than a labeled dataset.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

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

July 1, 2015

Merit Medical Systems, Inc. Siobhan King Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland

Re: K151497

Trade/Device Name: EN Snare Endovascular Snare System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: MMX Dated: June 2, 2015 Received: June 4, 2015

Dear 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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" (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

M.A. Hillebrand

for Bram Zuckerman, MD
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) K151497

Device Name EN Snare Endovascular Snare 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)

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 PRAStaff@fda.hhs.gov

"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)

PSC Fublishing Services (301)-445-5740 EF

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

510(k) Summary Submitter Name: Merit Medical Systems, Inc. Address: 1600 West Merit Parkway South Jordan, UT 84095 Telephone Number: (+353) 91 703700 (3061) Fax Number: (+353) 91 703772 Contact Person: Mark Mullaney Registration Number: 1721504 General Correspondent Name: Merit Medical Ireland Ltd. Provisions Address: Parkmore Business Park West Galway, Ireland Telephone Number: (+353) 91 703700 (3052) Fax Number: (+353) 91 703772 Contact Person: Siobhan King Date of Preparation: 17 June 2015 Registration Number: 9616662 Trade Name: EN Snare Endovascular Snare System Subject Common/Usual Name: Device, Percutaneous Retrieval Device Classification Name: Device, Percutaneous Retrieval Primary Predicate Device #1: Trade Name: EN Snare Endovascular Snare System Classification Name: Device, Percutaneous Retrieval Premarket Notification: K092343 Manufacturer: Merit Medical Systems, Inc. Predicate Device Reference Device #2: ONE Snare System Trade Name: Classification Name: Percutaneous retrieval device Premarket Notification: K122088 Manufacturer: Merit Medical Systems, Inc. Class II 21 CFR 870.5150 Classification Device, Percutaneous Retrieval FDA Product Code: MMX Review Panel: Division of Cardiovascular Devices The EN Snare Endovascular Snare System is intended for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate Intended Use foreign objects. Retrieval and manipulation procedures include, indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access venipuncture procedure assistance.

Section 5

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

The technological characteristics of the subject Merit EN Snare Endovascular Snare System are substantially equivalent to the Primary Predicate Device#1 Merit EN Snare Endovascular Snare System (K092343), and the Reference Device#2, Merit ONE Snare System, 510(k), K122088, for the following performance data - Corrosion Testing, Luer Testing and Packaging Testing, The Comparison to difference between the subject Merit EN Snare Endovascular Snare System and Predicate the Primary Predicate Device#1 Merit EN Snare Endovascular Snare System (K092343) relates to a modification to the catheter and insertion tool design and materials only. The snare device and the torque device remain unchanged. While the intended use remains unchanged the indications for use are being clarified.

No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject Merit EN Snare Endovascular Snare System was conducted based on risk analysis. A battery of testing was conducted in accordance with protocols based on requirements outlined in quidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.

Where appropriate, the tests were based on the requirements of the following documents:

FDA guidance Coronary and Cerebrovascular Guide Wire Guidance . January 1995.
Safety & Performance Tests

Device

Description

ISO 10555-1 2013 Intravascular catheters Sterile and single use ● catheters - Part 1: General Requirements.
ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, ● needles and certain other medical equipment - Part 1: General requirements
ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, . needles and certain other medical equipment - part 2: Lock fittings
. ISO 11135:2014 Sterilization of health care products-Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices.
ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier ● Systems for Medical Devices

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

ISO 2233:2000 Packaging complete, filled transport packages and unit ● loads - conditioning for testing . 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 following is a list of all significant testing that was successfully completed: Catheter and Insertion Tool Surface: external surface ● Radiodetectability of catheter/marker bands ● Dimensions: Catheter Markeband length ● Dimensions: Catheter Markerband placement ● Surface: Catheter PTFE Liner Inspection ● Dimensions: Catheter Tip Angle ● ● Dimensions: Catheter Tip Length Dimensions: Length, Diameter (ID/OD) ● Atraumatic Catheter Tip ● Markerband retention ● ● Torque Strength ● Kink resistance Buckling resistance ● Freedom from Liquid Leakage ● Freedom from Air Leakage ● Force at break(junction between catheter hub and tube) ● ●

System

Snare Loop Resistance
Guiding Catheter Resistance ●
. Snare insertion tool fitment
Snare insertion ●
Insertion Tool tear away force from the snare ●
. Snare inspection after insertion tool removal
- Snare loop protrusion

Biocompatibility testing included

Cytotoxicity ●
Sensitization ●
Irritation ●
Acute Systemic Toxicity ●
Pyrogenicity ●
Genotoxicity ●
Hemolysis ●
Thrombogenicity .
Complement Activation
Chemical Tests

The subject Merit EN Snare Endovascular Snare System met the acceptance criteria applicable to the safety and effectiveness of the device. This has demonstrated the subject device Merit EN Snare Endovascular Snare System is substantially equivalent to the Primary Predicate Device#1 EN Snare Endovascular Snare System, K092343.

Safety & Performance

Tests

continued

Force at break(junction between insertion tool hub and tube)
Catheter hub with female luer ●
. Corrosion resistance

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

Summary of	Based on the Indications for Use, design, safety and performance testing, the
Substantial	subject Merit EN Snare Endovascular Snare System is substantially equivalent
Equivalence	to the Primary Predicate Device#1 Merit EN Snare Endovascular Snare System,K092343 and the Reference Device#2, Merit ONE Snare System, 510(k),K122088 for Performance data.

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).