The EN Snare Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.

Device Description

The EN Snare ® Endovascular Snare System consists of four individual components: snare; catheter; snare introducer; and torque device. The snare is comprised of 3 cable loops which are secured to a shaft wire. The construction of the snare enables it to be introduced through a catheter and manipulated by use of an external torque device. A snare introducer is also included for optional back-end loading of the snare into a pre-placed catheter.

AI/ML Overview

This document is a 510(k) Premarket Notification for the EN Snare® Endovascular Snare System. It aims to demonstrate substantial equivalence to a predicate device, rather than providing a study proving a device meets specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC).

Therefore, many of the requested categories are not applicable or cannot be answered from the provided text, as this type of submission focuses on demonstrating equivalence in design, materials, and intended use, not on a clinical performance study with predefined acceptance criteria for diagnostic accuracy.

Here's an analysis based on the provided text, addressing the applicable points:

1. A table of acceptance criteria and the reported device performance

This information is not present in the document. The submission is for a medical device that aims to be substantially equivalent to a predicate device, not a device that reports performance against specific diagnostic acceptance criteria. The document explicitly states: "No safety or performance testing is required to establish the safety and efficacy of the subject device" due to its identical nature to the predicate.

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

Not applicable. No performance study with a test set was conducted or reported for this 510(k) submission.

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)

Not applicable. No ground truth establishment by experts was part of this submission.

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

Not applicable. No test set or adjudication method was described.

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

Not applicable. This is not an AI-assisted device, and no MRMC study was conducted or reported.

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

Not applicable. This is a medical instrument (snare system), not an algorithm.

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

Not applicable. No ground truth was established as no performance study was conducted.

8. The sample size for the training set

Not applicable. This is a medical instrument, not an AI/ML algorithm requiring a training set.

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

Not applicable.

Summary of the document's approach:

The core of this 510(k) submission (K097343) for the EN Snare® Endovascular Snare System is to demonstrate substantial equivalence to a previously cleared predicate device (K021606). The key argument for substantial equivalence is that the subject device is "manufactured with identical design, materials and processes as that of the currently marketed EN Snare® Endovascular Snare System."

Therefore, the "acceptance criteria" for this submission are met by demonstrating that:

Intended Use is identical: "The EN Snare Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects."
Technological Characteristics are identical: "There are no technological differences between the subject and predicate devices. The system is manufactured with identical design, materials and processes..."
Safety & Performance Testing: The submission explicitly states, "No safety or performance testing is required to establish the safety and efficacy of the subject device," because it is identical to a device already on the market with a proven safety and efficacy profile.

In essence, the "study" proving the device meets its "acceptance criteria" here is the analysis demonstrating identicality to the predicate device, which itself was cleared based on its own safety and performance pathway.

Summary

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AUG 0`7 2009

Merit Medical Systems, Inc.
EN Snare® Endovascular Snare System Traditional 510(k) Premarket Notification Section 5
510(k) Summary

K097343

Section 5

510(k) Summary

GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4795(801) 253-6996Glenn NortonJuly 30, 20091721504
SubjectDevice	Trade Name:Common/Usual Name:Regulation Name:Manufacturer:	EN Snare® Endovascular Snare SystemIntravascular snare and catheterDevice, Percutaneous RetrievalMerit Medical Systems, Inc
PredicateDevice	Trade Name:Common/Usual Name:Regulation Name:Manufacturer:Premarket Notification:Decision Date:	EN Snare® Endovascular Snare SystemIntravascular snare and catheterDevice, Percutaneous RetrievalMedical Device Technologies, IncK02160605/31/2002
Classification	Class IIEmbolectomy Catheter21 CFR § 870.5150, 74 MMXDivision of Cardiovascular Devices
Intended Use	The EN Snare Endovascular Snare and Catheter is intended for usein the cardiovascular system or hollow viscous to retrieve andmanipulate foreign objects. Manipulation procedures includeindwelling venous catheter repositioning, indwelling venous catheterfibrin sheath stripping, and central venous access venipunctureprocedure assistance.
DeviceDescription	The EN Snare ® Endovascular Snare System consists of fourindividual components: snare; catheter; snare introducer; and torquedevice.
	The snare is comprised of 3 cable loops which are secured to a shaftwire. The construction of the snare enables it to be introducedthrough a catheter and manipulated by use of an external torquedevice. A snare introducer is also included for optional back-endloading of the snare into a pre-placed catheter.
TechnologicalCharacteristics	There are no technological differences between the subject andpredicate devices. The system is manufactured with identicaldesign, materials and processes as that of the currently marketedEN Snare ® Endovascular Snare System.
Safety &PerformanceTests	No safety or performance testing is required to establish the safetyand efficacy of the subject device.
Summary ofSubstantialEquivalence	The EN Snare device built by Merit is substantially equivalent to theEN Snare device legally marketed by MD Tech via 510(k) K021606,due to identical intended use, design specifications, materialspecifications, manufacturing specifications and technologicalcharacteristics.

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K0923413 page 1 of 1

Merit Medical Systems, Inc.
EN Snare® Endovascular Snare System Traditional 510(k) Premarket Notification

、

Section 5 510(k) Summary

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-609 Silver Spring, MD 20993-0002

AUG 0 7 2009

Merit Medical Systems, Inc. c/o Glenn Norton 1600 West Merit Pkwy. South Jordan, UT 84095

Re: K092343

Trade/Device Name: EN Snare Endovascular Snare System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: MMX Dated: July 30, 2009 Received: August 3, 2009

Dear Mr. Norton:

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.

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

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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); good manufacturing practice requirements as set forth in 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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

uma R. Kirchner

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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K0923343 page lot.1

Merit Medical Systems, Inc. EN Snare® Endovascular Snare System Traditional 510(k) Premarket Notification

Section 4 Indications for Use Statement

Section 4

Indications for Use Statement

KO92343

510(k) Number (if known):

Device Name: EN Snare® Endovascular Snare System

Indications for Use:

Prescription Use X (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)

Duma R. V. Aimes

Sign-Off)
Division of Cardiovascular Devices

510(k) Number_

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).