The Merit Embolectomy Catheter is intended for use for the removal of fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.

Device Description

The Merit Embolectomy Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm guide wires with related accessories. The catheter has a maximum outer diameter of 0.068"/1.73mm and a working length of 140 cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90cm, 100 cm, and 110 cm proximal of the distal tip.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Merit Embolectomy Catheter (K100569). It primarily focuses on demonstrating substantial equivalence to a predicate device through safety and performance testing. However, it does NOT contain the specific information required to complete the table and answer the study-related questions.

Here's why and what can be extracted:

What's missing for your request?
The provided text is a 510(k) summary and FDA clearance letter. It outlines the device, its intended use, lists the tests performed, and states that acceptance criteria were met. However, it does not provide:

The specific acceptance criteria values.
The reported device performance values against those criteria.
Details about any clinical studies (such as sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) that would typically be associated with performance claims for AI-driven devices. Embolectomy catheters are physical devices, and their evaluation typically involves bench testing, animal models, and sometimes human clinical trials, but not in the format of AI performance metrics.

Extracted Information (based on the provided text):

1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document states that a "battery of tests was performed... and were shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device," but it does not list these criteria or the test results.

2. Sample size used for the test set and the data provenance
Not applicable/provided for this type of device. The testing described is primarily bench-top (physical and mechanical properties) and biocompatibility, not data-driven performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/provided for this type of device. Ground truth as typically understood for AI/diagnostic devices is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/provided for this type of device.

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
No. This is a physical medical device (embolectomy catheter), not an AI/software device, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for this type of device. The "ground truth" for this device would relate to its physical performance (e.g., successful clot removal in a model, material integrity, biocompatibility), which is assessed through the listed tests.

8. The sample size for the training set
Not applicable/provided for this type of device. There is no "training set" as this is not an AI/machine learning product.

9. How the ground truth for the training set was established
Not applicable/provided for this type of device.

Summary of Device and Testing (from the document):

Device Name: Merit Embolectomy Catheter
Intended Use: Removal of fresh, soft emboli and thrombi from vessels of the arterial system (not for cerebral vasculature).
Regulatory Class: Class II
Product Code: OEZ (initially DXE, updated to OEZ in 2021)
Predicate Device: Pronto V3 Extraction Catheter, Model 5003 (K063371)
Tests Performed: A comprehensive battery of tests was performed based on ISO standards and FDA requirements, covering:
- Surface Condition
- Force at Break
- Freedom from Leakage (Pressure & Aspiration)
- Dimensional Verification (OD, lengths, marks, tip angle)
- Radio-detectability
- Visual Inspection
- Aspiration
- Flow
- Lubricious Coating Effectiveness (Lubricity and Durability, Accelerated Aging)
- Coating Integrity (Dye Test)
- Lubricious Coating Length
- Guide Wire Compatibility
- Stiffness (Proximal, Mid, Distal Section)
- Kink Test (Proximal, Mid, Distal Section)
- Marker Band Retention
- Rapid Exchange Lumen Attachment
- Simulated Use Testing:
  - Tortuous Path (Tracking, Guide Wire, Crossing a deployed stent, Soft emboli aspiration)
- Biocompatibility Tests:
  - Cytotoxicity
  - Sensitization
  - Irritation
  - Acute Systemic Toxicity
  - Pyrogenicity
  - Genotoxicity
  - Hemocompatibility
- Packaging Performance:
  - Bubble emission
  - Dye penetration
  - Seal peel tensile strength
  - Burst strength
  - Visual inspection (before and after accelerated aging and simulated shipping)

The document concludes that the device "meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device" based on these tests.

Summary

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February 8, 2021

Merit Medical Systems, Inc. Lindsay Martin Regulatory Affairs Specialist 1600 West Merit Pkwy. South Jordan, Utah 84095

Re: K100569

Trade/Device Name: Merit Embolectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEZ

Dear Lindsay Martin:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 11, 2011. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075. Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.02.08 07:54:50 -05'00'

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

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings. 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 Control Room -WO66-G609 Silver Spring, MI) 20993-0002

Merit Medical Systems, Inc. c/o Ms. Lindsay Martin 1600 West Merit Parkway South Jordan, UT 84095

Re: K100569

Trade Name: Merit Embolectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE Dated: February 26, 2011 Received: March 1, 2011

MAR 1 1 2011

Dear Ms. Martin:

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. Iisting 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

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Page 2 - Ms. Linday Martin

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

ff 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

R. Vachner

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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510(k) Number (if known):	K100569
Device Name:	Merit Embolectomy Catheter

Indications for Use:

The Merit Embolectomy Catheter is intended for use for the removal of fresh, soft emboli and thrombi from vessels of the arterial system.

Not for use in cerebral vasculature.

Prescription Use	X	AND/OR	Over-The-Counter Use	_________________
(Part 21 CFR 801 Subpart D)			(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)

}

Anna R. Vahmen

(Division Sign-Off) Division of Čardiovascular Devices

510(k) Number_K1 0 0569

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Section 5 510(k) Summary for K100569

General Provisions

Submitter Name:	Merit Medical Systems, Inc.
Address:	1600 West Merit Parkway, South Jordan, UT 84095
Telephone Number:	(801) 208-4187
Fax Number:	(801) 253-6905
Contact Person:	Lindsay Martin
Date of Preparation:	February 26, 2010
Registration Number:	1721504

Subject Device

Trade Name: ASAP Catheter Common/Usual Name: Merit ASAP Embolectomy Catheter Classification Name: Catheter, Embolectomy

Predicate Device

Trade Name:	Pronto V3 Extraction Catheter, Model 5003
Classification Name:	Catheter, Embolectomy
Premarket Notification:	K063371
Manufacturer:	Vascular Solutions, Inc.

Classification

Class II per 21 CFR § 870.5150 DXE Product Code: Division of Cardiovascular Devices Review Branch:

Intended Use

The intended use of the Merit Embolectomy Catheter is to remove or aspirate fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.

Device Description

Safety & Performance Tests

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, a battery of tests was performed according to protocols based on the requirements of the following documents, and were shown to meet the

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acceptance criteria that were determined to be applicable to the safety and efficacy of the device:

@ ISO 10555-1, Sterile, single-use intravascular catheters, Part 1. General requirements.

@ ISO 10555-2, Sterile, single-use intravascular catheters, Part 2. Angiographic catheters

@ ISO 594-2, Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings

@ ISO 11135, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization

@ ISO 10993-1, Biological Evaluation of medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile

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

Surface Condition

Force at Break

Freedom from Leakage 1 - Leak under Pressure

Freedom from Leakage 2- Aspiration Leak

Dimensional Verification

. Outside Diameter

. Effective Length
. Usable Length
. Depth Marks
. Tip Angle

Radio-detectability

Visual

Aspiration

Flow

Lubricious Coating Effectiveness - Coating Lubricity and Durability Test and Accelerated Aging Assessment

Coating Integrity- Dye Test

Lubricious Coating Length

Guide Wire Compatibility

Stiffness- Proximal, Mid, Distal Section

Kink Test- Proximal, Mid, Distal Section

Marker Band Retention

Rapid Exchange Lumen Attachment

Simulated Use Testing:

Tortuous Path- Tracking

Tortuous Path- Guide Wire

Tortuous Path- Crossing a deployed stent

Tortuous Path- Soft emboli aspiration

Biocompatibility Tests

. Cytotoxicity
Sensitization
. Irritation
Acute Systemic Toxicity
. Pyrogenicity
. Genotoxicity
Hemocompatibility .

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Packaging performance before and after exposure to accelerated aging and simulated shipping and handling conditions

. bubble emission
. dye penetration
. seal peel tensile strength
. burst strength
. visual inspection

Summary of Substantial Equivalence

Based on the indications for use, design, and safety and performance test results, the subject Merit Embolectomy Catheter meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Pronto V3 Embolectomy Catheter manufactured by Vascular Solutions, Inc.

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).