Merit Pursue Microcatheter

K173548 · Merit Medical Systems, Inc. · DQY · Mar 30, 2018 · Cardiovascular

Device Facts

• Record ID: K173548
• Device Name: Merit Pursue Microcatheter
• Applicant: Merit Medical Systems, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the Microcatheter can be used for the controlled and selective infusion of diagnostics, embolic, or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.

Device Story

Merit Pursue Microcatheter is a percutaneous catheter for peripheral and coronary vasculature. Device features 2.9F/2.0F or 2.8F/1.7F configurations; lengths of 110cm, 130cm, 150cm; straight or pre-shaped (45 degree/swan neck) distal tips. Proximal end includes molded winged hub with strain relief; distal 80cm shaft has hydrophilic coating for insertion; radiopaque marker at tip for fluoroscopic visualization. Used by physicians in clinical settings to access subselective regions and deliver diagnostic, embolic, or therapeutic agents. Output is visual confirmation via fluoroscopy and delivery of infused materials. Benefits include precise, controlled delivery of therapeutic/diagnostic agents to target vessels.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, thrombogenicity, complement activation), ISO 10555-1 performance testing (surface, leakage, tensile force, corrosion), and ISO 594-2 luer fitting testing. Additional design verification included lubricity, dimensional testing, marker band retention, torque strength, kink resistance, and particulate analysis.

Technological Characteristics

Percutaneous catheter; hydrophilic coating on distal 80cm; radiopaque marker band; molded winged hub with tapered strain relief. Materials meet ISO 10993. Sterilization via ethylene oxide (ISO 11135). Conforms to ISO 10555-1 (general requirements) and ISO 594-2 (luer fittings). Dimensions: 2.9F/2.0F or 2.8F/1.7F; 110-150cm lengths. Standalone device.

Indications for Use

Indicated for general intravascular use in peripheral and coronary vasculature for controlled and selective infusion of diagnostic, embolic, or therapeutic materials. Contraindicated for use in cerebral vessels.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Excelsior™ 1018™ and SL-10 Pre-Shaped Microcatheter (K042568)
• Maestro Microcatheter (K172081)

Submission Summary (Full Text)

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March 30, 2018

Merit Medical Systems, Inc. Niloufar Samimi Regulatory Affairs Specialist II 1600 West Merit Parkwav South Jordan, Utah 84095

Re: K173548

Trade/Device Name: Merit Pursue Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 5, 2018 Received: November 17, 2017

Dear Niloufar Samimi:

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 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.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerelv.

M.A. Hillemann

for 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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# Indications for Use

510(k) Number (if known) K173548

Device Name Merit Pursue Microcatheter

#### Indications for Use (Describe)

The Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the Microcatheter can be used for the controlled and selective infusion of diagnostics, embolic, or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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# K173548- 510(k) Summary

| General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Contact Person:<br>Date Prepared:<br>Registration Number: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>[phone]<br>Niloufar Samimi<br>11/15/2017<br>1721504 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:<br>Common/Usual Name:<br>Classification Name:<br>Regulatory Class:<br>Product Code:<br>21 CFR §:<br>Review Panel: | Merit Pursue Microcatheter<br>Microcatheter<br>Percutaneous catheter<br>2<br>DQY<br>870.1250<br>Cardiovascular |
| Predicate<br>Device | Premarket Notification Predicate #1:<br>Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer:<br><br>Premarket Notification Reference Predicate #2:<br>Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer:<br>These predicate devices have not been subject to a design-related<br>recall. | Excelsior™ 1018™ and SL-10 Pre-Shaped<br>Microcatheter<br>Percutaneous catheter<br>K042568<br>Stryker<br><br>Maestro Microcatheter<br>Catheter, Continuous Flush<br>K172081<br>Merit Medical System, Inc. |
| Device<br>Description | | The Merit Pursue Microcatheter is available in two French<br>configurations, 2.9F (proximal) / 2.0F (distal) and 2.8F (proximal / 1.7F<br>(distal) and 110cm, 130cm and 150cm lengths. The distal tip of the |
| | microcatheter is offered in straight or pre-shaped 45 degree and swan<br>neck configurations. The proximal end of the microcatheter consists of<br>a molded winged hub with a tapered strain relief. The outer surface of<br>the distal 80cm of the microcatheter shaft is coated with a hydrophilic<br>coating designed to facilitate the introduction of the microcatheter into<br>the vasculature. The microcatheter incorporates a radiopaque marker<br>at the distal tip to facilitate fluoroscopic visualization.<br>The Merit Pursue Microcatheter is offered with two 3mL syringes. | |
| Indications for<br>Use | The Microcatheter is intended for general intravascular use, including<br>peripheral and coronary vasculature. Once the subselective region has<br>been accessed, the Microcatheter can be used for the controlled and<br>selective infusion of diagnostic, embolic, or therapeutic materials into<br>vessels. The catheter should not be used in the cerebral vessels. | |
| Comparison to<br>Predicate<br>Devices | The design and technological characteristics of the subject Merit<br>Pursue Microcatheter are substantially equivalent to those of the<br>Predicate Device #1, Excelsior™ 1018™ and SL10- Pre-shaped<br>Microcatheter and Reference Predicate Device #2 Maestro<br>Microcatheter. The subject device has a similar basic design as the<br>predicates.<br>The comparison between the subject and the predicate devices is<br>based on the following:<br>• Similar Intended use<br>• Similar Indications for use<br>• Similar material types that meet ISO 10993 biocompatibility<br>requirements<br>• Similar design<br>• Same sterilization methods<br>• Same fundamental technology/principle of operation | |
| Performance<br>Data | No performance standards have been established under Section 514 of<br>the Food, Drug and Cosmetic Act for these devices. Performance<br>testing of the subject Merit Pursue Microcatheter was conducted based<br>on the risk analysis and based on the requirements of the following<br>international standards:<br>• ISO 10555-1:2013, Intravascular Catheters – Sterile and single-<br>use catheters – Part 1: General requirements<br>• ISO 11135:2014, Sterilization of health care products - Ethylene<br>oxide - Requirements for the development, validation and routine<br>control of a sterilization process for medical devices<br>• ISO 10993-1: 2009/Technical Corrigendum 1 2010 Biological<br>Evaluation of Medical Devices Part 1: Evaluation and Testing | |

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within a risk management process, and FDA quidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (2010)

- . ISO 10993-4: 2017, Biological Evaluation of Medical Devices -Part 4: Selection of Tests for Interactions with Blood
- ISO 10993-4:2002/Amendment 1 2006, Biological evaluation of . medical devices – Part 4: Selection of tests for interaction with blood
- . ISO 10993-5:2009. Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010. Biological evaluation of medical devices -● Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2006, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
- United States Pharmacopeia 40, National Formulary 35, 2017 <151> Pyrogen Test
- ASTM F756-17 Standard Practice for Assessment of Hemolytic . Properties of Materials
- ISO 10993-7:2008, Biological evaluation of medical devices -. Part 7: Ethylene oxide sterilization residuals
- ISO 2233:2000, Packaging complete, filled transport packages . and unit loads -conditioning for testing
- . ASTM D4169-14:2014, Standard practice for performance testing of shipping containers and systems
- . ISO 594-2: 1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings

The following performance data were provided in support of the substantial equivalence determination.

# Biocompatibility testing

The biocompatibility evaluation for the Merit Pursue Microcatheter was conducted in accordance with FDA guidance use of International standard ISO-10993, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The battery of testing included the following tests:

- Cytotoxicity ●
- Sensitization
- Irritation .
- Acute Systemic Toxicity ●
- Pvrogenicitv ●
- Hemolysis ●
- Thrombogenicity ●
- Complement Activation ●

The Merit Pursue Microcatheter is considered to have circulating blood contact for a limited (< 24 hours) duration.

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#### Performance Testing-Bench

### ISO 594-2 Performance testing/ Design verification

- Gauging ●
- Separation Force ●
- Unscrewing Torque ●
- Ease of Assembly ●
- Resistance to Overriding
- Stress Cracking .

#### ISO 10555-1 Performance testing

- Surface ●
●

- Freedom from Liquid Leakage ●
- Freedom from Air Leakage ●

#### Performance Data cont.

- Power injection ● Peak Tensile Force
- Corrosion Resistance ●

## Additional Testing (Design verification and validation)

- Lubricity .
- Dimensional testing ●
- Design Validation
- Marker Band Retention ●
- Tip Shape
- Torque Strength ●
- Radio-detectability
- . Kink Resistance
- Chemical Compatibility .
- Particulate Analysis ●

## Summary of Substantial Equivalence

Based on the indications for use, design, safety and performance testing, the subject Merit Pursue Microcatheter meets the requirements that are considered essential for its intended use and is substantially equivalent to the Predicate Device #1 Stryker, the Excelsior 1018 and SL-10 [K042568].