MERIT MICROCATHETER

K082613 · Merit Medical Systems, Inc. · KRA · Dec 30, 2008 · Cardiovascular

Device Facts

• Record ID: K082613
• Device Name: MERIT MICROCATHETER
• Applicant: Merit Medical Systems, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Dec 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Merit 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 diagnostic, embolic or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.

Device Story

Merit Microcatheter is a continuous flush catheter used for intravascular access in peripheral and coronary vasculature. Device features distal radiopaque marker for fluoroscopic visualization and hydrophilic coating on distal shaft to facilitate vessel entry. Available in 2.8/2.8 Fr and 2.8/2.4 Fr sizes with lengths of 110, 130, and 150 cm. Operated by clinicians in clinical settings to deliver diagnostic, embolic, or therapeutic agents to subselective regions. Device provides controlled infusion capabilities; benefits include precise delivery of materials to target vessels.

Clinical Evidence

Bench testing only. Performance verified against ISO 10555-1 (general requirements), ISO 10555-2 (angiographic catheters), ISO 594-2 (luer lock fittings), ISO 11135 (sterilization), and ISO 10993-1 (biocompatibility).

Technological Characteristics

Continuous flush catheter; 2.8/2.8 Fr and 2.8/2.4 Fr diameters; 110-150 cm lengths. Features distal radiopaque marker and hydrophilic coating. Sterilized via ethylene oxide. Complies with ISO 10555-1, ISO 10555-2, ISO 594-2, ISO 11135, and ISO 10993-1 standards.

Indications for Use

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

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• RenegadeTM Fiber Braided Microcatheter with Hydro PassTM Hydrophilic Coating (K973645)

Submission Summary (Full Text)

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K082613

DEC 3 0 2008

## Section 5

## 510(k) Summary

| General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date of Preparation:<br>Registration Number: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>[phone]<br>[phone]<br>Michaela Rivkowich<br>September 5, 2008<br>1721504 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject<br>Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | To be assigned<br>Merit Microcatheters<br>Continuous Flush Catheter |
| Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | RenegadeTM Fiber Braided Microcatheter with<br>Hydro PassTM Hydrophilic Coating<br>Continuous Flush Catheter<br>K973645<br>Boston Scientific Corporation |
| Classification | Class II<br>21 CFR § 870.1210, 74 KRA<br>Division of Cardiovascular, Respiratory and Neurological Devices | |
| Intended Use | The Merit 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 diagnostic, embolic or therapeutic materials into vessels. | |
| Device<br>Description | The Merit Microcatheter is available in 2.8/2.8 Fr and 2.8/2.4 Fr sizes<br>with lengths of 110, 130 and 150 cm. The outer surface of the distal<br>segment of the catheter shaft is coated with a hydrophilic coating<br>designed to facilitate the introduction of the catheter into the vessels.<br>The Microcatheter has a radiopaque marker at the distal tip to<br>facilitate fluoroscopic visualization. | |
| Safety &<br>Performance<br>Tests | No performance standards have been established under Section 514<br>of the Food, Drug and Cosmetic Act for these devices. However, a<br>battery of tests was performed according to protocols based on the<br>requirements of the following documents, and were shown to meet<br>the acceptance criteria that were determined to be applicable to the<br>safety and efficacy of the device:<br>• ISO 10555-1: 1995, Sterile, single-use intravascular catheters,<br>Part 1. General requirements.<br>• ISO 10555-2: 1996, Sterile, single-use intravascular catheters,<br>Part 2. Angiographic catheters<br>• ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes,<br>needles and certain other medical equipment - Part 2: Lock<br>fittings<br>• ISO 11135: 1994, Medical Devices - Validation and Routine<br>Control of Ethylene Oxide Sterilization<br>• ISO 10993-1: 2003, Biological Evaluation of medical Devices Part<br>1: Evaluation and Testing, and the FDA Modified ISO 10993 Test<br>Profile | |
| Summary of<br>Substantial | Based on the indications for use, design, and safety and<br>performance testing, the subject Merit Microcatheter meets the<br>minimum requirements that are considered essential for its intended | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 3 0 2008

Merit Medical Systems, Inc. c/o Mr. Glenn Norton Director of Regulatory Affairs 1600 West Merit Parkway South Jordan, UT 84095

Re: K082613

> Trade/Device Name: Merit Microcatheter Common Name: catheter, continuous flush Regulation Number: 21 CFR 870.1210 Regulatory Class: II Product Code: KRA Dated: December 19, 2008 Received: December 22, 2008

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 such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

M. A. Killennan

ﻣﺮ 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): K082613

Device Name: Merit Microcatheters

Indications for Use:

The Merit 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 diagnostic, embolic or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.

Prescription Use X

. 1988

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)

M. G. Hillebert

vascular Devices

**510(k) Number** K082613