IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING

K093004 · Merit Medical Systems, Inc. · DQO · Feb 12, 2010 · Cardiovascular

Device Facts

• Record ID: K093004
• Device Name: IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING
• Applicant: Merit Medical Systems, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Feb 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

Angiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.

Device Story

Single lumen angiographic catheter; 4F and 5F sizes; 40cm to 125cm lengths. Distal shaft segment features hydrophilic coating to facilitate navigation. Used by physicians in clinical settings for vascular access; delivers radiopaque contrast media to target sites for diagnostic imaging. Marker bands allow for anatomical measurements. Device provides improved trackability and reduced friction during insertion compared to non-coated catheters.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Single lumen catheter; 4F/5F diameters; 40-125cm lengths. Distal segment features hydrophilic coating. Diagnostic intravascular catheter (21 CFR 870.1200).

Indications for Use

Indicated for delivery of radiopaque media to vascular sites during diagnostic procedures; optional use for anatomical measurements via marker bands. No specific patient population or contraindications defined.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Impress® Angiographic Catheter (K053171)
• Radifocus® Glidecath™ (K915414)

Submission Summary (Full Text)

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K093004

:

| Section 5 | | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 510(k) Summary | | | FEB 12 2010 |
| 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 25, 2009<br>1721504 | |
| Subject<br>Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | Impress® Angiographic Catheter with<br>Hydrophilic Coating<br>Angiographic Catheter<br>Diagnostic Intravascular Catheter | |
| Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | Impress® Angiographic Catheter<br>Diagnostic Intravascular Catheter<br>K053171<br>Merit Medical Systems, Inc. | |
| Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | Radifocus® Glidecath™<br>Diagnostic Intravascular Catheter<br>K915414<br>Terumo Corporation | |
| Classification | Class II<br>21 CFR § 870.1200, 74 DQO<br>Division of Cardiovascular Devices | | |
| Intended Use | Angiography catheters are designed to be used for delivering<br>radiopaque media to selected sites in the vascular system in<br>conjunction with routine diagnostic procedures. Angiographic<br>catheters with marker bands may also be used for anatomical<br>measurements. | | |

and the control of the county of

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| Device<br>Description | The Impress® Angiographic Catheters with hydrophilic coating are<br>single lumen catheters offered in 4F and 5F sizes and 40cm to<br>125cm. The outer surface of the distal segment of the catheter shaft<br>is coated with a hydrophilic coating. |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | Technological characteristics of the subject Impress catheter with<br>hydrophilic coating are substantially equivalent to those of the<br>predicate devices, the Impress Angiographic Catheter (K053171)<br>and the Radifocus Glidecath Angiographic Catheter (K915414). |
| 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,<br>testing was performed demonstrating that the subject device met the<br>acceptance criteria determined to demonstrate the safety and<br>efficacy of the device. |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, design, safety and performance<br>testing, the subject Impress® Angiographic Catheter with hydrophilic<br>coating is substantially equivalent to the predicate devices, the<br>Impress® Angiographic Catheter, manufactured by Merit Medical<br>Systems, Inc., and the Radifocus Glidecath Angiographic Catheter,<br>manufactured by Terumo Corporation. |

. . .

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a logo for the Department of Health & Human Services - CSA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - CSA" arranged around the top half of the circle. In the center of the circle is an abstract image of three human profiles facing to the right, which is a common symbol used by the Department of Health and Human Services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Merit Medical Systems, Inc. c/o Ms. Michaela Rivkowich Regulatory Affairs Specialist III 1600 West Merit Parkway South Jordan, UT 84095

FEB 1 2 2010

Re: K093004

Trade/Device Name: Impress® Angiographic Catheter with Hydrophilic Coating Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQO Dated: January 28, 2010 Received: January 29, 2010

Dear Ms. Rivkowich:

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.

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Page 2 – Ms. Michaela Rivkowich

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 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

una R. Viilunen

Image /page/3/Picture/8 description: The image shows a signature. The signature is written in black ink on a white background. The signature appears to be a stylized version of the letters 'S' and 'M' connected together with a horizontal line underneath.

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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Section 4

## Indications for Use

510(k) Number (if known):

Device Name: Impress® Angiographic Catheter with Hydrophilic Coating

KO93004

Indications for Use:

Angiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.

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)

Duna R. Vi

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