MERIT IMPRESS DIAGNOSTIC CATHETER

K053171 · Merit Medical Systems, Inc. · DQO · Jan 19, 2006 · Cardiovascular

Device Facts

• Record ID: K053171
• Device Name: MERIT IMPRESS DIAGNOSTIC CATHETER
• Applicant: Merit Medical Systems, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Jan 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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

Merit Impress Radiology Catheter is a diagnostic intravascular catheter; consists of a wire-braid reinforced shaft, molded proximal hub, and flexible tapered distal tip. Device functions as a passive conduit for delivery of radiopaque contrast media to vascular sites under high pressure. Used by clinicians in diagnostic angiography procedures. Flexible distal tip design minimizes potential for vessel trauma; tapered tip facilitates high-volume flow and media dispersion. Marker bands allow for anatomical measurements. Device is substantially equivalent to predicate catheters in design, materials, and method of operation.

Clinical Evidence

Bench testing only. Performance testing conducted per international standards and in-house protocols to compare safety and effectiveness against predicate devices. Conformance to validated criteria confirmed.

Technological Characteristics

Wire-braid reinforced shaft; molded proximal hub; flexible tapered distal tip. Passive conduit for contrast media delivery. Materials similar to predicate diagnostic catheters. No software or electronic components.

Indications for Use

Indicated for use in patients requiring delivery of radiopaque contrast media to selected vascular sites during routine diagnostic angiography procedures. May be used for anatomical measurements when equipped with marker bands.

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

• Performa® Diagnostic Radiology Catheter (K000659)
• AngioDynamics Inc., Soft-VU® Omni FlushTM Radiology Catheter (K001578)

Submission Summary (Full Text)

{0}------------------------------------------------

JAN 1 9 2006

K05317/

#### 11.0 Premarket Notification [510(k)] Summary of Safety and Effectiveness

Submitter

Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, Utah 84095-2416 USA

Establishment Registration Number

Contact Person(s) Primary Contact Person Title

> Phone Fax e-mail

Alternate Contact Person Title

Phone Fax e-mail

Date Prepared

Name of Medical Device

Classification Name:

Common/Usual Name: Trade/Proprietary Name:

Device Classification

Panel: Device Class: Product Code: Regulation Number:

Predicate Device Identification

Predicate 1.

Device Brand Name Classification Name

Device Class Classification Panel Number Product Code Clearance Status

William D. Jordan Regulatory Affairs Specialist Merit Medical Systems, Inc. [phone] [phone]

[e-mail]

1721504

Stephanie A. Erskine Vice President Regulatory Affairs Merit Medical Systems, Inc. [phone] [phone] [e-mail]

September 30, 2005

Merit Impress Radiology Catheter

Catheter, Intravascular, Diagnostic (21 CFR 870.1200) Diagnostic Catheter Merit Impress Radiology Catheter

Cardiovascular Class II 74 DOQ 21 CFR 870.1200

Performa® Diagnostic Radiology Catheter Catheter, Intravascular, Diagnostic (21 CFR 870.1200) Class II 870 Cardiovascular Devices DOO K000659

{1}------------------------------------------------

# Merit Medical Systems, Inc. Merit Impress™ Radiology Catheter PREMARKET NOTIFICATION [510(k)} CONFIDENTIAL 510(k) Summary (per 21 CFR 807.92)

Manufacturer Registration Number

Predicate 2.

Device Brand Name

Classification Name

- Device Class Classification Panel Number Product Code Clearance Status Manufacturer Registration Number
Merit Medical Systems 1721504

AngioDynamics Inc., Soft-VU® Omni FlushTM Radiology Catheter Catheter, Intravascular, Diagnostic (21 CFR 870.1200) Class II (Performance Standards) 870 Cardiovascular DOO K001578 AngioDynamics Inc. 1319211

#### Device Description

Merit's Impress consists of a shaft with molded hub and an overmolded segment at the proximal end of the device. The shaft is initially available in a wirebraid reinforced shaft. The distal tip is tapered for even high volume flow and dispersion of the contrast media, and flexible to minimize the potential for vessel trauma.

#### 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.

{2}------------------------------------------------

### Summary of Characteristics in Relation to Predicate Device(s)

#### Does the new device have the same indication statement as the predicate device?

Yes.

The Merit Impress™ Radiology Catheter is intended for use in delivering radiopaque media to slected sites in the vascular system in conjunction with routine diagnostic procedures.

#### Does the new device have the same technological characteristics, e.g., design, materials, etc. as the predicate device?

Yes.

The Merit Impress™ Radiology Catheter employs a similar method of operation and design as compared to the predicate devices. Both the new and predicate devices consist of a proximal hub, shaft and distal tip. Both the new and predicate devices are comprised of similar materials and serve as passive conduits for the delivery of contrast media under high pressure.

#### Are the descriptive characteristics precise enough to ensure equivalence to the predicate device?

No.

Bench testing was conducted on the Impress in order to establish substantial equivalence.

#### Are performance data available to assess effects of the new device as compared to the predicate device?

Yes.

Performance testing was conducted according to protocols based on international standards as well as Merit's in-house protocols. Where performance could affect the safety or effectiveness of the Impress, comparison with the predicate devices was conducted, and conformance to validated criteria was confirmed.

### Does performance data demonstrate equivalence?

Yes.

Performance data demonstrates that the Impress is substantially equivalent to the predicate devices.

#### Conclusion: "Substantial Equivalence" Determination

Based on CDRH's substantial equivalence decision tree, the Impress is substantially equivalent to the predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)

JAN I 9 2006

Merit Medical Systems, Inc. c/o KEMA Quality B.V. 4377 County Line Road Chalfont, PA 18914 Attn: Mr. J.A. Van Vugt

Re: K053171 Merit Impress Radiology Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: DOO Dated: December 22, 2005 Received: December 23, 2005

Dear Ms. Erskine:

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, Dr g 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.

{4}------------------------------------------------

Page 2 - Mr. J.A. Van Vugt

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. 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Dina R. Viener

Image /page/4/Picture/5 description: The image contains a handwritten symbol that appears to be a cursive letter 's' or 'j'. The symbol is drawn with a thick line, and it has a loop at the top and a stroke extending to the left at the bottom. The background is plain white.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Merit Medical Systems, Inc. Merit Impress™ Diagnostic Radiology Catheter PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL

# INDICATION(S) FOR USE STATEMENT *

510(k) Number (if known): KCS317 |

Device Name:

Merit Impress TM Diagnostic Radiology Catheter

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 901 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart O)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dune R. Hines
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_K0531 7