CONCIERGE GUIDING CATHETER

K132409 · Merit Medical Systems, Inc. · DQY · Aug 29, 2013 · Cardiovascular

Device Facts

• Record ID: K132409
• Device Name: CONCIERGE GUIDING CATHETER
• Applicant: Merit Medical Systems, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 29, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Concierge Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

Device Story

Concierge Guiding Catheter is a single-lumen catheter used by clinicians to facilitate the delivery of interventional or diagnostic devices into coronary or peripheral vasculature. Device consists of Pebax body, stainless steel wire braid reinforcement, PTFE lubricious inner lumen, and soft radiopaque tip. Available in 5F, 6F, 7F, and 8F sizes, 100cm length, and various shapes. Operates as a conduit for other devices; no active components or electronic processing. Used in clinical settings; provides a pathway for diagnostic/interventional tools to reach target vascular sites.

Clinical Evidence

Bench testing only. No clinical data. Testing included dimensions, air/liquid leak, tip support/attachment, tensile strength, shaft kink/stiffness, simulated use, packaging integrity (dye penetration, burst, seal peel), and biocompatibility (cytotoxicity, hemocompatibility, chemical characterization).

Technological Characteristics

Single-lumen catheter; Pebax body; stainless steel wire braid reinforcement; PTFE lubricious inner lumen; soft radiopaque tip. Sizes: 5F, 6F, 7F, 8F; length: 100cm. Standards: ISO 10555-1/2, ISO 10993-1/5/7/17/18, ISO 11135-1, ISO 11607, ASTM D4169, ASTM F756, ASTM F1929, ASTM F2096, ASTM F88/F88M, ASTM F1140. Sterilization: Ethylene oxide.

Indications for Use

Indicated for intravascular introduction of interventional or diagnostic devices into coronary or peripheral vascular systems.

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

• Concierge Guiding Catheter (K121051)

Submission Summary (Full Text)

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# K132409

# Section 5

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## 510(k) Summary ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| General<br>Provisions | Submitter Name: Merit Medical Systems, Inc.<br>Address: 1600 West Merit Parkway<br>South Jordan, UT 84095<br>Telephone Number: [phone]<br>Fax Number: [phone]<br>Contact Person: Vicki Godwin<br>Date of Preparation: August 1,2013<br>Registration Number: 1721504<br>AUG 2 9 2013 |
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| Subject<br>Device | Trade Name: Concierge® Guiding Catheter<br>Common/Usual Name: Guiding Catheter<br>Classification Name: Percutaneous Catheter |
| Predicate<br>Device | Trade Name: Concierge® Guiding Catheter<br>Classification Name: Percutaneous Catheter<br>Premarket Notification: K121051<br>Manufacturer: Merit Medical Systems, Inc. |
| Classification | Class II<br>21 CFR § 870.1250<br>FDA Product Code: DQY<br>Review Panel: Cardiovascular |
| Intended Use | The Concierge Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems. |
| Device<br>Description | The Concierge Guiding Catheter is a single lumen catheter that incorporates a Pebax body reinforced with stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip. It is available in 5F, 6F, 7F and 8F sizes, 100cm long and is produced in a variety of shapes. |
| Comparison to<br>Predicate<br>Device | The technological characteristics of the subject Concierge Guiding<br>Catheters are substantially equivalent to those of the predicate<br>device. The 5F, 7F and 8F Concierge Guiding Catheter sizes are<br>modifications of the predicate 6F Concierge Guiding Catheter. In<br>addition, changes were made to the device material and packaging |
| 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. Performance<br>testing of the subject Concierge Guiding Catheter was conducted<br>based on the risk analysis and based on the requirements of the<br>following international standards:<br>ISO 10555-1:1995, Sterile, single-use intravascular<br>catheters - Part 1: General requirements ISO 10555-2:1996, Sterile, single-use intravascular<br>catheters - Part 2: Angiographic catheters ISO 11135-1: 2007, Sterilization of health care products<br>- Ethylene oxide - Part 1: Requirements for<br>development, validation and routine control of a<br>sterilization process for medical devices ISO 10993-1: 2009, Biological Evaluation of Medical<br>Devices Part-1: Evaluation and Testing within a risk<br>management process ISO 10993-5: 2009, Biological Evaluation of Medical<br>Devices Part-5: Tests for In Vitro Cytotoxicity ISO 10993-7: 2008, Biological Evaluation of Medical<br>Devices Part-7 Ethylene Oxide Sterilization Residuals ISO 10993-17: 2002, Biological Evaluation of Medical<br>Devices - Part 17: Establishment of allowable limits for<br>leachable substances ISO 10993-18: 2005, Biological Evaluation of Medical<br>Devices - Part 18: Chemical Characterization of<br>Materials ISO 2233: 2000: Packaging - complete, filled transport<br>packages and unit loads - conditioning and testing BS EN ISO 11607: 2009, Packaging for terminally<br>sterilized medical devices Part 1: Requirements for<br>materials, sterile barrier systems and packaging systems<br>(ISO 11607-1:2006) ASTM D4169-09: 2009, Standard practice for<br>performance testing of shipping containers and systems ASTM F756-08, 2008: Standard Practice for<br>Assessment of Hemolytic Properties of Materials ASTM F1929-98(2004): 1998, Standard test method for<br>detecting seal leaks in porous medical packaging by dye<br>penetration |

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- ASTM F2096-11: 2011, Standard test method for ● detecting gross leaks in medical packaging by internal pressurization (bubble test)
- . ASTM F88/F88M-09: 2009 Standard test method for seal strength of flexible barrier materials
- ASTM F1140-07, Standard test methods for internal . pressurization failure resistance of unrestrained packages

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

#### Device Testing

- Dimensions ●
- Air Leak
- Liquid Leak .
- Catheter Tip Support and Attachment ●
- Tensile .
- Shaft Kink .
- . Shaft Stiffness
- . Simulated use testing

#### Packaging testing

- Visual Inspection .
- . Dye Penetration
- . Underwater Leak Test
- . Seal Peel Tensile Test
- Burst Strength Test �
- Aseptic Peel Opening .

#### Biocompatibility testing

- Cytotoxicity .
- Hemocompatibility
- . Chemical Characterization

The results of the testing demonstrated that the subject Concierge Guiding Catheters met the pre-determined acceptance criteria applicable to the safety and efficacy of the device.

Summary of Substantial Equivalence

Based on the indications for use, design, safety and performance testing, the subject Concierge Guiding Catheters meet the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Concierge Guiding Catheter, manufactured by Merit Medical Systems, Inc.

Safety & Performance Tests cont.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which is a stylized representation of an eagle or bird with three wing-like shapes. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 29, 2013

Merit Medical Systems, Inc. c/o Vicki Godwin 1600 West Merit Parkway South Jordan, Utah 84095

Re: K132409

Trade/Device Name: Concierge Guiding Catheter Regulation Number: 21 CFR § 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 1, 2013 Received: August 2, 2013

Dear Ms. Godwin:

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 (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.

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Page 2 - Ms. Vicki Godwin

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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,

M. L. Hillen

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

Enclosure

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### Section 4

### Indications for Use

K132409 510(k) Number (if known):

Device Name: Concierge® Guiding Catheter

Indications for Use:

The Concierge® Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

Prescription Use × (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)

M. Z. Hilleman