MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE

K091584 · Merit Medical Systems, Inc. · DRE · Oct 9, 2009 · Cardiovascular

Device Facts

• Record ID: K091584
• Device Name: MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE
• Applicant: Merit Medical Systems, Inc.
• Product Code: DRE · Cardiovascular
• Decision Date: Oct 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Intended Use

The Merit MAK® (Mini Access Kit) is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire into the vascular system.

Device Story

Merit MAK (Mini Access Kit) facilitates percutaneous vascular access; utilizes small diameter coaxial introducer/dilator pair and 0.018" guide wire to place larger diameter guide wires into vasculature; preferred for small needle stick procedures. Components include 21-gauge introducer needle, coaxial introducer/dilator pair, and guide wire (stainless steel or nitinol with palladium tip). Used by clinicians in clinical settings to establish vascular access; enables subsequent placement of larger diagnostic or therapeutic devices. Benefits include reduced trauma via smaller initial needle stick.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing conducted according to industry standards and internal protocols demonstrated that the device meets all acceptance criteria for safety and efficacy.

Technological Characteristics

Components: 21-gauge introducer needle, 4F or 5F coaxial introducer/dilator pair, and guide wire. Materials: Stainless steel or nitinol wire with palladium tip. Connectivity: None. Energy source: None (manual). Sterilization: Not specified.

Indications for Use

Indicated for percutaneous placement of 0.035" or 0.038" guide wires into the vascular system for patients requiring vascular access.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Predicate Devices

• Merit MAK (Mini Access Kit) (K031691)

Submission Summary (Full Text)

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Merit Medical Systems, Inc. Section 5 Merit MAK with Palladium Tip Guide Wire 510(k) Summary Traditional Premarket Notification 510(k) 1091584 . ب . 2. 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Section 5 OCT 2 9 2009 510(k) Summary Submitter Name: Merit Medical Systems, Inc. 1600 West Merit Parkway Address: South Jordan, UT 84095 General Telephone Number: [phone] Provisions Fax Number: [phone] Contact Person: Susan Christensen May 28, 2009 Date of Preparation: Registration Number: 1721504 Trade Name: Merit MAK® (Mini Access Kit) Subject Common/Usual Name:Vessel Dilator/Introducer Sheath Device Classification Name: Vessel Dilator for Percutaneous Catheterization Trade Name: Merit® MAK (Mini Access Kit) Vessel Dilator for Percutaneous Classification Name: Predicate Catheterization Device Premarket Notification: K031691 Manufacturer: Merit Medical Systems, Inc. Class II 21 CFR § 870.1310, 74 DRE Classification Division of Cardiovascular Devices The Merit MAK (Mini Access Kit) is intended for percutaneous Intended Use placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire into the vascular system.

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| | The Merit MAK® (Mini Access Kit) utilizes a small diameter coaxial<br>introducer/dilator pair and guide wire for placement of larger<br>diameter guide wires into the vasculature system when a small<br>needle stick is preferred. |
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| Device<br>Description | The Merit MAK® consists of the following components:<br>One (1) 4F or 5F Coaxial Introducer/Dilator Pair<br>One (1) 21 gauge Introducer Needle<br>One (1) 0.018" (0.46mm) Guide Wire<br>Two new versions of guide wires will be offered:<br>Stainless Steel Wire with Palladium Tip<br>Nitinol Wire with Palladium Tip |
| Technological<br>Characteristics | Technological characteristics of the subject Merit MAK® with<br>palladium tip guide wire are substantially equivalent to those of the<br>predicate, the currently marketed Merit MAK with platinum tip guide<br>wire [K031691]. |
| 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 industry standards and guidances and were shown<br>to meet the acceptance criteria that were determined to demonstrate<br>the safety and efficacy of the device. |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, design, safety, and performance<br>testing, the subject Merit MAK® with palladium tip guide wire meets<br>the requirements that are considered essential for its intended use<br>and is substantially equivalent to the predicate device, the currently<br>marketed Merit MAK with platinum tip guide wire manufactured by<br>Merit Medical Systems, Inc. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health.

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. Susan Christensen Regulatory Affairs Specialist II 1600 West Merit Parkway South Jordan, UT 84095

## OCT 2 9 2009

Re: K091584

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Trade/Device Name: Merit MAK® (Mini Access Kit) Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II (two) Product Code: DRE Dated: September 30, 2009 Received: October 1, 2009

Dear Ms. Christensen:

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. Drue, 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. Susan Christensen

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.

Kc

Bram b. 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 Statement

510(k) Number (if known):

Device Name: Merit MAK® (Mini Access Kit) with Palladium Tip Guide Wire

K091584

Indications for Use:

The Merit MAK® (Mini Access Kit) is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire into the vascular system.

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)

K. L. Cox

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K091584