OSTIAL PRO STENT POSITIONING SYSTEM

K122089 · Merit Medical Systems, Inc. · DQX · Sep 21, 2012 · Cardiovascular

Device Facts

• Record ID: K122089
• Device Name: OSTIAL PRO STENT POSITIONING SYSTEM
• Applicant: Merit Medical Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 21, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position stents and other interventional devices within the coronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.

Device Story

Disposable medical-grade guidewire system; used by interventional cardiologists and radiologists in aorta-ostial procedures (coronary and renal stenting). Facilitates precise stent implantation and alignment of interventional devices. Compatible with 6, 7, and 8 French catheters. Provided sterile for single use. Device functions as mechanical alignment tool to assist physician during interventional procedures; improves accuracy of stent placement in ostial lesions. Benefits include reduced procedural complexity and enhanced precision in stent positioning.

Clinical Evidence

No clinical data. Bench testing only. Testing included dimensions, torque strength, torque-ability, feet deflection force, austenite finish temperature, wire Af, coating integrity, catheter compatibility, radio-opacity, feet force deflection/compression, fatigue loading, and tensile strength (linear/angular).

Technological Characteristics

Disposable guidewire system; medical-grade materials. Compatible with 6, 7, 8 French catheters. Sterilized via ethylene oxide (AAMI/ANSI/ISO 11135-1). Packaging compliant with AAMI/ANSI/ISO 11607-1 and ISO 2233. Mechanical design features feet for positioning/alignment. No software or electronic components.

Indications for Use

Indicated for use in aorta-ostial procedures to introduce and position stents and other interventional devices within the coronary and peripheral vasculature, and to facilitate alignment of interventional devices. Used by interventional cardiologists and radiologists for coronary and renal stenting procedures.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Ostial Pro Stent Positioning System (K062192)

Submission Summary (Full Text)

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K122089

SEP 21 2012

### 510(k) Summary Submitter Name: Merit Medical Systems, Inc. Address: 1600 West Merit Parkway South Jordan, UT 84095 General Telephone Number: [phone] Provisions Fax Number: [phone] Contact Person: David Thomas Date of Preparation: . July 11, 2012 Registration Number: 1721504 Ostial Pro Stent Positioning System Trade Name: Subject Common/Usual Name:Stent Positioning System Device Classification Name: Catheter Guidewire Trade Name: Ostial Pro Stent Positioning System Common/Usual Name: Stent Positioning System Classification Name: Catheter Guidewire Predicate Device Premarket Notification:K062192 Manufacturer: Merit Medical Systems, Inc. Class II Classification 21 CFR § 870.1330 Cardiovascular The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position stents and other interventional devices within the coronary and peripheral Intended Use vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.

Section 5

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| Device Description | The Ostial Pro Stent Positioning System is a medical grade, disposable guidewire system. The Ostial Pro Stent Positioning System will be used by interventional cardiologists and interventional radiologists to ensure precise stent implantation in aorta-ostial procedures. The product will be used in coronary and renal stenting procedures. This product is provided sterile and intended for single use. This finished product will be compatible with 6, 7 and 8 French catheters. |
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| Technological Characteristics | The technological characteristics of the subject Ostial Pro Stent Position System are substantially equivalent to those of the predicate device, the Ostial Pro Stent Positioning System, 510(k) K062192. |

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K122089 Page 2 of 4

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No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject Ostial Pro Stent Positioning System was conducted based on the risk analysis and based on the requirements of the following FDA guidance document and international standards:

- . AAMI/ANSI/ISO 11135-1: 2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- AAMI/ANSI/ISO 11607-1: 2006, Packaging for terminally . sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 2233:2000, Packaging complete, filled transport . packages and unit loads - conditioning and testing

## Safety & Performance Tests

- . ASTM D4169-09, Standard practice for performance testing of shipping containers and systems
- AAMI/ANSI/ISO 10993-7: 2008 Biological Evaluation of . Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
- ASTM F1980:2007 Standard Guide for Accelerated Aging of . Sterile Barrier Systems for Medical Devices.
- Coronary and Cerebrovascular Guidewire Guidance Jan ● 1995
- Non-Clinical Engineering Tests and Recommended Labeling . for Intravascular Stents and Associated Delivery Systems -April 2010.

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

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| Safety &<br>Performance<br>Tests cont. | Design Verification<br>Dimensions<br>Torque Strength<br>Torque-Ability<br>Feet Deflection Force Test<br>Body Af (Austenite Finish Temperature) Test<br>Wire Af Test<br>Coating Adherence/Integrity<br>Catheter Compatibility<br>Radio-opacity<br>Feet Force Deflection/Compression Test<br>Fatigue Loading of Feet<br>Linear Tensile Strength<br>Angular Tensile Strength |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety &<br>Performance<br>Tests cont. | The results of the testing demonstrated that the subject Ostial Pro<br>Stent Positioning System met the pre-determined acceptance<br>criteria applicable to the safety and efficacy of the device. |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, design, and safety and<br>performance testing, the subject Ostial Pre Stent Positioning<br>System meets the requirements that are considered essential for<br>its intended use and is substantially equivalent to the predicate<br>device, the Ostial Pro Stent Positioning System, manufactured by<br>Ostial Solutions LLC. |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

#### Public Health Service

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

2 1 2012

Merit Medial Systems, Inc.
c/o David Thomas
1600 West Merit Parkway
South Jordan, Utah 84095

Re: K122089

Trade/Device Name: Ostial Pro Stent Positioning System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: August 23, 2012 Received: August 24, 2012

Dear Mr. Thomas:

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

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## Page 2 – Mr. David Thomas

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/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

W. A. Hillen

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: Ostial Pro Stent Positioning System

Indications for Use:

The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position stents and other interventional devices within the coronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.

× 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)

U.A. Miller

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ 11 122089