True Form Reshapable Guide Wire

K170532 · Merit Medical Systems, Inc. · DQX · Jul 21, 2017 · Cardiovascular

Device Facts

• Record ID: K170532
• Device Name: True Form Reshapable Guide Wire
• Applicant: Merit Medical Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jul 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The True Form Reshapable Guide Wire is intended to facilitate the placement of catheters within the peripheral and coronary vasculature for various diagnostic and interventional procedures. The True Form Reshapable Guide Wire should not be used in the neurovasculature

Device Story

True Form Reshapable Guide Wire facilitates catheter placement in peripheral and coronary vasculature. Device consists of stainless steel core wire, flattened at distal end, with 5cm gold-plated tungsten coil attached via solder joints; fully jacketed with radiopaque-filled polymer and hydrophilic coating. Provided in straight and angled versions with insertion tool, tip straightener, and torque device. Used by clinicians in interventional/diagnostic procedures to navigate vasculature. Clinician manually manipulates wire to guide catheters to target sites. Benefits include improved trackability and placement of diagnostic/interventional devices. Not for neurovascular use.

Clinical Evidence

Bench testing only. No clinical data. Testing included size designation, radiodetectability, tip shape, tensile/torque strength, torqueability, tip flexibility, fracture/flex tests, lubricity, corrosion resistance, device compatibility, tip curve shapeability, particulate, and coating durability. Biocompatibility testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, genotoxicity, hemolysis, thrombogenicity, and complement activation.

Technological Characteristics

Stainless steel core wire; 5cm gold-plated tungsten coil; radiopaque-filled polymer jacket; hydrophilic coating. Sterilization via ethylene oxide (ISO 11135:2014). Accelerated aging per ASTM F1980-07. Biocompatibility per ISO 10993-1:2009. Manual operation; no energy source.

Indications for Use

Indicated for patients requiring catheter placement within peripheral and coronary vasculature for diagnostic and interventional procedures. Contraindicated for use in the neurovasculature.

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

• Boston ChoICE PT (K143587)
• Bard Porter (K060551)

Submission Summary (Full Text)

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Public Health Service

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

July 21, 2017

Merit Medical Systems, Inc. Michael O'Sullivan Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland

Re: K170532

Trade/Device Name: True Form Reshapable Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: June 15, 2017 Received: June 19, 2017

Dear Michael O'Sullivan:

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 of medical device

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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 contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely,

## Kenneth J. Cavanaugh -S

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K170532

Device Name True Form Reshapable Guide Wire

Indications for Use (Describe)

The True Form Reshapable Guide Wire is intended to facilitate the placement of catheters within the peripheral and coronary vasculature for various diagnostic and interventional procedures.

The True Form Reshapable Guide Wire should not be used in the neurovasculature

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#

| | Submitter Name: | Merit Medical Systems, Inc. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| | Address: | 1600 West Merit Parkway<br>South Jordan, UT 84095 |
| | Telephone Number: | ([phone] (Ext. 3061) |
| | Fax Number: | ([phone] |
| | Contact Person: | Mark Mullaney |
| | Registration Number: | 1721504 |
| General<br>Provisions | Correspondent Name: | Merit Medical Ireland Ltd. |
| | Address: | Parkmore Business Park<br>Parkmore, Galway, Ireland |
| | Telephone Number: | ([phone] (Ext. 3223) |
| | Fax Number: | ([phone] |
| | Contact Person: | Michael O'Sullivan |
| | Date of Preparation: | 20th February 2017 |
| | Registration Number: | 9616662 |
| Subject<br>Device | Trade Name: | True Form Reshapable Guide Wire |
| | Common/Usual Name: | Guide Wire |
| | Classification Name: | Wire, Guide, Catheter |
| Predicate<br>Device | Premarket Notification Predicate #1: | |
| | Trade Name: | Boston ChoICE PT |
| | Classification Name: | 21 CFR 870.1330 Catheter guide wire |
| | Premarket Notification: | K143587 |
| | Manufacturer: | Boston Scientific Corporation |
| | Premarket Notification Reference Predicate #2: | |
| | Trade Name: | Bard Porter |
| | Classification Name: | 21 CFR 870.1330 Catheter guide wire |
| | Premarket Notification: | K060551 |
| | Manufacturer: | Brivant Ltd. |
| Classification | Class II | |
| | 21 CFR § 870.1330 | |
| | Product code: | DQX |
| | Division of Cardiovascular Devices | |
| Intended Use | The True Form Reshapable Guide Wire is intended to facilitate the<br>placement of catheters within the peripheral and coronary<br>vasculature for various diagnostic and interventional procedures.<br>The True Form Reshapable Guide Wire should not be used in the<br>neurovasculature | |
| Device<br>Description | The Merit True Form Reshapable Guide Wire consists of a stainless<br>steel core wire, flattened at the distal end, with a 5cm Gold Plated<br>Tungsten coil attached to the distal tip and is fully jacketed with a<br>radiopaque filled polymer jacket. The True Form Reshapable Guide<br>Wire is fully coated with a hydrophilic coating. The 5cm radiopaque<br>coil is attached to the internal stainless steel core wire with a<br>multitude of solder joints. | |
| | The wires are placed within a spiralled hoop dispenser with a flush<br>luer attached and clips to secure the wire within the hoop. Included<br>within the pouch, with the spiralled hooped guidewire, is another<br>pouch containing an Insertion Tool, a Tip Straightener, and a Torque<br>device. | |
| | The wire will be offered in straight and angled versions, in various<br>lengths. | |
| Comparison<br>to Predicate | The Technological characteristics of the subject Merit True Form<br>Reshapable Guide Wire are substantially equivalent to those of<br>Predicate Device #1, the Boston Choice PT[K143587] and<br>Reference Predicate #2, the Bard Porter [K060551]. The subject<br>device has the same basic design as the predicates, in that they all<br>consist of a metallic core wire covered in a radiopaque polymer<br>jacket with some or all the wire jacket having a hydrophilic coating.<br>The fundamental technology and operating principles of the subject<br>and the predicates are the same and while the indications for use<br>wordings are not identical, the intended use is the same, with all<br>wires used for the placement of devices during intravascular<br>procedures. | |
| Safety &<br>Performance<br>Tests | No performance standards have been established under section<br>514 of the Food, Drug and Cosmetic Act for these devices. A battery<br>of testing was conducted, on the Merit True Form Reshapable Guide<br>Wire, in accordance with protocols based on requirements outlined | |

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Merit Medical Systems, Inc.
Merit True Form Reshapable Guide Wire
Traditional Premarket Notification 510(k)

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in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.

Where appropriate, the tests were based on the requirements of the following documents:

- FDA guidance Coronary and Cerebrovascular Guide Wire ● Guidance January 1995.
- . ISO 11070:2014, Sterile Single-Use Intravascular Catheter Introducers.
- ISO 11135:2014 Sterilization of health care products-. Ethylene oxide-: Requirements for the development, validation and routine control of a sterilization process for medical devices.
- ASTM F1980-07 Standard Guide for Accelerated Aging of ● Sterile Barrier Systems for Medical Devices
- . ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and the FDA Modified ISO 10993 Test Profile FDA Memo G95-1.

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

## Performance Testing-Bench

- Size Designation ●
- . Radiodetectability
- Tip Shape Testing ●
- Surface .
- Tensile Strenath ●
- Torque Strength ●
- Torqueability
- . Tip Flexibility
- Fracture test ●
- Flex test ●
- Lubricitv ●
- Corrosion Resistance
- Device Compatibility ●
- Tip Curve Shapeability ●
- Particulate ●
- Coating Durability ●
- Packaging

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Merit Medical Systems, Inc.
Merit True Form Reshapable Guide Wire
Traditional Premarket Notification 510(k)

## Biocompatibility

| Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Genotoxicity Hemolysis Thrombogenicity Complement Activation All test results were comparable to the predicate devices and the subject Merit True Form Reshapable Guide Wire met the predetermined acceptance criteria. This has demonstrated that the subject device is substantially equivalent to the predicate devices. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Summary of Substantial Equivalence</b><br>Based on the Indications for Use, design, safety and performance testing, the subject Merit True Form Reshapable Guide Wire meets the requirements that are considered essential for its intended use and is substantively equivalent to Predicate Device #1, the Boston Choice PT [K143587], manufactured by Boston Scientific Corporation and Reference Predicate #2, the Bard Porter [K060551], manufactured by Brivant Ltd. |