CHARTER GUIDEWIRE

K122856 · Brivant, Ltd. · DQX · Oct 17, 2012 · Cardiovascular

Device Facts

• Record ID: K122856
• Device Name: CHARTER GUIDEWIRE
• Applicant: Brivant, Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 17, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Charter™ Guidewires are intended for use in the coronary and peripheral vasculature.

Device Story

Charter™ Guidewire is a single-use, disposable device used to navigate coronary and peripheral vasculature. It consists of a stainless steel core wire (0.014", 0.016", or 0.018" diameter) with a tapered distal end created via centerless grinding to provide variable stiffness. The distal section features a platinum-tungsten spring coil for radiopacity and an Estane 88A polymer sleeve. The device is coated to enhance lubricity for advancement through guide catheters and vessels. Operated manually by clinicians during percutaneous interventions, the guidewire facilitates access to target sites. The device provides structural support and navigation, aiding the physician in placing therapeutic devices. Benefits include improved vessel access and visibility under X-ray.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing only, including tensile strength, torque strength, outer diameter measurement, torque response, catheter compatibility, coating adherence/integrity, tip stiffness, and particulate residue testing. Results met all product specifications and demonstrated performance comparable to the predicate device.

Technological Characteristics

Materials: stainless steel core, platinum-tungsten spring coil, Estane 88A radiopaque polymer tubing, lubricious coatings. Dimensions: 140cm, 180cm, or 300cm lengths; 0.014", 0.016", or 0.018" diameters. Principle: manual mechanical navigation. Design features: centerless ground tapered core for variable stiffness. Sterilization: not specified. Connectivity: none.

Indications for Use

Indicated for use in coronary and peripheral vasculature. Contraindicated for use in cerebral vasculature and for patients not acceptable for percutaneous intervention (PCI).

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

• Charter Guidewire (K103377)

Submission Summary (Full Text)

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K122856 page 1 of 2

ОСТ

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Charter 510(k) Application

## 510(k) Summary as required by 21 CFR 807.92(c)

| Device Name | Charter™ Guidewire | | | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------|---------------|
| Submitters | Brivant Ltd, | | | |
| name/contact | Parkmore West Business Park, | | | |
| details | Galway, | | | |
| | Ireland | | | |
| | | | | |
| | Contact Details: | | | |
| | Kenneth Walsh | | | |
| | Senior QA/RA Supervisor | | | |
| | Tel: [phone] | | | |
| | Fax: [phone] | | | |
| Summary | 31st August 2012 | | | |
| Preparation Date | | | | |
| Device Name & | Trade Name: | Charter™ Guidewire | | |
| Classification | Common Name: | Guidewire | | |
| | Classification Name: | Catheter, Guidewire | | |
| | Device Classification: | Class II, 21 CFR §870.1330 | | |
| | Product Code: | DQX | | |
| Intended Use | Intended Use: | | | |
| | The Charter™ Guidewires are intended for use in the coronary and peripheral | | | |
| | vasculature. | | | |
| | | | | |
| | Contraindications: | | | |
| | The Charter™ Guidewire is not intended for use in the cerebral vasculature. | | | |
| | Patients judged not acceptable for percutaneous intervention (PCI) | | | |
| Device Description | The Charter™ Guidewire is a disposable medical device designed for single use | | | |
| | only. It consists of a PTFE coated 140cm, 180cm, or 300cm 0.014", 0.016" or | | | |
| | 0.018" diameter stainless steel core wire, one end of which is reduced in | | | |
| | diameter over a 43cm approx. segment in a progressive fashion through a | | | |
| | centreless grinding operation. The profile of this reduced section affords the | | | |
| | product a reduced area of stiffness and can be varied to produce various levels<br>of support. | | | |
| | | | | |
| | The distal part of the reduced section is covered with a 3cm, 0.010" platinum<br>tungsten spring coil. This provides greater visibility on x-ray equipment. A 39cm<br>approx. length of black / grey Estane 88A radiopaque heat shrink polymer tubing | | | |
| | | | | |
| | | | | |
| | is applied over the tapered distal end of the wire and ground to form a constant | | | |
| | outer diameter, OD, equivalent in diameter to the main core body. | | | |
| | Coatings are placed on the device to improve the lubricity and ease in its<br>advancement through the guide catheter and the blood vessel | | | |
| | | | | |
| Predicate Devices | | Manufacturer | 510k | Date |
| | Charter Guidewire | | K103377 | 18th May 2011 |
| Principle of | The Charter™ Guidewire is operated manually by a manual process | | | |

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Charter 510(k) Application Operation The Charter™ wire has the following differences from the originally approved Comparison of Technological devices. Introduction of a 0.016" diameter range. Characteristics Introduction of a "soft" version tip providing models with greater distal flexibility. Introduction of 300cm length models. In vitro bench testing was performed to support a determination of substantial equivalence (refer to performance testing below) between the new Charter™ Guidewires models and the existing. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use and performs comparably to the existing devices in the range. The introduction of these new models raise no new issues of safety and effectiveness such that the proposed new Charter™ Guidewire models are considered substantially equivalent to the predicate devices. In vitro bench tests were carried out to demonstrate equivalence with reference Performance Testing (nonto the FDAs guidance document "Coronary and Cerebrovascular Guidewire clinical) Guidance, Jan 1995". The following bench tests were performed: . Tensile Strength Torque Strength Outer Diameter measurement Torque Response Catheter Compatibility Coating Adherence/Coating Integrity Tip Stiffness Particulate Residue The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device. Conclusions Based on safety and performance testing, technological characteristics and the indications for use for the device, the proposed new Charter™ Guidewire models has been demonstrated to be appropriate for its intended use and is considered

to be substantially equivalent to the original

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

OCT 17 2012

Brivant Ltd. Lake Region Medical International Research & Development Centre c/o Kenneth Walsh Parkmore West Business Park Galway Ireland

Re: K122856

Trade/Device Name: Charter Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX

Dear Mr. Walsh:

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. Kenneth Walsh

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Tu A. Sillel

\$\mathscr{R}\$

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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## Indications for Use Statement

510{k) Number (if known):

Device Name:

CHARTER™ GUIDEWIRE

and peripheral vasculature.

K122856

Indications for Use:

Contraindications:

The Charter Guidewire is not intended.for use in the cerebral vasculature. Patients judged not acceptable for percutaneous intervention (PCI).

Charter™ Guidewires are intended for use in the coronary

MZKilleh

iovascular Devices

510(k) Number K112286