CRUISER 18 GUIDEWIRE

K102211 · Brivant, Ltd. · DQX · Sep 3, 2010 · Cardiovascular

Device Facts

• Record ID: K102211
• Device Name: CRUISER 18 GUIDEWIRE
• Applicant: Brivant, Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 3, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Cruiser-18 Guidewires are intended for use in the peripheral vasculature.

Device Story

Cruiser-18 Guidewire is a disposable, single-use device for peripheral vasculature navigation. It features a 0.018" diameter stainless steel core wire with a centreless-ground reduced-diameter segment (13cm) to provide variable stiffness. The distal end includes a stainless steel spring coil over a radiopaque platinum-tungsten alloy coil for X-ray visualization. Operated manually by clinicians during percutaneous procedures to facilitate catheter placement. Provides mechanical support and guidance within peripheral vessels. Benefits include improved navigation and vessel access.

Clinical Evidence

No clinical data. Substantial equivalence established via in vitro bench testing, including tensile strength, torque strength, outer diameter measurement, torque response, catheter compatibility, coating adherence/integrity, and tip flexibility. Biocompatibility established per ISO 10993-1.

Technological Characteristics

0.018" diameter stainless steel core wire; centreless-ground distal segment; stainless steel spring coil; radiopaque platinum-tungsten alloy coil. Manual operation. Biocompatibility per ISO 10993-1. Bench testing performed per FDA guidance 'Coronary and Cerebrovascular Guidewire Guidance, Jan 1995'.

Indications for Use

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

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

• Brivant Guidewire (K060551)
• Courier Guidewire (K073082)

Submission Summary (Full Text)

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Cruiser-18 - 510(k) Application

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

| Device Name | Cruiser-18 Guidewire | | | | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------|-------------|------------|
| Submitters name/contact details | Brivant Ltd,<br>Parkmore West Business Park,<br>Galway,<br>Ireland<br><br>Contact Details:<br>Tomas Furey<br>Operations Manager,<br>Tel: [phone]<br>Fax: [phone] | | | | SEP 3 2010 |
| Summary Preparation Date | 19th July 2010 | | | | |
| Device Name & Classification | Trade Name: | Cruiser-18 Guidewire | | | |
| | Common Name: | Guidewire | | | |
| | Classification Name: | Catheter, Guidewire | | | |
| | Device Classification: | Class II, 21 CFR §870.1330 | | | |
| | Product Code: | DQX | | | |
| Intended Use | Intended Use: | The Cruiser-18 Guidewires are intended for use in the peripheral vasculature. | | | |
| | Contraindications:<br>The Cruiser-18 guide wire is not intended for use in the coronary or cerebral vasculature.<br>Patients judged not acceptable for percutaneous intervention (PPCI) | | | | |
| Device Description | The guide wire is a disposable medical device designed for single use only. It consists of a 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over a 13cm segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness. This reduced section is covered with a spring coil of equivalent diameter to the main core body. The coiled segment consists of a stainless steel coil placed over a radiopaque coil made of a platinum tungsten alloy. This coil provides greater visibility on x-ray equipment. The profile of the reduced section is varied to provide a range of products with mixed stiffness. | | | | |
| Predicate Devices | Manufacturer | | 510k | Date | |
| | Brivant Ltd, Brivant Guidewire | | K060551 | 07 Jun 2006 | |
| | Brivant Ltd, Courier Guidewire | | K073082 | 09 Jan 2008 | |
| Principle of Operation | The Cruiser-18 Guidewire is operated manually by a manual process | | | | |
| Comparison of | The Cruiser-18 wire has minor differences in construction to the approved | | | | |

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| | Cruiser-18 - 510(k) Application |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | Brivant Guidewire.<br>In vitro bench testing was performed to support a determination of substantial<br>equivalence (i.e. tip flexibility, tip flexibility and device compatibility) between<br>the Cruiser-18 Guidewires (in its various configurations) and the predicate<br>devices.<br>The results of these tests provide reasonable assurance that the proposed device<br>has been designed and tested to assure conformance to the requirements for its<br>intended use and performs comparably to the predicate devices. The differences<br>in construction between the Cruiser-18 wire and the predicate device raise no<br>new issues of safety and effectiveness such that the Cruiser-18 Guidewire is<br>considered substantially equivalent to the predicate devices. |
| Performance<br>Testing (non-<br>clinical) | In vitro bench tests were carried out to demonstrate equivalence with reference<br>to the FDAs guidance document "Coronary and Cerebrovascular Guidewire<br>Guidance, Jan 1995".<br>The following bench tests were performed:<br>- Tensile Strength<br>- Torque Strength<br>- Outer Diameter measurement<br>- Torque Response<br>- Catheter Compatibility<br>- Coating Adherence/Coating Integrity<br>- Tip Flexibility<br>The results from these performance evaluations demonstrated that the Cruiser-<br>18 Guidewire met the acceptance criteria defined in the product specification<br>and performed comparably to the predicate device. Biological Safety of the<br>device has been established through biocompatibility testing carried out in<br>compliance with ISO 10993-1 |
| Conclusions | Based on safety and performance testing, technological characteristics and the<br>indications for use for the device, the Cruiser-18 Guidewire has been<br>demonstrated to be appropriate for its intended use and is considered to be<br>substantially equivalent to the predicate devices. |

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Brivant, Ltd. c/o Tomas Furey, Operations Manager Parkmore West Business Park Galway, County Galway Ireland

3 2010 SEP

Re: K102211

Trade/Device Name: Cruiser-18 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DOX Dated: July 20, 2010 Received: August 5, 2010

Dear Mr. Furey:

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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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 i 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.

R. Vahner

A 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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Cruiser-18 - 510(k) Application

## Indications for Use Statement

8 2010 SEP

510(k) Number (if known): K102211

Device Name: Cruiser-18 Guidewire Indications for Use: The Cruiser-18 Guidewires are intended for use in the peripheral vasculature The Cruiser-18 guide wire is not intended for use in the Contraindications: coronary or cerebral vasculature. Patients judged not acceptable for percutaneous intervention (PPCI)

Duma D. helmer

wascular Devices

510(k) Number