3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON

K093515 · Brivant, Ltd. · DQX · Feb 16, 2010 · Cardiovascular

Device Facts

• Record ID: K093515
• Device Name: 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON
• Applicant: Brivant, Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Parodi Guidewire is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures.

Device Story

Parodi Guidewire is a disposable, multi-component system for directing catheters during diagnostic or interventional procedures. Available in 2-piece (0.014" guidewire, 0.035" outer member) or 3-piece (adds intermediate stiffener) configurations. User manually manipulates components to vary stiffness. Features hydrophilic coating on distal portions and PTFE coating on proximal portions. Includes torque device to assist manipulation. Packaged in polyethylene hoop within sealed pouch. Used by clinicians in clinical settings to facilitate catheter navigation through vasculature; provides mechanical support and guidance to reach target anatomy.

Clinical Evidence

Bench testing only. Evaluations included tip flexibility, lateral stiffness, and device compatibility. Biocompatibility established per ISO 10993-1. No clinical data presented.

Technological Characteristics

Multi-component guidewire system; 0.014" wire and 0.035" outer member; optional intermediate stiffener. Materials include hydrophilic distal coating and PTFE proximal coating. Manual operation. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for directing catheters to desired anatomical locations during diagnostic or interventional procedures in patients requiring such access.

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)
• Terumo Radiofocus Glidewire for coronary use with platinum coil (K953533)
• Boston Scientific Amplatz Superstiff Guidewire (K944959)

Submission Summary (Full Text)

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K093515 page 1 of 2

Traditional 510(k) Notification Parodi Guidewire

FEB 1 6 2010

## 510(k) Summary

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## as required by 21 CFR 807.92(c)

| Device Name | Parodi Guidewire | | |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------|
| Submitters<br>name/contact<br>details | Brivant Ltd, | | |
| | Parkmore West Business Park, | | |
| | Galway, | | |
| | Ireland | | |
| | Contact Details: | | |
| | Tomas Furey | | |
| | Operations Manager, | | |
| | Tel: [phone] | | |
| | Fax: [phone] | | |
| Summary<br>Preparation Date | 04th November 2009 | | |
| Device Name &<br>Classification | Trade Name:<br>Parodi Guidewire | | |
| | Common Name:<br>Guidewire | | |
| | Classification Name:<br>Catheter, Guidewire | | |
| | Device Classification:<br>Class II, 21 CFR §870.1330 | | |
| Intended Use | The Parodi Guidewire is designed to direct a catheter to the desired anatomical | | |
| | location during diagnostic or interventional procedures. | | |
| Device Description | The Parodi Guidewire Assembly is a disposable medical device designed for | | |
| | single use only. It is a multi-component system which can be manipulated to vary | | |
| | the stiffness characteristics as required during a procedure. | | |
| | The device is available in 2 main configurations: | | |
| | 2-piece system: Comprising a 0.014" guidewire and Outer 0.035"<br>member. | | |
| | 3-piece system: Comprising a 0.014" guidewire, Outer 0.035" member<br>and an Intermediate stiffener. A 3-piece system is depicted in figure 1<br>below. The Intermediate Stiffener is not present in a 2-piece system.<br>A hydrophilic coating is applied to the distal portion of the wire of the 0.014"<br>guidewire and the 0.035" outer assembly. PTFE coating is applied to the proximal | | |
| | portions of these devices. | | |
| | The wire is packaged in a polyethylene hoop contained within a sealed pouch. A<br>torque device is included within the pouch to assist with torquing the device if | | |
| | required. | | |
| Predicate Devices | Manufacturer | 510k | Date |
| | Brivant Ltd, Brivant Guidewire | K060551 | 07 Jun 2006 |
| | Terumo Radiofocus Glidewire for coronary use<br>with platinum coil | K953533 | 18 Oct 1995 |
| | Boston Scientific Amplatz Superstiff Guidewire | K944959 | 04 Nov 1994 |
| Principle of<br>Operation | The Parodi Guidewire is operated manually by a manual process | | |
| Comparison of<br>Technological | Although differing in construction to the predicate wires, the Parodi wire is | | |
| | designed to have similar performance characteristics to the predicate devices | | |

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Traditional 510(k) Notification Parodi Guidewire

| Characteristics | depending on the level of stiffness (configuration) selected by the user.<br>In vitro bench testing was performed to support a determination of substantial<br>equivalence (i.e. tip flexibility, lateral stiffness, tip flexibility and device<br>compatibility) between the Parodi Guidewires (in its various configurations) and<br>the predicate 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 and materials between the Parodi wire and the predicate devices<br>raise no new issues of safety and effectiveness such that the Parodi Guidewire is<br>considered substantially equivalent to the predicate devices. |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Testing (non-<br>clinical) | In vitro bench testing performance evaluations demonstrated that the Parodi<br>Guidewire met the acceptance criteria defined in the product specification and<br>performed comparably to the predicate.<br>Biological Safety of the device has been established through biocompatibility<br>testing carried out in compliance with ISO 10993-1 |
| Conclusions | Based on safety and performance testing, technological characteristics and the<br>indications for use for the device, the Parodi Guidewire has been demonstrated<br>to be appropriate for its intended use and is considered to be substantially<br>equivalent to the predicate devices. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract image of an eagle or other bird with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

## FEB 1 6 2010

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

Re: K093515

Trade/Device Name: Parodi Guidewire System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: January 18, 2010 Received: January 22, 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.

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Page 2 - Mr. Tomas Furey

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 on models.
Forth in the reads 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 100-1000.

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.html 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 notfication" (21CFR Pract, 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 tolli the [phone] or [phone] or at its Internet address

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

Sincerely yours.

Dma R. Vicher

Image /page/3/Picture/8 description: The image contains a handwritten symbol that appears to be a stylized signature or initial. It consists of a curved line at the top, resembling a wave or a simplified letter, connected to a more angular line below. The overall impression is that of a quick, fluid stroke, possibly representing the letter 'B' or a similar character.

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

510(k) Number (if known):__K093515

Device Name: Parodi Guidewire

Indications For Use:

The Parodi Guidewire is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures.

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Luner

(Division Sign-Off) (Division Sign Sign Similar Devices

510(k) Number k093515

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