FINDRWIRZ GUIDE WIRE SYSTEM

K080364 · Sentreheart, Inc. · DQX · Aug 11, 2008 · Cardiovascular

Device Facts

• Record ID: K080364
• Device Name: FINDRWIRZ GUIDE WIRE SYSTEM
• Applicant: Sentreheart, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The FindrWIRZ System is intended for use in the cardiovascular system for introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures. A FindrWIRZ may also be used to manipulate and or reposition another FindrWIRZ. The FindrWIRZ System is not intended for use in the coronary or cerebral vasculature.

Device Story

FindrWIRZ Guide Wire System consists of two guide wires (0.035" and 0.025"), introducer, and torque device. Each wire features tapered core, distal coil, and encapsulated magnet of opposite polarization at distal tip. Magnets facilitate proximity sensing and connection between wires to assist in manipulation and positioning during cardiovascular interventional procedures. Used by physicians in clinical settings for catheter/device placement. Contraindicated for coronary/cerebral vasculature, MRI, and use with ferromagnetic devices or rotational atherectomy. System provides mechanical guidance and positioning aid; magnets allow wires to 'find' and connect to each other, simplifying complex navigation tasks.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included functional evaluation of the guide wire system and biocompatibility testing of materials to support substantial equivalence.

Technological Characteristics

System includes 0.035" and 0.025" guide wires with tapered core, distal coil, and encapsulated magnets. Materials include PTFE jacket and hydrophilic coating. Sterilized via 100% ethylene oxide. Mechanical sensing principle via magnetic attraction for wire-to-wire connection. No electronic or software components.

Indications for Use

Indicated for use in the cardiovascular system for introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures. Contraindicated for use in coronary or cerebral vasculature, with rotational atherectomy devices, ferromagnetic interventional devices, Inferior Vena Cava (IVC) filters, and in MRI 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

• OnTrac, Lake Region (K914138)
• Cronus Wire, Stereotaxis (K042854)
• Radius Snare Device, Radius Medical Technologies (K071457)

Submission Summary (Full Text)

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# SECTION 4 - 510(K) SUMMARY

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) number: _KOB6364

Date Prepared: February 06, 2008 AUG 1 2 2008

Applicant Information: SentreHEART 2468 Embarcadero Way Palo Alto, CA 94303

## Contact Person:

Linda Guthrie, Manager Regulatory Affairs Phone Number: [phone] x105 Fax Number: [phone]

Device Information:

| Trade Name: | FindrWIRZ Guide Wire System |
|----------------------|-----------------------------|
| Classification: | Class II per 21CFR 870.1330 |
| Classification Name: | Wire, Guide, Catheter |
| Product Code: | DQX |

Physical Description:

The FindrWIRZ System consists of the following components: A 0.035" x 90 cm FindrWIRZ A 0.025" x 260 cm FindrWIRZ Guide wire introducer Torque device

Each FindrWIRZ is configured with a tapered core wire and a distal coil, the 0.035 FindrWIRZ has a proximal PTFE jacket and both wires have a hydrophilic coating. The distal tip of each wire has an encapsulated magnet of opposite polarization which is used for proximity sensing and connection of the two guide wires to facilitate manipulation and positioning of each other. The FindrWIRZ System is sterilized with 100% ethylene oxide.

## Intended Use:

The FindrWIRZ System is intended for use in the cardiovascular system for introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures. A FindrWIRZ may also be used to manipulate and or reposition another FindrWIRZ.

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# SECTION 4 - 510(K) SUMMARY

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The FindrWIRZ System is not intended for use in the coronary or cerebral vasculature. FindrWIRZ are not intended for use in crossing chronic total occlusions.

Contraindications: The FindrWIRZ system is contraindicated for use with rotational atherectorny devices, ferromagnetic interventional devices and Inferior Vena Cava (IVC) filters. The Findr WIRZ system is also contraindicated for use in MRI procedures.

Predicate Devices:

OnTrac, Lake Region (K914138) Cronus Wire, Stereotaxis (K042854) Radius Snare Device, Radius Medical Technologies (K071457)

Safety and Performance:

#### Performance

Functional testing was conducted to support the claim of substantial equivalence and to demonstrate the FindrWIRZ Guide Wire System is safe and effective for its intended use.

## Biocompatibility

The materials used in the FindrWIRZ Guide Wire System are commonly used materials in other medical devices. Results of testing demonstrate the FindrWIRZ Guide Wire System is biocompatible.

## Summary:

Based on the intended use, product testing, and information provided in this notification, the subject device has been shown to be safe and effective for its intended use and substantially 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 stylized depiction of a human figure with three overlapping profiles, suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure, emphasizing the organization's name and national scope.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 2 2006

Sentreheart Inc. c/o Ms. Linda Guthrie 2460 Embarcadero Way Palo Alto, CA 94303

Re: K080364 Trade/Device Name: FindrWirz Guidewire System Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DQX Dated: July 16, 2008 Received: July 18, 2008

Dear Ms. Guthrie:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html,

Sincerely yours,

Donna R. Vachner

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 3 - INDICATIONS FOR USE STATEMENT

510(k) Number (if known): __K080364

Device Name: FindrWIRZ Guide Wire System

Indications for Use: The FindrWIRZ System is intended for use in the cardiovascular system for introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures. A FindrWIRZ may also be used to manipulate and or reposition another FindrWIRZ.

> The FindrWIRZ System is not intended for use in the coronary or cerebral vasculature.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. James

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko80364 SentreHEART CONFIDENTIAL

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