VISION WIRE CORONARY GUIDEWIRE

K082935 · Biotronik, Inc. · DQX · Dec 4, 2008 · Cardiovascular

Device Facts

• Record ID: K082935
• Device Name: VISION WIRE CORONARY GUIDEWIRE
• Applicant: Biotronik, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VisionWire coronary guide wire is intended for the following applications: - Its positioning in the coronary vascular system (probing coronary vessel anatomy) - Connection to an external pacing system analyzer in order to perform the following intraoperative tests in several places e.g. of the coronary sinus: - Measuring the left ventricular threshold - Measuring the intracardiac signals - Temporary pacing of the left ventricle - As a guide wire for positioning compatible over-the-wire (OTW) pacing leads in the coronary sinus

Device Story

VisionWire is a transvenous guidewire with integrated sensing and stimulation capabilities; used by physicians during CRT lead implantation. Device navigates coronary venous anatomy to position over-the-wire (OTW) pacing leads. Prior to lead placement, wire connects to external pacing system analyzer to measure LV thresholds and intracardiac signals; enables temporary pacing to identify optimal pacing sites in tortuous or angled veins. Output is electrical signal data and pacing delivery; physician uses data to select optimal lead placement site. Benefits include improved lead positioning and site optimization for CRT.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing and design comparison to predicate devices.

Technological Characteristics

Transvenous guidewire with integrated sensing/stimulation electrodes. Single-use, disposable. Designed for compatibility with OTW pacing leads. Connectivity via external pacing system analyzer. No software or complex algorithms; passive electrical conduction for sensing/pacing.

Indications for Use

Indicated for patients undergoing cardiac resynchronization therapy (CRT) requiring placement of left ventricular pacing leads. Used for coronary vascular navigation, intraoperative pacing site assessment (threshold/signal measurement), and temporary pacing within the coronary venous system.

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

• Guidant's HI-TORQUE WHISPER Guidewires (K030019)
• HI-TORQUE WHISPER VIEW Guidewire (K061453)
• Medtronic Performr Electrode Catheter (K964272)

Submission Summary (Full Text)

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K082935

BIOTRONIK, Inc., VisionWire Coronary Guidewire, 510(k)

September 30, 2008

# VisionWire Coronary Guidewire 510(k) Premarket Notification

DEC 0 4 2008

#### GUIDEWIRE 510(K) SUMMARY 1.

Name and Address of Applicant:

BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035

Establishment Registration Number:

1028232

Device Name:

Proprietary Name: Classification: Classification Name: Product Code:

VisionWire Coronary Guidewire Class II (21 CFR 870.1330) Wire, Guide, Catheter DOX

#### Date Prepared:

September 30, 2008

#### General Description:

The VisionWire coronary guidewire is a transvenous wire with sensing and stimulation capabilities. The VisionWire is intended to be used to facilitate the positioning of left ventricular (LV) pacing leads, with compatible guidewire lumen, within the coronary venous system during the implantable pulse generator (IPG) or Implantable Cardioverter Defibillator (ICD) for Cardiac Resynchronization Therapy (CRT). The VisionWire is used as a guide to position the over-the-wire (OTW) lead, especially in angled or tortuous veins. Prior to lead positioning, the VisionWire can be used to perform comparative intraoperative measurements of various pacing sites within the coronary venous system. Thus the physician can identify an appropriate pacing site for a LV lead.

The VisionWire coronary quidewire is a disposable medical device designed for single use only.

#### Predicate Device:

BIOTRONIK proposes the following guidewires and catheter, cleared through 510(k) notification, as the predicate devices for the VisionWire coronary guidewire:

- Guidant's HI-TORQUE WHISPER Guidewires (Models 6726, 6737, 6738, 4482, 4483, 4581, 4586, . 4583, and 4588), #K030019, cleared on 01-24-2003 and HI-TORQUE WHISPER VIEW Guidewire (Model #4631-4639), #K061453, cleared on 06-22-2006
- Medtronic Performr Electrode Catheter, #K964272, cleared on 01-23-1997

#### Indications for Use:

The VisionWire coronary quidewire is intended for the following applications:

- Its positioning in the coronary vascular system (probing coronary vessel anatomy)
- Connection to an external pacing system analyzer in order to perform the following intraoperative tests in several places e.g. of the coronary sinus:
- ಂ Measuring the left ventricular threshold
- Measuring the intracardiac signals O
- Temporary pacing of the left ventricle 0
- As a guidewire for positioning compatible over-the-wire (OTW) pacing leads in the coronary sinus

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#### Name and Address of Manufacturing Site:

Brivant Ltd. Parkmore West Business Park Galway, Ireland.

Manufacturer's Establishment Registration Number / Owner's Number: 3006010712 / 9083703

#### Manufacturing Site Contact Person and Phone Number:

Conan Campbell Quality Engineer Brivant Ltd. Parkmore West Business Park Galway, Ireland (353) 91 358 376

#### 510(k) Contact Person and Phone Number:

Jon Brumbaugh Vice President, Regulatory Affairs and Compliance BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 [phone]

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is rendered in black and white, providing a clear and recognizable emblem for the department.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 4 2008

Biotronik, Inc. c/o Mr. Jon Brumbaugh 6024 Jean Road Lake Oswego, Oregon 97035

Re: K082935

Trade/Device Name: VisionWire Coronary Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: September 30, 2008 Received: October 1, 2008

Dear Mr. Brumbaugh:

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

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## Page 2 - Mr. Jon Brumbaugh

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

If 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 vours.

R. lohner

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

#### K082935 510(k) Number (if known):

### Device Name: VisionWire Coronary Guidewire

#### Indications for Use:

. :

The VisionWire coronary guide wire is intended for the following applications:

- Its positioning in the coronary vascular system (probing coronary vessel anatomy) ●
- Connection to an external pacing system analyzer in order to perform the following . intraoperative tests in several places e.g. of the coronary sinus:
- o Measuring the left ventricular threshold
- o Measuring the intracardiac signals
- Temporary pacing of the left ventricle o
- As a guide wire for positioning compatible over-the-wire (OTW) pacing leads in the coronary sinus

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) (Division of Cardiovascular Devices

510(K) Number_K082935

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