POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS

K080637 · Stereotaxis, Inc. · DQX · Aug 12, 2008 · Cardiovascular

Device Facts

• Record ID: K080637
• Device Name: POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
• Applicant: Stereotaxis, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerAssert™ Radiofrequency Guidewire (PARG) is intended for use with a Stereotaxis Niobe Magnetic Navigation System for the recanalization of occluded peripheral vessels.

Device Story

PowerAssert Radiofrequency Guidewire (PARG) is a sterile, single-use, magnetically steerable endovascular guidewire. It utilizes mechanical or radiofrequency (RF) energy to create a channel through occlusive material in peripheral vessels. The device is used in conjunction with the Stereotaxis Niobe Magnetic Navigation System and a Baylis RF generator. The guidewire is 0.018" in diameter and available in 185 cm and 300 cm lengths. It features a hydrophilic lubricious coating on the distal tip. The device is operated by a physician in an interventional setting. By enabling magnetic navigation and RF-assisted recanalization, the device allows for the subsequent introduction of adjunct therapeutic devices to alleviate vessel occlusion, potentially improving patient outcomes in peripheral vascular procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

0.018" diameter guidewire; 185/300 cm lengths; hydrophilic lubricious distal tip coating; magnetically steerable; RF energy source (Baylis RF generator, max 25W, 3s dwell time); EtO sterilized; single-use; compatible with Stereotaxis Niobe Magnetic Navigation System.

Indications for Use

Indicated for recanalization of occluded peripheral vessels in patients requiring endovascular intervention using the Stereotaxis Niobe Magnetic Navigation 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

• Baylis Medical's RF Tunneler Wire (K051670)
• Cronus Guidewire (K042854)
• Assert Guidewire (K043457)

Submission Summary (Full Text)

{0}------------------------------------------------

### Appendix 1: 510(k) Summary per 21CFR §807.92 AUG 1 2 2008

| Submitter's<br>information | Stereotaxis, Inc.<br>4320 Forest Park Ave, Suite 100<br>St. Louis, MO 63108<br>Contact: Dennis Pozzo, Regulatory Affairs Specialist<br>Phone: [phone]<br>February 27, 2008 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device/<br>classification<br>name | • Device Name:<br>PowerAssert™ Radiofrequency Guidewire (PARG)<br>• Classification/Common name:<br>Catheter Wire Guide<br>• The marketed device(s) to which substantial equivalence is claimed:<br>– Baylis Medical's RF Tunneler Wire - 510(k), K051670<br>– Cronus Guidewire – 510(k), K042854<br>– Assert Guidewire - 510(k), K043457 |
| Device<br>description | The PARG is a sterile, single use, magnetically steerable endovascular<br>guidewire intended to create a channel through occlusive material in vessels<br>using mechanical or radiofrequency energy. Once a channel is created this<br>will allow the introduction of adjunct devices/therapies to more completely<br>alleviate the occlusion. |
| Intended use | The PowerAssert™ Radiofrequency Guidewire (PARG) is intended for use with a<br>Stereotaxis Niobe Magnetic Navigation System for the recanalization of occluded<br>peripheral vessels. |
| | Continued on next page |

-

{1}------------------------------------------------

### KCECE 37 For John

# Appendix 1: 510(k) Summary per 21CFR §807.92, Continued

| Device Characteristic | Proposed PARG<br>K080637 | Predicate Baylis RF<br>Tunneler Wire<br>K051670 | Predicate Stereotaxis<br>Cronus® & Assert™<br>Guidewires<br>K042854 & K043457 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The PowerAssert™<br>Radiofrequency<br>Guidewire is intended<br>for use in recanalization<br>of occluded peripheral<br>vessels. | The RF Tunneler Wire<br>is intended to create a<br>channel in totally<br>occluded peripheral<br>vessels 3mm or greater. | The guidewires are<br>intended to introduce and<br>position over-the-wire<br>catheters and other over-<br>the-wire therapeutic<br>devices within the<br>coronary and peripheral<br>vasculature during PTCA<br>or other intravascular<br>interventional procedures. |
| RF Capable | Yes | Yes | No |
| Magnetic<br>Navigation Capable | Yes | No | Yes |
| Wire Diameter | 0.018" | 0.035" | 0.014" |
| Wire Length(s) | 185 and 300 cm | 250 cm | 180, 210, 235 & 300 cm |
| Max. RF Power | 25 watts | 25 watts | NA |
| RF Dwell Time | 3 seconds | 99 seconds | NA |
| Sterilization Method | EtO | EtO | EtO |
| Single Use | Yes | Yes | Yes |
| Distal Tip<br>Lubricious Coating | Hydrophilic | Hydrophilic | Hydrophilic |
| Energy Source | Baylis' RF Generator | Baylis' RF Generator | NA |
| | | | |

The table below lists device characteristics. Technological characteristics

#### Performance Based upon the objective evidence presented in this 510(k) it has been demonstrated that the PARG is substantially equivalent to the predicate data devices it has been compared to in this submission.

1 1

{2}------------------------------------------------

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 eagle or bird-like symbol with three curved lines forming its body and wings. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2008

Stereotaxis, Inc. c/o Mr. Dennis Pozzo 4320 Forest Park Avenue, Suite 100 St. Louis, MO 63108

Re: K080637 Trade/Device Name: PowerAssert Radiofrequency Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DOX Dated: July 29, 2008 Received: July 30, 2008

Dear Mr. Pozzo:

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

{3}------------------------------------------------

Page 2 - Mr. Dennis Pozzo

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 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 [phone]. 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,

R. V. Anes

A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Appendix 2: Indications for Use Statement

Statement The indications for Use Statement:

510(k) Number: K080637

Device Name: PowerAssert™ Radiofrequency Guidewire

The PowerAssert™ Radiofrequency Guidewire (PARG) is intended for use with a Stereotaxis Niobe Magnetic Navigation System for the recanalization of occluded peripheral vessels.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page | of |

Duna R. Vuchner

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number_Ko80637