WILDCAT CATHETER

K113838 · Avinger, Inc. · PDU · Mar 12, 2012 · Cardiovascular

Device Facts

• Record ID: K113838
• Device Name: WILDCAT CATHETER
• Applicant: Avinger, Inc.
• Product Code: PDU · Cardiovascular
• Decision Date: Mar 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Wildcat Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Wildcat Catheter is contraindicated for use in the illiac, coronary, cerebral or carotid vasculature. The Juicebox is an optional accessory that may be used to facilitate catheter tip rotation when using a compatible Avinger catheter.

Device Story

Wildcat Catheter is a sterile, single-use, 6F-compatible, 110 cm long catheter designed to cross chronic total occlusions (CTOs) in peripheral vasculature. Device features a distal tip and bilateral wedges visible under fluoroscopy to facilitate guidewire placement. Juicebox is an optional, single-use, sterile accessory that attaches to the catheter handle to provide assisted distal tip rotation via a toggle switch. Operated by physicians in a clinical setting, the device is used to navigate lesions; once the guidewire is placed, the catheter is removed to allow for subsequent therapeutic interventions like atherectomy, PTCA, or stenting. The device provides mechanical assistance for crossing difficult lesions, potentially improving procedural success in peripheral vascular interventions.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing confirming performance according to intended use and design specifications.

Technological Characteristics

6F guide-compatible catheter, 110 cm length, for 0.035" guidewires. Features distal tip and bilateral wedges for fluoroscopic visualization. Juicebox accessory provides mechanical assisted tip rotation via handle-mounted toggle switch. Sterile, single-use, disposable. No software or electronic algorithms; purely mechanical operation.

Indications for Use

Indicated for facilitating intraluminal placement of conventional guidewires beyond stenotic lesions, including sub-total and chronic total occlusions (CTOs), in the peripheral vasculature prior to further percutaneous intervention. Contraindicated for use in iliac, coronary, cerebral, or carotid vasculature.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Avinger Wildcat Catheter (K111338)
• Avinger Wildcat Guidewire Support Catheter 6F used with the Juicebox (K111704)

Submission Summary (Full Text)

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

# 510(k) Summary

# MAR 1 2 2012

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

#### A. Name and Address of Applicant

Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063 Phone: [phone] Fax: [phone]

#### Contact Person B.

Sevrina Ciucci, RAC Regulatory Affairs Consultant Phone: [phone]

#### C. Date Prepared

December 27, 2011

- D. Device Name

| Trade Name: | Wildcat Catheter used with Juicebox |
|----------------------|------------------------------------------|
| Common Name: | Guidewire Support Catheter and Accessory |
| Classification Name: | Percutaneous Catheter |

#### Device Classification E.

| Classification: | 21 CFR §870.1250 |
|-----------------|------------------|
| Product Code: | DQY |
| Device Class: | Class II |

#### F. Predicate Device

The Avinger Wildcat Catheter used with the Juicebox is substantially equivalent to the Avinger Wildcat Catheter (K111338) and the Avinger Wildcat Guidewire Support Catheter 6F used with the Juicebox (K111704).

#### G. Device Description

The Wildcat Catheter is a sterile, single-use, disposable catheter designed to cross chronic total occlusions (CTOs) and to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions in the peripheral vasculature.

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

The Wildcat Catheter consists of the distal tip, catheter shaft, and proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. The catheter is 6F guide compatible, 110 cm long, and intended for use with 0.035" guidewires. Two key elements of the device define the treatment modality - the distal tip and the bilateral wedges. Both elements are visible through fluoroscopy and allow for CTO crossing and facilitation of guidewire placement.

Subsequent to conventional quidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit.

Juicebox is an optional accessory used to provide assisted distal tip rotation when using a compatible Avinger catheter. It consists of a handle with a rotation toggle switch and a release button. Juicebox is designed to be placed over the catheter handle. This accessory is provided separately, irradiated for sterility, and intended for single use only.

#### H. Intended Use

The Wildcat Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous The Wildcat Catheter is contraindicated for use in the illiac, intervention. coronary, cerebral or carotid vasculature.

The Juicebox is an optional accessory that may be used to facilitate catheter tip rotation when using a compatible Avinger catheter.

#### Substantial Equivalence l.

The Avinger Wildcat Catheter is substantially equivalent to the Avinger Wildcat Catheter (K111338) and the Avinger Wildcat Guidewire Support Catheter 6F used with the Juicebox (K111704). The Wildcat Catheter used with the Juicebox substantially equivalent to the stated predicates in technological is characteristics, device design and packaging, procedural steps, performance testing, safety characteristics, and product labeling. The subject and predicate devices have the same mechanism of action (manual advancement of the Catheter) and perform the same function (access discrete regions of the peripheral vasculature). The Wildcat Catheter is the exact same device as the Wildcat Guidewire Support Catheter 6F and is identical in design, manufacturing, operation, and material composition as its FDA-cleared predicates, and as such, has the same technological characteristics. The changes to the Wildcat Catheter

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

labeling cleared under K111338 result in no significant changes to technological characteristics and do not raise any new issues of safety or effectiveness.

#### J. Non-Clinical Performance Data

The following non-clinical testing was conducted to support a determination of substantial equivalence to the predicate devices.

| <br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>содарии и под д. полности композиции всемента в полности в полности в полности в полности в полности в полности в полности в полности в полнительно под всемента в полнительно<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>nuoron Cathotar .<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br>No. on antiquestion<br>CONSULTION OF CHIP CONTRACT OF CHIP CONTRACT OF CLAIM OF CHEARTH AND THE CHART OF CHEARTH A |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| --------------------------------------<br>Controllation and control of the production and charges of the company of the company of the company of<br>. Datation with/without Dofloction<br>And Andrew<br><br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>-------------------<br>A Bourney of Concession Company of Concellented | |

The collective results of the above testing confirmed that the Wildcat Catheter performs according to the stated intended use and raises no new issues of safety or effectiveness when used with the Juicebox. Results of non-clinical testing demonstrated that the Wildcat Catheter used with the Juicebox is substantially equivalent to the predicate devices for its intended use.

#### K. Conclusions

The Avinger Wildcat Catheter used with the Juicebox has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to validate the performance of the device and ensure the Wildcat Catheter used with the Juicebox functions as intended and meets design specifications. The comparison and non-clinical results demonstrate that the Wildcat Catheter used with the Juicebox is substantially equivalent to the predicate device for its intended use.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Avinger, Inc. c/o Ms. Sevrina Ciucci Regulatory Affairs Consultant 400 Chesapeake Drive Redwood, CA 94063

SEP 18 2013

Re: K113838 Trade/Device Name: Wildcat Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter

Regulatory Class: Class II Product Code: PDU Dated: December 27, 2011 Received: December 28, 2011

Dear Ms. Ciucci:

This letter corrects our substantially equivalent letter of March 12, 2012.

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 or any Federal statutes and regulations administered by other Federal agencies. You must

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

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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,

Zm.Z.

for

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

Enclosure

{5}------------------------------------------------

## Indications for Use Statement

K113838

510(k) Number (if known): K

Wildcat Catheter Device Name:

×

### Indications for Use:

The Wildcat Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the garipheral vasculature prior to further percutaneous intervention. The Wildcat Catheter pontraindicated for use in the illiac, coronary, cerebral or carotid vasculature.

The Juicebox is an optional accessory that may be used to facilitate catheter tip rotation when using a compatible Avinger Wildcat catheter.

Prescription Use

Or

Over-The-Counter Use

(per 21 CFR 801.109)

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sigh-Off) Division of C 510(k) Number