OCELOT SYSTEM

K122380 · Avinger, Inc. · PDU · Nov 7, 2012 · Cardiovascular

Device Facts

• Record ID: K122380
• Device Name: OCELOT SYSTEM
• Applicant: Avinger, Inc.
• Product Code: PDU · Cardiovascular
• Decision Date: Nov 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Ocelot System 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 using OCT-assisted orientation as an adjunct to fluoroscopy. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.

Device Story

Ocelot System facilitates guidewire placement across peripheral artery stenotic lesions/chronic total occlusions (CTOs). System comprises Ocelot Catheter, Lightbox Console, and Umbilical. Catheter incorporates optical fiber for Optical Coherence Tomography (OCT)-assisted orientation; used as adjunct to fluoroscopy. Physician operates device in clinical setting to navigate vasculature. OCT provides real-time intravascular visualization; assists clinician in orienting catheter to cross lesions where conventional guidewires fail. Output enables precise guidewire positioning in distal true lumen; improves procedural success rates for CTO crossing; reduces risk of vessel perforation.

Clinical Evidence

CONNECT II study: multi-center, prospective, non-randomized. 122 subjects with PAD (Rutherford 2-5) and 99-100% femoropopliteal stenoses (1-30 cm). Primary safety endpoint: composite of MAEs and angiographic complications (perforations, embolizations, Grade C+ dissections). 2% perforation rate; 0% MAEs. Primary effectiveness endpoint: successful CTO crossing and guidewire placement in distal true lumen. 97% success rate. Study confirms safety and effectiveness for crossing CTOs where conventional guidewires failed.

Technological Characteristics

Over-the-wire catheter (6F sheath, 0.014" guidewire compatible, 110cm length). Utilizes optical fiber for OCT-assisted orientation. System includes Lightbox Console and Umbilical. Electrical safety, electromagnetic compatibility, and laser safety testing performed. Software verification and validation conducted. Biocompatibility, sterilization, packaging, and shelf-life validated.

Indications for Use

Indicated for patients with Peripheral Artery Disease (Rutherford 2-5) requiring intraluminal guidewire placement across 1-30 cm stenotic lesions or chronic total occlusions in femoropopliteal arteries. Contraindicated for iliac, coronary, cerebral, renal, 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)
• Safe-Cross® Radio Frequency Total Occlusion Crossing System (K050916)

Submission Summary (Full Text)

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AVINGER, INC.

#### OCELOT SYSTEM 510(k) Premarket Notification

# 510(k) Notification K122380

### GENERAL INFORMATION

:

#### Applicant:

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

# Contact Person:

Albert Boniske Sr. Manager, Regulatory and Quality Affairs Avinger, Inc. Phone: [phone] Fax: [phone]

SIDK S

#### Date Prepared:

August 3, 2012

#### DEVICE INFORMATION

# Trade Name:

Ocelot System

#### Generic/Common Name:

Percutaneous catheter

#### Classification:

21 CFR§870.1250, Percutaneous catheter, Class II

#### Product Code:

DQY,

#### PREDICATE DEVICE(S)

- Avinger Wildcat Catheter (K111338) o
- Safe-Cross® Radio Frequency Total Occlusion Crossing System ("Safe-Cross . System") (K050916)

**NOV** 7 2012

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#### INDICATIONS FOR USE

The Ocelot System 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 using OCT-assisted orientation as an adjunct to fluoroscopy. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.

#### DEVICE DESCRIPTION

The Ocelot System consists of the Ocelot Catheter, the Lightbox Console and the Umbilical. The Ocelot Catheter is an over-the-wire device that is compatible with a 6F sheath and 0.014" guidewire. The Ocelot Catheter has a working length of 110cm and incorporates an optical fiber used to facilitate Optical Coherence Tomography (OCT)-assisted orientation as an adjunct to fluoroscopy.

#### SUBSTANTIAL EQUIVALENCE

The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the Ocelot System. The Ocelot Cather operates using the p op boundly would be acteristics for the same intended use as its predicate in the Avinger family of catheters, the Wildcat Catheter. The Ocelot System provides information on intravascular orientation using a similar interferometry-based technology for the same intended use as the Safe-Cross System. The nonclinical and clinical testing results demonstrate that any differences in the technological characteristics between the subject and predicate devices do not raise any new issues of safety or effectiveness. Thus, the Ocelot System is substantially equivalent to the predicate devices.

# NONCLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary performance testing was conducted on the Ocelot System to support a determination of substantial equivalence to the predicate devices. The non-clinical bench testing included:

- Design verification and bench validation studies 0
- Biocompatibility 0
- o Sterilization
- Packaging and shelf-life 0
- Software verification and validation 0
- Electrical safety, electromagnetic compatibility, and laser safety testing o

Two acute in-vivo animal studies were also conducted for the Ocelot System. One study evaluated the trackability of the catheter in the peripheral vasculature and one characterized the flow rate and the related pressures to capture OCT images. These studies were conducted in a healthy porcine model and supported the clinical use of the Ocelot System. The collective results of the non-clinical testing demonstrate that the Ocelot

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System meets the established specifications necessary for consistent performance for its intended use.

# CLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

A multi-center, prospective, non-randomized study (CONNECT II Study) was conducted to evaluate the safety and effectiveness of the Ocelot System used to cross chronic total occlusions in the superficial femoral and popliteal arteries. Subjects were followed through 30-days post procedure.

The Ocelot System was used in 122 subjects enrolled in the study from 15 sites in the United States and European Union. The population consisted of those presenting with Peripheral Artery Disease who met all eligibility criteria, including documented Rutherford Classification ranging from 2-5 and angiographic evidence of 99-100% stenosed femoropopliteal arteries that were ≥ 1 cm and ≤ 30 cm in length. Primary safety and effectiveness endpoints were based on independent angiographic reviewers.

The primary safety endpoint was a composite endpoint identified by both site reported safety data (MAEs) and angiographic data (clinically significant perforations, embolizations and Grade C or greater dissections) assessed by independent angiographic reviewers. Two clinically significant perforation (2%) occurred at the time of the procedure, as identified by the independent angiographic reviewers. No further sequelae were reported by any of the subjects prior to discharge. There were no occurrences of MAEs (0.0%) or unanticipated adverse events. The primary safety endpoint was met.

The primary effectiveness endpoint, defined as successful CTO crossing by the Ocelot System and subsequent guidewire positioning through the distal true lumen (confirmed by angiography), was achieved in 97% of subjects. The primary effectiveness endpoint was met.

In conclusion, the results of the CONNECT II Study demonstrate that the Ocelot System was able to safely and effectively facilitate crossing of CTOs in the peripheral vasculature where a conventional guidewire was unsuccessful.

#### CONCLUSION

The results of the nonclinical and clinical testing demonstrate that the Ocelot System is a safe and effective device when used for the stated indication for use. The clinical testing demonstrates that the new technological characteristics employed by the Ocelot System do not raise any new issues of safety or effectiveness. Therefore, the Ocelot System is substantially equivalent to the predicate devices.

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

Avinger, Inc. Mr. Albert Boniske Sr. Manager, Regulatory and Ouality Affairs 400 Chesapeake Drive Redwood City, CA 94063

SEP 1 8 2013

Re: K122380

Trade/Device Name: Ocelot System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: October 10, 2012 Received: October 11, 2012

Dear Mr. Boniske:

This letter corrects our substantially equivalent letter of November 7, 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

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Page 2 - Mr. Albert Boniske

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.

Zucker, Z.

for

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 STATEMENT 3.0

510(k) Number (if known): ≤22380

Device Name: Ocelot System

### Indications For Use:

The Ocelot System 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 using OCT-assisted orientation as an adjunct to fluoroscopy. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

.25. Hilliber

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices X122380 510(k) Number _