MATCHEDFLICKER

K090266 · Eyeic Corporation · NFJ · May 6, 2009 · Radiology

Device Facts

• Record ID: K090266
• Device Name: MATCHEDFLICKER
• Applicant: Eyeic Corporation
• Product Code: NFJ · Radiology
• Decision Date: May 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The MatchedFlicker® device is a software program that is intended for use by health care professionals to collect, store, and spatially calibrate (i.e. register and align) images of the posterior segment of the human eye.

Device Story

MatchedFlicker is digital imaging software for healthcare professionals; collects, stores, and spatially calibrates (registers/aligns) time-series images of the posterior segment of the human eye. Device aids clinicians in comparing and annotating serial mono or stereo-photographs to monitor progression of glaucoma and other retinal diseases. By aligning images, software facilitates detection of structural changes in optic nerve and retina over time, which may precede visual field loss. Output is viewed by clinicians to assist in clinical decision-making regarding disease progression. Device functions as a Picture Archiving and Communication System (PACS) component.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital imaging software; functions as a Picture Archiving and Communication System (PACS) under 21 CFR 892.2050. Core functionality includes image registration and spatial alignment algorithms for posterior segment eye images. Operates as standalone software for image management and comparison.

Indications for Use

Indicated for use by healthcare professionals to collect, store, and spatially calibrate (register and align) posterior segment eye images for monitoring disease progression, including glaucoma.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• NAVIS by Nidek, Inc. (K013694)
• Retasure by Digital Healthcare, Inc. (K071299)
• IMAGEnet by Topcon Corp (K082364)

Submission Summary (Full Text)

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510(k): k 090266

# 510(k) SUMMARY EyeIC's MatchedFlicker® Device

MAY

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

| Morris Waxler, Ph.D. | Tel: [phone] |
|------------------------------------|---------------------|
| President | No FAX number |
| Waxler Regulatory Consultancy, LLC | [e-mail] |
| 1920 Arlington Place | |
| Madison, WI 53726-4002 | |

Contact Person: Morris Waxler, Ph.D Date Prepared: January 29, 2009

#### Name of Device and Name/Address of Sponsor

| Ira Wallace, MD, MBA<br>CEO<br>EyeIC Corporation<br>231 Tower Lane<br>Suite 200<br>Narbeth, PA 19072-1127 | Phone [phone]<br>Cell 610-331-5759<br>Fax [phone]<br>[e-mail] |
|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|

# MatchedFlicker®

Common or Usual Name: Digital Imaging Software

Classification Name: Picture Archiving & Communication System (21 CFR 892.2050. NFJ)

### Predicate Devices

- 1. NAVIS by Nidek, Inc. (K013694)
- 2. Retasure by Digital Healthcare, Inc. (K071299),
- 3. IMAGEnet by Topcon Corp (K082364)

### Intended Use:

The MatchedFlicker® device is a software program that is intended for use by health care professionals to collect, store, and spatially calibrate (i.e. register and align) images of the posterior segment of the human eye.

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#### Technological Characteristics and Substantial Equivalence:

The MatchedFlicker® device is software to aid professionals to more easily compare and annotate time-series images of the posterior segment of the human eye for monitoring the progression of glaucoma and other diseases. Currently these analyses are performed by a side-by-side comparison of serial mono or stereo-photographs. For example, in glaucoma there are two challenges to assessing the structure of the optic nerve. The first is distinguishing between a normal and a glaucomatous optic nerve. Changes in retinal structure, which signal the advent and progression of retinal disease, can be seen in photographs much earlier than in visual field tests. The more important challenge is detecting glaucoma progression over time prior to visual field loss. The MatchedFlicker® device is an aid to photo-documentation of stereo evidence of glaucomatous (or other diseases') changes in the retina and other structures of the posterior segment over time.

MatchedFlicker® is digital imaging software regulated by FDA as a type of Picture Archiving and Communications System (21CFR 892.2050) under product code NFJ. It is substantially equivalent to other legally marketed digital imaging software. Specifically, EyeIC's MatchedFlicker® software is substantially equivalent to NAVIS manufactured by Nidek, Inc. (K013694), to Retasure manufactured by Digital Healthcare, Inc. (K071299), and to IMAGEnet manufactured by Topcon Corp (K082364).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAY - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EyeIC, Corporation c/o Morris Waxler, Ph.D. Waxler Regulatory Consultancy, LLC 1920 Arlington Place Madison, Wisconsin 53726

Re: K090266

Trade/Device Name: MatchedFlicker™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: NFJ Dated: April 6, 2009 Received: April 7, 2009

Dear Dr. Waxler:

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 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); 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.

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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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

M. B. Eglekus, MD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

k090266 510(k) Number (if known):

Device Name: MatchedFlicker®

Indications for Use:

The MatchedFlicker" device is a software program that is indicated for use by health care professionals to collect, store, and spatially calibrate (i.e. register and align) images of the posterior segment of the human eye.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER LINE IF NECESSARY0

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Diysion Sign-Off) Division of Ophthalmic & ENT Devices

510(k) Number

Prescription Use_X or Over-The-Counter Use (Optional Format 1-2-96)

EyeIC

Additional Information for K

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