(92 days)
Not Found
No
The summary mentions image processing (spatial calibration, registration, and alignment) but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The description of the technology focuses on standard image processing techniques.
No.
The device's intended use is to collect, store, and spatially calibrate images of the human eye, which is a diagnostic or image processing function, not a therapeutic one.
No
The device is described as software for collecting, storing, and spatially calibrating images, not for diagnosing conditions. Its stated "Intended Use" focuses on image management rather than diagnostic interpretation.
Yes
The device description explicitly states it is a "software program" and its function is to process images. There is no mention of accompanying hardware being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the MatchedFlicker® device is to collect, store, and process images of the posterior segment of the human eye. This involves analyzing images, not biological samples.
- The description focuses on image processing and calibration. The core function is manipulating and aligning images, which is not the typical function of an IVD.
- The anatomical site is the posterior segment of the human eye. This is a part of the living body, not a specimen taken from the body.
The device appears to be a medical image processing software, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
NFJ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior segment of the human eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
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: 608-219-7547 |
|---|---|
| President | No FAX number |
| Waxler Regulatory Consultancy, LLC | mwaxler@charter.net |
| 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
CEO
EyeIC Corporation
231 Tower Lane
Suite 200
Narbeth, PA 19072-1127 | Phone 610-617-8957
Cell 610-331-5759
Fax 610-617-8883
iwallace@eyeic.com |
| ----------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------- |
|---|
MatchedFlicker®
Common or Usual Name: Digital Imaging Software
Classification Name: Picture Archiving & Communication System (21 CFR 892.2050. NFJ)
Predicate Devices
-
- NAVIS by Nidek, Inc. (K013694)
-
- Retasure by Digital Healthcare, Inc. (K071299),
-
- 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.
1
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).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle.
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
4
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
April 13, 2009 Page 1 of 1