(43 days)
No
The description focuses on image collection, storage, management, and basic processing (stitching, size estimation) without mentioning AI/ML algorithms or capabilities.
No
The device is a software system for collecting, storing, and managing digital images and data from diagnostic imaging devices. It does not provide therapy or treatment.
No
The device is described as a software system for the collection, storage, and management of digital images and data from computerized diagnostic imaging devices, not as a diagnostic device itself. It processes images, but it does not state that it performs diagnostic interpretations or renders a diagnosis.
Yes
The device is described as a "software program" and a "computerized software system" that is installed on a standard PC. While it interacts with imaging devices, the 510(k) summary focuses solely on the software's functions (collection, storage, management, processing) and does not describe any proprietary hardware components included as part of the device submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device function: The IMAGEnet Professional PC Software System is described as a software program for the collection, storage, and management of digital images acquired from diagnostic instruments that capture images of the retina and anterior segment of the eye. It processes and manages images, but it does not analyze biological specimens.
- Input: The input is digital images, not biological samples.
- Purpose: The purpose is to manage and process images for diagnostic information, but the diagnosis itself is derived from the interpretation of these images by a healthcare professional, not from the software's analysis of a biological sample.
Therefore, while it is a medical device used in the diagnostic process, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The IMAGEnet Professional PC Software System is a software program that is intended for r no mir reallection, storage and management of digital images, patient data, diagnostic data and clinical information from computerized diagnostic imaging devices through direct connection with the instruments or through computerized networks.
The software system is indicated for use with retinal camera or digital camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slintor ms.
Product codes
NFJ
Device Description
The IMAGEnet Professional PC Software System is a computerized software system that The INAOLIC: Professional - images of the retina and anterior segment of the eye. The collects, stores, and manificante sincessor with retinal camera or digital IMAGEIEL Protessional I O betware Byoten in Cameras, non-mydriatic retinal cameras, and slit camera imaging devices, including retinal cameras, non-mydriatio retinal cameras, camera iniaging dovroob, metaling reasing reached in a Windows 2000 or lamps. The MACLife. I rolossional PC Borthale of image capture, database archival of images, Windows XF Companiele I C to laomate the finitered. On the suptional functions that and image processing. The thirle interestigal images together or estimate the desired laser treatment size for photodynamic therapy (PDT). The Topcon IMAGEnet Professional PC Software System is intended as a software program for the use in the management of digital images acquired from diagnostic instruments that capture images of the retina and anterior segment of the eye.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images from computerized diagnostic imaging devices, specifically retinal cameras, non-mydriatic retinal cameras, and slit lamps.
Anatomical Site
retina and anterior segment of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Software validation testing and image capture testing were performed on the IMAGEnet Professional PC Software System. Test results for the IMAGEnet Professional Software Frorem demonstrated sufficient agreement with captured images. The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 3 0 2008
210(K)
Page 16 of 98
1 (
5. 510(k) Summary as required by 21 CFR 807.92(c)
510(k) Owner:
Topcon Corporation. 75-1 Hasunuma-cho, Itabashi-ku Tokyo, Japan 174
U.S. Facility: Topcon Medical Systems, Inc. 37 West Century Road Paramus, New Jersey 07652 Telephone: (201) 599-5153 Facsimile: (201) 599-5240
Contact person:
Barbara S. Fant, Pharm.D. Clinical Research Consultants, Inc. 310 Terrace Avenue Suite 201 Cincinnati, OH 45220 Phone: (513) 961-8200 Facsimile: (513) 961-2858
Date: April 28, 2008
IMAGEnet Professional PC Software System Trade Name:
Digital Image Management Software Common names: Digital Imaging Software for Retinal Cameras Digital Imaging Software for Slit Lamps
Classification Name: Picture archiving and communications system 21 CFR 892.2050
Product Code: NFJ
Identification of a Legally Marketed Predicate Device
The IMAGEnet Professional PC Software System is substantially equivalent to the IMAGEnet Digital Ophthalmic Imaging System (v.2.12; IMAGEnet 2000) marketed by Topcon, 510(k) Premarket Notification Number K870039, FDA Product Code DSF Secondly, it is substantially equivalent to the Nider Rolly Courted Vision Information System (NAVIS) marketed by Nidek Inc., 510(k) Premarket Notification Number: K013694, FDA Product Code NFJ.
General Description
1
Page 17 of 98
510(K)
The IMAGEnet Professional PC Software System is a computerized software system that The INAOLIC: Professional - images of the retina and anterior segment of the eye. The collects, stores, and manificante sincessor with retinal camera or digital IMAGEIEL Protessional I O betware Byoten in Cameras, non-mydriatic retinal cameras, and slit
camera imaging devices, including retinal cameras, non-mydriatio retinal cameras, camera iniaging dovroob, metaling reasing reached in a Windows 2000 or lamps. The MACLife. I rolossional PC Borthale of image capture, database archival of images, Windows XF Companiele I C to laomate the finitered. On the suptional functions that and image processing. The thirle interestigal images together or estimate the desired laser treatment size for photodynamic therapy (PDT). The Topcon IMAGEnet Professional PC Software System is intended as a software program for the use in the management of digital images acquired from diagnostic instruments that capture images of the retina and anterior segment of the eye.
Intended Use
The IMAGEnet Professional PC Software System is a software program that is intended for r no mir reallection, storage and management of digital images, patient data, diagnostic data and clinical information from computerized diagnostic imaging devices through direct connection with the instruments or through computerized networks.
Performance Data
Software validation testing and image capture testing were performed on the IMAGEnet Professional PC Software System. Test results for the IMAGEnet Professional Software Frorem demonstrated sufficient agreement with captured images. The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device.
Basis of Substantial Equivalence
The IMAGEnet Professional PC Software System is substantially equivalent to the IMAGEnet Digital Ophthalmic Imaging System (v.2.12 IMAGEnet 2000) marketed by Topcon, 510(k) Premarket Notification Number K870039, FDA Product Code DSF, and regulation 21CFR $870.2810 (Recorder, paper chart) in software design and specifications, intended use, and compatible digital diagnostic equipment. Secondly, it is also substantially equivalent to the Nidek Advanced Vision Information System (NAVIS) marketed by Nidek Inc., 510(k) Premarket Notification Number: K013694, FDA Product Code NFJ, and regulation 21CFR $892.2050 (picture archiving and communications system) in basic design concept, in intended use, and use with similar digital diagnostic equipment.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the bird.
SEP 3 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Topcon Corporation c/o Tamas Borsai, TUV Rheinland of North America 12 Commerce Road Newton, CT 06470
Re: K082364
Trade/Device Name: IMAGEnet Professional PC Software System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: NFJ Dated: September 15th, 2008 Received: September 18th, 2008
Dear Mr. Borsai:
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 forth in the quality systems (OS) 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
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 (240) 276-0115. 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 Biometric's (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 240-276-3464. 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. Egerston, 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
Page 15 of 98
510(K)
4. Indications for Use Statement
K082364 510(k) Number (if known):
Device Name: IMAGEnet Professional PC Software System
Indications for Use:
The IMAGEnet Professional PC Software System is a software program that is intended for use in the collection, storage and management of digital images, paticant data, diagnostic data and clinical information from computerized diagnostic imaging devices through direct connection with the instruments or through computcrized networks.
The software system is indicated for use with retinal camera or digital camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slintor ms.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-The-Counter Use
Ba
(Division Sign-Off)
610(k) Number k 082364