(88 days)
Not Found
No
The document describes standard digital imaging and processing capabilities, with no mention of AI or ML algorithms for image analysis or interpretation. The focus is on image capture, storage, and basic manipulation controlled by the user.
No.
The device is used for capturing, archiving, recalling, and displaying images of the retina to aid in diagnosis and monitoring, which is an imaging and diagnostic function, not a therapeutic one.
Yes.
The "Intended Use / Indications for Use" section states that the device is "to aid in the diagnosis and monitoring of diseases of the eye".
No
The device description explicitly states that the system is comprised of hardware components including a digital sensor head (digital camera), a computer interface circuit board, connecting cables, a computer (CPU), monitor, keyboard, and mouse, in addition to the software.
Based on the provided information, the OPTO Global Digital Fundus Camera System Model ADS 1.5 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that this system captures images of the retina and surrounding areas non-invasively. This means it is imaging the body directly, not analyzing samples taken from the body.
- The device's function is image capture, storage, and display. While these images are used to aid in diagnosis and monitoring, the device itself is not performing a test on a biological sample to determine the presence or absence of a disease or condition.
The device is an ophthalmic imaging system used for diagnostic imaging, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Opto Global Digital Fundus Camera System Model ADS 1.5 is intended to be used to capture, archive, and display digital images of the eye, particularly the retina obtained through the use of an ophthalmic camera (fundus camera).
The OPTO Global Digital Fundus Camera System Model ADS 1.5 is intended to be used to capture, archive, recall and display black and white, and color images of the retina, as well as surrounding areas, to aid in the diagnosis and monitoring of diseases of the eye that may be viewed and photographed non-invasively.
Product codes
HKI, NFF, NFG
Device Description
The OPTO Global ADS 1.5 Digital Fundus Camera System is an automated imaging device used in conjunction with a digital camera that requires ninimal intervention during the capture of an image. The system is simple to use and requires minimal training for a user to become proficient with the system. Like the listed predicate devices, the Opto Global Digital Fundus Camera System Model ADS 1.5 is comprised of a digital imaging camera, computer hardware, and a software platform intended to be used to store images captured by the fundus camera. Thus the Opto Global Digital Fundus Camera System Model ADS 1.5 has the same intended use and indications as the listed predicate devices.
The Opto Global Digital Fundus Camera System Model ADS 1.5 is comprised of the following components: A digital sensor head (digital camera) a computer interface circuit board (digital image capture card), and connecting cables. These components are then combined and sold together with our "OPTO Global Capture" proprietary imaging software and a computer (CPU) monitor, keyboard and mouse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye, retina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Ophthalmologist, or Photographer
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
OPTO Global Inc. has performed several software validation tests the results of which clearly indicate that the Opto Global Digital Fundus Camera System Model ADS 1.5 meets comparable system and software standards exhibited by the predicate devices listed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
JAN 2 4 2006
510(k) Summary
Name of device:
OPTO GLOBAL Digital Fundus Camera System Model ADS 1.5
Common or usual name: Camera, Ophthalmic (AC Powered)
Classification Name:
Ophthalmic Camera (per 21 CFR.886.1120) Device, Storage, Images, Ophthalmic (per 21 CFR.892.2010 Device, Communication, Images, Ophthalmic (per CFR 21 892.2020)
Product Code:
HKI, NFF, NFG
Submitter: OPTO Global, Inc.
4021 Daggett Drive Granite Bay, CA 95746 Phone: (916) 783-3223 Facsimile: (916) 782-5847 Contact Person: Mark T. Fukuhara Date Prepared: 20 August 2005
Predicate Devices
| Trade Name | Manufacturer | 510 (k) |
|---|---|---|
| Visucam | Carl Zeiss Ophthalmic Systems Inc | K021787 |
| FF450 plus Visupac System | Carl Zeiss Jena GmbH | K011877 |
| Imagenet Digital Ophthalmic Imaging* | ||
| *(Sold in the U.S. for years) | Topcon Corp | Cannot Locate |
| 50X, 50 EX Fundus camera* | ||
| *( Sold in the U.S. for years) | Topcon Corp | Cannot Locate |
Sec 12: 1 of 4
1
Intended Use
The Opto Global Digital Fundus Camera System Model ADS 1.5 is intended to be used to capture, archive, and display digital images of the eye, particularly the retina obtained through the use of an ophthalmic camera (fundus camera).
Device Description
The OPTO Global ADS 1.5 Digital Fundus Camera System is an automated imaging device used in conjunction with a digital camera that requires ninimal intervention during the capture of an image. The system is simple to use and requires minimal training for a user to become proficient with the system. Like the listed predicate devices, the Opto Global Digital Fundus Camera System Model ADS 1.5 is comprised of a digital imaging camera, computer hardware, and a software platform intended to be used to store images captured by the fundus camera. Thus the Opto Global Digital Fundus Camera System Model ADS 1.5 has the same intended use and indications as the listed predicate devices.
Substantial Equivalence
The Opto Global Digital Fundus Camera System Model ADS 1.5 and the predicate devices listed all have the same intended use: to capture and archive images of the retina taken with a fundus camera. The Opto Global Digital Fundus Camera System Model ADS 1.5 and the predicate devices listed have equivalent principles of operation and technological characteristics. Each of the devices is a digital ophthalmic camera system and image storage device. The user views the patient's retina through a fundus camera. A light source is used to illuminate the repacency the fundus triggers the digital cameras to capture images of the retina. These digitized images are then archived for future use or record.
The Opto Global Digital Fundus Camera System Model ADS 1.5 and all of the listed predicate devices use, and are operated by, PC's with keyboards and a or and operated mouse. While there may be some very minor differences in types of processor (Intel Pentium IV or AMD Athelon) processors speed, and software platform, these minor differences do not raise any new issues of safety or effectiveness and do not affect the imaging capabilities of the Opto Global Digital Fundus Camera System Model ADS 1.5 or any of the predicate devices listed.
2
The Opto Global Digital Fundus Camera System Model ADS 1.5 and all of the predicate devices have the same basic software functions: image acquisition, storage, analysis, and retrieval. The principle differences can be found incon, graphical user interface.
Most software platforms found in the predicate devices are windows based and effectively function using different screens for different functions, and drop down menus and graphic buttons to control, or perform, various tasks in the crop ure, archive, and recall of images.
These slight differences do not raise new or additional questions regarding safety or efficacy in the OPTO Global Digital Fundus Camera System Model ADS 1.5 r other predicate systems. OPTO Global Inc. has performed several software validation tests the results of which clearly indicate that the Opto Global Digital Fundus Camera System Model ADS 1.5 meets comparable system and software standards exhibited by the predicate devices listed.
The OPTO Global Digital Fundus Camera System Model ADS 1.5 and all of the predicate devices listed are operated in the same manner. The Ophthalmolngist, or Photographer, views the patients eye through an ophthalmic camera (ffundyis camera) with a digital camera used to capture, manipulate and archive images. using the graphical user software interface. The Opto Global Digital Fundus Camera System Model ADS 1.5 and all of the predicate devices listed use the system software to manipulate images into produce proof sheets (photo collages of the patients eye captured during the procedure) the software also carries the capabilities of printing individual images or proof sheets, view individual photos or proof sheets on the computer monitor, and to archive selected captured images onto the computers hard drive or several types of removable media such in standard CD's or DVD's.
Performance characteristics
The Opto Global Digital Fundus Camera System Model ADS 1.5 is comprised of the following components: A digital sensor head (digital camera) a computer interface circuit board (digital image capture card), and connecting cables. These components are then combined and sold together with our "OPTO Global Capture" proprietary imaging software and a computer (CPU) monitor, keyboard and mouse.
3
This total system with imaging software provides acquisition and hardware control capabilities used to take digital pictures of the retina which are then transferred via the digital camera and connecting cable to the computer system transment can be viewed, modified, stored or printed. The Opto Global Digital Funchs Camera System Model ADS 1.5 is intended to capture and store images of the Retina, and it is also indicated for use as an ophthalmic camera for individuals where documentation of the retina is important to follow and treat certain pathologies.
The Opto Global Digital Fundus Camera System Model ADS 1.5 software interface allows images from the fundus camera to be acquired, monitored, stored and retrieved. Imaging, focusing, and camera orientation in relation to the relina are controlled by the user. With verification and monitoring, the software allows the user to monitor, capture, and process, images thus verifying the device is operating correctly. The image viewed through the fundus camera and captured by the digital camera is then stored as individual images in a non compressed state on the hard drive of the computer to be displayed electronically as the user requires it.
Conclusion
The Opto Global Digital Fundus Camera System Model ADS 1.5 has the same intended use, indications, and very similar principals of operation to the predicate devices listed. The Opto Global Digital Fundus Camera System Model ADS 1.5 also has similar technological characteristics (hardware and software) to the predicate devices listed.
The minor differences between the Opto Global Digital Fundus Camera System Model ADS 1.5 and those of the listed predicate devices do not raise any new questions of safety or of effectiveness in comparison to the predicate devices. Thus the Opto Global Digital Fundus Camera System Model ADS 1.5 is substantially equivalent to legally marketed ophthalmic camera systems.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines, positioned to the right. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2006
OPTO Global, Inc. C/O Lorinda Badalian Senior Project Engineer Underwriters Laboratories, Inc. 455 E. Trimble Rd San Jose, CA 95131-1230
Re: K053044
Trade/Device Name: OPTO Global Digital Fundus Camera System Model ADS 1.5 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI; NFF; NFF; NFG Dated: January 10, 2006 Received: January 11, 2006
Dear Ms. Badalian:
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 (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.
5
Page 2 - Lorinda Badalian
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 Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B.Egelman, MD
Malvina B. Eydelman, M.D Acting Division Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if Known): K053044
Device Name: OPTO Global Digital Fundus Camera System Model ADS 1.5
Indications for Use :
The OPTO Global Digital Fundus Camera System Model ADS 1.5 is intended to be used to capture, archive, recall and display black and white, and color images of the retina, as well as surrounding areas, to aid in the diagnosis and monitoring of diseases of the eye that may be viewed and photographed non-invasively.
Prescription Use (Per CFR 21 801.109)
or
Over-the-counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
Division of Ophthalmic Ear,
Nose and Throat Devises
10(k) Number KOS 306
Sec 10: 1 of 1