(112 days)
No
The description focuses on standard digital imaging capture, storage, and manipulation. There is no mention of AI, ML, or advanced analytical capabilities beyond basic image processing.
No
The device is described as an "Imaging System" intended to "capture, archive and manipulate digital images of the eye." Its components and function are solely for image acquisition, storage, and processing, not for treating or diagnosing a medical condition.
No
The device is used to capture, archive, and manipulate digital images of the eye. It does not provide a medical diagnosis or interpret the images to diagnose a condition.
No
The device description explicitly lists multiple hardware components (digital camera, imaging board, personal computer, monitor, Jaz drive) in addition to the software.
Based on the provided information, the OphthaVision Imaging System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "capture, archive and manipulate digital images of the eye." This describes a system for acquiring and managing images, not for performing tests on biological samples (in vitro).
- Device Description: The components listed (digital camera, imaging board, computer, monitor, software) are consistent with an imaging system, not a diagnostic device that analyzes samples.
- Anatomical Site: The system is used to image the eye, which is an in vivo (within the living body) process, not an in vitro process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on the analysis of such samples. The system is focused on image acquisition and management.
While the system is used in ophthalmic procedures and can be used for digital angiography (which can aid in diagnosis), the system itself is a tool for capturing and managing the images, not for performing the diagnostic test on a sample. The diagnosis would be made by the ophthalmologist based on their interpretation of the images.
N/A
Intended Use / Indications for Use
The OphthaVision Imaging System is intended to be used to capture, archive and manipulate digital images of the eye obtained through the use of an ophthalmic camera.
Product codes
86 HKI
Device Description
The OphthaVision Imaging System consists of: (1) a digital camera; (2) an imaging board: (3) a personal computer; (4) a monitor; and (5) MRP Group Inc.'s Microsoft Windows based image processing software. The OphthaVision Imaging System is used in ophthalmic procedures such as digital angiography during which the patient's retina is viewed through a slit lamp or a fundus camera. Images are transferred to the OphthaVision Imaging System's imaging board, located in the OphthaVision Imaging System's personal computer and stored in the computer's Random Access Memory (RAM) and hard drive. As the images accumulate, the user downloads the images from the hard drive onto the computer's Jaz drive, a removable media drive, by using the computer keyboard and mouse to manipulate the software interface.
After downloading the images to the Jaz drive, the ophthalmologist may continue to capture images or process the images previously captured and downloaded to the Jaz drive. To further process the images with the OphthaVision Imaging System software, the ophthalmologist can choose options to perform the functions, described in more detail below, for analysis, archival and retrieval of images. In addition, the ophthalmologist may view the images on the monitor or print them on paper.
Each image captured by the digital camera is transferred to the imaging board. The image transfer and processing does not use data compression. The personal computer is an off-the-shelf Performance/VS Pentium Pro computer. The personal computer has MRP Group Inc.'s Microsoft Windows-based image processing software installed which has the capability of saving displaying and archiving images. The software permits the user to manipulate and enhance the image. The image may be magnified, reduced, inverted. flipped or rotated. The user also has the ability to adjust the image's brightness, sharpness and contrast. The image may be enhanced by shadow, edge trace, and blur The software performs seven image-processing functions: (1) print; (2) functions. extract/delete: (3) save: (4) auto-align; (5) image compare; (6) animate; and (7) stereo imaging.
Images may be printed in portrait or landscape mode depending of the user's selections. Each image may be annotated with patient specific data such as the patient's name, date, and selected eve. The image may be printed on any Microsoft Windows compatible printer.
Mentions image processing
Yes
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
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
Not Found
Key Metrics
Not Found
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.
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510(k) SUMMARY
MAY 1 9 1998
MRP Group, Inc.
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared
MRP Group, Inc.
| Phone: | (781)595-5105 |
|---|---|
| Facsimile: | (781)595-8615 |
Matthew Carnevale Contact Person:
Date Prepared: January 26, 1998
Name of Device and Name/Address of Sponsor
OphthaVision Imaging System
MRP Group, Inc. 1111 West Lowell Ave. Haverhill, MA 01832
Common or Usual Name
Camera, Ophthalmic, AC-powered
Classification Name
Camera, Ophthalmic, AC-powered with digital imaging system.
Predicate Devices
Ophthalmic Imaging Systems - DFC Digital Imaging System (K913929) Midwest Ophthalmic Instruments - ORIMS Digital Angiography (K952480) Tomey Corporation USA - ImageScape Digital Retinal Image System (K971685) Topcon - Imagenet Digital Imaging System
Intended Use
The OphthaVision Imaging System is intended to be used to capture, archive and manipulate digital images of the eye obtained through the use of an ophthalmic camera.
1
Substantial Equivalence
MRP Group, Inc.'s OphthaVision Imaging System, Ophthalmic Imaging System's DFC, Midwest Ophthalmic Instrument's ORIMS, Tomey Corporation's ImageScape and Topcon's Imagenet all have the same intended use: to capture, archive, and manipulate digital images of the eye obtained though the use of an ophthalmic camera. The OphthaVision Imaging System, DFC, ORIMS, ImageScape, and Imagenet also have substantially equivalent technological characteristics. For instance, the OphthaVision, DFC. ImageScape and Imagenet all are equipped with the same Kodak MegaPlus digital camera and 1 gigabyte Jaz drive, and store the files in a TIFF file format.
The OphthaVision Imaging System and the predicate devices are all operated using personal computers with keyboards and a hand-operated mouse. The OphthaVision Imaging System, DFC, ImageScape and Imagenet use the Pentium chip-based personal computers with Microsoft Windows-based software. The OphthaVision Imaging System, DFC. ImageScape and Imagenet systems also have similar storage capabilities and monitors. Minor differences do not raise any new issues of safety or effectiveness because the OphthaVision's storage capabilities are superior to those of Imagenet and DFC's storage capabilities and do not affect the imaging capabilities of the device.
The OphthaVision Imaging System and the predicate devices all have the same basic software functions: image acquisition, analysis, storage and retrieval. The OphthaVision Imaging System and the ImageScape software have nearly identical functions because the OphthaVision Imaging System software was developed to have many of the same functions. The principal difference between the two is the graphical user interface. This difference does not raise any new issues of safety or effectiveness because both systems are graphical user interface systems in which the user clicks a mouse on a button to perform a task. Furthermore, MRP Group, Inc. has performed the software verification and validation. The verification and validation results demonstrate that the device meets the system and software specifications and requirements.
MRP Group Inc.'s OphthaVision Imaging System and the predicate devices are operated in the same manner. The ophthalmologist views the patient's eve through an ophthalmic camera with a digital camera mounted on a C-Mount to capture, archive and manipulate images. The patient is prepared for imaging in accordance with standard ophthalmic procedures and the ophthalmologist operates the joystick to send images to the digital camera in the same manner. For the Ophtha Vision Imaging System and the predicate devices, images are captured and manipulated using a graphical user interface. The systems software for the various devices also permit the ophthalmologist to print images, view images on the monitor, and archive the images on a removable media drive.
2
Performance Characteristics
The OphthaVision Imaging System consists of: (1) a digital camera; (2) an imaging board: (3) a personal computer; (4) a monitor; and (5) MRP Group Inc.'s Microsoft Windows based image processing software. The OphthaVision Imaging System is used in ophthalmic procedures such as digital angiography during which the patient's retina is viewed through a slit lamp or a fundus camera. Images are transferred to the OphthaVision Imaging System's imaging board, located in the OphthaVision Imaging System's personal computer and stored in the computer's Random Access Memory (RAM) and hard drive. As the images accumulate, the user downloads the images from the hard drive onto the computer's Jaz drive, a removable media drive, by using the computer keyboard and mouse to manipulate the software interface.
After downloading the images to the Jaz drive, the ophthalmologist may continue to capture images or process the images previously captured and downloaded to the Jaz drive. To further process the images with the OphthaVision Imaging System software, the ophthalmologist can choose options to perform the functions, described in more detail below, for analysis, archival and retrieval of images. In addition, the ophthalmologist may view the images on the monitor or print them on paper.
Each image captured by the digital camera is transferred to the imaging board. The image transfer and processing does not use data compression. The personal computer is an off-the-shelf Performance/VS Pentium Pro computer. The personal computer has MRP Group Inc.'s Microsoft Windows-based image processing software installed which has the capability of saving displaying and archiving images. The software permits the user to manipulate and enhance the image. The image may be magnified, reduced, inverted. flipped or rotated. The user also has the ability to adjust the image's brightness, sharpness and contrast. The image may be enhanced by shadow, edge trace, and blur The software performs seven image-processing functions: (1) print; (2) functions. extract/delete: (3) save: (4) auto-align; (5) image compare; (6) animate; and (7) stereo imaging.
Images may be printed in portrait or landscape mode depending of the user's selections. Each image may be annotated with patient specific data such as the patient's name, date, and selected eve. The image may be printed on any Microsoft Windows compatible printer.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 1998
MRP Group, Inc. Mr. Matthew Carnevale 1111 West Lowell Ave. Haverhill, MA 01832
Re: K980295 Trade Name: Ophthavision Imaging System Regulatory Class: II Product Code: 86 HKI Dated: May 6, 1998 Received: May 8, 1998
Dear Mr. Carnevale:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal
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Page 2 - Mr. Matthew Carnevale
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on. the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Roerl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K980295 510(k) Number (if known):
Device Name: OPHTHAVISION IMAGING SYSTEM
Indications For Use:
The OphthaVision Imaging System is intended to be used to capture, archive and manipulate digital images of the eye obtained through the use of an ophthalmic camera.
Image /page/5/Picture/5 description: The image shows a document with the text 'FDA/CDRH/ODE/DMC' vertically aligned on the left side. To the right of this, the date '8 May 98' is printed vertically, followed by the numbers '20100'. On the left side of the image, the word 'RECEIVED' is printed vertically.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of device Evaluation (ODE)
Everette Deen
(Division Sign-Off) Division of Ophthalmic Devices 980295 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)