(112 days)
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.
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.
This 510(k) submission (K980295) for the OphthaVision Imaging System, an ophthalmic camera with a digital imaging system, does not contain a study that establishes performance criteria and demonstrates the device meets those criteria.
Instead, this submission focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics. The "Performance Characteristics" section describes the components and functions of the OphthaVision Imaging System but does not present data from a formal study with acceptance criteria.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving their fulfillment. The provided text primarily addresses:
- Intended Use: To capture, archive, and manipulate digital images of the eye obtained through the use of an ophthalmic camera.
- Technological Characteristics Comparison: The device uses a Kodak MegaPlus digital camera, a 1-gigabyte Jaz drive, stores files in TIFF format, operates on Pentium-chip personal computers with Microsoft Windows-based software, and has similar storage capabilities and monitors to predicate devices.
- Software Functions: Similar to predicate devices, providing image acquisition, analysis, storage, and retrieval. Specific functions include printing, extracting/deleting, saving, auto-aligning, image comparison, animation, and stereo imaging, along with image manipulation (magnify, reduce, invert, flip, rotate, brightness, sharpness, contrast, shadow, edge trace, blur).
- Verification and Validation: The document states that "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." However, the details of these verification and validation activities, including specific acceptance criteria or study results, are not included in the provided text.
Without a performance study in the provided text, I cannot populate the table or answer the specific questions related to a study's methodology (sample size, ground truth, experts, adjudication, MRMC, standalone performance, training set).
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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.
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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.
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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.
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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
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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)
§ 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.