(28 days)
Not Found
No
The description focuses on image capture, storage, and basic image processing, with no mention of AI, ML, or related concepts like deep learning or algorithms for automated analysis or interpretation.
No
This software system is intended for the collection, storage, and management of digital images and patient data from diagnostic imaging devices. It does not provide any therapy or treatment.
No
The OVision Imaging System is described as a software program that collects, stores, and manages digital images and patient data from computerized diagnostic imaging devices. It does not perform diagnostic functions itself but rather facilitates the handling of data from other diagnostic imaging devices.
Yes
The device is described as a "software program" and a "software system" that collects, stores, and manages images and data from existing imaging devices. While it connects to hardware (retinal cameras, digital cameras, and a computer), the 510(k) summary explicitly states it does not alter or control the parameters of the imaging hardware and its function is solely related to the software-based handling of the images and data.
Based on the provided information, the OVision Imaging System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The OVision Imaging System works with images captured directly from the patient's eye using imaging devices like retinal cameras and slit lamps. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for the collection, storage, and management of digital images and associated data. While this data might be used for diagnostic purposes by a healthcare professional, the software itself is a tool for handling the images, not for performing a diagnostic test on a biological specimen.
- The device description focuses on image capture, storage, and display. It acts as a digital archive and viewing system for ophthalmic images.
- The mention of "image processing" is a common function in image management software and doesn't automatically classify it as an IVD. Image processing in this context likely refers to basic adjustments for viewing or organization, not analysis of biological markers.
In summary, the OVision Imaging System is a medical device, specifically an imaging system accessory, but its function is centered around managing images of the eye, not performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The OVision Imaging System is a software program that is intended for use in the collection, storage, and management of digital images, patient data, diagnostic data and clinical information from computerized diagnostic imaging devices through direct connection with the instruments.
The software system is indicated for use with retinal camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slit lamps.
Product codes
NFJ
Device Description
The OVision Imaging System is a software system that collects, stores, and maintains images of the retina and anterior segment of the eye. The Ovision Imaging System is used together with retinal cameras or digital camera imaging devices.
In operation, the retinal camera will be operated as normally intended, with the OVision Imaging System capturing images of the patient. The OVision Imaging System does not alter or control the parameters of the retinal camera.
The OVision Imaging System software accessory captures images from USB or Firewire digital cameras that are commercially available for both color and monochromatic imaging. The digital camera output of the fundus camera is tethered to the commercially available computer via a USB or FireWire cable.
The OVision Imaging System software system receives the images captured by the retinal camera or digital camera. The images are stored in the computer's random access memory (RAM) and then saved on the local storage of the computer. The patient and exam information are stored in the system's database.
The OVision Imaging System attaches directly to an existing retinal camera or digital camera via a communication cable. The user is able to operate the fundus camera in the manner it was intended, either viewing and focusing on the patient's retina through the eye piece or through the external monitor. During operation, the digital camera will transfer captured images to the computer to then store on its local drive.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images from retinal camera or digital camera imaging devices
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
Performance testing was performed on the OVision Imaging System during software verification and validation. During verification, the OVision Imaging System was found to meet the requirements, and during validation, the OVision Imaging System was found to perform as intended.
Key Metrics
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 3, 2020
Ophthalmic Labs, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K200275
Trade/Device Name: OVision Imaging System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: NFJ Dated: January 30, 2020 Received: February 4, 2020
Dear Dave Yungvirt:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Tieuvi Nguyen, Ph. D. Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200275
Device Name
OVision Imaging System
Indications for Use (Describe)
The OVision Imaging System is a software program that is intended for use in the collection, storage, and management of digital images, patient data, diagnostic data and clinical information from computerized diagnostic imaging devices through direct connection with the instruments.
The software system is indicated for use with retinal camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slit lamps.
| Type of Use (Select one or both, as applicable) |
|---|
| ✖ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Submitted By
Ophthalmic Labs, Inc. 18 Berlin Ave. Milton, MA 02186 Tel: 877-510-8300 Fax: 978-824-9308
Contact Person
Matthew Carnevale President and CEO 877-263-0003 mcarnevale@ophthalmiclabs.com
Date Prepared
March 2, 2020
Submission Type
Traditional 510(k)
Trade Name
OVision Imaging System
Common Name
Ophthalmic Image Management System
Classification
Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: NFJ
Indications for Use
The OVision Imaging System is a software program that is intended for use in the collection, storage, and management of digital images, patient data, diagnostic data and clinical information from computerized diagnostic imaging devices through direct connection with the
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instruments. The software system is indicated for use with retinal camera or digital camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slit lamps.
Predicate Device
Topcon Corp. IMAGEnet Professional PC Software System K082364 CFR Number: 21 CFR 892.2050 Product Code: NFJ
Description of the Device
The OVision Imaging System is a software system that collects, stores, and maintains images of the retina and anterior segment of the eye. The Ovision Imaging System is used together with retinal cameras or digital camera imaging devices.
In operation, the retinal camera will be operated as normally intended, with the OVision Imaging System capturing images of the patient. The OVision Imaging System does not alter or control the parameters of the retinal camera.
The OVision Imaging System software accessory captures images from USB or Firewire digital cameras that are commercially available for both color and monochromatic imaging. The digital camera output of the fundus camera is tethered to the commercially available computer via a USB or FireWire cable.
The OVision Imaging System software system receives the images captured by the retinal camera or digital camera. The images are stored in the computer's random access memory (RAM) and then saved on the local storage of the computer. The patient and exam information are stored in the system's database.
The OVision Imaging System attaches directly to an existing retinal camera or digital camera via a communication cable. The user is able to operate the fundus camera in the manner it was intended, either viewing and focusing on the patient's retina through the eye piece or through the external monitor. During operation, the digital camera will transfer captured images to the computer to then store on its local drive.
Comparison to Predicate Device
The OVision Imaging System and the predicate device, the IMAGEnet Professional PC Software System, have the same intended use. The two software devices have technological characteristics. With either system, the user views the patient's retina through an existing fundus camera's eye piece or external display and operates the fundus camera as normally intended.
Both software devices have the same basic functions: image capture, display, database archival of images and image processing. The OVision Imaging System and the predicate device serve the same clinical purpose and provide the same functionality. The OVision Imaging System and the IMAGEnet Professional PC Software System are both used together with retinal cameras or digital camera imaging devices. They both capture images of the retina and anterior segment of the eye. Both provide for color and monochrome imaging modalities, image review, enhance and print capabilities, and both provide archive and retrieve functionality.
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A minor technological difference between the OVision Imaging System and the predicate device is that the OVision Imaging System does not have functions to allow stitching of retinal images together or estimating the desired laser treatment size for photodynamic therapy (PDT). The minor differences do not impact substantial equivalence or patient safety, as evidenced by the fact that these functions are described as optional in the predicate device. Therefore, the OVision Imaging System and the IMAGEnet Professional PC Software System are substantially equivalent.
Non-Clinical Performance Data
Performance testing was performed on the OVision Imaging System during software verification and validation. During verification, the OVision Imaging System was found to meet the requirements, and during validation, the OVision Imaging System was found to perform as intended.
Conclusions from Non-Clinical Tests
Based upon the results of the non-clinical performance testing, the OVision Imaging System has demonstrated that it is Substantially Equivalent (SE) in safety and effectiveness to the selected predicate device.