KEELER KAPTURE SOFTWARE

{0}------------------------------------------------ টি বিশ্ববিদ্যালয়ের প্রতিষ্ঠান করে পারে। বিশ্বকাপের প্রতিষ্ঠান করে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে করে পারে করে পারে করে আর করে আর করে আর করে আর করে পা Ophthalmic Instruments ## 510(k) Summary of Safety and Effectiveness #### 1. Submitter's Information The submitter of this special pre-market notification is: | Name: | Mr. Neil Atkins (Engineering Manager). | |------------------------|----------------------------------------------------------------------| | Address: | Keeler Limited, Clewer Hill Road, Windsor,<br>Berkshire, SL4 4AA, UK | | Company Phone No: | +44 (0) 1753 827125 | | Company Fax No: | +44 (0) 1753 827145 | | Contact Person: | Mr. Neil Atkins | | Date summary prepared: | 19th February, 2014 | | Date summary reviewed: | 17th June, 2014 | #### 2. Device Identification | Device Trade Name: | Keeler Kapture Software | |-----------------------|-----------------------------| | Common Name: | Ophthalmic Camera Accessory | | Class: | II | | Classification Panel: | 86 | | Product Code: | HKI | | Regulation Number: | 886.1120 | #### 3. Predicate Device K000368 Clement Clarke International Ltd EyeCap Imaging System #### 4. Device Description The Keeler Kapture software is an ophthalmic imaging system. The Kapture software package is intended to run on a PC and will allow the user to capture images from a digital slit lamp or other camera for review and storage. Images can have basic adjustments (such as colour, brightness and contrast) and images can be visually compared. #### ક. Indications for Use The Keeler Kapture Software is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps. {1}------------------------------------------------ Keeler ## Ophthalmic Instruments #### Summary of Technological Characteristics 6. Both the Keeler Kapture Software and the EyeCap Imaging System predicate device are software applications running under the Microsoft Windows Operating System on a Personal Computer. Both products have exactly the same technological characteristics in terms of network capability, workstations, camera interfaces and patient database. #### 7. Comparison with Cleared Device The Keeler Kapture Software and the EveCap Imaging System predicate device have exactly the same Indications for Use, technological characteristics and performance specifications. #### 8. Summary of Non-clinical Tests A number of functional tests were carried out to verify the performance of the Keeler Kapture Software against the EyeCap Imaging System, a brief description of the tests is provided in the table below. All tests were passed. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image contains the word "Keeler" in a bold, sans-serif font. The letters are evenly spaced and the word is horizontally oriented. The text is black against a white background. ## Ophthalmic Instruments | Kapture function/Feature | Present in EyeCap | |-------------------------------------------------------------------------------------------------------------|-------------------| | Administration | Yes | | Allow log-in as administrator or user | Yes | | Add and manage users and their scope | Yes | | Add cameras and manage cameras | Yes | | Assign cameras to workstations | Yes | | Manage user configurable options | Yes | | Manage user definable fields | Yes | | Manage data entry formats | Yes | | Manage system settings and file locations | Yes | | Manage the database | Yes | | Track changes to the database in an audit trail | Yes | | Show statistical information about the system | Yes | | Patient Database | Yes | | Allow addition, deletion and editing of patient data | Yes | | Information and images collected from each patient<br>visit shall be stored separately | Yes | | Allow review of patient data and images | Yes | | Allow searching of the database | Yes | | Allow configuration of search reports | Yes | | Image Capture | Yes | | Image capture shall be available from within a patient<br>episode | Yes | | It shall be possible to capture images from a camera | Yes | | It shall be possible to adjust the brightness of images<br>captured from a camera | Yes | | It shall be possible to import an image from a file | Yes | | When and image is captured, an "X" is assigned to<br>indicate that there is no left or right eye assignment | Yes | | It shall be possible to manually assign "L" or "R" to an<br>image to indicate left or right eye | Yes | | Image Adjustment | | | It shall be possible to assign notes to an image | Yes | | It shall be possible to alter how images are printed | Yes | | It shall be possible to mosaic several images together | Yes | | It shall be possible to split image planes by colour | Yes | | It shall be possible to make annotations on the<br>captured image | Yes | | It shall be possible to present images together for<br>comparison | Yes | | Tools shall be provided to grade images | Yes | | An image brightness map, or histogram shall be<br>provided | Yes | | It shall be possible to undo any image manipulation | Yes | | It shall be possible to apply a time and date to<br>captured images | Yes | 510(k) Keeler Kapture Software . / {3}------------------------------------------------ # Keeler ## Ophthalmic Instruments {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Keeler Ophthalmic Instruments. The word "Keeler" is in a large, bold font at the top of the image. Below that, in a smaller font, are the words "Ophthalmic Instruments." #### 9. Conclusion In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this Premarket Notification, Keeler Limited conclude that the Keeler Kapture Software is substantially equivalent to the predicate device. {5}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Commi Center - WO66-G60 Silver Spring, MD 20993-0002 #### June 17, 2014 Keeler Ophthalmic Instruments. Inc. Mr. Eugene R. VanArsdale Marketing Manager 456 Parkway Broomall, PA 19008 Re: K140450 Trade/Device Name: Kecler Kapture Software (Versions: KAPTURE, KAPTURE Lite. KAPTURE Digital, KAPTURE View, and KAPTURE View+) Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: II Product Code: HKI Dated: May 8, 2014 . Received: May 9, 2014 Dear Mr. Arnsdale: 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. Please note: CDRH docs 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. {6}------------------------------------------------ ## Page 2 - Mr. Eugene R. VanArsdale 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, ## Kesia Y. Alexander -S for 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 {7}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. #### 510(k) Number (if known) K140450 #### Device Name Keeler Kapture Software Package (Versions: KAPTURE Lite, KAPTURE Digital, KAPTURE View, and KAPTURE View+) #### Indications for Use (Describe) The Keeler Kapture Software Package is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video 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) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure) Marsha L. Burke Nicholas -S Digitally signed by Marsha L. Burke Nicholas -S DN: c=US, o=U.S. Govemment, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300014022, cn=Marsha L. Burke Nicholas Date: 2014.06.11 20:33:36 -04'00' This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (1/14)