(113 days)
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
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.
The provided text describes the Keeler Kapture Software, an ophthalmic imaging system, and its substantial equivalence to a predicate device. However, it does not contain the specific information required to answer all parts of your request. Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with quantitative metrics. Instead, it details a comparison of functional features between the Keeler Kapture Software and the predicate device, EyeCap Imaging System. The acceptance criterion implicitly seems to be functional equivalence to the predicate device.
| Kapture function/Feature | Acceptance Criterion (Presence in EyeCap) | Reported Device Performance (Kapture) |
|---|---|---|
| Administration | Yes | Yes (Implied: All tests passed) |
| Allow log-in as administrator or user | Yes | Yes (Implied: All tests passed) |
| Add and manage users and their scope | Yes | Yes (Implied: All tests passed) |
| Add cameras and manage cameras | Yes | Yes (Implied: All tests passed) |
| Assign cameras to workstations | Yes | Yes (Implied: All tests passed) |
| Manage user configurable options | Yes | Yes (Implied: All tests passed) |
| Manage user definable fields | Yes | Yes (Implied: All tests passed) |
| Manage data entry formats | Yes | Yes (Implied: All tests passed) |
| Manage system settings and file locations | Yes | Yes (Implied: All tests passed) |
| Manage the database | Yes | Yes (Implied: All tests passed) |
| Track changes to the database in an audit trail | Yes | Yes (Implied: All tests passed) |
| Show statistical information about the system | Yes | Yes (Implied: All tests passed) |
| Patient Database | Yes | Yes (Implied: All tests passed) |
| Allow addition, deletion and editing of patient data | Yes | Yes (Implied: All tests passed) |
| Information and images collected from each patient visit shall be stored separately | Yes | Yes (Implied: All tests passed) |
| Allow review of patient data and images | Yes | Yes (Implied: All tests passed) |
| Allow searching of the database | Yes | Yes (Implied: All tests passed) |
| Allow configuration of search reports | Yes | Yes (Implied: All tests passed) |
| Image Capture | Yes | Yes (Implied: All tests passed) |
| Image capture shall be available from within a patient episode | Yes | Yes (Implied: All tests passed) |
| It shall be possible to capture images from a camera | Yes | Yes (Implied: All tests passed) |
| It shall be possible to adjust the brightness of images captured from a camera | Yes | Yes (Implied: All tests passed) |
| It shall be possible to import an image from a file | Yes | Yes (Implied: All tests passed) |
| When an image is captured, an "X" is assigned to indicate that there is no left or right eye assignment | Yes | Yes (Implied: All tests passed) |
| It shall be possible to manually assign "L" or "R" to an image to indicate left or right eye | Yes | Yes (Implied: All tests passed) |
| Image Adjustment | Yes (Notes to image) | Yes (Implied: All tests passed) |
| It shall be possible to alter how images are printed | Yes | Yes (Implied: All tests passed) |
| It shall be possible to mosaic several images together | Yes | Yes (Implied: All tests passed) |
| It shall be possible to split image planes by colour | Yes | Yes (Implied: All tests passed) |
| It shall be possible to make annotations on the captured image | Yes | Yes (Implied: All tests passed) |
| It shall be possible to present images together for comparison | Yes | Yes (Implied: All tests passed) |
| Tools shall be provided to grade images | Yes | Yes (Implied: All tests passed) |
| An image brightness map, or histogram shall be provided | Yes | Yes (Implied: All tests passed) |
| It shall be possible to undo any image manipulation | Yes | Yes (Implied: All tests passed) |
| It shall be possible to apply a time and date to captured images | Yes | Yes (Implied: All tests passed) |
2. Sample size used for the test set and the data provenance
The document states, "A number of functional tests were carried out to verify the performance of the Keeler Kapture Software against the EyeCap Imaging System." It does not specify a numerical sample size for a test set in terms of patients or images. The data provenance is not mentioned. The study appears to be a functional verification against a predicate device, not a clinical study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The testing described focuses on functional equivalence to the predicate device, not on establishing a clinical ground truth with expert consensus.
4. Adjudication method for the test set
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study is mentioned in the provided text. The Keeler Kapture Software is described as an ophthalmic imaging system for capturing, storing, and managing images, not an AI-powered diagnostic tool for interpretation or assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of the Keeler Kapture Software as described. It is a software package for managing images, not an algorithm performing a diagnostic task independently. Its performance is evaluated based on its functionality matching a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the functional behavior and features of the predicate device, the Clement Clarke International Ltd EyeCap Imaging System. The Keeler Kapture Software was tested to ensure its functions matched those of the EyeCap.
8. The sample size for the training set
This information is not provided. The Keeler Kapture Software is not an AI/ML model that would typically have a "training set" in the sense of supervised learning. It's application software.
9. How the ground truth for the training set was established
This is not applicable, as it's not an AI/ML model requiring a training set with established ground truth from data. Its ground truth for development and testing was likely the functional specifications derived from the predicate device.
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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,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.
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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.
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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 patientvisit 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 patientepisode | Yes |
| It shall be possible to capture images from a camera | Yes |
| It shall be possible to adjust the brightness of imagescaptured 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 toindicate that there is no left or right eye assignment | Yes |
| It shall be possible to manually assign "L" or "R" to animage 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 thecaptured image | Yes |
| It shall be possible to present images together forcomparison | Yes |
| Tools shall be provided to grade images | Yes |
| An image brightness map, or histogram shall beprovided | Yes |
| It shall be possible to undo any image manipulation | Yes |
| It shall be possible to apply a time and date tocaptured images | Yes |
510(k) Keeler Kapture Software
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Keeler
Ophthalmic Instruments
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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.
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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.
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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
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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'
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FORM FDA 3881 (1/14)
§ 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.