(61 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, deep learning, or any related concepts, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is used to test the visual field, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The intended use of the Kasha Visual Field System is to "test the visual field of the human eye," which implies gathering information about the eye's function to identify potential issues or diagnose conditions.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the Kasha Visual Field System is software-only or includes hardware components.
Based on the provided information, it is highly unlikely that the Kasha Visual Field System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "test the visual field of the human eye." This describes a test performed on the patient (in vivo), not a test performed on a sample taken from the patient (in vitro).
- Anatomical Site: The anatomical site is the "human eye," which is a part of the living body. IVD tests are performed on samples like blood, urine, tissue, etc., which are taken from the body.
- Lack of IVD Indicators: The description lacks any mention of:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information about a patient's health status based on analysis of biological samples.
In summary, the Kasha Visual Field System appears to be a diagnostic device that interacts directly with the patient's eye to assess its function, which is characteristic of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Kasha Visual Field System should be used to test the visual field of the human eye.
Product codes
86 HPT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human eye
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.1605 Perimeter.
(a)
Identification. A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
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Image /page/0/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & H. SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 28 1997
Mr. John R. Kasha President Kasha Software, Inc. 1700 Interface Lane #208 Charlotte, NC 28262
Re: K971156 Trade Name: Kasha Visual Field System Regulatory Class: I Product Code: 86 HPT Dated: May 6, 1997 Received: May 12, 1997
Dear Mr. Kasha:
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 your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. John R. Kasha
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 at (301) 443-6597.
Sincerely yours,
Alayl Rriittand
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
of Page_
大971156 510(k) Number (if known):_ Visual Fish ashle Device Name:
Indications For Use:
510(k) Number: K971156 Kasha Visual Field System Device Name:
The Kasha Visual Field System should be used to test the visual field of the human eye.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ah Williams
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K971156
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
$\qquad 4K=32$