← Product Code [HPT](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPT) · K971156 # KASHA VISUAL FIELD SYSTEM (K971156) _Kasha Software, Inc. · HPT · May 28, 1997 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPT/K971156 ## Device Facts - **Applicant:** Kasha Software, Inc. - **Product Code:** [HPT](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPT.md) - **Decision Date:** May 28, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.1605 - **Device Class:** Class 1 - **Review Panel:** Ophthalmic ## Indications for Use The Kasha Visual Field System should be used to test the visual field of the human eye. ## Device Story The Kasha Visual Field System is a diagnostic device used to test the visual field of the human eye. It is intended for prescription use by healthcare professionals in a clinical setting. The system functions by presenting visual stimuli to the patient and recording their responses to map the visual field. The output provides clinicians with data regarding the patient's visual field, which is used to assist in the diagnosis and monitoring of ocular conditions. The device benefits patients by enabling standardized assessment of visual function. ## Technological Characteristics Visual field testing system; intended for clinical use; prescription-only device. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 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, ![img-0.jpeg](img-0.jpeg) A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} Page 1 of 1 510(k) Number (if known): K971156 Device Name: Kasha Visual Field System Indications For Use: 510(k) Number: K971156 Device Name: Kasha Visual Field System 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) ![img-1.jpeg](img-1.jpeg) Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96) 4K: 32 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPT/K971156](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPT/K971156) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com