(232 days)
Not Found
Not Found
No
There is no mention of AI, ML, or related concepts in the provided 510(k) summary.
No
The intended use, "Specular Observation of the tear film," describes a diagnostic or observational function, not a therapeutic intervention.
Yes
The intended use of "Specular Observation of the tear film" suggests the device is used to observe and analyze a physiological condition (tear film), which falls under the definition of a diagnostic device. A diagnostic device is used to detect, diagnose, treat, or prevent disease or other conditions. In this case, observing the tear film can be part of diagnosing ocular surface diseases or conditions.
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device description. Without knowing the device's components and how it achieves its intended use, it's impossible to determine if it's software-only.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Specular Observation of the tear film." This describes a method of observing a biological sample (tear film) in situ on the patient's eye, not a test performed in vitro (outside the body) on a sample.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing a biological sample (other than observation).
- Using reagents or other substances to perform a test.
- Providing diagnostic information based on the analysis of a sample.
- Any of the typical components or processes associated with IVD devices (e.g., sample collection, assay methods, analytical measurements).
In summary, the intended use points towards a device used for direct observation of a biological structure on the patient, which is not the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Specular Observation of the tear film
Product codes
86 HJO
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
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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
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Key Metrics
Not Found
Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 7 1998
Mr. Eugene R. Van Arsdale Marketing Manager Keeler Instruments, Inc. 456 Parkway Broomall, PA 19008
Re: K973064
Trade Name: KEELER TEARSCOPE-PLUS Regulatory Class: II Product Code: 86 HJO Dated: February 11, 1998 Received: February 17, 1998
Dear Mr. Arsdale:
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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.
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Page 2 - Mr. Eugene R. Van Arsdale
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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if Known): K973064
Device Name: Keeler Tearscope-Plus
Indications For Use: Specular Observation of the tear film
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use - تا
OR
Over-The-Counter USE__________________________________________________________________________________________________________________________________________________________
AD me to Been
hthalmic 510(k) Number
(Optional Format 1-2-96)