(288 days)
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Not Found
No
The description explicitly states it is a "manual device" and there are no mentions of AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices.
No.
The device is described as a "manual device intended to measure intraocular pressure," indicating a diagnostic rather than therapeutic function.
Yes
The device is described as "A manual device intended to measure intraocular pressure," and measuring something like intraocular pressure (IOP) is a diagnostic function to assess a patient's health status related to conditions like glaucoma.
No
The description explicitly states it is a "manual device" that involves "applying a small flat disk to the cornea," which clearly indicates a physical, hardware-based device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device measures intraocular pressure by directly interacting with the cornea (applying a small flat disk). It does not analyze a sample taken from the body.
- Intended Use: The intended use is to measure a physical parameter (intraocular pressure) directly on the patient, not to analyze a biological sample for diagnostic information.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea).
Product codes
86 HKY
Device Description
Tonometer, Manual A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea).
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
cornea
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles or figures connected by flowing lines, possibly representing interconnectedness or support.
Public Health Service
JUN - 6 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CSO c/o R. Brent Miner 197 Belvoir Road Williamsville, NY 14221
Re: K992835 Trade Name: C.S.O. Tonometer Regulatory Class: II Regulation: 886.1930 Product Code: 86 HKY Dated: March 23, 2000 Received: March 23, 2000
Dear Mr. Miner:
We have reviewed your Section 510(k) notification of intent to market the device referenced w surve 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, I son - 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. R. Brent Miner
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) 594-6413. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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510 (K) NUNGER (IF KNOWN) : K992835 DEVICE NAME: Tonometer, Manual INOICATIONS FOR USE: C.S.O. Tonometer
A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea).
(PLEASE DO HOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER IF NEEDBO.)
Concurrence of CORH, Office of Device Evaluation TOD
Prescription Use
(Per 21 CFR 801.109)
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Haska K. Burke Victoria
Division Sign-Off) Division of Ophthalmic Device 10(k) Number .