(174 days)
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No
The description focuses on a manual applanation tonometer, a traditional method for measuring IOP, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
No.
The device is intended for the diagnosis of glaucoma by measuring intraocular pressure, not for treating or preventing a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The device is intended for use in the diagnosis of glaucoma."
No
The device description explicitly states it is a "manual tonometer" that measures IOP by "applying a known force" and using a "small measuring prism to the cornea," indicating a physical hardware component is involved in the measurement process.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description clearly states that this device measures intraocular pressure by applying a force to the global of the eye and the cornea. This is a direct measurement on the living body, not an examination of a specimen taken from the body.
- The intended use is for diagnosis of glaucoma. While diagnosis is a key aspect of IVD devices, the method of obtaining the diagnostic information is the crucial factor. This device obtains the information through a physical measurement on the eye itself.
Therefore, this device falls under the category of a medical device used for diagnosis, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is a manual tonometer intended to measure intraocular pressure (IOP) by applying a know force to the qlobal of the eye. The device measures the IOP by applanation (application of a small measuring prism to the cornea).The device is intended for use in the diagnosis of glaucoma.
Product codes
HKX
Device Description
The device is a manual tonometer intended to measure intraocular pressure (IOP) by applying a know force to the qlobal of the eye. The device measures the IOP by applanation (application of a small measuring prism 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
eye, cornea
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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three curved lines representing wings or streams.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2003
Optilasa S.L. c/o Jose Maria Bobes 338 Arturo Soria St. Madrid, Spain 28033
Re: K023676
Trade/Device Name: Applanation Tonometer Model OP1H and OP1S Regulation Number: 21 CFR 866.1930 Regulation Name: Tonometer and accessories Regulatory Class: Class II Product Code: HKX Dated: April 7, 2003 Received: April 7, 2003
Dear Mr. Bobes:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); 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.
1
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
A. Katzir Koremthal
A. Ralph Rosenthal, 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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Page 1 of 1
510(k) Number (if known): K023676
Device Name: Applanation tonometer
Indications For Use:
The device is a manual tonometer intended to measure intraocular pressure (IOP) by applying a know force to the qlobal of the eye. The device measures the IOP by applanation (application of a small measuring prism to the cornea).The device is intended for use in the diagnosis of glaucoma.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ﺴ ،
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K023676
(Optional Format 3-10-98)