(420 days)
None
Not Found
No
The summary describes a simple tip cover for a tonometer and contains no mention of AI, ML, or any related concepts like image processing or performance studies typically associated with AI/ML devices.
No
The device is a tip cover for a tonometer, which is used for diagnosis, not for therapy or treatment.
No
The device itself (Tono-Film Tonometer Tip Cover) is an accessory for a diagnostic device (Tono-Pen Tonometer) and is not performing the diagnostic function of measuring intraocular pressure or diagnosing glaucoma.
No
The device description clearly states "Tonometer Tip Covers," which are physical components, not software. The intended use also describes a physical tonometer.
Based on the provided information, the Tono-Film Tonometer Tip Cover is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Tono-Film Tonometer Tip Cover is a physical cover used with a tonometer, which measures pressure in vivo (within the living eye). It does not analyze biological samples.
- The intended use is to cover a tonometer tip for measuring intraocular pressure. This is a direct measurement on the patient, not an analysis of a specimen.
- The device description is simply "Tonometer Tip Covers". This reinforces its role as an accessory for a medical device used for direct patient measurement.
Therefore, the Tono-Film Tonometer Tip Cover is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Tono-Film Tonometer Tip Cover is intended to be used in conjunction with the Tono-Pen Tonometer, which is intended to be used to measure intraocular pressure and used in the diagnosis of glaucoma.
Product codes
HKY
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
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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
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Key Metrics
Not Found
Predicate Device(s)
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Reference Device(s)
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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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2004
TRA & ACCESSORIES c/o Mr. Richard Mastroleo 449 West Allen Ave. Suite 107 San Dimas, CA 91773
Re: K033146
Trade/Device Name: Tono-Pen Tonometer Tip Cover Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKY Dated: October 12, 2004 Received: November 18, 2004
Dear Mr. Mastroleo:
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,
Afalgi korenthal
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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510(k) Submission TRA & ACCESSORIES Tonometer Tip Covers - Tonometer, Manual
Statement of Indications for Use
The Tono-Film Tonometer Tip Cover is intended to be used in conjunction with the Tono-Pen Tonometer, which is intended to be used to measure intraocular pressure and used in the diagnosis of glaucoma.
Prescription Use
(Per 21 CFR 801.109)
Everette K. Bean
(Division Sign-Off)
on of Ophthalmic Ear and Throat D
510(k) Number K033146