(94 days)
Not Found
Not Found
No
The device is a simple optical accessory for a manual tonometer and the summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and descriptions of training/test sets.
No
The device is described as an accessory to a tonometer, which is used to measure intraocular pressure. Measuring is a diagnostic function, not a therapeutic one. The device itself is an optical plastic piece that aids observation.
Yes
Explanation: The device is an accessory to a tonometer, which is a device used to measure intraocular pressure of the eye. Measuring intraocular pressure is a diagnostic step for conditions like glaucoma.
No
The device description clearly states it is a physical, optical plastic piece, not software.
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: The description clearly states the device is an accessory to a tonometer, which is a manual device used to measure intraocular pressure of the eye. This is a direct measurement on the living body, not a test performed on a sample taken from the body.
- Lack of IVD Keywords: The description does not mention any terms related to samples, testing of biological materials, or laboratory procedures, which are characteristic of IVDs.
Therefore, the Luneau tonometer separation prisms, as described, is a medical device used for direct measurement on a patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The tonometer separation prisms is an accessory to the tonometer which is a manual device used to measure the intraocular pressure of the eye.
Product codes
HKY
Device Description
The Luneau tonometer separation prisms is an optical plastic monobloc piece which is transparent made of 1 plane surface in contact with the eye and of 2 small prisms allowing the ophthalmologists to observe 2 half circles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmologists
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2003
LUNEAU S.A c/o Jean Noel Young B.P. 252 28005 Chartres Cedex France
Re: K023838
Trade/Device Name: Luneau tonometer separation prisms Regulation Number: 886.1930 Regulation Name: Manual tonometer Regulatory Class: II Product Code: HKY Dated: February 6, 2003 Received: February 10, 2003
Dear Mr. Young:
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. Iisting 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.
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Page 2 - Mr. Jean Noel Young
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 vours.
A halpi 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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Page Of 1
510 (k) NUMBER (IF KNOWN) : Not yet allocated.
Luneau tonometer separation prisms. DEVICE NAME:
INDICATIONS FOR USE:
Indications for use :
The tonometer separation prisms is an accessory to the tonometer which is a manual device used to measure the intraocular pressure of the eye.
Description of the device : .
The Luneau tonometer separation prisms is an optical plastic monobloc piece which is transparent made of 1 plane surface in contact with the eye and of 2 small prisms allowing the ophthalmologists to observe 2 half circles.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED: )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use "Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-
Dennis L. McCarthy
(Division Sign Off)
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K023838