(239 days)
Not Found
No
The device description focuses on electronic sensors and an LCD display for measuring and displaying pressure, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is described as an ophthalmodynamometer, which measures and displays the amount of force applied to the eye during an examination. Its purpose is for "examination of the ocular fundus, vitreous and retinal structures," not for treating a disease or condition. While it aids in diagnosis by providing measurement, it does not directly perform therapy.
No
The device measures and displays the amount of force applied to the eye during an examination, but it does not diagnose a medical condition based on that measurement or any other acquired data. Its purpose is to quantify the applied force during manual examination of ocular structures.
No
The device description explicitly states it is a "classic Goldmann three-mirror examination contact glass that has been adapted with precision electronic sensors" and has an "LCD display," indicating it includes physical hardware components beyond just 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 Meditron Contact Lens Ophthalmodynamometer is a device used for direct examination of the eye's internal structures (ocular fundus, vitreous, and retinal structures) and for measuring the force applied to the eye during this examination. It does not analyze samples taken from the body.
- Anatomical Site: The device is applied directly to the eye (globe or cornea), not used to process samples taken from the eye or other parts of the body.
Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics. It is a medical device used for direct examination and measurement on the patient's body.
N/A
Intended Use / Indications for Use
The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye.
Product codes
NYK
Device Description
The Meditron Contact Lens Ophthalmodynamometer is a classic Goldmann three-mirror examination contact glass that has been adapted with precision electronic sensors for continuous measurement of pressure applied to the eye. Electronic signals from the sensors are used to determine pressure values, which are then displayed on the device’s LCD display.
The patient contact portion of the examination glass consists of a curved shell of acrylic plastic (PMMA) that is applied for a short period of time directly on the globe or cornea of the eye. PMMA is commonly used as a material in examination contact glasses having the same intended purpose.
The mirror angles are the same as the original Goldmann and predicate devices: 59/66/73 degrees.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular fundus, vitreous and retinal structures, eye, globe or cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The user must be qualified in ophthalmic examination procedures, and must be familiar with all labeling and instructions for use associated with the device.
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
Repeatability and reproducibility of the device was determined under simulated use conditions. All results of the study were within acceptable tolerances.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.
0
| Meditron GmbH |
|---|
| Contact Lens Ophthalmodynamometer |
510(k) Number: __ K052674 May 19, 2006 Date: Date: Date: Page 1 of 2
510(k) Summary
Introduction
This summary is intended to comply with requirements of the SMDA and 21CFR§807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.
510(k) Applicant
Meditron GmbH Postrasse 19-21 D-66333 Voelklingen, Germany
510(k) Correspondent
Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors 13605 West 7th Ave., Golden, CO 80401 USA
Date Prepared
May 19, 2006
Trade Name of Device
Contact Lens Ophthalmodynamometer
Classification Name
Polymethylmethacrylate (PMMA) diagnostic contact lens
Classification
Regulation: 21CFR§886.1385 Product Code: NYK, Class II
Device Description
The Meditron Contact Lens Ophthalmodynamometer is a classic Goldmann three-mirror examination contact glass that has been adapted with precision electronic sensors for continuous measurement of pressure applied to the eye. Electronic signals from the sensors are used to determine pressure values, which are then displayed on the device's LCD display.
The patient contact portion of the examination glass consists of a curved shell of acrylic plastic (PMMA) that is applied for a short period of time directly on the globe or cornea of the eye. PMMA is commonly used as a material in examination contact glasses having the same intended purpose.
1
| Meditron GmbH | 510(k) Number: | K052674 |
|---|---|---|
| Contact Lens Ophthalmodynamometer | Date: | May 19, 2006 |
| Page 2 of 2 |
The mirror angles are the same as the original Goldmann and predicate devices: 59/66/73 degrees.
Intended Use
The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eve with the contact lens. The device measures and displays the amount of force that is applied to the eye.
Predicate Device
K051103 - Haag-Streit Contact Glasses manufactured by Haag-Streit USA Inc, Mason, Ohio.
Voluntary Standards
EN 60601-1 / IEC 60601-1. "Medical Electrical Equipment - Part 1: General Requirements for Safety"
EN 60601-1-2 / IEC 60601-1-2, "Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests"
ISO 13485:2003, "Medical devices - Quality management systems - Requirements for regulatory purposes"
ISO 14971, "Medical devices - Application of risk management to medical devices"
Laboratory Testing
Repeatability and reproducibility of the device was determined under simulated use conditions. All results of the study were within acceptable tolerances.
Risk Management
This device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program.
The user must be qualified in ophthalmic examination procedures, and must be familiar with all labeling and instructions for use associated with the device.
Meditron GmbH believes that the Contact Lens Ophthalmodynamometer is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2006
Meditron Gmbh c/o Mr. Robert N. Clark Medical Device Regulatory Advisors 13605 West 7th Avenue Golden, CO 80401
Re: K052674
Trade/Device Name: Contact Lens Ophthalmodynamometer Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) diagnostic contact lens Regulatory Class: II Product Code: NYK Dated: April 26, 2006 Received: April 28, 2006
Dear Mr. Clark:
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.
3
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) 827-8910. 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/industry/support/index.html.
Sincerely yours,
MBEychus-MD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Contact Lens Ophthalmodynamometer Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye.
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ming-Chun Shih
Division of Onhth
510(k) Number 052674