(239 days)
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.
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.
The Meditron Contact Lens Ophthalmodynamometer is intended 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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Repeatability | All results of the study were within acceptable tolerances. |
| Reproducibility | All results of the study were within acceptable tolerances. |
| Safety (Electrical) | Complies with EN 60601-1 / IEC 60601-1 |
| Safety (EMC) | Complies with EN 60601-1-2 / IEC 60601-1-2 |
| Risk Management | Rigorous application of a risk management program. |
| Substantial Equivalence | Found substantially equivalent to K051103. |
2. Sample Size and Data Provenance
The summary states that "Repeatability and reproducibility of the device was determined under simulated use conditions." However, it does not provide specific details on:
- Sample size used for the test set: No number of devices or measurements is specified.
- Data provenance: It's unclear if this was prospective or retrospective data, or if any specific geographical region was involved in the "simulated use conditions." Given the manufacturer is German (Meditron GmbH), it's reasonable to infer the testing might have occurred in Europe, but this is not explicitly stated.
3. Number of Experts and Qualifications for Ground Truth
- Number of experts: Not specified.
- Qualifications of those experts: Not specified.
- Role of experts: The ground truth for the "repeatability and reproducibility" study likely involved comparison to a reference standard or expected range for the force measurements. The summary states "All results of the study were within acceptable tolerances," implying a predetermined range for acceptable performance, but how these tolerances or the ground truth were established (e.g., by experts) is not detailed.
- The overall safety and effectiveness is tied to the expertise of the user, stating: "The user must be qualified in ophthalmic examination procedures, and must be familiar with all labeling and instructions for use associated with the device."
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The study description is very brief, simply stating that results were "within acceptable tolerances." This suggests a direct comparison to predefined benchmarks rather than an expert consensus/adjudication process for discrepancy resolution.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device's purpose is to measure applied force during an ophthalmic examination, not to interpret images or assist human readers in diagnosis in a way that would lend itself to an MRMC study comparing AI-assisted vs. unassisted human performance.
6. Standalone (Algorithm Only) Performance Study
The information provided implicitly describes standalone performance. The "repeatability and reproducibility" test assesses the device's inherent ability to consistently measure force under simulated conditions. There is no mention of human interaction or a "human-in-the-loop" component in this specific test. The device itself is designed to make a direct physical measurement.
7. Type of Ground Truth Used
The ground truth for the "repeatability and reproducibility" study seems to be based on predefined acceptable tolerances for force measurements. The exact method of establishing these tolerances (e.g., specific engineering specifications, clinical requirements, or comparison to an established reference dynamometer) is not detailed. It is not based on expert consensus, pathology, or outcomes data as these are not relevant to the performance metrics being evaluated (repeatability and reproducibility of force measurement).
8. Sample Size for the Training Set
No training set is mentioned. This device is a measurement instrument, not an AI/machine learning model that typically requires a training set. The "electronic sensors" and "calibration" implicit in such a device would be based on engineering principles and physical standards, not a data-driven training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set is mentioned or implied for this type of device.
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| 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.
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| 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.
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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.
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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
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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
§ 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.