(161 days)
The device is designed to detect and quantify the amount of aniseikonia of a patient. Aniseikonia is defined as a condition of binocular vision where there is a relative difference in the size and/or shape of the ocular image of the two eyes. If a significant amount of aniseikonia is detected in a patient, a new prescription (contact lenses and/or glasses) can be calculated to reduce the amount of aniseikonia.
This device is intended to assist in the detection and management of aniseikonia.
The device is based on an old technique called 'direct comparison eikonometry'. I.e. the two eyes are offered a different image and the subject needs to determine if there is a size imbalance between the two images. If there is an imbalance in size, the size 16 a one of the images is changed until the subject perceives the two images as equal in size. The extent in which one of the images needed to be changed in size is a measure for the amount of aniseikonia of the subject. In The Aniseikonia Inspector the separation between the two eyes is accomplished by holding a red and a green filter in front of the eyes. The images are created on a computer screen and they can be altered by using a computer periheral such as the keyboard.
The provided 510(k) summary does not contain information about acceptance criteria, device performance, study details, and related elements typically found in a clinical study report. The document describes the device, its intended use, and its substantial equivalence to a predicate device, but it lacks the specific data requested in the prompt.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, and performance metrics based solely on the provided text. The document is primarily a notification of intent to market and a confirmation of FDA's substantial equivalence determination, rather than a detailed report of a performance study.
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510(k) SUMMARY
Culemborg, October 28, 2001 DEC 1 9 2001
1. Submitter information
Gerard de Wit, Ph. D. Optical diagnostics Eikvaren 19 4102 XE Culemborg The Netherlands Tel. (+31) 345- 518116
2. Device name The Aniseikonia Inspector
3. Substantial equivalence
Substantial Cquirvationer aniseikonia.
4. Description of the device
The device is based on an old technique called 'direct comparison eikonometry'. I.e. the two eyes are offered a different image and the subject needs to determine if there is a size imbalance between the two images. If there is an imbalance in size, the size 16 a one of the images is changed until the subject perceives the two images as equal in size. The extent in which one of the images needed to be changed in size is a measure for the amount of aniseikonia of the subject.
In The Aniseikonia Inspector the separation between the two eyes is accomplished by holding a red and a green filter in front of the eyes. The images are created on a computer screen and they can be altered by using a computer periheral such as the keyboard.
5. Intended use
The device is designed to detect and quantify the amount of aniseikonia of a patient. Aniseikonia is defined as a condition of binocular vision where there is a relative difference in the size and/or shape of the ocular image of the two eyes. If a significant amount of aniseikonia is detected in a patient, a new prescription (contact lenses and/or glasses) can be calculated to reduce the amount of aniseikonia.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is composed of three lines that form the shape of the bird's head and wings. The text is in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2001
Optical Diagnostics, Inc. c/o Ms. Joyce De Wit Eikvaren 19 4102 XE Culemborg The Netherlands
Re: K013110
Trade/Device Name: The Aniseikonia Inspector Regulation Number: 21 CFR 886.1340 Regulation Name: Haploscope Regulatory Class: I Product Code: HJT Dated: October 31, 2001 Received: November 13, 2001
Dear Ms. De Wit:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave ro roved your betermined 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 conimores 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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Page 2 – Ms. Joyce De Wit
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with ation. The FDA finding of substantial equivalence of your device to a legally promaticated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of Compinatee alease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph Rosenthal
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
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Page 1 of 1
510(k) Number (if known): K013110
Device Name: The Aniseikonia Inspector
Indications For Use:
This device is intended to assist in the detection and management of aniseikonia.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quyntin Horng Scientific Reviewer
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K013110
(Optional Format 3-10-98)
§ 886.1340 Haploscope.
(a)
Identification. A haploscope is an AC-powered device that consists of two movable viewing tubes, each containing a slide carrier, a low-intensity light source for the illumination of the slides, and a high-intensity light source for creating afterimages. The device is intended to measure strabismus (eye muscle imbalance), to assess binocular vision (use of both eyes to see), and to treat suppression and amblyopia (dimness of vision without any apparent disease of the eye).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.