(15 days)
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No
The summary describes a standard ophthalmoscope for illumination and viewing, with no mention of AI/ML, image processing, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an ophthalmoscope used for "illuminating and viewing parts of the eye" and to "diagnose the eye," which are diagnostic functions, not therapeutic ones.
Yes
The device is described as being used "to diagnose the eye," which indicates a diagnostic purpose.
No
The device description explicitly states it is a "head mounted Binocular Indirect ophthalmoscope," which is a physical hardware device used for illuminating and viewing parts of the eye. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests 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 that the AAIO-7 & AAIO Wireless is a Binocular Indirect Ophthalmoscope used for illuminating and viewing parts of the eye (Cornea, retina, fundus). It's a tool for direct observation of the eye's internal structures.
- No Sample Analysis: There is no mention of the device analyzing any samples taken from the patient. It's a visual examination tool.
Therefore, this device falls under the category of an ophthalmic examination device used for direct visualization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AAIO-7 & AAIO Wireless, is a head mounted Binocular Indirect ophthalmoscope designed to be Used by trained personnel for illuminating and viewing parts of the eye such as the Cornea and retina when used in conjunction with an ophthalmic lens.
Binocular Indirect Ophthalmoscope provides an illumination system to direct appropriately, focused light into the eye in order to obtain an intermediate image of the fundus (retina) that is viewed by the observer to diagnose the eye.
Product codes
HLI, HLJ
Device Description
AAIO-7 & AAIO Wireless, is a head mounted Binocular Indirect ophthalmoscope designed to be Used by trained personnel for illuminating and viewing parts of the eye such as the Cornea and retina when used in conjunction with an ophthalmic lens.
Binocular Indirect Ophthalmoscope provides an illumination system to direct appropriately, focused light into the eye in order to obtain an intermediate image of the fundus (retina) that is viewed by the observer to diagnose the eye.
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
Cornea and retina, eye, fundus (retina)
Indicated Patient Age Range
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Intended User / Care Setting
trained personnel
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads facing right, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Appasamy Associates c/o Marc M. Mouser Engineering Leader and FDA Office Coordinator Underwriters Laboratories. Inc. 2600 NW Lake Road Camas, Washington 98607-9526
FEB 9 2011
Re: K110205
Trade/Device Name: AA10-7. AA10 Wireless Regulation Number: 21 CFR 882.1570 Regulation Name: Opthalmoscope Regulatory Class: Class II Product Code: HLI and HLJ Dated: December 23, 2010 Received: January 25, 2011
Dear Mr. Mouser:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
and the same of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the s
1
Page 2 - Ms. Diana Hong
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.hyn for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
MAPPASAMY ASSOCIATES, Chennai, INDIA
| SECTION: 06 | |
|---|---|
| TITLE: INDICATION FOR USE | |
| ISSUE NO. | 02 |
| DATE | 20/06/2010 |
| PAGE | 6-1 |
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Binocular Indirect ophthalmoscope: AAIO-7 AAIO WIRELESS
Indications for Use:
AAIO-7 & AAIO Wireless, is a head mounted Binocular Indirect ophthalmoscope designed to be Used by trained personnel for illuminating and viewing parts of the eye such as the Cornea and retina when used in conjunction with an ophthalmic lens.
Binocular Indirect Ophthalmoscope provides an illumination system to direct appropriately, focused light into the eye in order to obtain an intermediate image of the fundus (retina) that is viewed by the observer to diagnose the eye.
Prescription Use (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)
Zas Rulm
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear Nose and Throat Devices .
510(k) Number K110205