(303 days)
The EyeQuick Digital Ophthalmoscope Camera is intended for use in capturing approximately eight degrees narrow angle field of view images of the eyelids, retina and the anterior segment of the eye.
The EyeQuick Digital Ophthalmoscope Camera is an ophthalmoscope with an integrated digital camera. The system includes an LCD viewfinder and can be used handheld without any cables. The Digital Ophthalmoscope has on board memory to store images which can be downloaded to a PC via a USB connection.
The provided text describes a 510(k) premarket notification for the EyeQuick Digital Ophthalmoscope Camera (K102412). However, it does not contain detailed information about specific acceptance criteria related to clinical performance or a comprehensive study proving the device meets those criteria, as typically requested for AI/ML-based medical devices.
Instead, the document focuses on:
- Substantial equivalence: Comparing the device to legally marketed predicate devices in terms of intended use, operating principle, and function.
- Compliance with general standards: Stating that the device has been tested and met requirements for ISO 10940, IEC 60601-1, IEC 60601-1-2, and EN55011, and that it meets requirements for safe radiation emission. These are primarily electrical safety, EMC, and ophthalmic instrument-specific safety standards, not typically clinical performance metrics like sensitivity or specificity.
- Intended Use: Defining the device's purpose, which is "capturing approximately eight degrees narrow angle field of view images of the eyelids, retina and the anterior segment of the eye."
Therefore, based on the provided text, I can only provide limited information directly addressing your request.
Here's a breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Compliance with ISO 10940 (Ophthalmic instruments - Fundus cameras) | "The EveQuick Digital Ophthalmoscope has been tested and has met all the necessary requirements for ISO 10940." |
| Compliance with IEC 60601-1 (Medical electrical equipment – General requirements for basic safety and essential performance) | "The EveQuick Digital Ophthalmoscope has been tested and has met all the necessary requirements for IEC 60601-1." |
| Compliance with IEC 60601-1-2 (Medical electrical equipment – Electromagnetic compatibility) | "The EveQuick Digital Ophthalmoscope has been tested and has met all the necessary requirements for IEC 60601-1-2." |
| Compliance with EN55011 (Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics – Limits and methods of measurement) | "The EveQuick Digital Ophthalmoscope has been tested and has met all the necessary requirements for EN55011." |
| Safe radiation emission | "The device meets the requirements for safe radiation emission." |
| Equivalence to identified predicate devices (K050271, K053425, K950461, K974735) | "The EyeQuick Digital Ophthalmoscope is substantially equivalent to the predicate devices with regard to intended use, operating principle and function." |
Note: The document does not report specific clinical performance metrics such as accuracy (sensitivity, specificity), image quality metrics, or diagnostic agreement rates that would typically be associated with clinical acceptance criteria for AI/ML devices or devices performing an interpretation function. This is a digital ophthalmoscope camera, which is a capture device, and its performance evaluation focuses on safety, electrical, and optical standards rather than diagnostic efficacy based on clinical studies.
Regarding a "study that proves the device meets the acceptance criteria":
The text states, "All testing deemed necessary including requirements set forth in device industry International Standards have been conducted to ensure that the EyeQuick Digital Ophthalmoscope Camera is safe and effective for its intended use..." This indicates that technical compliance testing (for standards like ISO, IEC, EN) was performed, rather than a clinical study with human subjects validating diagnostic performance. The 510(k) summary provided does not detail the methodology or results of these specific compliance tests beyond stating that the device "met all the necessary requirements."
The following information elements are NOT available in the provided text:
- 2. Sample sized used for the test set and the data provenance: Not applicable, as this was not a clinical performance study with a test set of data/patients. The "tests" mentioned are technical compliance tests.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a manual ophthalmoscope with an integrated camera, not an AI/ML diagnostic aid.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable. Equipment performance testing does not involve training sets in the AI/ML sense.
- 9. How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
510(k) Summary
EveOuick, LLC
1400 Common Drive
El Paso, TX 79936
JUN 2 3 2011
Submitter/Applicant Name: Address:
Date prepared:
Trade name:
Classification name:
Fax number: (915) 975-8262 Contact: Marc Ellman, M.D. June 14, 2011
Phone number: (915) 490-1766
EyeQuick Digital Ophthalmoscope Camera
Ophthalmic Camera, AC-Powered 21 CFR Part 886.1120 Class II
Substantial equivalence claimed to:
Kowa Genesis D (K050271) Precision Optics Corporation, Inc. Digital Ophthalmoscope (K053425) Welch Allyn 11720 Ophthalmoscope (K950461) Discam Digital Imaging System (K974535)
The EyeQuick Digital Ophthalmoscope is substantially equivalent to the predicate devices with regard to intended use, operating principle and function.
Description
The EyeQuick Digital Ophthalmoscope Camera is an ophthalmoscope with an integrated digital camera. The system includes an LCD viewfinder and can be used handheld without any cables. The Digital Ophthalmoscope has on board memory to store images which can be downloaded to a PC via a USB connection.
Intended Use
The EveOuick Digital Ophthalmoscope Camera is intended for use in capturing approximately eight degrees narrow angle field of view images of the eyelids, retina and the anterior segment of the eye.
Performance
The EveQuick Digital Ophthalmoscope has been tested and has met all the necessary requirements for ISO 10940, IEC 60601-1, IEC 60601-1-2, and EN55011. The device meets the requirements for safe radiation emission.
Conclusion
All testing deemed necessary including requirements set forth in device industry International Standards have been conducted to ensure that the EyeQuick Digital Ophthalmoscope Camera is safe and effective for its intended use, when used according to its instructions for use. Equivalence to identified predicate devices has been established.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
EveOuick. LLC c/o Marc Ellman, MD Manager 1400 Common Drive El Paso, TX 79936
JUN 23 2011
Re: K102412
Trade/Device Name: EyeQuick Digital Ophthalmoscope Model 1000 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera, AC-Powered Regulatory Class: Class II Product Code: HKI Dated: June 14, 2011 Received: June 20, 2011
Dear Dr. Ellman:
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.
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.
{2}------------------------------------------------
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/ucm115809.htm 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/2/Picture/5 description: The image contains a handwritten word "for" in cursive script. The letter 'f' has a descending loop that extends below the baseline, and the 'o' and 'r' are connected with a smooth, flowing line. The writing appears to be done with a pen or marker, and the overall style is elegant and fluid.
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
{3}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): K102412
Device Name: EyeQuick Digital Ophthalmoscope Camera
Indications for Use:
产
The EyeQuick Digital Ophthalmoscope Camera is intended for use in capturing approximately eight degrees narrow angle field of view images of the eyelids, retina and the anterior segment of the eye.
X Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________ or
(21 CFR 807 Subpart C) (21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Fesu
(Division Sign-OM) Division of Ophthalmic, Neurological and Ear, Nose and Threat Devices
510(k) Number K102412
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.