(86 days)
Optomed Smartscope M3-1 EY1 digital ophthalmoscope is intended to capture digital images and video of the cornea, aqueous, lens, vitreous and retina of the human eye.
Optomed Smartscope M3-1 EY1 is a hand-held digital ophthalmoscope used to capture digital images and video of the cornea, aqueous, lens, vitreous and retina of the human eye. M3-1 EY1 has a LED light source. Image data is stored on the Flash memory card using 6.6 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable batteries.
The provided text describes the Optomed Smartscope M3-1 EY1, a digital ophthalmoscope, and its substantial equivalence to predicate devices for regulatory approval (K092056). However, the document does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding a ground truth establishment process for image analysis.
The document primarily focuses on establishing substantial equivalence to predicate devices (WELCH ALLYN 11810 Ophthalmoscope and KOWA GENESIS-D hand-held retinal camera) based on:
- Intended Use: Similar capabilities for capturing images/video of eye structures.
- Technological Features: Similar image capture methods, data storage, illumination, user interfaces, etc.
- Non-clinical Performance Data: Optical Equivalency and Radiation Safety measurements described in FDA's Ophthalmoscope Guidance.
- Field of View Comparison: The Optomed device's field of view is stated to be similar to or larger than the predicate Welch Allyn PanOptic Series 118 ophthalmoscope.
Therefore, it is not possible to fill out the requested table and sections as the provided text does not contain the necessary information regarding acceptance criteria, a specific performance study with a test set, ground truth, or details about training sets, MRMC studies, or standalone performance.
The document is a 510(k) summary, which typically focuses on demonstrating equivalence rather than providing detailed clinical study results against specific performance metrics for a novel technology or AI-driven diagnostic device.
If this were a submission for an AI/ML-driven device, the information requested (acceptance criteria, performance metrics, ground truth, study design, etc.) would be crucial. However, for a digital ophthalmoscope seeking equivalence to existing devices, the focus is on safety and effectiveness through technological similarity and adherence to established guidance.
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K092056
510(K) SUMMARY 5
OCT -1 2009
| Date: | October 30, 2008 |
|---|---|
| 510(k) owner's name: | Optomed Oy |
| Address: | Hallituskatu 13-17 D 96, 90100 Oulu, Finland |
| Name of contact person: | Mr. Jeffrey Rongero, UL RTP OFFICE COORDINATOR |
| Phone: | 919 549 1922 |
| Device name: | Trade name: Optomed Smartscope M3-1 EY1Common/usual name: Digital OphthalmoscopeClassification name: camera, ophthalmic, ac-powered (21 CFR 886.1120, Product code: HKI) |
| Predicate devices: | 1. WELCH ALLYN 11810 OPTHALMOSCOPE (510(k) number: K003376Product code: HLI)2. KOWA GENESIS-D hand-held retinal camera (510(k) number: K080681, Product code: HKI) |
Device description, Intended use & Effectiveness:
Optomed Smartscope M3-1 EY1 is a hand-held digital ophthalmoscope used to capture digital images and video of the cornea, aqueous, lens, vitreous and retina of the human eye. M3-1 EY1 has a LED light source. Image data is stored on the Flash memory card using 6.6 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable batteries.
Optomed Smartscope M3-1 EY1 and Kowa Genesis-D have similar indications for use, similar method of operation, and similar technological features such as; image capture method, data storage using SD card, LED for illumination, graphical user interface, USB cable, and display. Optomed Smartscope M3-1 EY1 and Welch Allyn Series 118 Ophthalmoscope have a similar kind of intended use, similar kind of modular configuration, similar radiation safety measures and similar performance in fundus examination. Table below gives a summary about comparison of the Optomed Smartscope M3-1 EY1 and the predicate devices.
| Optomed Smartscope M3-1 EY1 | KOWA GENESIS-D | WELCH ALLYN 11800OPTHALMOSCOPE | |
|---|---|---|---|
| Intended use | to capture digital imagesand video of the cornea,aqueous, lens, vitreousand retina of the humaneye. | to capture and save fundusimages with mydriatic | to be used to examine thecornea, aqueous, lens,vitreous, and retina of theeye. It has the sameoperating principles andintended use as manycompetitiveophthalmoscopes alreadyin commercial distribution. |
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| Usage | Prescription use | Prescription use | Prescription use. Trainedpersonnel within medicalor school environment. |
|---|---|---|---|
| Use condition | With or without mydriatic. | With mydriatic. | With or without mydriatic. |
| Observationlight source | Visible LED | Visible LED | Halogen lamp (visible light) |
| Observation | 2.5" active matrix colorTFT LCD | Visual observation2.5" active matrix colorTFT LCD for capturedimage observation | Visual observation |
| Photographinglight source | Visible LED | Xenon flash lamp | |
| Dioptrecompensation | at least - 20 D to + 20 D | -15 D ~ +35 D | -20 D to + 20 D |
| Apertures | - | Multiple | Multiple |
| Picture angle | At least 25 degree | Horizontal 30 degreeVertical 25 degree | 25 degree |
| Storage media | Flash memory card | Flash memory card | - |
| Cameraspecification | Color CMOS camera6,600,000 pixels | Color CCD camera2,000,000 pixels | - |
| Imagedataformat | JPEG, MPEG-4 | JPEG and uncompressedformat | - |
| Weight | Camera unit: 0,5 kg | Camera unit: 1 kg | Ophthalmoscope withhandle 0,35 kg |
| Powerconsumption | Battery 4.8V; Charging unit44 VA | 60 VA | Battery handle 3.5 V |
| Outputterminals | USB (1.1) terminal (B-connector). Compatiblewith Windows® XP/VISTA. | USB (1.1) terminal (B-connector). Compatiblewith Windows®ME/2000/XP. Foot switchconnection cable terminal. | - |
| Standards | IEC 60601-1:1988+A1+A2IEC 60601-1-2:2001+A1IEC 60601-1-4:2000EN 60825-1:2001+A1:2002+A2:2001ISO 15004-2:2007 | 60601-1:1988+A1+A2IEC 60825-1:1993+A1+A2 | EN60601-1IEC 60601-1-2CAN/CSA-C22.2 No. 601.1-M90UL 2601-1, Second Edition,1997 |
General Equivalency comparison between Optomed Smartscope M3-1 EY1 and its predicates has been assessed by studying non-clinical performance data. Optical Equivalency and Radiation Safety measurements have been conducted as described in the FDA's Ophthalmoscope Guidance (Version 1.0, Issued on July 8, 1998) and Optomed Smartscope M3-1 EY1 has been found to be as safe as Welch Allyn Series 118 ophthalmoscope. In addition, a field of view comparison has been made and conclusion is, that field of view of the Optomed Smartscope M3-1 EY1 is similar or bigger than field of view of the Welch Allyn PanOptic Series 118 ophthalmoscope.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Optomed Ov c/o Jeff D. Rongero Reviewer, Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709-3995
OCT - 1 2009
Re: K092056
Trade/Device Name: Optomed Smartscope M3-1 EY 1 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: II Product Code: HKI Dated: September 16, 2009 Received: September 18, 2009
Dear Mr. Rongero:
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 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 (OS) 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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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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Kesia Alexander for
Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE
K092056 510(k) Number (if known):
Device Name: Optomed Smartscope M3-1 EY1
Indications for Use: Optomed Smartscope M3-1 EY1 digital ophthalmoscope is intended to capture digital images and video of the cornea, aqueous, lens, vitreous and retina of the human eye.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bruce Drum
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K092056
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§ 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.