(38 days)
Not Found
No
The summary describes a digital ophthalmoscope for image capture and storage, with no mention of AI, ML, or image processing capabilities beyond basic capture and transfer.
No.
The device is used to capture digital images and video of the fundus of the human eye and surrounding area for diagnostic purposes, not to treat a condition.
No.
The device is a digital ophthalmoscope intended to capture images and video of the fundus, but the provided information does not mention that it analyzes or interprets these images to provide a diagnosis. Its function is limited to image capture.
No
The device description explicitly states it is a "hand-held digital ophthalmoscope" with hardware components like an LED light source, CMOS sensor, Flash memory card, USB connection, and rechargeable batteries. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "capture digital images and video of the fundus of the human eye and surrounding area." This describes a device used for imaging and visualization of a part of the human body.
- Device Description: The description reinforces this by detailing how it captures images and video using a camera and light sources.
- Lack of IVD Characteristics: IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. This device does not interact with or analyze biological samples.
Therefore, the Optomed Smartscope M5 camera with optics modules EY3 and ES1 is a medical device used for ophthalmic imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Optomed Smartscope M5 camera with optics modules EY3 and ES1 is a digital ophthalmoscope intended to capture digital images and video of the fundus of the human eye and surrounding area.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
Optomed Smartscope M5 is a hand-held digital ophthalmoscope that together with the optics modules EY3 and ES1 is used to capture digital images and video of fundus and surrounding area of the human eye. M5 EY3 has an LED light source with visible white light and infrared light. M5 ES1 has an LED light source with white light and cobalt blue light. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable batteries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fundus of the human eye and surrounding area, surface of the eye and surrounding areas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained personnel within medical or school environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Technical Information was gathered by side-by-side comparison and labeling of the devices. Optomed Smartscope M5 with optics modules EY3 and its predicates were also evaluated by Optomed development team and practicing physicians throughout the product development. Outcome of the evaluation is that ease-of-use and effectiveness of the Optomed Smartscope M5 with optics modules EY3 and ES1 is equivalent or better as its predicates.
Following laboratory bench tests demonstrate Optical radiation safety of the Optomed Smartscope M5 with EY3 and ES1:
-
- Optical radiation hazards as defined by standard ISO 15004-2, Ophthalmic instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection. First edition 2007-02-15.
- Maximum photometric luminance 2.
- the optical radiation hazards as defined by ISO 15004 for: 3. (i) ultraviolet and infrared radiation, and (ii) visible light and near IR radiation (blue-light weighted radiance and aphakic weighted radiance).
The maximum exposure has been demonstrated to be well below the accepted threshold limits for Group 1 devices set out in ISO 15004-2:2007 (see Attachment in Section 9 of the submittal). This is the basis for substantial equivalence related to safety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the word "OPTOMED" in bold, black letters. The "O" in the middle is replaced with an eye symbol, which is a circle with a smaller circle inside and a dot in the center. The text is slightly distressed, giving it a textured appearance.
$\sin(1): \leftarrow 110486$
MAY 1 6 2011
5 510(K) SUMMARY
| Date: | February 25, 2011 |
|---|---|
| 510(k) owner's name: | Optomed Oy |
| Address: | Hallituskatu 13-17 D 96, 90100 Oulu, Finland |
| Contact person: | Laura Piila, Quality Manager |
| Company phone: | +358 20 741 3380 |
| Fax number: | +358 42 588 1187 |
| Device name: | Trade name: Optomed Smartscope M5 EY3, Optomed Smartscope M5 ES1 |
| Common/usual name: Digital Ophthalmoscope, Exterior ocular photography module | |
| Classification name: camera, ophthalmic, ac-powered (21 CFR 886.1120, Product code: HKI) | |
| Predicate devices: | 1. Optomed Smartscope M3-1 EY1 digital ophthalmoscope (510(k) number: K092056, Product code: HKI) |
- WELCH ALLYN 11810 OPTHALMOSCOPE (510(k) number: K003376, Product code: HLI)
- KOWA GENESIS-D hand-held retinal camera (510(k) number: K080681. Product code: HKI) |
Device description, Intended use & Effectiveness:
Indications for use: Optomed Smartscope M5 camera with optics modules EY3 and ES1 is a digital ophthalmoscope intended to capture digital images and video of the fundus of the human eye and surrounding area.
Optomed Smartscope M5 is a hand-held digital ophthalmoscope that together with the optics modules EY3 and ES1 is used to capture digital images and video of fundus and surrounding area of the human eye. M5 EY3 has an LED light source with visible white light and infrared light. M5 ES1 has an LED light source with white light and cobalt blue light. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable batteries. Table 5-1 below includes a summary of the technical information used in the substantial equivalence discussion.
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Table 5-1. Summary of the technical information used in the substantial equivalence discussion. WELCH ALLYN KOWA GENESIS-Point of Optomed Optomed Smartscope M3-D 11800 Smartscope M5 comparison OPTHALMOSCOPE 1 EY1 with EY3 and ES1 to be used to Optomed to capture digital to capture and Indications of examine the images and video save fundus Smartscope M5 use cornea, aqueous, camera with optics of fundus of the images with modules EY3 and human eye. mydriatic lens, vitreous, and retina of the eye. It ES1 is a digital has the same ophthalmoscope operating principles intended to capture and intended use as digital images and many competitive video of the fundus ophthalmoscopes of the human eye already in and surrounding commercial area. distribution. Prescription use. Prescription use Prescription use Prescription use Usage Trained personnel within medical or school environment. With mydriatic. With or without Intended to use With or without Use condition mydriatic. mydriatic. without mydriatic but can be used also with mydriatic Visible LED Halogen HPX lamp, Visible and infrared Visible LED Observation 4 VA (approx. 1 visible light light source LED. EY3 LEDs: W) White: LWW5SM-KY-QK. NIR: SFH4232 (bin DA) ES1 LEDs: White : Osram Advanced Power Topled LW G6SP-EAFA-JKQL-1 Blue : Osram Advanced Power Topled LB G6SP-V2BB-35-1 Visual observation Observation 2.4" active matrix 2.5" active Visual matrix color TFT observation and display color TFT LCD LCD system Visible and infrared Visible LED Xenon flash Photographin lamp LED g light source
2
Image /page/2/Picture/0 description: The image shows the word "OPTOMED" in all caps. The "O" in "OPTOMED" is replaced with an image of an eye. The text is in a bold, sans-serif font.
The first of the state of the state of the state of the first and
| Camera
specification | Color CMOS
camera maximum
resolution 5Mp.
ES1 uses maximum
resolution. EY3 uses
2,76 Mp. | Color CMOS
camera 6,6Mp.
EY1 uses 0,8Mp. | Color CCD
camera
2,000,000 pixels | | |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--|
| Dioptre
compensation
(patient) | at least -20 D to
+20 D | at least - 20 D to
- 20 D | -15 D ~ +35 D | -20 D to + 20 D | |
| Apertures | | | Multiple | Multiple | |
| Picture angle | Over 40 degrees | At least 25
degree | Horizontal 30
degree
Vertical 25
degree | 25 degree | |
| Storage
media | Flash memory card | Flash memory
card | Flash memory
card | - | |
| Image data
format | JPEG, MPEG-1,
MPEG-4 | JPEG, MPEG-4 | JPEG and
uncompressed
format | - | |
| Weight | Camera: 400g,
EY3: 180G, ES1: 80g | Whole system:
0,6 kg | Camera unit: 1
kg | Ophthalmoscope
with handle 0,35 kg | |
| Power
consumption | Re-chargeable Ni-
MH Battery 4.8V;
Charging unit 44 VA | Re-chargeable
Ni-MH Battery
4.8V; Charging
unit 44 VA | 60 VA | Re-chargeable
battery handle 3.5
V | |
| Output
terminals and
data
collection | USB (1.1) terminal
(B-connector).
Compatible with
Windows®
XP/VISTA/7. | USB (1.1)
terminal (B-
connector).
Compatible with
Windows®
XP/VISTA. | USB (1.1)
terminal (B-
connector).
Compatible with
Windows®
ME/2000/XP.
Foot switch
connection
cable terminal. | - | |
| Exposure
parameters | Class 1 LED
according to IEC
60825-1:2001
Group 1 instrument
according to ISO
15004-2:2007 | Class 1 LED
according to IEC
60825-1:2001
Group 1
instrument
according to ISO
15004-2:2007 | LED is classified
according to IEC
60825-
1:1993+A1+A2 | | |
| Maximum
temperature
of parts | Look at discussion | | | | |
| Flammability
of materials | Look at discussion | | | | |
| Brightness
controls | Look at discussion | | | | |
3
Image /page/3/Picture/0 description: The image shows the word "OPTOMED" in all caps. The "O" in "OPTOMED" is replaced with an image of an eye. The text is in black and the background is white.
| Standards | |||
|---|---|---|---|
| IEC 60601- | |||
| 1:1988+A1+A2 | |||
| IEC 60601-1- | |||
| 2:2001+A1 IEC | |||
| 60601-1-4:2000 | |||
| EN (IEC) 60825- | |||
| 1:2001 | |||
| +A1:2002+A2:200 | |||
| 1 | |||
| ISO 15004-2:2007 | IEC 60601- | ||
| 1:1988+A1+A2 | |||
| IEC 60601-1- | |||
| 2:2001+A1 IEC | |||
| 60601-1-4:2000 | |||
| EN (IEC) 60825- | |||
| 1:2001 | |||
| +A1:2002+A2:2001 | |||
| ISO 15004-2:2007 | 60601- | ||
| 1:1988+A1+A2 | |||
| IEC 60825- | |||
| 1:1993+A1+A2 | EN60601-1 | ||
| IEC 60601-1-2 | |||
| CAN/CSA-C22.2 No. | |||
| 601.1-M90 | |||
| UL 2601-1, Second | |||
| Edition, 1997 | |||
| Method of operation | Look at discussion | ||
| Image quality discussion | Look at discussion |
Technical Information was gathered by side-by-side comparison and labeling of the devices. Optomed Smartscope M5 with optics modules EY3 and its predicates were also evaluated by Optomed development team and practicing physicians throughout the product development. Outcome of the evaluation is that ease-of-use and effectiveness of the Optomed Smartscope M5 with optics modules EY3 and ES1 is equivalent or better as its predicates.
Following laboratory bench tests demonstrate Optical radiation safety of the Optomed Smartscope M5 with EY3 and ES1:
-
- Optical radiation hazards as defined by standard ISO 15004-2, Ophthalmic instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection. First edition 2007-02-15.
- Maximum photometric luminance 2.
- the optical radiation hazards as defined by ISO 15004 for: 3. (i) ultraviolet and infrared radiation, and (ii) visible light and near IR radiation (blue-light weighted radiance and aphakic weighted radiance).
The maximum exposure has been demonstrated to be well below the accepted threshold limits for Group 1 devices set out in ISO 15004-2:2007 (see Attachment in Section 9 of the submittal). This is the basis for substantial equivalence related to safety.
The following comparisons of features between subject device and predicate devices provides basis for substantial equivalence related to effectiveness.
Optomed Smartscope M3-1 camera is a predecessor of Smartscope M5 camera, and EY1 eye optics is a predecessor of EY3 eve optics. The improvements in M5 camera with EY3 optics compared to M3-1 camera with EY1 optics are:
- Infrared light for image targeting and capturing .
- Autofocus functionality with 3 different shooting modes .
- Improved image quality due to
- New sensor with lower noise ਂ
- Improved image quality due to
4
- Image pixel resolution is increased O
- Optics efficiency is increased resulting in lower integration time. With lower o integration time it is easier to achieve images with less motion blur.
- No visible back reflection in retinal images
When Optomed Smartscope M5 with EY3 and ES1 optics modules is compared to the Kowa Genesis-D, it can be seen that both devices have similar indications for use, and multiple similar technological features. Similar features are:
- Digital image capture method using image sensor. Kowa Genesis-D has a CCD sensor . and Optomed Smartscope M5 has a CMOS sensor. Both types of sensors accomplish a same task of capturing light and converting it into electrical signals.
- Both devices store images to a flash memory card and have connectivity towards PC . using an USB 1.1 interface.
- Both devices have connectivity to the Microsoft Windows® XP. In addition, Optomed . Smartscope has connectivity to the Microsoft Vista® and Windows 7®. Kowa Genesis-D connects also to the Windows ME and Windows 2000. Optomed believes that lack of connectivity to the Windows ME and 2000 does not raise considerations related to the safety and effectiveness when Smartscope is compared to the Genesis-D. Reasoning for this is that both Windows ME and 2000 have mostly been superseded by newer Microsoft operating systems and Smartscope's manuals clearly identify the supported operating systems.
- Both devices have a LED for illumination. In addition, Kowa Genesis has a Xenon flash . lamp for photographic illumination.
- Devices have similar method of operation from a user's point of view. Both devices have . a graphical user interface and keypad that is used for making adjustments before and during examination and fundus image capture. One obvious difference between devices is that Smartscope does not have a direct visual observation that Genesis-D has. Optomed believes that this technological difference does not raise concerns related to the device safety and effectiveness because from the user's point of view, it does not make a difference, whether target area is studied directly, or from a color TFT display that displays a live image.
- Both Smartscope M5 with EY3 optics module and Kowa Genesis-D store images in a . JPEG format. In addition to this, Genesis-D stores uncompressed RAW files and Smartscope stores MPEG-4 videos.
- Smartscope M5 with ES1 optics module is intented for taking images and video of the . surface of the eye and surrounding areas while Kowa Genesis-D does not have suitable functionality for examining these parts of the eye.
When Optomed Smartscope M5 with EY3 and ES1 optics modules is compared to the Welch Allyn series 118 Ophthalmoscope, it can be seen that both devices have similar indications for use, and multiple similar technological features. Similar features are:
- Optical Equivalency and Radiation Safety measurements indicate that Optomed . Smartscope M5 with EY3 and ES1 is at least safe as Welch Allyn series 118 Ophthalmoscope although these devices have different illumination sources. Smartscope has a LED illumination and Welch Allyn Series 118 Ophthalmoscope has a halogen lamp.
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Image /page/5/Picture/0 description: The image shows the word "OPTOMED" in all caps. The "O" in the middle is replaced with an image of an eye. The text is in a bold, sans-serif font and is black.
- Both devices can be used without mydriatic and field of views are similar. �
- Both devices are battery powered and batteries are re-chargeable. .
- Viewing path and materials used are somewhat similar in both of the devices. Optomed . Smartscope M5 with EY3 does not have apertures or different illumination spot sizes as PanOptic 11810 does have. The advantage of the digital imaging is that user of the device can later observe digital images on a computer screen and thus filters or different spot sizes are not needed in order to get best possible outlook of the details of the retina.
- Both devices have a mechanism for refractive error compensation for patient's eye. . Smartscope has autofocus functionality and it is also possible to adjust focus by hand using keypad of the device.
- . Both devices can be used for examining the exterior parts of the eye and both have a blue illumination source in addition to white light.
To conclude the comparisons above Optomed Smartscope M5 with EY3 and ES1:
- has easier usability than predicate device M3-1 EY1 with addition of IR aiming and . autofocus function
- t has better picture quality due to better pixel·resolution and no back reflection when compared to predicate device M3-1 EY1
- has improved user experience due to non-mydriatic imaging compared to predicate . device Kowa Genesis-D
- has better connectivity to newer operating systems than predicate device Kowa . Genesis-D
- increased user experience and ease of use compared to Welch Allyn PanOptic due to . autofocus functionality
Based on these comparisons the subject device is substantially equivalent to predicate devices regarding effectiveness.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Optomed OY c/o Mr. Jeffrey D. Rongero Senior Project Engineer, UL Health Sciences Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle, NC 27709
MAY 1 6 2011
Re: K110986
Trade/Device Name: Optomed Smartscope M5 EY3 and ES1 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: II Product Codes: HKI Dated: April 7, 2011 Received: April 8, 2011
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
7
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/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,
Debra Halls
Malvina B. Evdelman, M.D. Director Division of Ophthalmic. Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
4. INDICATIONS FOR USE
510(k) Number (if known): _ k | / 0 7 8 6
Device Name: Optomed Smartscope M5 with ophthalmoscopic module EY3 and exterior ophthalmic module ES1
Indications for Use: Optomed Smartscope M5 camera with optics modules EY3 and ES1 is a digital ophthalmoscope intended to capture digital images and video of the fundus of the human eye and surrounding area.
Use Prescription ਮ 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)
R
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number L110986
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