OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2

K132186 · Optomed OY · HKI · Dec 18, 2013 · Ophthalmic

Device Facts

• Record ID: K132186
• Device Name: OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
• Applicant: Optomed OY
• Product Code: HKI · Ophthalmic
• Decision Date: Dec 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye. Optomed Smartscope M5 with optics module ES2 is intended to capture images and video of the surface of the human eye and surrounding areas.

Device Story

Handheld digital ophthalmic camera system; consists of M5 handset, attachable optics modules (EY4 for fundus, ES2 for anterior segment), and charging/transfer cradle. EY4 module uses white/infrared LEDs and fixation target LEDs to capture retinal images. ES2 module uses white/cobalt blue LEDs for anterior imaging. Device utilizes 5MP CMOS sensor; stores images/video on flash memory card; transfers data to PC via USB. Operated by clinicians in clinical settings. Provides digital visualization of ocular structures to assist in ophthalmic examination and documentation. Benefits include portable, non-mydriatic-capable imaging for eye health assessment.

Clinical Evidence

Bench testing only. Evaluated optical radiation safety per ISO 15004-2:2007, including photometric luminance, UV/IR radiation, and blue-light weighted radiance. Device classified as Class 2 instrument per ISO 15004-2:2007. Performance verified through side-by-side comparison with predicate and evaluation by development team and practicing physicians.

Technological Characteristics

Handheld ophthalmic camera; 5MP CMOS sensor; 2.4" TFT LCD display. EY4 module: white/NIR LEDs, fixation target LEDs. ES2 module: white/cobalt blue LEDs, internal baffle/diffuser. Connectivity: USB 1.1. Power: 4.8V Ni-MH battery. Standards: IEC 60601-1 (3rd ed), IEC 60601-1-2, ISO 15004-2:2007, EN 62471:2008. Dioptre compensation: -20D to +20D.

Indications for Use

Indicated for capturing digital images and video of the human eye fundus (EY4 module) or the surface of the eye and surrounding areas (ES2 module). Intended for prescription use; can be used with or without mydriatic agents.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*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.

Predicate Devices

• Optomed Smartscope M5 with optics modules EY3 with ES1 (K110986)

Submission Summary (Full Text)

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13.12.2013 1/3

DEC 18 2013

K132186

#### 510(k) Su nmary

| Date: | December 13, 2013 | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) owner's name: | Optomed Oy | |
| Address: | Hallituskatu 13-17 D, 90100 Oulu, Finland | |
| Contact person: | Jyri Leskelä, Quality Manager | |
| Company phone: | [phone] | |
| Fax number: | [phone] | |
| Device name: | Trade name: Optomed Smartscope M5 digital camera with<br>Optomed Smartscope EY4 optics module and Optomed<br>Smartscope ES2 optics module<br>Common/usual name: Ophthalmic camera<br>Classification name: camera, ophthalmic; ac-powered (21 CFR<br>886.1120, Product code: HKI) | |
| Predicate device: | Optomed Smartscope M5 with optics modules EY3 with ES1<br>(510(k) number: K110986, Product code: HKI) | |
| Indications for Use: | Optomed Smartscope M5 digital camera with EY4 optics module is<br>intended to capture digital images and video of the fundus of the<br>human eye. Optomed Smartscope M5 with optics module ES2 is<br>intended to capture images and video of the surface of the human<br>eye and surrounding areas. | |
| Point of comparison | Optomed Smartscope M5 with EY4 and ES2 | Optomed Smartscope M5 with EY3 and ES1 |
| Indications for use | Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye. Optomed Smartscope M5 with optics module ES2 is intended to capture images and video of the surface of the human eye and surrounding areas. | Optomed Smartscope M5 camera with optics modules EY3 and ES1 is digital ophthalmoscope intended to capture digital images and video of the fundus of the human eye and surrounding area. |
| Usage | Prescription use | Prescription use |
| Use condition | Intended to use without mydriatic but can be used also with mydriatic | Intended to use without mydriatic but can be used also with mydriatic |
| Observation light source | Visible and infrared LED. EY4 LEDs:<br>White: OSRAM Oslon LUW-H9GP<br>NIR: OSRAM Oslon SFH-4715<br>Target LEDs: OSRAM LR QH9F<br>ES2 LEDs: White : Osram Advanced Power Topled LW G6SP-EAFA-JKQL-1<br>Blue : Osram Advanced Power Topled LB G6SP-V2BB-35-1 | Visible and infrared LED. EY3 LEDs:<br>White: LWW5SM-KY-QK.<br>NIR: SFH4232 (bin DA)<br>ES1 LEDS:: White : Osram Advanced Power Topled LW G6SP-EAFA-JKQL-<br>Blue : Osram Advanced Power Topled LB G6SP-V2BB-35-1 |
| Observation and display system | 2.4" active matrix color TFT LCD | 2.4" active matrix color TFT LCD |
| Photographing light source | Visible and infrared LED | Visible and infrared LED |
| Camera specification | Color CMOS camera maximum resolution 5Mp. ES2 uses maximum resolution. EY4 uses 1,77 Mp. | Color CMOS camera maximum resolution 5Mp. ES1 uses maximum resolution. EY3 uses 2,76 Mp. |
| Dioptre compensation (patient) | at least -20 D to +20 D | at least -20 D to +20 D |
| Picture angle | 40 degrees | Over 40 degrees |
| Storage media | Flash memory card | Flash memory card |
| Image data format | JPEG, MPEG-1, MPEG-4 | JPEG, MPEG-1, MPEG-4 |
| Weight | Camera: 400g, EY4: 300g, ES2: 92g | Camera: 400g, EY3: 180g, ES1: 80g |
| Power consumption | Re-chargeable Ni-MH Battery 4.8V;<br>Charging unit 44 VA | Re-chargeable Ni-MH Battery 4.8V;<br>Charging unit 44 VA |
| Output terminals and | USB (1.1) terminal (B-connector) | USB (1.1) terminal (B-connector) |

## Device description, Intended use & Effectiveness:

Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye.

The device set for retinal imaging consists of:

- Camera handset M5 .
- Attachable ophthalmic lens EY4 ●
- Eye cup for EY4 .
- Cradle for charging and image transfer
- Slit Lamp Adapter

Optomed Smartscope M5 with optics module ES2 is intended to capture images and the surface of the human eye and surrounding areas.

. :

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The device set for anterior ophthalmic imaging consists of

- Camera handset M5
- Attachable anterior ophthalmic lens ES2
- Cradle for charging and image transfer

Optomed O

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EY4 has an LED light source with visible white and infrared light. Also red light target LED's are used to eye position fixation during imaging. ES2 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 battery. Table 1 below includes a summary of the technical information used in the substantial equivalence comparison.

Optomed Oy,
Hallituskatu 1 90100 Oulu Finland 14

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| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Administration<br>Acres of can and<br>4<br>Acres Access characterial | Stanner<br><br> | 1<br>Achelond Arthul<br>****<br>1 | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------------------------|--|
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| Exposure parameters | "Exempt Group" (no risk) LED product<br>according to EN 62471:2008<br>Group 2 instrument according to ISO<br>15004-2:2007 | Class 1 LED according to IEC 60825-<br>1:2001<br>Group 1 instrument according to ISO<br>15004-2:2007 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Standards | IEC 60601-1:2005 (3rd edition)<br>IEC 60601-1-2:2007 (3rd edition)<br>EN 62471:2008<br>ISO 15004-2:2007 | IEC 60601-1:1988+A1+A2<br>IEC 60601-1-2:2001+A1 IEC 60601-1-<br>4:2000<br>EN (IEC) 60825-1:2001<br>+A1:2002+A2:2001<br>ISO 15004-2:2007 |

Technical Information was gathered by side-by-side comparison and labeling of the devices. Optomed Smartscope M5 with optics modules EY4 and ES2 and its predicate was also evaluated by Optomed development team and practicing physicians throughout the product development.

Following laboratory bench tests demonstrate Optical radiation safety of the Optomed Smartscope M5 with EY4 and ES2:

- 1. 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.
- 2. Maximum photometric luminance
- 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).

Optomed Smartscope M5 with optics modules EY4 and ES2 is classified as Class 2 instrument according to the international standard ISO 15004-2:2007.

Optomed Smartscope EY3 eye optics is a predecessor of EY4 eye optics The modifications in M5 camera with EY4 optics compared to M5 camera with EY3 optics are:

- Resolution is improved to meet the requirements of ISO10940 (Fundus camera standard) .
- Target LED's for eye position fixation during imaging
- 9 pcs of LEDs at different viewing angles o
- o Allows stabilizing the eye of the patient for a specific direction.

Optomed Smartscope ES1 eye optics is a predecessor of ES2 eye optics. The modifications in M5 camera with ES2 optics compared to M5 camera with ES1 optics are:

- Illumination concept is improved
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- New diffuser structure to improve image quality o
- Separate baffle is included in the illumination path to block excess reflections of o stray light from the sides of the module

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- to enhance image contrast : O
to allow shorter camera integration times to reduce n - O

Based on the comparison and supportive information, the subject device is subs equivalent to the predicate device.

Od.Oy
katu 13-17,D
Oulu
www.optomed.com

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Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized symbol with three abstract human figures connected in a circular shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is printed in a simple, sans-serif font to the right of the symbol.

Food and Drug Administration 10903 New Hampshire Avenu Document Control Center - WO66 Silver Spring, MD 20993-0002

December 18, 2013

Optomed Oy % Mr. Jyri Leskelä Quality Manager Hallituskatu 13-17 FI 90100, Oulu Finland

Re: K132186

Trade/Device Name: Optomed Smartscope M5 digital camera with Optomed Smartscope EY4 optics module and Optomed Smartscope ES2 optics module Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: November 4, 2013 Received: November 6, 2013

Dear Mr. Leskelä:

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

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Page 2 - Mr. Jyri Leskelä

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Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-204] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Kesia Y.Alexander -S

for Malvina B. Eydelman, M.D.

Director

Division of Ophthalmic, and Ear, Nose, Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

#### 510(k) Number (if known): K132186

Device Name: Optomed Smartscope M5 digital camera, Optomed Smartscope EY4 optics module, Optomed Smartscope ES2 optics module

#### Indications for Use:

.

Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye.

Optomed Smartscope M5 with optics module ES2 is intended to capture images and video of the surface of the human eye and surrounding areas.

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)

Andrew Yang -S
2013.12.15
21:44:49 -05'00'

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