Optomed Aurora Camera is a medical digital camera that is used with dedicated optics modules intended to capture images and video of the fundus of the eye and surface of the eye.

Optomed Aurora Camera with Optomed Aurora Retinal Module is intended to capture digital images and video of the fundus of the human eye.

Optomed Aurora Camera with Optomed Aurora Anterior Module is intended to capture digital images and video of the surface of the human eye and surrounding areas.

Device Description

Optomed Aurora device set for ophthalmic imaging consists of Optomed Aurora Camera, Optomed Aurora Retinal Module and Optomed Aurora Anterior Module with following accessories Optomed Aurora Charging Station, USB cable, power supply, eye cups (2 pcs), batteries (2 pcs), USB flash drive and cleaning cloth.

Optomed Aurora Camera is designed for use in a medical environment. Captured images and video are used for documentation. Optomed Aurora Camera has a memory card where captured images and recorded videos are saved. Optomed Aurora Camera is used with interchangeable optics modules Optomed Aurora Retinal Module and Optomed Aurora Anterior Module. Optics modules are attached to the camera with bayonet connectors.

Optomed Aurora Retinal Module is designed for non-mydriatic fundus imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the fundus and white light is flashed when an image is taken. The pupil does not respond to the infrared light so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. Optomed Aurora Retinal Module has nine internal fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-centered image. The material of the eye cup is Momentive LIM 6030AB.

Optomed Aurora Anterior Module has two light sources for imaging eye surface and surrounding areas: white and cobalt blue light enables capturing of fluorescent images. There are four focus windows to focus the image. The material of the eye cup is Momentive Silopren LSR 4040.

Optomed Aurora Camera has a WLAN module inside and when WLAN is used, Optomed Aurora Camera transfers captured images and recorded videos to the PC automatically after imaging. Images and videos can also be transferred to PC from the memory card when the camera is placed on Optomed Aurora Charging Station and the USB cable is connected between Optomed Aurora Charging Station and the PC. The image data transfer method to PC is similar as with any other USB mass storage device.

Optomed Aurora Camera has a rechargeable Li-ion battery that is charged when the camera is placed on Optomed Aurora Charging Station, which is connected to the mains by power supply cable. Optomed Aurora Charging Station can also be used as an external battery charger for the spare battery included in sales case. When Optomed Aurora Camera is not used, it may be stored on Optomed Aurora Charging Station. Storing the device on Optomed Aurora Charging Station is not harmful for the battery.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Optomed Aurora Camera with Optomed Aurora Retinal Module and Optomed Aurora Anterior Module. It focuses on demonstrating substantial equivalence to a predicate device (Optomed Smartscope M5 with Smartscope EY4 and ES2 optics modules) through various performance tests, rather than providing a detailed study that establishes specific acceptance criteria and then proves the device meets those criteria for general effectiveness.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" related to diagnostic performance (e.g., accuracy, sensitivity, specificity) is not explicitly present in the provided document. The document focuses on demonstrating that the new device is as safe and effective as the predicate based on engineering and safety standards, as well as functional similarities.

However, I can extract information regarding general acceptance criteria for safety, performance, and functionality, as well as the studies/tests conducted to meet these.

Here's a breakdown of what can be extracted and what cannot:

Information that can be extracted:

Table of Acceptance Criteria and Reported Device Performance (interpreted from the document's structure): The document doesn't present a formal table with acceptance criteria versus reported performance in the way a diagnostic study would. Instead, it lists standards followed and states that the device "fulfills the requirements" or "complies with the standards."

Acceptance Criteria (based on standards)	Reported Device Performance
Electrical safety (IEC 60601-1:2012)	Fulfills the requirements of IEC 60601-1:2012 (safety).
Electromagnetic compatibility (EMC) (IEC 60601-1-2:2014)	Fulfills the requirements of IEC 60601-1-2:2014 (EMC).
Optical safety (IEC 62471:2006 for LEDs)	Optomed Aurora Retinal Module and Optomed Aurora Anterior Module are classified as "Exempt Group" (NO RISK) LED products.
Optical safety (ISO 15004-2:2007 for ophthalmic instruments)	Optomed Aurora Retinal Module and Optomed Aurora Anterior Module are classified as Group 2 ophthalmic instruments.
Software Verification and Validation (IEC 62304:2006+A1:2015)	Software level of concern is moderate. Software V&V conducted to ensure fulfillment of system requirements and functional specifications. Complies with IEC 62304:2006+A1:2015.
Environmental testing (ISO 15004-1:2006, IEC 60601-1, IEC 60068-2)	Tested to verify mechanical stress and ambient conditions for use and storage. Also tested for high temperature, low temperature, shock, vibration, and bump for transportation. Fulfills the requirements of these standards.
Biocompatibility (ISO 10993-5:2009 for eye cup materials)	In vitro cytotoxicity tests performed using ISO 10993-5:2009 for Momentive LIM 6030AB (Retinal Module eye cup) and Momentive Silopren LSR 4040 (Anterior Module eye cup). Biocompatibility is at a suitable level.
Optical performance (ISO 10940:2009 for Fundus cameras)	Aurora Camera with Aurora Retinal Module fulfills the requirements of ISO 10940:2009 Ophthalmic instruments - Fundus cameras.
Usability/Human Factors (IEC 60601-1-6:2010+A1:2013 and IEC 62366-1:2015)	Designed and evaluated following usability engineering principles. Usage evaluated to be suitable for intended use and complies with IEC 60601-1-6:2010+A1:2013 and IEC 62366-1:2015.
Substantial Equivalence (Overall)	Based on provided performance data and comparison, the device "is as safe, as effective and performs as well as or better than the predicate device. Optomed Aurora is substantially equivalent to the predicate device."

Information that cannot be extracted from the document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable to the types of engineering and safety tests performed. No patient image data test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not established as no diagnostic performance study is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 document does not describe an AI/CADe/CADx device or a clinical comparative effectiveness study involving human readers and AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-only device. It's an ophthalmic camera.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there is no diagnostic performance study. The "ground truth" for the engineering/safety performance criteria are the standards themselves (e.g., meeting the electrical safety parameters of IEC 60601-1).
The sample size for the training set: Not applicable, as there is no AI/machine learning component described that would require a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 5, 2018

Optomed Oy Jyri Leskela Quality Manager Yrttipellontie 1 Oulu. 90230 Fi

Re: K180378

Trade/Device Name: Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: January 31, 2018 Received: February 12, 2018

Dear Jyri Leskela:

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.

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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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Denise L. Hampton -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and 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)

K180378

Device Name Optomed Aurora Camera Optomed Aurora Retinal Module Optomed Aurora Anterior Module

Indications for Use (Describe)

Optomed Aurora Camera is a medical digital camera that is used with dedicated optics modules intended to capture images and video of the fundus of the eye and surface of the eye.

Optomed Aurora Camera with Optomed Aurora Retinal Module is intended to capture digital images and video of the fundus of the human eye.

Optomed Aurora Camera with Optomed Aurora Anterior Module is intended to capture digital images and video of the surface of the human eye and surrounding areas.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

510(k) submitter:	Optomed Oy
Address:	Yrttipellontie 1, FI-90230 Oulu, Finland
Company phone:	+358 20 741 3380
Contact person:	Mr. Jyri Leskelä, Quality Manager
Date:	April 4, 2018
Subject device:	Trade name: Optomed Aurora CameraOptomed Aurora Retinal ModuleOptomed Aurora Anterior Module
	510(k) number: K180378
	Common/usual name: Ophthalmic camera
	Classification name: camera, ophthalmic, ac-powered (21 CFR 886.1120)
	Regulatory Class: II
	Product Code: HKI
Predicate device:	Trade name: Optomed Smartscope M5 digital cameraOptomed Smartscope EY4 optics moduleOptomed Smartscope ES2 optics module
	510(k) number: K132186
	Regulatory Class: II
	Product code: HKI

Image /page/3/Picture/2 description: The image shows the word "OPTOMED" in blue. The "O" in "OPTOMED" is replaced with an eye symbol. The eye symbol is also blue and has a white pupil.

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Description of the Device

Image /page/4/Picture/7 description: The image shows the contact information for OPTOMED OY. The address is Yrttipellontie 1, 90230 Oulu, Finland. The phone number is +358 20 741 3380, the email address is info@optomed.com, and the website is www.optomed.com.

Image /page/4/Picture/8 description: The image shows the word "OPTOMED" in blue font. The "O" in "OPTOMED" is replaced with an eye symbol. The eye symbol is a blue circle with a white center and a blue dot in the middle.

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Indications for Use

Optomed Aurora Camera is a medical digital camera that is used with dedicated optics modules intended to capture images and video of the fundus of the eye and surface of the eye.

Optomed Aurora Camera with Optomed Aurora Retinal Module is intended to capture digital images and video of the fundus of the human eye.

Optomed Aurora Camera with Optomed Aurora Anterior Module is intended to capture digital images and video of the surface of the human eye and surrounding areas.

Optomed Aurora is classified as prescription device. Federal law restricts this device to sale by or on the order of a physician or licensed practitioner. The device may only be operated by persons who have been properly trained or who have the required knowledge and experience to do so. The device may only be used in accordance with its intended use.

The operating principle and the intended use of Optomed Aurora Camera with Optomed Aurora Retinal Module and Optomed Aurora Anterior Module are the same than Smartscope M5 camera with Smartscope EY4 optics module and Smartscope ES2 optics module. There are incremental changes in mechanics, software, hardware and optics. These changes do not affectiveness of the product.

Comparison of Technological Characteristics

Table 1 below includes a summary of the technical information used in the substantial equivalence discussion.

Point ofcomparison	Optomed Aurora CameraOptomed Aurora Retinal ModuleOptomed Aurora Anterior Module	Optomed Smartscope M5Optomed Smartscope EY4Optomed Smartscope ES2
510(k) number	K180378	K132186
Indications ofuse	Optomed Aurora Camera is a medicaldigital camera that is used with dedicatedoptics modules intended to captureimages and video of the fundus of the eyeand surface of the eye.	Optomed Smartscope M5 is a medicaldigital camera that is used with dedicatedoptics lens intended to take images of theeye fundus and surface of the eye.
	Optomed Aurora Camera with OptomedAurora Retinal Module is intended tocapture digital images and video of thefundus of the human eye.Optomed Aurora Camera with OptomedAurora Anterior Module is intended tocapture digital images and video of thesurface of the human eye andsurrounding areas.	Optomed Smartscope M5 digital camerawith Smartscope EY4 optics module isintended to capture digital images andvideo of the fundus of the human eye.Optomed Smartscope M5 digital camerawith Smartscope ES2 optics module isintended to capture images and video ofthe surface of the human eye andsurrounding areas.
Usage	Prescription use	Prescription use
Use condition	Intended to be used without mydriasisbut can be used also with mydriaticdrops.	Intended to be used without mydriasisbut can be used also with mydriaticdrops.
Illumination	Aurora Retinal Module:	Smartscope EY4:
source	White: OSRAM Oslon LUW-H9GP	White: OSRAM Oslon LUW-H9GP
	NIR: OSRAM Oslon SFH-4716	NIR: OSRAM Oslon SFH-4715
	Target LEDs: Vishay VLMS1500 - GS08	Target LEDs: OSRAM LR QH9F
	Aurora Anterior Module:	Smartscope ES2:
	White: Osram Advanced Power TopledLW G6SP-EAFA-JKQL-1	White: Osram Advanced Power TopledLW G6SP-EAFA-JKQL-1
	Blue: Osram Advanced Power Topled LBG6SP-V2BB-35-1	Blue: Osram Advanced Power Topled LBG6SP-V2BB-35-1
Display system	4.0", TFT-LCD, 800x480 pixels,16.7 M colors, anti-glare coating	2.4", TFT-LCD, 240x320 pixels,262 000 colors, antireflective coating
Camera sensorspecification	Color CMOS camera maximum resolution5 Mp	Color CMOS camera maximum resolution5 Mp
Dioptercompensation	From -20 D to +20 D	At least from -20 D to +20 D
Field of view	50x40 degrees	40 degrees
Storage media	MicroSDHC memory card	MicroSDHC memory card
Image dataformat	JPEG, MPEG-4	JPEG, MPEG-1, MPEG-4
Weight	Aurora Camera: 514 gAurora Retinal Module: 310 gAurora Anterior Module: 105 g	Smartscope M5: 400gSmartscope EY4: 300gSmartscope ES2: 90 g
Battery	Re-chargeable Li-Ion battery,50000655, 3.63 V, 2600 mAh	Re-chargeable Ni-MH battery,HR4U700AAA, 4.8V, 1000 mAh
Outputterminals anddata collection	USB (1.1) terminal (B-connector).Compatible with Windows® 7/8.1/10 andmacOS (three latest versions).	USB (1.1) terminal (B-connector).Compatible with Windows® 7/8.1/10.
Exposureparameters	"Exempt Group" (no risk) LED productaccording to IEC 62471:2006Group 2 instrument according to ISO15004-2:2007	"Exempt Group" (no risk) LED productaccording to IEC 62471:2006Group 2 instrument according to ISO15004-2:2007
Standards	IEC 60601-1:2005+A1:2012(edition 3.1)IEC 60601-1-2:2014 (edition 4.0)IEC 60601-1-6:2010+A1:2013 (edition 3.1)IEC 62471:2006ISO 15004-1:2006ISO 15004-2:2007ISO 10940:2009ISO 10993-5:2009IEC 62304:2006+A1:2015IEC 62366-1:2015	IEC 60601-1:2005+A1:2012 (edition 3.1)IEC 60601-1-2:2007 (edition 3.0)IEC 60601-1-6:2010+A1:2013 (edition 3.1)IEC 62471:2006ISO 15004-1:2006ISO 15004-2:2007ISO 10940:2009ISO 10993-5:2009IEC 62304:2006+A1:2015IEC 62366-1:2015

Table 1. Summary of technical information used in the substantial equivalence discussion.

Image /page/5/Picture/10 description: The image shows the word "OPTOMED" in blue. The "O" in "OPTOMED" is replaced with an eye symbol. The eye symbol is a circle with a smaller circle inside of it.

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Image /page/6/Picture/1 description: The image shows the word "OPTOMED" in blue font. The "O" in "OPTOMED" is replaced with an eye symbol. The eye symbol is a blue circle with a white dot in the center.

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The modifications in Optomed Aurora Camera with Optomed Aurora Retinal Module and Optomed Aurora Anterior Module compared to Optomed Smartscope M5 with Optomed Smartscope EY4 optics module and Optomed Smartscope ES2 optics module are:

Aurora Camera:

. New industrial design
New user interface: rotary encoder, capacitive touch buttons, battery charging indicator LEDs
Improved, larger display
. New battery
Improved WLAN functionality
New GUI (graphical user interface with new colors, fonts and structure) ●

Image /page/7/Picture/9 description: The image shows the word "OPTOMED" in blue font. The "O" in "OPTOMED" is replaced with an eye symbol. The eye symbol is a blue circle with a white dot in the center, surrounded by a blue ring. The word "OPTOMED" is written in a sans-serif font.

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Aurora Retinal Module:

New industrial design
. Increased FOV (field of view)
. Higher image resolution

Aurora Anterior Module

. New industrial design
Aurora Charging Station
. New industrial design
. External battery charger

Performance Data

The following performance data is provided in support of the substantial equivalence determination.

Electrical safety and electromagnetic compatibility (EMC)

Optomed Aurora Camera with Optomed Aurora Retinal Module and Optomed Aurora Anterior Module was tested according to all suitable clauses of IEC 60601-1:2012 (safety) and IEC 60601-1-2:2014 (EMC). Optomed Aurora Camera with Optomed Aurora Retinal Module and Optomed Aurora Anterior Module fulfills the requirements of the standards.

Optical safety

Optomed Aurora Retinal Module and Optomed Aurora Anterior Module were tested according to the standard IEC 62471:2006 and are classified as "Exempt Group" (NO RISK) LED products.

Optomed Aurora Retinal Module and Optomed Aurora Anterior Module were tested according to the standard ISO 15004-2:2007 and are classified as Group 2 ophthalmic instruments.

Software Verification and Validation

The level of concern of the software is moderate. Software verification and validation were conducted to ensure the fulfillment of the system requirements and functional specifications. Optomed Aurora Camera with Optomed Aurora Retinal Module and Optomed Aurora Anterior Module complies with the standard IEC 62304:2006+A1:2015.

Image /page/8/Picture/18 description: The image shows the word "OPTOMED" in blue font. The "O" in "OPTOMED" is replaced with a blue circle with a white dot in the center, resembling an eye. The text is simple and clear, with a modern sans-serif typeface.

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Environmental testing

Optomed Aurora Camera with Optomed Aurora Retinal Module and Optomed Aurora Anterior Module was tested according to ISO 15004-1:2006, IEC 60601-1 and IEC 60068-2 standards to verify the mechanical stress and ambient conditions for use and storage as prescribed for the devices fulfill the requirements of the standard. In addition, Optomed Aurora Camera with Optomed Aurora Retinal Module and Optomed Anterior Module was tested according to IEC 60068-2 for high temperature, low temperature, shock, vibration and bump to verify transportation conditions.

Biocompatibility

Optomed Aurora Retinal Module and Optomed Aurora Anterior Module have an eye cup that contacts skin around eye during normal usage of the device. The material of Optomed Aurora Retinal Module eye cup is Momentive LIM 6030AB and the material of Optomed Aurora Anterior Module eye cup is Momentive Silopren LSR 4040. In vitro cytotoxicity tests according to ISO 10993-5:2009 were performed to the materials of the eye cups, and the biocompatibility of Optomed Aurora Retinal Module and Optomed Aurora Anterior Module are at suitable level.

Optical performance

Aurora Camera with Aurora Retinal Module fulfills the requirements of the standard ISO 10940:2009 Ophthalmic instruments - Fundus cameras.

Usability (Human Factors)

Optomed Aurora Camera with Optomed Aurora Retinal Module and Optomed Aurora Anterior Module was designed and evaluated by following the principles depicted in the usability engineering process. The usage of Optomed Aurora Camera with Optomed Aurora Retinal Module and Optomed Aurora Anterior Module was evaluated to be suitable for its intended use and the devices complies with the standards IEC 60601-1-6:2010+A1:2013 and IEC 62366-1:2015.

Conclusions

Based on the provided performance data and the comparison, Optomed Aurora including Optomed Aurora Camera, Optomed Aurora Retinal Module and Optomed Aurora Anterior Module, is as safe, as effective and performs as well as or better than the predicate device. Optomed Aurora is substantially equivalent to the predicate device.

Image /page/9/Picture/10 description: The image shows the word "OPTOMED" in blue font. The "O" in "OPTOMED" is replaced with an eye symbol, also in blue. The background is a light gray color. The logo is simple and modern.

Regulation Number and Section

§ 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.