Optomed Smartscope M5 camera with Smartscope FA optics module is designed for use in a medical environment. Captured images and video are used for documentation and consultation. Optomed Smartscope M5 camera has a memory card where captured images and recorded videos are saved. Optomed Smartscope M5 camera is used with interchangeable optics modules previously cleared Smartscope EY4 and Smartscope ES2 and subject device Smartscope FA. Optics modules are attached to the camera with bayonet connectors.

Optomed Smartscope FA optics module is designed for fundus fluorescein angiography imaging of the human eye. Optomed Smartscope FA optics module includes two light sources: Blue light and infrared light, optical component that reflects light to the optical path and lenses that guide light through the pupil to the back of the eye and back to the camera sensor. Optomed Smartscope FA optics module has nine internal fixation targets for the patient to fixate on during imaging. Optomed Smartscope FA optics module receives power from Optomed Smartscope M5 digital camera.

Optomed Smartscope M5 camera has a WLAN module inside and when WLAN is used, Optomed Smartscope M5 camera transfers captured images and recorded videos to the PC automatically immediately after imaging. Images and videos can also be transferred to PC from the memory card when the camera is placed on Charging Station and the USB cable is connected between Charging Station and the PC. The image data transfer method to PC is similar as with any other USB mass storage device.

Optomed Smartscope M5 camera has a rechargeable Ni-MH battery that is charged when the camera is placed on Charging Station, which is connected to the mains by power supply cable. Charging Station can also be used as an external battery charger for the spare battery included in sales case. When Optomed Smartscope M5 camera is not used, it may be stored on Charging Station. Storing the device on Optomed Smartscope M5 camera Charging Station is not harmful for the battery.

AI/ML Overview

The provided text describes the regulatory clearance of the Optomed Smartscope M5 with Optomed Smartscope FA. It outlines numerous performance tests and standards met by the device to establish its substantial equivalence to predicate devices. However, it does not include specific acceptance criteria with corresponding reported device performance in the format of a table, nor does it detail a study proving the device meets acceptance criteria in terms of diagnostic performance.

The information provided focuses on demonstrating safety, electromagnetic compatibility, optical safety, software validation, environmental testing, biocompatibility, optical performance (in relation to a standard), and usability. There is no mention of a clinical study assessing the device's diagnostic accuracy or effectiveness in capturing fluorescein angiograms against specific performance metrics (e.g., sensitivity, specificity for a particular pathology).

Therefore, based only on the provided text, the requested information regarding acceptance criteria and a study proving diagnostic performance cannot be fully extracted or answered.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document lists various standards that the device complies with, which can be considered "acceptance criteria" in a broad sense for safety and basic functionality. However, it does not present these in a comparative table with specific performance metrics as usually seen for diagnostic devices (e.g., sensitivity, specificity, image quality scores).

Acceptance Criteria (Standard / Requirement Met)	Reported Device Performance
Electrical Safety (IEC 60601-1:2005+A1:2012)	Fulfills requirements of the standard.
Electromagnetic Compatibility (EMC) (IEC 60601-1-2:2014)	Fulfills requirements of the standard.
Optical Safety (IEC 62471:2006)	Classified as "Exempt Group" (NO RISK) LED product.
Optical Safety (ANSI Z80.36-2016)	Classified as Group 1 ophthalmic instrument.
Software Verification & Validation (IEC 62304:2006+A1:2015)	Complies with the standard.
Environmental Testing (ISO 15004-1:2006, IEC 60601-1, IEC 60068-2)	Fulfills requirements for mechanical stress, ambient conditions for use and storage; verified transportation conditions.
Biocompatibility (ISO 10993-5:2009, ISO 10993-10:2009)	Biocompatibility of eye cup material is at suitable level (in vitro cytotoxicity, irritation, and skin sensitization tests performed).
Optical Performance (ISO 10940:2009)	Fulfills the requirements of the standard.
Usability (Human Factors) (IEC 60601-1-6:2010+A1:2013, IEC 62366-1:2015)	Usage evaluated as suitable for intended use, complies with standards.

Missing Information: There are no acceptance criteria or reported device performance metrics related to the diagnostic capability of capturing fluorescein angiograms (e.g., image quality scores deemed acceptable for diagnosis, agreement with expert graders for specific features, etc.). The "Optical performance" entry refers to compliance to an instrument standard (ISO 10940:2009), not clinical performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing. The document does not describe any clinical study involving a test set of patient data to evaluate the device's performance in capturing fluorescein angiograms. The performance data section focuses on engineering and regulatory compliance testing rather than clinical validation on a patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing. As no clinical test set is described, there's no mention of experts or ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing. As no clinical test set is described, there's no mention of an adjudication method.

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

Missing. The document does not describe an MRMC study. This device is an ophthalmic camera for capturing images, not an AI-assisted diagnostic tool for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Missing. This device is an imaging capture device. There is no mention of an embedded algorithm for standalone diagnostic performance being evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Missing. As no clinical study or test set is described, there's no mention of the type of ground truth used.

8. The sample size for the training set

The document does not describe any machine learning or AI component requiring a training set. The descriptions relate to the hardware and associated software fulfilling design requirements and safety standards.

9. How the ground truth for the training set was established

Missing. As no training set or AI component is described, this information is not applicable.

Summary regarding diagnostic performance study:

The provided text details the compliance of the Optomed Smartscope M5 with Optomed Smartscope FA to various safety, electrical, mechanical, biocompatibility, and optical performance standards (e.g., IEC, ISO, ANSI). This typically constitutes the "performance data" required for a 510(k) submission to demonstrate substantial equivalence, particularly for a device primarily focused on image capture over automated diagnosis.

However, the document does not contain information about a clinical study that evaluates the device's effectiveness in terms of diagnostic image quality, accuracy in detecting ocular pathologies from fluorescein angiograms, or any other performance metrics typically associated with studies proving a medical device meets specific diagnostic acceptance criteria based on patient data. The "optical performance" mentioned refers to compliance with ISO 10940:2009 (Ophthalmic instruments - Fundus cameras), which likely deals with technical specifications of the camera itself (e.g., resolution, field of view stability) rather than its diagnostic utility on actual patient cases.

Summary

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

Optomed Oyj Jyri Leskelä Director Q&RA Yrttipellontie 1 Oulu, 90230 Finland

Re: K201325

Trade/Device Name: Optomed Smartscope M5 with Optomed Smartscope FA Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: May 7, 2020 Received: May 18, 2020

Dear Jyri 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Elvin Ng

Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201325

Device Name Optomed Smartscope M5 Optomed Smartscope FA

Indications for Use (Describe)

Optomed Smartscope M5 digital camera with Smartscope FA optics module is intended to capture fluorescein angiograms of the human eye.

Type of Use (Select one or both, as applicable)
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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 Oyj
Address:	Yrttipellontie 1, FI-90230 Oulu, Finland
Company phone:	+358 20 741 3380
Contact person:	Mr. Jyri Leskelä, Quality and Regulatory Director
Date:	October 15, 2020
Subject device:	Trade name:	Optomed Smartscope FA
	Common/usual name:	Ophthalmic camera
	Classification name:	camera, ophthalmic, ac-powered (21 CFR 886.1120)
	Regulatory Class:	II
	Product Code:	HKI
Predicate device:(Primary)	Trade name:	Optomed Smartscope M5 digital cameraOptomed Smartscope EY4 optics module
	510(k) number:	K132186
	Regulatory Class:	II
	Product code:	HKI
Predicate device:	Trade name:	Kowa Genesis Df
	510(k) number:	K091098
	Regulatory Class:	II
	Product code:	HKI

Image /page/3/Picture/4 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 circle with a smaller circle inside of it.

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Description of the Device

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Indications for Use

Optomed Smartscope M5 digital camera with Smartscope FA optics module is intended to capture fluorescein angiograms of the human eye.

Optomed Smartscope FA 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.

Optomed Smartscope M5 camera is modular and can be used together with dedicated optics modules (Smartscope EY4 and Smartscope FA) to capture images from the fundus of the eye. Predicate device Kowa Genesis Df is used to fundus imaging as well. Changes implemented to subject device Smartscope FA do not affect safety and effectiveness of the product.

Comparison of Technological Characteristics

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

Point of comparison	Optomed Smartscope M5Optomed Smartscope FA	Optomed Smartscope M5Optomed Smartscope EY4	Kowa Genesis Df
510(k) number	K201325	K132186	K091098
Indications for use	Optomed Smartscope M5digital camera withSmartscope FA opticsmodule is intended tocapture fluoresceinangiograms of the humaneye.	Optomed Smartscope M5digital camera withSmartscope EY4 opticsmodule is intended tocapture digital images andvideo of the fundus of thehuman eye.	A hand-held mydriaticretinal camera whichcaptures fundus image(For color and FA retinalphotography)
Usage	Prescription use	Prescription use	Prescription use
Use condition	Intended to be used withmydriatic drops.	Intended to be usedwithout mydriasis but canbe used also withmydriatic drops.	Intended to be used withmydriatic drops

Image /page/5/Picture/9 description: The image shows the word "OPTOMED" in blue font. The two Os are stylized, with the second O having a circle around it and a dot in the center, resembling an eye. The font is bold and sans-serif, and the overall design is simple and modern. The background is a light gray color.

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Illumination source	Smartscope FA:Blue: Osram Oslon LBH9GPNIR: OSRAM Oslon SFH-4715Target LEDs: OSRAM LRQH9F	Smartscope EY4:White: OSRAM OslonLUW-H9GPNIR: OSRAM Oslon SFH-4715Target LEDs: OSRAM LRQH9F	Observation light source:white LED / blue LEDPhotographing light source:Xenon flash lamp 23WS
Display system	2.4", TFT-LCD, 240x320pixels, 262 000 colors,antireflective coating	2.4", TFT-LCD, 240x320pixels, 262 000 colors,antireflective coating	Visual observation
Camera sensorspecification	Color CMOS cameramaximum resolution 5 Mp	Color CMOS cameramaximum resolution 5 Mp	Color CCD camera2,000,000 pixels
Diopter compensation	From -20 D to +20 D	At least from -20 D to +20D	-15D~+35D
Field of view	40 degrees	40 degrees	Horizontal: 30 degreeVertical: 25 degree
Storage media	MicroSDHC memory card	MicroSDHC memory card	Flash memory card
Image data format	JPEG, MPEG-1, MPEG-4	JPEG, MPEG-1, MPEG-4	JPEG, uncompressed data
Weight	Smartscope M5: 400gSmartscope FA: 300g	Smartscope M5: 400gSmartscope EY4: 300g	Approx.1kg
Battery	Re-chargeable Ni-MHbattery,HR4U700AAA, 4.8V, 1000mAh	Re-chargeable Ni-MHbattery,HR4U700AAA, 4.8V, 1000mAh	Not battery-operateddevice
Output terminals and datacollection	USB (1.1) terminal (B-connector).Compatible withWindows® 7/8.1/10.	USB (1.1) terminal (B-connector).Compatible withWindows® 7/8.1/10.	USB (1.1) terminal (Bconnector)Foot Switch connectorcable terminal
Exposure parameters	"Exempt Group" (no risk)LED product according toIEC 62471:2006	"Exempt Group" (no risk)LED product according toIEC 62471:2006	N/A

Image /page/6/Picture/3 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 circle with a smaller circle inside, and a white dot in the center.

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	Group 1 instrumentaccording to ANSI Z80.36-2016	Group 2 instrumentaccording to ISO 15004-2:2007
Standards	IEC 60601-1:2005+A1:2012 (edition3.1)	IEC 60601-1:2005+A1:2012 (edition3.1)	N/A
	IEC 60601-1-2:2014(edition 4.0)	IEC 60601-1-2:2014(edition 4.0)
	IEC 60601-1-6:2010+A1:2013 (edition3.1)	IEC 60601-1-6:2010+A1:2013 (edition3.1)
	IEC 62471:2006	IEC 62471:2006
	ISO 15004-1:2006	ISO 15004-1:2006
	ANSI Z80.36-2016	ISO 15004-2:2007
	ISO 10940:2009	ISO 10940:2009
	ISO 10993-5:2009	ISO 10993-5:2009
	ISO 10993-10:2009	ISO 10993-10:2009
	IEC 62304:2006+A1:2015	IEC 62304:2006+A1:2015
	IEC 62366-1:2015	IEC 62366-1:2015

The modifications in Optomed Smartscope M5 camera with Smartscope FA optics module compared to Optomed Smartscope M5 camera with Optomed Smartscope EY4 optics module are:

Smartscope FA:

. Illumination source blue led
. Short pass filter in illumination path in front of blue led
Barrier filter in imaging path
. Optical safety Group 1 tested according to ANSI Z80.36-2016

The differences in Optomed Smartscope M5 camera with Smartscope FA optics module compared to Kowa Genesis Df are:

Smartscope FA:

. Increased FOV (field of view)
Higher image resolution

OPTOMED

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Performance Data

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

Electrical safety and electromagnetic compatibility (EMC)

Optomed Smartscope M5 camera with Smartscope FA optics module was tested according to all suitable clauses of IEC 60601-1:2005+A1:2012 (safety) and IEC 60601-1-2:2014 (EMC). Optomed Smartscope M5 camera with Smartscope FA optics module fulfills the requirements of the standards.

Optical safety

Optomed Smartscope M5 camera with Smartscope FA optics module was tested according to the standard IEC 62471:2006 and is classified as "Exempt Group" (NO RISK) LED products.

Optomed Smartscope M5 camera with Smartscope FA optics module was tested according to the standard ANSI Z80.36-2016 and is classified as Group 1 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 Smartscope M5 camera with Smartscope FA optics module complies with the standard IEC 62304:2006+A1:2015.

Environmental testing

Optomed Smartscope M5 camera with Smartscope FA optics 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 device fulfills the requirements of the standard. In addition, Optomed Smartscope M5 camera with Smartscope FA optics module was tested according to IEC 60068-2 for high temperature, low temperature, shock, vibration and bump to verify transportation conditions.

Biocompatibility

Optomed Smartscope FA optics module has an eye cup that contacts skin around eye during normal usage of the device. The material of Optomed Smartscope FA optics module eye cup is Momentive LIM 6030AB. In vitro cytotoxicity tests according to ISO 10993-5:2009 and Irritation and skin

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sensitization tests according to ISO 10993-10:2009 were performed to the material of the eye cup, and the biocompatibility of Optomed Smartscope FA optics module is at suitable level.

Optical performance

Optomed M5 camera with Optomed Smartscope FA optics module fulfills the requirements of the standard ISO 10940:2009 Ophthalmic instruments - Fundus cameras.

Usability (Human Factors)

Optomed M5 camera with Optomed Smartscope FA optics module was designed and evaluated by following the principles depicted in the usability engineering process. The usage of Optomed M5 camera with Optomed Smartscope FA optics 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 M5 camera with Optomed Smartscope FA optics module, is as safe, as effective and performs similar to the predicate devices. Optomed M5 camera with Optomed Smartscope FA optics module is substantially equivalent to the predicate devices.

Image /page/9/Picture/8 description: The image shows the word "OPTOMED" in blue. The "O" in "OPTOMED" is replaced with an eye symbol. The eye symbol is a blue circle with a white dot in the center.

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.