The Daytona ICG scanning laser ophthalmoscope is indicated for use as a wide field scanning laser ophthalmoscope for viewing choroidal circulation patterns that are illuminated using indocyanine green dye and for aiding both in the assessment of choroidal circulation and in the diagnosis of choroiditis or choroidal diseases.

Device Description

The Optos P200TICG is a scanning laser ophthalmoscope that uses a laser as a light source to illuminate the eye. The device consists of the following components and accessories:

A scanhead which houses the lasers, the scanning elements of the light input path and the . light return path including the detectors which convert light into electronic signal. With the exception of the chin support, the scanhead forms the key patient interface with a facepad and associated aperture where the eye is placed and a griphandle at each side of the scanhead. The image capture is controlled by a computer and associated embedded software including a safety module within the scanhead. This software runs on a Linux operating system.
A chin support is juxta-positioned to the scanhead to support the patient head and reduce . patient movement when the eye is placed at the aperture of the scanhead.
· A touchscreen is attached by a cable to the scanhead to assist the operator in ootimal patient positioning and to initiate an image capture. An image is displayed on the screen to allow the operator to confirm a suitable image has been taken.
A personal computer with a monitor to allow image review and storage in a Windows . environment.

AI/ML Overview

The provided text describes the Optos Daytona ICG (P200TICG) Ophthalmoscope and its substantial equivalence to a predicate device. However, it does not contain information about a study with acceptance criteria and specific reported device performance in the way typically found for a diagnostic algorithm or a clinical trial.

Instead, the performance data presented focuses on engineering and safety compliance rather than a clinical effectiveness study against specific diagnostic metrics.

Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy for a particular condition) are explicitly stated for the Daytona ICG (P200TICG) device in the provided text. The performance data focuses on compliance with various safety and operational standards.

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated as such for clinical performance)	Reported Device Performance
Operational & Safety	Adequate pixel/grey scale range for ICG angiography with blood concentrations from 0.05 mg/L to 50 mg/L.	Adequate pixel/grey scale range achieved using equine blood with various ICG concentrations in a phantom eye. In vivo concentrations peak at ~25-30 mg/L.
Electrical Safety	Compliant with IEC 60601-1, IEC 60601-1-2, and 47 CFR Part 15 subpart B.	Device meets requirements; no procedure deviations, non-standard test methods, or additional testing needed. No abnormalities or departures from standard conditions.
Light Hazard	Class 1 to IEC 60825 (lowest, safest classification). Compliant with ISO 15004-2 (Group 1 ophthalmic instrument).	Device is Class 1 to IEC 60825. Device is a Group 1 ophthalmic instrument to ISO 15004-2.
Biocompatibility	Contact points (face pad, chin cup, handgrips) meet short duration intact skin ISO 10993-1 criteria: cytotoxicity, sensitization, irritation/intracutaneous reactivity.	Face pad: Cytotoxicity test (ISO 10993-5) - not considered to have cytotoxic potential. Irritation/sensitization (ISO 10993-10, intracutaneous injection) - sites did not show significantly greater biological rate than control. Kligman sensitization - Grade 1 rate not significant, meets requirement. Chin cup & Handgrips: Cytotoxicity test (ISO 10993-5) - not considered to have cytotoxic potential. Irritation/sensitization (ISO 10993-10, intracutaneous injection) - sites did not show significantly greater biological rate than control. Kligman sensitization - Grade 1 rate not significant, meets requirement.
Software	Complied with IEC 60601-1-4; no unresolved major or critical bugs; software development lifecycle and V&V activities met requirements.	Product found to comply with requirements.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: No specific "test set" in a clinical sense (i.e., human subjects or patient data for diagnostic accuracy) is mentioned. The performance data relies on laboratory ex vivo testing and compliance with engineering standards.
Data Provenance (e.g., country of origin of the data, retrospective or prospective):
- Ex Vivo Testing: Equine blood and a phantom eye were used. This is a laboratory setting, not clinical patient data.
- Electrical, Light Hazard, Biocompatibility, Software Testing: Conducted to international standards (e.g., IEC, ISO). The location of these tests is not specified in the summary, but the submitter is based in the UK. This is engineering verification, not clinical data provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided as there was no clinical "test set" for diagnostic performance in the traditional sense, and thus no expert ground truth establishment for a clinical diagnosis. The "ground truth" for the ex-vivo testing was based on known concentrations of ICG in equine blood.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable as there was no clinical "test set" requiring expert adjudication for diagnostic ground truth.

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

No MRMC or comparative effectiveness study involving human readers or AI assistance is mentioned. This device is a standalone imaging device, not an AI diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is an imaging instrument (ophthalmoscope), not an algorithm. Its performance is evaluated based on its ability to capture images and meet safety/engineering standards, not as a diagnostic algorithm. Therefore, "standalone" algorithm performance in the context of an AI device is not applicable. The device itself operates "stand-alone" in terms of capturing images for physicians to interpret.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the ex-vivo testing, the "ground truth" was the known, controlled concentrations of indocyanine green (ICG) in equine blood passing through a phantom eye.
For safety and electrical testing, the ground truth was compliance with international standards and regulations (e.g., IEC, ISO).

8. The Sample Size for the Training Set

This information is not applicable. The document describes an imaging device, not an AI model that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there was no training set for an AI model.

Summary

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K134039

510(k) SUMMARY

Traditional 510k Summary	Optos Daytona ICG (P200TICG) Device
Name of Device:	Daytona ICG Ophthalmoscope (P200TICG)
Common or Usual Name:	Scanning laser ophthalmoscope
Classification Name:	Scanning laser ophthalmoscope (per 21 C.F.R. § 866.1570)
Product Code:	MYC
Submitter:	Optos plc,Queensferry House,Carnegie Business CampusDunfermline,Fife,KY11 8GRUnited KingdomPhone: 011 44 1383 843300Facsimile: 011 44 1383 843333
Contact Person:	Robert Tweedlie Ph.D.
Date Prepared:	April 10, 2014
Predicate Device:	Heidelberg Retina Angiography 2 (K971671)

Indications for Use

Device Description

The Optos P200TICG is a scanning laser ophthalmoscope that uses a laser as a light source to illuminate the eye. The device consists of the following components and accessories:

A scanhead which houses the lasers, the scanning elements of the light input path and the . light return path including the detectors which convert light into electronic signal. With the exception of the chin support, the scanhead forms the key patient interface with a facepad and associated aperture where the eye is placed and a griphandle at each side of the scanhead. The image capture is controlled by a computer and associated embedded software including a safety module within the scanhead. This software runs on a Linux operating system.
A chin support is juxta-positioned to the scanhead to support the patient head and reduce . patient movement when the eye is placed at the aperture of the scanhead.

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· A touchscreen is attached by a cable to the scanhead to assist the operator in ootimal patient positioning and to initiate an image capture. An image is displayed on the screen to allow the operator to confirm a suitable image has been taken.
A personal computer with a monitor to allow image review and storage in a Windows . environment.

Principles of Operation and Technological Characteristics

The Optos P200TICG uses light that is scanned by a deflection system in two axes across the layers of the eye to generate an image. The returned light then travels back along the same path to a light detector that converts the light to an electrical signal is digitized and used to build up an electronic picture in a computer and output on a display screen.

A summary of the safety system is as follows:

. Fast scan idle speed monitored. Power only supplied to beam delivery module if idle speed >7000rom.
Fast scan operating speed monitored. Laser enable only permitted if fast scan speed >30.000rpm
. Laser status monitored. Any conflict in laser status results in a system trip.
. Laser powers monitored. If làser power is outside 25% of the nominal power, the system will trip.
. Shutter status monitored. If conflict detected, system will trip.
. Line start rate monitored as back up to fast scan speed monitor (this detects that the light pulse is not static).

The fast scan and line start signals are implemented as low-voltage differential signalling (LVDS signals) to prevent failure occurring and all functionality is monitored on dual channels. All monitoring and decision making is implemented in discrete logic.

The layer of the eye viewed is determined by the wavelength of the laser utilized to illuminate the eye and the return path configured for the light either reflected and/or emitted by fluorescensce. For the P200TICG, the laser illuminating the eye is infrared and the returned light is the fluorescence signal induced by the injection of indo cyanine green (ICG) dye. The detector used to capture this signal is optimized to detect infrared light and a filter is used to transmit only the fluoresced infra-red light which is at a slightly longer wavelength than the incident infra-red light entering the eye. This change in wavelength is a fundamental property of fluorescence.

Performance Data

In all instances, the Optos Daytona ICG device functioned as intended and compliance to electrical safety, light safety and biocompatibility has been established. The software development lifecycle and the associated verification & validation activities have no unresolved major or critical bugs and complied with IEC 60601-1-4. The light captured from the return path and translation to an electrical signal was as expected. Additionally this signal has the grey scale/ pixel characteristics to generate a satisfactory image over the indocyanine green (ICG) concentrations found in blood during an ICG angiography exam. >

A summary of the testing supporting this conclusion follows:

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Ex Vivo testing

The use of equine blood with various concentrations of ICG pervading through a phantom eye was used to determine than an adequate pixel/grey scale range can be achieved to generate an image. This is for indocyanine green blood concentrations ranging from 0.05 mg/L to 50 mg/L. In vivo concentrations during an indocyanine procedure peak at approximately 25-30 mg per liter of blood.

Electrical Safety testing (general and electromagnetic compatibility)

The Daytona ICG device meets the requirements of IEC 60601-1. There were no procedure deviations, no non-standard test methods were used and no additional testing deemed necessary.

The Daytona is compliant to the specification IEC 60601-1-2 and 47 CFR Part 15 subpart B with no abnormalities or departures from the standard conditions.

IEC 60825 (Light Hazard standard)

The Optos device is class I to standard IEC 60825. Class I is the lowest, safest classification.

ISO 10993 (Biocompatibility)

As per ISO 10993-1 the contact is surface, intact skin for a limited duration (≤24 hours), requiring cytotoxicity, sensitization and irritation or intracutaneous reactivity. The patient contact points are the face pad and the chin cup and handgrips. The results are tabulated as follows:-

Material	Test	Result
Face pad	Cytotoxicity test ISO 10993-5	Test article not considered to have cytotoxic potential
Face pad	Tests for irritation and skin sensitization ISO 10993-10, intracutaneous injection	Test article sites did not show a significantly greater biological rate than control
Face pad	Tests for irritation and skin sensitization ISO 10993-10, Kligman sensitization	A grade 1 sensitization rate is not considered significant and the test article meets the requirement
Chin cup and handgrips	Cytotoxicity test ISO 10993-5	Test article not considered to have cytotoxic potential
Chin cup and handgrips	Tests for irritation and skin sensitization ISO 10993-10, intracutaneous injection	Test article sites did not show a significantly greater biological rate than control
Chin cup and handgrips	Tests for irritation and skin sensitization ISO 10993-10, Kligman sensitization	A grade 1 sensitization rate is not considered significant and the test article meets the requirement

ISO 15004-2: Ophthalmic Instruments, light hazard protection

The device is a group 1 ophthalmic instrument.

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IEC 60601-1-4 Medical electrical equipment. General requirements for safety. Collateral standard. General Requirements for programmable electrical medical svstems.

The product has been found to comply with the requirements of this specification.

Substantial Equivalence

The Daytona ICG (P200TICG) device is as safe and effective as the predicate device, the Heidelberg Retina Angiography 2 (K971671).

The Panoramic Daytona ICG (P200TICG) has the same intended use and indications for use and similar principles of operation and technological characteristics as the predicate device for choroidal angiography. The predicate device also uses an infra-red light source of similar wavelength, requires an injection of indocyanine green dye, and is dependent on the fluorescent properties of this dye in the generation of images appropriate for aiding in the assessment of choroidal circulation and diagnosis of choroiditis or choroidal diseases. Similar to the Optos P200TICG, the predicate device requires the laser to be scanned horizontally and vertically and requires a filter in front of a detector to select only the fluorescent signal for detection. The detection converts the light to an electronic signal for subsequent display on a screen.

The predicate device is of similar construction and being an optomechanical electronic device utilizing a laser(s) is subject to the same general electrical, light hazard and software standards for such medical electrical equipment. Additionally, both the Optos and predicate device are class I in terms of laser power at the eye as defined by IEC 60825 so both devices are dependent on comparable incident light levels to possess this functionality.

The table below provides a side-by-side comparison of the Optos and predicate device:

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OPTONA ICG (P200TICG) OPTOS PLC

SUBSTANTIAL EQUIVALENCE (P200TICG)
SUBSTANTIAL EQUIVALENCE CHART

Device	Daytona ICG (P200TICG)	Heidelberg RetinaAngiograph 2
Device	Daytona ICG (P200TICG)	HeidelbergAngiography 2 Retina
Common Name	Scanning LaserOphthalmoscope	Scanning LaserOphthalmoscope
510(k) number	Pending	K971671
Materials	No flammable materials areused near the light source.	No flammable materials areused near the light source.
Max. Temperature of accessible	Does not exceed ambient bymore than 10°C.
Intended Use	To provide images that aid inexamining the eye	To provide images that aidin examining the eye
Indications for Use	A wide field scanning laserophthalmoscope for viewingchoroidal circulation patternsthat are illuminated usingindocyanine green dye andfor aiding both in theassessment of choroidalcirculation and in thediagnosis of choroiditis orchoroidal diseases	Device is intended forviewing the retinal and/orchoroidal circulationpatterns that are illuminatedusing fluorescein orindocyanine green dye, andfor aiding in the:• Management of age-related maculardegeneration (AMD)• Detection of choroidalneovascularization(CNV)• Assessment of diabeticretinopathy• Assessment of diabeticmaculopathy• Treatment control ofdiabetic maculopathy,AMD,CNV• Detection of retinalvascular diseases• Assessment of choroidalcirculation• Diagnosis of choroiditisor choroidal diseases
Method of Operation	Confocal laser scanningsystem; laser light source;deflection system; scans intwo orthogonal axes of theretina; photosensitive devicethat converts light into imageof retina; display system	Confocal laser scanningsystem; laser light source;deflection system; scans intwo orthogonal axes of theretina; photosensitive devicethat converts light intoimage of retina; displaysystem
Device	Daytona ICG (P200TICG)	Heidelberg RetinaAngiograph 2
Technological Characteristics	Scanning laserophthalmoscope	Scanning laserOphthalmoscope
Light Source	Laser	Laser
Wavelength and Color of Light	802 nm infra-red	488nm; blue790nm; infrared
Exposure Parameters/laser class	Class 1 to IEC 60825	Class 1 to IEC 60825
Number of lasers Used per scan	1	1 or 2
Fixation Pattern	Array of LED's Group 1 toISO15004-2	Array of LED's
Brightness Controls	Exempt from requirementsas a Class 1 laser	Exempt from requirementsas a Class 1 laser
Cleaning anddisinfection/sterilization	Sterilization not required.Clean/disinfect contact points	Non optical surfaces can bedisinfected
Point of contact	Chin rest, face pad and griphandles	Chin & head rest
Data collection and/or displaysystem	Light sensitive detector thatconverts light into electricalsignal. Signal digitised andcomputer or electronicimaging device to convertdigital image for display	Light sensitive detector thatconverts light into electricalsignal. Signal digitised andcomputer or electronicimaging device to convertdigital image for display
External field of view	120°	15°, 20°, 30°
Internal field of view	200°	N/A
Wide Angle Digitised Image Size	3900x3072 pixels	High speed:768x768 pixelsat 30° High Resolution:1536x1536 pixels at 30°
Pupil Dilation	Normally advised for ICG butdetermined by practitioner	Normally advised for ICGbut determined bypractitioner
Mains currentAC 115/240V	6.3A	230V 1.25AT110V 2.5AT
Approx. weight	Scanhead 27 kg	N/A
Dimensions (l x w x h)	500mm x 440mm x x795mm	N/A
Power Source	Mains powered	Mains powered
Safety Features	Laser overpower and correctfunctioning of scanningelements	Laser overpower andcorrect functioning ofscanning elements
Biocompatibility	Contact points meet shortduration intact skin ISO10993-1 criteria	Not known, but similarcontact points
Software	Embedded and application	Embedded and application
Standards with which the DeviceComplies	IEC 60601-1, -1-2,-1-4, ISO10993, ISO 15004-2, IEC60824	IEC 60601-1, IEC 60601-1-2, IEC 60825

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・

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The minor technological differences between the P200TICG and the predicate device do not raise any new questions of safety and effectiveness. Performance data demonstrate that the Optos P200TICG is as safe and effective as the Heidelberg Retina Angiography 2 (K971671) Scanning Laser Ophthalmoscope (SLO).

Thus, the Optos Daytona ICG (P200TICG) Ophthalmoscope is substantially equivalent to legally marketed Heidelberg Retina Angiography 2 (K971671) Scanning Laser Ophthalmoscope (SLO).

Conclusions

The Optos Daytona ICG (P200TICG) has similar characteristics as determined by electrical, light hazard and biocompatibility type testing. Additionally the laser light wavelength, fluorescence barrier filter and non-clinical signal profiling demonstrate that the device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MID 20993-0002

April 11, 2014

Optos plc % Mr. Randy J. Prebula, JD Partner Hogan Lovells, US LLP Columbia Square 555 Thirtcenth Street, NW Washington, DC 20004

Re: K134039

Trade/Device Name: Daytona ICG (P200TICG) Ophthalmoscope (Model A10642) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC Dated: March 6, 2014 Received: March 6, 2014

Dear Mr. Prebula:

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

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Page 2 - Mr. Randy J. Prebula

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.

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) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K134039

Device Name

Daytona ICG (P200TICG)

Indications for Use (Describe)

The Daytona ICG scanning laser ophthalmoscope is indicated for use as a wide field scanning laser ophthalmoscope for viewing choroidal circulation patterns that are illuminated using indocyanine green dye and for aiding in both the assessment of choroidal circulation and in the diagnosis of choroiditis or choroidal diseases.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

10, 19200300, 100, 1.1=1300014022, cm-Ma Marsha L. Burke Nicholas - S 404 20 13:04:48 -04TH

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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FORM FDA 3881 (1/14)

Page 1 of 1 FDA

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.