· viewing the posterior segment of the eye, including two- and three-dimensional imaging
· cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
· fundus imaging
· fluorescence imaging (fluorescein angiography, indocyanine green angiography, SPECTRALIS HRA+OCT, SPECTRALIS HRA)
· autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
· performing measurements of ocular anatomy and ocular lesions.

The device is indicated as an aid in the detection and management of various ocular diseases, including:

age-related macular degeneration
macular edema
· diabetic retinopathy
· retinal and choroidal vascular diseases
glaucoma

The device is indicated for viewing geographic atrophy.

The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:
• a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects
• a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

Device Description

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laser-scanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image.

A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared super-luminescent diode and a spectral interferometer are used to create the cross-sectional images.

AI/ML Overview

The provided text is a 510(k) summary for the Heidelberg Engineering SPECTRALIS HRA+OCT and variants, a non-contact ophthalmic diagnostic imaging device. The submission outlines modifications to an existing cleared device (K192391).

Here's an analysis of the acceptance criteria and study information based on the provided document:

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

The document does not explicitly state quantitative acceptance criteria or reported device performance in a dedicated table format. Instead, it uses a "TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART" to compare the modified device against its predicate (K192391). The "Discussion" column in this chart implicitly indicates whether performance is considered equivalent ("Same") or if differences are minor and do not impact safety/effectiveness.

The implied acceptance criterion for most characteristics is "Same as predicate device" or that any differences do not introduce new safety or effectiveness concerns.

Feature	Predicate Device (K192391 SPECTRALIS HRA+OCT)	Subject Device	Discussion / Implied Performance
Device classification name	Optical Coherence Tomographer (OCT)	Optical Coherence Tomographer (OCT)	Same
Technology and optical setup	Confocal Scanning Laser Ophthalmoscope (SLO) and Spectral-Domain Optical Coherence Tomograph (OCT)	Confocal Scanning Laser Ophthalmoscope (SLO) and Spectral-Domain Optical Coherence Tomograph (OCT)	Same
Light sources and wavelength	Near infrared, blue, green diode lasers; superluminescence diode for OCT	Near infrared, blue, green diode lasers; superluminescence diode for OCT	Same
Amount of light irradiated	Low amount, does not exceed Class I laser accessible emission limits	Low amount, does not exceed Class I laser accessible emission limits	Same
Accessory objective lenses	ASM, WFO, UWF, HMM	ASM, WFO, UWF, HMM	Same
Lateral field of view (SLO)	$15°x15°$ to $30°x30°$ (SO), $8°$ (HMM), $25°x25°$ to $55°$ (WFO/WFO2), $51°x51°$ to $102°$ (UWF)	Same range as predicate	Same
Lateral digital resolution (SLO)	high speed mode: 3µm (HMM), 11 µm (SO) to 40 µm (UWF); high resolution mode: 1.5µm (HMM), 6 µm (SO) to 20 µm (UWF)	Same resolution as predicate	Same
Lateral optical resolution (OCT)	14 µm (standard objective), 24 µm (WFO/WFO2)	Same resolution as predicate	Same
Optical depth resolution (OCT)	7 µm	7 µm	Same
Digital image size (SLO)	High Speed mode: 384x384 to 768x768 pixels; High Resolution mode: 768x768 to 1536x1536 pixels	Same size ranges as predicate	Same
OCT acquisition speed	40 kHz (Firewire), 85 kHz (Thunderbolt)	40 kHz (Firewire), 85 kHz (Thunderbolt)	Same
OCT Scanner Controller	Standard controller	Updated controller	Different; reduces scanner non-linearity, repositioning error, settle times (Improvement)
OCT Beam Splitter	Standard coating	Modified coating	Different; modified to allow more light to the reference arm (Improvement)
OCT imaging modes	Standard, Enhanced Depth Imaging (EDI)	Standard, Enhanced Depth Imaging (EDI), Enhanced Vitreous Imaging (EVI)	Different; Addition of EVI mode (New Feature)
OCTA scan types	Volume	Volume, OCTA Scout, OCTA DART Volume, OCTA DART Line	Different; Additional predefined OCTA scan patterns (New Feature)

Study Proving Acceptance Criteria:

The study proving the device meets acceptance criteria is described as non-clinical performance testing, including bench testing of OCT imaging properties, validation and verification activities, and ongoing quality control. These tests confirmed that the modified SPECTRALIS HRA+OCT functions equivalently to the predicate SPECTRALIS HRA+OCT.

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). The study described is entirely non-clinical bench testing, not a human reader study or clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The study was non-clinical bench testing. There were no human experts establishing ground truth for a test set in the context of diagnostic interpretation.

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

Not applicable. There was no test set requiring expert adjudication.

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. The document explicitly states: "The changes applied to the SPECTRALIS since the clearance in K192391 do not change the intended patient populations, the type of acquired images, or that the SPECTRALIS may be used as an aid to clinical evaluation." This implies that the device is an imaging tool, not one that directly interacts with human readers for diagnostic interpretation (i.e., no AI assistance component or comparative effectiveness with human readers is mentioned).

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

No. The device is an imaging hardware system, not an algorithm, and the modifications are to hardware and software features that enhance image acquisition and scanning patterns, not an AI or standalone diagnostic algorithm.

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

For the non-clinical bench testing, the "ground truth" would be established by objective physical measurements, engineering specifications, and validated measurement standards to assess optical properties, scanner linearity, light exposure, and image quality parameters. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. The document does not describe the development or training of an algorithm or AI model.

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

Not applicable. The document does not describe the development or training of an algorithm or AI model.

Summary

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September 9, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC. 1655 Forest Drive Medina, Ohio 44256

Re: K201252

Trade/Device Name: Spectralis HRA+OCT and variants Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, MYC Dated: June 10, 2020 Received: June 11, 2020

Dear Lena Sattler:

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 Actinclude 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

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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 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 (QS) 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-devices/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 (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,

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

Enclosure

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Indications for Use

510(k) Number (if known) K201252

Device Name SPECTRALIS HRA+OCT and variants

Indications for Use (Describe)

The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:

· viewing the posterior segment of the eye, including two- and three-dimensional imaging
· cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
· fundus imaging

· fluorescence imaging (fluorescein angiography, indocyanine green angiography, SPECTRALIS HRA+OCT, SPECTRALIS HRA)

· autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
· performing measurements of ocular anatomy and ocular lesions.

The device is indicated as an aid in the detection and management of various ocular diseases, including:

age-related macular degeneration
macular edema
· diabetic retinopathy
· retinal and choroidal vascular diseases
glaucoma

The device is indicated for viewing geographic atrophy.

The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:

• a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects

• a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of the word "HEIDELBERG" stacked on top of the word "ENGINEERING". To the left of each word is a red square. The text is in a bold, sans-serif font.

510(K) SUMMARY

Date Prepared

August 18, 2020

SPONSOR/510(K) OWNER/ MANUFACTURER

Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 69115 Heidelberg, Germany Telephone: Facsimile: Email: Establishment Registration No.:

+49 6221 / 64 63 0 +49 6221 / 64 63 62 Christoph.Schoess@HeidelbergEngineering.com 8043762

OFFICIAL CONTACT PERSON

Lena Sattler Orasi Consulting, LLC. 1655 Forest Dr. Medina, OH 44256 Telephone: Facsimile: E-mail:

(440) 554-3706 (866) 904-4315 lena@orasiconsulting.com

COMMON/USUAL NAME

Optical Coherence Tomography

PROPRIETARY OR TRADE NAMES

SPECTRALIS HRA+OCT and variants

CLASSIFICATION INFORMATION

Regulation Number:	21 CFR 886.1570
Classification name:	Ophthalmoscope
Device Class:	II
Common name:	Optical Coherence Tomography
Product Codes, Name:	OBO (Tomography, Optical Coherence)MYC (Ophthalmoscope, Laser, Scanning)
Medical Specialty:	Ophthalmic
Classification Panel:	Ophthalmic Device Panel

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Image /page/5/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on either end. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING".

LEGALLY MARKETED UNMODIFIED PREDICATE DEVICE

Trade/Device Name: Applicant: 510(k) Premarket Notification number: Classification: Regulation Number: Product Codes, Name:

Common Name: Medical Specialty: Classification Panel:

SPECTRALIS HRA+OCT and variants Heidelberg Engineering GmbH K192391 Class II 21 CFR 886.1570 OBO (Tomography, Optical Coherence) MYC (Ophthalmoscope, Laser, Scanning) Optical Coherence Tomography Ophthalmic Ophthalmic Device Panel

GENERAL DEVICE DESCRIPTION

DEVICE MODIFICATIONS

The purpose of this premarket notification [510(k)] is to modify the SPECTRALIS HRA+OCT with the updated camera head and OCT controller, the additional OCT scan mode, and predefined OCTA scan pattern.

The following changes have been applied to the device:

. Camera head hardware update
- O Modified beam splitter coating to allow for more light in the OCT reference arm
- Improved OCT scanner controller O

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Enhanced Vitreous Imaging OCT acquisition mode ●
Additional predefined scan patterns ●
- OCT Angiography Scout scan: A fast overview OCTA scan o
- OCT Angiography Dense ART (DART) scans: Narrow OCTA B-scans with flow O overlav

INDICATIONS FOR USE – SPECTRALIS PREDICATE DEVICE

The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:

. viewing the posterior segment of the eye, including two- and three-dimensional imaging
cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT) .
fundus imaging .
fluorescence imaging (fluorescein angiography, indocyanine green angiography; . SPECTRALIS HRA+OCT, SPECTRALIS HRA)
autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and . SPECTRALIS OCT with BluePeak)
. performing measurements of ocular anatomy and ocular lesions.

The device is indicated as an aid in the detection and management of various ocular diseases, including:

. age-related macular degeneration
macular edema .
diabetic retinopathy .
retinal and choroidal vascular diseases .
. glaucoma

The device is indicated for viewing geographic atrophy.

The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:

a retinal nerve fiber layer thickness reference database, which is used to quantitatively . compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects - the classification result being valid only for Caucasian subjects
. a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

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Image /page/7/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on either side. The first line says "HEIDELBERG" and the second line says "ENGINEERING".

INDICATIONS FOR USE – MODIFIED SPECTRALIS

The Indications for Use for the modified SPECTRALIS is identical to the Indications for Use of the cleared SPECTRALIS predicate device.

SUBSTANTIAL EQUIVALENCE

The Substantial Equivalence summary tables below illustrate the comparisons of the modified SPECTRALIS to the predicate device.

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Image /page/8/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text in a stylized, blocky font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a red square on the left side of the first line and on the right side of the second line.

INDICATIONS FOR USE STATEMENT CHART

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Image /page/9/Picture/0 description: The image contains the logo for Heidelberg Engineering. The logo consists of the company name in a stylized, blocky font. There are two red squares on either side of the company name.

TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART

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Image /page/10/Picture/0 description: The image contains the logo for Heidelberg Engineering. The logo consists of two lines of text in a stylized, blocky font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a dark red square to the left of the first line and to the right of the second line.

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Image /page/11/Picture/0 description: The image contains the logo for Heidelberg Engineering. The logo consists of two lines of text in a stylized, blocky font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a red square on the left side of the first line and a red square on the right side of the second line.

SUBSTANTIAL EQUIVALENCE DISCUSSION

The modified SPECTRALIS HRA+OCT is a device modification to the cleared SPECTRALIS HRA+OCT and variants (K192391) predicate device. Technological detail characteristics of the device are unchanged except for the modification as stated above. The modified SPECTRALIS has the same Indications for Use and maintains the same fundamental scientific technology as the predicate device.

The modified SPECTRALIS HRA+OCT and variants measures the same ophthalmic features as the cleared SPECTRALIS HRA+OCT in K192391. The changes applied to the SPECTRALIS since the clearance in K192391 do not change the intended patient populations, the type of acquired images, or that the SPECTRALIS may be used as an aid to clinical evaluation.

The light sources integrated into the modified device are the same as the predicate (unmodified) device. The modification of the OCT beam splitter coating to the predicate (unmodified) device does not alter the optical pathway, nor does it change the patient light exposure.

The addition of additional scan patterns, updated OCT scanner controller, and of Enhanced Vitreous Imaging mode, do not change the basic scientific technology of the predicate (unmodified) device.

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Non-clinical performance testing was conducted on the modified SPECTRALIS HRA+OCT to verify that the device is safe and effective for its intended use and indications for use. The modified SPECTRALIS was evaluated according to the requirements of FDA recognized consensus standards:

. ISO 14971: Medical Devices - Application of Risk Management to Medical Devices,
AAMI / ANSI ES60601-1:2005 Edition 3.1: Medical Electrical Equipment Part 1: ● General Requirements for Basic Safety and Essential Performance,
IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests,
. IEC 62304 Edition 1.1 2015-06: Medical Device Software - Software Life Cycle Processes,

and was found to meet the requirements of the applicable parts, demonstrating that the safety and efficacy of the modified device is comparable to the predicate.

Heidelberg Engineering performed bench testing including bench testing of OCT imaging properties, validation and verification activities, and ongoing quality control, to confirm that the modified SPECTRALIS HRA+OCT functions equivalently to the predicate SPECTRALIS HRA+OCT.

The modifications to the device do not raise issues of safety and effectiveness. A comparison of technological characteristics and non-clinical performance testing demonstrate that the SPECTRALIS device is substantially equivalent to the unmodified predicate device.

CONCLUSION

Comparison of technological characteristics and evaluation of non-clinical performance testing show that the modifications to the SPECTRALIS HRA+OCT and variants do not introduce any new potential safety risk and the device is as safe and effective as the predicate devices, therefore supporting a determination of substantial equivalence.

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.

	PREDICATE DEVICEK192391 SPECTRALISHRA+OCT	SUBJECT DEVICE	Discussion
Device classificationname	Optical CoherenceTomographer (OCT)	Optical CoherenceTomographer (OCT)	Same
Technology and opticalsetup	Confocal Scanning LaserOphthalmoscope (SLO) andSpectral-Domain OpticalCoherence Tomograph(OCT)	Confocal Scanning LaserOphthalmoscope (SLO) andSpectral-Domain OpticalCoherence Tomograph(OCT)	Same
Lights sources andwavelength of lightemitted	Near infrared reflectanceimages: diode laser, 815nm Blue light reflectanceimages: diode laser, 486nm, or optically pumpedsemiconductor laser, 488nm Green light reflectanceimages: diode laser, 518nm Fluorescein angiography:diode laser, 486 nm, oroptically pumpedsemiconductor laser, 488nm Indocyanine greenangiography: diode laser,786 nm Optical coherencetomography:superluminescence diode,840 nm to 920 nm(weighted average 880nm)	Near infrared reflectanceimages: diode laser, 815nm Blue light reflectanceimages: diode laser, 486nm, or optically pumpedsemiconductor laser, 488nm Green light reflectanceimages: diode laser, 518nm Fluorescein angiography:diode laser, 486 nm, oroptically pumpedsemiconductor laser, 488nm Indocyanine greenangiography: diode laser,786 nm Optical coherencetomography:superluminescence diode,840 nm to 920 nm(weighted average 880nm)	Same
Amount of lightirradiated to retina(exposure)	Low amount, does notexceed Class I laseraccessible emission limits	Low amount, does notexceed Class I laseraccessible emission limits	Same
Accessory objectivelenses (besides StandardObjective)	Anterior Segment Module(ASM)Wide Field Objective (WFO)Ultra Widefield Objective(UWF)High Magnification Module(HMM)	Anterior Segment Module(ASM)Wide Field Objective (WFO)Ultra Widefield Objective(UWF)High Magnification Module(HMM)	Same
	PREDICATE DEVICEK192391 SPECTRALISHRA+OCT	SUBJECT DEVICE	Discussion
Lateral field of view(SLO)	SO (standard objective):$15°$ x $15°$ to $30°$ x $30°$HMM:$8°$WFO/WFO2:$25°$ x $25°$ to Ø $55°$UWF Objective:$51°$ x $51°$ to Ø $102°$	SO (standard objective):$15°$ x $15°$ to $30°$ x $30°$HMM:$8°$WFO/WFO2:$25°$ x $25°$ to Ø $55°$UWF Objective:$51°$ x $51°$ to Ø $102°$	Same
Lateral digital resolution(SLO)	high speed mode: 3µm(HMM), 11 µm (SO) to 40µm (UWF)high resolution mode: 1.5µm(HMM), 6 µm (SO) to 20 µm(UWF)	high speed mode: 3µm(HMM), 11 µm (SO) to 40µm (UWF)high resolution mode: 1.5µm(HMM), 6 µm (SO) to 20 µm(UWF)	Same
Lateral opticalresolution (OCT)	14 µm (standard objective)24 µm (WFO/WFO2)	14 µm (standard objective)24 µm (WFO/WFO2)	Same
Optical depth resolution(OCT)	7 µm	7 µm	Same
Digital image size(SLO)	High Speed mode: 384x384pixels to 768x768 pixels;(with HMM: 768x768 pixelsonly)High Resolution mode:768x768 to 1536 x 1536pixels; (with HMM: 1536 x1536 pixels only)	High Speed mode: 384x384pixels to 768x768 pixels;(with HMM: 768x768 pixelsonly)High Resolution mode:768x768 to 1536 x 1536pixels; (with HMM: 1536 x1536 pixels only)	Same
OCT acquisition speed(Maximum A-scan rate)	40 kHz (Firewire)85 kHz (Thunderbolt)	40 kHz (Firewire)85 kHz (Thunderbolt)	Same
OCT Scanner Controller	Standard controller	Updated controller	Different; theupdatedcontrollerreduces scannernon-linearity,repositioningerror and settletimes
	PREDICATE DEVICEK192391 SPECTRALISHRA+OCT	SUBJECT DEVICE	Discussion
OCT Beam Splitter	Standard coating	Modified coating	Different;coatingmodified toallow morelight to thereference arm
OCT imaging modes	StandardEnhanced Depth Imaging(EDI)	StandardEnhanced Depth Imaging(EDI)Enhanced Vitreous Imaging(EVI)	Different:Addition ofEVI mode
OCTA scan types	Volume	VolumeOCTA ScoutOCTA DART VolumeOCTA DART Line	Different:AdditionalpredefinedOCTA scanpattern