Who is the manufacturer of SPECTRALIS HRA+OCT and variants?

Heidelberg Engineering GmbH filed the 510(k) submission for SPECTRALIS HRA+OCT and variants (K240221).

What is the FDA product code for SPECTRALIS HRA+OCT and variants?

OBO. It is classified under 21 CFR 886.1570 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for SPECTRALIS HRA+OCT and variants?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SPECTRALIS HRA+OCT and variants?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SPECTRALIS HRA+OCT and variants

Q: What are the predicate devices for SPECTRALIS HRA+OCT and variants?

SPECTRALIS HRA+OCT and variants (K223557).

K240221 · Heidelberg Engineering GmbH · OBO · Jul 1, 2024 · Ophthalmic

Device Facts

Record ID	K240221
Device Name	SPECTRALIS HRA+OCT and variants
Applicant	Heidelberg Engineering GmbH
Product Code	OBO · Ophthalmic
Decision Date	Jul 1, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.1570
Device Class	Class 2

Intended Use

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 imaqinq · 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 Story

Non-contact ophthalmic diagnostic imaging device; combines confocal laser-scanning ophthalmoscope (cSLO) and spectral-domain optical coherence tomographer (SD-OCT). Inputs: reflectance, fluorescence, and OCT signals from eye. Operation: uses blue, green, and infrared lasers for cSLO; infrared superluminescent diode and spectral interferometer for SD-OCT. New modification adds 125 kHz scan speed for OCTA and GPGPU for real-time processing. Output: 2D/3D images, cross-sectional scans, and ocular measurements displayed on PC monitor. Used in clinical settings by eye care professionals. Output aids clinicians in detecting/managing ocular diseases (e.g., AMD, glaucoma, diabetic retinopathy) by visualizing vascular structures and retinal anatomy. Benefits: non-invasive diagnostic assessment of ocular pathology.

Clinical Evidence

Prospective, observational study (S-2020-5) of 79 subjects (25 normal, 54 pathology). Compared investigational 125 kHz OCTA scan types to 85 kHz predicate. Primary endpoints: image quality, visualization of vascular structures, and agreement in identifying vascular abnormalities (MA, RI, RNV, CNV). Results: 96.2-98.7% of images rated better than 'Poor'; vascular structure visualization achieved in ≥92.3% of cases. Agreement rates, PPA, and NPA were ≥88.7% for most abnormalities. Study confirms substantial equivalence in diagnostic performance.

Technological Characteristics

Confocal scanning laser ophthalmoscope (cSLO) and spectral-domain OCT. Light sources: laser diodes (486/488nm, 518nm, 786nm, 815nm) and superluminescent diode (840-920nm). Materials: metal housing. Connectivity: PC-based. Software: GPGPU-accelerated processing. Standards: IEC 60601-1, IEC 60601-1-2, ANSI Z80.36, ISO 10993.

Indications for Use

Indicated for patients 22+ years old requiring posterior segment imaging, cross-sectional imaging, fundus imaging, fluorescence/autofluorescence imaging, and ocular measurements. Aids in detection/management of age-related macular degeneration, macular edema, diabetic retinopathy, retinal/choroidal vascular diseases, glaucoma, and geographic atrophy. OCTA module aids visualization of retinal/choroidal vascular structures.

Regulatory Classification

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.

Special Controls

*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 Devices

SPECTRALIS HRA+OCT and variants (K223557)

Related Devices

K223557 — SPECTRALIS HRA+OCT and variants · Heidelberg Engineering GmbH · Oct 20, 2023
K250868 — SPECTRALIS HRA+OCT and variants · Heidelberg Engineering GmbH · May 12, 2025
K201252 — Spectralis HRA+OCT and variants · Heidelberg Engineering GmbH · Sep 9, 2020
K181594 — Spectralis HRA+OCT and variants with OCT Angiography Module · Heidelberg Engineering GmbH · Sep 13, 2018
K231222 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) · Topcon Corporation · Oct 30, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ July 1, 2024 Image /page/0/Picture/1 description: The image shows 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. Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC. 226 1st Street Bonita Springs, Florida 34134 Re: K240221 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: January 26, 2024 Received: May 31, 2024 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, # Elvin Y 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 {2}------------------------------------------------ Enclosure {3}------------------------------------------------ ## Indications for Use Submission Number (if known) K240221 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 imaqinq - · 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) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ 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 says "HEIDELBERG" and the second line says "ENGINEERING". # 510(K) SUMMARY Date Prepared January 25, 2023 ### 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 arianna.schoess.vargas@heidelbergengineering.com 8043762 ### OFFICIAL CONTACT PERSON Lena Sattler Orasi Consulting, LLC. 226 1st Street Bonita Springs, FL 34134 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 | Classification Name: | Tomography, Optical Coherence Ophthalmoscope, Laser, Scanning | |-----------------------|------------------------------------------------------------------| | Medical Specialty: | Ophthalmic | | Device Class: | II | | Classification Panel: | Ophthalmic Device Panel | | Product Codes: | OBO, MYC | ### PRODUCT CODE: CLASSIFICATION / CFR TITLE OBO, MYC: Class II § 21 CFR 886.1570 {6}------------------------------------------------ ### PREDICATE DEVICE SPECTRALIS HRA+OCT and variants (K223557), Heidelberg Engineering GmbH ### INDICATIONS FOR USE 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 ● guantitatively 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) ### GENERAL 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 Heidelberg Engineering GmbH K240221 Traditional 510(k): SPECTRALIS Page 2 of 10 {7}------------------------------------------------ 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 superluminescent diode and a spectral interferometer are used to create the crosssectional images. The following modifications have been applied to the device subject of this 510(k): - . Addition of scan acquisitions for the SPECTRALIS OCT Angiography Module (OCTA) at 125 kH - Addition of a General-Purpose Graphics Processing Unit (GPGPU) . ### COMPARISON BETWEEN THE SUBJECT AND THE PREDICATE DEVICE The modified SPECTRALIS HRA+OCT and variants is a device modification to the cleared SPECTRALIS HRA+OCT and variants (K223557) predicate device. Detailed technological characteristics of the device are unchanged except for the modifications as stated above. The modified SPECTRALIS has the same Indications for Use and maintains the same fundamental scientific technology as the predicate device. The Substantial Equivalence summary tables below illustrate the comparisons of the modified SPECTRALIS to the predicate device. {8}------------------------------------------------ ### INDICATIONS FOR USE STATEMENT CHART | PREDICATE DEVICE K223557 | SUBJECT DEVICE | Same or Different | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | SPECTRALIS HRA+OCT | SPECTRALIS HRA+OCT | | | | 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 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. | Same | | | 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) | 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) | | | | | PREDICATE DEVICE K223557 SPECTRALIS HRA+OCT | SUBJECT DEVICE SPECTRALIS HRA+OCT | Same or Different | | 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 | | Physical Dimensions | • Laser scanning camera: 235 mm x 100 mm x 205 mm • Instrumentation Mount (KT): 470 mm x 325 mm x 550 mm • Power supply including spectrometer: 180 mm x 335 mm x 165 mm • Operation panel: 170 mm x 185 mm x 100 mm | • Laser scanning camera: 235 mm x 100 mm x 205 mm • Instrumentation Mount (KT): 470 mm x 325 mm x 550 mm • Power supply including spectrometer: 180 mm x 335 mm x 165 mm • Operation panel: 170 mm x 185 mm x 100 mm | Same | | Lights sources and wavelength of light emitted | • Near infrared reflectance images: diode laser, 815 nm, • Blue light reflectance images: diode laser, 486 nm, or optically pumped semiconductor laser, 488 nm • Green light reflectance images: diode laser, 518 nm • Fluorescein angiography: diode laser, 486 nm, or optically pumped semiconductor laser, 488 nm • Indocyanine green angio- graphy: diode laser, 786 nm • Optical coherence tomography: superluminescence diode, 840 nm to 920 nm (weighted average 880 nm) | • Near infrared reflectance images: diode laser, 815 nm, • Blue light reflectance images: diode laser, 486 nm, or optically pumped semiconductor laser, 488 nm • Green light reflectance images: diode laser, 518 nm • Fluorescein angiography: diode laser, 486 nm, or optically pumped semiconductor laser, 488 nm • Indocyanine green angio- graphy: diode laser, 786 nm • Optical coherence tomography: superluminescence diode, 840 nm to 920 nm (weighted average 880 nm) | Same | | Wavelength of light detected | • Near infrared reflectance images: 815 nm • Blue light reflectance images: 486-488 nm • Green light reflectance images: 518 nm • Fluorescein angiography: 500 nm to 720 nm • Indocyanine green angiography: 800 nm to 900 nm Optical coherence tomography: 840 nm to 920 nm | • Near infrared reflectance images: 815 nm • Blue light reflectance images: 486-488 nm • Green light reflectance images: 518 nm • Fluorescein angiography: 500 nm to 720 nm • Indocyanine green angiography: 800 nm to 900 nm Optical coherence tomography: 840 nm to 920 nm | Same | | Type of light source used | Laser diodes (LD) and superluminescence diode (SLD) | Laser diodes (LD) and superluminescence diode (SLD) | Same | | Amount of light irradiated to retina (exposure) | Low amount, does not exceed Class I laser accessible emission limits | Low amount, does not exceed Class I laser accessible emission limits | Same | | Lateral optical resolution (OCT) | 14 µm (standard objective) 24 µm (WFO2) | 14 µm (standard objective) 24 µm (WFO2) | Same | | | PREDICATE DEVICE K223557 SPECTRALIS HRA+OCT | SUBJECT DEVICE SPECTRALIS HRA+OCT | Same or Different | | Focus adjustment range | Correction of patient's refractive errors: minimum range: -12 to +12 diopters | Correction of patient's refractive errors: minimum range: -12 to +12 diopters | Same | | Optical depth resolution (OCT) | 7 µm | 7 µm | Same | | OCT acquisition speed modes (A-scan rate) | 40 kHz (Firewire) 85 kHz (Thunderbolt) | 40 kHz (Firewire) 85 kHz (Thunderbolt) 125 kHz (Thunderbolt) for OCT Angiography only | Different; additional scan speed for OCTA | | OCT real-time image processing | CPU | GPU (optional; with suitable graphics card only) CPU (else) | Different; porting of real-time processing to GPU (for all A-scan rates), when scan speed 125 kHz was activated | | OCT acquisition modes | Standard Enhanced Depth Imaging (EDI) Enhanced Vitreous Imaging (EVI) | Standard Enhanced Depth Imaging (EDI) Enhanced Vitreous Imaging (EVI) | Same | | OCTA scan types | Volume OCTA Scout Volume OCTA DART Line | Volume OCTA Scout Volume OCTA DART Line | Same | | Lateral field of view (SLO) | SO (standard objective): 15°x15° to 30x30° HMM: 8°x8° WFO2: 25°x25° to Ø 55° UWF Objective: 51°x1° to Ø102° | SO (standard objective): 15°x15° to 30x30° HMM: 8°x8° WFO2: 25°x25° to Ø 55° UWF Objective: 51°x1° to Ø102° | Same…

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