(49 days)
Not Found
No
The document does not mention the use of AI, DNN, or ML models.
No.
The device is described as a "non-contact ophthalmic diagnostic imaging device" intended for "viewing the posterior segment of the eye" and as "an aid in the detection and management of various ocular diseases." It acquires images and performs measurements, but does not provide treatment or directly modify anything for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device." It further elaborates that it is an "aid in the detection and management of various ocular diseases."
No
The device description clearly states it is a combination of a confocal laser-scanning ophthalmoscope (cSLO) and a spectral-domain optical coherence tomographer (SD-OCT), both of which are imaging hardware components. The modifications described are related to scan acquisitions and display settings for an OCT Angiography Module, which is part of the hardware system.
No.
The device is a diagnostic imaging device that views anatomical structures of the eye but does not analyze samples taken from the body.
N/A
Intended Use / 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 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)
Product codes
OBO, MYC
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.
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 250 kHz
- Update of the default contrast display setting from 1:4 to 1:2 for the Superficial Vascular Complex (SVC) and the Deep Vascular Complex (DVC) for the acquisition speeds of 125 kHz and 250 kHz
Mentions image processing
OCT real-time image processing
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Confocal Scanning Laser Ophthalmoscopy (cSLO), Spectral-Domain Optical Coherence Tomography (SD-OCT), Fluorescence Angiography, Autofluorescence Imaging, MultiColor imaging, OCT Angiography.
Anatomical Site
posterior segment of the eye, anterior and posterior segments of the human eye, retina, choroid, retinal nerve fiber layer, optic nerve head.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
One retrospective image grading case study (S-2023-1) was performed using clinical data collected prospectively (S-2020-5) at a single clinical site, located in the United States.
In S-2023-1, grading data was collected for agreement analysis to show substantial equivalence between the investigational study device and stated predicate. Using scan data of the effectiveness analysis population acquired in S-2020-5, OCTA study scans were masked and imported into the investigational software which displayed the predicate scan types (cleared contrast settings) and investigational scan types (including updated contrast settings) for grading to be performed by a Reading Center.
Three independent reviewers from the Reading Center graded the OCTA scans on image quality, visibility of key anatomical vascular structures, and identification of pathologies.
There were two study populations, the "Normal population" (without ocular pathology) and the "Pathology population" (those with retinal vascular pathologies affecting different anatomic depths through the retina and choroid). In the S-2020-5 study, eighty-six (86) subjects signed the informed consent form and were enrolled. The effectiveness analysis population consisted of 79 subjects. All 25 Normal subjects and 54 Pathology subjects from the S-2020-5 effectiveness analysis population were included in this retrospective study. However, this effectiveness count ranges from 74 to 78 subjects for direct comparison between the predicate device and the investigational device depending on the scan type.
Based on the eye examination, the eyes in the Normal population did not have any retinal conditions or abnormalities reported. The eyes in the Pathology population had the highest frequency of the following retinal conditions: wet age-related macular degeneration (nARMD) (16.7%), non-proliferative diabetic retinopathy (NPDR) (16.7%), proliferative diabetic retinopathy (PDR) (37.0%), and macular telangiectasia (Mac Tel) (14.8%). The highest reported abnormalities in the Pathology population were microaneurysm (MA) (46.3%), choroidal neovascularization (CNV) (24.1%), and retinal neovascularization (RNV) (20.4%).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: Retrospective image grading case study (S-2023-1) using prospectively collected data (S-2020-5).
Sample size: Effectiveness analysis population consisted of 79 subjects (25 Normal, 54 Pathology). Direct comparison effectiveness count between predicate and investigational device ranged from 74 to 78 subjects depending on scan type.
Key results:
- Overall image quality (percentage of images graded better than Poor - Good or Average):
- HR10 @ 125 kHz: 97.4%
- HR10 @ 250 kHz: 96.1%
- HS20 @ 125 kHz: 96.2%
- HS20 @ 250 kHz: 93.3%
- Scout @ 125 kHz: 98.7%
- Visualization of key anatomic structures (percentage of structures graded better than Unable to Distinguish - Easy, Difficult or Not Applicable):
- HR10 @ 125 kHz: ≥ 92.3%
- HR10 @ 250 kHz: ≥ 94.8%
- HS20 @ 125 kHz: ≥ 96.2%
- HS20 @ 250 kHz: ≥ 93.3%
- Scout @ 125 kHz: ≥ 96.2%
- Agreement in identification of vascular abnormalities (between predicate and investigational scan types):
- Microaneurysms (MAs): Agreement rate, positive percent agreement (PPA; with some exceptions) and negative percent agreement (NPA) were ≥ 86.4%.
- Retinal ischemia (RI): Agreement rate, PPA and NPA were ≥ 77.4%.
- Retinal neovascularization (RNV): Agreement rate, PPA and NPA were ≥ 88.9%.
- Choroidal neovascularization (CNV): Agreement rate, PPA and NPA were ≥ 88.9%.
- Agreement in identification of the primary vascular abnormality of interest (PVAOI):
- 10x10 HR scan types: Agreement rate, PPA and NPA was at least 80%.
- 20x20 HS scan types: Agreement rate, PPA and NPA was at least 83.3%.
The results showed the ability to identify each pre-specified vascular abnormality is similar between the predicate and investigational scan types.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive percent agreement (PPA), Negative percent agreement (NPA), Agreement rate.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
FDA Clearance Letter for SPECTRALIS HRA+OCT
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 7 . 0 5
Silver Spring, MD 20993
www.fda.gov
May 12, 2025
Heidelberg Engineering GmbH
℅ Lena Sattler
Consultant
Orasi Consulting, LLC.
226 1st Street
Bonita Springs, Florida 34134
Re: K250868
Trade/Device Name: SPECTRALIS HRA+OCT and variants
Regulation Number: 21 CFR 886.1570
Regulation Name: Ophthalmoscope
Regulatory Class: Class II
Product Code: OBO
Dated: March 21, 2025
Received: March 24, 2025
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.
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K250868 - Lena Sattler Page 2
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).
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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K250868 - Lena Sattler Page 3
assistance/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. Ng -S
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
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.
Page 5
510(K) SUMMARY
Date Prepared March 20, 2025
SPONSOR/510(K) OWNER/ MANUFACTURER
Heidelberg Engineering GmbH
Max-Jarecki-Strasse 8
69115 Heidelberg, Germany
Telephone: +49 6221 / 64 63 0
Facsimile: +49 6221 / 64 63 62
Email: arianna.schoess.vargas@heidelbergengineering.com
Establishment Registration No.: 8043762
OFFICIAL CONTACT PERSON
Lena Sattler
Orasi Consulting, LLC.
226 1st Street
Bonita Springs, FL 34134
Telephone: (440) 554-3706
Facsimile: (866) 904-4315
E-mail: 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
Heidelberg Engineering GmbH
K250868 Traditional 510(k): SPECTRALIS
Page 1 of 10
Page 6
PREDICATE DEVICE
SPECTRALIS HRA+OCT and variants (K240221), 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 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)
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
Heidelberg Engineering GmbH
K250868 Traditional 510(k): SPECTRALIS
Page 2 of 10
Page 7
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.
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 250 kHz
- Update of the default contrast display setting from 1:4 to 1:2 for the Superficial Vascular Complex (SVC) and the Deep Vascular Complex (DVC) for the acquisition speeds of 125 kHz and 250 kHz
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 (K240221) 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.
Heidelberg Engineering GmbH
K250868 Traditional 510(k): SPECTRALIS
Page 3 of 10
Page 8
INDICATIONS FOR USE STATEMENT CHART
| PREDICATE DEVICE K240221 SPECTRALIS HRA+OCT | SUBJECT DEVICE SPECTRALIS HRA+OCT | Same or Different |
|---|---|---|
| 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) | 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) | Same |
Heidelberg Engineering GmbH
K250868 Traditional 510(k): SPECTRALIS
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TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART
| PREDICATE DEVICE K240221 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 angiography: 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 angiography: 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 |
Heidelberg Engineering GmbH
K250868 Traditional 510(k): SPECTRALIS
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| PREDICATE DEVICE K240221 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: -12to +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) | |||
| 125 kHz (Thunderbolt), for OCT Angiography only | 40 kHz (Firewire) | ||
| 85 kHz (Thunderbolt) | |||
| 125 kHz (Thunderbolt), for OCT Angiography only | |||
| 250 kHz (Thunderbolt), for OCT Angiography only | Different: Additional scan speed for OCTA | ||
| Default contrast setting (OCTA) | 1:4 Superficial Vascular Complex (SVC) | ||
| 1:4 Deep Vascular Complex (DVC) | 125 kHz and 250 kHz: | ||
| 1:2 Superficial Vascular Complex (SVC) | |||
| 1:2 Deep Vascular Complex (DVC) | Similar: Same except for the SVC and DVC at faster scan speeds | ||
| OCT real-time image processing | GPU (optional; with suitable graphics card only) | ||
| CPU (else) | GPU (optional; with suitable graphics card only) | ||
| CPU (else) | Same | ||
| 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 | ||
| Lateral field of view (OCT) | Standard objective lens: 15°-30° | ||
| WFO2: 25°-55° | Standard objective lens: 15°-30° | ||
| WFO2: 25°-55° | Same | ||
| Lateral digital resolution (SLO) | High speed mode: 3 µm (HMM), 11 μm (SO) to 40 μm (UWF) | ||
| High resolution mode: 1.5µm (HMM), 6 μm (SO) to 20 μm (UWF) | High speed mode: 3 µm (HMM), 11 μm (SO) to 40 μm (UWF) | ||
| High resolution mode: 1.5µm (HMM), 6 μm (SO) to 20 μm (UWF) | Same | ||
| Lateral digital resolution (OCT) | Standard and WFO2 objective lenses: same as SLO | Standard and WFO2 objective lenses: same as SLO | Same |
| Digital axial resolution (pixel size OCT) | 3.9 µm | 3.9 µm | Same |
| Digital image size (SLO) | High speed mode: 384x384 pixels to 768x768 pixels | ||
| high resolution mode: 768x768 to 1536x1536 pixels | High speed mode: 384x384 pixels to 768x768 pixels | ||
| high resolution mode: 768x768 to 1536x1536 pixels | Same |
Heidelberg Engineering GmbH
K250868 Traditional 510(k): SPECTRALIS
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| PREDICATE DEVICE K240221 SPECTRALIS HRA+OCT | SUBJECT DEVICE SPECTRALIS HRA+OCT | Same or Different | |
|---|---|---|---|
| Acquisition of three-dimensional images | Yes | ||
| HRA: stacks of confocal section images; | |||
| OCT: OCT volume scan | Yes | ||
| HRA: stacks of confocal section images; | |||
| OCT: OCT volume scan | Same | ||
| Image compression | No | No | Same |
| Display of the data | Images are visible on a standard PC-Monitor | Images are visible on a standard PC-Monitor | Same |
| Physical layout | • Instrumentation mount with headrest | ||
| • optical camera head | |||
| • power supply and spectrometer unit | |||
| • touch panel | |||
| • computer with monitor, keyboard, mouse, and printer | • Instrumentation mount with headrest | ||
| • optical camera head | |||
| • power supply and spectrometer unit | |||
| • touch panel | |||
| • computer with monitor, keyboard, mouse, and printer | Same | ||
| Flammability of the materials | The metal housing of the device prevents flammability | The metal housing of the device prevents flammability | Same |
| Standard Objective Lens | 19.5 mm working distance, 31 mm length, 49 outer mm diameter | 19.5 mm working distance, 31 mm length, 49 outer mm diameter | Same |
| High Magnification Module (HMM) | 50 mm working distance, 29 mm length, 49 mm outer diameter; | ||
| not used for measurements; | 50 mm working distance, 29 mm length, 49 mm outer diameter; | ||
| not used for measurements; | Same | ||
| Anterior Segment Module (ASM) Objective Lens | 12 mm working distance, 65 mm length, 49.5 mm outer diameter | ||
| 30° field of view | |||
| not used for measurements | 12 mm working distance, 65 mm length, 49.5 mm outer diameter | ||
| 30° field of view | |||
| not used for measurements | Same | ||
| Wide Field Objective (WFO2) | 10 mm working distance, 46 mm length, 49mm outer diameter; | ||
| 55° field of view; not used for measurements; | |||
| WFO2 has the same design and optical layout as WFO, but an improved anti-reflective coating | 10 mm working distance, 46 mm length, 49mm outer diameter; | ||
| 55° field of view; not used for measurements; | |||
| WFO2 has the same design and optical layout as WFO, but an improved anti-reflective coating | Same | ||
| Ultra-Widefield (UWF) Accessory Objective Lens | 7.8 mm working distance, 167 mm length, 80 mm outer diameter; | ||
| 102° field of view; | |||
| not used for measurements | 7.8 mm working distance, 167 mm length, 80 mm outer diameter; | ||
| 102° field of view; | |||
| not used for measurements | Same | ||
| Supported Operating System | Windows 10 | ||
| Windows 11 | Windows 10 | ||
| Windows 11 | Same |
Heidelberg Engineering GmbH
K250868 Traditional 510(k): SPECTRALIS
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NON-CLINICAL PERFORMANCE TESTING
Software documentation was provided, and software verification and validation were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions."
Documentation regarding cybersecurity was submitted as recommended by FDA's Guidance for Industry and FDA Staff, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
Documentation regarding cybersecurity was submitted as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" and an overall risk assessment regarding security and safety of the device was conducted due to ISO 14971:2019.
Tests for electrical safety (IEC 60601-1:2020) and electromagnetic compatibility (IEC 60601-1-2:2020 and IEC TR 60601-4-2: 2016) were performed with the SPECTRALIS HRA+OCT device and passed the relevant requirements of the applied standards
Laser safety testing for the light sources used in the SPECTRALIS HRA+OCT device was provided and showed that the requirements according to FDA recognized standard ANSI Z80.36:2021 was fulfilled.
Biocompatibility of the device was previously demonstrated by cytotoxicity testing, skin sensitization testing and chemical analysis according to ISO 10993-5:2009, ISO 10993-10:2021 and ISO 10993-18:2005, respectively, and supported by biocompatibility assessment according to 10993-1:2018. The test results remain valid for the subject SPECTRALIS.
CLINICAL PERFORMANCE TESTING
One retrospective image grading case study (S-2023-1) was performed using clinical data collected prospectively (S-2020-5) at a single clinical site, located in the United States, to demonstrate substantial equivalence in support of this 510(k) submission to add investigational OCTA scan types [HR10 @ 250 kHz, HS20 @ 250 kHz] to the SPECTRALIS with OCT Angiography Module (OCTA Module) device and set the default contrast display settings for Superficial Vascular Complex and Deep Vascular Complex to 1:2 for 125 kHz [HR10, HS20 and Scout] and 250 kHz [HR10 and HS20] acquisitions. The predicate device used in the study was the cleared SPECTRALIS HRA+OCT with OCTA Angiography Module scan types [HR10 @ 85 kHz, HS20 @ 85 kHz].
In S-2023-1, grading data was collected for agreement analysis to show substantial equivalence between the investigational study device and stated predicate. Using scan data of the effectiveness analysis population acquired in S-2020-5, OCTA study scans were masked and imported into the investigational software which displayed the predicate scan types (cleared contrast settings) and investigational scan types (including updated contrast settings) for grading to be performed by a Reading Center.
Heidelberg Engineering GmbH
K250868 Traditional 510(k): SPECTRALIS
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Three independent reviewers from the Reading Center graded the OCTA scans on image quality, visibility of key anatomical vascular structures, and identification of pathologies.
There were two study populations, the "Normal population" (without ocular pathology) and the "Pathology population" (those with retinal vascular pathologies affecting different anatomic depths through the retina and choroid). In the S-2020-5 study, eighty-six (86) subjects signed the informed consent form and were enrolled. The effectiveness analysis population consisted of 79 subjects. All 25 Normal subjects and 54 Pathology subjects from the S-2020-5 effectiveness analysis population were included in this retrospective study. However, this effectiveness count ranges from 74 to 78 subjects for direct comparison between the predicate device and the investigational device depending on the scan type.
Based on the eye examination, the eyes in the Normal population did not have any retinal conditions or abnormalities reported. The eyes in the Pathology population had the highest frequency of the following retinal conditions: wet age-related macular degeneration (nARMD) (16.7%), non-proliferative diabetic retinopathy (NPDR) (16.7%), proliferative diabetic retinopathy (PDR) (37.0%), and macular telangiectasia (Mac Tel) (14.8%). The highest reported abnormalities in the Pathology population were microaneurysm (MA) (46.3%), choroidal neovascularization (CNV) (24.1%), and retinal neovascularization (RNV) (20.4%).
The results of this study showed that when evaluating performance of the investigational SPECTRALIS scan types at acquiring clinically acceptable images, summarized based on the percentage of images graded better than Poor (i.e., Good or Average) on consensus in the effectiveness population, overall image quality was sufficient to assess the clinically relevant content in 97.4% of HR10 @ 125 kHz, 96.1% of HR10 @ 250 kHz, 96.2% of HS20 @ 125 kHz, 93.3% of HS20 @ 250 kHz, and 98.7% of Scout @ 125 kHz images. Additionally, based on the percentage of structures graded better than Unable to Distinguish (i.e., Easy, Difficult or Not Applicable), visualization of key anatomic structures on the investigational SPECTRALIS scan types was achieved on at least 92.3% of assessments performed on the HR10 @ 125 kHz scan type, ≥ 94.8% on HR10 @ 250 kHz, ≥ 96.2% on HS20 @ 125 kHz, ≥ 93.3% on HS20 @ 250 kHz, and ≥ 96.2% on Scout @ 125 kHz.
For the agreement in identification of vascular abnormalities [microaneurysms (MA), retinal ischemia (RI), retinal neovascularization (RNV), choroidal neovascularization (CNV)] between the predicate scan types and the corresponding investigational scan types, agreement was assessed by the vascular abnormalities identified from the predicate scan types. For both the 10x10 HR and 20x20 HS scan patterns, in all subject populations, agreement rate, positive percent agreement (PPA; with some exceptions) and negative percent agreement (NPA) were ≥ 86.4% for MAs, ≥ 77.4% for retinal ischemia, ≥ 88.9% for RNV, and ≥ 88.9% for CNV. Similarly, for identification of the primary vascular abnormality of interest (PVAOI), agreement rate, PPA and NPA was at least 80% for the 10x10 HR scan types and at least 83.3% for 20x20 HS scan types, in all subject populations. The results are similar between the investigational scan types and the predicate scan types, indicating that the ability to identify each pre-
Heidelberg Engineering GmbH
K250868 Traditional 510(k): SPECTRALIS
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specified vascular abnormality is similar between the predicate and investigational scan types.
CONCLUSION
The modified SPECTRALIS HRA+OCT and variants measures the same ophthalmic features as the predicate SPECTRALIS HRA+OCT cleared in K240221. The additional scan speed of 250 kHz and the implementation of a default contrast display setting of 1:2 for SVC and DVC for 125 kHz and 250 kHz do not change the fundamental technology, the type of acquired images, the intended patient populations, or that the SPECTRALIS may be used as an aid to clinical evaluation. Results of the non-clinical performance testing demonstrate that the subject SPECTRALIS device functions as intended. The clinical study shows similar results for the predicate and investigational scan types for the SPECTRALIS with OCTA Module with regard to image quality, the ability to visualize key vascular anatomical structures, and the ability to identify various vascular abnormities. The non-clinical and clinical performance testing demonstrate that the subject SPECTRALIS device is as safe, as effective, and thus substantially equivalent to the predicate device.
Heidelberg Engineering GmbH
K250868 Traditional 510(k): SPECTRALIS
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