(157 days)
No
The document describes standard ophthalmic imaging technologies (OCT, SLO, angiography) and image processing techniques. While it mentions reference databases for comparison, there is no indication of AI/ML being used for image analysis, diagnosis, or any other function. The addition of a GPGPU is for general-purpose processing, not specifically indicative of AI/ML.
No.
The document states that the device is a "non-contact ophthalmic diagnostic imaging device" and is "indicated as an aid in the detection and management of various ocular diseases." Its function is to view and image the eye, and to perform measurements of ocular anatomy and lesions, which are all diagnostic functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device." It also lists its purpose as an "aid in the detection and management of various ocular diseases."
No
The device description explicitly states it is a combination of a confocal laser-scanning ophthalmoscope (cSLO) and a spectral-domain optical coherence tomographer (SD-OCT), which are hardware components. It also mentions the use of lasers and a superluminescent diode.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device that directly images the posterior segment of the eye. It does not analyze samples taken from the body.
- Intended Use: The intended use describes viewing, imaging, and measuring structures within the eye and aiding in the detection and management of ocular diseases. This is a direct imaging and diagnostic process, not an in vitro test.
- Device Description: The description details the imaging modalities (cSLO and SD-OCT) and the light sources used to acquire images of the eye. It does not mention any components or processes related to analyzing biological samples.
Therefore, the SPECTRALIS falls under the category of an ophthalmic imaging device used for in vivo diagnosis, not an In Vitro Diagnostic device.
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 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)
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 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)
Mentions image processing
OCT real-time image processing
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT), Confocal Laser Scanning Ophthalmoscope (cSLO), Fluorescein Angiography, Indocyanine Green Angiography, Autofluorescence Imaging, MultiColor imaging (infrared, green, and blue reflectance images).
Anatomical Site
posterior segment of the eye, ocular anatomy, ocular lesions, retina, choroid, retinal nerve fiber layer, optic nerve head neuroretinal rim.
Indicated Patient Age Range
The effectiveness analysis population consisted of 79 subjects, 25 Normal subjects and 54 Pathology subjects. All 79 participants in the effectiveness analysis population were 22 years of age or older, met eligibility criteria in at least one eye and were enrolled into either the "Normal population" or the "Pathology population".
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 clinical, prospective, observational case study (S-2020-5) was performed at a single clinical site, located in the United States, to collect data in support of this 510(k) submission to add investigational OCTA scan types [HR10 @ 125 kHz, HS20 @ 125 kHz, Scout @ 125 kHz] to the SPECTRALIS with OCT Angiography Module (OCTA Module) device. 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. 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). Randomization was performed for the following: Eye selection (if applicable), dilated versus undilated OCTA imaging (Normal population only), and scan type order (which includes device order).
Three independent reviewers from a reading center graded the OCTA scans on image quality, visibility of key anatomical vascular structures, and identification of pathologies. The analyses were based on the grading results from the effectiveness analysis population, which included all eligible study eyes with an OCTA image result for at least one investigational scan type (125 kHz) from the reading center.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical, prospective, observational case study (S-2020-5).
Sample Size:
- 86 subjects enrolled.
- 80 subjects completed the study.
- 79 subjects in the effectiveness analysis population (25 Normal, 54 Pathology).
- Safety population: 84 subjects (27 Normal, 57 Pathology).
Key Results:
- Overall Image Quality: For the effectiveness population, 96.2% of HR10 @ 125 kHz, 98.7% of HS20 @ 125 kHz, and 98.7% of Scout @ 125 kHz images from the investigational SPECTRALIS scan types were assessed as having overall image quality sufficient to assess the clinically relevant content.
- Visualization of Key Anatomic Structures: ≥ 92.3% of assessments performed on the HR10 @ 125 kHz scan type, ≥ 93.6% on HS20 @ 125 kHz, and ≥ 96.2% on Scout @ 125 kHz were graded better than "Unable to Distinguish".
- Comparison to Predicate (85 kHz): The investigational SPECTRALIS OCTA images provide similar visibility as compared to the predicate (85 kHz).
- Agreement in Identification of Vascular Abnormalities (MA, RI, RNV, CNV): Agreement rate, PPA (Positive Percent Agreement) and NPA (Negative Percent Agreement) were greater than or equal to 88.7% for all pre-specified vascular abnormalities (except for RI, which was 86.5% in the Pathology population) for both 10x10 HR and 20x20 HS scan patterns, in all subject populations.
- Agreement in Identification of Primary Vascular Abnormality of Interest (PVAOI): Agreement rate, PPA and NPA were at least 85.7% for the 10x10 HR scan types and at least 92.3% for 20x20 HS scan types, in all subject populations.
- Conclusion on Substantial Equivalence: The results are similar between the investigational scan types and the predicate scan types, indicating that the ability to identify each pre-specified vascular abnormality is similar between the predicate and investigational scan types. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement rate, PPA (Positive Percent Agreement) and NPA (Negative Percent Agreement). Numerical values are presented in the "Summary of Performance Studies" section.
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.
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)
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
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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 |
| 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 |
| 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 |
| | PREDICATE DEVICE K223557
SPECTRALIS HRA+OCT | SUBJECT DEVICE
SPECTRALIS HRA+OCT | Same or
Different |
| 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 |
9
TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART
10
iheiderberg ENGINEELING
11
12
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 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.
CLINICAL PERFORMANCE TESTING
One clinical, prospective, observational case study (S-2020-5) was performed at a single clinical site, located in the United States, to collect data in support of this 510(k) submission to add investigational OCTA scan types [HR10 @ 125 kHz, HS20 @ 125 kHz, Scout @ 125 kHz] to the SPECTRALIS with OCT Angiography Module (OCTA Module) device. 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. 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). Randomization was performed for the following: Eye selection (if applicable), dilated versus undilated OCTA imaging (Normal population only), and scan type order (which includes device order).
Three independent reviewers from a reading center graded the OCTA scans on image quality, visibility of key anatomical vascular structures, and identification of pathologies. The analyses were based on the grading results from the effectiveness analysis population, which included all eligible study eyes with an OCTA image result for at least one investigational scan type (125 kHz) from the reading center.
Data were collected for agreement analysis to show substantial equivalence between
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Traditional 510(k): SPECTRALIS Page 8 of 10
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the investigational study device and stated predicate. Eighty-six (86) subjects signed the informed consent form and were enrolled in the study. Of the 86 subjects enrolled, 80 completed the study and six subjects were discontinued. Four subjects (one Normal, three Pathology) were discontinued due to failure to meet inclusion/exclusion criteria, one Pathology subject was discontinued due to "Region of Interest not within view" and one subject was discontinued due to an adverse event1 [subject reported eye pain due to panretinal photocoagulation (PRP) in the fellow eye, which occurred just prior to study imaging]. One Normal subject completed the study but was identified as "Failure to meet inclusion/exclusion criteria" during study monitoring.
The safety population consisted of 84 subjects, 27 Normal subjects and 57 Pathology subjects. The effectiveness analysis population consisted of 79 subjects, 25 Normal subjects and 54 Pathology subjects. However, this effectiveness count ranges for direct comparison between the predicate device and the investigational device depending on the scan type.
All 79 participants in the effectiveness analysis population were 22 years of age or older, met eligibility criteria in at least one eye and were enrolled into either the "Normal population" or the "Pathology population".
The study included 65.8% female and 34.2% male participants. The mean age was 58.6 ± 13.8 years overall, with the Pathology population subjects being older. Ninetyfour percent (94%) were not Hispanic or Latino, and 67% were Caucasian. Thirty percent (30%) were Black/African American and two percent (2%) were Asian.
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 found that based on the proportion of images graded better than Poor on consensus in the effectiveness population, 96.2% of HR10 @ 125 kHz, 98.7% of HS20 @ 125 kHz, and 98.7% of Scout @ 125 kHz images from the investigational SPECTRALIS scan types were assessed as having overall image quality sufficient to assess the clinically relevant content. Additionally, based on the proportion of structures graded better than Unable to Distinguish, 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, ≥ 93.6% on HS20 @ 125 kHz, and ≥ 96.2% on Scout @ 125 kHz. In general, the results demonstrate that the investigational SPECTRALIS OCTA images provide similar visibility as compared to the predicate (85 kHz).
For the agreement in identification of vascular abnormalities [microaneurysms (MA), retinal ischemia (RI), retinal neovascularization (RNV), choroidal neovascularization
I There was only one adverse event that occurred during the course of the study. Heidelberg Engineering GmbH Traditional 510(k): SPECTRALIS K240221 Page 9 of 10
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(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. Agreement rate, PPA and NPA were greater than or equal to 88.7% for all pre-specified vascular abnormalities (except for RI, which was 86.5% in the Pathology population) for both scan patterns (10x10 HR and 20x20 HS), in all subject populations. Similarly, for identification of the primary vascular abnormality of interest (PVAOI), the agreement rate, PPA and NPA was at least 85.7% for the 10x10 HR scan types and at least 92.3% 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-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 cleared SPECTRALIS HRA+OCT in K223557. The additional scan speed and the correlated GPGPU processing 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.