(329 days)
Not Found
No
The document describes standard ophthalmic imaging technologies (cSLO, SD-OCT) and image processing techniques. While it mentions "Regression analysis in Glaucoma Module Premium Edition," regression analysis is a statistical method and does not inherently imply the use of AI/ML. There are no mentions of AI, ML, deep learning, neural networks, or any related concepts in the intended use, device description, or performance studies summary. The focus is on hardware modifications, software updates for compatibility and artifact suppression, and standard statistical analysis for comparison to reference databases.
No
The device is used for diagnostic imaging and measurements, aiding in the detection and management of ocular diseases, but it does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device." It further elaborates on its use 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 used for imaging. The 510(k) also details the lasers and diodes used for imaging.
Based on the provided text, the SPECTRALIS device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- SPECTRALIS Function: The SPECTRALIS device is described as a "non-contact ophthalmic diagnostic imaging device." It directly images the posterior and anterior segments of the eye using light and lasers. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "viewing the posterior segment of the eye," "cross-sectional imaging," "fundus imaging," "fluorescence imaging," "autofluorescence imaging," and "performing measurements of ocular anatomy and ocular lesions." These are all direct imaging and measurement activities on the living eye.
- Device Description: The description details the use of light sources (lasers, superluminescent diode) and imaging techniques (cSLO, SD-OCT) to capture images of the eye. There is no mention of handling or analyzing biological specimens.
Therefore, the SPECTRALIS device falls under the category of an in vivo diagnostic imaging device, 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 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 superluminescent diode and a spectral interferometer are used to create the cross-sectional images.
The following changes have been applied to the device subject of this 510(k):
- Widefield Reflectance mode for artifacts suppression
- Regression analysis in Glaucoma Module Premium Edition
- Thunderbolt 3 interface
- Thunderbolt cable fan
- Process separation of acquisition software module
- Windows 11 Support
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Confocal Laser-Scanning Ophthalmoscopy (cSLO), Spectral-Domain Optical Coherence Tomography (SD-OCT), fluorescence angiography, autofluorescence imaging, MultiColor imaging.
Anatomical Site
Posterior segment of the eye, human eye, retina, choroid.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was conducted on the modified SPECTRALIS HRA+OCT to verify that the device is safe and effective for its intended use and indications for use. No data from human clinical studies has been included to support the substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
October 20, 2023
Image /page/0/Picture/1 description: The image contains 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: K223557
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: September 15, 2023 Received: September 15, 2023
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 mediation-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. 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
2
Enclosure
3
Indications for Use
510(k) Number (if known) K223557
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)
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/1 description: The image contains the logo for Heidelberg Engineering. The logo consists of two lines of text in a bold, sans-serif font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a red square to the left of the word "HEIDELBERG" and to the right of the word "ENGINEERING".
510(K) SUMMARY
Date Prepared
October 20, 2023
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: aschoess@hdeng.de 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
6
PREDICATE DEVIC
SPECTRALIS HRA+OCT and variants (K201252), 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 threedimensional 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)
7
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 laserscanning 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 cross-sectional images.
The following changes have been applied to the device subject of this 510(k):
- Widefield Reflectance mode for artifacts suppression ●
- Regression analysis in Glaucoma Module Premium Edition .
- Thunderbolt 3 interface ●
- . Thunderbolt cable fan
- Process separation of acquisition software module ●
- Windows 11 Support
COMPARISON BETWEEN THE SUBJECT AND THE PREDICATE DEVICE
The modified SPECTRALIS HRA+OCT is a device modification to the cleared SPECTRALIS HRA+OCT and variants (K201252) predicate device. Technological detail characteristics of the device are unchanged except for the modification as stated in the General Device Description. 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
| K221252 PREDICATE DEVICE | SUBJECT DEVICE | Same or
Different | |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| The SPECTRALIS is a non-contact ophthalmic | The SPECTRALIS is a non-contact ophthalmic | Same | |
| diagnostic imaging device. It is intended for: | diagnostic imaging device. It is intended for: | | |
| • viewing the posterior segment of the eye, | • viewing the posterior segment of the eye, | | |
| including two- and three-dimensional imaging | including two- and three-dimensional imaging | | |
| • cross-sectional imaging (SPECTRALIS | • cross-sectional imaging (SPECTRALIS | | |
| HRA+OCT and SPECTRALIS OCT) | HRA+OCT and SPECTRALIS OCT) | | |
| • fundus imaging | • fundus imaging | | |
| • fluorescence imaging (fluorescein | • fluorescence imaging (fluorescein | | |
| angiography, indocyanine green angiography; | angiography, indocyanine green angiography; | | |
| SPECTRALIS HRA+OCT, SPECTRALIS | SPECTRALIS HRA+OCT, SPECTRALIS | | |
| HRA) | HRA) | | |
| • autofluorescence imaging (SPECTRALIS | • autofluorescence imaging (SPECTRALIS | | |
| HRA+OCT, SPECTRALIS HRA and | HRA+OCT, SPECTRALIS HRA and | | |
| SPECTRALIS OCT with BluePeak) | SPECTRALIS OCT with BluePeak) | | |
| • performing measurements of ocular anatomy | • performing measurements of ocular anatomy | | |
| and ocular lesions. | and ocular lesions. | | |
| The device is indicated as an aid in the | The device is indicated as an aid in the | | |
| detection and management of various ocular | detection and management of various ocular | | |
| diseases, including: | diseases, including: | | |
| • age-related macular degeneration | • age-related macular degeneration | | |
| • macular edema | • macular edema | | |
| • diabetic retinopathy | • diabetic retinopathy | | |
| • retinal and choroidal vascular diseases | • retinal and choroidal vascular diseases | | |
| • glaucoma | • glaucoma | | |
| The device is indicated for viewing geographic | The device is indicated for viewing geographic | | |
| atrophy. | atrophy. | | |
| The SPECTRALIS OCT Angiography Module | The SPECTRALIS OCT Angiography Module | | |
| is indicated as an aid in the visualization of | is indicated as an aid in the visualization of | | |
| vascular structures of the retina and choroid. | vascular structures of the retina and choroid. | | |
| The SPECTRALIS HRA+OCT and | The SPECTRALIS HRA+OCT and | | |
| SPECTRALIS OCT include the following | SPECTRALIS OCT include the following | | |
| reference databases: | reference databases: | | |
| • a retinal nerve fiber layer thickness reference | • a retinal nerve fiber layer thickness reference | | |
| database, which is used to quantitatively | database, which is used to quantitatively | | |
| compare the retinal nerve fiber layer in the | compare the retinal nerve fiber layer in the | | |
| human retina to values of Caucasian normal | human retina to values of Caucasian normal | | |
| subjects – the classification result being valid | subjects - the classification result being valid | | |
| only for Caucasian subjects | only for Caucasian subjects | | |
| • a reference database for retinal nerve fiber | • a reference database for retinal nerve fiber | | |
| layer thickness and optic nerve head | layer thickness and optic nerve head | | |
| neuroretinal rim parameter measurements, | neuroretinal rim parameter measurements, | | |
| which is used to quantitatively compare the | which is used to quantitatively compare the | | |
| retinal nerve fiber layer and neuroretinal rim in | retinal nerve fiber layer and neuroretinal rim in | | |
| the human retina to values of normal subjects | the human retina to values of normal subjects | | |
| of different races and ethnicities representing | of different races and ethnicities representing | | |
| the population mix of the USA (Glaucoma | the population mix of the USA (Glaucoma | | |
| Module Premium Edition) | Module Premium Edition) | | |
| | PREDICATE DEVICE
K201252 SPECTRALIS | SUBJECT DEVICE | Same or
Different |
| | HRA+OCT | | |
| Device
classification
name | Optical Coherence
Tomographer (OCT) | Optical Coherence
Tomographer (OCT) | Same |
| Technology
and optical
setup | Confocal Scanning Laser
Ophthalmoscope (SLO) and
Spectral- Domain Optical
Coherence Tomograph (OCT) | Confocal Scanning Laser
Ophthalmoscope (SLO) and
Spectral- Domain Optical
Coherence Tomograph (OCT) | Same |
| 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: | • 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: | 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 um (standard objective)
24 um (WFO2) | 14 um (standard objective)
24 um (WFO2) | Same |
| 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 um | 7 um | Same |
| OCT
acquisition
speed
(Maximum A-
scan rate) | 40 kHz (Firewire)
85 kHz (Thunderbolt) Has
possibility for higher speeds
(future submission) | 40 kHz (Firewire)
85 kHz (Thunderbolt) Has
possibility for higher speeds
(future submission) | Same |
| OCT
acquisition
modes | Standard Enhanced Depth
Imaging (EDI)
Enhanced Vitreous Imaging
(EVI) | Standard Enhanced Depth
Imaging (EDI)
Enhanced Vitreous Imaging
(EVI) | Same |
| cSLO imaging
modes for
artifact
suppression | Reflectance (R)
Cross-Polarization (XP) | Reflectance (R)
Cross-Polarization (XP)
Widefield Reflectance (WR) | Different;
the WR filter
has been
introduced
for the
modified
device as an
alternative
option to XP |
| OCTA scan
types | Volume OCTA Scout
OCTA DART Volume
OCTA DART Line | Volume OCTA Scout
OCTA DART Volume
OCTA DART Line | Same |
| Lateral field of
view (SLO) | SO (standard objective):
15°x15° to 30 x30°
HMM: 8°x8°
WFO2: 25°x25° to Ø 55°
UWF Objective: 51°x 1°
to Ø102° | SO (standard objective):
15°x15° to 30 x30°
HMM: 8°x8°
WFO2: 25°x25° to Ø 55°
UWF Objective: 51°x 1°
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: 3um (HMM),
11 um (SO) to 40 um (UWF)
high resolution mode:
1.5µm (HMM), 6 µm
(SO) to 20 um (UWF) | high speed mode: 3um (HMM),
11 um (SO) to 40 um (UWF)
high resolution mode:
1.5µm (HMM), 6 µm
(SO) to 20 um (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
1536 x
1536 pixels | high speed mode: 384x384
pixels to 768x768 pixels
high resolution mode: 768x768 to
1536 x
1536 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 |
| Glaucoma
Module: BMO-
MRW and
RNFL thickness | Measured data points are displayed | Regression line is displayed for
measured data points | Different,
regression
line has been
added for
measured
data |
| Start of the
acquisition
module software | The acquisition module software is
loaded by HEYEX as DLL file | New proxy DLL is loaded by
Heyex and starts the acquisition
module software as a new process | Different;
the HEYEX
and AQM
software
memory
have been
separated |
| 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 |
| Thunderbolt
Interface | • Thunderbolt-2 Interface | • Thunderbolt-3 Interface with
additional fan | Different;
TDI-3 is
applied
because of
discontinued
TDI-2,
additional
cooling of
Thunderbolt
cable |
| Flammability of
the materials | The metal housing of the device | The metal housing of the device | 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) | 50mm working distance, 29mm
length, 49mm outer diameter;
not used for measurements | 50mm working distance, 29mm
length, 49mm 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, 49 mm
outer diameter;
55° field of view; not used for
| 10 mm working
distance, 46 mm length, 49 mm
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 10
Windows 11 | Different;
Windows 11
is supported
in addition
to Windows
10 |
9
TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART
10
11
12
NON-CLINICAL PERFORMANCE TESTING
The modified SPECTRALIS was evaluated according to the requirements of FDA recognized consensus standards:
- . ISO 14971: 2019 Medical Devices - Application of Risk Management to Medical Devices,
- AAMI / ANSI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and . A2:2010/(R)2012 Edition 3.1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance,
- . IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests,
- IEC 62304 Edition 1.1 2015-06: Medical Device Software Software Life ● Cycle Processes,
and was found to meet the requirements of the applicable parts, demonstrating that the safety and efficacy of the modified device is comparable to the predicate.
13
Software documentation was provided, and software verification and validation was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
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".
CLINICAL PERFORMANCE TESTING
No data from human clinical studies has been included to support the substantial equivalence of the modified SPECTRALIS HRA+OCT and variants with the cleared SPECTRALIS device (K201252).
CONCLUSION
The modified SPECTRALIS HRA+OCT and variants measures the same ophthalmic features as the cleared SPECTRALIS HRA+OCT in K201252. The changes applied to the SPECTRALIS since the clearance in K201252 introduce an additional cSLO imaging suppression mode, a regression line for measured data in the Glaucoma Module, Thunderbolt-3 interface with cable fan and a separated start of the acquisition software module. They 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.
Non-clinical performance testing was conducted on the modified SPECTRALIS HRA+OCT to verify that the device is safe and effective for its intended use and indications for use.
The modifications to the device do not raise issues of safety and effectiveness. A comparison of technological characteristics and non-clinical performance testing demonstrate that the modified SPECTRALIS device is substantially equivalent to the predicate device.