(30 days)
Not Found
No
The summary describes standard ophthalmic imaging technologies (cSLO and SD-OCT) and a new objective lens. It explicitly states that no quantitative automatic measurements or classifications against reference data are performed on images acquired with the new module. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is described as a non-contact ophthalmic diagnostic imaging device. It is intended for viewing, imaging, and performing measurements to aid in the detection and management of ocular diseases, not for treating them.
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. The submission is for adding an accessory objective lens, also a hardware component.
Based on the provided information, the SPECTRALIS device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- SPECTRALIS Function: The SPECTRALIS device directly images the posterior segment of the eye using non-contact methods (light and lasers). It does not analyze specimens taken from the body.
- Intended Use: The intended use describes the device as a "non-contact ophthalmic diagnostic imaging device" for "viewing the posterior segment of the eye" and "performing measurements of ocular anatomy and ocular lesions." This aligns with in vivo imaging, not in vitro analysis.
- Device Description: The description details the use of light and lasers to acquire images of the eye, further supporting its role as an in vivo imaging device.
Therefore, the SPECTRALIS device falls under the category of an in vivo diagnostic imaging device, not an In Vitro Diagnostic.
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 purpose of this premarket notification [510(k)] is to add the High Magnification Module (HMM) as an optional, exchangeable accessory objective lens to the SPECTRALIS HRA+OCT.
The HMM is offering an 8° field of view (FOV) and allows for cSLO imaging only. It offers a magnified view of parts of the retina with improved resolution. Compared to the standard objective with 30° FOV, it has an approximately 4 times increased digital resolution, with optical resolution approximately 25% improved compared to the standard objective. With the new HMM objective, the digital resolution for a FOV of 8° is 1536x1536 pixels for High Resolution imaging, and 768x768 pixels for High Speed imaging. The functionality for averaging images with the proprietary automatic real-time (ART) eye tracking is still maintained.
cSLO imaging with the HMM is only intended for qualitative use.
- No quantitative automatic measurements are performed on HMM images. -
- No classifications against reference data are performed on HMM images -
Besides the addition of the optional High Magnification Module, the SPECTRALIS device is unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Confocal Scanning Laser Ophthalmoscope (SLO)
Spectral-Domain Optical Coherence Tomograph (OCT)
Anatomical Site
Posterior segment of the eye; retina; choroid; optic nerve head.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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.
The imaging parameters, which characterize the field of view, scaling, lateral resolution, and image quality of the HMM were evaluated by simulation (ray tracing) and could be verified experimentally. Whenever it was possible, reasonable acceptance criteria were predefined and the values were compared to the 30° standard objective. All the relevant optical parameters of the HMM are in very good agreement with the theoretical values, resulting by ray tracing. Additionally, it could be shown that the image quality of the HMM is comparable to the SO regarding illumination homogeneity and structure sharpness. For all verification tests, the predefined acceptance criteria were fulfilled, showing that the device with HMM is as safe and effective as the unmodified device.
Heidelberg Engineering performed bench testing – including risk mitigation measures, field of view, image geometry, lateral resolution, and image quality assessment- and software verification and validation, to confirm that the modified SPECTRALIS HRA+OCT functions equivalently to the predicate SPECTRALIS HRA+OCT.
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.
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October 18, 2018
Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC. 1655 Forest Dr. Medina, OH 44256
Re: K182569
Trade/Device Name: Spectralis HRA+OCT and variants with High Magnification Module Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, MYC Dated: September 17, 2018 Received: September 18, 2018
Dear Lena Sattler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
Bradley S. Cunningham -A
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182569
Device Name
SPECTRALIS HRA+OCT and variants with High Magnification Module
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.
3
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K182569 510(K) SUMMARY
Date Prepared
September 26, 2018
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@HeidelbergEngineering.com 8043762
OFFICIAL CONTACT PERSON
Lena Sattler Orasi Consulting, LLC. 1655 Forest Dr. Medina, OH 44256 Telephone: Facsimile: E-mail:
(440) 554-3706 (866) 904-4315 lena@orasiconsulting.com
COMMON/USUAL NAME
Optical Coherence Tomography
PROPRIETARY OR TRADE NAMES
SPECTRALIS HRA+OCT with High Magnification Module
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 |
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Image /page/5/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on the left side of the first line and a red square on the right side of the second line. The text is in a bold, sans-serif font.
PRODUCT CODE: CLASSIFICATION / CFR TITLE
OBO, MYC:
Class II § 21 CFR 886.1570
LEGALLY MARKETED UNMODIFIED PREDICATE DEVICE
Trade/Device Name:
Applicant: 510(k) Premarket Notification number: Classification: CFR Title: FDA Product Code(s): Classification Name:
Common Name: Medical Specialty: Classification Panel:
SPECTRALIS HRA+OCT and variants with OCT Angiography Module Heidelberg Engineering GmbH K181594 Class II 21 CFR 886.1570 OBO, MYC Tomography, Optical Coherence Ophthalmoscope, Laser, Scanning Optical Coherence Tomography Ophthalmic Ophthalmic Device Panel
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 purpose of this premarket notification [510(k)] is to add the High Magnification Module (HMM) as an optional, exchangeable accessory objective lens to the SPECTRALIS HRA+OCT.
The HMM is offering an 8° field of view (FOV) and allows for cSLO imaging only. It offers a magnified view of parts of the retina with improved resolution. Compared to
Heidelberg Engineering GmbH
6
the standard objective with 30° FOV, it has an approximately 4 times increased digital resolution, with optical resolution approximately 25% improved compared to the standard objective. With the new HMM objective, the digital resolution for a FOV of 8° is 1536x1536 pixels for High Resolution imaging, and 768x768 pixels for High Speed imaging. The functionality for averaging images with the proprietary automatic real-time (ART) eye tracking is still maintained.
cSLO imaging with the HMM is only intended for qualitative use.
- No quantitative automatic measurements are performed on HMM images. -
- No classifications against reference data are performed on HMM images -
Besides the addition of the optional High Magnification Module, the SPECTRALIS device is unchanged.
INDICATIONS FOR USE – SPECTRALIS PREDICATE DEVICE
The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:
- viewing the posterior segment of the eye, including two- and three-dimensional . imaging
- cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT) .
- fundus imaging .
- fluorescence imaging (fluorescein angiography, indocyanine green ● angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
- . autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
- performing measurements of ocular anatomy and ocular lesions. .
The device is indicated as an aid in the detection and management of various ocular diseases, including:
- . age-related macular degeneration
- macular edema
- diabetic retinopathy .
- retinal and choroidal vascular diseases .
- . glaucoma
The device is indicated for viewing geographic atrophy.
The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.
The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:
7
- 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)
INDICATIONS FOR USE - MODIFIED SPECTRALIS
The Indications for Use for the modified SPECTRALIS is identical to the Indications for Use of the cleared SPECTRALIS predicate device.
SUBSTANTIAL EQUIVALENCE
The modified SPECTRALIS HRA+OCT with High Magnification Module is a device modification to the cleared SPECTRALIS HRA+OCT and variants (K181594) 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.
The modified SPECTRALIS HRA+OCT and variants measures the same ophthalmic features and parameters as the cleared SPECTRALIS HRA+OCT in K181594. The changes applied to the SPECTRALIS since the clearance in K181594 do not change the intended patient populations, the type of acquired images, or how 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 modification to the device does not raise issues of safety and effectiveness. A comparison of technological characteristics and non-clinical performance testing demonstrate that the SPECTRALIS device is substantially equivalent to the unmodified predicate device.
The Substantial Equivalence Summary tables below illustrate the comparisons of the modified SPECTRALIS to the predicate devices.
8
INDICATIONS FOR USE STATEMENT CHART
| K181594 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 detection | The device is indicated as an aid in the detection | |
| and management of various ocular diseases, | and management of various ocular diseases, | |
| including: | 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 is | The SPECTRALIS OCT Angiography Module is | |
| indicated as an aid in the visualization of | 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 neuroretinal | layer thickness and optic nerve head neuroretinal | |
| rim parameter measurements, which is used to | rim parameter measurements, which is used to | |
| quantitatively compare the retinal nerve fiber | quantitatively compare the retinal nerve fiber | |
| layer and neuroretinal rim in the human retina to | layer and neuroretinal rim in the human retina to | |
| values of normal subjects of different races and | values of normal subjects of different races and | |
| ethnicities representing the population mix of the | ethnicities representing the population mix of the | |
| USA (Glaucoma Module Premium Edition) | USA (Glaucoma Module Premium Edition) | |
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TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART
| | PREDICATE DEVICE
K181594 SPECTRALIS
HRA+OCT | SUBJECT DEVICE | Discussion |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| 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 |
| 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 |
| 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 field of
view (SLO) | SO (standard objective):
15° x 15° to 30° x 30°
WFO/WFO2:
25° x 25° to Ø 55°
UWF Objective:
51° x 51° to Ø 102° | SO (standard objective):
15° x 15° to 30° x 30°
HMM:
8°
WFO/WFO2:
25° x 25° to Ø 55°
UWF Objective:
51° x 51° to Ø 102° | Different;
introduction of
HMM |
| | PREDICATE DEVICE
K181594 SPECTRALIS
HRA+OCT | SUBJECT DEVICE | Discussion |
| Lateral digital
resolution (SLO) | high speed mode: 11 µm (SO)
to 40 µm (UWF)
high resolution mode: 6 µm
(SO) to 20 µm (UWF) | high speed mode: 3µm
(HMM), 11 µm (SO) to 40
µm (UWF)
high resolution mode: 1.5µm
(HMM ), 6 µm (SO) to 20 µm
(UWF) | Different;
increased
digital
resolution with
HMM |
| 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;
(with HMM: 768x768 pixels
only)
High Resolution mode:
768x768 to 1536 x 1536
pixels; (with HMM: 1536 x
1536 pixels only) | Different; only
one image size
available for
HMM |
| 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) | not available | 50mm working distance,
29mm length, 49mm outer
diameter;
not used for measurements; | Different;
introduction of
HMM |
| 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 (WFO)
and WFO2 | 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 | 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 |
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The imaging parameters, which characterize the field of view, scaling, lateral resolution, and image quality of the HMM were evaluated by simulation (ray tracing) and could be verified experimentally. Whenever it was possible, reasonable acceptance criteria were predefined and the values were compared to the 30° standard objective. All the relevant optical parameters of the HMM are in very good agreement with the theoretical values, resulting by ray tracing. Additionally, it could be shown that the image quality of the HMM is comparable to the SO regarding illumination homogeneity and structure sharpness. For all verification tests, the predefined acceptance criteria were fulfilled, showing that the device with HMM is as safe and effective as the unmodified device.
The 30° standard objective is still delivered with all the Spectralis units and is not intended to be replaced as standard imaging objective by HMM imaging. A snap-in bayonet mount allows for fast and easy exchange of the objectives in case where a higher lateral resolution (and smaller field of view) seems to be favorable (HMM), or a standard field of view is advantageous (SO).
NON-CLINICAL PERFORMANCE TESTING
The modified SPECTRALIS was evaluated according to the requirements of FDA recognized consensus standards:
- ISO 14971: Medical Devices - Application of Risk Management to Medical Devices,
- AAMI / ANSI ES60601-1:2005 Edition 3.1: Medical Electrical Equipment -. Part 1: General Requirements For Basic Safety And Essential Performance,
- IEC 60825-1 Edition 2.0 2007-03: Safety of Laser Products Part 1: . Equipment Classification, And Requirements,
- AAMI / ANSI / IEC 62304:2006: Medical Device Software - Software Life Cycle Processes, and
- . ANSI AAMI IEC 62366-1:2015: Medical devices - Part 1: Application of usability engineering to medical devices
and was found to meet the requirements of the applicable parts.
Biocompatibility and electromagnetic compatibility testing was conducted on the previously cleared SPECTRALIS HRA+OCT device. Applicable parts are unchanged for the addition of the HMM in raw materials, design, manufacturing, and material processing since their last clearance and therefore repeated tests were not required for the addition of the HMM.
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DESIGN CONTROL
Heidelberg Engineering designed and developed the modified SPECTRALIS per the company's Design Control procedure, which complies with the FDA Quality System Regulations CFR Part 820 and ISO 13485:2016. The Design Control procedure also incorporates Risk Management procedures, which comply with ISO 14971:2007.
Risk assessment was conducted on the modified SPECTRALIS, and the impact of the design modifications were assessed on the predicate 510(k) cleared device.
The modified SPECTRALIS is manufactured and tested in the exact manner as the predicate 510(k) cleared device.
Heidelberg Engineering performed bench testing – including risk mitigation measures, field of view, image geometry, lateral resolution, and image quality assessment- and software verification and validation, to confirm that the modified SPECTRALIS HRA+OCT functions equivalently to the predicate SPECTRALIS HRA+OCT.
CONCLUSION
Comparison of technological characteristics and evaluation of non-clinical performance testing show that the modifications to the SPECTRALIS HRA+OCT and variants do not introduce any new potential safety risk and the device is as safe and effective as the predicate devices, therefore supporting a determination of substantial equivalence.