(168 days)
No
The summary describes a diagnostic imaging device based on existing technologies (cSLO and SD-OCT) and focuses on image acquisition and visualization. There is no mention of AI, ML, or any algorithms that perform automated analysis or interpretation of the images beyond basic visualization. The performance studies focus on image quality and agreement in identifying abnormalities by human readers, not on the performance of an AI/ML algorithm.
No.
The device is described as a "non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid." Its purpose is diagnostic imaging, not therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a non-contact ophthalmic diagnostic imaging device."
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.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "non-contact ophthalmic diagnostic imaging" to "aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid." This describes a device that images the physical structures of the eye.
- Device Description: The description reinforces this by stating it's for "visualization of the posterior segments of the human eye" using imaging technologies (cSLO and SD-OCT).
- Lack of In Vitro Activity: An IVD is a device used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, disease, or congenital abnormality. This device operates in vivo (within the living body) by directly imaging the eye.
The device is an ophthalmic diagnostic imaging device, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid. SPECTRALIS with Flex Module is intended for imaging of adults and pediatric patients in supine position.
Product codes
OBO, MYC
Device Description
The Heidelberg Engineering SPECTRALIS with Flex Module is based on the predicate SPECTRALIS HRA+OCT consisting of an accessory device mount allowing imaging of patients in supine position. The SPECTRALIS with Flex Module is intended for visualization of the posterior segments of the human eye. The SPECTRALIS with Flex Module is using the identical technologies as the predicate SPECTRALIS tabletop configuration (K223557), i.e. it is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Confocal Laser-Scanning Ophthalmoscope (cSLO) and Spectral-Domain Optical Coherence Tomograph (OCT)
Anatomical Site
posterior segment structures of the eye and vasculature of the retina and choroid.
Indicated Patient Age Range
adults and pediatric patients
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
Three independent readers from a reading center graded the IR cSLO, OCT and OCTA images on overall image quality, and for OCT and OCTA only, the readers assessed visibility of key anatomic structures, and identified the presence of abnormalities (or lack thereof). The analyses were based on the grading results from the effectiveness analysis population, which included all eligible study eyes with an image result for at least one acquisition from the investigational device (SPECTRALIS with Flex) from the reading center.
Eighty-eight (88) subjects signed the informed consent form and were enrolled in the study. Of the 88 subjects enrolled, 84 completed the study and 4 were discontinued (2 subjects were unable to complete required scans, 1 subject withdrew voluntarily and for 1 subject there was a device deficiency that occurred prior to attempting any imaging). There were 9 subjects (5 Normal, 4 Posterior Segment Abnormality) who completed the study but subsequently identified as having failed to meet inclusion/exclusion criteria during study monitoring. One Normal subject who was unable to complete required scans was included in the effectiveness population as they had acceptable scans from both devices on at least one acquisition type.
The safety population consisted of 87 subjects, 30 Normal subjects and 57 Posterior Segment Abnormality subjects. No adverse events occurred during the course of the study. The effectiveness population consisted of 25 Normal subjects and 51 Posterior Segment Abnormality subjects. The effectiveness population count differed for each image type based on the Abnormalities of Interest specified and availability of acceptable acquisitions.
All 76 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 Posterior Segment Abnormality population.
The mean age was 57.3 ± 19.2 years overall, with the Posterior Segment Abnormality population subjects being older. The study population had more female subjects (59.2%) than male (40.8%). A majority (96.1%) did not identify as Hispanic or Latino, while 80% identified as White, 18.4% identified as Black/African American and 2.6% identified as Asian.
The Normal population had normal (or non-clinicant) eye examination findings for all study eyes, while 100% of the Posterior Segment Abnormality population study eyes had abnormal (or clinically significant) retina, macular and/or periphery eye examination findings. Posterior Segment Abnormality population study eyes also had abnormal (or clinically significant) ophthalmoscopy findings for 13.8% (undilated) to 22.7% (dilated) of eyes when assessing the optic nerve, and 34.5% (undilated) to 36.4% (dilated) of eyes when assessing the vitreous.
Summary of Performance Studies
One clinical, prospective, observational case study (S-2018-3) was performed at a single clinical site, located in the United States.
The study recruited 88 subjects, with 84 completing the study. The safety population included 87 subjects (30 Normal, 57 Posterior Segment Abnormality), with no adverse events. The effectiveness population included 76 subjects (25 Normal, 51 Posterior Segment Abnormality), all 22 years or older.
The study evaluated image quality and visualization of key anatomic structures for OCT, OCTA, and IR cSLO images.
Results indicated that 100% of OCT images and IR cSLO images, and 97.2% of OCTA images from the investigational SPECTRALIS with Flex were assessed as having sufficient overall image quality. Clinically acceptable visualization of key anatomic structures was achieved in 100% of OCT assessments and 94.4% to 97.2% of OCTA assessments.
Agreement rates for identification of pre-specified abnormalities were >= 84.3% for structural abnormalities on OCT and >= 85.1% for vascular abnormalities on OCTA. Negative Percent Agreement (NPA) was at least 87.8% on OCT and 92.6% on OCTA for all pre-specified abnormalities. Positive Percent Agreement (PPA) for all pre-specified abnormalities on OCT and OCTA with more than 2 cases identified on the predicate was at least 75%.
The study concluded that image quality, visibility of key anatomic structures, and identification of structural and vascular abnormalities are similar between the investigational device and the predicate SPECTRALIS.
Key Metrics
- Overall image quality sufficient to assess clinically relevant content: 100% for OCT, 100% for IR cSLO, 97.2% for OCTA images.
- Clinically acceptable visualization of key anatomic structures: 100% for OCT, 94.4% to 97.2% for OCTA.
- Agreement rates for identifying pre-specified abnormalities compared to predicate:
- Structural abnormalities on OCT: >= 84.3%
- Vascular abnormalities on OCTA: >= 85.1%
- Negative Percent Agreement (NPA) for all pre-specified abnormalities:
- OCT: >= 87.8%
- OCTA: >= 92.6%
- Positive Percent Agreement (PPA) for all pre-specified abnormalities with more than 2 cases identified on the predicate:
- OCT: >= 75%
- OCTA: >= 75%
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 11, 2024
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC. 226 1st Street Bonita Springs, Florida 34134
Re: K241163
Trade/Device Name: SPECTRALIS with Flex Module Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, MYC Dated: April 26, 2024 Received: April 26, 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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).
2
Sincerely,
Elvin Y. Ng -S
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241163
Device Name SPECTRALIS with Flex Module
Indications for Use (Describe)
The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid. SPECTRALIS with Flex Module is intended for imaging of adults and pediatric patients in supine position.
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) |
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Image /page/4/Picture/1 description: The image contains the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on either side. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". The text is in a bold, sans-serif font.
510(K) SUMMARY
Date Prepared
September 09, 2024
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 with Flex 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 |
PRODUCT CODE: CLASSIFICATION / CFR TITLE
OBO, MYC: Class II § 21 CFR 886.1570
5
PRIMARY PREDICATE DEVICE
SPECTRALIS HRA+OCT and variants (K223557), Heidelberg Engineering GmbH
SECONDARY PREDICATE DEVICE
Bioptigen ENVISU Spectral Domain Ophthalmic Imaging System (K120057)
INDICATIONS FOR USE
The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid. SPECTRALIS with Flex Module is intended for imaging of adults and pediatric patients in supine position.
GENERAL DEVICE DESCRIPTION
The Heidelberg Engineering SPECTRALIS with Flex Module is based on the predicate SPECTRALIS HRA+OCT consisting of an accessory device mount allowing imaging of patients in supine position. The SPECTRALIS with Flex Module is intended for visualization of the posterior segments of the human eye. The SPECTRALIS with Flex Module is using the identical technologies as the predicate SPECTRALIS tabletop configuration (K223557), i.e. it is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT).
COMPARISON BETWEEN THE SUBJECT AND THE PREDICATE DEVICE
The modifications made to the SPECTRALIS HRA+OCT with the introduction of the optional accessory, the Flex Module do not change the applied technologies (OCT, cSLO) and the imaging modes of SPECTRALIS. The main differences between the SPECTRALIS with Flex Module and the predicate tabletop configuration cleared in K223557 are that the SPECTRALIS with Flex Module is for visualization only and allows imaging of supine patients. The imaging of supine patients expands the patient profile by including patients unable to follow simple instructions (e.g., unconscious, pediatrics). The tabletop SPECTRALIS with headrest requires upright sitting and thus awake patients able to follow simple instructions and provides measurements and includes reference databases.
The application of a non-contact ophthalmic OCT device for imaging of conscious or unconscious pediatrics and adults in supine position is also supported by the secondary predicate device, the Bioptigen ENVISU Imaging System which was cleared in K120057. The Bioptigen ENVISU device consists of a handheld, lightweight camera (scan head) which can be also mounted and provides a mobile cart for the optical engine and power supply. Due to the principle of using a handheld camera the physical dimensions and layout is different for the Bioptigen ENVISU and the subject and predicate SPECTRALIS devices, respectively.
Accordingly, due to its use for imaging supine patients, the mobile Flex Module has a different layout as well as larger dimensions and weight than the fixed camera mount
Heidelberg Engineering
6
used for the tabletop. All other components to be used with the SPECTRALIS device are unchanged for the SPECTRALIS with Flex Module and are similar for the Bioptigen ENVISU. The SPECTRALIS with Flex Module uses an identical camera, the same power supply and touch panel as the predicate tabletop SPECTRALIS.
The Substantial Equivalence summary tables below illustrate the comparisons of the subject SPECTRALIS to the predicate devices.
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Image /page/7/Picture/0 description: The image contains the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on either side. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING".
INDICATIONS FOR USE STATEMENT CHART
| Subject Device
SPECTRALIS with Flex Module
(K241163) | Primary Predicate Device
SPECTRALIS
(K223557) | Secondary Predicate Device
Bioptigen ENVISUTM Spectral
Domain Ophthalmic Imaging
System (K120057) | Same, similar or
different |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| The SPECTRALIS with Flex Module is a non-
contact ophthalmic diagnostic imaging device
intended to aid in the visualization of the posterior
segment structures of the eye and vasculature of
the retina and choroid. SPECTRALIS with Flex
Module is intended for imaging of adults and
pediatric patients in supine position. | 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 | Bioptigen ENVISUTM Spectral Domain
Ophthalmic Imaging System (SDOIS) is
intended to acquire, process, display and
save depth-resolved images of ocular
tissue microstructure using Spectral
Domain Optical Coherence Tomography
(SD-OCT). The ENVISU SDOIS is
indicated for use as an aid in the
diagnosis of physiologic and pathologic
conditions of the eye through non-contact
optical imaging. Imaging of the various
tissues of the eye is supported through
the use of interchangeable lenses. It is
indicated for use on patient populations
from premature and neonatal infants to
adult, and is suitable for patients
ambulatory or confined. The system is
indicated for use in upright or supine
imaging, handheld or mounted, and is
suited for imaging patients under
anesthesia. | K223557: Different
(measurements,
upright patients)
K120057: Similar
(visualization only,
pediatric and
supine patients) |
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iheidelberg 는! 15/11 1는문! || 16
| 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) | |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART
| Feature | Subject Device
SPECTRALIS with Flex
Module | Primary Predicate Device
SPECTRALIS
(K223557) | Secondary Predicate
Device
Bioptigen ENVISU Spectral
Domain Ophthalmic Imaging
System (K120057) | Same, similar or different |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
classification
name | Optical Coherence Tomographer
(OCT) | Optical Coherence Tomographer
(OCT) | Optical Coherence Tomographer
(OCT) | K223557, K120057: 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) | Spectral-Domain Optical
Coherence Tomograph (OCT) | K223557: Same
K120057: Similar (OCT only) |
| Physical
Dimensions | Laser scanning camera: 235 mm x
100 mm x 205 mm
Weight camera head: 5.6 kg
Flex Module:
Height 1690 plus 300 swivel range
in mm, width 1467 mm maximum
Operation panel:
170 mm x 185 mm x 100 mm | Laser scanning camera: 235 mm x
100 mm x 205 mm
Weight camera head: 5.6 kg
Camera Mount:
470 mm x 325 mm x 550 mm
Operation panel:
170 mm x 185 mm x 100 mm | OCT Scan head: 170 mm high x 80
mm wide x 230 mm long (incl. lens)
Scan head weight: 1.6 kg
Cart footprint:
Height 953 mm alone, 1549 mm with
monitor, width 787 mm, depth 559
mm | K223557: Different
K120057: Different:
The Flex Module for supine
patients has other
dimensions than the
predicate tabletop mount with
headrest (K223557). The
predicate Bioptigen
(K120057) is a handheld |
| Feature | Subject Device
SPECTRALIS with Flex
Module | Primary Predicate Device
SPECTRALIS
(K223557) | Secondary Predicate
Device
Bioptigen ENVISU Spectral
Domain Ophthalmic Imaging
System (K120057) | Same, similar or different |
| | Power supply including
spectrometer:
180 mm x 335 mm x 165 mm | Power supply including
spectrometer: 180 mm x 335mm x
165 mm | mountable camera with a
mobile cart. | |
| 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, 488nm
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, 488nm
Indocyanine green angiography:
diode laser, 786 nm
Optical coherence tomography:
superluminescence diode, 840 nm
to 920 nm (weighted average 880
nm) | No Laser Scanning (cSLO)
available
Optical coherence tomography:
superluminescence diode, 760 nm
to 930 nm (860 nm) | K223557: Same (cSLO)
K120057: N/A (cSLO)
K223557: Same (OCT)
K120057: Similar (OCT) |
| 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 | Class 1 LED | K223557, K120057: Same |
| Lateral optical
resolution (OCT) | 14 μm (standard objective), 24 μm
(WFO2) | 14 μm (standard objective), 24 μm
(WFO2) | Retina: 20 μm in tissue | K223557: Same
K120057: Similar |
| 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 | Not known | K223557: Same
K120057: N/A |
| Optical depth
resolution (OCT) | 7 μm | 7 μm | ≤ 6 μm (High Resolution, HR)