(185 days)
Not Found
No
The summary describes standard imaging and measurement capabilities, including a reference database for comparison, but does not mention any AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as an imaging and diagnostic tool, indicated to "aid in the diagnosis, documentation and management of ocular health and diseases," with no mention of treating or curing any conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states "The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2)is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population."
No
The device description clearly states it is a non-contact ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography, including an optical system of OCT, fundus camera, and anterior observation camera. This indicates significant hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The device description clearly states that the TOPCON 3D OCT-1 (Type:Maestro2) is a noncontact imaging device that examines the eye in vivo (within the living body). It acquires images of the eye's structures directly, rather than analyzing a sample like blood, urine, or tissue.
- The intended use is for imaging and measurement of ocular structures. The device is used to visualize and measure parts of the eye, aiding in diagnosis and management of ocular health and diseases. This is a direct examination of the body, not an analysis of a sample.
Therefore, the TOPCON 3D OCT-1 (Type:Maestro2) falls under the category of an ophthalmic imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a noncontact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.
It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects.
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2)is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.
Product codes (comma separated list FDA assigned to the subject device)
OBO, HKI
Device Description
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) is a non-contact ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography. Maestro2 includes an optical system of OCT, fundus camera (color, IR and Red-free image), and anterior observation camera. The color fundus camera acquires color images of the posterior segment of the eye under mydriatic or non-mydriatic conditions.
Mentions image processing
(Note 1) Digital red-free photography that processes a color image and displays it in pseudo-red-free condition.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT), Digital Color Fundus Photography
Anatomical Site
retina, retinal nerve fiber layer, macula and optic disc, anterior ocular structures
Indicated Patient Age Range
adult population
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
It has been verified that the subject devices function as intended by tests or evaluations based on the following FDA-recognized, voluntary consensus standards, and the in-house test specification. The results of the testing support substantial equivalence by demonstrating that the device performs as intended and complies with the same standards as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" in large font and "ADMINISTRATION" in smaller font below.
October 30, 2023
Topcon Corporation % Lena Sattler President Orasi Consulting, LLC 226 1st Street Bonita Springs, Florida 34134
Re: K231222
Trade/Device Name: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2), Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HKI Dated: September 28, 2023 Received: September 28, 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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
2
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)
Device Name 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
Indications for Use (Describe) 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
The TOPCON 3D Optical Coherence Tomography3D OCT-1 (Type:Maestro2) is a noncontact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic conditions.
The 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.
It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects.
The 3D Optical Cherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.
| 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) |
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4
510(k) SUMMARY TOPCON CORPORATION Traditional 510(k) for: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
GENERAL INFORMATION
Submitter's information: TOPCON Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo, 174-8580, Japan
Contact person:
Lena Sattler President, Orasi Consulting Phone: 440-554-3706
Date Prepared:
October 27, 2023
DEVICE INFORMATION
SUBJECT DEVICE: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
| Name of Device: | 3D OPTICAL COHERENCE TOMOGRAPHY
3D OCT-1(type: Maestro2) |
|----------------------|-------------------------------------------------------------|
| Device Class: | Class II |
| Classification Name: | 21 C.F.R. § 886.1570, Ophthalmoscope |
| Product Code: | OBO, HKI |
PREDICATE DEVICE:
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2):
| Company | Topcon Corporation |
|---|---|
| Device | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 |
| 510(k) No. | K170164 |
Brief Device Description
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) is a non-contact ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography. Maestro2 includes an optical system of OCT, fundus camera (color, IR and Red-free image), and anterior observation camera. The color fundus camera acquires color images of the posterior segment of the eye under mydriatic or non-mydriatic conditions.
5
Intended Use / Indications for Use
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a noncontact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.
It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects.
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2)is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.
Performance Data
It has been verified that the subject devices function as intended by tests or evaluations based on the following FDA-recognized, voluntary consensus standards, and the in-house test specification. The results of the testing support substantial equivalence by demonstrating that the device performs as intended and complies with the same standards as the predicate device.
| FDA-recognized, voluntary consensus standards | |
|---|---|
| IEC 60601-1-2:2014+AMD1:2020 | Medical electrical equipment - Part 1-2: |
| General requirements for basic safety and essential performance - | |
| Collateral standard: Electromagnetic disturbances - Requirements | |
| and tests | |
| ANSI AAMI ES60601- 1:2005/(R)2012 and | |
| A1:2012, C1:2009/(R)2012 and | |
| A2:2010/(R)2012 | Medical electrical equipment - Part 1: General requirements for |
| basic safety and essential performance | |
| ISO 15004-1:2020 | Ophthalmic instruments - Fundamental requirements and test |
| methods - Part 1: General requirements applicable to all | |
| ophthalmic instruments | |
| ISO 10940:2009 | Ophthalmic instruments - Fundus cameras |
| ANSI Z80.36-2021 | American National Standard for Ophthalmics - Light Hazard |
| Protection for Ophthalmic Instruments | |
| IEC 60601-1-6: 2013 | Medical electrical equipment - Part 1-6: General requirements for |
| basic safety and essential performance - Collateral standard: | |
| Usability | |
| IEC62366-1:2015+AMD1:2020 | Medical devices - Part 1: Application of usability engineering to |
| medical devices |
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
6
| FDA-recognized, voluntary consensus standards | |
|---|---|
| IEC 60825-1: 2007 | Safety of laser products - Part 1: Equipment classification, and requirements |
| ISO 10993-1:2018 | Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process |
| ISO 10993-5:2009 | Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization |
| IEC 62304:2015 | Medical device software - Software life cycle processes |
| NEMA PS 3.1 - 3.20 2021e | Digital Imaging and Communications in Medicine (DICOM) Set |
Software for Maestro2 was concluded to be a Moderate level of concern. Software verification and validation testing were performed, and documentation was provided as recomment Guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005).
Clinical Performance Data
This section is not applicable because clinical data was not required for this 510(k)
7
Substantial Equivalence
The subject device is substantially equivate device because the intended use indications for use, operation principle and technological characteristics of the subject device is substantially equivalent to the predicate device as shown in Table 1 below.
| Model Number | Subject Device
3D OCT-1 Maestro2 | Predicate device
3D OCT-1 | Substantial
Equivalence
Discussion |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | 3D OPTICAL COHERENCE TOMOGRAPHY | 3D OPTICAL COHERENCE TOMOGRAPHY | N/A |
| | 3D OCT-1(type: Maestro2) | 3D OCT-1 | |
| 510(k)
submitter/holder | TOPCON Corporation | TOPCON Corporation | Same |
| 510(k) Number | TBD | K170164 | N/A |
| Product code | OBO, HKI | OBO, HKI | Same |
| Regulation No. | 21 C.F.R. § 886.1570 | 21 C.F.R. § 886.1570 | Same |
| Product class | II | II | Same |
| Indications for
Use | The TOPCON 3D Optical Coherence Tomography 3D OCT-1
(Type:Maestro2) is a noncontact, high resolution tomographic and
biomicroscopic imaging device that incorporates a digital camera
for photographing, displaying and storing the data of the retina and
surrounding parts of the eye to be examined under Mydriatic and
non-Mydriatic conditions.
The 3D Optical Coherence Tomography 3D OCT-1
(Type:Maestro2) is indicated for in vivo viewing, axial cross
sectional, and three-dimensional imaging and measurement of
posterior ocular structures, including retina, retinal nerve fiber
layer, macula and optic disc as well as imaging of anterior ocular
structures.
It also includes a Reference Database for posterior ocular
measurements which provide for the quantitative comparison of | The TOPCON 3D OCT-1 Maestro is a non-contact, high resolution
tomographic and biomicroscopic imaging device that incorporates
a digital camera for photographing, displaying and storing the data
of the retina and surrounding parts of the eye to be examined under
Mydriatic and non-Mydriatic conditions.
The 3D OCT-1 Maestro is indicated for in vivo viewing, axial cross
sectional, and three-dimensional imaging and measurement of
posterior ocular structures, including retina, retinal nerve fiber
layer, macula and optic disc as well as imaging of anterior ocular
structures.
It also includes a Reference Database for posterior ocular
measurements which provide for the quantitative comparison of | Different
There is a
difference in
product name
where "(type:
Maestro2)" was
added. However,
a difference in
product name
does not affect SE
of subject device
and predicate
device. |
8
| Model Number | Subject Device
3D OCT-1 Maestro2 | Predicate device
3D OCT-1 | Substantial
Equivalence
Discussion | | | | |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--|--------------------------------------------------------------------------------------------------------------------------------|------|
| | retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. | retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. | | | | | |
| | The 3D Optical Coherence Tomography 3D OCT-1
(Type:Maestro2) is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population. | The 3D OCT-1 Maestro is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population. | | | | | |
| | Item | | Device Specification | Item | | Device Specification | Same |
| | Observation & photographing of the fundus | | | Observation & photographing of the fundus | | | |
| | Type of photography | | Color, Red-free (Note 1) & IR (Note 3) | Type of photography | | Color, Red-free (Note 1) & IR (Note 3) | |
| Device
Specifications | Picture angle for
observation/photography | | 45° ±5% or less 30° or equivalent
(digital zoom) | Picture angle for
observation/photography | | 45° ±5% or less 30° or equivalent
(digital zoom) | |
| | Operating distance | | 34.8 ±0.1mm (when taking a picture of fundus) | Operating distance | | 34.8 ±0.1mm (when taking a picture of fundus) | |
| | Observable/photographable diameter of pupil | | φ4.0mm or more: When small pupil diaphragm is NOT used.
φ3.3mm or more: When small pupil diaphragm is used. | Observable/photographable diameter of pupil | | φ4.0mm or more: When small pupil diaphragm is NOT used.
φ3.3mm or more: When small pupil diaphragm is used. | |
| | Fundus image resolution (on fundus) | | Optical Function
Center: 60 lines/mm or more
Middle (r/2): 40 lines/mm or more
Periphery (r): 25 lines/mm or more | Fundus image resolution (on fundus) | | With Camera Function
Center: 50 lines/mm or more
Middle (r/2): 40 lines/mm or more
Periphery (r): 25 lines/mm or more | |
9
| Model Number | Subject Device
3D OCT-1 Maestro2 | | Predicate device
3D OCT-1 | Substantial
Equivalence
Discussion |
|--------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| | or more
IR photography: Center: 5 lines/mm
or more (Note 3) | | or more
IR photography: Center: 5 lines/mm or
more (Note 3) | |
| | Observation & photographing of the fundus
tomogram | | Observation & photographing of the fundus
tomogram | |
| | Scan range
(on fundus) | Horizontal direction 3 - 12mm ±5% or less
Vertical direction 3 – 9mm ±5% or less | Horizontal direction 3 - 12mm ±5% or less
Vertical direction 3 – 9mm ±5% or less | |
| | Scan pattern | 3D scan (horizontal)
Linear scan (Line-scan/Cross-scan) | 3D scan (horizontal)
Linear scan (Line-scan/Cross-scan) | |
| | Scan speed | 50,000 A-Scans per second | 50,000 A-Scans per second | |
| | Lateral
resolution | 20μm | 20μm | |
| | In-depth
resolution | 6μm | 6μm | |
| | Photographab
le diameter of
pupil | φ2.5mm or more | φ2.5mm or more | |
| | Observation & photographing of the fundus
image/fundus tomogram | | Observation & photographing of the fundus
image/fundus tomogram | |
| | Fixation
target | Internal fixation target:
Dot matrix type organic EL display
The display position can be changed
and adjusted. The displaying method
can be changed. | Internal fixation target:
Dot matrix type organic EL display
The display position can be changed
and adjusted. The displaying method
can be changed. | |
10
| Model Number | Subject Device
3D OCT-1 Maestro2 | Predicate device
3D OCT-1 | Substantial
Equivalence
Discussion |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| | Peripheral fixation target:
This is displayed according to the
internal fixation target displayed
position.
External fixation target | Peripheral fixation target:
This is displayed according to the
internal fixation target displayed
position.
External fixation target | |
| | Observation & photographing of anterior segment | Observation & photographing of anterior segment | |
| | Type of
photography | Color & IR (Note 3) | Color & IR (Note 3) |
| | Operating
distance | 62.6 ±0.1mm (when taking a picture
of anterior segment) (Note 2) | 62.6 ±0.1mm (when taking a picture
of anterior segment) (Note 2) |
| | Observation & photographing of the anterior
segment tomogram | Observation & photographing of the anterior
segment tomogram | |
| | Operating
distance | 62.6 ±0.1mm (when taking a picture
of anterior segment) (Note 2) | 62.6 ±0.1mm (when taking a picture
of anterior segment) (Note 2) |
| | Scan range
(on cornea)
(Note 2) | Horizontal direction 3 – 6mm ±5% or
less
Vertical direction 3 – 6mm ±5% or les | Horizontal direction 3 – 6mm ±5% or
less
Vertical direction 3 – 6mm ±5% or les |
| | Scan pattern | Linear scan (Line-scan/Radial-scan) | Linear scan (Line-scan/Radial-scan) |
| | Scan speed | 50,000 A-Scans per second | 50,000 A-Scans per second |
| | Fixation
target | External fixation target | External fixation target |
| | | (Note 1) Digital red-free photography that processes a color
image and displays it in pseudo-red-free condition. | (Note 1) Digital red-free photography that processes a color
image and displays it in pseudo-red-free condition. |
11
| Model Number | Subject Device
3D OCT-1 Maestro2 | Predicate device
3D OCT-1 | Substantial
Equivalence
Discussion | |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | (Note 2) When the attachment for anterior segment is included in
the system configuration.
(Note 3) This is used only for recording the position where a
tomogram is captured. | (Note 2) When the attachment for anterior segment is included in
the system configuration.
(Note 3) This is used only for recording the position where a
tomogram is captured. | | |
| | Cameras for imaging and IR observation | Color fundus imaging | Different | |
| | Resolution: 6M pixels
Sensor type: CMOS
IF: USB3.0
IR observation: | Resolution: 5M pixels
Sensor type: CMOS
IF: GigE
Pixel size: 2.2 um×2.2 µm | The 3D OCT-1
predicate
incorporated two
cameras. One for
fundus image | |
| | Pixel size: 9.6 um×9.6 um | IR observation camera | capture and one | |
| Specification of
Cameras for
imaging and
observation | Color:
Pixel size: 2.4 um×2.4 um | Resolution: 0.3M pixels
Sensor type: CMOS
IF: Parallel 8-bit
Pixel size: 5.6 µm×5.6 µm | for IR
observation. The
subject device
(Maestro2) has
one camera which
functions as
camera for both
fundus image
capture and IR
observation.
This difference
does not affect the
SE discussion
because device
testing confirmed
Maestro2 fulfills
the standard for
fundus camera;
therefore, | |
12
| Page | 9 | of | 12 |
|---|---|---|---|
| ------ | --- | ---- | ---- |
| Model Number | Subject Device
3D OCT-1 Maestro2 | Predicate device
3D OCT-1 | Substantial
Equivalence
Discussion |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | technically
equivalent with
3D OCT-1. |
| | | | Different
In accordance
with the
modification to
the camera,
Maestro2 is
equipped with
movable IR filter
while 3D OCT-1
is equipped with
fixed IR filter. |
| Movable IR filter | YES | NO | This difference
does not affect the
SE discussion
because the
spectral properties
of the IR filter
itself is the same
with 3D OCT-1
and Maestro2.
Device testing
confirmed
Maestro2 fulfills
the standard for
fundus camera;
therefore,
technically
equivalent with |
| Model Number | Subject Device
3D OCT-1 Maestro2 | Predicate device
3D OCT-1 | Substantial
Equivalence
Discussion |
| | | | 3D OCT-1. |
| | | | Different
The pixel size
between the
camera for the 3D
OCT-1 predicate
and the Maestro2
is different. This
pixel size change
caused by the |
| Focal length of
relay lens of
imaging optical
system | IR wavelength
Wavelength used: 760 nm to 780 nm
View angle of fundus camera:
within 45°±5%
Horizontal magnification of fundus camera: 0.20
Horizontal resolution of fundus camera:
Center: 5 line/mm or more | IR wavelength:
Wavelength used: 760 nm to 780 nm
View angle of fundus camera:
within 45°±5%
Horizontal magnification of fundus camera: 0.35
Horizontal resolution of fundus camera:
Center: 5 lines/mm or more | magnification
between the
fundus and the
camera on the
fundus camera.
The focal length
of the relay lens
of the image
capture optical
system was
modified to
maintain the size
of the fundus per
pixel. |
| | | | This difference
does not affect the
SE discussion
because the
device testing
confirmed |
13
14
| Model Number | Subject Device
3D OCT-1 Maestro2 | Predicate device
3D OCT-1 | Substantial
Equivalence
Discussion |
|------------------------|----------------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| External
Appearance | Image: Subject Device | Image: Predicate Device | the standard for
fundus camera;
therefore,
technically
equivalent with
3D OCT-1.
Different
There is a
difference in the
external
appearance.
However, this
difference does
not affect safety
and effectiveness
of the device;
therefore, does
not affect SE
discission of
subject device and
predicate device. |
| Overall
Dimensions | 340-480mm (W) × 543-680mm (D) × 500-735mm(H) | 307-442mm (W) × 472 -668mm (D) × 518 -722mm(H) | Different
There is a
difference in the
overall
dimensions due to
a modification of
the external cover.
However, this
difference does
not affect safety
and effectiveness |
510(k) Summary: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
15
| Page | 12 | of | 12 | |
|---|---|---|---|---|
| -- | ------ | ---- | ---- | ---- |
| Model Number | Subject Device
3D OCT-1 Maestro2 | Predicate device
3D OCT-1 | Substantial
Equivalence
Discussion |
|-----------------------------|-------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | of the device;
therefore, does
not affect SE
discission of
subject device and
predicate device |
| Windows
operating system | MS Windows 10 | MS Windows 7, 8.1 | Different
There is a
difference in
version of
windows
operating systems.
This difference
does not affect the
SE discussion
because software
testing confirmed
Maestro2
functions as
intended with the
updated windows
OS version;
therefore,
technically
equivalent with
3D OCT-1. |