(156 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and there is no other language in the summary that suggests the use of AI or ML. The device description focuses on the imaging modalities and the reference database for quantitative comparison, which is a standard feature in many medical imaging devices and does not inherently imply AI/ML.
No
The device is described as an imaging and diagnostic device for viewing posterior and anterior ocular structures, aiding in the diagnosis, documentation, and management of ocular health and diseases. It does not mention any therapeutic function.
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 explicitly states it includes an optical system of OCT, fundus camera, and anterior observation camera, which are hardware components. While it uses PC software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The TOPCON 3D OCT-1 (Maestro2) is described as a noncontact imaging device that directly examines the eye in vivo (within the living body). It acquires images and measurements of ocular structures.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient.
Therefore, while it is a diagnostic device used to aid in the diagnosis and management of ocular health and diseases, it does not fit the definition of an In Vitro Diagnostic device.
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 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 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 laver, 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
OBO, HKI
Device Description
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) with System linkage software (herein referred to as "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. Maestro2 is used together with IMAGEnet6 by connecting via System linkage software which is a PC software installed to off the shelf PC connected to Maestro2. The remote operation function is not intended to be used from any further distance (e.g., operation from different rooms or different buildings) other than social distancing recommendations.
Mentions image processing
Not Found
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, 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 device functions 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.
For the modified remote operation function, comparison testing confirmed that image quality and diagnosability is the same with or without the remote operation function.
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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Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
Topcon Corporation % Lena Sattler President Orasi Consulting 226 1st Street Bonita Springs, Florida 34134
Re: K233561
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: November 6, 2023 Received: November 6, 2023
Dear Lena Sattler:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the 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).
Sincerelv.
Elvin Y. Ng - S
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233561
Device Name 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
Indications for Use (Describe)
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 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 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 laver, 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.
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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510(k) SUMMARY TOPCON CORPORATION Traditional 510(k) for: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) with System linkage software
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 Email: lena@orasiconsulting.com
Date Prepared:
April 5, 2024
DEVICE INFORMATION
SUBJECT DEVICE:
| 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
21 C.F.R. §886.1120, Ophthalmic camera |
| Product Code: | OBO, HKI |
PREDICATE DEVICE:
| Company | Topcon Corporation |
|---|---|
| Device | 3D OPTICAL COHERENCE TOMOGRAPHY |
| 3D OCT-1(type: Maestro2) | |
| 510(k) No. | K231222 |
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Image /page/4/Picture/0 description: The image shows the logo for TOPCON. The logo features a stylized blue symbol that resembles two overlapping letter 'N' shapes. Below the symbol, the word "TOPCON" is written in a bold, sans-serif font, with the letters in black.
Brief Device Description
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) with System linkage software (herein referred to as "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. Maestro2 is used together with IMAGEnet6 by connecting via System linkage software which is a PC software installed to off the shelf PC connected to Maestro2. The remote operation function is not intended to be used from any further distance (e.g., operation from different rooms or different buildings) other than social distancing recommendations.
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 device functions 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: |
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| FDA-recognized, voluntary consensus standards | |
|---|---|
| ANSI AAMI ES60601- | |
| 1:2005/(R)2012 and A1:2012, | |
| C1:2009/(R)2012 and | |
| A2:2010/(R)2012 | General requirements for basic safety and |
| essential performance - Collateral standard: | |
| Electromagnetic disturbances - Requirements | |
| and tests | |
| ISO 15004-1:2020 | Medical electrical equipment - Part 1: General |
| requirements for basic safety and essential | |
| performance | |
| ISO 10940:2009 | Ophthalmic instruments - Fundamental |
| requirements and test methods - Part 1: | |
| General requirements applicable to all | |
| ophthalmic instruments | |
| ANSI Z80.36-2021 | Ophthalmic instruments – Fundus cameras |
| IEC 60601-1-6: 2013 | American National Standard for Ophthalmics |
- Light Hazard Protection for Ophthalmic
Instruments |
| IEC62366-1:2015+AMD1:2020 | Medical electrical equipment - Part 1-6:
General requirements for basic safety and
essential performance - Collateral standard:
Usability |
| IEC 60825-1: 2007 | Medical devices - Part 1: Application of
usability engineering to medical devices |
| ISO 10993-1:2018 | Safety of laser products - Part 1: Equipment
classification, and requirements |
| ISO 10993-5:2009 | Biological evaluation of medical devices-Part
1: Evaluation and testing within a risk
management process |
| ISO 10993-10:2010 | Biological evaluation of medical devices-Part
5: Tests for in vitro cytotoxicity |
| IEC 62304:2015 | Biological evaluation of medical devices-Part
10: Tests for irritation and skin sensitization |
| NEMA PS 3.1 - 3.20 2021e | Medical device software - Software life cycle
processes |
Software for Maestro2 was concluded to be a Basic documentation level. Software verification and validation testing such as software system testing was performed for Maestreo2 as recommended by FDA's Guidance document Content of Premarket Submissions for Device Software Functions (issued on June 14, 2023).
For the modified remote operation function, comparison testing confirmed that image quality and diagnosability is the same with or without the remote operation function.
Maestro2 is a cyber device per 524B(c) of the Food, Drug & Cosmetic Act. Maestro2 followed the recommendations in the FDA's Guidance document Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (issued on
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September 27, 2023).
Clinical Performance Data
This section is not applicable because clinical data was not required for this 510(k) submission.
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Substantial Equivalence
The subject device is substantially equivalent to the predicate device because the intended use/indications for use, operation principle and technological characteristics of the subject device is substantially equivalent to those of the predicate device as shown in Table 1 below.
| Model
Number | Subject Device
3D OCT-1 Maestro2 | Predicate Device
3D OCT-1 Maestro2 | Substantial Equivalence
Discussion |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Trade Name | 3D OPTICAL COHERENCE TOMOGRAPHY
3D OCT-1(type: Maestro2) | 3D OPTICAL COHERENCE TOMOGRAPHY
3D OCT-1(type: Maestro2) | N/A |
| 510(k)
submitter/holder | TOPCON Corporation | TOPCON Corporation | Same |
| 510(k)
Number | K233561 | K231222 | 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. | 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. | Same |
TABLE 1: SUBSTANTIAL EQUIVALENCE: MAESTRO2
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Image /page/8/Picture/0 description: The image shows the logo for TOPCON. The logo consists of the word "TOPCON" in bold, black letters, with a stylized blue symbol above it. The symbol appears to be two overlapping shapes, possibly representing stylized eyes or lenses, which are a bright blue color.
| Model
Number | Subject Device
3D OCT-1 Maestro2 | Predicate Device
3D OCT-1 Maestro2 | Substantial Equivalence
Discussion | | | | | | | | | | | | | | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|------|
| | 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. | 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 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 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. | | | | | | | | | | | | | | | |
| Device
Specifications | Item Device Specification Observation & photographing of the fundus Type of
photography Color, Red-free (Note 1) & IR
(Note 3) 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) Observable/
photographable
diameter of
pupil ф4.0mm or more: When small
pupil diaphragm is NOT used.
ф3.3mm 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 | | | | | | | | | | | | | | | | Same |
Topcon Corporation
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Image /page/9/Picture/0 description: The image features the logo for TOPCON. The logo consists of a stylized, abstract symbol in blue, resembling two overlapping shapes that could be interpreted as stylized letters or wings. Below the symbol, the word "TOPCON" is printed in a bold, sans-serif font, also in black.
| Model
Number | Subject Device
3D OCT-1 Maestro2 | Predicate Device
3D OCT-1 Maestro2 | Substantial Equivalence
Discussion | | |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (r): 25 lines/mm
or more | Periphery (r):
25 lines/mm
or more | | | |
| | more
Periphery
(r): 25
lines/mm or
more | more
Periphery
(r): 25
lines/mm or
more | | | |
| | IR photography: Center: 5
lines/mm or more (Note 3) | 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 | Scan range (on
fundus) | Horizontal direction 3 – 12mm ±5% or less | |
| | | Vertical direction 3 – 9mm ±5%
or less | | Vertical direction 3 – 9mm ±5% or less | |
| | Scan pattern | 3D scan (horizontal)
Linear scan (Line-scan/Cross-scan) | Scan pattern | 3D scan (horizontal)
Linear scan (Line-scan/Cross-scan) | |
| | Scan speed | 50,000 A-Scans per second | Scan speed | 50,000 A-Scans per second | |
| | Lateral
resolution | 20μm | Lateral
resolution | 20μm | |
| | In-depth
resolution | 6μm | In-depth
resolution | 6μm | |
| | Photographable
diameter of
pupil | φ2.5mm or more | Photographabl
e diameter of
pupil | 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. | 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. | |
| Model
Number | Subject Device
3D OCT-1 Maestro2 | Predicate Device
3D OCT-1 Maestro2 | 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) | Type of
photography | | |
| | Operating
distance | 62.6 ±0.1mm (when taking a
picture of anterior segment)
(Note 2) | Operating
distance | 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) | Operating
distance | 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 less | Scan range (on
cornea) (Note
2) | Horizontal direction 3 – 6mm
±5% or less
Vertical direction 3 – 6mm ±5%
or less | |
| | Scan pattern | Linear scan (Line-scan/Radial-
scan) | Scan pattern | Linear scan (Line-
scan/Radial-scan) | |
| | Scan speed | 50,000 A-Scans per second | Scan speed | 50,000 A-Scans per second | |
| | Fixation target | External fixation target | Fixation target | External fixation target | |
| Linkage with
IMAGEnet6
via PC
software for
System
Linkage | | Yes | | No | Different
The difference in instrument
and PC software does not affect
the SE discussion because the
programing language and core
algorithm of the Maestro2
predicate and Maestro2 is the
same. |
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| Model
Number | Subject Device
3D OCT-1 Maestro2 | Predicate Device
3D OCT-1 Maestro2 | Substantial Equivalence
Discussion |
|---------------------------------------------|-------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Optional
Remote
operation
function | Yes | No | Different
For the modified remote
operation function, comparison
testing confirmed that image
quality and diagnosability is the
same with or without the remote
operation function. |
Conclusions
Topcon's 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) is as safe and effective as the previously cleared 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2), K231222.