3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))

K233561 · Topcon Corporation · OBO · Apr 10, 2024 · Ophthalmic

Device Facts

• Record ID: K233561
• Device Name: 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
• Applicant: Topcon Corporation
• Product Code: OBO · Ophthalmic
• Decision Date: Apr 10, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended 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.

Device Story

Maestro2 is a non-contact ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography; includes optical system for OCT, fundus camera (color, IR, Red-free), and anterior observation camera. Device captures images of posterior/anterior ocular structures; data displayed/stored via IMAGEnet6 software on off-the-shelf PC. Operated by clinicians in clinical settings. Includes reference database for quantitative comparison of retinal nerve fiber layer, optic nerve head, and macula against normal subjects. New remote operation function allows operation within social distancing limits; comparison testing confirms image quality/diagnosability equivalent to non-remote operation. Device aids in diagnosis, documentation, and management of ocular health/diseases.

Clinical Evidence

No clinical data required for this submission. Substantial equivalence supported by bench testing, including software verification/validation, cybersecurity assessment, and comparison testing of the remote operation function.

Technological Characteristics

Spectral-domain OCT; digital color fundus camera (color, IR, Red-free); anterior observation camera. Scan speed: 50,000 A-scans/sec. Lateral resolution: 20μm; In-depth resolution: 6μm. Connectivity: PC-based via IMAGEnet6. Standards: IEC 60601-1-2, ANSI AAMI ES60601-1, ISO 15004-1, ISO 10940, ANSI Z80.36, IEC 62366-1, IEC 60825-1, ISO 10993 series, IEC 62304, NEMA PS 3.1-3.20.

Indications for Use

Indicated for in vivo viewing, axial cross-sectional, and 3D imaging and measurement of posterior ocular structures (retina, retinal nerve fiber layer, macula, optic disc) and anterior ocular structures in the adult population. Used to aid in diagnosis, documentation, and management of ocular health and diseases.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) (K231222)

Submission Summary (Full Text)

{0}------------------------------------------------

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 ([e-mail]) or phone [phone] 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)

| <div> <span> <svg height="15" width="15"> <rect fill="white" height="15" stroke="black" stroke-width="1" width="15"></rect> <path d="M2 2 L13 13 M13 2 L2 13" stroke="black" stroke-width="1"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="15" width="15"> <rect fill="white" height="15" stroke="black" stroke-width="1" width="15"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.#### This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the

time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Topcon. The logo consists of a stylized blue symbol above the word "TOPCON" in black, block letters. The symbol is composed of two overlapping shapes that resemble stylized letter 'N's, creating a sense of interconnectedness and modernity.

## 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: [phone] Email: [e-mail]

### Date Prepared:

April 5, 2024

### DEVICE INFORMATION

### SUBJECT DEVICE:

| Name of Device: | 3D OPTICAL COHERENCE TOMOGRAPHY<br>3D OCT-1(type: Maestro2) |
|----------------------|--------------------------------------------------------------------------------|
| Device Class: | Class II |
| Classification Name: | 21 C.F.R. § 886.1570, Ophthalmoscope<br>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 |

{4}------------------------------------------------

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: |

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for TOPCON. The logo consists of a stylized, abstract symbol in blue, resembling two overlapping ellipses or curved shapes. Below the symbol, the word "TOPCON" is written in a bold, sans-serif font, also in blue. The overall design is simple and modern.

| FDA-recognized, voluntary consensus standards | |
|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| ANSI AAMI ES60601-<br>1:2005/(R)2012 and A1:2012,<br>C1:2009/(R)2012 and<br>A2:2010/(R)2012 | General requirements for basic safety and<br>essential performance - Collateral standard:<br>Electromagnetic disturbances - Requirements<br>and tests |
| ISO 15004-1:2020 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance |
| ISO 10940:2009 | Ophthalmic instruments - Fundamental<br>requirements and test methods - Part 1:<br>General requirements applicable to all<br>ophthalmic instruments |
| ANSI Z80.36-2021 | Ophthalmic instruments – Fundus cameras |
| IEC 60601-1-6: 2013 | American National Standard for Ophthalmics<br>- Light Hazard Protection for Ophthalmic<br>Instruments |
| IEC62366-1:2015+AMD1:2020 | Medical electrical equipment - Part 1-6:<br>General requirements for basic safety and<br>essential performance - Collateral standard:<br>Usability |
| IEC 60825-1: 2007 | Medical devices - Part 1: Application of<br>usability engineering to medical devices |
| ISO 10993-1:2018 | Safety of laser products - Part 1: Equipment<br>classification, and requirements |
| ISO 10993-5:2009 | Biological evaluation of medical devices-Part<br>1: Evaluation and testing within a risk<br>management process |
| ISO 10993-10:2010 | Biological evaluation of medical devices-Part<br>5: Tests for in vitro cytotoxicity |
| IEC 62304:2015 | Biological evaluation of medical devices-Part<br>10: Tests for irritation and skin sensitization |
| NEMA PS 3.1 - 3.20 2021e | Medical device software - Software life cycle<br>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

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image contains the logo for TOPCON. The logo features a stylized blue symbol above the word "TOPCON" which is also in blue. The symbol appears to be two overlapping shapes, possibly representing the letter 'N'.

September 27, 2023).

## Clinical Performance Data

This section is not applicable because clinical data was not required for this 510(k) submission.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Topcon. The logo consists of a stylized blue symbol above the word "TOPCON" in black, block letters. The symbol is composed of two curved shapes that resemble overlapping or intersecting letter "N" shapes, creating a dynamic and modern design.

#### 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<br>Number | Subject Device<br>3D OCT-1 Maestro2 | Predicate Device<br>3D OCT-1 Maestro2 | Substantial Equivalence<br>Discussion |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Trade Name | 3D OPTICAL COHERENCE TOMOGRAPHY<br>3D OCT-1(type: Maestro2) | 3D OPTICAL COHERENCE TOMOGRAPHY<br>3D OCT-1(type: Maestro2) | N/A |
| 510(k)<br>submitter/holder | TOPCON Corporation | TOPCON Corporation | Same |
| 510(k)<br>Number | K233561 | K231222 | N/A |
| Product code | OBO, HKI | OBO, HKI | Same |
| Regulation<br>No. | 21 C.F.R. § 886.1570 | 21 C.F.R. § 886.1570 | Same |
| Product class | II | II | Same |
| Indications<br>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.<br><br>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.<br><br>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

{8}------------------------------------------------

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<br>Number | Subject Device<br>3D OCT-1 Maestro2 | Predicate Device<br>3D OCT-1 Maestro2 | Substantial Equivalence<br>Discussion | | | | | | | | | | | | | | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|------|
| | It also includes a Reference Database for posterior<br>ocular measurements which provide for the<br>quantitative comparison of retinal nerve fiber layer,<br>optic nerve head, and the macula in the human retina<br>to a database of known normal subjects. | It also includes a Reference Database for posterior<br>ocular measurements which provide for the<br>quantitative comparison of retinal nerve fiber layer,<br>optic nerve head, and the macula in the human retina<br>to a database of known normal subjects. | | | | | | | | | | | | | | | |
| | The 3D Optical Coherence Tomography 3D OCT-1<br>(Type:Maestro2) is indicated for use as a diagnostic<br>device to aid in the diagnosis, documentation and<br>management of ocular health and diseases in the adult<br>population. | The 3D Optical Coherence Tomography 3D OCT-1<br>(Type:Maestro2) is indicated for use as a diagnostic<br>device to aid in the diagnosis, documentation and<br>management of ocular health and diseases in the adult<br>population. | | | | | | | | | | | | | | | |
| Device<br>Specifications | Item Device Specification Observation & photographing of the fundus Type of<br>photography Color, Red-free (Note 1) & IR<br>(Note 3) Picture angle<br>for<br>observation/photography 45° ±5% or less 30° or<br>equivalent (digital zoom) Operating<br>distance 34.8 ±0.1mm (when taking a<br>picture of fundus) Observable/<br>photographable<br>diameter of<br>pupil ф4.0mm or more: When small<br>pupil diaphragm is NOT used.<br>ф3.3mm or more: When small<br>pupil diaphragm is used. Fundus image<br>resolution (on<br>fundus) Optical<br>Function<br>Center: 60<br>lines/mm or<br>more Middle<br>(r/2): 40<br>lines/mm or<br>more Periphery | | | | | | | | | | | | | | | | Same |

Topcon Corporation

{9}------------------------------------------------

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<br>Number | Subject Device<br>3D OCT-1 Maestro2 | Predicate Device<br>3D OCT-1 Maestro2 | Substantial Equivalence<br>Discussion | | |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (r): 25 lines/mm<br>or more | Periphery (r):<br>25 lines/mm<br>or more | | | |
| | more<br>Periphery<br>(r): 25<br>lines/mm or<br>more | more<br>Periphery<br>(r): 25<br>lines/mm or<br>more | | | |
| | IR photography: Center: 5<br>lines/mm or more (Note 3) | IR photography: Center: 5<br>lines/mm or more (Note 3) | | | |
| | Observation & photographing of the fundus<br>tomogram | Observation & photographing of the fundus<br>tomogram | | | |
| | Scan range (on<br>fundus) | Horizontal direction 3 – 12mm<br>±5% or less | Scan range (on<br>fundus) | Horizontal direction 3 – 12mm ±5% or less | |
| | | Vertical direction 3 – 9mm ±5%<br>or less | | Vertical direction 3 – 9mm ±5% or less | |
| | Scan pattern | 3D scan (horizontal)<br>Linear scan (Line-scan/Cross-scan) | Scan pattern | 3D scan (horizontal)<br>Linear scan (Line-scan/Cross-scan) | |
| | Scan speed | 50,000 A-Scans per second | Scan speed | 50,000 A-Scans per second | |
| | Lateral<br>resolution | 20μm | Lateral<br>resolution | 20μm | |
| | In-depth<br>resolution | 6μm | In-depth<br>resolution | 6μm | |
| | Photographable<br>diameter of<br>pupil | φ2.5mm or more | Photographabl<br>e diameter of<br>pupil | φ2.5mm or more | |
| | Observation & photographing of the fundus<br>image/fundus tomogram | Observation & photographing of the fundus<br>image/fundus tomogram | | | |
| | Fixation target | Internal fixation target:<br>Dot matrix type organic EL<br>display<br>The display position can be<br>changed and adjusted. The<br>displaying method can be<br>changed. | Fixation target | Internal fixation target:<br>Dot matrix type organic EL<br>display<br>The display position can be<br>changed and adjusted. The<br>displaying method can be<br>changed. | |
| Model<br>Number | Subject Device<br>3D OCT-1 Maestro2 | Predicate Device<br>3D OCT-1 Maestro2 | Substantial Equivalence<br>Discussion | | |
| | Peripheral fixation target:<br>This is displayed according to<br>the internal fixation target<br>displayed position.<br><br>External fixation target | Peripheral fixation target:<br>This is displayed according to<br>the internal fixation target<br>displayed position.<br><br>External fixation target | | | |
| | Observation & photographing of anterior<br>segment | Observation & photographing of anterior<br>segment | | | |
| | Type of<br>photography | Color & IR (Note 3) | Type of<br>photography | | |
| | Operating<br>distance | 62.6 ±0.1mm (when taking a<br>picture of anterior segment)<br>(Note 2) | Operating<br>distance | 62.6 ±0.1mm (when taking a<br>picture of anterior segment)<br>(Note 2) | |
| | Observation & photographing of the anterior<br>segment tomogram | Observation & photographing of the anterior<br>segment tomogram | | | |
| | Operating<br>distance | 62.6 ±0.1mm (when taking a<br>picture of anterior segment)<br>(Note 2) | Operating<br>distance | 62.6 ±0.1mm (when taking a<br>picture of anterior segment)<br>(Note 2) | |
| | Scan range (on<br>cornea) (Note<br>2) | Horizontal direction 3 – 6mm<br>±5% or less<br>Vertical direction 3 – 6mm ±5%<br>or less | Scan range (on<br>cornea) (Note<br>2) | Horizontal direction 3 – 6mm<br>±5% or less<br>Vertical direction 3 – 6mm ±5%<br>or less | |
| | Scan pattern | Linear scan (Line-scan/Radial-<br>scan) | Scan pattern | Linear scan (Line-<br>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<br>IMAGEnet6<br>via PC<br>software for<br>System<br>Linkage | | Yes | | No | Different<br>The difference in instrument<br>and PC software does not affect<br>the SE discussion because the<br>programing language and core<br>algorithm of the Maestro2<br>predicate and Maestro2 is the<br>same. |

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for Topcon. The logo consists of the word "TOPCON" in black, block letters. Above the word is a blue symbol that resembles two overlapping, stylized letter "C" shapes. The symbol is a vibrant blue color and is the most prominent element of the logo.

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for Topcon. The logo consists of a stylized blue symbol above the word "TOPCON" in black, block letters. The symbol is composed of two overlapping shapes that resemble stylized wings or curved brackets, creating a modern and abstract design.

| Model<br>Number | Subject Device<br>3D OCT-1 Maestro2 | Predicate Device<br>3D OCT-1 Maestro2 | Substantial Equivalence<br>Discussion |
|---------------------------------------------|-------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Optional<br>Remote<br>operation<br>function | Yes | No | <b>Different</b><br>For the modified remote<br>operation function, comparison<br>testing confirmed that image<br>quality and diagnosability is the<br>same with or without the remote<br>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.