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

K231222 · Topcon Corporation · OBO · Oct 30, 2023 · Ophthalmic

Device Facts

• Record ID: K231222
• Device Name: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
• Applicant: Topcon Corporation
• Product Code: OBO · Ophthalmic
• Decision Date: Oct 30, 2023
• 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

Non-contact ophthalmic imaging device; combines spectral-domain optical coherence tomography (SD-OCT) with digital color fundus camera. Inputs: optical signals from retina/anterior eye segments. Operation: SD-OCT captures tomographic cross-sections; fundus camera captures color, IR, and red-free images. Device uses internal/external fixation targets for patient alignment. Output: high-resolution tomographic images, fundus photographs, and quantitative measurements of ocular structures. Used in clinical settings by eye care professionals. Output aids diagnosis, documentation, and management of ocular health/disease. Benefits: non-invasive visualization and objective measurement of ocular structures.

Clinical Evidence

Bench testing only; no clinical data required.

Technological Characteristics

Spectral-domain OCT; digital fundus camera (color, IR, red-free). 6M pixel CMOS sensor. 50,000 A-scans/sec. Connectivity: USB 3.0. Standards: IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 10940, ANSI Z80.36, IEC 60825-1, ISO 10993, IEC 62304, DICOM. Software: Moderate level of concern.

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. Includes reference database for quantitative comparison of posterior ocular measurements to normal subjects.

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 (K170164)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Elvin Y. Ng -S

Elvin Ng Assistant Director

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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

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# Indications for Use

510(k) Number (if known)

K231222

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) | |
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| <div> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## 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: [phone]

#### 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<br>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.

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## 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:<br>General requirements for basic safety and essential performance -<br>Collateral standard: Electromagnetic disturbances - Requirements<br>and tests |
| ANSI AAMI ES60601- 1:2005/(R)2012 and<br>A1:2012, C1:2009/(R)2012 and<br>A2:2010/(R)2012 | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance |
| ISO 15004-1:2020 | Ophthalmic instruments - Fundamental requirements and test<br>methods - Part 1: General requirements applicable to all<br>ophthalmic instruments |
| ISO 10940:2009 | Ophthalmic instruments - Fundus cameras |
| ANSI Z80.36-2021 | American National Standard for Ophthalmics - Light Hazard<br>Protection for Ophthalmic Instruments |
| IEC 60601-1-6: 2013 | Medical electrical equipment - Part 1-6: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Usability |
| IEC62366-1:2015+AMD1:2020 | Medical devices - Part 1: Application of usability engineering to<br>medical devices |

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

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| 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)

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## 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<br>3D OCT-1 Maestro2 | Predicate device<br>3D OCT-1 | Substantial<br>Equivalence<br>Discussion |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | 3D OPTICAL COHERENCE TOMOGRAPHY | 3D OPTICAL COHERENCE TOMOGRAPHY | N/A |
| | 3D OCT-1(type: Maestro2) | 3D OCT-1 | |
| 510(k)<br>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<br>Use | The TOPCON 3D Optical Coherence Tomography 3D OCT-1<br>(Type:Maestro2) is a noncontact, high resolution tomographic and<br>biomicroscopic imaging device that incorporates a digital camera<br>for photographing, displaying and storing the data of the retina and<br>surrounding parts of the eye to be examined under Mydriatic and<br>non-Mydriatic conditions.<br><br>The 3D Optical Coherence Tomography 3D OCT-1<br>(Type:Maestro2) is indicated for in vivo viewing, axial cross<br>sectional, and three-dimensional imaging and measurement of<br>posterior ocular structures, including retina, retinal nerve fiber<br>layer, macula and optic disc as well as imaging of anterior ocular<br>structures.<br><br>It also includes a Reference Database for posterior ocular<br>measurements which provide for the quantitative comparison of | The TOPCON 3D OCT-1 Maestro is a non-contact, high resolution<br>tomographic and biomicroscopic imaging device that incorporates<br>a digital camera for photographing, displaying and storing the data<br>of the retina and surrounding parts of the eye to be examined under<br>Mydriatic and non-Mydriatic conditions.<br><br>The 3D OCT-1 Maestro is indicated for in vivo viewing, axial cross<br>sectional, and three-dimensional imaging and measurement of<br>posterior ocular structures, including retina, retinal nerve fiber<br>layer, macula and optic disc as well as imaging of anterior ocular<br>structures.<br><br>It also includes a Reference Database for posterior ocular<br>measurements which provide for the quantitative comparison of | Different<br>There is a<br>difference in<br>product name<br>where "(type:<br>Maestro2)" was<br>added. However,<br>a difference in<br>product name<br>does not affect SE<br>of subject device<br>and predicate<br>device. |

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| Model Number | Subject Device<br>3D OCT-1 Maestro2 | Predicate device<br>3D OCT-1 | Substantial<br>Equivalence<br>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<br>(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<br>Specifications | Picture angle for<br>observation/photography | | 45° ±5% or less 30° or equivalent<br>(digital zoom) | Picture angle for<br>observation/photography | | 45° ±5% or less 30° or equivalent<br>(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.<br>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.<br>φ3.3mm or more: When small pupil diaphragm is used. | |
| | Fundus image resolution (on fundus) | | Optical Function<br>Center: 60 lines/mm or more<br>Middle (r/2): 40 lines/mm or more<br>Periphery (r): 25 lines/mm or more | Fundus image resolution (on fundus) | | With Camera Function<br>Center: 50 lines/mm or more<br>Middle (r/2): 40 lines/mm or more<br>Periphery (r): 25 lines/mm or more | |

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| Model Number | Subject Device<br>3D OCT-1 Maestro2 | | Predicate device<br>3D OCT-1 | Substantial<br>Equivalence<br>Discussion |
|--------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| | or more<br>IR photography: Center: 5 lines/mm<br>or more (Note 3) | | or more<br>IR photography: Center: 5 lines/mm or<br>more (Note 3) | |
| | Observation & photographing of the fundus<br>tomogram | | Observation & photographing of the fundus<br>tomogram | |
| | Scan range<br>(on fundus) | Horizontal direction 3 - 12mm ±5% or less<br>Vertical direction 3 – 9mm ±5% or less | Horizontal direction 3 - 12mm ±5% or less<br>Vertical direction 3 – 9mm ±5% or less | |
| | Scan pattern | 3D scan (horizontal)<br>Linear scan (Line-scan/Cross-scan) | 3D scan (horizontal)<br>Linear scan (Line-scan/Cross-scan) | |
| | Scan speed | 50,000 A-Scans per second | 50,000 A-Scans per second | |
| | Lateral<br>resolution | 20μm | 20μm | |
| | In-depth<br>resolution | 6μm | 6μm | |
| | Photographab<br>le diameter of<br>pupil | φ2.5mm or more | φ2.5mm or more | |
| | Observation & photographing of the fundus<br>image/fundus tomogram | | Observation & photographing of the fundus<br>image/fundus tomogram | |
| | Fixation<br>target | Internal fixation target:<br>Dot matrix type organic EL display<br>The display position can be changed<br>and adjusted. The displaying method<br>can be changed. | Internal fixation target:<br>Dot matrix type organic EL display<br>The display position can be changed<br>and adjusted. The displaying method<br>can be changed. | |

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| Model Number | Subject Device<br>3D OCT-1 Maestro2 | Predicate device<br>3D OCT-1 | Substantial<br>Equivalence<br>Discussion |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| | Peripheral fixation target:<br>This is displayed according to the<br>internal fixation target displayed<br>position.<br><br>External fixation target | Peripheral fixation target:<br>This is displayed according to the<br>internal fixation target displayed<br>position.<br><br>External fixation target | |
| | Observation & photographing of anterior segment | Observation & photographing of anterior segment | |
| | Type of<br>photography | Color & IR (Note 3) | Color & IR (Note 3) |
| | Operating<br>distance | 62.6 ±0.1mm (when taking a picture<br>of anterior segment) (Note 2) | 62.6 ±0.1mm (when taking a picture<br>of anterior segment) (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 picture<br>of anterior segment) (Note 2) | 62.6 ±0.1mm (when taking a picture<br>of anterior segment) (Note 2) |
| | Scan range<br>(on cornea)<br>(Note 2) | Horizontal direction 3 – 6mm ±5% or<br>less<br>Vertical direction 3 – 6mm ±5% or les | Horizontal direction 3 – 6mm ±5% or<br>less<br>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<br>target | External fixation target | External fixation target |
| | | (Note 1) Digital red-free photography that processes a color<br>image and displays it in pseudo-red-free condition. | (Note 1) Digital red-free photography that processes a color<br>image and displays it in pseudo-red-free condition. |

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| Model Number | Subject Device<br>3D OCT-1 Maestro2 | Predicate device<br>3D OCT-1 | Substantial<br>Equivalence<br>Discussion | |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | (Note 2) When the attachment for anterior segment is included in<br>the system configuration.<br>(Note 3) This is used only for recording the position where a<br>tomogram is captured. | (Note 2) When the attachment for anterior segment is included in<br>the system configuration.<br>(Note 3) This is used only for recording the position where a<br>tomogram is captured. | | |
| | Cameras for imaging and IR observation | Color fundus imaging | Different | |
| | Resolution: 6M pixels<br>Sensor type: CMOS<br>IF: USB3.0<br>IR observation: | Resolution: 5M pixels<br>Sensor type: CMOS<br>IF: GigE<br>Pixel size: 2.2 um×2.2 µm | The 3D OCT-1<br>predicate<br>incorporated two<br>cameras. One for<br>fundus image | |
| | Pixel size: 9.6 um×9.6 um | IR observation camera | capture and one | |
| Specification of<br>Cameras for<br>imaging and<br>observation | Color:<br>Pixel size: 2.4 um×2.4 um | Resolution: 0.3M pixels<br>Sensor type: CMOS<br>IF: Parallel 8-bit<br>Pixel size: 5.6 µm×5.6 µm | for IR<br>observation. The<br>subject device<br>(Maestro2) has<br>one camera which<br>functions as<br>camera for both<br>fundus image<br>capture and IR<br>observation.<br>This difference<br>does not affect the<br>SE discussion<br>because device<br>testing confirmed<br>Maestro2 fulfills<br>the standard for<br>fundus camera;<br>therefore, | |

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| Model Number | Subject Device<br>3D OCT-1 Maestro2 | Predicate device<br>3D OCT-1 | Substantial<br>Equivalence<br>Discussion |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | technically<br>equivalent with<br>3D OCT-1. |
| | | | Different<br>In accordance<br>with the<br>modification to<br>the camera,<br>Maestro2 is<br>equipped with<br>movable IR filter<br>while 3D OCT-1<br>is equipped with<br>fixed IR filter. |
| Movable IR filter | YES | NO | This difference<br>does not affect the<br>SE discussion<br>because the<br>spectral properties<br>of the IR filter<br>itself is the same<br>with 3D OCT-1<br>and Maestro2.<br>Device testing<br>confirmed<br>Maestro2 fulfills<br>the standard for<br>fundus camera;<br>therefore,<br>technically<br>equivalent with |
| Model Number | Subject Device<br>3D OCT-1 Maestro2 | Predicate device<br>3D OCT-1 | Substantial<br>Equivalence<br>Discussion |
| | | | 3D OCT-1. |
| | | | Different<br>The pixel size<br>between the<br>camera for the 3D<br>OCT-1 predicate<br>and the Maestro2<br>is different. This<br>pixel size change<br>caused by the |
| Focal length of<br>relay lens of<br>imaging optical<br>system | IR wavelength<br>Wavelength used: 760 nm to 780 nm<br>View angle of fundus camera:<br>within 45°±5%<br>Horizontal magnification of fundus camera: 0.20<br>Horizontal resolution of fundus camera:<br>Center: 5 line/mm or more | IR wavelength:<br>Wavelength used: 760 nm to 780 nm<br>View angle of fundus camera:<br>within 45°±5%<br>Horizontal magnification of fundus camera: 0.35<br>Horizontal resolution of fundus camera:<br>Center: 5 lines/mm or more | magnification<br>between the<br>fundus and the<br>camera on the<br>fundus camera.<br>The focal length<br>of the relay lens<br>of the image<br>capture optical<br>system was<br>modified to<br>maintain the size<br>of the fundus per<br>pixel. |
| | | | This difference<br>does not affect the<br>SE discussion<br>because the<br>device testing<br>confirmed |

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| Model Number | Subject Device<br>3D OCT-1 Maestro2 | Predicate device<br>3D OCT-1 | Substantial<br>Equivalence<br>Discussion |
|------------------------|----------------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| External<br>Appearance | Image: Subject Device | Image: Predicate Device | the standard for<br>fundus camera;<br>therefore,<br>technically<br>equivalent with<br>3D OCT-1.<br>Different<br>There is a<br>difference in the<br>external<br>appearance.<br>However, this<br>difference does<br>not affect safety<br>and effectiveness<br>of the device;<br>therefore, does<br>not affect SE<br>discission of<br>subject device and<br>predicate device. |
| Overall<br>Dimensions | 340-480mm (W) × 543-680mm (D) × 500-735mm(H) | 307-442mm (W) × 472 -668mm (D) × 518 -722mm(H) | Different<br>There is a<br>difference in the<br>overall<br>dimensions due to<br>a modification of<br>the external cover.<br>However, this<br>difference does<br>not affect safety<br>and effectiveness |

510(k) Summary: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

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| Model Number | Subject Device<br>3D OCT-1 Maestro2 | Predicate device<br>3D OCT-1 | Substantial<br>Equivalence<br>Discussion |
|-----------------------------|-------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | of the device;<br>therefore, does<br>not affect SE<br>discission of<br>subject device and<br>predicate device |
| Windows<br>operating system | MS Windows 10 | MS Windows 7, 8.1 | Different<br>There is a<br>difference in<br>version of<br>windows<br>operating systems.<br>This difference<br>does not affect the<br>SE discussion<br>because software<br>testing confirmed<br>Maestro2<br>functions as<br>intended with the<br>updated windows<br>OS version;<br>therefore,<br>technically<br>equivalent with<br>3D OCT-1. |