Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image processing, measurement, and comparison to a reference database, but does not mention any AI or ML algorithms. The performance study focuses on comparing the device's image quality and feature identification to a predicate device, not on validating an AI/ML algorithm's performance.

Therapeutic

No
The device is described as an "imaging device" and "diagnostic device" to aid in diagnosis, documentation, and management of ocular health and diseases. Its stated purpose is to visualize and measure ocular structures and provide quantitative comparisons, not to treat or alleviate diseases.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "It 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."

SaMD (Software as a Medical Device)

No

The device description clearly states that the Maestro2 is a non-contact ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography, including an optical system, fundus camera, and anterior observation camera. While IMAGEnet6 is a software program, the overall system includes significant hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the device described, the Topcon 3D Optical Coherence Tomography 3D OCT-1 (Type: Maestro2) in combination with IMAGEnet 6, is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use/Indications for Use: The intended use clearly states that the device is a "non-contact, high resolution tomographic and biomicroscopic imaging device" for "in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures" and "imaging of anterior ocular structures." It is indicated for use as a "diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases." These descriptions focus on imaging and measurement of structures within the living eye.
Device Description: The device description reinforces that it is an "ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography." It describes the optical systems and how it's used for imaging.
Anatomical Site: The anatomical sites mentioned are all parts of the eye (retina, optic disc, macula, choroid, etc.), which are in vivo structures.
Lack of In Vitro Activity: There is no mention of the device being used to examine samples of human origin (like blood, tissue, urine, etc.) outside of the body. IVDs are specifically designed for testing such samples to provide information about a person's health.

The device is an in vivo diagnostic imaging device used to visualize and measure structures within the eye to aid in the diagnosis and management of ocular conditions. This is distinct from an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions.

It is indicated for in vivo viewing, axial cross sectional, and threedimensional 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.

It 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.

All the above functionalities and indications are available in combination with IMAGEnet 6.

IMAGEnet6 Ophthalmic Data System

The IMAGEnet6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices.

It is intended for processing and displaying ophthalmic images and optical coherence tomography data.

The IMAGEnet6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.

Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6

Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

Product codes

OBO, HKI, NFJ

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. 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 is capable of OCT imaging and color fundus photography. For this 510(k) notification, Maestro2 has been modified to allow for OCT "angiographic" imaging (only in conjunction with IMAGEnet6).

The software version for this 510(k) are: Maestro2 Main software: Ver.3.00 PC Software for System Linkage: Ver.3.00

IMAGEnet6 Ophthalmic Data System

IMAGEnet6 is a software program installed on a server computer and operated via web browser on a client computer. It is used in acquiring, storing, managing, processing, measuring, displaying of patient information, examination information and image information delivered from TOPCON devices.

When combined with Maestro2, IMAGEnet6 plays an essential role as the user interface of the external PC by working together with the linkage software of Maestro2. In this configuration, IMAGEnet6 performs general GUI functions such as providing of the log-in screen, display of the menu icons, display function, measurement, analysis function, image editing functions, storing and management of data of the captured OCT scans and provides the reference database for quantitative comparison. For this 510(k) notification, IMAGEnet6 has been modified to allow for OCT "angiographic" imaging on the Maestro2.

IMAGEnet6 also provides the GUI for remote operation. This function is an optional function which enables end-users to use some of the image capture function by operating the PC or tablet PC connected to the external PC of Maestro2 via ethernet cable. 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.

The software version for this 510(k) is: IMAGEnet6 Ophthalmic Data System Ver. 4.01

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical Coherence Tomography (OCT), fundus photography (color, IR, Red-free)

Anatomical Site

Retina, retinal nerve fiber layer, macula, optic disc, choroid, anterior ocular structures (cornea, corneal epithelium, anterior segment, anterior chamber).

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

A prospective, multi-center, observational study was conducted to compare the OCTA imaging performance (i.e., image quality and visualization of vascular features in the macula and optic disc) of the Maestro2 and the CIRRUS HD-OCT and to compare visualization of pathologic vascular features in the retina and choroid between the Maestro2 and CIRRUS HD-OCT versus dye-based angiography (e.g., fluorescein angiography). Maestro2 and CIRRUS HD-OCT images (OCTA macula 3x3-mm scan, macula 6x6-mm scan, and disc 4.5x4.5-mm scan) collected by the clinical sites were sent to an independent reading center (RC) for image grading. Participants age 22 years or older with or without relevant vascular pathology in at least one eye were enrolled and assigned to one of two groups: 1) "Normal Population" ("eyes without clinically significant pathology") and 2) "Pathology Population" ("eyes with vascular pathologies affecting different anatomical depths of the retina and choroid"). Best-corrected visual acuity (BCVA, in the study eye) in the "Pathology Population" was required to be 20/400 or better, in the "Normal Population 20/40 or better. The "Pathology Population" group was further stratified by vascular pathology primarily in the Outer Retina and/or Choriocapillaris slabs vs. vascular pathology in the Superficial and/or Deep slabs.

133 participants were enrolled. There were 41 eyes in the "normal" group, 93 eyes in the "pathology" group. 124 eyes of 122 subjects fulfilled eligibility criteria. Primary analyses were based on a cohort of these 124 eyes (eligible eyes with OCTA or FA/ICGA imaging; 38 "normal," 86 "pathology"). Participant age ranged from 22 to 87 years, with a mean age of 54.1±18.4 years (37.9 years in the "normal" group, 61 years in the "pathology" group). 45.9% (56/122) were men and 54.1% (66/122) were women. 71.3% (87/122) are White, 17.2% (21/122) Black/African American, 1.6% (2/122) American Indian/Alaskan Native, 7.4% (9/122) Asian. 0.8% (1/122) Native Hawaiian/Pacific Islander, and 2.5% (3/122) Other. 18.0% (22/122) are Hispanic or Latino and 82.0% (100/122) are not.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

A prospective, multi-center, observational study was conducted.
Sample Size: 133 participants (124 eligible eyes from 122 subjects).
Key Results:

Image Quality Response Rate:
- Entire cohort: 3x3-mm macular scan (75.0%), 6x6-mm macular scan (71.0%), and 4.5x4.5-mm disc scan (71.0%).
- "Pathology" group: 3x3-mm macular scan (75.6%), 6x6-mm macular scan (77.9%), and 4.5x4.5-mm disc scan (74.4%).
Visibility of Key Anatomical Features Response Rate:
- 3x3-mm macular scan: FAZ visibility (87.1%), medium vessels (87.9%), small vessels/capillaries (82.3%).
- 6x6-mm macular scan: FAZ visibility (81.5%), large vessels (87.1%), medium vessels (77.4%), small vessels/capillaries (79.8%).
- 4.5x4.5-mm disc scan: large vessels (83.9%), medium vessels (80.6%), small vessels/capillaries (80.6%).
Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) for Key Pathological Vascular Features (in "pathology" group):
- Microaneurysms (MAs):
  - 3x3-mm macular scans: PPA 96.6%, NPA 92.7%. Response rate: 81.0%.
  - 6x6-mm macular scans: PPA 96.6%, NPA 92.7%. Response rate: 82.1%.
  - 4.5x4.5-mm disc scans: PPA 73.9%, NPA 100%. Response rate: 75.6%.
- RI/CD:
  - 3x3-mm scans: PPA 93.1%, NPA 85.4%. Response rate: 76.2%.
  - 6x6-mm scans: PPA 100%, NPA 87.8%. Response rate: 79.8%.
  - 4.5x4.5-mm disc scans: PPA 75.0%, NPA 85.7%. Response rate: 71.8%.
- CNV:
  - 3x3-mm macular scans: PPA 88.9%, NPA 82.7%. Response rate: 79.8%.
  - 6x6-mm macular scans: PPA 84.2%, NPA 84.3%. Response rate: 81.0%.
  - 4.5x4.5-mm disc scans: PPA 66.7%, NPA 98.4%. Response rate: 75.3%.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found. (PPA and NPA are provided in Summary of Performance Studies)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K181534, K233561, K232828

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

July 17, 2024

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 in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

Topcon Corporation % Lena Sattler President Orasi Consulting 226 1st Street Bonita Springs, Florida 34134

Re: K241081

Trade/Device Name: 3D OPTICAL COHERENCE TOMOGRAPHY (3D OCT-1(type: Maestro2)); IMAGEnet6 Ophthalmic Data System Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HKI, NFJ Dated: April 18, 2024 Received: April 19, 2024

Dear Lena Sattler:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elvin Y. Ng -S

Elvin Ng Assistant Director 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

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Enclosure

3

Indications for Use

510(k) Number (if known) K241081

Device Name

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

IMAGEnet6 Ophthalmic Data System

Indications for Use (Describe)

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

The Topcon 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic conditions.

It 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 human retina to a database of known normal subjects.

It 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.

All the above functionalities and indications are available in combination with IMAGEnet 6.

· Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6

Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

· IMAGEnet6 Ophthalmic Data System
The IMAGEnetto Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices.

It is intended for processing and displaying ophthalmic images and optical coherence tomography data.

The IMAGEnet6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.

· Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6

Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/5/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 eyes or lenses, giving the logo a modern and technological feel.

510(k) SUMMARY

I. 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:

July 16, 2024

II. Subject device:

| Name of Device: | 1) 3D OPTICAL COHERENCE TOMOGRAPHY
3D OCT-1(type: Maestro2)
2) IMAGEnet6 Ophthalmic Data System |
|--------------------------|-------------------------------------------------------------------------------------------------------|
| Device Class: | Class II |
| Classification Name: | 21 C.F.R. § 886.1570, Ophthalmoscope |
| Product Code: | OBO |
| Associated Product Code: | HKI, NFJ |

III. Predicate devices:

PRIMARY PREDICATE DEVICE:

Company	Carl Zeiss Meditec, Inc.
Device	CIRRUS HD-OCT with Software Version 10
510(k) No.	K181534
Classification Name:	21 CFR § 886.1570
Ophthalmoscope
Product Code:	OBO

SECONDARY PREDICATE DEVICES:

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Image /page/6/Picture/0 description: The image shows the logo for Topcon. The logo features a stylized blue symbol resembling two overlapping letter 'C' shapes. Below the symbol, the word "TOPCON" is written in a bold, sans-serif font, also in blue. The logo is simple and modern.

(1) 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2):
Company	Topcon Corporation
Device	3D OPTICAL COHERENCE TOMOGRAPHY
3D OCT-1(type: Maestro2)
510(k) No.	K233561
Classification Name:	21CFR § 886.1570 Ophthalmoscope
Product Code:	OBO HKI

	(2) IMAGEnet6 Ophthalmic Data System:

Company	Topcon Corporation
Device	IMAGEnet6 Ophthalmic Data System
510(k) No.	K232828
Classification Name:	21 C.F.R. § 892.2050
Medical image management and processing system
Product Code:	NFJ

IV. Brief Device Descriptions

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. 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 is capable of OCT imaging and color fundus photography. For this 510(k) notification, Maestro2 has been modified to allow for OCT "angiographic" imaging (only in conjunction with IMAGEnet6).

The software version for this 510(k) are: Maestro2 Main software: Ver.3.00 PC Software for System Linkage: Ver.3.00

IMAGEnet6 Ophthalmic Data System

IMAGEnet6 is a software program installed on a server computer and operated via web browser on a client computer. It is used in acquiring, storing, managing, processing, measuring, displaying of patient information, examination information and image information delivered from TOPCON devices.

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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 overlapping shapes that resemble stylized eyes or lenses, giving the logo a modern and technological feel.

When combined with Maestro2, IMAGEnet6 plays an essential role as the user interface of the external PC by working together with the linkage software of Maestro2. In this configuration, IMAGEnet6 performs general GUI functions such as providing of the log-in screen, display of the menu icons, display function, measurement, analysis function, image editing functions, storing and management of data of the captured OCT scans and provides the reference database for quantitative comparison. For this 510(k) notification, IMAGEnet6 has been modified to allow for OCT "angiographic" imaging on the Maestro2.

IMAGEnet6 also provides the GUI for remote operation. This function is an optional function which enables end-users to use some of the image capture function by operating the PC or tablet PC connected to the external PC of Maestro2 via ethernet cable. 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.

The software version for this 510(k) is: IMAGEnet6 Ophthalmic Data System Ver. 4.01

V. Intended use

The Maestro2 has the same intended use as the primary predicate and IMAGEnet 6 has the same intended use as the secondary predicate K232828. The modified Maestro2 and IMAGEnet6 devices will have the following Indications for Use (IFU) statements, which are not substantially different from those of the primary and/or secondary predicates:

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 non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions.

It is indicated for in vivo viewing, axial cross sectional, and threedimensional 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.

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Image /page/8/Picture/1 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 stylized wings or petals, with a horizontal line running through the center, creating a sense of connection or unity.

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 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.

All the above functionalities and indications are available in combination with IMAGEnet 6.

IMAGEnet6 Ophthalmic Data System ●

The IMAGEnet6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices.

It is intended for processing and displaying ophthalmic images and optical coherence tomography data.

The IMAGEnet6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.

. Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6

Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

VI. Comparison of the technological characteristics between the subject and predicate devices

The subject and predicate devices do not share identical technological characteristics. However, these differences do not raise new or different questions of safety and effectiveness.

Comparison of the technological characteristics between the subject and predicate devices are summarized in Tables 1, 2 and 3 below.

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Image /page/9/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 eyes or lenses.

TABLE 1: PREDICATE COMPARISON–MAESTRO2 AND IMAGENET6 VERSUS PRIMARY PREDICATE ON OCT ANGIOGRAPHY

	(Under lines shows the differences.)
Model
Number	Subject Device
3D OCT-1 Maestro2
Software version
Maestro2 Main software:
Ver.3.00
PC Software for System
Linkage: Ver.3.00	Subject Device
IMAGEnet6
Software version Ver4.01	Primary predicate device
CIRRUS HD-OCT	Substantial
Equivalence
Discussion
Trade Name	3D OPTICAL
COHERENCE
TOMOGRAPHY 3D OCT-
1(type: Maestro2)	Ophthalmic Data System
IMAGEnet6	CIRRUS HD-OCT	NA
510(k)
submitter	TOPCON Corporation	TOPCON Corporation	Carl Zeiss Meditec, Inc.	NA
510(k)
Number	K241081	K241081	K181534	NA
Primary
Product code	OBO	OBO	OBO	Same
Regulation No.	21 C.F.R. § 886.1570	21 C.F.R. § 886.1570*
*Due to bundling of
Maestro2 and IMAGEnet6
under the same 510(k)
submission	21 C.F.R. § 886.1570	Same
Product class	II	II	II	Same
Indications for
Use	The Topcon 3D Optical
Coherence Tomography 3D
OCT-1 (Type:Maestro2) is
a non-contact, high
resolution tomographic and
biomicroscopic imaging
device that incorporates a
digital camera for
photographing, displaying
and storing the data of the
retina and surrounding
parts of the eye to be
examined under Mydriatic
and non-Mydriatic
conditions.
It 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	The IMAGEnet6
Ophthalmic Data System is
a software program that is
intended for use in the
collection, storage and
management of digital
images, patient data,
diagnostic data and clinical
information from Topcon
devices.
It is intended for
processing and displaying
ophthalmic images and
optical coherence
tomography data.
The IMAGEnet6
Ophthalmic Data System
uses the same algorithms
and reference databases
from the original data
capture device as a
quantitative tool for the
comparison of posterior
ocular measurements to a
database of known normal
subjects.	CIRRUS™ HD-OCT is a
non-contact, high
resolution tomographic and
biomicroscopic imaging
device intended for in-vivo
viewing, axial cross-
sectional, and three-
dimensional imaging of
anterior and posterior
ocular structures. The
device is indicated for
visualizing and measuring
anterior and posterior
ocular structures, including
cornea, corneal epithelium,
retina, retinal nerve fiber
layer, ganglion cell plus
inner plexiform layer,
macula, and optic nerve
head.
The CIRRUS normative
databases are quantitative
tools indicated for the
comparison of retinal nerve
fiber layer thickness,
macular thickness,
ganglion cell plus inner
plexiform layer thickness,
and optic nerve head
measurements to a
database of normal
subjects.	Similar.
The combination
of Maestro2 and
IMAGEnet6 is
similar to the
CIRRUS HD-OCT.
Both are OCT
imaging systems
with a reference
database (RDB).
OCTA and fundus
camera features.
Clinical
performance
testing was
conducted on the
OCTA function of
Maestro2 (and
IMAGEnet6
combination) and
on the CIRRUS
HD-OCT.
(Under lines shows the differences.)
Model
Number	Subject Device
3D OCT-1 Maestro2
Software version
Maestro2 Main software:
Ver.3.00
PC Software for System
Linkage: Ver.3.00	Subject Device
IMAGEnet6
Software version Ver4.01	Primary predicate device
CIRRUS HD-OCT	Substantial
Equivalence
Discussion
Indications for
Use
of
the
combination of
the Maestro2
in conjunction
with
IMAGEnet6	to a database of known
normal subjects.
It 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.
All the above
functionalities and
indications are available in
combination with
IMAGEnet 6.	Maestro2 in combination with IMAGEnet 6 is indicated as
an aid in the visualization of vascular structures of the
posterior segment of the eye including the retina, optic disc
and choroid.	Angiography is indicated
as an aid in the
visualization of vascular
structures of the retina and
choroid. (Model 5000
only.)
CIRRUS HD-OCT is
indicated as a diagnostic
device to aid in the
detection and management
of ocular diseases
including, but not limited
to, macular holes, cystoid
macular edema, diabetic
retinopathy, age-related
macular degeneration, and
glaucoma.	NA
Light Source	Spectral domain OCT
(SDOCT) using a super
luminescent diode (SLD)
with center wavelength 840
nm.	NA	Spectral domain OCT
(SDOCT) using a super
luminescent diode (SLD)
with center wavelength 840
nm.	Same
Scan Speed	50,000 A-scans/sec	NA	27,000 A-scans/sec
68,000 A-scans/sec for
OCT Angiography	Different.
There is a
difference in scan
speed.
Clinical
performance
testing was
conducted on the
OCTA function of
Maestro2 and
IMAGEnet6
combination and
on the CIRRUS
HD-OCT.
A-scan Depth	2.6 mm (in tissue)	NA	2.0 mm	Different.
Clinical
performance
testing was
conducted on the
OCTA function of
Maestro2 and
IMAGEnet6
combination and
(Under lines shows the differences.)
Model
Number	Subject Device
3D OCT-1 Maestro2
Software version
Maestro2 Main software:
Ver.3.00
PC Software for System
Linkage: Ver.3.00	Subject Device
IMAGEnet6
Software version Ver4.01	Primary predicate device
CIRRUS HD-OCT	Substantial
Equivalence
Discussion
				on the CIRRUS
HD-OCT.
Different.
Resolution	Axial: 6 μm (in tissue)
Transverse: 20 μm
(in
tissue)	NA	Axial: 5 μm (in tissue)
Transverse: ≤15 μm	Clinical
performance
testing was
conducted on the
OCTA function of
Maestro2 and
IMAGEnet6
combination and
on the CIRRUS
HD-OCT.
Scan Patterns	For posterior
3D scan

12x9 mm (512x128)
6x6 mm (512x128)
Line scan
6 mm (1024)
9 mm (1024)
5LineCross scan
6 mm (1024) x 5 x 2
9 mm (1024) x 5 x 2
For anterior
Radial scan
6 mm x 12 (1024x12)
Line scan
3 mm (1024)
6 mm (1024) | NA | Macular Cube
6x6 mm (512x128)
6x6 mm (200x200)
Optic Disc Cube
6x6 mm (200x200)
5 Line Raster
HD (high-definition)
Raster
HD 1 Line 100x
HD 21 Line
HD Radial
HD Cross
HD 5-Line Raster
Anterior Segment Cube
Scan
512x128
Anterior Segment 5-Line
Raster
HD Angle
Anterior Chamber
Wide-to-Angle
HD Cornea
Pachymetry | Similar |
| OCTA Scan
Patterns | Macular
3x3mm (256x256)
6x6mm (360x360)
Disc:
4.5x4.5mm (320x320) | NA | AngioPlex
3x3 mm
6x6 mm
8 x8 mm | Different. Clinical
performance
testing was
conducted on the
OCTA function of
Maestro2 and
IMAGEnet6
combination and
on the CIRRUS
HD-OCT. |
| OCTA
algorithm | OCTARA | NA | OMAG | Different
Clinical
performance |
| | (Under lines shows the differences.) | | | |
| Model
Number | Subject Device
3D OCT-1 Maestro2
Software version
Maestro2 Main software:
Ver.3.00
PC Software for System
Linkage: Ver.3.00 | Subject Device
IMAGEnet6
Software version Ver4.01 | Primary predicate device
CIRRUS HD-OCT | Substantial
Equivalence
Discussion |
| | | | | testing was
conducted on the
OCTA function of
Maestro2 and
IMAGEnet6
combination and
on the CIRRUS
HD-OCT. |
| Default OCTA
en face slabs | NA | Macular scans default slabs
Superficial- ILM to
IPL/INL + 15.6µm
Deep- IPL/INL + 15.6µm
to IPL/INL + 70.2µm
Outer Retina- IPL/INL +
70.2µm to BM
Choriocapillaris- BM to
BM + 20.8µm
Disc scans default slabs
Vitreous- Top to ILM
Optic Disc- ILM to BM -
50µm
RPC- ILM to RNFL/GCL
Choriocapillaris- BM to
BM + 20.8µm | Macular scans default slabs
Superficial- ILM to IPL
Deep- IPL to OPL
Avascular- OPL to RPE -
70µm
Choriocapillaris- RPE +
29µm to RPE + 49µm
Disc scans default slabs
Vitreous Retinal Interface-
ILM - 300µm to ILM
Retina- ILM to RPE
RPC- ILM to RNFL | Different
Clinical
performance
testing was
conducted on the
OCTA function of
Maestro2 and
IMAGEnet6
combination and
on the CIRRUS
HD-OCT. |
| Layer
Segmentation | For posterior:

ILM
RNFL/GCL
IPL/INL
OS/RPE
BM
For anterior:
N/A | Manual adjustment of
segmented layer. | Unknown | Similar. |
| Quantitative
Analyses | For posterior:

Retinal layer
segmentation
Optic disc analysis
OCTA: None (qualitative
visualization only)
For anterior:
N/A | Thickness calculation | For posterior:
RNFL, Macula,
Anterior
Segmentation
RNFL Thickness
analysis
Optic Nerve Head
(ONH) analysis
Guided Progression
Analysis (GPA) for
RNFL
Guided Progression
Analysis (GPA) for
Ganglion Cell/IPL
Macular Thickness
Analysis
Ganglion Cell OU
Analysis
Advanced RPE
Analysis
PanoMap Analysis
For anterior: | Similar. There are
no quantitative
analyses associated
with OCTA
imaging from
either the Maestro2
or CIRRUS HD-
OCT. |
| (Under lines shows the differences.) | | | | |
| Model
Number | Subject Device
3D OCT-1 Maestro2
Software version
Maestro2 Main software:
Ver.3.00
PC Software for System
Linkage: Ver.3.00 | Subject Device
IMAGEnet6
Software version Ver4.01 | Primary predicate device
CIRRUS HD-OCT | Substantial
Equivalence
Discussion |
| | | | • Anterior Segment-
Analysis with
quantitative
measurement tools. | |
| Display of En-
face images | NA | YES | YES | Same |
| Fundus
imaging
available | Yes | NA | Yes | Same |

10

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11

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12

Image /page/12/Picture/0 description: The image shows the logo for Topcon. The logo consists of a stylized blue symbol above the word "TOPCON" in a bold, sans-serif font. The symbol appears to be two overlapping shapes, possibly representing a stylized letter or design element.

13

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TABLE 2 SUBSTANTIAL EQUIVALENCE - MAESTRO2 VERSUS SECONDARY PREDICATE DEVICE

(Under lines shows the differences.)
Model
Number	Subject Device
3D OCT-1 Maestro2
Software version
Maestro2 Main software: Ver.3.00
PC Software for System Linkage: Ver.3.00	Secondary predicate device
3D OCT-1 Maestro2
Software version
Maestro2 Main software: Ver.2.11.1
PC Software for System Linkage: Ver.2.11.1	Substantial
Equivalence
Discussion
Trade Name	3D OPTICAL COHERENCE
TOMOGRAPHY 3D OCT-1(type:
Maestro2)	3D OPTICAL COHERENCE
TOMOGRAPHY 3D OCT-1(type: Maestro2)	Same
510(k)
submitter	TOPCON Corporation	TOPCON Corporation	Same
510(k)
Number	K241081	K233561	NA
Primary
Product code	OBO	OBO	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 non-contact, high resolution
tomographic and biomicroscopic imaging
device that incorporates a digital camera
for photographing, displaying and storing
the data of the retina and surrounding parts
of the eye to be examined under Mydriatic
and non-Mydriatic conditions.
It 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	The 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	Different.
The modified
Maestro2 can
perform OCT
Angiography in
combination
with
IMAGEnet6.
(Under lines shows the differences.)
	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.
It 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.
All the above functionalities and
indications are available in combination
with IMAGEnet 6.
Indications for Use of the combination of
the Maestro2 in conjunction with
IMAGEnet6
Maestro2 in combination with IMAGEnet
6 is indicated as an aid in the visualization
of vascular structures of the posterior
segment of the eye including the retina,
optic disc and choroid.	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.
Light Source	Spectral domain OCT (SDOCT) using a
super luminescent diode (SLD) with center
wavelength 840 nm.	Spectral domain OCT (SDOCT) using a
super luminescent diode (SLD) with center
wavelength 840 nm.	Same
Scan Speed	50,000 A-scans/sec	50,000 A-scans/sec	Same
A-scan Depth	2.6 mm (in tissue)	2.6 mm (in tissue)	Same
	Axial: 6 micron (in tissue)	Axial: 6 micron (in tissue)
Resolution	Transverse: 20 micron (in tissue)	Transverse: 20 micron (in tissue)	Same
Scan Patterns	For posterior:
3D scan

12x9 mm (512x128)
6x6 mm (512x128)
Line scan
6mm (1024)
9mm (1024)
5LineCross scan
6mm (1024) x 5 x 2
9mm (1024) x 5 x 2
For anterior:
Radial scan
6mm x 12 (1024x12)
Line scan | For posterior:
3D scan
12x9 mm (512x128)
6x6 mm (512x128)
Line scan
6mm (1024)
9mm (1024)
5LineCross scan
6mm (1024) x 5 x 2
9mm (1024) x 5 x 2
For anterior:
Radial scan
6mm x 12 (1024x12)
Line scan | Same |
| | - 3mm (1024) | - 3mm (1024) | |
| | - 6mm (1024) | - 6mm (1024) | |
| Layer
Segmentation | For posterior:

ILM
RNFL/GCL
IPL/INL
OS/RPE
Bruch's membrane (BM) | For posterior:
ILM
RNFL/GCL
IPL/INL
OS/RPE | Different.
To support the
addition of
OCTA imaging,
the Maestro2
was modified to
be able to detect |
| (Under lines shows the differences.) | | | |
| | For anterior:
N/A | For anterior:
N/A | BM. |
| Thickness
Calculation | No | No | Same |
| Analysis | Yes | Yes | Same |
| OCTA image
capture | Macular

3x3mm (256x256)
6x6mm (360x360)
Disc:
4.5x4.5mm (320x320) | None | Different.
Addition of
OCTA-specific
scan patterns for
acquisition of
OCTA images. |
| Image | Color/Digital red-free image | Color/Digital red-free image | Same |
| Angle of View | 45 degree
30 degree (digital zoom) | 45 degree
30 degree (digital zoom) | Same |
| Operating
Distance | 34.8 mm (fundus photography)
62.6 mm (anterior photography) | 34.8 mm (fundus photography)
62.6 mm (anterior photography) | Same |
| Dioptric
Compensation | -33D to +40D | -33D to +40D | Same |
| Power Source | Voltage/frequency: AC 100-240V/50-60Hz
Power input: 70-150VA | Voltage/frequency: AC 100-240V/50-60Hz
Power input: 70-150VA | Same |
| Overall
Dimensions | 340-480mm (W) × 543-680mm (D) × 500
-735mm(H) | 340-480mm (W) × 543-680mm (D) × 500 -
735mm(H) | Same |
| Linkage with
IMAGEnet6
via PC
software for
System
Linkage | Yes | Yes | Same |
| Optional
Remote
operation
function | Yes | Yes | Same |

14

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15

Image /page/15/Picture/0 description: The image contains the logo for Topcon. The logo features a stylized blue symbol resembling two overlapping letter 'C' shapes with a horizontal white line running through the middle. Below the symbol, the word "TOPCON" is written in a bold, sans-serif font, also in blue.

TABLE 3 SUBSTANTIAL EQUIVALENCE – IMAGENET6 VERSUS SECONDARY PREDICATE DEVICE ON FUNCTION OTHER THAN OCT ANGIOGRAPHY

(Under lines shows the differences.)
Model Number	Subject Device
IMAGEnet6
Software version Ver4.01	Secondary predicate device
IMAGEnet6 predicate
Software version Ver2.52.1	Substantial
Equivalence
Discussion
Trade Name	Ophthalmic Data System IMAGEnet6	Ophthalmic Data System IMAGEnet6	N/A
510(k) submitter	TOPCON Corporation	TOPCON Corporation	Same
510(k) Number	K241081	K232828	N/A
Primary
Product code	OBO	NFJ	Different.
This difference is
due to the bundling
rule and does not
affect SE.
Regulation No.	21 C.F.R. § 886.1570	21 CFR 892.2050	Different.
This difference is
due to the bundling
rule and does not
(Under lines shows the differences.)
Product class	II	II	affect SE.
Indications for
use	The IMAGEnet6 Ophthalmic Data
System is a software program that is
intended for use in the collection, storage
and management of digital images,
patient data, diagnostic data and clinical
information from Topcon devices.
It is intended for processing and
displaying ophthalmic images and optical
coherence tomography data.
The IMAGEnet6 Ophthalmic Data
System uses the same algorithms and
reference databases from the original data
capture device as a quantitative tool for
the comparison of posterior ocular
measurements to a database of known
normal subjects.
Indications for Use of the combination of
the Maestro2 in conjunction with
IMAGEnet6
Maestro2 in combination with IMAGEnet
6 is indicated as an aid in the visualization
of vascular structures of the posterior
segment of the eye including the retina,
optic disc and choroid.	The IMAGEnet6 Ophthalmic Data
System is a software program that is
intended for use in the collection, storage
and management of digital images,
patient data, diagnostic data and clinical
information from Topcon devices.
It is intended for processing and
displaying ophthalmic images and optical
coherence tomography data.
The IMAGEnet6 Ophthalmic Data
System uses the same algorithms and
reference databases from the original data
capture device as a quantitative tool for
the comparison of posterior ocular
measurements to a database of known
normal subjects.	Different.
The modified
Maestro2 can
perform OCT
Angiography in
combination with
IMAGEnet6
Connectable
devices	TRC-50DX
TRC-NW300
TRC-NW7SF MARK III
TRC-NW8
TRC-NW8F
TRC-NW8F plus
TRC-NW400
DC-3
DC-4
3D OCT-1000
3D OCT-2000
3D OCT-1 Maestro
3D OCT-1(Type: Maestro2)
DRI OCT Triton
CA-800
KR-800PA
Aladdin
NW500	TRC-50DX
TRC-NW300
TRC-NW7SF MARK III
TRC-NW8
TRC-NW8F
TRC-NW8F plus
TRC-NW400
DC-3
DC-4
3D OCT-1000
3D OCT-2000
3D OCT-1 Maestro
3D OCT-1(Type: Maestro2)
DRI OCT Triton
CA-800
KR-800PA
Aladdin
NW500	Same
Database	YES	YES	Same
Patient
management	YES	YES	Same
Acquisition	YES	YES	Same
Archive and
Backup	YES	YES	Same
DVD / CD-R for
archiving	YES	YES	Same
(Under lines shows the differences.)
Image processing	YES	YES	Same
Import/Export
images DICOM	YES	YES	Same
Combination with
Maestro2	YES	YES	Same
Display OCTA
data and creation
of En-face image	YES	None	Different
Addition of OCTA
data.
This function is
evaluated with the
primary predicate
device.

16

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17

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VII. Non-clinical performance testing

It has been verified that Maestro2 and IMAGEnet6 functions as intended by tests or evaluations based on the following FDA-recognized, voluntary consensus standards, and the in-house test specification. The result of the testing supports substantial equivalence by demonstrating that the device(s) perform as intended and comply with the same standards as the predicate device(s).

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

FDA-recognized, voluntary consensus standards
IEC 60601-1-2:2014+AMD1:2020	Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
ANSI AAMI ES60601-1:2005/(R)2012 &
A1:2012, C1:2009/(R)2012 &
A2:2010/(R)2012 (Cons. Text) [Incl.
AMD2:2021]	Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
(IEC 60601-1:2005, MOD) [Including Amendment 2
(2021)]
ISO 15004-1:2020	Ophthalmic instruments - Fundamental requirements
and test methods - Part 1: General requirements
applicable to all ophthalmic instruments
ISO 10940:2009	Ophthalmic instruments – Fundus cameras
ANSI Z80.36-2021	American National Standard for Ophthalmics - Light
Hazard Protection for Ophthalmic Instruments
IEC 60601-1-6: 2020	Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance

Collateral standard: Usability |
| IEC62366-1:2015+AMD1:2020 | Medical devices - Part 1: Application of usability
engineering to medical devices |
| 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 |

18

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FDA-recognized, voluntary consensus standards
ISO 10993-5:2009	Biological evaluation of medical devices-Part 5: Tests
for in vitro cytotoxicity
ISO 10993-10:2021	Biological evaluation of medical devices - Part 10:
Tests for skin sensitization
ISO 10993-23:2021	Biological evaluation of medical devices - Part 23:
Tests for irritation
IEC 62304:2015	Medical device software - Software life cycle processes
ISO 14155: 2020	Clinical investigation of medical devices for human
subjects - Good clinical practice

Software for Maestro2 was concluded to be a Basic Documentation Level. Software verification and validation testing such as software system testing was performed for Maestro2 as recommended by FDA's Guidance document Content of Premarket Submissions for Device Software Functions (issued on June 14, 2023).

For the remote operation function cleared in K233561, 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 September 27, 2023).

IMAGEnet6 Ophthalmic Data System

FDA-recognized, voluntary consensus standards
IEC 62304:2015	Medical device software - Software life cycle processes
NEMA PS 3.1 - 3.20 2022d	Digital Imaging and Communications in Medicine (DICOM) Set
ISO 14155: 2020	Clinical investigation of medical devices for human subjects - Good
clinical practice

Software for IMAGEnet6 was concluded to be a Basic Documentation Level. Software verification and validation testing such as software system testing was performed for IMAGEnet6 as recommended by FDA's Guidance document Content of Premarket Submissions for Device Software Functions (issued on June 14, 2023).

For the remote operation function cleared in K232828, comparison testing confirmed that image quality and diagnosability is the same with or without the remote operation function.

IMAGEnet6 is a cyber device per 524B(c) of the Food, Drug & Cosmetic Act. IMAGEnet6 followed the recommendations in the FDA's Guidance document Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (issued on September 27, 2023).

19

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VIII. Clinical performance testing

A prospective, multi-center, observational study was conducted to compare the OCTA imaging performance (i.e., image quality and visualization of vascular features in the macula and optic disc) of the Maestro2 and the CIRRUS HD-OCT and to compare visualization of pathologic vascular features in the retina and choroid between the Maestro2 and CIRRUS HD-OCT versus dye-based angiography (e.g., fluorescein angiography). Maestro2 and CIRRUS HD-OCT images (OCTA macula 3x3-mm scan, macula 6x6-mm scan, and disc 4.5x4.5-mm scan) collected by the clinical sites were sent to an independent reading center (RC) for image grading. Participants age 22 years or older with or without relevant vascular pathology in at least one eye were enrolled and assigned to one of two groups: 1) "Normal Population" ("eyes without clinically significant pathology") and 2) "Pathology Population" ("eyes with vascular pathologies affecting different anatomical depths of the retina and choroid"). Best-corrected visual acuity (BCVA, in the study eye) in the "Pathology Population" was required to be 20/400 or better, in the "Normal Population 20/40 or better. The "Pathology Population" group was further stratified by vascular pathology primarily in the Outer Retina and/or Choriocapillaris slabs vs. vascular pathology in the Superficial and/or Deep slabs. The following endpoints were evaluated:

1. OCTA image "quality response rate" (percentage of eyes whose Maestro2 scans have the same or better grade than the corresponding CIRRUS HD-OCT scans).
1. Visibility of key anatomical vascular features (foveal avascular zone [FAZ] border, large blood vessels, medium blood vessels, and small blood vessels/capillaries) "response rate" (percentage of eyes whose Maestro2 scans have the same or better grade than the corresponding CIRRUS HD-OCT scans).
1. Positive percent agreement (PPA) and negative percent agreement (NPA) between Maestro2 and CIRRUS HD-OCT in the identification of key pathological vascular features (microaneurysms [MA], retinal ischemia/capillary dropout [RI/CD], and choroidal neovascularization [CNV]). In addition, a "response rate" was calculated based on the match outcome based on whether pathology identification was the same (i.e., a "match") between OCTA and FA/ICGA (percentage of eyes whose Maestro2 scans have the same or better outcome than the corresponding CIRRUS HD-OCT scans).

133 participants were enrolled. There were 41 eyes in the "normal" group, 93 eyes in the "pathology" group. 124 eyes of 122 subjects fulfilled eligibility criteria. Primary analyses were based on a cohort of these 124 eyes (eligible eyes with OCTA or FA/ICGA imaging; 38 "normal," 86 "pathology"). Participant age ranged from 22 to 87 years, with a mean age of 54.1±18.4 years (37.9 years in the "normal" group, 61 years in the "pathology" group). 45.9% (56/122) were men and 54.1% (66/122) were women. 71.3% (87/122) are White, 17.2% (21/122) Black/African American, 1.6% (2/122) American Indian/Alaskan Native, 7.4% (9/122) Asian. 0.8% (1/122) Native Hawaiian/Pacific Islander, and 2.5% (3/122)

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Other. 18.0% (22/122) are Hispanic or Latino and 82.0% (100/122) are not. In the "pathology" sub-group, 25.6% (22/86) had neovascular age-related macular degeneration, 22.1% (19/86) had non-proliferative diabetic retinopathy, 11.6% (10/86) had "other" retinal conditions (e.g., choroidal rupture), 10.5% (9/86) had proliferative diabetic retinopathy, 10.5% had branch retinal vein occlusion, 9.3% (8/86) had polypoidal choroidal vasculopathy, 8.1% had myopic CNV, 5.8% (5/86) had central retinal vein occlusion, 4.7% (4/86) had macular telangiectasia, 2.3% (2/86) had sickle cell retinopathy, 2.3% had central serous chorioretinopathy with CNV, and 2.3% had traumatic CNV. The distribution of vascular abnormalities is shown in the following table:

TABLE 4: ABNORMALITY OF STUDY EYES PER PRINCIPAL INVESTIGATOR (ANALYSIS POPULATION)

| Retinal Abnormality1 | Normal
N = 38 | Pathology
N = 86 | Total
N = 124 |
|-------------------------------------------------|------------------|---------------------|------------------|
| | n (%) | n (%) | n (%) |
| Abnormalities | | | |
| None | 38 (100%) | 0 (0.0%) | 38 (30.6%) |
| Retinal Ischemia (capillary dropout) (RI/CD) | 0 (0.0%) | 11 (12.8%) | 11 (8.9%) |
| Microaneurysm (MA) | 0 (0.0%) | 29 (33.7%) | 29 (23.4%) |
| Macroaneurysms | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Choroidal neovascularization (CNV) | 0 (0.0%) | 28 (32.6%) | 28 (22.6%) |
| Retinal neovascularization (RNV) | 0 (0.0%) | 11 (12.8%) | 11 (8.9%) |
| Macular Telangiectasia (MacTel) | 0 (0.0%) | 4 (4.7%) | 4 (3.2%) |
| Sickle Cell Retinopathy | 0 (0.0%) | 2 (2.3%) | 2 (1.6%) |
| Polypoidal choroidal vasculopathy (PCV) | 0 (0.0%) | 7 (8.1%) | 7 (5.6%) |
| Intraretinal microvascular abnormalities (IRMA) | 0 (0.0%) | 4 (4.7%) | 4 (3.2%) |
| Retinal Tortuosity | 0 (0.0%) | 9 (10.5%) | 9 (7.3%) |
| Geographic Atrophy | 0 (0.0%) | 4 (4.7%) | 4 (3.2%) |
| Branch Retinal Vein Occlusion (BRVO) | 0 (0.0%) | 7 (8.1%) | 7 (5.6%) |
| Central Retinal Vein Occlusion (CRVO) | 0 (0.0%) | 5 (5.8%) | 5 (4.0%) |
| Central Retinal Arterial Occlusion (CRAO) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Other | 0 (0.0%) | 19 (22.1%) | 19 (15.3%) |
| None | 38 (100%) | -- | 38 (30.6%) |
| Retinal Ischemia (capillary dropout) (RI/CD) | -- | 6 (7.0%) | 6 (4.8%) |
| Microaneurysm (MA) | -- | 15 (17.4%) | 15 (12.1%) |
| Macroaneurysms | -- | 1 (1.2%) | 1 (0.8%) |
| Choroidal neovascularization (CNV) | -- | 21 (24.4%) | 21 (16.9%) |
| Retinal neovascularization (RNV) | -- | 6 (7.0%) | 6 (4.8%) |
| Macular Telangiectasia (MacTel) | -- | 4 (4.7%) | 4 (3.2%) |
| Sickle Cell Retinopathy | -- | 2 (2.3%) | 2 (1.6%) |
| Polypoidal choroidal vasculopathy (PCV) | -- | 8 (9.3%) | 8 (6.5%) |
| Intraretinal microvascular abnormalities (IRMA) | -- | 2 (2.3%) | 2 (1.6%) |
| Retinal Tortuosity | -- | 5 (5.8%) | 5 (4.0%) |
| Geographic Atrophy | -- | 1 (1.2%) | 1 (0.8%) |
| Branch Retinal Vein Occlusion (BRVO) | -- | 4 (4.7%) | 4 (3.2%) |
| Central Retinal Vein Occlusion (CRVO) | -- | 4 (4.7%) | 4 (3.2%) |

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Other	--	7 (8.1%)	7 (5.6%)
-------	----	----------	----------

An eye could have multiple retinal conditions.

The following results were obtained for the above endpoints:

1. Results for the image quality response rate for the entire cohort were as follows: for the 3x3-mm macular scan, 6x6-mm macular scan, and 4.5x4.5-mm disc scan were 75.0%, 71.0% and 71.0%, respectively. The overall response rates for the "pathology" group between the two devices for the 3x3-mm macular scan, 6x6-mm macular scan, and 4.5x4.5-mm disc scan were 75.6%, 77.9% and 74.4%, respectively.
1. Results for visibility of key anatomical features for the entire cohort were as follows: for the 3x3-mm macular scan, the response rates for FAZ visibility, medium vessels, and small vessels/capillaries were 87.1%, 87.9%, and 82.3%, respectively. For the 6x 6mm macular scan, the response rates for FAZ visibility, large vessels, medium vessels, and small vessels/capillaries were 81.5%, 87.1%, 77.4%, and 79.8%, respectively. For the 4.5x4.5-mm disc scan, the response rates for visibility of large vessels, medium vessels, and small vessels/capillaries were 83.9%, 80.6%, and 80.6%, respectively.
1. Results for key pathological vascular features for the "pathology" group were as follows:
- The Maestro2 PPA and NPA for microaneurysms (MAs) were 96.6% and 92.7% for a. 3×3-mm macular scans, respectively; 96.6% and 92.7% for 6×6-mm macular scans, respectively; 73.9% and 100% for 4.5×4.5-mm disc scans, respectively. The response rates for identification of MAs were 81.0% and 82.1% for the 3×3-mm and 6×6-mm macular scans, respectively. The MA response rate was 75.6% for the 4.5×4.5-mm disc scan.
- b. The Maestro2 PPA and NPA for RI/CD were 93.1% and 85.4% for 3×3-mm scans, respectively; 100% and 87.8% for 6×6-mm scans, respectively; 75.0% and 85.7% for 4.5×4.5-mm disc scans, respectively. The response rates were 76.2%, 79.8%, and 71.8% for the 3×3-mm macular, 6×6-mm macular, and 4.5×4.5-mm disc scans, respectively.
- The Maestro2 PPA and NPA for CNV were 88.9% and 82.7% for 3×3-mm macular c. scans, respectively; 84.2% and 84.3% for 6×6-mm macular scans, respectively; and 66.7% and 98.4% for 4.5×4.5-mm disc scans, respectively. The response rates were 79.8% and 81.0% for the 3×3-mm and 6×6-mm macular scans and 75.3% for the disc scan.

IX. Conclusions

The Maestro2 and the IMAGEnet6 have the same intended uses as the legally marketed

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predicate devices identified in this 510(k) notification. The Indications for Use (IFU) statements differ from those of the predicate devices, but these differences do not change the intended use of the devices. The technological characteristics of the Maestro2 and IMAGEnet6 differ from those of the predicate devices, however, the differences do not raise new or different questions of safety or effectiveness. Results of the non-clinical performance testing demonstrate that Maestro2 and IMAGEnet6 function as intended. Results of the clinical performance testing demonstrate a favorable clinical performance profile that supports a determination of substantial equivalence.