Predicate Devices

Reference Devices

CIRRUS HD-OCT Model 500, 5000 (K181534)

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a reference database and statistical analysis (regression) for comparison, not AI/ML algorithms for image analysis or diagnosis.

Therapeutic

No

The device is described as an imaging and diagnostic device to aid in the detection and management of ocular diseases, not for therapeutic purposes.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states: "The CIRRUS™ HD-OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases...".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "computerized instrument that acquires and analyses cross-sectional tomograms" and employs "non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images." This indicates the device includes hardware components for image acquisition, not just software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The text explicitly states the CIRRUS™ HD-OCT is a "non-contact, high resolution tomographic and biomicroscopic imaging device" indicated for "in-vivo viewing" and imaging of ocular structures. This means it is used directly on a living patient, not on a sample taken from a patient.
The device description focuses on imaging technology and analysis of in-vivo images. It describes the use of low-coherence interferometry to obtain images of ocular structures.
The intended use and indications for use describe imaging and measurement of ocular structures within the eye. This is consistent with an in-vivo imaging device.
The reference database is used for comparison of measurements taken from the in-vivo images to a database of healthy subjects. This is a diagnostic aid based on imaging data, not on the analysis of a biological specimen.

Therefore, the CIRRUS™ HD-OCT is an in-vivo imaging device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head.

The CIRRUS™ HD-OCT Reference Database is a quantitative tool used 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 healthy subjects.

CIRRUS™ HD-OCT AngioPlex angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The CIRRUS™ HD-OCT is indicated for use 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.

Product codes

OBO

Device Description

The subject device is a computerized instrument that acquires and analyses cross-sectional tomograms of anterior ocular structures (including cornea, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. CIRRUS 6000 has a 100kHz scan rate for all structural and angiography scans.

The subject device uses the same optical system, and principle of operation as the previously cleared CIRRUS 6000 (K222200) except for the reference database functionality.

The subject device contains a newly acquired reference database which was collected on K222200. This study data compares macular thickness, ganglion cell thickness, optic disc and RNFL measurements to a reference range of healthy eyes as guided by the age of the patient and /or optic disc size. Reference database outputs are available on Macular Cube 200x200, and Optic Disc Cube 200x20 scan patterns. All other technical specifications have remained the same as the predicate K222200.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical Coherence Tomography (OCT)

Anatomical Site

cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head

Indicated Patient Age Range

18 years of age and older

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

A prospective, multi-site reference database (RDB) study was conducted at eight (8) clinical sites across the USA to develop the CIRRUS 6000 RDB for macular thickness and optic nerve head scan values.

The Subject Device's RDB was created to help clinicians assess and effectively compare a patient's measurements to that of healthy subjects, representative of the general population.

The eligibility criteria included subjects 18 years of age and older, best corrected visual acuity (BCVA) of 20/40 or better in either eye, IOP

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

May 17, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Carl Zeiss Meditec Inc Tanesha Bland Senior Regulatory Affairs Specialist- US SSC 5300 Central Parkway Dublin, California 94568

Re: K233933

Trade/Device Name: CIRRUS™ HD-OCT Model 6000 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: April 3, 2024 Received: April 8, 2024

Dear Tanesha Bland:

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"

1

(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 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

2

Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

Submission Number (if known)

K233933

Device Name

CIRRUS™ HD-OCT Model 6000

Indications for Use (Describe)

The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head.

The CIRRUS™ HD-OCT Reference Database is a quantitative tool used 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 healthy subjects.

CIRRUS™ HD-OCT AngioPlex angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The CIRRUS™ HD-OCT is indicated for use 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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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4

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Page 1 of 28

In accordance with 21 CFR 807.92 the 510(k) Summary for the CIRRUS Model 6000 RDB is provided below.

SUBMITTER 1.

| Applicant: | Carl Zeiss Meditec Inc
5300 Central Parkway
Dublin, CA 94568
USA |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Contact Name | Vidita Desai
Senior Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
Mobile:(925) 413-1644
E-mail: vidita.desai@zeiss.com (preferred) |
| Primary Correspondent | Tanesha Bland
Senior Regulatory Affairs Specialist USA
Carl Zeiss Meditec, Inc.
5300 Central Parkway Dublin, CA 94568
Mobile:(925) 216-7963
E-mail: Tanesha.bland@zeiss.com (preferred) |
| Secondary Correspondent | Maria Golovina, MS MBA
Head of Regulatory Affairs – USA
Carl Zeiss Meditec USA Inc.
5300 Central Parkway, Dublin CA USA 94568
Mobile: 925.216.1078
Email:Maria.Golovina@zeiss.com (preferred) |

Date Prepared:

May 3, 2024

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Page 2 of 28

SUBJECT DEVICE 2.

Device Trade Name:	CIRRUS HD-OCT Model 6000
Classification:	21CFR886.1570 Optical Coherence Tomography (OCT)
Regulatory Class:	II
Product Code:	OBO

3. PREDICATE DEVICE

Predicate Device:	CIRRUS HD-OCT Model 6000 (K222200)
Classification:	21CFR886.1570 Optical Coherence Tomography (OCT)
Regulatory Class:	II
Product Code:	OBO
Reference Device:	CIRRUS HD-OCT Model 500, 5000 (K181534)
Classification:	21CFR886.1570 Optical Coherence Tomography (OCT)
Regulatory Class:	II
Product Code:	OBO

4. DEVICE DESCRIPTION

The subject device is a computerized instrument that acquires and analyses cross-sectional tomograms of anterior ocular structures (including comea, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. CIRRUS 6000 has a 100kHz scan rate for all structural and angiography scans.

The subject device uses the same optical system, and principle of operation as the previously cleared CIRRUS 6000 (K222200) except for the reference database functionality.

The subject device contains a newly acquired reference database which was collected on K222200. This study data compares macular thickness, ganglion cell thickness, optic disc and RNFL measurements to a reference range of healthy eyes as guided by the age of the patient and /or optic disc size. Reference database outputs are available on Macular Cube 200x200, and Optic Disc Cube 200x20 scan patterns. All other technical specifications have remained the same as the predicate K222200.

6

K233933 - 510(k) Summary INDICATIONS FOR USE 5.

Page 3 of 28

The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It in-vivo viewing, axial cross-sectional, and three-diment of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head.

The CIRRUS™ HD-OCT Reference Database is a quantitative tool used for the comparison of retimal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of healthy subjects.

CIRRUS™ HD-OCT AngioPlex angiography is indicated as an aid in the visualization of vascular structures of the retima and chorod.

The CIRRUS™ HD-OCT is indicated for use 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.

SUBSTANTIAL EQUIVALENCE TO PRIMARY PREDICATE 6.

Table 1. Subject to Predicate Device Comparison Table - Indications for Use

| Device | Subject Device -CIRRUS 60000
with RDB | Predicate Device – CIRRUS 6000 | Reference Device - CIRRUS
5000 (K181534) | Equivalency
Analysis |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Indications for
Use | CIRRUS™ HD-OCT is a non-contact,
high resolution tomographic and
biomicroscopic imaging device. It is
indicated for in-vivo viewing, axial
cross-sectional, and three-dimensional
imaging and measurement of anterior
and posterior ocular structures,
including cornea, retina, retinal nerve
fiber layer, ganglion cell plus inner
plexiform layer, macula, and optic
nerve head.
CIRRUS™ HD-OCT Reference
Database is a quantitative tool used
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 healthy 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.
CIRRUS AngioPlex OCT Angiography
with is indicated as an aid in the
visualization of vascular structures of
the retina and choroid. | 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 | Identical to the
reference device. |

7

K233933 - 510(k) Summary			Page 4 of 28
Device	Subject Device -CIRRUS 60000
with RDB	Predicate Device – CIRRUS 6000	Reference Device – CIRRUS 5000 (K181534)	Equivalency Analysis
	CIRRUS™ HD-OCT AngioPlex
angiography is indicated as an aid in
the visualization of vascular structures
of the retina and choroid.	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.	layer thickness, and optic nerve
head measurements to a database
of normal subjects.

CIRRUS AngioPlex OCT
Angiography with is indicated as
an aid in the visualization of
vascular structures of the retina
and choroid.

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. | | |
| | CIRRUS™ HD-OCT is indicated for
use 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. | | | | |

Table 2. Subject to Predicate Device Comparison Table – Technical Characteristics

| Device | CIRRUS™ HD-OCT 6000 v.
11.7
Subject Device | CIRRUS™ HD-OCT 6000
Predicate Device (K222200) | Reference Device –
CIRRUS 5000 (K181534) | Analysis |
|--------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------|
| Device
Classification Name | Tomography, Optical
Coherence | Tomography, Optical
Coherence | Tomography, Optical
Coherence | Identical |
| Generic/
Common Name | Optical Coherence Tomography
(OCT) | Optical Coherence Tomography
(OCT) | Optical Coherence
Tomography (OCT) | Identical |
| Classification
Product Code | | | | Identical |
| Class | II | II | II | Identical |
| Technology | Spectral Domain (Spatially
encoded Frequency Domain
and Fourier Domain Principle) | Spectral Domain (Spatially
encoded Frequency Domain
and Fourier Domain Principle) | Spectral Domain (Spatially
encoded Frequency Domain
and Fourier Domain
Principle) OCT | Identical |

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K233933 - 510(k) Summary Page 5 of 28
	OCT	OCT
Illumination
Sources used in
Instrument	Light Emitting Diode 700 nm –
Iris Viewer
LSO Super Luminescent Diode
750 nm
OCT Super Luminescent Diode
840 nm	Light Emitting Diode 700 nm –
Iris Viewer
LSO Super Luminescent Diode
750 nm
OCT Super Luminescent Diode
840 nm	Light Emitting Diode
700 nm – Iris Viewer
LSO Super Luminescent
Diode 750 nm
OCT Super Luminescent
Diode 840 nm	Identical
Models	6000	6000	5000	Identical to the predicate
device.
	OCT IMAGING
Methodology	Spectral domain OCT (SD-
OCT)	Spectral domain OCT (SD-
OCT)	Spectral domain OCT (SD-
OCT)	Identical
OCT Optical
Source	OCT Super Luminescent
Diode, 840 nm wavelength	OCT Super Luminescent Diode,
840 nm wavelength	OCT Super Luminescent
Diode, 840 nm
wavelength	Identical
Optical Power	1200 μW at the cornea +/- 300
μW (0.9 - 1.5 mW) at the
cornea.	1200 μW at the cornea +/- 300
μW (0.9 - 1.5 mW) at the
cornea.	only for OCT Angiography	Identical to the predicate
device.
Axial Scan Depth
(Max)- Retina	• 2.9 mm for 12 mm 1
Line 100x HD Raster,
HD Angio 8x8, Angio
8x8, and Angiography
12x12
• 2.0 mm for all other
scans	• 2.9 mm for 12 mm 1
Line 100x HD Raster,
HD Angio 8x8, Angio
8x8, and Angiography
12x12
• 2.0 mm for all other
scans	2.0 mm	Identical to the predicate
device.
Axial Scan Depth
(Max)- Retina	2.0 mm (in tissue), 1024 pixels
per A-scans for all other scan
except for the ones listed above	2.0 mm (in tissue), 1024 pixels
per A-scans for all other scan
except for the ones listed above	2.0 mm (in tissue), 1024
pixels per A-scans.	Identical
K233933 - 510(k) Summary		Page 6 of 28
Axial Scan Depth
(Max) –Anterior
Segment	2.0 mm (Anterior 5-Line
Raster) – 1024 points2.0 mm
(Anterior Segment Cube) –
1024 points
5.8 mm (Anterior Chamber) –
2048 points
2.9 mm (Wide Angle-to-Angle) –
1024 points
2.9 mm (HD Angle) – 1024
points
2.0 mm (HD Cornea) – 1024
points
2.0 mm (Pachymetry) – 1024
points	2.0 mm (Anterior 5-Line
Raster) – 1024 points2.0 mm
(Anterior Segment Cube) –
1024 points
5.8 mm (Anterior Chamber) –
2048 points
2.9 mm (Wide Angle-to-Angle) –
1024 points
2.9 mm (HD Angle) – 1024
points
2.0 mm (HD Cornea) – 1024
points
2.0 mm (Pachymetry) – 1024
points	2.0 mm (Anterior 5-Line
Raster) – 1024 points2.0 mm
(Anterior Segment Cube) –
1024 points
5.8 mm (Anterior Chamber) –
2048 points
2.9 mm (Wide Angle-to-
Angle) – 1024 points
2.9 mm (HD Angle) – 1024
points
2.0 mm (HD Cornea) – 1024
points
2.0 mm (Pachymetry) –
1024 points	Identical
External Anterior
Segment Lens	Anterior Chamber Lens
Cornea Lens	Anterior Chamber Lens
Cornea Lens	Anterior Chamber Lens
Cornea Lens	Identical
Transverse Scan
Range
(Lateral range in
degrees)
Retina	10° x 0° on retina (Minimum)
42° x 42° on retina (Maximum)	10° x 0° on retina (Minimum)
42° x 42° on retina (Maximum)	10° x 0° on retina
(Minimum)
31° x 31° on retina
(Maximum)	Identical to the predicate
device.
Transverse Scan
Range –Anterior
Segment	3 mm (Minimum)
15 mm (Maximum)	3 mm (Minimum)
15 mm (Maximum)	3 mm (Minimum)
15 mm (Maximum)	Identical
Axial Resolution	5 μm (in tissue)	5 μm (in tissue)	5 μm (in tissue)	Identical
Transverse
Resolution – Retina	≤ 15 μm (in tissue)	≤ 15 μm (in tissue)	≤ 15 μm (in tissue)	Identical
Transverse
Resolution –
Anterior Segment	20 μm (in tissue)
20 μm @ 6mm FOV
25 μm @ 9mm FOV	20 μm (in tissue)
20 μm @ 6mm FOV
25 μm @ 9mm FOV	20 μm (in tissue)
20 μm @ 6mm FOV
25 μm @ 9mm FOV	Identical
	K233933 - 510(k) Summary
Page 7 of 28	45 μm @ 15mm FOV	45 μm @ 15mm FOV	25 μm @ 9mm FOV
45 μm @ 15mm FOV
	Scan patterns
Non-angiography	Line, circle, crosshair, raster (a series of closely spaced lines, aka cube scan), radial scans and combinations of the above.	Line, circle, crosshair, raster (a series of closely spaced lines, aka cube scan), radial scans and combinations of the above.	Line, circle, crosshair, raster (a series of closely spaced lines, aka cube scan), radial scans and combinations of the above.	Identical
	Scan types
Non-angiography	Macular Cube 512 x 128 = 6 mm x 6 mm	Macular Cube 512 x 128 = 6 mm x 6 mm	Macular Cube 512 x 128 = 6 mm x 6 mm	Identical
		Macular Cube 200 x 200 = 6 mm x 6 mm	Macular Cube 200 x 200 = 6 mm x 6 mm	Macular Cube 200 x 200 = 6 mm x 6 mm	Identical
		Optic Disc Cube 200 x 200 = 6 mm x 6 mm	Optic Disc Cube 200 x 200 = 6 mm x 6 mm	Optic Disc Cube 200 x 200 = 6 mm x 6 mm	Identical
		Not available	Not available	5-Line Raster	Identical to the predicate device.
		HD (high-definition) Raster

HD 1 Line 100x (2.9 mm depth and up to 12 mm in length)
HD 21 Line
HD Radial
HD Cross
HD 5-Line Raster | HD (high-definition) Raster
HD 1 Line 100x (2.9 mm depth and up to 12 mm in length)
HD 21 Line
HD Radial
HD Cross
HD 5-Line Raster | HD (high-definition) Raster
HD 1 Line 100x (2.0 mm depth and up to 9 mm in length)
HD 21 Line
HD Radial
HD Cross
HD 5-Line Raster | Identical to the predicate device. |
| | | Anterior Segment Cube 512 x 128 | Anterior Segment Cube 512 x 128 | Anterior Segment Cube 512 x 128 | Identical |
| K233933 - 510(k) Summary | | Page 8 of 28 | | | |
| | Anterior Segment 5-Line Raster | Anterior Segment 5-Line Raster | Anterior Segment 5-Line Raster | Identical | |
| | HD Angle | HD Angle | HD Angle | Identical | |
| | Anterior Chamber | Anterior Chamber | Anterior Chamber | Identical | |
| | Wide Angle-to-Angle | Wide Angle-to-Angle | Wide Angle-to-Angle | Identical | |
| | HD Cornea | HD Cornea | HD Cornea | Identical | |
| | Pachymetry | Pachymetry | Pachymetry | Identical | |
| OCT Angiography
scans | Scans: | Scans: | Scans: | Scans: | |
| | AngioPlex 3x3 mm scan | AngioPlex 3x3 mm scan | AngioPlex 3x3 mm scan | Identical | |
| | AngioPlex 6x6 mm scan | AngioPlex 6x6 mm scan | AngioPlex 6x6 mm scan | Identical | |
| | AngioPlex 8x8 mm scan,
(2.9mm scan depth) | AngioPlex 8x8 mm scan,
(2.9mm scan depth) | AngioPlex 8x8 mm scan,
(2.0mm scan depth) | Identical to the predicate
device. | |
| | AngioPlex 12x12 mm scan
(2.9mm scan depth) | AngioPlex 12x12 mm scan
(2.9mm scan depth) | Not Available | Identical to the predicate
device. | |
| | AngioPlex HD 6x6 mm scan | AngioPlex HD 6x6 mm scan | Not Available | Identical to the predicate
device. | |
| | AngioPlex HD 8x8 mm scan
(2.9mm scan depth) | AngioPlex HD 8x8 mm scan
(2.9mm scan depth) | Not Available | Identical to the predicate
device. | |
| | 6 x 6 mm Montage AngioPlex | 6 x 6 mm Montage AngioPlex | Not Available | Identical to the predicate
device. | |
| | 8 x 8 mm Montage AngioPlex | 8 x 8 mm Montage AngioPlex | Not Available | Identical to the predicate
device. | |
| K233933 - 510(k) Summary | | Page 9 of 28 | | | |
| Retina Tracking | FastTrac Retinal Tracking
Track-to-prior to Scan
Acquisition tracking. | FastTrac Retinal Tracking
Track-to-prior to Scan
Acquisition tracking. | FastTrac Retinal Tracking
Track-to-prior to Scan
Acquisition tracking. | Identical | |
| OCT Angiography
Algorithms
(OCTA) | - En face Algorithm
Segmentation Algorithm
Z-Motion Correction
Algorithm
Flow Contrast Algorithm
(intensity based + phase=
complex-based OCT
Angiography) | - En face Algorithm
Segmentation Algorithm
Z-Motion Correction
Algorithm
Flow Contrast Algorithm
(intensity based + phase=
complex-based OCT
Angiography) | - En face Algorithm
Segmentation
Algorithm
Z-Motion Correction
Algorithm
Flow Contrast
Algorithm (intensity
based + phase=
complex-based OCT
Angiography) | Identical | |
| RNFL, Macula,
Anterior Segment | ANALYSIS AND REPORTS
Analyses for the Optic Disc:
• ONH/RNFL OU
Analysis
• Guided Progression
Analysis
• Advanced Visualization
• En face
• 3D Visualization
• Panomap | Analyses for the Optic Disc:
• ONH/RNFL OU
Analysis
• Guided Progression
Analysis
• Advanced Visualization
• En face
• 3D Visualization
• Panomap | Analyses for the Optic
Disc:
• ONH/RNFL OU
Analysis
• Guided
Progression
Analysis
• Advanced
Visualization
• En face
• 3D Visualization | Identical | |

9

10

11

12

13

K233933 - 510(k) Summary	Page 10 of 28
	• Single Eye Summary	• Panomap
	Analyses for the Macula: Macular thickness Macular change Advanced RPE PanoMap Advanced visualization High-definition image En face Analysis 3D Visualization Ganglion Cell Guided Progression	Single Eye Summary Analyses for the Macula: Macular thickness Macular change Advanced RPE PanoMap Advanced visualization High-definition image En face Analysis 3D Visualization Ganglion Cell Guided Progression
	Analyses for the Anterior Segment: Anterior Segment Analysis High-Definition Image Analysis Anterior Chamber Scan Analysis HD Angle Analysis HD Cornea Analysis	Analyses for the Anterior Segment: Anterior Segment Analysis High-Definition Image Analysis
		Anterior Chamber Scan Analysis HD Angle Analysis HD Cornea Analysis

14

K233933 - 510(k) Summary		Page 11 of 28
	Pachymetry Analysis with Epithelial Thickness Wide Angle-to-Angle Analysis 3D visualization	Pachymetry Analysis with Epithelial Thickness Wide Angle-to-Angle Analysis 3D visualization	Anterior Chamber Scan Analysis HD Angle Analysis HD Cornea Analysis Pachymetry Analysis with Epithelial Thickness Wide Angle-to-Angle Analysis 3D visualization
RNFL Thickness Analysis	OCT Fundus image with RNFL Calculation circle OCT Image Extracted from Calculation Circle with RNFL Segmentation RNFL Thickness Map Deviation from Normal Map Average Thickness	OCT Fundus image with RNFL Calculation circle OCT Image Extracted from Calculation Circle with RNFL Segmentation RNFL Thickness Map Average Thickness Quadrant Thicknesses Clock Hour Thicknesses	OCT Fundus image with RNFL Calculation circle OCT Image Extracted from Calculation Circle with RNFL Segmentation RNFL Thickness Map Deviation from Normal Map	Identical to the reference device.
K233933 - 510(k) Summary		Page 12 of 28
	Quadrant Thicknesses Clock Hour Thicknesses Symmetry value TSNIT (or NSTIN format) RNFL thickness graph with color coding as shown in the Reference Database	Symmetry value TSNIT(or NSTIN format) RNFL thickness graph.	Average Thickness Quadrant Thicknesses Clock Hour Thicknesses Symmetry value Normative database TSNIT RNFL thickness graph with color coding
Optic Nerve Head (ONH) analysis	Rim Area / Disc Area Average C/D Ratio Vertical C/D Ratio: Cup Volume Neuro-retinal Rim Thickness B-scan cross section of the ONH Automatic outline of disc margin Automatic outline of cup edge ONH B-scan slices and segmentation Reference ONH database color coding	Rim Area / Disc Area Average C/D Ratio Vertical C/D Ratio: Cup Volume Neuro-retinal Rim Thickness B-scan cross section of the ONH Automatic outline of disc margin Automatic outline of cup edge ONH B-scan slices and segmentation Disc size	Rim Area / Disc Area Average C/D Ratio Vertical C/D Ratio: Cup Volume Neuro-retinal Rim Thickness B-scan cross section of the ONH Automatic outline of disc margin Automatic outline of cup edge ONH B-scan slices and segmentation Normative ONH database color coding	Identical to the reference device.
K233933 - 510(k) Summary
Page 13 of 28
	Disc size
Guided Progression
Analysis (GPA) for
RNFL	Multiple RNFL Thickness Maps OCT Fundus image with Calculation circle Overall Average RNFL Thickness Graph Superior RNFL Thickness Graph Inferior RNFL Thickness Graph RNFL Thickness Profile RNFL Summary: RNFL Thickness Map Progression RNFL Thickness Profiles Progression Average RNFL Thickness Progression Manual selection option of scans to include in change analysis	Multiple RNFL Thickness Maps OCT Fundus image with Calculation circle Overall Average RNFL Thickness Graph Superior RNFL Thickness Graph Inferior RNFL Thickness Graph RNFL Thickness Profile RNFL Summary: RNFL Thickness Map Progression RNFL Thickness Profiles Progression Average RNFL Thickness Progression Manual selection option of scans to include in change analysis	Multiple RNFL Thickness Maps Multiple Deviation from Normal Maps OCT Fundus image with Calculation circle Overall Average RNFL Thickness Graph Superior RNFL Thickness Graph Inferior RNFL Thickness Graph RNFL Thickness Profile RNFL Summary: RNFL Thickness Map Progression RNFL Thickness Profiles Progression Average RNFL Thickness Progression Manual selection option of scans to include in change analysis	Identical to the predicate
device.
K233933 - 510(k) Summary		Page 14 of 28
Guided Progression
Analysis (GPA) for
Ganglion Cell/IPL	- Sequential display of
Macular images in Guided
Progression Analysis
(GPA) for Ganglion Cell
Layer/Inner Plexiform
Layer (GCL/IPL)

Multiple GCL/IPL
Thickness Maps
Overall Average GCL/IPL
Thickness Graph
Superior GCL/IPL
Thickness Graph
Inferior GCL/IPL
Thickness Graph
GCL/IPL Summary:
GCL Thickness Map
Progression
GCL Thickness
Progression | - Sequential display of
Macular images in Guided
Progression Analysis
(GPA) for Ganglion Cell
Layer/Inner Plexiform
Layer (GCL/IPL)
Multiple GCL/IPL
Thickness Maps
Overall Average GCL/IPL
Thickness Graph
Superior GCL/IPL
Thickness Graph
Inferior GCL/IPL
Thickness Graph
GCL/IPL Summary:
GCL Thickness Map
Progression
GCL Thickness
Progression | - Sequential display of
Macular images in
Guided Progression
Analysis (GPA) for
Ganglion Cell
Layer/Inner
Plexiform Layer
(GCL/IPL)
Multiple GCL/IPL
Thickness Maps
Overall Average
GCL/IPL Thickness
Graph
Superior GCL/IPL
Thickness Graph
Inferior GCL/IPL
Thickness Graph
GCL/IPL Summary:
GCL Thickness Map
Progression
GCL Thickness
Progression | Identical |
| Macular Thickness
Analysis and
Display | - Fundus Image with scan
cube overlay
Average thickness and
volume table
ETDRS grid map with
reference database color
coding
Slice navigators | - Fundus Image with scan
cube overlay
Average thickness and
volume table
ETDRS grid map
Slice navigators
Horizontal B-scan (X-
image) | - Fundus Image with
scan cube overlay
Average thickness
and volume table
ETDRS grid map
with normative
database color coding
Slice navigators | Identical to the reference
device |

15

16

17

18

K233933 - 510(k) Summary	Page 15 of 28
Horizontal B-scan (X-image)
Vertical slice - A-scan (Y-image)
3-D color ILM-RPE thickness map
3-D surface map of ILM
3-D surface map of RPE
Segmentation line toggle
Measurement calipers
Automatic fovea finding and coordinates
Assorted controls for aligning ETDRS grid
High-Resolution Images option
Edit Layers (enhanced interface)
Zoom controls
Save Image options
Movie option	Vertical slice - A-scan (Y-image)
3-D color ILM-RPE thickness map
3-D surface map of ILM
3-D surface map of RPE
Segmentation line toggle
Measurement calipers
Automatic fovea finding and coordinates
Assorted controls for aligning ETDRS grid
High-Resolution Images option
Edit Layers (enhanced interface)
Zoom controls
Save Image options
Movie option	Horizontal B-scan (X-image)
Vertical slice - A-scan (Y-image)
3-D color ILM-RPE thickness map
3-D surface map of ILM
3-D surface map of RPE
Segmentation line toggle
Measurement calipers
Automatic fovea finding and coordinates
Assorted controls for aligning ETDRS grid
High-Resolution Images option
Edit Layers (enhanced interface)
Zoom controls
Save Image options
Movie option

19

K233933 - 510(k) Summary				Page 16 of 28
High Definition
Display	- Fundus image with OCT b-
scan reference line (slice
navigator) overlays

Enlarged B-scan image of
selected line
Up to 5 thumbnail images | - Fundus image with OCT b-
scan reference line (slice
navigator) overlays
Enlarged B-scan image of
selected line
Up to 5 thumbnail images | - Fundus image with
OCT b-scan reference
line (slice navigator)
overlays
Enlarged B-scan
image of selected line
Up to 5 thumbnail
images | Identical |
| Ganglion Cell OU
Analysis | - GCA Thickness Map
GCA Deviation Map
Six sectors of average
thickness – color coded per
RDB limits
Horizontal Macular B-scan
Vertical Macular B-scan
Average GCL+IPL
thickness (chart)
Data available on screen &
on printout | - GCA Thickness Map
Six sectors of average
thickness
Horizontal Macular B-scan
Vertical Macular B-scan
Average GCL+IPL
thickness (chart)
Minimum GCL+IPL
thickness (chart)
Data available on screen &
on printout | - GCA Thickness Map
GCA Deviation Map
Six sectors of average
thickness - color
coded per NDB limits
Horizontal Macular
B-scan
Vertical Macular B-
scan
Average GCL+IPL
thickness (chart)
Minimum GCL+IPL
thickness (chart)
Data available on
screen & on printout | Identical to the reference
device |
| K233933 - 510(k) Summary | | Page 17 of 28 | | |
| Single Eye
Summary
(Data from macula
scan and optic disc
scan are shown in
one report) | Macula Analysis:
en face image of macular
cube
Macular Thickness map
ETDRS grid sector
thicknesses with
comparison to reference
data
Macular B-scan
ONH/RNFL Analysis:
en face image of Optic
Disc Cube
RNFL Thickness map
Data Table with RNFL and
ONH data
RNFL TSNIT Thickness
graph
ONH B-scan
Data available on screen &
on printout | Macula Analysis:
en face image of macular
cube
Macular Thickness map
ETDRS grid sector
thicknesses
Macular B-scan
ONH/RNFL Analysis:
en face image of Optic
Disc Cube
RNFL Thickness map
Data Table with RNFL and
ONH data
RNFL TSNIT Thickness
graph
ONH B-scan
Data available on screen &
on printout | Macula Analysis:
en face image of
macular cube
Macular Thickness
map
ETDRS grid sector
thicknesses with
comparison to
normative data
Macular B-scan
ONH/RNFL Analysis:
en face image of
Optic Disc Cube
RNFL Thickness map
Data Table with
RNFL and ONH data
RNFL TSNIT
Thickness graph
ONH B-scan
Data available on
screen & on printout | Identical to the reference
device |
| Advanced RPE
Analysis | - Advanced RPE Analysis | - Advanced RPE Analysis | - Advanced RPE
Analysis | Identical |
| PanoMap Analysis | - Macular Cube 512x128 or
Macular Cube 200x200
and
Optic Disc Cube 200x200
scan for the same eye. | - Macular Cube 512x128 or
Macular Cube 200x200 and
Optic Disc Cube 200x200
scan for the same eye.
Montage of Macular Cube | - Macular Cube
512x128 or
Macular Cube
200x200 and
Optic Disc Cube | Identical |
| | K233933 - 510(k) Summary
Page 18 of 28 | | | |
| Wellness Exam
Report | • Montage of Macular Cube
and Optic Disc Cube OCT
en face images

This is an OU wide field
analysis that combines
information from the macular
thickness analysis. PanoMap
analysis, RNFL and ONH
analysis and ganglion cell OU
analysis into one report. | • and Optic Disc Cube OCT
en face images

This is an OU wide field
analysis that combines
information from the
macular thickness analysis.
PanoMap analysis, RNFL
and ONH analysis and
ganglion cell OU analysis
into one report. | 200x200 scan for the
same eye.
• Montage of
Macular Cube and
Optic Disc Cube OCT
en face images
• Not Available | Identical to the predicate
device. |
| OCT Angiography
Report / Analysis | • OCT Angiography Report
• OCT Angiography Change
Analysis | • OCT Angiography Report
• OCT Angiography Change
Analysis | • OCT Angiography
Report
• OCT Angiography
Change Analysis | Identical |
| ORCC & RPE-to-
RPE Fit Slabs (pre-
set) in OCTA
Analysis | • ORCC (Outer Retina to
ChorioCapillaris), Sub-
RPE, RPE-to-RPEFit slabs
in OCTA Analysis | • ORCC (Outer Retina to
ChorioCapillaris), Sub-
RPE, RPE-to-RPEFit slabs
in OCTA Analysis | Not Available | Identical to the predicate
device. |

20

21

22

	K233933 - 510(k) Summary			Page 19 of 28
Anterior Segment -
Analysis with
Quantitative
Measurement Tools	Anterior 5-Line Raster Thickness calipers Anterior Segment Cube 3D Visualization Thickness calipers Pachymetry Scan Corneal thickness Epithelial thickness	Anterior 5-Line Raster Thickness calipers Anterior Segment Cube 3D Visualization Thickness calipers Pachymetry Scan Corneal thickness Epithelial thickness	Anterior 5-Line Raster Thickness calipers Anterior Segment Cube 3D Visualization Thickness calipers Pachymetry Scan Corneal thickness Epithelial thickness	Identical
ONH Angiography
Two-Visit
Comparison	visual side by side comparison of two angiography visits on the analysis screen and corresponding report print out.	visual side by side comparison of two angiography visits on the analysis screen and corresponding report print out.	visual side by side comparison of two angiography visits on the analysis screen and corresponding report print out.	Identical
Reference Database,
Diverse	Retinal Nerve Fiber Layer (RNFL) Thickness Macular Thickness Optic Nerve Head (ONH) Parameters Ganglion Cell/IPL Thickness	Not Applicable	Retinal Nerve Fiber Layer (RNFL) Thickness Macular Thickness Optic Nerve Head (ONH) Parameters Ganglion Cell/IPL Thickness	Equivalent to the reference device.
CIRRUS 6000 RDB provides additional colors when the measurements are within overlapping confidence intervals of the quantile limits.
	FUNDUS IMAGING
Methodology	Line Scanning Ophthalmoscope	Line Scanning Ophthalmoscope	Line Scanning Ophthalmoscope	Identical

23

| | K233933 - 510(k) Summary
Page 20 of 28 | | | |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Optical Source | Super Luminescent Diode
(SLD)
750 nm | Super Luminescent Diode
(SLD)
750 nm | Super Luminescent Diode
(SLD)
750 nm | Identical |
| Optical Power | 20 Hz | > 20 Hz | > 20 Hz | Identical |
| Transverse
Resolution | 25 µm (in tissue) | 25 µm (in tissue) | 25 µm (in tissue) | Identical |
| | IRIS IMAGING | | | |
| Methodology | CMOS camera and LED
illumination | CMOS camera and LED
illumination | CMOS camera and LED
illumination | Identical |
| Optical source | 1280 x 1024 | 1280 x 1024 | 1280 x 1024 | Identical |
| Resolution | During alignment | During alignment | During alignment | Identical |
| Live iris image | Light emitting diode (LED),
700 nm | Light emitting diode (LED),
700 nm | Light emitting diode (LED),
700 nm | Identical |
| | FIXATION | | | |
| Internal fixation
source | LED Array, 21 positions | LED Array, 21 positions | LED Array, 9 positions | Identical to the predicate
device. |
| Internal fixation
focus adjustment | -20D to +20D (diopters) | -20D to +20D (diopters) | -20D to +20D (diopters) | Identical |
| External fixation
source | Mechanically adjustable arm
with LED at the tip | Mechanically adjustable arm
with LED at the tip | Mechanically adjustable arm
with LED at the tip | Identical |
| | ELECTRICAL, PHYSICAL, ENVIRONMENTAL | | | |
| Configuration | Patient module, computer,
media and power supply
integrated into single compact
module | Patient module, computer,
media and power supply
integrated into single compact
module | Patient module, computer,
media and power supply
integrated into single
compact module | Identical |
| Computer | High performance multi-core
processor CORE i7 @ 3.6 GHz,
32GB RAM, 2TB Hard Disk,
Windows 10, SSD | High performance multi-core
processor CORE i7 @ 3.6 GHz,
32GB RAM, 2TB Hard Disk,
Windows 10, SSD | High performance multi-
core processor CORE i7 @
3.1GHz, 16GB RAM, 2TB
Hard Disk, Windows 10 | Identical to the predicate
device. |
| K233933 - 510(k) Summary | | Page 21 of 28 | | |
| Input Devices | Computer mouse/keyboard | Computer mouse/keyboard | Computer mouse/keyboard | Identical |
| Display | 22" Widescreen HD
(Resolution 1920 x 1080) | 22" Widescreen HD
(Resolution 1920 x 1080) | 19" Color Flat Panel Display
(Resolution 1280 x 1024) | Identical to the predicate
device. |
| Network | Network and additional USB
connectors under rear cover. | Network and additional USB
connectors under rear cover. | Network and additional USB
connectors under rear cover. | Identical |
| Optical media
formats supported | 6 USB Media ports | 6 USB Media ports | 6 USB Media ports | Identical |
| Weight | 35 kg (77 lbs) (without
monitor) | 35 kg (77 lbs) (without
monitor) | 36 kg (80 lbs) | Identical to the predicate
device |
| Dimensions | 62.2L x 42.5W x 49.4H (cm) | 62.2L x 42.5W x 49.4H (cm) | 62.2L x 42.5W x 49.4H (cm) | Identical |
| Electrical rating
(115V) | 100-120 V~ 50-60 Hz 6.3A | 100-120 V~ 50-60 Hz 6.3A | 100-120 V~ 50-60 Hz 6.3A | Identical |
| Power rating (115V) | 500W | 500W | 350W | Identical to the predicate
device |
| Fuse rating (115V) | T 6.3 A 250V | T 6.3 A 250V | T 5A 250V | Identical to the predicate
device |
| Max amperage and
voltage rating | T 6.3A 250V | T 6.3 A 250V | T 5A 250V | Identical to the predicate
device |
| Environmental
Conditions:
Transport and
Storage | Temp. -40° to +70° C
30% to 75% (excluding
condensation)
Atmospheric Pressure
500 to 1060 hPa | Temp. -40° to +70° C
30% to 75% (excluding
condensation)
Atmospheric Pressure
500 to 1060 hPa | Temp. -40° to +70° C
30% to 75% (excluding
condensation)
Atmospheric Pressure
500 to 1060 hPa | Identical |
| Environmental
Conditions:
Operation | Temperature:
+10 to +35° С
Relative Humidity:
30% to 75% (excluding
condensation)
Atmospheric Pressure:
700 to 1060 hPa | Temperature:
+10 to +35° С
Relative Humidity:
30% to 75% (excluding
condensation)
Atmospheric Pressure:
700 to 1060 hPa | Temperature:
+10 to +35° C
Relative Humidity:
30% to 75% (excluding
condensation)
Atmospheric Pressure:
700 to 1060 hPa | Identical |

24

25

K233933 - 510(k) Summary Page 22 of 28
Enclosure-
Flammability
Ratings	UL 94V-0	UL 94V-0	UL 94V-0	Identical
	UX
Protocol buttons	- Workflow buttons filter scan patterns for acquisition	- Workflow buttons filter scan patterns for acquisition	Not Available	Identical to the predicate device
Scan Protocols	- user-selectable scan protocols on the patient management screen that define a specific set of scans to be acquired.	- User-selectable scan protocols on the patient management screen that define a specific set of scans to be acquired.	Not Available	Identical to the predicate device
Preferred Analysis	- allows the user to preconfigure the preferred analysis to auto load. This is a UI update that allows the user to see first 4 preferred analyses every time	- Allows the user to preconfigure the preferred analysis to auto load. This is a UI update that allows the user to see first 4 preferred analyses every time	Not Available	Identical to the predicate device
Anterior Segment
Caliper Tool	- This tool is able to snap to the surfaces identified by the software, including anterior cornea and posterior cornea.	This tool is able to snap to the surfaces identified by the software, including anterior cornea and posterior cornea.	Not Available	Identical to the predicate device
Analysis switch eye	- allows the user to switch to the 'other' eye for the same analyses	allows the user to switch to the 'other' eye for the same analyses	Not Available	Identical to the predicate device
New Circle Tool for
Angiography	- a manually placed circle tool for annotation purposes	a manually placed circle tool for annotation purposes	Not Available	Identical to the predicate device
K233933 - 510(k) Summary				Page 23 of 28
New Freehand Tool
for Angiography		A scalable circle and
freeform measurement tools
for the OCT Angiography
and ONH Angiography
enface image which
displays estimated values
for area and
perimeter/diameter	A scalable circle and freeform
measurement tools for the OCT
Angiography and ONH
Angiography enface image
which displays estimated values
for area and perimeter/diameter	Not Available	Identical to the predicate
device

26

27

Non-Clinical Performance Testing

Non-clinical system testing was provided on the predicate K222200 and no new non-clinical information is provided in this submission since sterlity, shelf-life, biocompatibility, and animal testing was not performed as there were no modifications made to the device in this regard.

Other verification and validation testing (such as software) was conducted, and documentation was provided as recommended by the FDA's Guidance for Industry and Staff "Content of Premarket Submissions for Device Software Functions (June 2023)". All testing passed.

Clinical Performance Testing

Repeatability and Reproducibility testing was leveraged from the K22200; and thus, was not provided in this submission.

The addition of the reference database required new testing which is summarized below.

A prospective, multi-site reference database (RDB) study was conducted at eight (8) clinical sites across the USA to develop the CIRRUS 6000 RDB for macular thickness and optic nerve head scan values.

The Subject Device's RDB was created to help clinicians assess and effectively compare a patient's measurements to that of healthy subjects, representative of the general population.

The eligibility criteria included subjects 18 years of age and older, best corrected visual acuity (BCVA) of 20/40 or better in either eye, IOP