Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states that the device uses the same segmentation algorithms as the predicate device and does not mention any AI or ML components.

Therapeutic

No
Explanation: The device is described as an imaging and diagnostic device to aid in the detection and management of ocular diseases, not for therapeutic intervention.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states: "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."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "imaging device" and describes hardware components like an "optical system," "CMOS camera," and "LED illumination." It also details non-clinical performance testing that includes hardware-related tests like "IEC 60601-1-2 testing" and "Optical resolution testing."

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The device is intended for in vivo viewing, imaging, and measurement of ocular structures. It is used to visualize and aid in the detection and management of ocular diseases. This involves examining structures within the living body, not analyzing samples taken from the body.
Device Description: The description focuses on the optical system, scanning capabilities, and imaging of ocular structures. There is no mention of analyzing biological samples like blood, urine, or tissue.
Anatomical Site: The anatomical sites listed are all structures within the eye.
Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on biological samples.

The device is a medical imaging device used for diagnostic purposes, but it operates in vivo rather than in vitro.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 ocular structures. The device is indicated for visualizing and measuring and posterior ocular structures, including corneal epithelium, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head.

CIRRUS' AngioPlex OCT 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.

This device is Prescription Use (Rx) only.

Product codes (comma separated list FDA assigned to the subject device)

OBO

Device Description

The CIRRUS™ HD-OCT Model 6000 is indicated for in-vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of anterior and posterior ocular structures. The clinical purpose of this device has not been modified as compared to the predicate.

CIRRUS 6000 uses the same optical system, architecture, and principle of operation as the previously cleared CIRRUS 5000 (K181534). CIRRUS 6000 has a 100 kHz scan rate for all structural and angiography scans. The primary impact of the higher acquisition speed is its impact on signal-to-noise ratio. The signal-to-noise ratio m the subject device is calibrated to match the specifications of the CIRRUS 6000 uses the same segmentation algorithms as the predicate device and therefore the segmentation results will be equivalent.

In addition to the acquisition speed change, CIRRUS 6000 also has a wider field of view (FOV) and has increased the number of fixation points to 21.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical Coherence Tomography (OCT), Line Scanning Ophthalmoscope, CMOS camera and LED illumination

Anatomical Site

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

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use (Rx) only.

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

CIRRUS 6000 Repeatability and Reproducibility (R&R) Study:

Sample Size: 117 subjects were enrolled: 27 without ocular pathology (normal), 37 with glaucoma, 30 with retinal pathology, and 23 with status post refractive surgery or with corneal pathology. 9 subjects were disqualified because they did not meet the inclusion or were disqualified after scans due to the presence of macular changes due to drusen.
Data Source: Multi-site prospective study.
Annotation Protocol: Three acceptable scans of each scan type were acquired on each of the study devices (three CIRRUS 6000 and three CIRRUS 5000 devices) with assigned operator/device pairs. Analysis of variance was performed to determine the repeatability and reproducibility as well as the variance associated with the combination of operator and device. Agreement between CIRRUS 5000 and CIRRUS 6000 was evaluated with Bland-Altman Limits of Agreement, and Deming Regression analysis methods.

CIRRUS 6000 Angiography Image Quality Study:

Sample Size: 110 subjects aged 18 years or older were enrolled: 103 retinal diseased subjects, 7 normal subjects. 7 normal subjects were disqualified because they did not meet the inclusion/exclusion criteria, eleven others were disqualified because the operator was unable to acquire quality study scans, and one subject was discontinued due to the inability to continue the study visit. Two subjects were disqualified due to lack of any CIRRUS 6000 scans acquired; and two subjects were discontinued because they did not return for their second study visit. 93 subjects had at least one valid OCT scan or valid FA/ICGA images. However, only 92 subjects had at least one valid OCT scan.
Data Source: Multi-site prospective study.
Annotation Protocol: Three independent reviewers from a reading center graded the OCTA scans on image quality and clinically relevant information according to pre-determined grading criteria.

CIRRUS 6000 Raster Image Quality Study:

Sample Size: 68 subjects were enrolled: 20 subjects with normal eyes and 48 subjects with retinal disease.
Data Source: Multi-site prospective study.
Annotation Protocol: Three independent graders from a reading center graded the raster B-scans on image quality and clinically relevant information according to pre-determined grading criteria.

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

Non-Clinical Performance Testing

Study Type: Non-clinical system testing, Software verification and validation testing, Bench Testing (Spatial performance, Device sensitivity, OCT angiography, Auxiliary functions testing, Safety and Essential Performance: IEC 60601-1, Electromagnetic Compatibility: IEC 60601-1-2, Usability: IEC 62366-1, Optical resolution testing (lateral and axial resolution), Light Hazard Protection for Ophthalmic Instruments: ANSI Z80.36-2016, Gage R&R segmentation comparison between CIRRUS 5000 and CIRRUS 6000)
Key Results: Functional and system level testing demonstrated that the system met the defined specifications. ZEISS demonstrated non-clinical equivalency between the CIRRUS 6000 and CIRRUS 5000 scan data using a phantom retina, which shows the equivalency of the segmentation results as the segmentation algorithms are the same in both instruments. All testing passed. No additional safety or performance concerns have been raised during development or device testing.

Clinical Performance Testing

Study Type: Repeatability and Reproducibility (R&R) study, Qualitative image grading and agreement for Angiography, Qualitative image grading and agreement for Raster Image Quality.
Sample Size (R&R): 117 subjects (27 normal, 37 glaucoma, 30 retinal pathology, 23 status post refractive surgery or with corneal pathology). 9 subjects disqualified.
Sample Size (Angiography): 110 subjects aged 18 years or older (103 retinal diseased, 7 normal). 18 subjects disqualified/discontinued. 93 subjects had at least one valid OCT scan or valid FA/ICGA images, 92 subjects had at least one valid OCT scan.
Sample Size (Raster Image Quality): 68 subjects (20 normal, 48 retinal disease).
Key Results (R&R): Presented in tables (Tables 3-12) for Ganglion Cell Thickness, Macular Thickness, ONH, RNFL Thickness, and Epithelial Thickness including Mean, DevOp SD, Residual SD, Repeat. %CV, Repeat. Limit, Repro. SD, Repro. %CV, Repro. Limit for Normal, Glaucoma, and Retina subjects. 96.0% of CIRRUS 6000 and 94.9% of CIRRUS 5000 scans acquired were valid and analyzed.
Key Results (Angiography): 78.3% of CIRRUS 6000 and 77.2% of CIRRUS 5000 scans acquired were valid and analyzed. The proportion of Clinically Acceptable Overall Images was 0.98 or above for the CIRRUS 6000 device and 0.94 and above for the CIRRUS 5000 device for all subjects.
Key Results (Raster Image Quality): 92.3% of CIRRUS 6000 and 91.3% of CIRRUS 5000 scans acquired were valid and analyzed. The proportion of Clinically Acceptable Overall Images was 1.00 for all scan types across the CIRRUS 6000 and the CIRRUS 5000 device for all subjects.

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

Key metrics in the performance tables include: Mean, DevOp SD, Residual SD, Repeat. %CV, Repeat. Limit, Repro. SD, Repro. %CV, Repro. Limit for various anatomical measurements (Ganglion Cell Thickness, Macular Thickness, ONH parameters, RNFL Thickness, Epithelial Thickness, Pachymetry Thickness).

Repeatability %CV:
- Ganglion Cell Thickness: 0.5% - 12.5%
- Macular Thickness: 0.4% - 0.9%
- ONH: 1.9% - 7.6%
- RNFL Thickness: 1.2% - 9.1%
- Epithelial Thickness: 1.8% - 9.2%
- Pachymetry Thickness: 0.2% - 1.6%
Reproducibility %CV:
- Ganglion Cell Thickness: 0.6% - 13.5%
- Macular Thickness: 0.5% - 0.8%
- ONH: 2.0% - 8.7%
- RNFL Thickness: 1.8% - 10.2%
- Epithelial Thickness: 3.8% - 7.8%
- Pachymetry Thickness: 0.4% - 2.2%

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.

CIRRUS HD-OCT Model 5000 (K181534)

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

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Image /page/0/Picture/0 description: The image contains 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Carl Zeiss Meditec Inc % Tanesha Bland Senior Regulatory Affairs Specialist Carl Zeiss Meditec USA Inc 5300 Central Parkway Dublin, California 94568

Re: K222200

Trade/Device Name: Cirrus HD-OCT Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: March 2, 2023 Received: March 6, 2023

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 (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 located 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.

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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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

Enclosure

2

Indications for Use

510(k) Number (if known) K22200

Device Name CIRRUS HD-OCT Model 6000

Indications for Use (Describe)

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 ocular structures. The device is indicated for visualizing and measuring and posterior ocular structures, including corneal epithelium, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head.

CIRRUS' AngioPlex OCT 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.

This device is Prescription Use (Rx) only.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Page 1 of 41

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

SUBMITTER 1. Applicant: Carl Zeiss Meditec, Inc. 5300 Central Parkway Dublin, CA USA Tanesha Bland Primary Correspondent Sr. Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5300 Central Parkway | Dublin, CA 94568 (925) 216-7963 Phone | (925) 557-4259 Fax E-mail: tanesha.bland(@zeiss.com (preferred) Development Center Contact Vidita Desai Sr. Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5300 Central Parkway | Dublin, CA 94568 (925) 413-1644 Phone | (925) 557-4259 Fax E-mail: vidita.desai@zeiss.com (preferred) April 12, 2023 Date Prepared:

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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 5000 (K181534)
Classification:	21CFR886.1570 Optical Coherence Tomography (OCT)
Regulatory Class:	II
Product Code:	OBO, IYO, ITX

4. DEVICE DESCRIPTION

The CIRRUS™ HD-OCT Model 6000 is indicated for in-vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of anterior and posterior ocular structures. The clinical purpose of this device has not been modified as compared to the predicate.

CIRRUS 6000 uses the same optical system, architecture, and principle of operation as the previously cleared CIRRUS 5000 (K181534). CIRRUS 6000 has a 100 kHz scan rate for all structural and angiography scans. The primary impact of the higher acquisition speed is its impact on signal-to-noise ratio. The signal-to-noise ratio m the subject device is calibrated to match the specifications of the CIRRUS 6000 uses the same segmentation algorithms as the predicate device and therefore the segmentation results will be equivalent.

In addition to the acquisition speed change, CIRRUS 6000 also has a wider field of view (FOV) and has increased the number of fixation points to 21.

INDICATIONS FOR USE న్.

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 ocular structures, including cornea, corneal epithelium, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head.

CIRRUS' AngioPlex OCT 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.

This device is Prescription Use (Rx) only.

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6. SUBSTANTIAL EQUIVALENCE TO PRIMARY PREDICATE

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

| Device | Subject Device – CIRRUS 6000 | Predicate Device – CIRRUS 5000
(K181534) | Equivalency
Analysis |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Indications
for Use | 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, retinalerve fiber layer, ganglion cell plus
inner plexiform layer, macula, and
optic nerve head. | 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. | Identical (except
the normative
database) |
| | CIRRUS AngioPlex OCT
Angiography with is indicated as an
aid in the visualization of vascular
structures of the retina and choroid. | 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 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 | |

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Page 4 of 41

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

Device	CIRRUSTM HD-OCT 6000 v. 11.5.4	CIRRUS™ HD-OCT 5000 v. 10.0	Analysis
	Subject Device	Predicate Device (K181534)
Device Classification
Name	Tomography, Optical Coherence	Tomography, Optical Coherence	Identical
Generic/
Common Name	Optical Coherence Tomography (OCT)	Optical Coherence Tomography (OCT)	Identical
Classification Product
Code	OBO	OBO	Identical
Class	II	II	Identical
Technology	Spectral Domain (Spatially encoded
Frequency Domain and Fourier
Domain Principle) OCT	Spectral Domain (Spatially encoded
Frequency Domain and Fourier
Domain Principle) OCT	Identical
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	Identical
Models	6000	5000	N/A
OCT IMAGING
Methodology	Spectral domain OCT (SD-OCT)	Spectral domain OCT (SD-OCT)	Identical
K222200 - 510(k) Summary		Page 5 of 41
Device	CIRRUSTM HD-OCT 6000 v. 11.5.4
Subject Device	CIRRUSTM HD-OCT 5000 v. 10.0
Predicate Device (K181534)	Analysis
OCT Optical Source	OCT Super Luminescent Diode,
840 nm wavelength	OCT Super Luminescent Diode,
840 nm wavelength	Identical
Optical Power	$1200 \mu W +/- 300 \mu W$ (0.9 - 1.5 mW)
at the cornea	$ 20 Hz	> 20 Hz	Identical
Transverse Resolution	25 um (in tissue)	25 um (in tissue)	Identical
IRIS IMAGING
Methodology	CMOS camera and LED illumination	CMOS camera and LED illumination	Identical
Optical source	1280 x 1024	1280 x 1024	Identical
Resolution	During alignment	During alignment	Identical
Live iris image	Light emitting diode (LED), 700 nm	Light emitting diode (LED), 700 nm	Identical
FIXATION
Internal fixation source	LED Array, 21 positions (Same 9
positions as CIRRUS 5000 plus an
additional 12 positions)	LED Array, 9 positions	Different
Internal fixation focus
adjustment	-20D to +20D (diopters)	-20D to +20D (diopters)	Identical
K222200 - 510(k) Summary		Page 22 of 41
Device	CIRRUS™ HD-OCT 6000 v. 11.5.4
Subject Device	CIRRUS™ HD-OCT 5000 v. 10.0
Predicate Device (K181534)	Analysis
External fixation source	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	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 @ 3.1GHz, 16GB RAM,
2TB Hard Disk, Windows 10	Different
Input Devices	Computer mouse/keyboard	Computer mouse/keyboard	Identical
Display	22" Widescreen HD
(Resolution 1920 x 1080)	19" Color Flat Panel Display
(Resolution 1280 x 1024)	Different
Network	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	Identical
Weight	35 kg (77 lbs) (without monitor)	36 kg (80 lbs)	Different
Dimensions	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	Identical
Power rating (115V)	500W	350W	Different
Device	CIRRUSTM HD-OCT 6000 v. 11.5.4	CIRRUSTM HD-OCT 5000 v. 10.0	Analysis
	Subject Device	Predicate Device (K181534)
Fuse rating (115V)	T 6.3 A 250V	T 5A 250V	Different, power consumption
for enhanced speed and
capabilities push the power
budget to the place where higher
rated power supply is needed
Max amperage and
voltage rating	T 6.3A 250V	T 5A 250V	Different, Compliant with IEC
60601 requirements.
Environmental
Conditions:
Transport and Storage	Temp. -40° to +70° C
30% to 75% (excluding condensation)	Temp. -40° to +70° C
30% to 75% (excluding condensation)	Identical
	Atmospheric Pressure
500 to 1060 hPa	Atmospheric Pressure
500 to 1060 hPa
Environmental
Conditions: Operation	Temperature:
+10 to +35° C	Temperature:
+10 to +35° C	Identical
	Relative Humidity:
30% to 75% (excluding condensation)	Relative Humidity:
30% to 75% (excluding condensation)
	Atmospheric Pressure:
700 to 1060 hPa	Atmospheric Pressure:
700 to 1060 hPa
Enclosure-Flammability
Ratings	UL 94V-0	UL 94V-0	Identical
UX
Device	CIRRUS™ HD-OCT 6000 v. 11.5.4
Subject Device	CIRRUS™ HD-OCT 5000 v. 10.0
Predicate Device (K181534)	Analysis
Protocol buttons	- Workflow buttons filter scan
patterns for acquisition	Not Available	Different
Scan Protocols	- user-selectable scan protocols on
the patient management screen that
define a specific set of scans to be
acquired.	Not Available	Different
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	Not Available	Different
This is a workflow
improvement, not a technical
improvement. This provides the
user a streamlined selection
based on their preferences
and/or practices.
Anterior Segment
Caliper Tool	- This tool is able to snap to the
surfaces identified by the software,
including anterior cornea and
posterior cornea.	Not Available	Different
User interface improvements
Analysis switch eye	- allows the user to switch to the
'other' eye for the same analyses	Not Available	Different, user interface
improvements
New Circle Tool for
Angiography	- a manually placed circle tool for
annotation purposes	Not Available	Different, user interface
improvements
K222200 - 510(k) Summary		Page 25 of 41
Device	CIRRUS TM HD-OCT 6000 v. 11.5.4
Subject Device	CIRRUS TM HD-OCT 5000 v. 10.0
Predicate Device (K181534)	Analysis
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	Not Available	Different, user interface
improvements

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Image /page/7/Picture/0 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and set against a solid blue background. The bottom of the blue background is curved.

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. . . .

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Image /page/15/Picture/0 description: The image contains the word "ZEISS" in white text on a blue background. The word is written in a bold, sans-serif font. The blue background is a solid color and takes up most of the image. The word "ZEISS" is positioned at the top of the blue background.

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Image /page/19/Picture/0 description: The image shows the logo for ZEISS. The logo consists of the word "ZEISS" in a bold, sans-serif font, stacked on top of a blue rectangle. The bottom of the blue rectangle has a curved shape.

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Image /page/20/Picture/0 description: The image shows the logo for ZEISS. The logo consists of the word "ZEISS" in a bold, sans-serif font, stacked on top of a blue rectangle. The bottom of the blue rectangle is curved, creating a subtle, convex shape.

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Page 23 of 41

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Image /page/27/Picture/0 description: The image shows the ZEISS logo. The logo consists of the word "ZEISS" in a bold, sans-serif font, stacked on top of a blue rectangle. The rectangle has a curved bottom edge. The logo is simple and recognizable.

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7. SUMMARY OF STUDIES

Non-Clinical Performance Testing

Non-clinical system testing provided an evaluation of the system relevant to each of the system specifications. The functional and system level that the system met the defined specifications. ZEISS demonstrated non-clinical equivalency between the CIRRUS 6000 and CIRRUS 5000 scan data using a phantom retina, which shows the equivalency of the segmentation results as the segmentation algorithms are the same in both instruments.

Sterility, Shelf-Life, Biocompatibility, and Animal testing was not required for this submission and thus not used in substantiation of equivalence.

Software verification and validation testing were conducted, and documentation was provided as recommended by the FDA's Guidance for Industry and Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". There have been no changes in level of concern or software architecture. All testing passed.

Due to changes to hardware stated in the device description section, updated IEC 60601-1-2 was provided to demonstrate that the changes did not have a negative impact on the device's electrical safety profile. All testing has passed.

Bench Testing followed FDA's 510(k) OCT Pilot Program Recommendations

. Spatial performance
Device sensitivity
OCT angiography ●
Auxiliary functions testing ●
Safety and Essential Performance: IEC 60601-1 ●
Electromagnetic Compatibility: IEC 60601-1-2
Usability: IEC 62366-1 ●
Optical resolution testing (lateral and axial resolution)
Light Hazard Protection for Ophthalmic Instruments: ANSI Z80.36-2016 ●
. Gage R&R segmentation comparison between CIRRUS 5000 and CIRRUS 6000

All the above testing passed. No additional safety or performance concerns have been raised during development or device testing.

Clinical Performance Testing

Clinical performance testing was performed to substantiate subject device's equivalence. These studies included repeatability and reproducibility, qualitative image grading and agreement.

CIRRUS 6000 Repeatability and Reproducibility (R&R)

This was a prospective. multi-site study. A total of 117 subjects were enrolled: 27 without ocular pathology (normal), 37 with glaucoma, 30 with retinal pathology, and 23 with status post refractive surgery or with corneal pathology. 9 subjects were disqualified because they did not meet the inclusion or were disqualified after scans due to the presence of macular changes due to drusen. The subject age range was 20-90, with a mean

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age of 53.9 ± 12.4 for the normal sub-group, 71.2 ± 10.0 for the glaucoma subgroup, 73.0 ± 11.3 for the retinal pathology subgroup, 66.9 ± 15.9 for the cornea subgroup. The study population was composed of 46 (42.6%) females and 62 (57.4%) male subjects. 18 (16.7%) subjects were Asian. 5 (4.6%) subjects were Black, 79 (73.1%) subjects were Caucasian, and 6 (5.6%) subjects were listed as "Other". 96.0% of CIRRUS 6000 and 94.9% of CIRRUS 5000 scans acquired were valid and analyzed. Acquired scans were invalidated due to poor image quality (1.2-1.3%), scan decentration (1.7-2.4%), eye did not meet inclusion criteria (1.1%), poor signal strength (0.1%), or algorithm failure (0.2%).

Three acceptable scans of each scan type were acquired on each of the study devices (three CIRRUS 6000 and three CIRRUS 5000 devices) with assigned operator/device pairs. Analysis of variance was performed to determine the repeatability and reproducibility as well as the variance associated with the combination of operator and device. Agreement between CIRRUS 5000 and CIRRUS 6000 was evaluated with Bland-Altman Limits of Agreement, and Deming Regression analysis methods.

The CIRRUS 6000 (C6000) R&R results are presented in the tables below:

| Variable | Mean | DevOp
SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
|-------------------------|-------|-------------|----------------|----------------|------------------|--------------|---------------|-----------------|
| Ganglion Cell Thickness | | | | | | | | |
| Average Thickness (µm) | 82.1 | 0.20 | 0.41 | 0.5% | 1.1 | 0.48 | 0.6% | 1.3 |
| Temporal Superior (µm) | 81.2 | 0.13 | 0.65 | 0.8% | 1.8 | 0.79 | 1.0% | 2.2 |
| Superior (µm) | 82.6 | 0.36 | 0.72 | 0.9% | 2.0 | 0.82 | 1.0% | 2.3 |
| Nasal Superior (µm) | 83.8 | 0.39 | 0.74 | 0.9% | 2.1 | 0.92 | 1.1% | 2.6 |
| Nasal Inferior (µm) | 81.9 | 0.25 | 0.70 | 0.8% | 1.9 | 0.80 | 1.0% | 2.2 |
| Inferior (µm) | 80.3 | 0.33 | 0.78 | 1.0% | 2.2 | 0.87 | 1.1% | 2.4 |
| Temporal Inferior (µm) | 82.8 | 0.12 | 0.69 | 0.8% | 1.9 | 0.85 | 1.0% | 2.4 |
| Minimum Thickness (µm) | 80.6 | 0.14 | 0.80 | 1.0% | 2.2 | 0.86 | 1.1% | 2.4 |
| Macular Thickness | | | | | | | | |
| Central Subfield (µm) | 267.8 | 0.031 | 1.0 | 0.4% | 2.9 | 2.0 | 0.7% | 5.6 |
| Inner Temporal (µm) | 316.2 | 0.91 | 1.2 | 0.4% | 3.4 | 2.5 | 0.8% | 7.1 |
| Inner Superior (µm) | 329.3 | 0.76 | 1.3 | 0.4% | 3.8 | 2.4 | 0.7% | 6.6 |
| Inner Nasal (µm) | 331.4 | 0.81 | 1.2 | 0.4% | 3.3 | 2.3 | 0.7% | 6.5 |
| Inner Inferior (µm) | 325.4 | 0.24 | 1.2 | 0.4% | 3.3 | 2.3 | 0.7% | 6.5 |
| Outer Temporal (µm) | 265.3 | 1.3 | 1.3 | 0.5% | 3.6 | 2.4 | 0.9% | 6.9 |
| Outer Superior (µm) | 284.2 | 1.1 | 1.1 | 0.4% | 3.1 | 2.0 | 0.7% | 5.6 |
| Outer Nasal (µm) | 303.1 | 0.98 | 0.95 | 0.3% | 2.7 | 2.0 | 0.7% | 5.7 |
| Outer Inferior (µm) | 270.7 | 1.1 | 1.3 | 0.5% | 3.5 | 2.4 | 0.9% | 6.7 |

Table 3. C6000 Macular Cube 512x128 Macular Thickness scans, Normal Subjects (n=225 scans), Precision Summary

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Image /page/30/Picture/0 description: The image shows the word "ZEISS" in white letters on a blue background. The word is in a bold, sans-serif font. Below the word is a curved white line, which gives the impression of a horizon. The logo is simple and modern.

K222200 - 510(k) Summary Page 28 of 41
Variable	Mean	DevOp
SD	Residual
SD	Repeat.
%CV	Repeat.
Limit	Repro.
SD	Repro.
%CV	Repro.
Limit
Average Cube Thickness
(μm)	285.2	1.0	1.3	0.5%	3.7	2.0	0.7%	5.5
Volume Cube (mm3)	10.3	0.032	0.052	0.5%	0.15	0.077	0.8%	0.22

Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components.

Repeatability and reproducibility limits are 2.8 · SD.

%CV is calculated as 100*SD/Mean.

Table 4. C6000 Optic Disc Cube 200x200 RNFL Thickness scans, Normal Subjects (n=214 scans), Precision Summary

| Variable | Mean | DevOp
SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
|--------------------------------|-------|-------------|----------------|----------------|------------------|--------------|---------------|-----------------|
| ONH | | | | | | | | |
| Rim Area (mm2) | 1.3 | 0.004 | 0.063 | 4.9% | 0.18 | 0.084 | 6.6% | 0.24 |
| Disc Area (mm2) | 1.8 | 0.000 | 0.11 | 6.4% | 0.32 | 0.16 | 8.7% | 0.43 |
| Average Cup/Disc Ratio | 0.51 | 0.000 | 0.018 | 3.6% | 0.052 | 0.022 | 4.3% | 0.061 |
| Vertical C/D Ratio | 0.48 | 0.005 | 0.024 | 5.0% | 0.067 | 0.028 | 5.7% | 0.078 |
| Cup Volume (mm3) | 0.15 | 0.000 | 0.007 | 4.5% | 0.018 | 0.008 | 5.2% | 0.022 |
| RNFL Thickness | | | | | | | | |
| Average RNFL Thickness
(μm) | 95.9 | 0.54 | 1.2 | 1.2% | 3.3 | 1.7 | 1.8% | 4.9 |
| Temporal (µm) | 64.9 | 0.24 | 2.1 | 3.3% | 5.9 | 2.6 | 4.0% | 7.3 |
| Superior (µm) | 118.6 | 1.7 | 2.7 | 2.3% | 7.6 | 4.3 | 3.7% | 12.2 |
| Nasal (µm) | 74.8 | 0.63 | 2.1 | 2.8% | 5.9 | 2.9 | 3.9% | 8.2 |
| Inferior (µm) | 125.2 | 0.55 | 2.8 | 2.2% | 7.8 | 3.3 | 2.6% | 9.3 |
| Clock hour 1 (μm) | 107.9 | 2.8 | 3.7 | 3.4% | 10.3 | 5.9 | 5.4% | 16.4 |
| Clock hour 2 (µm) | 92.7 | 0.000 | 3.6 | 3.9% | 10.2 | 5.2 | 5.6% | 14.6 |
| Clock hour 3 (μm) | 60.7 | 1.4 | 2.4 | 4.0% | 6.8 | 3.7 | 6.1% | 10.4 |
| Clock hour 4 (μm) | 70.9 | 0.66 | 2.9 | 4.1% | 8.1 | 4.1 | 5.8% | 11.6 |
| Clock hour 5 (μm) | 102.4 | 0.48 | 3.1 | 3.0% | 8.6 | 4.4 | 4.3% | 12.2 |
| Clock hour 6 (μm) | 139.2 | 0.000 | 4.8 | 3.4% | 13.3 | 5.6 | 4.0% | 15.6 |
| Clock hour 7 (μm) | 134.1 | 0.000 | 4.4 | 3.3% | 12.4 | 5.8 | 4.3% | 16.3 |
| Clock hour 8 (μm) | 63.6 | 0.000 | 2.6 | 4.1% | 7.3 | 3.3 | 5.1% | 9.1 |
| Clock hour 9 (μm) | 51.4 | 0.000 | 1.9 | 3.7% | 5.3 | 2.4 | 4.6% | 6.6 |
| Clock hour 10 (μm) | 79.7 | 0.55 | 2.7 | 3.4% | 7.7 | 3.9 | 4.9% | 10.9 |

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Image /page/31/Picture/0 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue background. The logo is simple and recognizable, reflecting the company's focus on precision and quality.

K222200 - 510(k) Summary						Page 29 of 41
Variable	Mean	DevOp SD	Residual SD	Repeat. %CV	Repeat. Limit	Repro. SD	Repro. %CV	Repro. Limit
Clock hour 11 (μm)	130.4	0.000	3.8	2.9%	10.6	4.8	3.7%	13.5
Clock hour 12 (μm)	117.5	2.1	4.1	3.5%	11.4	6.5	5.6%	18.3

Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components.

Repeatability and reproducibility limits are 2.8 · SD.

%CV is calculated as 100*SD/Mean.

Table 5. C6000 Pachymetry Thickness scans, Normal Subjects (n=207 scans), Precision Summary

| Variable SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
|--------------------- | Epithelial Thickness | Central (um) | Inner Nasal (um) | Inner SuperoNasal (um) | Inner Superior (um) | Inner SuperoTemporal
(um) | 46.5 | 0.000 | Inner Temporal (um) | Inner InferoTemporal (um) | Inner Inferior (um) | Inner InferoNasal (um) | Middle Nasal (um) | Middle SuperoNasal (um) | Middle Superior (um) | Middle SuperoTemporal
(um) | 43.8 | 0.30 | Middle Temporal (um) | Middle InferoTemporal
(um) | 47.0 | 0.25 | Middle Inferior (um) | Middle InferoNasal (um) | Outer Nasal (um) | Outer SuperoNasal (um) | Outer Superior (um) | Outer SuperoTemporal
(um) | 41.3 | 0.000 | Mean | DevOp
----------|------|-------------|----------------|----------------|------------------|--------------|---------------|-----------------|
| | | | | | | | |
| 49.1 | 0.000 | 0.90 | 1.8% | 2.5 | 1.8 | 3.8% | 5.2 |
| 48.1 | 0.22 | 1.2 | 2.6% | 3.5 | 2.2 | 4.6% | 6.2 |
| 47.6 | 0.55 | 1.2 | 2.5% | 3.4 | 2.1 | 4.4% | 5.8 |
| 46.6 | 0.26 | 1.2 | 2.7% | 3.5 | 2.0 | 4.2% | 5.5 |
| 1.1 | 2.5% | 3.2 | 2.1 | 4.6% | 6.0 |
| 47.0 | 0.000 | 1.1 | 2.4% | 3.1 | 2.1 | 4.5% | 5.9 |
| 47.9 | 0.000 | 1.1 | 2.3% | 3.1 | 2.3 | 4.9% | 6.6 |
| 48.6 | 0.34 | 1.1 | 2.3% | 3.1 | 2.6 | 5.3% | 7.2 |
| 48.5 | 0.47 | 1.1 | 2.2% | 3.1 | 2.5 | 5.1% | 7.0 |
| 46.9 | 0.000 | 1.3 | 2.7% | 3.6 | 2.5 | 5.3% | 6.9 |
| 45.6 | 0.27 | 1.5 | 3.3% | 4.2 | 2.0 | 4.4% | 5.7 |
| 43.5 | 0.17 | 1.6 | 3.6% | 4.4 | 1.9 | 4.3% | 5.3 |
| 1.4 | 3.2% | 3.9 | 1.9 | 4.4% | 5.4 |
| 45.4 | 0.000 | 1.3 | 2.8% | 3.6 | 2.3 | 5.0% | 6.4 |
| 1.2 | 2.6% | 3.4 | 2.7 | 5.7% | 7.5 |
| 47.3 | 0.45 | 0.99 | 2.1% | 2.8 | 2.5 | 5.2% | 6.9 |
| 46.9 | 0.001 | 1.2 | 2.5% | 3.3 | 2.8 | 5.9% | 7.7 |
| 47.5 | 0.000 | 1.5 | 3.2% | 4.3 | 2.5 | 5.4% | 7.1 |
| 44.1 | 0.000 | 2.4 | 5.5% | 6.9 | 2.8 | 6.3% | 7.7 |
| 40.9 | 0.000 | 1.8 | 4.5% | 5.2 | 2.0 | 4.9% | 5.6 |
| 2.1 | 5.2% | 6.0 | 2.5 | 6.0% | 6.9 |

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Image /page/32/Picture/0 description: The image shows the ZEISS logo. The logo consists of the word "ZEISS" in a bold, sans-serif font, set against a solid blue background. The letters are white, creating a strong contrast with the background.

K222200 - 510(k) Summary						Page 30 of 41
Variable	Mean	DevOp
SD	Residual
SD	Repeat.
%CV	Repeat.
Limit	Repro.
SD	Repro.
%CV	Repro.
Limit
Outer Temporal (µm)	44.5	0.000	1.4	3.1%	3.8	2.4	5.4%	6.7
Outer InferoTemporal (µm)	46.9	0.000	1.7	3.6%	4.7	2.9	6.1%	8.0
Outer Inferior (µm)	45.6	0.000	1.0	2.3%	2.9	2.8	6.0%	7.7
Outer InferoNasal (µm)	46.4	0.000	2.0	4.3%	5.6	3.1	6.8%	8.8
Pachymetry Thickness
Central (µm)	543.3	0.000	1.2	0.2%	3.2	2.0	0.4%	5.5
Inner Nasal (μm)	566.0	0.27	2.5	0.4%	6.9	3.1	0.5%	8.7
Inner SuperoNasal (µm)	571.6	1.8	2.8	0.5%	7.8	3.8	0.7%	10.6
Inner Superior (µm)	570.9	2.4	3.2	0.6%	9.1	4.4	0.8%	12.3
Inner SuperoTemporal
(µm)	559.1	1.4	2.3	0.4%	6.4	3.2	0.6%	8.8
Inner Temporal (µm)	547.6	0.000	1.6	0.3%	4.4	2.4	0.4%	6.8
Inner InferoTemporal (µm)	548.0	1.2	2.1	0.4%	5.8	3.4	0.6%	9.6
Inner Inferior (µm)	556.0	1.5	3.0	0.5%	8.4	4.4	0.8%	12.3
Inner InferoNasal (µm)	562.1	1.2	2.8	0.5%	7.8	4.0	0.7%	11.1
Outer Nasal (µm)	599.8	1.2	3.7	0.6%	10.3	4.7	0.8%	13.2
Outer SuperoNasal (µm)	609.6	3.3	4.9	0.8%	13.8	7.1	1.2%	20.0
Outer Superior (µm)	610.4	4.7	6.0	1.0%	16.9	8.9	1.5%	24.8
Outer SuperoTemporal
(µm)	590.6	2.1	4.0	0.7%	11.2	5.0	0.9%	14.1
Outer Temporal (µm)	568.2	0.000	2.5	0.4%	7.0	3.3	0.6%	9.4
Outer InferoTemporal (µm)	570.4	0.000	3.6	0.6%	10.0	8.5	1.5%	23.9
Outer Inferior (µm)	585.2	1.7	4.4	0.8%	12.4	7.9	1.3%	22.0
Outer InferoNasal (µm)	594.7	1.6	4.0	0.7%	11.3	5.5	0.9%	15.5

Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components. Repeatability and reproducibility limits are 2.8 · SD.

%CV is calculated as 100*SD/Mean.

Table 6. C6000 Macular Cube 512x128 Macular Thickness scans, Glaucoma Subjects (n=271 scans), Precision Summary

| Variable | Mean | DevOp
SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
|-------------------------|------|-------------|----------------|----------------|------------------|--------------|---------------|-----------------|
| Ganglion Cell Thickness | | | | | | | | |

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Image /page/33/Picture/0 description: The image shows the logo for ZEISS, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font, set against a solid blue background. Below the wordmark, there is a curved shape, also in blue, that suggests the lens or optical element. The overall design is clean and modern, reflecting the company's focus on precision and technology.

K222200 - 510(k) Summary		Page 31 of 41
Variable	Mean	DevOp
SD	Residal
SD	Repeat.
%CV	Repeat.
Limit	Repro.
SD	Repro.
%CV	Repro.
Limit
Average Thickness
(μm)	61.5	0.000	0.82	1.3%	2.3	0.98	1.6%	2.7
Temporal Superior (µm)	62.1	0.000	1.2	2.0%	3.4	1.5	2.4%	4.1
Superior (µm)	62.5	0.000	2.3	3.7%	6.5	2.5	4.0%	7.0
Nasal Superior (µm)	64.1	0.000	1.4	2.1%	3.8	1.8	2.8%	5.1
Nasal Inferior (μm)	61.5	0.000	0.86	1.4%	2.4	1.1	1.7%	3.0
Inferior (µm)	58.7	0.000	1.4	2.5%	4.0	1.6	2.7%	4.5
Temporal Inferior (µm)	60.1	0.056	0.93	1.6%	2.6	1.1	1.8%	3.0
Minimum Thickness
(μm)	55.4	0.000	2.1	3.7%	5.8	2.1	3.7%	5.8
Macular Thickness
Central Subfield (µm)	262.5	0.000	1.3	0.5%	3.5	1.6	0.6%	4.5
Inner Temporal (µm)	289.2	0.39	1.6	0.6%	4.6	2.0	0.7%	5.6
Inner Superior (μm)	300.4	0.34	1.8	0.6%	4.9	2.0	0.7%	5.7
Inner Nasal (µm)	308.1	0.40	1.5	0.5%	4.2	1.8	0.6%	5.1
Inner Inferior (μm)	292.2	0.000	1.7	0.6%	4.8	2.0	0.7%	5.6
Outer Temporal (µm)	242.7	0.56	1.6	0.6%	4.4	2.0	0.8%	5.5
Outer Superior (µm)	256.3	0.64	1.5	0.6%	4.2	1.8	0.7%	5.1
Outer Nasal (μm)	269.8	0.74	1.5	0.6%	4.2	1.9	0.7%	5.4
Outer Inferior (µm)	239.5	0.76	1.5	0.6%	4.1	2.0	0.8%	5.6
Average Cube
Thickness (µm)	256.8	0.8	1.4	0.6%	4.0	2.1	0.8%	6.0
Volume Cube (mm3)	9.2	0.026	0.057	0.6%	0.16	0.075	0.8%	0.21

Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components. Repeatability and reproducibility limits are 2.8 · SD. %CV is calculated as 100*SD/Mean.

Table 7. C6000 Optic Disc Cube 200x200 RNFL Thickness scans, Glaucoma Subjects (n=260 scans)
Precision Summary

| Variable | Mean | DevOp
SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
|------------------------|------|-------------|----------------|----------------|------------------|--------------|---------------|-----------------|
| ONH | | | | | | | | |
| Rim Area (mm2) | 0.81 | 0.000 | 0.062 | 7.6% | 0.17 | 0.063 | 7.7% | 0.18 |
| Disc Area (mm2) | 1.7 | 0.000 | 0.12 | 7.2% | 0.34 | 0.12 | 7.2% | 0.34 |
| Average Cup/Disc Ratio | 0.68 | 0.000 | 0.013 | 1.9% | 0.036 | 0.014 | 2.0% | 0.039 |

34

Image /page/34/Picture/0 description: The image shows the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue background. The bottom of the image has a curved white shape, possibly part of a logo.

| K222200 - 510(k) Summary

Page 32 of 41
Variable	Mean	DevOp SD	Residual SD	Repeat. %CV	Repeat. Limit	Repro. SD	Repro. %CV	Repro. Limit
Vertical C/D Ratio	0.71	0.003	0.021	2.9%	0.058	0.023	3.2%	0.063
Cup Volume (mm3)	0.37	0.000	0.029	7.8%	0.082	0.029	7.8%	0.082
RNFL Thickness
Average RNFL Thickness (μm)	70.3	0.45	1.3	1.9%	3.7	1.7	2.4%	4.7
Temporal (μm)	50.1	0.30	1.6	3.1%	4.4	1.8	3.7%	5.2
Superior (μm)	83.6	0.96	2.5	3.0%	7.0	3.0	3.6%	8.4
Nasal (μm)	67.5	0.000	2.3	3.4%	6.4	3.0	4.4%	8.3
Inferior (μm)	80.3	0.73	2.6	3.2%	7.3	3.3	4.1%	9.1
Clock hour 1 (μm)	78.7	1.1	3.4	4.4%	9.6	4.4	5.5%	12.2
Clock hour 2 (μm)	75.0	0.000	3.5	4.6%	9.7	4.0	5.4%	11.3
Clock hour 3 (μm)	64.1	0.41	2.7	4.2%	7.6	3.4	5.3%	9.6
Clock hour 4 (μm)	63.3	0.000	2.9	4.5%	8.0	3.6	5.7%	10.1
Clock hour 5 (μm)	74.0	0.68	2.9	3.9%	8.1	4.1	5.5%	11.4
Clock hour 6 (μm)	87.9	0.94	4.4	5.0%	12.4	5.2	6.0%	14.7
Clock hour 7 (μm)	78.9	0.24	3.4	4.3%	9.5	4.1	5.2%	11.6
Clock hour 8 (μm)	49.0	0.39	2.6	5.3%	7.3	3.2	6.5%	8.9
Clock hour 9 (μm)	44.2	0.000	1.6	3.6%	4.4	2.1	4.7%	5.8
Clock hour 10 (μm)	56.9	0.41	2.5	4.4%	7.0	2.5	4.4%	7.1
Clock hour 11 (μm)	84.2	0.000	3.6	4.3%	10.1	4.4	5.3%	12.4
Clock hour 12 (um)	87.9	1.5	4.7	5.4%	13.2	5.1	5.8%	14.2

Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components. Repeatability and reproducibility limits are 2.8 · SD. %CV is calculated as 100*SD/Mean.

Table 8. C6000 Pachymetry Thickness scans, Glaucoma Subjects (n=254 scans), Precision Summary

| Variable | Mean | DevOp
SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
|-------------------------------|---------------|-------------|----------------|----------------|------------------|--------------|---------------|-----------------|
| Epithelial Thickness | | | | | | | | |
| Central (µm) | 47.0 | 0.000 | 1.5 | 3.2% | 4.2 | 1.9 | 4.1% | 5.3 |
| Inner Nasal (µm) | 45.3 | 0.000 | 1.6 | 3.5% | 4.5 | 2.3 | 5.0% | 6.3 |
| Inner SuperoNasal (µm) | 44.8 | 0.000 | 1.7 | 3.8% | 4.8 | 2.2 | 5.0% | 6.3 |
| Inner Superior (µm) | 44.2 | 0.21 | 1.5 | 3.4% | 4.2 | 2.0 | 4.5% | 5.5 |
| K222200 - 510(k) Summary | Page 33 of 41 | | | | | | | |
| Variable | Mean | DevOp
SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
| Inner SuperoTemporal
(μm) | 44.2 | 0.000 | 1.7 | 3.8% | 4.7 | 2.1 | 4.7% | 5.8 |
| Inner Temporal (μm) | 44.8 | 0.000 | 1.9 | 4.3% | 5.3 | 2.5 | 5.5% | 6.9 |
| Inner InferoTemporal (μm) | 45.9 | 0.000 | 1.9 | 4.2% | 5.4 | 2.6 | 5.7% | 7.3 |
| Inner Inferior (μm) | 47.0 | 0.27 | 2.0 | 4.3% | 5.6 | 2.5 | 5.4% | 7.1 |
| Inner InferoNasal (μm) | 46.5 | 0.000 | 1.9 | 4.1% | 5.4 | 2.4 | 5.1% | 6.7 |
| Middle Nasal (μm) | 44.2 | 0.000 | 1.6 | 3.5% | 4.4 | 2.2 | 5.0% | 6.2 |
| Middle SuperoNasal (μm) | 43.5 | 0.000 | 2.7 | 6.2% | 7.5 | 3.1 | 7.0% | 8.6 |
| Middle Superior (μm) | 41.8 | 0.000 | 1.7 | 4.1% | 4.8 | 2.3 | 5.5% | 6.4 |
| Middle SuperoTemporal
(μm) | 42.1 | 0.000 | 1.7 | 4.1% | 4.9 | 2.1 | 5.1% | 6.0 |
| Middle Temporal (μm) | 43.5 | 0.000 | 2.0 | 4.5% | 5.5 | 2.6 | 6.0% | 7.3 |
| Middle InferoTemporal
(µm) | 45.5 | 0.000 | 2.0 | 4.5% | 5.7 | 2.7 | 6.0% | 7.7 |
| Middle Inferior (μm) | 46.4 | 0.000 | 1.9 | 4.2% | 5.4 | 2.4 | 5.3% | 6.8 |
| Middle InferoNasal (μm) | 45.7 | 0.000 | 2.1 | 4.5% | 5.8 | 2.4 | 5.4% | 6.9 |
| Outer Nasal (μm) | 45.4 | 0.43 | 2.7 | 5.8% | 7.4 | 3.0 | 6.6% | 8.4 |
| Outer SuperoNasal (μm) | 42.8 | 0.000 | 2.2 | 5.2% | 6.2 | 2.8 | 6.5% | 7.8 |
| Outer Superior (μm) | 40.5 | 0.000 | 2.4 | 6.0% | 6.8 | 3.1 | 7.6% | 8.6 |
| Outer SuperoTemporal
(μm) | 40.6 | 0.000 | 2.2 | 5.4% | 6.1 | 2.5 | 6.1% | 6.9 |
| Outer Temporal (μm) | 43.6 | 0.001 | 2.4 | 5.4% | 6.6 | 2.7 | 6.1% | 7.5 |
| Outer InferoTemporal (μm) | 46.6 | 0.000 | 2.4 | 5.1% | 6.6 | 2.8 | 6.0% | 7.8 |
| Outer Inferior (μm) | 46.2 | 0.000 | 2.0 | 4.3% | 5.6 | 2.5 | 5.3% | 6.9 |
| Outer InferoNasal (μm) | 46.3 | 0.54 | 2.1 | 4.5% | 5.8 | 2.8 | 5.9% | 7.7 |
| Pachymetry Thickness | | | | | | | | |
| Central (μm) | 507.5 | 0.35 | 1.8 | 0.3% | 5.0 | 2.4 | 0.5% | 6.6 |
| Inner Nasal (μm) | 526.5 | 0.24 | 2.9 | 0.5% | 8.0 | 3.6 | 0.7% | 10.1 |
| Inner SuperoNasal (μm) | 533.4 | 1.4 | 3.8 | 0.7% | 10.5 | 4.8 | 0.9% | 13.5 |
| Inner Superior (μm) | 534.8 | 1.9 | 4.1 | 0.8% | 11.6 | 5.3 | 1.0% | 14.9 |
| Inner SuperoTemporal
(µm) | 524.1 | 1.4 | 3.0 | 0.6% | 8.5 | 4.1 | 0.8% | 11.4 |
| Inner Temporal (μm) | 512.2 | 0.000 | 2.1 | 0.4% | 6.0 | 2.8 | 0.5% | 7.8 |
| Inner InferoTemporal (µm) | 513.5 | 0.83 | 2.7 | 0.5% | 7.6 | 3.6 | 0.7% | 10.1 |
| K222200 - 510(k) Summary | Page 34 of 41 | | | | | | | |
| Variable | Mean | DevOp
SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
| Inner Inferior (μm) | 521.3 | 0.86 | 3.2 | 0.6% | 8.9 | 4.2 | 0.8% | 11.6 |
| Inner InferoNasal (μm) | 524.2 | 0.83 | 3.1 | 0.6% | 8.6 | 3.9 | 0.8% | 11.0 |
| Outer Nasal (μm) | 556.3 | 1.3 | 3.9 | 0.7% | 10.9 | 4.8 | 0.9% | 13.6 |
| Outer SuperoNasal (μm) | 569.0 | 3.2 | 5.4 | 0.9% | 15.1 | 7.6 | 1.3% | 21.4 |
| Outer Superior (μm) | 574.8 | 3.4 | 6.0 | 1.0% | 16.7 | 8.5 | 1.5% | 23.9 |
| Outer SuperoTemporal
(μm) | 556.5 | 1.5 | 4.4 | 0.8% | 12.2 | 5.6 | 1.0% | 15.5 |
| Outer Temporal (μm) | 532.0 | 0.000 | 2.6 | 0.5% | 7.4 | 3.5 | 0.7% | 9.9 |
| Outer InferoTemporal (μm) | 536.6 | 1.1 | 3.7 | 0.7% | 10.3 | 5.5 | 1.0% | 15.4 |
| Outer Inferior (μm) | 552.7 | 1.9 | 4.1 | 0.7% | 11.6 | 6.0 | 1.1% | 16.9 |
| Outer InferoNasal (μm) | 554.9 | 1.7 | 3.8 | 0.7% | 10.6 | 5.6 | 1.0% | 15.6 |

35

Image /page/35/Picture/0 description: The image shows the word "ZEISS" in a bold, sans-serif font. The word is white and is set against a solid blue background. The bottom of the image shows a curved white line, suggesting a partial circle or arc.

36

Image /page/36/Picture/0 description: The image shows the word "ZEISS" in bold, white letters against a solid blue background. The letters are stacked vertically, with the top of the "Z" aligned with the top of the image. The bottom of the image has a curved white line, creating a subtle contrast with the blue background. The overall design is simple and clean, emphasizing the brand name.

Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components.

Repeatability and reproducibility limits are 2.8 · SD.

Table 9. C6000 Macular Cube 512x128 Macular Thickness scans, Retina Subjects (n=260 scans), Precision Summary

| Variable | Mean | DevOp
SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
|-------------------------|-------|-------------|----------------|----------------|------------------|--------------|---------------|-----------------|
| Ganglion Cell Thickness | | | | | | | | |
| Average Thickness (µm) | 71.5 | 0.000 | 4.0 | 5.6% | 11.2 | 4.4 | 6.1% | 12.2 |
| Temporal Superior (µm) | 75.9 | 0.000 | 3.9 | 5.1% | 10.8 | 4.4 | 5.8% | 12.4 |
| Superior (µm) | 66.7 | 0.000 | 4.9 | 7.3% | 13.7 | 5.7 | 8.6% | 16.0 |
| Nasal Superior (µm) | 73.4 | 0.000 | 5.2 | 7.1% | 14.7 | 5.6 | 7.6% | 15.7 |
| Nasal Inferior (µm) | 73.1 | 0.000 | 4.2 | 5.8% | 11.9 | 4.6 | 6.3% | 13.0 |
| Inferior (µm) | 67.4 | 0.000 | 5.0 | 7.5% | 14.1 | 5.6 | 8.3% | 15.6 |
| Temporal Inferior (µm) | 72.2 | 0.000 | 4.6 | 6.3% | 12.8 | 4.7 | 6.6% | 13.3 |
| Minimum Thickness (µm) | 54.7 | 0.000 | 6.9 | 12.5% | 19.2 | 7.4 | 13.5% | 20.7 |
| Macular Thickness | | | | | | | | |
| Central Subfield (µm) | 274.2 | 0.31 | 2.4 | 0.9% | 6.6 | 2.6 | 1.0% | 7.3 |
| Inner Temporal (µm) | 310.7 | 0.82 | 1.9 | 0.6% | 5.2 | 2.3 | 0.7% | 6.4 |
| Inner Superior (µm) | 315.3 | 0.42 | 2.2 | 0.7% | 6.3 | 2.4 | 0.8% | 6.8 |
| Inner Nasal (µm) | 326.0 | 0.71 | 1.8 | 0.6% | 5.1 | 2.3 | 0.7% | 6.5 |
| Inner Inferior (µm) | 312.4 | 0.32 | 1.6 | 0.5% | 4.5 | 2.0 | 0.7% | 5.7 |

37

Image /page/37/Picture/0 description: The image contains the word "ZEISS" in large, bold, white letters against a solid blue background. The word is centrally aligned and takes up a significant portion of the image. Below the word, there is a curved white shape, possibly part of a logo, but the details are not fully visible.

K222200 - 510(k) Summary						Page 35 of 41
Outer Temporal (µm)	269.4	1.1	1.4	0.5%	4.0	2.1	0.8%	5.8
Outer Superior (µm)	275.9	0.33	1.4	0.5%	4.1	2.0	0.7%	5.6
Outer Nasal (μm)	293.7	0.57	1.1	0.4%	3.0	1.5	0.5%	4.2
Outer Inferior (µm)	265.1	0.95	1.3	0.5%	3.7	2.0	0.7%	5.5
Average Cube Thickness
(μm)	279.9	0.68	1.5	0.5%	4.2	1.9	0.7%	5.4
Volume Cube (mm3)	10.1	0.025	0.058	0.6%	0.16	0.072	0.7%	0.20

Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components.

Repeatability and reproducibility limits are 2.8 · SD.

38

Image /page/38/Picture/0 description: The image contains the logo for ZEISS. The logo is white text on a blue background. The text is the company name, ZEISS, in a stylized font.

Page 36 of 41

Table 10. C6000 Optic Disc Cube 200x200 RNFL Thickness scans, Retina Subjects (n=196 scans), Precision Summary

| Variable | Mean | DevOp
SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
|--------------------------------|---------------|-------------|----------------|----------------|------------------|--------------|---------------|-----------------|
| ONH | | | | | | | | |
| Rim Area (mm2) | 1.2 | 0.009 | 0.034 | 2.8% | 0.095 | 0.039 | 3.2% | 0.11 |
| Disc Area (mm2) | 1.8 | 0.014 | 0.046 | 2.7% | 0.13 | 0.056 | 3.2% | 0.16 |
| Average Cup/Disc Ratio | 0.50 | 0.001 | 0.012 | 2.4% | 0.034 | 0.013 | 2.5% | 0.036 |
| Vertical C/D Ratio | 0.51 | 0.000 | 0.022 | 4.4% | 0.062 | 0.023 | 4.6% | 0.065 |
| Cup Volume (mm3) | 0.16 | 0.001 | 0.008 | 5.1% | 0.023 | 0.009 | 5.4% | 0.025 |
| RNFL Thickness | | | | | | | | |
| Average RNFL Thickness
(μm) | 88.3 | 0.49 | 2.2 | 2.4% | 6.1 | 2.4 | 2.7% | 6.6 |
| Temporal (μm) | 64.7 | 0.31 | 2.8 | 4.3% | 7.7 | 3.0 | 4.6% | 8.3 |
| Superior (μm) | 106.7 | 0.80 | 3.5 | 3.3% | 9.8 | 4.3 | 4.0% | 11.9 |
| Nasal (μm) | 75.3 | 0.38 | 3.5 | 4.7% | 9.8 | 4.0 | 5.3% | 11.1 |
| Inferior (μm) | 106.7 | 0.000 | 4.4 | 4.1% | 12.3 | 4.9 | 4.6% | 13.6 |
| Clock hour 1 (μm) | 95.7 | 1.8 | 6.4 | 6.7% | 17.9 | 6.7 | 7.0% | 18.7 |
| Clock hour 2 (μm) | 88.6 | 0.000 | 4.5 | 5.1% | 12.7 | 5.5 | 6.2% | 15.3 |
| Clock hour 3 (μm) | 68.3 | 0.83 | 4.0 | 5.9% | 11.2 | 4.9 | 7.2% | 13.8 |
| Clock hour 4 (μm) | 68.9 | 0.65 | 5.6 | 8.1% | 15.7 | 5.8 | 8.4% | 16.2 |
| Clock hour 5 (μm) | 89.3 | 0.000 | 8.1 | 9.1% | 22.6 | 9.1 | 10.2% | 25.4 |
| Clock hour 6 (μm) | 119.5 | 1.0 | 5.3 | 4.5% | 14.9 | 5.9 | 4.9% | 16.4 |
| Clock hour 7 (μm) | 111.5 | 1.5 | 4.3 | 3.9% | 12.2 | 5.4 | 4.8% | 15.0 |
| Clock hour 8 (μm) | 64.0 | 1.4 | 4.2 | 6.6% | 11.8 | 4.4 | 6.9% | 12.4 |
| Clock hour 9 (μm) | 55.9 | 0.000 | 3.4 | 6.0% | 9.4 | 3.9 | 7.0% | 11.0 |
| Clock hour 10 (μm) | 74.2 | 0.000 | 2.4 | 3.3% | 6.8 | 2.9 | 3.9% | 8.1 |
| Clock hour 11 (μm) | 116.5 | 0.000 | 6.3 | 5.4% | 17.6 | 7.6 | 6.5% | 21.2 |
| Clock hour 12 (μm) | 107.9 | 1.4 | 4.9 | 4.6% | 13.8 | 5.9 | 5.5% | 16.6 |
| Variable | Mean | DevOp
SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
| Epithelial Thickness | | | | | | | | |
| Central (µm) | 48.5 | 0.25 | 1.7 | 3.6% | 4.9 | 2.2 | 4.5% | 6.1 |
| Inner Nasal (μm) | 47.3 | 0.49 | 1.9 | 4.1% | 5.4 | 2.4 | 5.2% | 6.8 |
| Inner SuperoNasal (µm) | 46.9 | 0.53 | 1.7 | 3.7% | 4.9 | 2.2 | 4.7% | 6.2 |
| Inner Superior (µm) | 45.7 | 0.25 | 1.6 | 3.4% | 4.4 | 2.0 | 4.3% | 5.6 |
| Inner SuperoTemporal
(μm) | 45.9 | 0.000 | 1.7 | 3.8% | 4.9 | 2.2 | 4.8% | 6.2 |
| Inner Temporal (µm) | 46.9 | 0.18 | 1.9 | 4.1% | 5.4 | 2.5 | 5.3% | 6.9 |
| Inner InferoTemporal (µm) | 47.9 | 0.74 | 1.8 | 3.7% | 5.0 | 2.5 | 5.3% | 7.1 |
| Inner Inferior (μm) | 47.9 | 0.60 | 1.8 | 3.8% | 5.1 | 2.5 | 5.2% | 7.0 |
| Inner InferoNasal (µm) | 48.0 | 0.55 | 2.0 | 4.2% | 5.6 | 2.5 | 5.3% | 7.1 |
| Middle Nasal (µm) | 46.2 | 0.39 | 1.8 | 4.0% | 5.1 | 2.2 | 4.7% | 6.1 |
| Middle SuperoNasal (µm) | 45.2 | 0.66 | 1.7 | 3.8% | 4.9 | 2.1 | 4.7% | 6.0 |
| Middle Superior (µm) | 42.7 | 0.46 | 1.9 | 4.4% | 5.3 | 2.0 | 4.7% | 5.6 |
| Middle SuperoTemporal
(μm) | 43.4 | 0.45 | 1.8 | 4.2% | 5.1 | 2.2 | 5.1% | 6.1 |
| Middle Temporal (µm) | 45.8 | 0.20 | 1.9 | 4.1% | 5.2 | 2.4 | 5.2% | 6.6 |
| Middle InferoTemporal
(μm) | 46.6 | 0.66 | 2.0 | 4.2% | 5.5 | 2.8 | 6.0% | 7.8 |
| Middle Inferior (µm) | 46.7 | 0.50 | 1.7 | 3.5% | 4.6 | 2.4 | 5.1% | 6.7 |
| Middle InferoNasal (µm) | 46.7 | 0.61 | 1.6 | 3.4% | 4.4 | 2.2 | 4.7% | 6.2 |
| Outer Nasal (µm) | 47.0 | 0.000 | 1.7 | 3.6% | 4.7 | 1.8 | 3.8% | 4.9 |
| Outer SuperoNasal (µm) | 43.8 | 0.20 | 3.1 | 7.2% | 8.8 | 3.4 | 7.7% | 9.5 |
| Outer Superior (µm) | 40.1 | 0.000 | 1.9 | 4.7% | 5.3 | 2.0 | 5.0% | 5.6 |
| Outer SuperoTemporal
(μm) | 41.0 | 0.27 | 2.0 | 5.0% | 5.7 | 2.2 | 5.3% | 6.1 |
| Outer Temporal (µm) | 44.9 | 0.000 | 1.9 | 4.3% | 5.4 | 2.3 | 5.0% | 6.3 |
| Outer InferoTemporal (µm) | 46.3 | 0.000 | 2.5 | 5.4% | 7.0 | 2.8 | 6.1% | 7.9 |
| Outer Inferior (µm) | 45.8 | 0.000 | 1.4 | 3.1% | 4.0 | 1.9 | 4.2% | 5.3 |
| Outer InferoNasal (µm) | 46.9 | 0.000 | 2.5 | 5.4% | 7.1 | 2.6 | 5.6% | 7.3 |
| Pachymetry Thickness | | | | | | | | |
| Central (µm) | 537.4 | 0.000 | 1.9 | 0.3% | 5.2 | 2.2 | 0.4% | 6.1 |
| Inner Nasal (um) | 561.4 | 0.000 | 3.2 | 0.6% | 9.1 | 3.4 | 0.6% | 9.6 |
| K22200 - 510(k) Summary | Page 38 of 41 | | | | | | | |
| Variable | Mean | DevOp
SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
| Inner SuperoNasal (um) | 568.1 | 0.77 | 4.5 | 0.8% | 12.5 | 5.1 | 0.9% | 14.2 |
| Inner Superior (um) | 567.6 | 1.2 | 4.9 | 0.9% | 13.7 | 5.8 | 1.0% | 16.2 |
| Inner SuperoTemporal
(um) | 554.0 | 0.61 | 3.9 | 0.7% | 11.0 | 4.5 | 0.8% | 12.5 |
| Inner Temporal (um) | 541.4 | 0.000 | 2.4 | 0.4% | 6.6 | 2.9 | 0.5% | 8.2 |
| Inner InferoTemporal (um) | 542.9 | 0.98 | 2.7 | 0.5% | 7.6 | 4.0 | 0.7% | 11.3 |
| Inner Inferior (um) | 550.9 | 1.3 | 3.8 | 0.7% | 10.7 | 4.7 | 0.9% | 13.3 |
| Inner InferoNasal (um) | 556.7 | 1.4 | 3.6 | 0.6% | 10.1 | 4.3 | 0.8% | 12.1 |
| Outer Nasal (um) | 598.9 | 0.73 | 4.6 | 0.8% | 12.8 | 5.3 | 0.9% | 14.9 |
| Outer SuperoNasal (um) | 611.3 | 1.7 | 6.1 | 1.0% | 17.0 | 7.4 | 1.2% | 20.7 |
| Outer Superior (um) | 612.6 | 2.4 | 6.6 | 1.1% | 18.4 | 9.0 | 1.5% | 25.2 |
| Outer SuperoTemporal
(um) | 588.8 | 0.68 | 5.4 | 0.9% | 15.2 | 6.5 | 1.1% | 18.1 |
| Outer Temporal (um) | 563.2 | 0.78 | 3.4 | 0.6% | 9.7 | 4.2 | 0.7% | 11.6 |
| Outer InferoTemporal (um) | 567.6 | 2.3 | 4.4 | 0.8% | 12.3 | 6.3 | 1.1% | 17.6 |
| Outer Inferior (um) | 584.7 | 3.5 | 5.7 | 1.0% | 16.0 | 7.6 | 1.3% | 21.4 |
| Outer InferoNasal (um) | 592.2 | 2.2 | 5.1 | 0.9% | 14.2 | 6.0 | 1.0% | 16.7 |

Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components.

Repeatability and reproducibility limits are 2.8 · SD.

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Page 37 of 41

Table 11. C6000 Pachymetry Thickness scans, Retina Subjects (n=211 scans), Precision Summary

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Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components.

Repeatability and reproducibility limits are 2.8 · SD.

%CV is calculated as 100*SD/Mean.

Table 12. C6000 Pachymetry Thickness scans, Cornea Subjects (n=204 scans), Precision Summary

| Variable | Mean | DevOp
SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
|-------------------------------|-------|---------------|----------------|----------------|------------------|--------------|---------------|-----------------|
| Epithelial Thickness | | | | | | | | |
| Central (µm) | 48.2 | 0.29 | 1.6 | 3.3% | 4.5 | 2.3 | 4.8% | 6.5 |
| Inner Nasal (µm) | 47.8 | 0.39 | 1.9 | 4.0% | 5.4 | 2.7 | 5.6% | 7.5 |
| Inner SuperoNasal (µm) | 47.0 | 0.41 | 2.0 | 4.2% | 5.5 | 2.5 | 5.4% | 7.1 |
| Inner Superior (µm) | 46.1 | 0.28 | 1.8 | 3.9% | 5.1 | 2.4 | 5.2% | 6.7 |
| Inner SuperoTemporal
(µm) | 46.7 | 0.000 | 1.9 | 4.1% | 5.4 | 2.4 | 5.0% | 6.6 |
| Inner Temporal (µm) | 47.2 | 0.086 | 2.1 | 4.4% | 5.8 | 2.4 | 5.1% | 6.7 |
| Inner InferoTemporal (µm) | 48.1 | 0.000 | 2.1 | 4.3% | 5.7 | 2.6 | 5.4% | 7.3 |
| Inner Inferior (µm) | 49.3 | 0.000 | 1.4 | 2.9% | 3.9 | 2.5 | 5.1% | 7.1 |
| Inner InferoNasal (µm) | 48.9 | 0.34 | 1.8 | 3.8% | 5.1 | 2.8 | 5.7% | 7.7 |
| Variable | Mean | DevOp
SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
| Middle Nasal (µm) | 45.7 | 0.000 | 1.9 | 4.2% | 5.4 | 2.5 | 5.5% | 7.0 |
| Middle SuperoNasal (µm) | 44.2 | 0.38 | 2.2 | 5.0% | 6.2 | 2.7 | 6.0% | 7.5 |
| Middle Superior (µm) | 42.0 | 0.21 | 2.1 | 4.9% | 5.8 | 2.4 | 5.8% | 6.8 |
| Middle SuperoTemporal
(µm) | 43.5 | 0.15 | 2.0 | 4.5% | 5.5 | 2.3 | 5.3% | 6.4 |
| Middle Temporal (µm) | 45.6 | 0.000 | 2.5 | 5.4% | 6.9 | 2.7 | 5.9% | 7.6 |
| Middle InferoTemporal
(µm) | 46.7 | 0.000 | 2.3 | 5.0% | 6.6 | 2.7 | 5.7% | 7.5 |
| Middle Inferior (µm) | 47.9 | 0.000 | 1.7 | 3.5% | 4.7 | 2.7 | 5.6% | 7.6 |
| Middle InferoNasal (µm) | 46.8 | 0.26 | 2.1 | 4.6% | 6.0 | 2.8 | 5.9% | 7.8 |
| Outer Nasal (µm) | 45.2 | 0.000 | 2.1 | 4.6% | 5.8 | 2.6 | 5.7% | 7.2 |
| Outer SuperoNasal (µm) | 43.0 | 0.000 | 3.0 | 7.0% | 8.4 | 3.3 | 7.8% | 9.4 |
| Outer Superior (µm) | 39.6 | 0.000 | 2.4 | 6.2% | 6.8 | 2.7 | 6.8% | 7.6 |
| Outer SuperoTemporal
(µm) | 41.1 | 0.000 | 2.4 | 5.9% | 6.8 | 2.5 | 6.1% | 7.0 |
| Outer Temporal (µm) | 44.4 | 0.70 | 2.3 | 5.2% | 6.4 | 2.6 | 5.9% | 7.4 |
| Outer InferoTemporal (µm) | 45.9 | 0.000 | 3.3 | 7.2% | 9.2 | 3.4 | 7.5% | 9.6 |
| Outer Inferior (µm) | 45.4 | 0.000 | 2.3 | 5.1% | 6.5 | 2.8 | 6.2% | 7.9 |
| Outer InferoNasal (µm) | 46.5 | 0.001 | 4.3 | 9.2% | 11.9 | 4.5 | 9.7% | 12.6 |
| Pachymetry Thickness | | | | | | | | |
| Central (µm) | 517.5 | 0.000 | 2.2 | 0.4% | 6.1 | 2.4 | 0.5% | 6.8 |
| Inner Nasal (µm) | 547.3 | 0.95 | 3.4 | 0.6% | 9.6 | 3.9 | 0.7% | 10.9 |
| Inner SuperoNasal (µm) | 551.9 | 0.13 | 3.9 | 0.7% | 10.8 | 4.2 | 0.8% | 11.8 |
| Inner Superior (µm) | 553.2 | 0.89 | 5.4 | 1.0% | 15.0 | 6.0 | 1.1% | 16.8 |
| Inner SuperoTemporal
(µm) | 542.4 | 0.89 | 4.9 | 0.9% | 13.8 | 5.6 | 1.0% | 15.7 |
| Inner Temporal (µm) | 527.2 | 0.43 | 3.0 | 0.6% | 8.4 | 3.8 | 0.7% | 10.5 |
| Inner InferoTemporal (µm) | 528.3 | 1.9 | 4.0 | 0.8% | 11.3 | 5.1 | 1.0% | 14.4 |
| Inner Inferior (µm) | 538.3 | 2.8 | 5.3 | 1.0% | 14.8 | 7.4 | 1.4% | 20.6 |
| Inner InferoNasal (µm) | 543.7 | 2.3 | 5.5 | 1.0% | 15.4 | 6.5 | 1.2% | 18.2 |
| Outer Nasal (µm) | 589.9 | 0.000 | 4.4 | 0.7% | 12.2 | 5.3 | 0.9% | 14.9 |
| Outer SuperoNasal (µm) | 597.5 | 2.8 | 6.5 | 1.1% | 18.1 | 8.1 | 1.4% | 22.8 |
| Outer Superior (µm) | 601.4 | 2.2 | 9.6 | 1.6% | 27.0 | 9.9 | 1.6% | 27.7 |
| K222200 - 510(k) Summary | | Page 40 of 41 | | | | | | |
| Variable | Mean | DevOp
SD | Residual
SD | Repeat.
%CV | Repeat.
Limit | Repro.
SD | Repro.
%CV | Repro.
Limit |
| Outer SuperoTemporal
(µm) | 582.0 | 0.28 | 7.7 | 1.3% | 21.5 | 8.3 | 1.4% | 23.1 |
| Outer Temporal (µm) | 555.8 | 1.3 | 3.8 | 0.7% | 10.7 | 4.5 | 0.8% | 12.7 |
| Outer InferoTemporal (µm) | 562.0 | 2.1 | 6.7 | 1.2% | 18.8 | 7.3 | 1.3% | 20.5 |
| Outer Inferior (µm) | 581.5 | 4.3 | 8.4 | 1.4% | 23.5 | 12.6 | 2.2% | 35.2 |
| Outer InferoNasal (µm) | 589.0 | 3.5 | 7.0 | 1.2% | 19.5 | 9.4 | 1.6% | 26.4 |

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Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components.

Repeatability and reproducibility limits are 2.8 · SD.

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CIRRUS 6000 Angiography Image Quality Study

This was a multi-site prospective study. A total of 110 subjects aged 18 years or older were enrolled: 103 retinal diseased subjects. 7 normal subjects were disqualified because they did not meet the inclusion/exclusion criteria, eleven others were disqualified because the operator was unable to acquire quality study scans, and one subject was discontinued due to the inability to continue the study visit. Two subjects were disqualified due to lack of any CIRRUS 6000 scans acquired; and two subjects were discontinued because they did not return for their second study visit. 93 subjects had at least one valid OCT scan or valid FA/ICGA images. However, only 92 subjects had at least one valid OCT scan. The subject age range was 19-91, with a mean age of 66.0 ± 14.8. The study population was composed of 42 (45.2%) females and 51 (54.8%) male subjects. 15 (16.1%) subjects were Asian, 4 (4.3%) subjects were Black, 63 (67.7%) subjects were Caucasian, 1 (1.1%) subject was Native Hawaiian/ Pacific Islander, and 10 (10.8%) subjects were listed as "Other". 78.3% of CIRRUS 6000 and 77.2% of CIRRUS 5000 scans acquired were valid and analyzed. Acquired scans were invalidated due to duplicate scans (1.1-2.5%), eye did not meet inclusion criteria (2.9-4.7%), poor image quality (7.6-10.6%), scan decentration (1.8-3.2%), poor signal strength (0.5-0.9%), or missing comparison photos (3.8-4.8%). Three independent reviewers from a reading center graded the OCTA scans on image quality and clinically relevant information according to pre-determined grading criteria. The proportion of Clinically Acceptable Overall Images was 0.98 or above for the CIRRUS 6000 device and 0.94 and above for the CIRRUS 5000 device for all subjects.

CIRRUS 6000 Raster Image Ouality Study

This was a multi-site prospective study. A total of 68 subjects were enrolled: 20 subjects with normal eyes and 48 subjects with retinal disease. The subject age range was 27-92, with a mean age of 64.3 ± 15.4. The study population was composed of 36 (52.9%) females and 32 (47.1%) male subjects. 14 (20.6%) subjects were Asian, 6 (8.8%) subjects were Black, 39 (57.4%) subjects were Caucasian and 9 (13.2%) subjects were listed as "Other". 92.3% of CIRRUS 6000 and 91.3% of CIRRUS 5000 scans acquired were valid and analyzed. Acquired scans were invalidated due to duplicate scans (6.2-6.9%), eye did not meet inclusion criteria (1.4%), poor image quality or blur (0.1-0.3%), or scan decentration (0.1%). Three independent graders from a reading center graded the raster B-scans on image quality and clinically relevant information according to pre-determined grading criteria. The proportion of Clinically Acceptable Overall Images was 1.00 for all scan types across the CIRRUS 6000 and the CIRRUS 5000 device for all subjects.

8. CONCLUSION

The indications for use are identical except for the removal of normative database for CIRRUS 6000 to the indications for use of the predicate device; and therefore, are determined to be substantially equivalent.

The technological characteristics and risk profile of the subject device are equivalent to the predicate device; and therefore, are determined to be substantially equivalent.

Testing methods are equivalent to those of the predicate device; are determined to be substantially equivalent.

Therefore, the subject device meets the requirements for substantial equivalence as compared to the proposed predicate device.