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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by the successful development of the CIRRUS™ HD-OCT Reference Database (RDB) and its ability to provide normative data for comparison. The study aims to establish these reference limits.

Acceptance Criteria Category	Specific Criteria (Inferred from study purpose)	Reported Device Performance (Summary of RDB Establishment)
Reference Database Functionality	Device can generate a normative reference database for key ocular parameters (Macular Thickness, Ganglion Cell Thickness, ONH parameters, RNFL thickness).	CIRRUS™ 6000 RDB for macular thickness and optic nerve head scan values was developed. Reference limits were established for Macular Thickness, Ganglion Cell Thickness, Optic Nerve Head parameters, and Retinal Nerve Fiber Layer thickness values.
Statistical Validity of RDB	Reference limits are calculated using appropriate statistical methods (regression analysis) and incorporate relevant covariates (age, optic disc size).	Reference range limits were calculated by regression analysis for the 1st, 95th, and 99th percentiles. Age was used as a covariate for Macular Thickness and Ganglion Cell Thickness. Age and Optic Disc Size were used as covariates for ONH parameters and RNFL thickness.
Clinical Applicability of RDB	The RDB allows for effective comparison of a patient's measurements to that of healthy subjects, aiding in the assessment and management of ocular diseases.	The 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 device provides color-coded indicators based on RDB limits.
Image Quality / Scan Acceptability	Only high-quality scans are included in the reference database.	Only the scans that met the pre-determined image quality criteria were included in analysis.
Safety	No adverse events or device effects during RDB development.	There were no adverse events or adverse device effects recorded during the study.

Study Details

Sample Size and Data Provenance:
- Test Set (for RDB establishment): 870 subjects had one eye included in the analysis from an initial enrollment of 1000 subjects.
  - Data Provenance: Prospective, multi-site study conducted at eight (8) clinical sites across the USA.
Number of Experts and Qualifications for Ground Truth:
- The document does not specify the number or qualifications of experts used to establish the ground truth for the test set regarding the "healthiness" of the subjects. The eligibility and exclusion criteria (e.g., "presence of any clinicant vitreal, retinal optic nerve, or choroidal disease in the study eye, including glaucoma or suspected glaucoma. This was assessed based on clinical examination and fundus photography.") imply that ophthalmologists or optometrists would have made these clinical judgments, but the specific number or their experience level is not detailed.
Adjudication Method for the Test Set:
- The document does not explicitly describe an adjudication method for determining the "healthy" status of the subjects. It states that inclusion/exclusion was "assessed based on clinical examination and fundus photography" by unnamed personnel at the clinical sites. There is no mention of a consensus process, independent review, or other adjudication for the ground truth.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done to assess how human readers improve with AI vs. without AI assistance. The study focuses solely on establishing the normative reference database for the device's measurements. The RDB itself is a tool to be used by clinicians, but its impact on clinical decision-making or reader performance was not evaluated in this submission.
Standalone Performance:
- This is a standalone performance study in the sense that the device, equipped with the new reference database, generates the normative values and compares patient data to them. It's the performance of the device's RDB calculation and display, not an AI algorithm performing diagnostic tasks without human input.
Type of Ground Truth Used:
- Clinical Ground Truth: The ground truth for defining "healthy subjects" was based on extensive clinical examination, fundus photography, and adherence to strict inclusion/exclusion criteria (e.g., no known ocular disease, specific visual acuity, IOP, refraction limits). This represents a clinically defined healthy population.
Sample Size for the Training Set:
- The term "training set" is not explicitly used in the context of a machine learning model, as the primary objective was to establish a statistical reference database. The entire dataset of 870 subjects (with qualified scans) was used to develop the reference database. So, the sample size for developing the reference database was 870 subjects.
How Ground Truth for the Training Set Was Established:
- The "ground truth" for the subjects included in the reference database was established by defining them as "healthy subjects" through rigorous inclusion and exclusion criteria applied at 8 clinical sites across the USA. These criteria included:
  - Age 18 years and older
  - Best corrected visual acuity (BCVA) of 20/40 or better in either eye
  - IOP < 21 mmHg in either eye
  - Manifest refraction spherical equivalent (MRSE) within -8 to +3D range and astigmatism correction < -2D
  - Exclusion criteria: Presence of any clinical vitreal, retinal optic nerve, or choroidal disease (including glaucoma or suspected glaucoma, assessed by clinical examination and fundus photography), history of ocular surgery (except uncomplicated cataract/refractive surgery), unreliable or visual field abnormalities, dense media opacities, active infection, current ocular medication, hydroxychloroquine/chloroquine use, diabetes, leukemia, multiple sclerosis, or debilitating disease.
- Only scans meeting pre-determined image quality criteria were used from these healthy subjects.

Summary

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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"

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(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

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

Enclosure

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Indications for Use

Submission Number (if known)

K233933

Device Name

CIRRUS™ HD-OCT Model 6000

Indications for Use (Describe)

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

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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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 Inc5300 Central ParkwayDublin, CA 94568USA
Applicant Contact Name	Vidita DesaiSenior Regulatory Affairs SpecialistCarl Zeiss Meditec, Inc.5300 Central Parkway Dublin, CA 94568Mobile:(925) 413-1644E-mail: vidita.desai@zeiss.com (preferred)
Primary Correspondent	Tanesha BlandSenior Regulatory Affairs Specialist USACarl Zeiss Meditec, Inc.5300 Central Parkway Dublin, CA 94568Mobile:(925) 216-7963E-mail: Tanesha.bland@zeiss.com (preferred)
Secondary Correspondent	Maria Golovina, MS MBAHead of Regulatory Affairs – USACarl Zeiss Meditec USA Inc.5300 Central Parkway, Dublin CA USA 94568Mobile: 925.216.1078Email: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 uses the same optical system, and principle of operation as the previously cleared CIRRUS 6000 (K222200) except for the reference database functionality.

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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.

SUBSTANTIAL EQUIVALENCE TO PRIMARY PREDICATE 6.

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

Device	Subject Device -CIRRUS 60000with RDB	Predicate Device – CIRRUS 6000	Reference Device - CIRRUS5000 (K181534)	EquivalencyAnalysis
Indications forUse	CIRRUS™ HD-OCT is a non-contact,high resolution tomographic andbiomicroscopic imaging device. It isindicated for in-vivo viewing, axialcross-sectional, and three-dimensionalimaging and measurement of anteriorand posterior ocular structures,including cornea, retina, retinal nervefiber layer, ganglion cell plus innerplexiform layer, macula, and opticnerve head.CIRRUS™ HD-OCT ReferenceDatabase is a quantitative tool usedfor the comparison of retinal nervefiber layer thickness, macularthickness, ganglion cell plus innerplexiform layer thickness, and opticnerve head measurements to adatabase of healthy subjects.	CIRRUS HD-OCT is a non-contact,high resolution tomographic andbiomicroscopic imaging deviceintended for in-vivo viewing, axialcross-sectional, and three-dimensionalimaging of anterior and posterior ocularstructures. The device is indicated forvisualizing and measuring anterior andposterior ocular structures, includingcornea, corneal epithelium, retina,retinal nerve fiber layer, ganglion cellplus inner plexiform layer, macula, andoptic nerve head.CIRRUS AngioPlex OCT Angiographywith is indicated as an aid in thevisualization of vascular structures ofthe retina and choroid.	CIRRUS HD-OCT is a non-contact, high resolutiontomographic and biomicroscopicimaging device intended for in-vivo viewing, axial cross-sectional, and three-dimensionalimaging of anterior and posteriorocular structures. The device isindicated for visualizing andmeasuring anterior and posteriorocular structures, includingcornea, corneal epithelium, retina,retinal nerve fiber layer, ganglioncell plus inner plexiform layer,macula, and optic nerve head. TheCIRRUS normative databases arequantitative tools indicated for thecomparison of retinal nerve fiberlayer thickness, macular thickness,ganglion cell plus inner plexiform	Identical to thereference device.

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K233933 - 510(k) Summary			Page 4 of 28
Device	Subject Device -CIRRUS 60000with RDB	Predicate Device – CIRRUS 6000	Reference Device – CIRRUS 5000 (K181534)	Equivalency Analysis
	CIRRUS™ HD-OCT AngioPlexangiography is indicated as an aid inthe visualization of vascular structuresof the retina and choroid.	CIRRUS HD-OCT is indicated as adiagnostic device to aid in the detectionand management of ocular diseasesincluding, but not limited to, macularholes, cystoid macular edema, diabeticretinopathy, age-related maculardegeneration, and glaucoma.	layer thickness, and optic nervehead measurements to a databaseof normal subjects.CIRRUS AngioPlex OCTAngiography with is indicated asan aid in the visualization ofvascular structures of the retinaand choroid.CIRRUS HD-OCT is indicated asa diagnostic device to aid in thedetection and management ofocular diseases including, but notlimited to, macular holes, cystoidmacular edema, diabeticretinopathy, age-related maculardegeneration, and glaucoma.
	CIRRUS™ HD-OCT is indicated foruse as a diagnostic device to aid in thedetection and management of oculardiseases including, but not limited to,macular holes, cystoid macularedema, diabetic retinopathy, age-related macular degeneration, andglaucoma.

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

Device	CIRRUS™ HD-OCT 6000 v.11.7Subject Device	CIRRUS™ HD-OCT 6000Predicate Device (K222200)	Reference Device –CIRRUS 5000 (K181534)	Analysis
DeviceClassification Name	Tomography, OpticalCoherence	Tomography, OpticalCoherence	Tomography, OpticalCoherence	Identical
Generic/Common Name	Optical Coherence Tomography(OCT)	Optical Coherence Tomography(OCT)	Optical CoherenceTomography (OCT)	Identical
ClassificationProduct Code				Identical
Class	II	II	II	Identical
Technology	Spectral Domain (Spatiallyencoded Frequency Domainand Fourier Domain Principle)	Spectral Domain (Spatiallyencoded Frequency Domainand Fourier Domain Principle)	Spectral Domain (Spatiallyencoded Frequency Domainand Fourier DomainPrinciple) OCT	Identical

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K233933 - 510(k) Summary Page 5 of 28
	OCT	OCT
IlluminationSources used inInstrument	Light Emitting Diode 700 nm –Iris ViewerLSO Super Luminescent Diode750 nmOCT Super Luminescent Diode840 nm	Light Emitting Diode 700 nm –Iris ViewerLSO Super Luminescent Diode750 nmOCT Super Luminescent Diode840 nm	Light Emitting Diode700 nm – Iris ViewerLSO Super LuminescentDiode 750 nmOCT Super LuminescentDiode 840 nm	Identical
Models	6000	6000	5000	Identical to the predicatedevice.
	OCT IMAGING
Methodology	Spectral domain OCT (SD-OCT)	Spectral domain OCT (SD-OCT)	Spectral domain OCT (SD-OCT)	Identical
OCT OpticalSource	OCT Super LuminescentDiode, 840 nm wavelength	OCT Super Luminescent Diode,840 nm wavelength	OCT Super LuminescentDiode, 840 nmwavelength	Identical
Optical Power	1200 μW at the cornea +/- 300μW (0.9 - 1.5 mW) at thecornea.	1200 μW at the cornea +/- 300μW (0.9 - 1.5 mW) at thecornea.	< 775 μW at the cornea	Identical to the predicatedevice.
Scan Speed	100,000 A-scans per second	100,000 A-scans per second	27,000 A-scans per second68,000 A-scans per secondonly for OCT Angiography	Identical to the predicatedevice.
Axial Scan Depth(Max)- Retina	• 2.9 mm for 12 mm 1Line 100x HD Raster,HD Angio 8x8, Angio8x8, and Angiography12x12• 2.0 mm for all otherscans	• 2.9 mm for 12 mm 1Line 100x HD Raster,HD Angio 8x8, Angio8x8, and Angiography12x12• 2.0 mm for all otherscans	2.0 mm	Identical to the predicatedevice.
Axial Scan Depth(Max)- Retina	2.0 mm (in tissue), 1024 pixelsper A-scans for all other scanexcept for the ones listed above	2.0 mm (in tissue), 1024 pixelsper A-scans for all other scanexcept for the ones listed above	2.0 mm (in tissue), 1024pixels per A-scans.	Identical
K233933 - 510(k) Summary		Page 6 of 28
Axial Scan Depth(Max) –AnteriorSegment	2.0 mm (Anterior 5-LineRaster) – 1024 points2.0 mm(Anterior Segment Cube) –1024 points5.8 mm (Anterior Chamber) –2048 points2.9 mm (Wide Angle-to-Angle) –1024 points2.9 mm (HD Angle) – 1024points2.0 mm (HD Cornea) – 1024points2.0 mm (Pachymetry) – 1024points	2.0 mm (Anterior 5-LineRaster) – 1024 points2.0 mm(Anterior Segment Cube) –1024 points5.8 mm (Anterior Chamber) –2048 points2.9 mm (Wide Angle-to-Angle) –1024 points2.9 mm (HD Angle) – 1024points2.0 mm (HD Cornea) – 1024points2.0 mm (Pachymetry) – 1024points	2.0 mm (Anterior 5-LineRaster) – 1024 points2.0 mm(Anterior Segment Cube) –1024 points5.8 mm (Anterior Chamber) –2048 points2.9 mm (Wide Angle-to-Angle) – 1024 points2.9 mm (HD Angle) – 1024points2.0 mm (HD Cornea) – 1024points2.0 mm (Pachymetry) –1024 points	Identical
External AnteriorSegment Lens	Anterior Chamber LensCornea Lens	Anterior Chamber LensCornea Lens	Anterior Chamber LensCornea Lens	Identical
Transverse ScanRange(Lateral range indegrees)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 predicatedevice.
Transverse ScanRange –AnteriorSegment	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
TransverseResolution – Retina	≤ 15 μm (in tissue)	≤ 15 μm (in tissue)	≤ 15 μm (in tissue)	Identical
TransverseResolution –Anterior Segment	20 μm (in tissue)20 μm @ 6mm FOV25 μm @ 9mm FOV	20 μm (in tissue)20 μm @ 6mm FOV25 μm @ 9mm FOV	20 μm (in tissue)20 μm @ 6mm FOV25 μm @ 9mm FOV	Identical
	K233933 - 510(k) SummaryPage 7 of 28	45 μm @ 15mm FOV	45 μm @ 15mm FOV	25 μm @ 9mm FOV45 μm @ 15mm FOV
	Scan patternsNon-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 typesNon-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 Angiographyscans	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 predicatedevice.
	AngioPlex 12x12 mm scan(2.9mm scan depth)	AngioPlex 12x12 mm scan(2.9mm scan depth)	Not Available	Identical to the predicatedevice.
	AngioPlex HD 6x6 mm scan	AngioPlex HD 6x6 mm scan	Not Available	Identical to the predicatedevice.
	AngioPlex HD 8x8 mm scan(2.9mm scan depth)	AngioPlex HD 8x8 mm scan(2.9mm scan depth)	Not Available	Identical to the predicatedevice.
	6 x 6 mm Montage AngioPlex	6 x 6 mm Montage AngioPlex	Not Available	Identical to the predicatedevice.
	8 x 8 mm Montage AngioPlex	8 x 8 mm Montage AngioPlex	Not Available	Identical to the predicatedevice.
K233933 - 510(k) Summary		Page 9 of 28
Retina Tracking	FastTrac Retinal TrackingTrack-to-prior to ScanAcquisition tracking.	FastTrac Retinal TrackingTrack-to-prior to ScanAcquisition tracking.	FastTrac Retinal TrackingTrack-to-prior to ScanAcquisition tracking.	Identical
OCT AngiographyAlgorithms(OCTA)	- En face Algorithm- Segmentation Algorithm- Z-Motion CorrectionAlgorithm- Flow Contrast Algorithm(intensity based + phase=complex-based OCTAngiography)	- En face Algorithm- Segmentation Algorithm- Z-Motion CorrectionAlgorithm- Flow Contrast Algorithm(intensity based + phase=complex-based OCTAngiography)	- En face Algorithm- SegmentationAlgorithm- Z-Motion CorrectionAlgorithm- Flow ContrastAlgorithm (intensitybased + phase=complex-based OCTAngiography)	Identical
RNFL, Macula,Anterior Segment	ANALYSIS AND REPORTSAnalyses for the Optic Disc:• ONH/RNFL OUAnalysis• Guided ProgressionAnalysis• Advanced Visualization• En face• 3D Visualization• Panomap	Analyses for the Optic Disc:• ONH/RNFL OUAnalysis• Guided ProgressionAnalysis• Advanced Visualization• En face• 3D Visualization• Panomap	Analyses for the OpticDisc:• ONH/RNFL OUAnalysis• GuidedProgressionAnalysis• AdvancedVisualization• En face• 3D Visualization	Identical

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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

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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) SummaryPage 13 of 28
	Disc size
Guided ProgressionAnalysis (GPA) forRNFL	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 predicatedevice.
K233933 - 510(k) Summary		Page 14 of 28
Guided ProgressionAnalysis (GPA) forGanglion Cell/IPL	- Sequential display ofMacular images in GuidedProgression Analysis(GPA) for Ganglion CellLayer/Inner PlexiformLayer (GCL/IPL)- Multiple GCL/IPLThickness Maps- Overall Average GCL/IPLThickness Graph- Superior GCL/IPLThickness Graph- Inferior GCL/IPLThickness Graph- GCL/IPL Summary:- GCL Thickness MapProgression- GCL ThicknessProgression	- Sequential display ofMacular images in GuidedProgression Analysis(GPA) for Ganglion CellLayer/Inner PlexiformLayer (GCL/IPL)- Multiple GCL/IPLThickness Maps- Overall Average GCL/IPLThickness Graph- Superior GCL/IPLThickness Graph- Inferior GCL/IPLThickness Graph- GCL/IPL Summary:- GCL Thickness MapProgression- GCL ThicknessProgression	- Sequential display ofMacular images inGuided ProgressionAnalysis (GPA) forGanglion CellLayer/InnerPlexiform Layer(GCL/IPL)- Multiple GCL/IPLThickness Maps- Overall AverageGCL/IPL ThicknessGraph- Superior GCL/IPLThickness Graph- Inferior GCL/IPLThickness Graph- GCL/IPL Summary:- GCL Thickness MapProgression- GCL ThicknessProgression	Identical
Macular ThicknessAnalysis andDisplay	- Fundus Image with scancube overlay- Average thickness andvolume table- ETDRS grid map withreference database colorcoding- Slice navigators	- Fundus Image with scancube overlay- Average thickness andvolume table- ETDRS grid map- Slice navigators- Horizontal B-scan (X-image)	- Fundus Image withscan cube overlay- Average thicknessand volume table- ETDRS grid mapwith normativedatabase color coding- Slice navigators	Identical to the referencedevice

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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 map3-D surface map of ILM3-D surface map of RPESegmentation line toggleMeasurement calipersAutomatic fovea finding and coordinatesAssorted controls for aligning ETDRS gridHigh-Resolution Images optionEdit Layers (enhanced interface)Zoom controlsSave Image optionsMovie option	Vertical slice - A-scan (Y-image)3-D color ILM-RPE thickness map3-D surface map of ILM3-D surface map of RPESegmentation line toggleMeasurement calipersAutomatic fovea finding and coordinatesAssorted controls for aligning ETDRS gridHigh-Resolution Images optionEdit Layers (enhanced interface)Zoom controlsSave Image optionsMovie option	Horizontal B-scan (X-image)Vertical slice - A-scan (Y-image)3-D color ILM-RPE thickness map3-D surface map of ILM3-D surface map of RPESegmentation line toggleMeasurement calipersAutomatic fovea finding and coordinatesAssorted controls for aligning ETDRS gridHigh-Resolution Images optionEdit Layers (enhanced interface)Zoom controlsSave Image optionsMovie option

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K233933 - 510(k) Summary				Page 16 of 28
High DefinitionDisplay	- Fundus image with OCT b-scan reference line (slicenavigator) overlays- Enlarged B-scan image ofselected line- Up to 5 thumbnail images	- Fundus image with OCT b-scan reference line (slicenavigator) overlays- Enlarged B-scan image ofselected line- Up to 5 thumbnail images	- Fundus image withOCT b-scan referenceline (slice navigator)overlays- Enlarged B-scanimage of selected line- Up to 5 thumbnailimages	Identical
Ganglion Cell OUAnalysis	- GCA Thickness Map- GCA Deviation Map- Six sectors of averagethickness – color coded perRDB limits- Horizontal Macular B-scan- Vertical Macular B-scan- Average GCL+IPLthickness (chart)- Data available on screen &on printout	- GCA Thickness Map- Six sectors of averagethickness- Horizontal Macular B-scan- Vertical Macular B-scan- Average GCL+IPLthickness (chart)- Minimum GCL+IPLthickness (chart)- Data available on screen &on printout	- GCA Thickness Map- GCA Deviation Map- Six sectors of averagethickness - colorcoded per NDB limits- Horizontal MacularB-scan- Vertical Macular B-scan- Average GCL+IPLthickness (chart)- Minimum GCL+IPLthickness (chart)- Data available onscreen & on printout	Identical to the referencedevice
K233933 - 510(k) Summary		Page 17 of 28
Single EyeSummary(Data from maculascan and optic discscan are shown inone report)	Macula Analysis:- en face image of macularcube- Macular Thickness map- ETDRS grid sectorthicknesses withcomparison to referencedata- Macular B-scanONH/RNFL Analysis:- en face image of OpticDisc Cube- RNFL Thickness map- Data Table with RNFL andONH data- RNFL TSNIT Thicknessgraph- ONH B-scan- Data available on screen &on printout	Macula Analysis:- en face image of macularcube- Macular Thickness map- ETDRS grid sectorthicknesses- Macular B-scanONH/RNFL Analysis:- en face image of OpticDisc Cube- RNFL Thickness map- Data Table with RNFL andONH data- RNFL TSNIT Thicknessgraph- ONH B-scan- Data available on screen &on printout	Macula Analysis:- en face image ofmacular cube- Macular Thicknessmap- ETDRS grid sectorthicknesses withcomparison tonormative data- Macular B-scanONH/RNFL Analysis:- en face image ofOptic Disc Cube- RNFL Thickness map- Data Table withRNFL and ONH data- RNFL TSNITThickness graph- ONH B-scan- Data available onscreen & on printout	Identical to the referencedevice
Advanced RPEAnalysis	- Advanced RPE Analysis	- Advanced RPE Analysis	- Advanced RPEAnalysis	Identical
PanoMap Analysis	- Macular Cube 512x128 or- Macular Cube 200x200and- Optic Disc Cube 200x200scan for the same eye.	- Macular Cube 512x128 or- Macular Cube 200x200 and- Optic Disc Cube 200x200scan for the same eye.- Montage of Macular Cube	- Macular Cube512x128 or- Macular Cube200x200 and- Optic Disc Cube	Identical
	K233933 - 510(k) SummaryPage 18 of 28
Wellness ExamReport	• Montage of Macular Cubeand Optic Disc Cube OCTen face imagesThis is an OU wide fieldanalysis that combinesinformation from the macularthickness analysis. PanoMapanalysis, RNFL and ONHanalysis and ganglion cell OUanalysis into one report.	• and Optic Disc Cube OCTen face imagesThis is an OU wide fieldanalysis that combinesinformation from themacular thickness analysis.PanoMap analysis, RNFLand ONH analysis andganglion cell OU analysisinto one report.	200x200 scan for thesame eye.• Montage ofMacular Cube andOptic Disc Cube OCTen face images• Not Available	Identical to the predicatedevice.
OCT AngiographyReport / Analysis	• OCT Angiography Report• OCT Angiography ChangeAnalysis	• OCT Angiography Report• OCT Angiography ChangeAnalysis	• OCT AngiographyReport• OCT AngiographyChange Analysis	Identical
ORCC & RPE-to-RPE Fit Slabs (pre-set) in OCTAAnalysis	• ORCC (Outer Retina toChorioCapillaris), Sub-RPE, RPE-to-RPEFit slabsin OCTA Analysis	• ORCC (Outer Retina toChorioCapillaris), Sub-RPE, RPE-to-RPEFit slabsin OCTA Analysis	Not Available	Identical to the predicatedevice.

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	K233933 - 510(k) Summary			Page 19 of 28
Anterior Segment -Analysis withQuantitativeMeasurement 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 AngiographyTwo-VisitComparison	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

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	K233933 - 510(k) SummaryPage 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	< 1.5 mW at the cornea	< 1.5 mW at the cornea	< 1.5 mW at the cornea	Identical
Field of View	36 degrees W x 30 degrees H	36 degrees W x 30 degrees H	36 degrees W x 30 degreesH	Identical
Frame Rate	> 20 Hz	> 20 Hz	> 20 Hz	Identical
TransverseResolution	25 µm (in tissue)	25 µm (in tissue)	25 µm (in tissue)	Identical
	IRIS IMAGING
Methodology	CMOS camera and LEDillumination	CMOS camera and LEDillumination	CMOS camera and LEDillumination	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 fixationsource	LED Array, 21 positions	LED Array, 21 positions	LED Array, 9 positions	Identical to the predicatedevice.
Internal fixationfocus adjustment	-20D to +20D (diopters)	-20D to +20D (diopters)	-20D to +20D (diopters)	Identical
External fixationsource	Mechanically adjustable armwith LED at the tip	Mechanically adjustable armwith LED at the tip	Mechanically adjustable armwith LED at the tip	Identical
	ELECTRICAL, PHYSICAL, ENVIRONMENTAL
Configuration	Patient module, computer,media and power supplyintegrated into single compactmodule	Patient module, computer,media and power supplyintegrated into single compactmodule	Patient module, computer,media and power supplyintegrated into singlecompact module	Identical
Computer	High performance multi-coreprocessor CORE i7 @ 3.6 GHz,32GB RAM, 2TB Hard Disk,Windows 10, SSD	High performance multi-coreprocessor CORE i7 @ 3.6 GHz,32GB RAM, 2TB Hard Disk,Windows 10, SSD	High performance multi-core processor CORE i7 @3.1GHz, 16GB RAM, 2TBHard Disk, Windows 10	Identical to the predicatedevice.
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 predicatedevice.
Network	Network and additional USBconnectors under rear cover.	Network and additional USBconnectors under rear cover.	Network and additional USBconnectors under rear cover.	Identical
Optical mediaformats supported	6 USB Media ports	6 USB Media ports	6 USB Media ports	Identical
Weight	35 kg (77 lbs) (withoutmonitor)	35 kg (77 lbs) (withoutmonitor)	36 kg (80 lbs)	Identical to the predicatedevice
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 predicatedevice
Fuse rating (115V)	T 6.3 A 250V	T 6.3 A 250V	T 5A 250V	Identical to the predicatedevice
Max amperage andvoltage rating	T 6.3A 250V	T 6.3 A 250V	T 5A 250V	Identical to the predicatedevice
EnvironmentalConditions:Transport andStorage	Temp. -40° to +70° C30% to 75% (excludingcondensation)Atmospheric Pressure500 to 1060 hPa	Temp. -40° to +70° C30% to 75% (excludingcondensation)Atmospheric Pressure500 to 1060 hPa	Temp. -40° to +70° C30% to 75% (excludingcondensation)Atmospheric Pressure500 to 1060 hPa	Identical
EnvironmentalConditions:Operation	Temperature:+10 to +35° СRelative Humidity:30% to 75% (excludingcondensation)Atmospheric Pressure:700 to 1060 hPa	Temperature:+10 to +35° СRelative Humidity:30% to 75% (excludingcondensation)Atmospheric Pressure:700 to 1060 hPa	Temperature:+10 to +35° CRelative Humidity:30% to 75% (excludingcondensation)Atmospheric Pressure:700 to 1060 hPa	Identical

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K233933 - 510(k) Summary Page 22 of 28
Enclosure-FlammabilityRatings	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 SegmentCaliper 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 forAngiography	- 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 Toolfor Angiography		A scalable circle andfreeform measurement toolsfor the OCT Angiographyand ONH Angiographyenface image whichdisplays estimated valuesfor area andperimeter/diameter	A scalable circle and freeformmeasurement tools for the OCTAngiography and ONHAngiography enface imagewhich displays estimated valuesfor area and perimeter/diameter	Not Available	Identical to the predicatedevice

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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 < 21 mmHg in either eye, manifest refraction spherical equivalent (MRSE) within -8 to +3D range and astigmatism correction < -2D in the study eye.

Subjects were excluded if there was presence of any clinicant vitreal, retinal optic nerve, or choroidal disease in the study eye, including glaucoma or suspected glaucoma. This was assessed based on clinical examination and fundus photography.

History of ocular surgery (except for uncomplicated cataract surgery and/or refractive surgery), history of unreliable or visual field abnormalities, dense media opacities, active infection, current ocular medication, or hydroxychloroquine/chloroquine use were also exclusion criteria.

Subjects with diabetes, leukemia, multiple sclerosis, or debilitating disease were excluded from the study. One thousand subjects ( 1000 ) were enrolled and screened, and one eye from eight hundred and seventy (870) subjects was included in analysis. Only the scans that met the pre-determined image quality criteria were included in analysis. There were no adverse events or adverse device effects recorded during the study.

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Demographic summary, subjects with any valid scans

Factor	Summary
N (subjects)	870
Age (years)
Mean(SD)	53.6 (15.1)
Median	56.0
Min, Max	[18.0, 88.0]
Age (by sampling categories)
Age 18-49	247/870 (28.4%)
Age 50-88	623/870 (71.6%)
Age (by decade)
Age 18-29	87/870 (10.0%)
Age 30-39	83/870 (9.5%)
Age 40-49	77/870 (8.9%)
Age 50-59	275/870 (31.6%)
Age 60-69	237/870 (27.2%)
Age 70 and older	111/870 (12.8%)
Gender n (%)
Female	511/870 (58.7%)
Male	359/870 (41.3%)
Race n (%)
Caucasian/White	474/870 (54.5%)
Black/African American	168/870 (19.3%)
Asian	160/870 (18.4%)
American.Ind/AK.Native	4/870 (0.5%)
Hawaiian/Pac.Islander	2/870 (0.2%)
Other	41/870 (4.7%)
Declines to State	21/870 (2.4%)
Ethnicity n (%)
Not Hispanic or Latino	742/870 (85.3%)
Hispanic or Latino	105/870 (12.1%)
Declines to State	23/870 (2.6%)
Study Eye n (%)
OD	438/870 (50.3%)
OS	432/870 (49.7%)
Factor	Summary
N (subjects)	870
MRSE
Mean(SD)	-0.8 (2.0)
Median	-0.25
Min, Max	[-7.75, 3.0]
Cylinder
Mean(SD)	-0.6 (0.5)
Median	-0.5
Min, Max	[-2.0, 0.0]
BCVA
20/15	21/870 (2.4%)
20/20	761/870 (87.5%)
20/25	74/870 (8.5%)
20/30	13/870 (1.5%)
20/40	1/870 (0.1%)
BCVA (logMAR¹)
Mean(SD)	0.01 (0.04)
Median	0.00
Min, Max	[-0.12, 0.30]
IOP (mmHg)
Mean(SD)	14.5 (3.1)
Median	14.0
Min, Max	[6.0, 21.0]
Axial Length (mm)
Mean(SD)	24.1 (1.1)
Median	24.0
Min, Max	[21.2, 28.4]
ONH, Horizontal C/D
Mean(SD)	0.334 (0.121)
Median	0.300
Min, Max	[0.100, 0.800]
ONH, Vertical C/D
Mean(SD)	0.336 (0.122)
Median	0.300
Min, Max	[0.100, 0.700]

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Summary of Ophthalmologic Evaluation, subjects with any valid scans

1-Converted from Snellen score using: logMAR = log10(SNELLEN/20).

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Table Qualified scans, by scan type.

	Macular Cube200x200	Macular Cube512x128	Optic Disc Cube200x200
AcceptableScans	826	831	854

Reference range limits were calculated by regression analysis for the 1st, 95th, and the 99th percentiles for the OCT structural measurements. The reference limits were calculated using age as a covariate for Macular Thickness and Ganglion Cell Thickness. Both Age and Optic Disc Size were used as covariates for ONH parameters and RNFL thickness. From this study, CIRRUS 6000 reference limits were established for Macular Thickness, Ganglion Cell Thickness, Optic Nerve Head parameters, and Retinal Nerve Fiber Layer thickness values.

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8. CONCLUSION

The subject device maintains existing technological characteristics of the predicate device while integrating a new reference database. The following parameters include the application of color-coded indicators that delineate the reference database limits: macular thickness, ganglion cell thickness, ONH values, and RNFL thickness. The technological characteristics and risk profile of the are equivalent to both the predicate device and reference device.

Results of the performance testing support a determination of substantial equivalence between the subject device and the predicate device for the proposed intended use. A reference device was used to support the test methodology used to validate the new reference database. Therefore, the subject and predicate devices are deemed to be substantially equivalent.

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.