The CLARUS 500 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view.

Device Description

The CLARUS™ 500 is an active, software controlled, high-resolution ophthalmic imaging device for In-vivo imaging of the human eye. Imaging modes include True color, Fundus Autofluorescence with green excitation, Fundus Auto-fluorescence with blue excitation, Stereo and External eye. All true color images can be separated into red, green and blue channel images to help enhance visual contrast of details in certain layers of the retina. With a single capture, CLARUS 500 produces a 90° high definition widefield image. Widefield images are automatically merged to achieve a 135° ultra-widefield view. The technology allows clinicians to easily review and compare high-quality images captured during a single exam while providing annotation and caliper measurement tools that allow analysis of eye health. CLARUS 500 is designed to optimize each patient's experience by providing a simple head and chin rest that allows the patient to maintain a stable, neutral position while the operator brings the optics to the patient, facilitating a more comfortable imaging experience. The ability to swivel the device between the right and left eye helps technicians capture an image without realigning the patient. Live Infrared Preview allows the technician to confirm image quality and screen for lid and lash obstructions, prior to imaging, ensuring fewer image recaptures.

The CLARUS 500 device's principle of operation is based on Slit Scanning Ophthalmoscope also referred to as Broad Line Fundus Imaging (BLFI). During image capture, a broad line of illumination is scanned across the retina. A monochromatic camera captures the returned light to image the retina. A single sweep of the illumination is used to illuminate the retina for image capture. Repeated sweeps of near infrared light are used for a live retina view for alignment. Red, green and blue LEDs sequentially illuminate to generate true color images. Blue and green LED illumination enables Fundus Autofluorescence (FAF) imaging.

The CLARUS 500 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply.

The CLARUS software provides the user the capability to align, capture, review and annotate images. The software has two installation configurations: Software installed on the Instrument (Acquisition & Review) as well as Software installed on a separate 'Review Station' (Laptop or Computer) (only Review).

The CLARUS 500 technical features relevant to the user are: Field of View (FoV), Image Resolution, Pixel Pitch and Focusing Range. The device meets the requirements of ISO 10940:2009 standard. The performance specifications are summarized in the Table 1 below.

AI/ML Overview

The provided document describes the Carl Zeiss Meditec CLARUS 500 ophthalmic camera. However, it does not explicitly state acceptance criteria or a detailed study proving the device meets specific performance criteria in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices for FDA clearance.

Despite this, I can extract information related to performance and testing:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a formal "acceptance criteria" table like one might find in a clinical trial protocol for an AI device. Instead, it lists technical specifications and states that the device meets an ISO standard and passed various verification and validation tests.

Feature	Specification (Acceptance Criterion - implied)	Reported Device Performance and Verification Method
Technical Specifications (from Table 1 - implying acceptance criteria for these features)
FoV – Widefield (single capture)	90°	Verified through bench testing using a test eye.
FoV - Ultra-widefield (montage)	135°	Verified through software algorithm verification.
Image Resolution	60 lp/mm at central field (0°), 40 lp/mm at 23° FOV, 25 lp/mm at 45° FOV	Data not explicitly stated, but the device "meets the requirements of ISO 10940:2009 standard," which would cover resolution.
Sensors	12 megapixel monochrome	Not explicitly tested as a performance criterion, rather a design characteristic.
Sensor Resolution	3000 x 3000 pixels	Not explicitly tested as a performance criterion, rather a design characteristic.
Focusing Range	+20 D to -24D	Data not explicitly stated, but the device "meets the requirements of ISO 10940:2009 standard," which would cover focusing range.
Pixel Pitch on the Fundus	7.3 µm/pixel	Not explicitly tested as a performance criterion, rather a design characteristic.
General Performance/Safety (implied acceptance criteria for compliance)
Design Requirements	Satisfy established system requirements	Design verification testing demonstrated compliance.
Customer Acceptance	Meet requirements set by Product Requirements Specifications and user experience acceptance criteria.	Design validation testing demonstrated these were met.
Consensus Standards Compliance	Meet requirements for conformity to multiple industry standards.	R&D evaluation documented compliance. Includes ISO 10940:2009 for fundus cameras, ANSI AAMI 60601-1:2005/(R) 2012 and A1:2012 (Ed 3.1) for electrical safety, IEC 60601-1-2:2014 Ed 4.0 for EMC, ANSI Z80.36-2016 and ISO 15004-2:2007 for optical safety, IEC 60825-1:2007 for laser safety, ISO 15004-1:2009 for environmental conditions, NEMA PS 3.1-3.20 (2016) for DICOM.
Software Performance	Comply with FDA's Guidance for Industry and FDA staff, "Guidance for the Content of premarket Submissions for Software Contained in Medical Devices."	Software verification testing was conducted and documented.
Biocompatibility	Comply with requirements of ISO 10993-1:2009 standard for patient-contact components.	Materials for patient chin rest and forehead rest were evaluated and comply.
Clinical Feature Resolution	Similar amount of clinical features resolved compared to reference device.	"Study results concluded that similar amount of clinical features can be resolved on CLARUS 500 images as the images from the reference device in almost all cases."
FAF Imaging Performance	Performance comparable to FAF imaging mode of reference device (CIRRUS photo).	A clinical study was performed to demonstrate the performance of the FAF-B and FAF-G imaging modes as compared to the FAF imaging mode of the reference device CIRRUS photo.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document mentions "A clinical study was conducted" for both general imaging modes and FAF imaging modes.

Sample Size: Not specified.
Data Provenance: Not specified (country/region, retrospective/prospective). It simply states "A clinical study was conducted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not specified. The document only mentions that the study "concluded that similar amount of clinical features can be resolved." There is no detail on how this "ground truth" or comparison was established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, this is not an AI device, and therefore no MRMC comparative effectiveness study involving AI assistance for human readers was done or described. The clinical study mentioned compares the device's imaging modes to a reference device. The focus is on the performance of the imaging capture, not an AI interpretation aid.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The CLARUS 500 is an imaging device, not an AI algorithm for interpretation. Its performance is inherent in the quality of the image capture. The "standalone" performance would be the image quality itself, which is verified through technical specifications and ISO compliance. The clinical study compares the "performance of the CLARUS 500 imaging modes" (standalone imaging output) to a reference device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the clinical study on imaging modes, the "ground truth" seems to be the ability to resolve "clinical features" when compared to images from a reference device. This implies a qualitative assessment, likely by clinicians, but the specific method or standard for "ground truth" (e.g., expert consensus on feature visibility, comparison to an actual disease state) is not detailed.

8. The sample size for the training set:

Not applicable, as this is an imaging device, not a machine learning algorithm that requires a training set in the typical sense. The software verification would involve testing against requirements, not "training data."

9. How the ground truth for the training set was established:

Not applicable, as it's not a machine learning algorithm with a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

January 10, 2019

Carl Zeiss Meditec, Inc. Saurabh Jamkhindikar Sr. Regulatory Affairs Specialist 5160 Hacienda Drive Dublin, CA 94568

Re: K181444

Trade/Device Name: Clarus Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: QER Dated: November 28, 2018 Received: November 30, 2018

Dear Saurabh Jamkhindikar:

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.

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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 (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

Bradley S. Cunningham -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181444

Device Name CLARUS Model 500

Indications for Use (Describe)

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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510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92), the 510(k) Summary for the CLARUS 500 with Software Version 1.0 is provided below.

GENERAL INFORMATION

Manufacturer:	Carl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, California 94568(925) 557-4100 (phone)(925) 557-4259 (fax)Est. Reg. No. 2918630
Contact Person:	Saurabh JamkhindikarSenior Regulatory Affairs SpecialistCarl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, California 94568saurabh.jamkhindikar@zeiss.com(925) 557-4696 (phone)(925) 557-4259 (fax)
Date Summary Prepared:	January 09, 2019
Classification Name:	Camera, Ophthalmic, Slit-scanning
Regulation Description:	Ophthalmic Camera (acc. 21 CFR 886.1120)
Classification:	Class II (acc. 21 CFR 886.1120)
Product Code:	QER
Trade/Proprietary Name:	CLARUS
Model(s):	500
PREDICATE DEVICE
Company:Device:	Carl Zeiss Meditec AGVISUCAM PRO NM (K052268)
REFERENCE DEVICE
Company:Device:	Carl Zeiss Meditec AGCIRRUS photo Model 600 (K133217)

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INTENDED USE / INDICATIONS FOR USE

DEVICE DESCRIPTION

The CLARUS 500 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply.

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Feature	Specification
FoV – Widefield (single capture)	• 90°
FoV - Ultra-widefield (montage)	• 135°
Image Resolution	• 60 lp/mm at central field (0°)• 40 lp/mm at 23° FOV• 25 lp/mm at 45° FOV
Sensors	• 12 megapixel monochrome
Sensor Resolution	• 3000 x 3000 pixels
Focusing Range	• +20 D to -24D
Pixel Pitch on the Fundus	• 7.3 µm/pixel

Table 1 - Specifications

RISK MANAGEMENT AND GENERAL SAFETY AND EFFECTIVENESS

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software means, user instructions. verification of requirements and validation of the clinical workflow to ensure that the product meets its intended uses. To minimize electrical, mechanical and radiation hazards. ZEISS adheres to recognized and established industry practice and relevant international standards.

BIOCOMPATIBILITY

The CLARUS 500 has two patient-contact components, i.e. the patient chin rest and the forehead rest, which are surface contacting and have transient contact. The materials have been evaluated for Biocompatibility and comply with requirements of ISO 10993-1:2009 standard.

PERFORMANCE DATA & SUMMARY OF VERIFICATION AND VALIDATION ACTIVITY

CLARUS 500 meets the requirements of ISO 10940:2009 standard for fundus cameras. The performance of widefield imaging mode in CLARUS 500 is verified through bench testing using a test eye. The performance of ultra-widefield montage in CLARUS 500 is verified through software algorithm verification.

The following performance testing for the CLARUS 500 is provided to support the substantial equivalence of the subject device:

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Design Verification Testing

The design verification testing results demonstrate that the system complies with the established system requirements.

Design Validation Testing

The purpose of the design validation testing is to measure customer acceptance of the intended use, features and the workflow. The validation results demonstrate that the device meets the requirements set out by the Product Requirements Specifications and all aspects of the user experience met the acceptance criteria.

Testing to Consensus Standards

The device was tested (as needed) to meet the requirements for conformity (where applicable) to multiple industry standards. The R&D evaluation of the relevant testing to consensus standards is documented.

Electrical Safety Testing

The electrical safety for the device has been evaluated and was found to be in compliance with the ANSI AAMI 60601-1:2005/(R) 2012 and A1:2012 (Ed 3.1) standard.

Electromagnetic Compatibility Testing

The electromagnetic compatibility (EMC) for the device has been evaluated and was found to be in compliance with the IEC 60601-1-2:2014 Ed 4.0 standard.

Optical Safety

The optical safety of the device with recognized consensus standard ANSI Z80.36-2016 and ISO 15004-2:2007 has been demonstrated by performing hazard analysis assessment. The device is determined to be a Group 1 instrument.

The safety of the device's laser components in accordance with the recognized consensus standard IEC 60825-1:2007 has been established. The device is determined to be a Class 1 laser system.

Environmental Conditions

The device complies with the requirements for environmental conditions for use, storage and transport as specified in the ISO 15004-1:2009 standard.

Software Verification:

Software verification testing for the device was conducted and documentation is provided as recommended by the FDA's Guidance for Industry and FDA staff, "Guidance for the Content of premarket Submissions for Software Contained in Medical Devices."

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DICOM Conformity Assessment

The device complies with the NEMA PS 3.1-3.20 (2016) standard and a DICOM Conformance Statement is provided.

CLINICAL TESTING

A clinical study was conducted to demonstrate the performance of the CLARUS 500 imaging modes as compared to the reference device. Study results concluded that similar amount of clinical features can be resolved on CLARUS 500 images as the images from the reference device in almost all cases. In addition, the wide field of view of the CLARUS 500 image allows more retinal area to be viewed in a single image.

SUBSTANTIAL EQUIVALENCE DISCUSSION

The predicate device is VISUCAM PRO NM (K052268). The intended use of both devices is the same. They are both used to capture, display, store and review images of the human retina and the surrounding parts of the eye under mydriatic and non-mydriatic conditions. Both devices support the diagnosis and monitoring of eye diseases.

The differences in the Indications for Use statement for the devices do not affect their intended use, anatomical site of application or target population.

Both devices have the same basic functions for capturing, displaying, storing and reviewing images of the human retina and surrounding parts of the eye. Both devices utilize a standard slit lamp-joystick mechanism. Both devices have a similar patient-operator interface and controls for operating the device. With both devices, an external monitor is used to view images. For both devices, the software provides image review functionality.

The CLARUS 500 provides a wide field of view (FoV) of 90° with a single capture, whereas the predicate provides traditional FoV of 30° and 45°. The different specifications for FoV does not impact safety. The predicate device also provides for a wider field of view in the Panorama (montage) mode. Design Verification activities demonstrate that the device specifications for a wider FoV were met.

Both devices use the Ophthalmoscope principle of modern AC-powered digital ophthalmic cameras for imaging. Both devices provide retinal imaging modes under non-mydriatic and mydriatic conditions. Both devices use an internal light source to illuminate the retinal area and digital image sensors for recording images.

The devices differ in the specifics of how they illuminate and image the retina and the ocular surface. The CLARUS 500 uses the Slit Scanning Ophthalmoscope technique (also referred to as Broad Line Fundus Imaging (BLFI). The predicate uses a more conventional flash photography illumination technique for retinal imaging. The Slit Scanning technique used in the device is very similar to the Line Scanning Ophthalmoscope technique used in currently marketed retinal cameras. The CLARUS 500 uses LEDs and near-infrared lasers for illumination, whereas the predicate uses a visible xenon flash lamp. The questions associated with these characteristics,

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however, are typical questions for ophthalmic imaging systems. Performance data is therefore provided to demonstrate that the device can achieve its intended use and is safe for the patient and the operator.

The CLARUS 500 provides Fundus Autofluorescence imaging: FAF-Blue and FAF-Green, not available in the predicate. FAF retinal imaging modality has been used in clinical practice for a number of years and is a proven method in retinal diagnosis. Design Verification testing was completed to demonstrate that the specified FAF imaging modes are provided and confirmed. A clinical study was performed to demonstrate the performance of the FAF-B and FAF-G imaging modes as compared to the FAF imaging mode of the reference device CIRRUS photo.

A comparison of the subject device to the predicate device is provided in Table 2.

Table 2: Comparison Table of Proposed Device CLARUS 500 with Software Version 1.0 and Predicate VISUCAM PRO NM (K052268)

DeviceCharacteristics	CLARUS Model 500 with SW version1.0 - Proposed Device	VISUCAM PRO NM (K052268) –Predicate Device
Manufacturer	Carl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, CA 94568, USA	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-52D-07745 Jena, Germany
510(k)	• K181444	• K052268
Proprietary Name	• CLARUS model 500	• VISUCAM PRO NM
DeviceClassificationName	• Camera, Ophthalmic, Slit-scanning	• Camera, Ophthalmic, Ac-Powered
Generic/ CommonName	• Ophthalmic camera	• Ophthalmic camera
Product Code	• QER	• HKI
RegulationNumber	• 886.1120	• 886.1120
Class	• II	• II
Review Panel	• Ophthalmic	• Ophthalmic
DeviceCharacteristics	CLARUS Model 500 with SW version1.0 - Proposed Device	VISUCAM PRO NM (K052268) –Predicate Device
Intended Use/Indications forUse	The CLARUS 500 ophthalmic camera isindicated to capture, display, annotate andstore images to aid in the diagnosis andmonitoring of diseases and disordersoccurring in the retina, ocular surface andvisible adnexa. It provides true color andautofluorescence imaging modes forstereo, widefield, ultra-widefield, andmontage fields of view.	The VISUCAMTM PRO NM DigitalCamera is suitable for photographing,displaying and storing the data of the retinaand surrounding parts of the eye to beexamined under mydriatic and non-mydriatic conditions. These photographssupport the diagnosis and subsequentobservation of eye diseases which can bevisually monitored and photographicallydocumented.
Target Population	OpticiansOphthalmic PhotographersOptometristsOphthalmologistsMedical AssistantsClinical Researchers	OpticiansOphthalmic PhotographersOptometristsOphthalmologistsMedical AssistantsClinical Researchers
Anatomical Site	Retina, ocular surface and visibleadnexa	Retina and surrounding parts of the eye
Device Type	Fundus Camera	Fundus Camera Main Unit
Methodology	Slit Scanning Ophthalmoscope	Ophthalmoscope (Fundus Imaging)
Principle ofFundus ImageCapturing	Broad Line Fundus Imaging (BLFI)using LEDs and laser illuminationNear-IR laser illumination for liveretina previewLEDs used for true color, and fundusautofluorescence imaging modesLive preview and image-capture with12 megapixel monochrome sensors	Short pulse flash lamp illumination fortaking fundus image (photographs)Continuous IR-LED-illumination forlive retina observationXenon flash lamp used as illuminationsource for all imaging modesLive observation and image-capturewith CCD-sensor
Image CaptureModes	True color (with red, green and bluechannel separation in review mode)Fundus autofluorescence with greenexcitationFundus autofluorescence with blueexcitationStereoExternal	ColorGreenRedBlueStereoPanorama (Montage)External
DeviceCharacteristics	CLARUS Model 500 with SW version1.0 - Proposed Device	VISUCAM PRO NM (K052268) –Predicate Device
Detector Type	• Internal CMOS sensors – 12 megapixels	• Internal CCD camera – 5.0 megapixels
Field of View	• 90° (widefield - single shot image)• 135° (ultra-widefield – two shot auto montage)	• 45° and 30°
Refractive ErrorCompensation	• +24 D.... -20 D, continuous	• +35 D.... -35 D, continuous
Minimum pupilsize	• 2.5 mm	• 4.0 mm; 3.3 mm (small pupil mode)
Working Distance	• 25 mm (patient's eye – front lens)	• 40 mm (patient's eye – front lens)

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A comparison of the subject device to the reference device CIRRUS photo is provided in Table 3. The reference device CIRRUS photo is used to claim equivalence for Fundus Autofluorescence imaging mode in CLARUS 500.

Table 3: Comparison Table of Proposed Device CLARUS 500 with Software Version 1.0 and Reference device CIRRUS photo (K133217)

DeviceCharacteristics	CLARUS Model 500 with SW version1.0 – Proposed Device	CIRRUS photo Model 600 (K133217) –Reference Device
Manufacturer	Carl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, CA 94568, USA	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-52D-07745 Jena, Germany
510(k)	• K181444	• K133217
DeviceClassificationName	• Camera, Ophthalmic, Slit-scanning	• Tomography, Optical Coherence• Camera, Ophthalmic, Ac-Powered
Generic/ CommonName	• Ophthalmic camera	• Optical Coherence Tomographer (OCT)• Ophthalmic camera
Product Code	• QER	• OBO• HKI
RegulationNumber	• 886.1120	• 886.1570• 886.1120
Anatomical Site	• Retina, ocular surface and visible adnexa	• Retina and surrounding parts of the eye

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DeviceCharacteristics	CLARUS Model 500 with SW version1.0 - Proposed Device	CIRRUS photo Model 600 (K133217) –Reference Device
Device Type	• Fundus Camera	• Fundus Camera Main Unit with SpectralDomain OCT Module (Line Scanningmodule)
Fundus ImageCapture Modes	• True color (with red, green and bluechannel separation in review mode)• Fundus autofluorescence withgreen excitation• Fundus autofluorescence withblue excitation• Stereo• External	• Color• Green• Red• Blue• Fundus autofluorescence• Fluorescein angiography• Indocyanine green angiography• Stereo• External

CONCLUSION

The intended use for the CLARUS 500 and VISUCAM PRO NM is the same. They are both used to capture, display, store and review images of the human retina and the surrounding parts of the eye under mydriatic and non-mydriatic conditions. Both devices support the diagnosis and monitoring of eye diseases.

Overall, the devices are similar in imaging modes, features and functions. There are differences in their technological characteristics. Both devices use the Ophthalmoscope principle of the modern AC-powered digital ophthalmic cameras for imaging. The devices differ in the specifics of how they illuminate and image the retina and the ocular surface. The questions associated with these characteristics, however, are typical questions for imaging systems and patient-contacting devices. Performance data is therefore provided to demonstrate the CLARUS 500 can achieve its intended use and is safe for the patient and the operator. Bench testing (including software and electrical/EMC safety) and biocompatibility all support that the proposed device is as safe and effective as the predicate, and is therefore considered substantially equivalent to the predicate VISUCAM PRO NM. In addition, a clinical study was performed to demonstrate the performance of the device imaging modes compared to the reference device in support of the differences in imaging modes and technical characteristics.

510(K) SUMMARY

Based on the successful Design Verification & Validation testing, it is Carl Zeiss Meditec, Inc.' s opinion that the CLARUS 500 does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate device.

Additionally, all testing deemed necessary was conducted on the CLARUS 500 to ensure that the device is as safe and effective when used in accordance with its Instructions for Use as the predicate device.

Regulation Number and Section

§ 886.1120 Ophthalmic camera.

(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.