(120 days)
Yes
The device description explicitly states: "The CLARUS 700 makes use of a deep learning algorithm for Optic Nerve Head (ONH) detection." Deep learning is a subset of AI.
No
The device is described as an "ophthalmic imaging device" used to capture, display, annotate, and store images to aid in diagnosis and monitoring, and visualization of vascular structures. This indicates a diagnostic rather than a therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to aid in the diagnosis and monitoring of diseases and disorders" and "is indicated as an aid in the visualization of vascular structures of the retina and the choroid." This clearly positions the device as providing information used for diagnostic purposes.
No
The device is not a software-only medical device. While it includes software components and even a deep learning algorithm, the "Device Description" clearly states that the CLARUS 700 is an "active, software controlled, high resolution ophthalmic imaging device" and details numerous physical hardware components such as an "acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply," as well as specific hardware changes for the new imaging modes (e.g., Lightbox for Infrared (IR) Laser, Modified Slit/Turret Filters, Alignment Tool, Power Meter Tool). This indicates it is a physical medical device that incorporates software.
No.
The device is an ophthalmic camera used for in-vivo imaging of the human eye, which is not an IVD. Its function is to capture, display, annotate, and store images to aid in the diagnosis and monitoring of eye diseases, rather than performing tests in vitro on samples derived from the human body.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The provided text includes no mention of a PCCP being authorized or cleared.
Intended Use / Indications for Use
The CLARUS 700 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.
The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and the choroid.
Product codes
QER
Device Description
The CLARUS 700 is an active, software controlled, high resolution ophthalmic imaging device for In-vivo imaging of the human eye. Imaging modes include True color, Fundus Auto-fluorescence with green excitation, Fundus Auto-fluorescence with blue excitation, Fluorescein Angiography, Stereo External eye and Fluorescein Angiography- Indocyanine green angiography (FA-ICGA). 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. The CLARUS 700 angiography imaging aids in the visualization of the vascular structures of the retina and the choroid. With a single capture, CLARUS 700 produces a 90º high definition widefield image. Widefield images are automatically merged to achieve a 135º ultra-widefield of view. The CLARUS 700 makes use of a deep learning algorithm for Optic Nerve Head (ONH) detection. The ultra-widefield montage on CLARUS 700 is no longer dependent just on the patient accurately fixating their gaze on the internal fixation. With the ONH detection, the software will find the optic nerve and determine based on the image(s) captured where the patient was gazing at the point of capture. The CLARUS 700 device allows clinicians to easily review and compare high-quality images captured during a single exam while providing annotation and caliper measurement tools that allow in-depth analysis of eye health. CLARUS 700 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 IR Preview allows the technician to confirm image quality and screen for lid and lash obstructions, prior to imaging, ensuring fewer image recaptures. The CLARUS 700 device's principle of operation is Slit Scanning Ophthalmic Camera also referred to as Broad Line Fundus Imaging (BLFI). During image capture, a line of illumination passes through the slit and scans across the retina. A 2D 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. Fluorescein Angiography images are captured with green LED illumination at a wavelength that stimulates fluorescence of the injected sodium fluorescein dye. The CLARUS 700 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply. The device hardware is based on the predicate CLARUS 700 (K191194) hardware. The new ICGA imaging mode on the device required the following hardware changes: Lightbox for Infrared (IR) Laser, Modified Slit filter, Modified Turret Filter 1, Added Turret Filter 2, Added Large Alignment Tool (LAT), Added ICG Power Meter Tool. 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 DEVICE software version 1.2 is based on the predicate CLARUS 700 software version 1.0 (K191194). Added capability for DEVICE software version 1.2 include: Simultaneous capture of Fluorescein Angiography (FA) + Indocyanine Green Angiography (ICGA), Angiography Movie, Early Treatment Diabetic Retinopathy Study (ETDRS) – Manual placement of ETDRS grids, ICGA Boost Mode, 8 up view.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
True Color, Fundus Autofluorescence (FAF) with green excitation, FAF with blue excitation, Fluorescein Angiography (FA), Indocyanine Green Angiography (ICGA), Stereo, External Eye.
Anatomical Site
retina, ocular surface and visible adnexa
Indicated Patient Age Range
Not Found
Intended User / Care Setting
• Opticians
• Ophthalmic Photographers
• Optometrists
• Ophthalmologists
• Medical Assistants
• Clinical Researchers
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing: ZEISS conducted biocompatibility testing on patient-contacting accessories in accordance with ISO 10993-1. The evaluations addressed cytotoxicity, sensitization, and irritation. Biocompatibility testing demonstrated equivalency between the subject device and the predicate device.
Laser safety, electrical safety and electromagnetic compatibility (EMC): CLARUS 700 was evaluated against ANSI/AAMI ES60601-1:2005/(R) 2012, ANSI Z80.36-2021, IEC 60601-1-2:2014, IEC 60825-1:2007, IEC 60601-2-22:2012, IEC 62133: 2012 and was found to comply.
Software Verification and Validation Testing: Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification and validation of CLARUS 700 demonstrated that the product works as designed.
Bench Testing: Non-clinical system testing provided an evaluation of the performance of the system relevant to each of the system specifications. The functional and system level testing showed that the system met the defined specifications. ZEISS demonstrated non-clinical equivalency between the subject device and the predicate device.
Clinical Data: ZEISS conducted clinical testing aimed at demonstrating the ability of the new model of CLARUS 700 to image a variety of retinal and choroidal conditions using simultaneous FA and simultaneous ICGA and standalone ICGA. Analysis of the grading of angiography images showed that the quality of the images captured by the CLARUS 700 simultaneous FA, simultaneous ICGA, and standalone ICGA were clinically acceptable by three independent graders. The overall results demonstrated the ability of the CLARUS 700 to produce high quality angiography images that aid in the visualization of vascular structures of the retina and the choroid.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
FDA 510(k) Clearance Letter - CLARUS 700
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 17, 2025
Carl Zeiss Meditec, Inc.
Tanesha Bland
Sr. Regulatory Affairs Specialist
5300 Central Parkway
Dublin, California 94568
Re: K243878
Trade/Device Name: Clarus (700)
Regulation Number: 21 CFR 886.1120
Regulation Name: Ophthalmic Camera
Regulatory Class: Class II
Product Code: QER
Dated: March 3, 2025
Received: March 3, 2025
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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K243878 - Tanesha Bland Page 2
(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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K243878 - Tanesha Bland Page 3
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243878
Device Name
CLARUS (700)
Indications for Use (Describe)
The CLARUS 700 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.
The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and the 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
K243878 - 510(k) Summary
Page 1 of 13
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92), the 510(k) Summary for CLARUS 700 is provided below.
1. SUBMITTER
Applicant: Carl Zeiss Meditec, Inc.
5300 Central Parkway
Dublin, California 94568
Applicant Contact/ Primary Correspondent
Tanesha Bland
Sr. Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5300 Central Parkway | Dublin, CA 94568
Phone: (925) 216-7963 | Fax: (925) 557-4259
E-mail: tanesha.bland@zeiss.com (preferred)
Secondary Correspondent
Chaitali Gawde
Sr. Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5300 Central Parkway | Dublin, CA 94568
E-mail: chaitali.gawde@zeiss.com (preferred)
Tammy Wharton
Staff Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5300 Central Parkway | Dublin, CA 94568
E-mail: tammy.wharton@zeiss.com (preferred)
Date Prepared: April 17, 2025
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K243878 - 510(k) Summary
Page 2 of 13
2. SUBJECT DEVICE
Device Trade Name: CLARUS 700 v 1.2
510(k) number: K243878
Classification: 21 CFR 886.1120 Ophthalmic Camera
Regulatory Class: Class II
Product Code: QER
3. PREDICATE DEVICE
Predicate Device: CLARUS 700 v 1.1
510(k) Number: K191194
Classification: 21 CFR 886.1120 Ophthalmic Camera
Regulatory Class: Class II
Product Code: QER
4. DEVICE DESCRIPTION
The CLARUS 700 is an active, software controlled, high resolution ophthalmic imaging device for In-vivo imaging of the human eye. Imaging modes include True color, Fundus Auto-fluorescence with green excitation, Fundus Auto-fluorescence with blue excitation, Fluorescein Angiography, Stereo External eye and Fluorescein Angiography- Indocyanine green angiography (FA-ICGA). 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.
Table 1: Scan Types
| Scan Type | Description |
|---|---|
| True Color | True color reflectance images are generated through the capture of sequential illumination by red, green and blue LEDs. |
| FAF-Green | Fundus autofluorescence with green excitation imaging. |
| FAF-Blue | Fundus autofluorescence with blue excitation imaging. |
| FA | FA images are captured with the green LED illumination at a wavelength that stimulates fluorescence of the injected sodium fluorescein dye. Fluorescein angiography imaging and video. |
| ICG | Indocyanine green angiography imaging and video. |
| FA-ICG (also referred to as ICGA) | Fluorescein angiography-Indocyanine green angiography simultaneous imaging and video. |
Note: Additional options are present for Stereo Imaging and External Eye.
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K243878 - 510(k) Summary
Page 3 of 13
The CLARUS 700 angiography imaging aids in the visualization of the vascular structures of the retina and the choroid. With a single capture, CLARUS 700 produces a 90º high definition widefield image. Widefield images are automatically merged to achieve a 135º ultra-widefield of view. The CLARUS 700 makes use of a deep learning algorithm for Optic Nerve Head (ONH) detection. The ultra-widefield montage on CLARUS 700 is no longer dependent just on the patient accurately fixating their gaze on the internal fixation. With the ONH detection, the software will find the optic nerve and determine based on the image(s) captured where the patient was gazing at the point of capture. The CLARUS 700 device allows clinicians to easily review and compare high-quality images captured during a single exam while providing annotation and caliper measurement tools that allow in-depth analysis of eye health. CLARUS 700 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 IR Preview allows the technician to confirm image quality and screen for lid and lash obstructions, prior to imaging, ensuring fewer image recaptures.
The CLARUS 700 device's principle of operation is Slit Scanning Ophthalmic Camera also referred to as Broad Line Fundus Imaging (BLFI). During image capture, a line of illumination passes through the slit and scans across the retina. A 2D 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. Fluorescein Angiography images are captured with green LED illumination at a wavelength that stimulates fluorescence of the injected sodium fluorescein dye. The principle of operation of CLARUS 700 has not changed since the previous clearance, K191194.
The CLARUS 700 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply.
The device hardware is based on the predicate CLARUS 700 (K191194) hardware. The new ICGA imaging mode on the device required the following hardware changes as stated in the summary above:
- Lightbox for Infrared (IR) Laser
- Modified Slit filter – FA/ICG Slit Excitation Filter – new coating, no change to FA
- Modified Turret Filter 1- FA/ICG Dual Band barrier filter – new coating, no change to FA.
- Added Turret Filter 2 – Added second filter. Same coating as Turret Filter 1 to eliminate cornea reflex band in ICG images with a different shape.
- Added Large Alignment Tool (LAT)
- Added ICG Power Meter Tool
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
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K243878 - 510(k) Summary
Page 4 of 13
(Acquisition & Review) as well as Software installed on a separate 'Review Station' (Laptop or Computer) (only Review).
The DEVICE software version 1.2 is based on the predicate CLARUS 700 software version 1.0 (K191194).
Added capability for DEVICE software version 1.2 include:
- Simultaneous capture of Fluorescein Angiography (FA) + Indocyanine Green Angiography (ICGA)
- Angiography Movie: Capture of multiple pictures in sequence, after a single press of a button. Available for FA, ICGA and Simultaneous FA+ICGA.
- Early Treatment Diabetic Retinopathy Study (ETDRS) – Manual placement of ETDRS grids (7 field ETDRS and Macula ETDRS) over the pictures:
- The ETDRS 7-fields grid in CLARUS is a display of the standard 7-fields in Color Fundus Photography used to determine an ETDRS (Early Treatment Diabetic Retinopathy Study) level for patients with Diabetic Retinopathy. These 7-fields in and around the macular region are displayed in one single widefield image according to definitions followed by the gold-standard 7-field images using narrow-field fundus cameras.
- The Macular ETDRS grids display assists in the identification of an ETDRS level in nine subfields centered around the fovea.
- ICGA Boost Mode: user-selectable option for ICGA capture that increase used light to obtain better picture at later phase.
- 8 up view: addition of the possibility to view eight pictures side by side (currently it is only possible to see 1, 2, 4, 16)
The CLARUS 700 device meets the requirements of ISO 10940:2009 standard. The device technical specifications are identical to the predicate device.
5. INDICATIONS FOR USE
The CLARUS 700 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.
The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.
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K243878 - 510(k) Summary
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This device is Prescription Use (Rx) only.
6. SUBSTANTIAL EQUIVALENCE TO PRIMARY PREDICATE
The indications for use of the CLARUS 700 are identical to those included in the previous 510(k) clearance. No changes have been made to the intended use or the indications for use of the device.
The technical characteristics of the subject device, CLARUS 700, remain consistent with those included in the previous 510(k) clearance, with the exception of the addition of Indocyanine Green Angiography (ICGA) functionality. All modifications to the device have been implemented solely to support this new feature.
Beyond the integration of ICGA functionality, there have been no changes to the design, materials, or performance specifications of the device. The fundamental technical characteristics and intended function of the device remain unchanged.
A comparison of the subject device to the predicate device is provided in Table 2.
Table 2: Subject to Predicate Device Comparison Table - Indications for Use
| Device | CLARUS Model 700 with SW version 1.2 (K243878) – Proposed Device | CLARUS Model 700 with SW version 1.1 (K191194) – Predicate Device | Equivalency Analysis |
|---|---|---|---|
| Device Classification Name | Ophthalmic camera | Ophthalmic camera | Identical |
| Generic/ Common Name | Ophthalmic camera | Ophthalmic camera | Identical |
| Classification Product Code | QER | QER | Identical |
| Regulation Number | 886.1120 | 886.1120 | Identical |
| Class | Class II | Class II | Identical |
| Review Panel | Ophthalmic | Ophthalmic | Identical |
| Intended Use/ Indications for Use | The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders | The CLARUS 700 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 | Identical |
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K243878 - 510(k) Summary
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| 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. The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structure of the retina and the choroid. | retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structure of the retina and the choroid. | ||
|---|---|---|---|
| Target Population | • Opticians | ||
| • Ophthalmic Photographers | |||
| • Optometrists | |||
| • Ophthalmologists | |||
| • Medical Assistants | |||
| • Clinical Researchers | • Opticians | ||
| • Ophthalmic Photographers | |||
| • Optometrists | |||
| • Ophthalmologists | |||
| • Medical Assistants | |||
| • Clinical Researchers | Identical | ||
| Anatomical Site | Retina, ocular surface and visible adnexa | Retina, ocular surface and visible adnexa | Identical |
| Device Type | Fundus Camera | Fundus Camera | Identical |
| Methodology | Slit Scanning Ophthalmoscope, also referred to as Broad Line Fundus Imaging (BLFI) | Slit Scanning Ophthalmoscope, also referred to as Broad Line Fundus Imaging (BLFI) | Identical |
| Principle of Fundus Image Capturing | • Broad Line Fundus Imaging (BLFI) using LEDs and laser illumination | ||
| • Near-IR laser illumination for live retina preview | |||
| • LEDs (red, green, blue) used for true color, fundus autofluorescence and fluorescein | • Broad Line Fundus Imaging (BLFI) using LEDs and laser illumination | ||
| • Near-IR laser illumination for live retina preview | |||
| • LEDs (red, green, blue) used for true color, fundus autofluorescence and fluorescein | Similar. The subject device incorporates Simultaneous Fundus Autofluorescence (FA)+ Indocyanine Green Angiography (ICGA) (bold and italicized). |
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K243878 - 510(k) Summary
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| | angiography imaging modes
• Live preview and image-capture with 12 megapixel monochrome sensors.
• Simultaneous Fundus Autofluorescence (FA)+ Indocyanine Green Angiography (ICGA) | angiography imaging modes
• Live preview and image-capture with 12 megapixel monochrome sensors. | |
|---|---|---|---|
| Image Capture Modes | • True color (with red, green and blue channel separation in review mode)
• Fundus autofluorescence with green excitation
• Fundus autofluorescence with blue excitation
• Fluorescein Angiography
• Stereo
• External
• Indocyanine Green Angiography (ICGA) allows study of the circulation of the choroid
• Angiography Movie – video frame rate angiography capture assists during fast moving early phase
• ETDRS
• ICG Boost Mode
• Autobrightness/delta brightness
• Simultaneous Fundus Autofluorescence (FA)+ Indocyanine Green Angiography (ICGA) | • True color (with red, green and blue channel separation in review mode)
• Fundus autofluorescence with green excitation
• Fundus autofluorescence with blue excitation
• Fluorescein Angiography
• Stereo
• External | Similar. The subject Device incorporates new Image Capture modes which support the ICGA functionality. |
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K243878 - 510(k) Summary
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| | • Live preview and image-capture with 12 megapixel monochrome sensors.
• Simultaneous Fundus Autofluorescence (FA)+ Indocyanine Green Angiography (ICGA) | • Live preview and image-capture with 12 megapixel monochrome sensors. | |
|---|---|---|---|
| Image Capture Modes | • True color (with red, green and blue channel separation in review mode)
• Fundus autofluorescence with green excitation
• Fundus autofluorescence with blue excitation
• Fluorescein Angiography
• Stereo
• External
• Indocyanine Green Angiography (ICGA) allows study of the circulation of the choroid
• Angiography Movie – video frame rate angiography capture assists during fast moving early phase
• ETDRS
• ICG Boost Mode
• Autobrightness/delta brightness | • True color (with red, green and blue channel separation in review mode)
• Fundus autofluorescence with green excitation
• Fundus autofluorescence with blue excitation
• Fluorescein Angiography
• Stereo
• External | Similar. The subject Device incorporates new Image Capture modes which support the ICGA functionality. |
| Illumination Source for Image Acquisition | • Red LED: 600-650 nm
• Green LED: 480-600 nm
• Blue LED: 430-480 nm
• Near-infrared laser diode: 780-800 nm | • Red LED: 585-640 nm
• Green LED: 500-585 nm
• Blue LED: 435-500 nm
• Near-infrared laser diode: 785 nm | The illumination source for image acquisition in Clarus 700 has been expanded to include additional wavelength ranges necessary to support the ICGA functionality. This adjustment ensures the system can excite the indocyanine green dye and capture its fluorescence while maintaining the performance of the existing imaging modalities. |
| Laser Class (Based on IEC 60825-1:2007) | Class I | Class I | Identical |
| Device Group (Optical Safety) | Group 1 (ANSI Z80.36-2021) | Group 1 (ANSI Z80.36-2016) | Identical |
| Illumination Source for Live Preview | Near-infrared laser diode: 785 nm | Near-infrared laser diode: 785 nm | Identical |
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| Detector Type | Internal CMOS sensors – 12 megapixels | Internal CMOS sensors – 12 megapixels | Identical |
|---|---|---|---|
| Filters | • Barrier and Excitation Filters for Fundus Autofluorescence Blue | ||
| • Barrier and Excitation Filters for Fundus Autofluorescence Green | |||
| • Barrier and Excitation Filters for Fluorescein Angiography | • Barrier and Excitation Filters for Fundus Autofluorescence Blue | ||
| • Barrier and Excitation Filters for Fundus Autofluorescence Green | |||
| • Barrier and Excitation Filters for Fluorescein Angiography | Identical | ||
| Field of View | • 90° (widefield-single shot image) | ||
| • 135° (ultra-widefield – two shot auto montage) | • 90° (widefield-single shot image) | ||
| • 135° (ultra-widefield – two shot auto montage) | Identical | ||
| Refractive Error Compensation | +24 D….-20 D, continuous | +24 D….-20 D, continuous | Identical |
| Minimum Pupil Size | 2.5 mm | 2.5 mm | Identical |
| Working Distance | 25 mm (patient's eye – front lens) | 25 mm (patient's eye – front lens) | Identical |
| Fixation Target | Internal and External | Internal and External | Identical |
| Configuration | • Acquisition unit consists of the acquisition head (includes image acquisition optics), cross-table and the patient support. | ||
| • Peripheral components include the All-in-One PC, keyboard, mouse. | • Acquisition unit consists of the acquisition head (includes image acquisition optics), cross-table and the patient support. | ||
| • Peripheral components include the All-in-One PC, keyboard, mouse. | Identical |
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| System Control Input Devices | • Joystick for operating image acquisition head.
• Keyboard/Touchpad/Mouse for operating internal computer. | • Joystick for operating image acquisition head.
• Keyboard/Touchpad/Mouse for operating internal computer. | Identical |
|---|---|---|---|
| Patient Contacting Components | • Chin rest
• Forehead rest | • Chin rest
• Forehead rest | Identical |
| Materials – Patient Contact | Chin rest and forehead rest – ABS/PC Alloy, Bayer Bay Blend #FR3010, Color – Medium Gray RAL-U713 | Chin rest and forehead rest – ABS/PC Alloy, Bayer Bay Blend #FR3010, Color – Medium Gray RAL-U713 | Identical |
| Operating System | Microsoft Window 10 I0T Enterprise Version 64 bit | Microsoft Window 10 I0T Enterprise Version 64 bit | Identical |
| Display Types | 22"Full HD MVA LCD with LED Backlight (external) | 22"Full HD MVA LCD with LED Backlight (external) | Identical |
| Data Storage | 2 TB (At-Instrument Computer) | 2 TB (At-Instrument Computer) | Identical |
| Export | Via FORUM/PACS, DICOM, network drive and USB thumb drives. | Via FORUM/PACS, DICOM, network drive and USB thumb drives. | Identical |
| Software Features | Review and Analysis of Fundus Images | Review and Analysis of Fundus Images | Identical |
| Electrical Requirements | • Input Voltage: 100-240 V, 50/60 Hz, 4A max
• Power Consumption: Max. 1315 VA for DEVICE and lift table configuration (standalone Device not available) | • Input Voltage: 100-240 V, 50/60 Hz, 4A max
• Power Consumption: Max. 1315 VA for DEVICE and lift table configuration (standalone Device not available) | Identical |
| Electrical Safety Parameters | • Protection Class: 1
• Device Type (IEC 60601-1): B | • Protection Class: 1
• Device Type (IEC 60601-1): B | Identical |
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| • Enclosure Protection: IPXO (No degree of protection against ingress of water or particulate matter) | • Enclosure Protection: IPXO (No degree of protection against ingress of water or particulate matter) | ||
|---|---|---|---|
| Environmental Conditions: Operation | • Temperature: +10° to +35° C | ||
| • Relative Humidity: 30% to 90% (excluding condensation) | |||
| • Atmospheric Pressure: 800 hPa to 1060 hPa | • Temperature: +10° to +35° C | ||
| • Relative Humidity: 30% to 90% (excluding condensation) | |||
| • Atmospheric Pressure: 800 hPa to 1060 hPa | Identical | ||
| Environmental Conditions: Storage | • Temperature: -10° to +55° C | ||
| • Relative Humidity 10% to 95% (excluding condensation) | |||
| • Atmospheric Pressure 700 hPa to 1060 hPa | • Temperature: -10° to +55° C | ||
| • Relative Humidity 10% to 95% (excluding condensation) | |||
| • Atmospheric Pressure 700 hPa to 1060 hPa | Identical | ||
| Environmental Conditions: Transport | • Temperature: -40° to +70°C | ||
| • Relative Humidity 10% to 95% (excluding condensation) | |||
| • Atmospheric Pressure 500hPa to 1060 hPa | • Temperature: -40° to +70°C | ||
| • Relative Humidity 10% to 95% (excluding condensation) | |||
| • Atmospheric Pressure 500hPa to 1060 hPa | Identical |
7. SUMMARY OF STUDIES
Biocompatibility Testing
ZEISS conducted biocompatibility testing on patient-contacting accessories in accordance with ISO 10993-1. The evaluations addressed cytotoxicity, sensitization, and irritation, aligning with the recommendations delineated in the FDA guidance document "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk
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Management Process". The testing performed aligns with current recognized standards and meets or exceeds testing performed on the predicate device. Biocompatibility testing demonstrated equivalency between the subject device and the predicate device.
Laser safety, electrical safety and electromagnetic compatibility (EMC)
CLARUS 700 was evaluated against the following requirements and was found to comply with:
- ANSI/AAMI ES60601-1:2005/(R) 2012
- ANSI Z80.36-2021
- IEC 60601-1-2:2014
- IEC 60825-1:2007
- IEC 60601-2-22:2012
- IEC 62133: 2012
Software Verification and Validation Testing
The software of this device is considered to have an Enhanced Documentation Level. Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification and validation of CLARUS 700 demonstrated that the product works as designed.
Bench Testing
Non-clinical system testing provided an evaluation of the performance of the system relevant to each of the system specifications. The functional and system level testing showed that the system met the defined specifications. ZEISS demonstrated non-clinical equivalency between the subject device and the predicate device.
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
ZEISS conducted clinical testing aimed at demonstrating the ability of the new model of CLARUS 700 to image a variety of retinal and choroidal conditions using simultaneous FA and simultaneous ICGA and standalone ICGA.
Our analysis of the grading of angiography images showed that the quality of the images captured by the CLARUS 700 simultaneous FA, simultaneous ICGA, and standalone ICGA were clinically acceptable by three independent graders.
The overall results demonstrated the ability of the CLARUS 700 to produce high quality angiography images that aid in the visualization of vascular structures of the retina and the choroid.
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8. CONCLUSION
The CLARUS 700 v 1.2 is substantially equivalent to the predicate device CLARUS 700 v 1.1 (K191194).
The CLARUS 700 v 1.2 is similar in technological characteristics, performance, and has identical indications for use and principle of operation as the predicate device. Any differences between the proposed device and the predicate and reference devices do not raise any new issues of safety or effectiveness. Thus, the CLARUS 700 v 1.2 is substantially equivalent to the predicate device.