CIRRUS™ HD-OCT Model 6000

K233933 · Carl Zeiss Meditec, Inc. · OBO · May 17, 2024 · Ophthalmic

Device Facts

• Record ID: K233933
• Device Name: CIRRUS™ HD-OCT Model 6000
• Applicant: Carl Zeiss Meditec, Inc.
• Product Code: OBO · Ophthalmic
• Decision Date: May 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The CIRRUS™ HD-OCT Reference Database is a quantitative tool used for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of healthy subjects. CIRRUS™ HD-OCT AngioPlex angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. The CIRRUS™ HD-OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

Device Story

The CIRRUS HD-OCT Model 6000 is a non-contact, spectral-domain OCT instrument for high-resolution ocular imaging. It uses low-coherence interferometry to acquire cross-sectional tomograms of anterior and posterior ocular structures. The device features a 100kHz scan rate and includes AngioPlex angiography for retinal/choroidal vascular visualization. Operated by clinicians in clinical settings, the device processes raw OCT signals to generate structural images, thickness maps, and quantitative measurements. The subject device integrates a new reference database (RDB) derived from healthy subjects, allowing clinicians to compare patient measurements (macular thickness, RNFL, GCL+IPL, ONH) against normative ranges. Output is displayed on a 22-inch monitor, aiding in the detection and management of ocular pathologies like glaucoma and AMD. The device utilizes FastTrac retinal tracking to ensure scan accuracy. Clinical decision-making is supported by automated segmentation, progression analysis, and color-coded deviation maps, enabling longitudinal monitoring of disease progression.

Clinical Evidence

A prospective, multi-site clinical study (n=870 healthy subjects, age 18-88) was conducted to develop and validate the new reference database. Eligibility required BCVA 20/40 or better, IOP < 21 mmHg, and no ocular disease. Primary endpoints included establishing reference range limits (1st, 95th, 99th percentiles) for macular thickness, ganglion cell thickness, ONH parameters, and RNFL thickness using regression analysis with age and optic disc size as covariates. No adverse events were reported.

Technological Characteristics

Spectral-domain OCT (SD-OCT) using 840 nm super luminescent diode. 100kHz scan rate. Axial resolution 5 μm (in tissue). Includes Iris Viewer (700 nm LED) and LSO (750 nm SLD). Connectivity via network/USB. Software includes automated segmentation and RDB comparison tools. Enclosure UL 94V-0. System integrated into a single compact module with high-performance multi-core processor (Core i7, 32GB RAM, Windows 10).

Indications for Use

Indicated for in-vivo imaging/measurement of anterior/posterior ocular structures (cornea, retina, RNFL, GCL+IPL, macula, optic nerve head) in patients 18+ years. Used as a diagnostic aid for ocular diseases including macular holes, cystoid macular edema, diabetic retinopathy, AMD, and glaucoma. Contraindications include patients with ocular disease, unreliable visual fields, dense media opacities, active infection, or specific systemic diseases (diabetes, leukemia, MS).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CIRRUS HD-OCT Model 6000 (K222200)

Reference Devices

• CIRRUS HD-OCT Model 500, 5000 (K181534)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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

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

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

The CIRRUS™ HD-OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Page 1 of 28

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

### SUBMITTER 1.

| Applicant: | Carl Zeiss Meditec Inc<br>5300 Central Parkway<br>Dublin, CA 94568<br>USA |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Contact Name | Vidita Desai<br>Senior Regulatory Affairs Specialist<br>Carl Zeiss Meditec, Inc.<br>5300 Central Parkway Dublin, CA 94568<br>Mobile:[phone]<br>E-mail: [e-mail] (preferred) |
| Primary Correspondent | Tanesha Bland<br>Senior Regulatory Affairs Specialist USA<br>Carl Zeiss Meditec, Inc.<br>5300 Central Parkway Dublin, CA 94568<br>Mobile:[phone]<br>E-mail: [e-mail] (preferred) |
| Secondary Correspondent | Maria Golovina, MS MBA<br>Head of Regulatory Affairs – USA<br>Carl Zeiss Meditec USA Inc.<br>5300 Central Parkway, Dublin CA USA 94568<br>Mobile: [phone]<br>Email:[e-mail] (preferred) |

Date Prepared:

May 3, 2024

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Page 2 of 28

#### SUBJECT DEVICE 2.

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

#### 3. PREDICATE DEVICE

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

### 4. DEVICE DESCRIPTION

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

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

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

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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.

The CIRRUS™ HD-OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

### SUBSTANTIAL EQUIVALENCE TO PRIMARY PREDICATE 6.

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

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

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| K233933 - 510(k) Summary | | | Page 4 of 28 | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--|
| Device | Subject Device -CIRRUS 60000<br>with RDB | Predicate Device – CIRRUS 6000 | Reference Device – CIRRUS 5000 (K181534) | Equivalency Analysis | |
| | CIRRUS™ HD-OCT AngioPlex<br>angiography is indicated as an aid in<br>the visualization of vascular structures<br>of the retina and choroid. | CIRRUS HD-OCT is indicated as a<br>diagnostic device to aid in the detection<br>and management of ocular diseases<br>including, but not limited to, macular<br>holes, cystoid macular edema, diabetic<br>retinopathy, age-related macular<br>degeneration, and glaucoma. | layer thickness, and optic nerve<br>head measurements to a database<br>of normal subjects.<br><br>CIRRUS AngioPlex OCT<br>Angiography with is indicated as<br>an aid in the visualization of<br>vascular structures of the retina<br>and choroid.<br><br>CIRRUS HD-OCT is indicated as<br>a diagnostic device to aid in the<br>detection and management of<br>ocular diseases including, but not<br>limited to, macular holes, cystoid<br>macular edema, diabetic<br>retinopathy, age-related macular<br>degeneration, and glaucoma. | | |
| | CIRRUS™ HD-OCT is indicated for<br>use as a diagnostic device to aid in the<br>detection and management of ocular<br>diseases including, but not limited to,<br>macular holes, cystoid macular<br>edema, diabetic retinopathy, age-<br>related macular degeneration, and<br>glaucoma. | | | | |

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

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

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| K233933 - 510(k) Summary Page 5 of 28 | | | | | |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| | OCT | OCT | | | |
| Illumination<br>Sources used in<br>Instrument | Light Emitting Diode 700 nm –<br>Iris Viewer<br>LSO Super Luminescent Diode<br>750 nm<br>OCT Super Luminescent Diode<br>840 nm | Light Emitting Diode 700 nm –<br>Iris Viewer<br>LSO Super Luminescent Diode<br>750 nm<br>OCT Super Luminescent Diode<br>840 nm | Light Emitting Diode<br>700 nm – Iris Viewer<br>LSO Super Luminescent<br>Diode 750 nm<br>OCT Super Luminescent<br>Diode 840 nm | Identical | |
| Models | 6000 | 6000 | 5000 | Identical to the predicate<br>device. | |
| | OCT IMAGING | | | | |
| Methodology | Spectral domain OCT (SD-<br>OCT) | Spectral domain OCT (SD-<br>OCT) | Spectral domain OCT (SD-<br>OCT) | Identical | |
| OCT Optical<br>Source | OCT Super Luminescent<br>Diode, 840 nm wavelength | OCT Super Luminescent Diode,<br>840 nm wavelength | OCT Super Luminescent<br>Diode, 840 nm<br>wavelength | Identical | |
| Optical Power | 1200 μW at the cornea +/- 300<br>μW (0.9 - 1.5 mW) at the<br>cornea. | 1200 μW at the cornea +/- 300<br>μW (0.9 - 1.5 mW) at the<br>cornea. | < 775 μW at the cornea | Identical to the predicate<br>device. | |
| Scan Speed | 100,000 A-scans per second | 100,000 A-scans per second | 27,000 A-scans per second<br>68,000 A-scans per second<br><i>only for OCT Angiography</i> | Identical to the predicate<br>device. | |
| Axial Scan Depth<br>(Max)- Retina | • 2.9 mm for 12 mm 1<br>Line 100x HD Raster,<br>HD Angio 8x8, Angio<br>8x8, and Angiography<br>12x12<br>• 2.0 mm for all other<br>scans | • 2.9 mm for 12 mm 1<br>Line 100x HD Raster,<br>HD Angio 8x8, Angio<br>8x8, and Angiography<br>12x12<br>• 2.0 mm for all other<br>scans | 2.0 mm | Identical to the predicate<br>device. | |
| Axial Scan Depth<br>(Max)- Retina | 2.0 mm (in tissue), 1024 pixels<br>per A-scans for all other scan<br>except for the ones listed above | 2.0 mm (in tissue), 1024 pixels<br>per A-scans for all other scan<br>except for the ones listed above | 2.0 mm (in tissue), 1024<br>pixels per A-scans. | Identical | |
| K233933 - 510(k) Summary | | Page 6 of 28 | | | |
| Axial Scan Depth<br>(Max) –Anterior<br>Segment | 2.0 mm (Anterior 5-Line<br>Raster) – 1024 points2.0 mm<br>(Anterior Segment Cube) –<br>1024 points<br>5.8 mm (Anterior Chamber) –<br>2048 points<br>2.9 mm (Wide Angle-to-Angle) –<br>1024 points<br>2.9 mm (HD Angle) – 1024<br>points<br>2.0 mm (HD Cornea) – 1024<br>points<br>2.0 mm (Pachymetry) – 1024<br>points | 2.0 mm (Anterior 5-Line<br>Raster) – 1024 points2.0 mm<br>(Anterior Segment Cube) –<br>1024 points<br>5.8 mm (Anterior Chamber) –<br>2048 points<br>2.9 mm (Wide Angle-to-Angle) –<br>1024 points<br>2.9 mm (HD Angle) – 1024<br>points<br>2.0 mm (HD Cornea) – 1024<br>points<br>2.0 mm (Pachymetry) – 1024<br>points | 2.0 mm (Anterior 5-Line<br>Raster) – 1024 points2.0 mm<br>(Anterior Segment Cube) –<br>1024 points<br>5.8 mm (Anterior Chamber) –<br>2048 points<br>2.9 mm (Wide Angle-to-<br>Angle) – 1024 points<br>2.9 mm (HD Angle) – 1024<br>points<br>2.0 mm (HD Cornea) – 1024<br>points<br>2.0 mm (Pachymetry) –<br>1024 points | Identical | |
| External Anterior<br>Segment Lens | Anterior Chamber Lens<br>Cornea Lens | Anterior Chamber Lens<br>Cornea Lens | Anterior Chamber Lens<br>Cornea Lens | Identical | |
| Transverse Scan<br>Range<br>(Lateral range in<br>degrees)<br>Retina | 10° x 0° on retina (Minimum)<br>42° x 42° on retina (Maximum) | 10° x 0° on retina (Minimum)<br>42° x 42° on retina (Maximum) | 10° x 0° on retina<br>(Minimum)<br>31° x 31° on retina<br>(Maximum) | Identical to the predicate<br>device. | |
| Transverse Scan<br>Range –Anterior<br>Segment | 3 mm (Minimum)<br>15 mm (Maximum) | 3 mm (Minimum)<br>15 mm (Maximum) | 3 mm (Minimum)<br>15 mm (Maximum) | Identical | |
| Axial Resolution | 5 μm (in tissue) | 5 μm (in tissue) | 5 μm (in tissue) | Identical | |
| Transverse<br>Resolution – Retina | ≤ 15 μm (in tissue) | ≤ 15 μm (in tissue) | ≤ 15 μm (in tissue) | Identical | |
| Transverse<br>Resolution –<br>Anterior Segment | 20 μm (in tissue)<br>20 μm @ 6mm FOV<br>25 μm @ 9mm FOV | 20 μm (in tissue)<br>20 μm @ 6mm FOV<br>25 μm @ 9mm FOV | 20 μm (in tissue)<br>20 μm @ 6mm FOV<br>25 μm @ 9mm FOV | Identical | |
| | K233933 - 510(k) Summary<br>Page 7 of 28 | 45 μm @ 15mm FOV | 45 μm @ 15mm FOV | 25 μm @ 9mm FOV<br>45 μm @ 15mm FOV | |
| | Scan patterns<br>Non-angiography | Line, circle, crosshair, raster (a series of closely spaced lines, aka cube scan), radial scans and combinations of the above. | Line, circle, crosshair, raster (a series of closely spaced lines, aka cube scan), radial scans and combinations of the above. | Line, circle, crosshair, raster (a series of closely spaced lines, aka cube scan), radial scans and combinations of the above. | Identical |
| | Scan types<br>Non-angiography | Macular Cube 512 x 128 = 6 mm x 6 mm | Macular Cube 512 x 128 = 6 mm x 6 mm | Macular Cube 512 x 128 = 6 mm x 6 mm | Identical |
| | | Macular Cube 200 x 200 = 6 mm x 6 mm | Macular Cube 200 x 200 = 6 mm x 6 mm | Macular Cube 200 x 200 = 6 mm x 6 mm | Identical |
| | | Optic Disc Cube 200 x 200 = 6 mm x 6 mm | Optic Disc Cube 200 x 200 = 6 mm x 6 mm | Optic Disc Cube 200 x 200 = 6 mm x 6 mm | Identical |
| | | Not available | Not available | 5-Line Raster | Identical to the predicate device. |
| | | HD (high-definition) Raster<br>- HD 1 Line 100x (2.9 mm depth and up to 12 mm in length)<br>- HD 21 Line<br>- HD Radial<br>- HD Cross<br>- HD 5-Line Raster | HD (high-definition) Raster<br>- HD 1 Line 100x (2.9 mm depth and up to 12 mm in length)<br>- HD 21 Line<br>- HD Radial<br>- HD Cross<br>- HD 5-Line Raster | HD (high-definition) Raster<br>- HD 1 Line 100x (2.0 mm depth and up to 9 mm in length)<br>- HD 21 Line<br>- HD Radial<br>- HD Cross<br>- HD 5-Line Raster | Identical to the predicate device. |
| | | Anterior Segment Cube 512 x 128 | Anterior Segment Cube 512 x 128 | Anterior Segment Cube 512 x 128 | Identical |
| K233933 - 510(k) Summary | | Page 8 of 28 | | | |
| | Anterior Segment 5-Line Raster | Anterior Segment 5-Line Raster | Anterior Segment 5-Line Raster | Identical | |
| | HD Angle | HD Angle | HD Angle | Identical | |
| | Anterior Chamber | Anterior Chamber | Anterior Chamber | Identical | |
| | Wide Angle-to-Angle | Wide Angle-to-Angle | Wide Angle-to-Angle | Identical | |
| | HD Cornea | HD Cornea | HD Cornea | Identical | |
| | Pachymetry | Pachymetry | Pachymetry | Identical | |
| OCT Angiography<br>scans | Scans: | Scans: | Scans: | Scans: | |
| | AngioPlex 3x3 mm scan | AngioPlex 3x3 mm scan | AngioPlex 3x3 mm scan | Identical | |
| | AngioPlex 6x6 mm scan | AngioPlex 6x6 mm scan | AngioPlex 6x6 mm scan | Identical | |
| | AngioPlex 8x8 mm scan,<br>(2.9mm scan depth) | AngioPlex 8x8 mm scan,<br>(2.9mm scan depth) | AngioPlex 8x8 mm scan,<br>(2.0mm scan depth) | Identical to the predicate<br>device. | |
| | AngioPlex 12x12 mm scan<br>(2.9mm scan depth) | AngioPlex 12x12 mm scan<br>(2.9mm scan depth) | Not Available | Identical to the predicate<br>device. | |
| | AngioPlex HD 6x6 mm scan | AngioPlex HD 6x6 mm scan | Not Available | Identical to the predicate<br>device. | |
| | AngioPlex HD 8x8 mm scan<br>(2.9mm scan depth) | AngioPlex HD 8x8 mm scan<br>(2.9mm scan depth) | Not Available | Identical to the predicate<br>device. | |
| | 6 x 6 mm Montage AngioPlex | 6 x 6 mm Montage AngioPlex | Not Available | Identical to the predicate<br>device. | |
| | 8 x 8 mm Montage AngioPlex…