CIRRUS HD-OCT

K222200 · Carl Zeiss Meditec, Inc. · OBO · Apr 13, 2023 · Ophthalmic

Device Facts

• Record ID: K222200
• Device Name: CIRRUS HD-OCT
• Applicant: Carl Zeiss Meditec, Inc.
• Product Code: OBO · Ophthalmic
• Decision Date: Apr 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior ocular structures. The device is indicated for visualizing and measuring and posterior ocular structures, including corneal epithelium, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. CIRRUS' AngioPlex OCT Angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. CIRRUS HD-OCT is indicated as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

Device Story

CIRRUS HD-OCT Model 6000 is a non-contact, high-resolution spectral domain OCT imaging device. It captures axial cross-sectional and 3D images of anterior and posterior ocular structures. Input data consists of optical signals from the eye; the device uses a 100 kHz scan rate to generate structural and angiography images. Operated by clinicians in clinical settings, the device provides visualization and measurement tools for ocular disease management. It features 21 fixation points and a wider field of view compared to the predicate. Output is displayed for healthcare providers to aid in diagnosing conditions like glaucoma and retinal diseases. The device includes automated segmentation algorithms to quantify ocular structures. It benefits patients by enabling non-invasive, high-speed imaging for longitudinal monitoring and disease detection.

Clinical Evidence

Prospective, multi-site studies evaluated repeatability and reproducibility (R&R) and image quality. R&R study (n=117) assessed ganglion cell, macular, and RNFL thickness measurements across normal, glaucoma, retinal pathology, and corneal pathology subgroups. Results showed high precision (low %CV and SD). Image quality studies (n=110 for Angiography, n=68 for Raster) compared CIRRUS 6000 to CIRRUS 5000; proportion of clinically acceptable images was ≥0.98 for the subject device, demonstrating equivalence.

Technological Characteristics

Spectral Domain (SD-OCT) using 840 nm SLD source. 100 kHz scan rate. 21-point LED fixation. Hardware: Intel Core i7, 32GB RAM, 2TB SSD, 22" HD display. Connectivity: Network/USB. Software: v. 11.5.4. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 62366-1, and ANSI Z80.36-2016.

Indications for Use

Indicated for patients requiring visualization and measurement of anterior and posterior ocular structures (cornea, corneal epithelium, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head) and vascular structures of the retina/choroid. Aids in detection/management of ocular diseases (e.g., macular holes, cystoid macular edema, diabetic retinopathy, AMD, glaucoma). Prescription use only.

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 5000 (K181534)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

#### Re: K222200

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

#### Dear Tanesha Bland:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([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 Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K22200

Device Name CIRRUS HD-OCT Model 6000

#### Indications for Use (Describe)

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

CIRRUS' AngioPlex OCT Angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

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

This device is Prescription Use (Rx) only.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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

#### SUBMITTER 1. Applicant: Carl Zeiss Meditec, Inc. 5300 Central Parkway Dublin, CA USA Tanesha Bland Primary Correspondent Sr. Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5300 Central Parkway | Dublin, CA 94568 [phone] Phone | [phone] Fax E-mail: tanesha.bland(@zeiss.com (preferred) Development Center Contact Vidita Desai Sr. Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5300 Central Parkway | Dublin, CA 94568 [phone] Phone | [phone] Fax E-mail: [e-mail] (preferred) April 12, 2023 Date Prepared:

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#### SUBJECT DEVICE 2.

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

#### 3. PREDICATE DEVICE

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

#### 4. DEVICE DESCRIPTION

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

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

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

#### INDICATIONS FOR USE న్.

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

CIRRUS' AngioPlex OCT Angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

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

This device is Prescription Use (Rx) only.

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#### 6. SUBSTANTIAL EQUIVALENCE TO PRIMARY PREDICATE

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

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

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Image /page/6/Picture/0 description: The image shows the logo for Zeiss. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue background. The blue background is in the shape of a rectangle with a curved bottom edge.

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

| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4 | CIRRUS™ HD-OCT 5000 v. 10.0 | Analysis |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device (K181534) | |
| Device Classification<br>Name | Tomography, Optical Coherence | Tomography, Optical Coherence | Identical |
| Generic/<br>Common Name | Optical Coherence Tomography (OCT) | Optical Coherence Tomography (OCT) | Identical |
| Classification Product<br>Code | OBO | OBO | Identical |
| Class | II | II | Identical |
| Technology | Spectral Domain (Spatially encoded<br>Frequency Domain and Fourier<br>Domain Principle) OCT | Spectral Domain (Spatially encoded<br>Frequency Domain and Fourier<br>Domain Principle) OCT | Identical |
| Illumination Sources<br>used in Instrument | Light Emitting Diode 700 nm - Iris<br>Viewer<br>LSO Super Luminescent Diode 750 nm<br>OCT Super Luminescent Diode<br>840 nm | Light Emitting Diode 700 nm - Iris<br>Viewer<br>LSO Super Luminescent Diode 750 nm<br>OCT Super Luminescent Diode<br>840 nm | Identical |
| Models | 6000 | 5000 | N/A |
| OCT IMAGING | | | |
| Methodology | Spectral domain OCT (SD-OCT) | Spectral domain OCT (SD-OCT) | Identical |
| K222200 - 510(k) Summary | | Page 5 of 41 | |
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4<br>Subject Device | CIRRUSTM HD-OCT 5000 v. 10.0<br>Predicate Device (K181534) | Analysis |
| OCT Optical Source | OCT Super Luminescent Diode,<br>840 nm wavelength | OCT Super Luminescent Diode,<br>840 nm wavelength | Identical |
| Optical Power | $1200 \mu W +/- 300 \mu W$ (0.9 - 1.5 mW)<br>at the cornea | $< 775 \mu W$ at the cornea | Different |
| Scan Speed | 100,000 A-scans per second | 27,000 A-scans per second<br>68,000 A-scans per second only for<br>OCT Angiography | Different |
| Axial Scan Depth<br>(Max)- Retina | • 2.9 mm for 12 mm 1 Line 100x<br>HD Raster, HD Angio 8x8,<br>Angio 8x8, and Angiography<br>12x12<br>• 2.0 mm for all other scans | 2.0 mm | Different |
| Axial Scan Depth<br>(Max)- Retina | 2.0 mm (in tissue), 1024 pixels per A-<br>scans for all other scan except for the<br>ones listed above | 2.0 mm (in tissue), 1024 pixels per A-scans. | Identical |
| Axial Scan Depth (Max)<br>-Anterior Segment | 2.0 mm (Anterior 5-Line Raster) –<br>1024 points2.0 mm (Anterior Segment<br>Cube) – 1024 points | 2.0 mm (Anterior 5-Line Raster) –<br>1024 points2.0 mm (Anterior Segment<br>Cube) - 1024 points | Identical |
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4<br>Subject Device | CIRRUS™ HD-OCT 5000 v. 10.0<br>Predicate Device (K181534) | Analysis |
| | 5.8 mm (Anterior Chamber) – 2048<br>points | 5.8 mm (Anterior Chamber) – 2048<br>points | |
| | 2.9 mm (Wide Angle-to-Angle) – 1024<br>points | 2.9 mm (Wide Angle-to-Angle) – 1024<br>points | |
| | 2.9 mm (HD Angle) – 1024 points | 2.9 mm (HD Angle) – 1024 points | |
| | 2.0 mm (HD Cornea) – 1024 points | 2.0 mm (HD Cornea) – 1024 points | |
| | 2.0 mm (Pachymetry) – 1024 points | 2.0 mm (Pachymetry) – 1024 points | |
| External Anterior<br>Segment Lens | Anterior Chamber Lens<br>Cornea Lens | Anterior Chamber Lens<br>Cornea Lens | Identical |
| Transverse Scan 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>31° x 31° on retina (Maximum) | Different |
| Transverse Scan Range<br>-Anterior Segment | 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) | Identical |
| Transverse Resolution –<br>Retina | ≤ 15 µm (in tissue) | ≤ 15 µm (in tissue) | Identical |
| K222200 - 510(k) Summary | | Page 7 of 41 | |
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4<br>Subject Device | CIRRUS™ HD-OCT 5000 v. 10.0<br>Predicate Device (K181534) | Analysis |
| Transverse Resolution -<br>Anterior Segment | 20 μm (in tissue)<br>20 μm @ 6mm FOV<br>25 μm @ 9mm FOV<br>45 μm @ 15mm FOV | 20 μm (in tissue)<br>20 μm @ 6mm FOV<br>25 μm @ 9mm FOV<br>45 μm @ 15mm FOV | Identical |
| Scan patterns<br>Non-angiography | Line, circle, crosshair, raster (a series<br>of closely spaced lines, aka cube scan),<br>radial scans and combinations of the<br>above. | Line, circle, crosshair, raster (a series<br>of closely spaced lines, aka cube scan),<br>radial scans and combinations of the<br>above. | Identical |
| Scan types<br>Non-angiography | Macular Cube 512 x 128 = 6 mm x 6<br>mm | Macular Cube 512 x 128 = 6 mm x 6<br>mm | Identical |
| | Macular Cube 200 x 200 = 6 mm x 6<br>mm | Macular Cube 200 x 200 = 6 mm x 6<br>mm | Identical |
| | Optic Disc Cube 200 x 200 = 6 mm x 6<br>mm | Optic Disc Cube 200 x 200 = 6 mm x 6<br>mm | Identical |
| | Not Available | 5-Line Raster | Different, scan type not<br>available for CIRRUS 6000 |
| | HD (high-definition) Raster<br>HD 1 Line 100x (2.9 mm depth<br>and up to 12 mm in length) | HD (high-definition) Raster<br>HD 1 Line 100x (2.0 mm depth<br>and up to 9 mm in length) | Identical except for HD 1 Line<br>100x scan depth and max length |
| K222200 - 510(k) Summary | | Page 8 of 41 | |
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4<br>Subject Device | CIRRUS™ HD-OCT 5000 v. 10.0<br>Predicate Device (K181534) | Analysis |
| | - HD 21 Line<br>- HD Radial<br>- HD Cross<br>- HD 5-Line Raster | - HD 21 Line<br>- HD Radial<br>- HD Cross<br>- HD 5-Line Raster | Identical |
| | Anterior Segment Cube 512 x 128 | Anterior Segment Cube 512 x 128 | Identical |
| | Anterior Segment 5-Line Raster | Anterior Segment 5-Line Raster | Identical |
| | HD Angle | HD Angle | Identical |
| | Anterior Chamber | Anterior Chamber | Identical |
| | Wide Angle-to-Angle | Wide Angle-to-Angle | Identical |
| | HD Cornea | HD Cornea | Identical |
| | Pachymetry | Pachymetry | Identical |
| OCT Angiography scans | Scans: | Scans:…