PLEX Elite 9000 SS-OCT

K161194 · Carl Zeiss Meditec, Inc. · OBO · Oct 26, 2016 · Ophthalmic

Device Facts

• Record ID: K161194
• Device Name: PLEX Elite 9000 SS-OCT
• Applicant: Carl Zeiss Meditec, Inc.
• Product Code: OBO · Ophthalmic
• Decision Date: Oct 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures.

Device Story

PLEX Elite 9000 is a desktop SS-OCT system for posterior ocular imaging. It uses a 1060 nm swept-source laser and low-coherence interferometry to acquire high-resolution cross-sectional tomograms and en face images without eye contact. The device features FastTrac 2.0 for real-time motion correction and OMAG (Optical Microangiography) processing for non-invasive retinal/choroidal microvasculature visualization. Operated by clinicians in a clinic setting, the system provides 3D structural and vascular data. Healthcare providers use these images to visualize ocular anatomy and blood flow, aiding in the detection and management of retinal and choroidal diseases. Benefits include high-resolution, wide-field imaging with improved depth penetration compared to spectral-domain OCT, enabling visualization of deeper ocular structures without intravenous contrast agents.

Clinical Evidence

Clinical evidence includes a case series comparing PLEX Elite 9000 OCT angiography to FA, ICGA, CIRRUS HD-OCT angiography, and color fundus photography in subjects with retinal pathologies (e.g., ischemia, microaneurysms, choroidal neovascularization). Results demonstrated high-quality imaging of retinal/choroidal structures and microvasculature comparable to the predicate. Supporting literature review provided for clinical efficacy of the SS-OCT laser system.

Technological Characteristics

Desktop SS-OCT system; 1060 nm swept-source tunable laser (Class 1); 100,000 A-scans/sec; 3.0 mm axial scan depth; 1536 pixels per A-scan. Includes iris viewer (700 nm LED) and line-scanning ophthalmoscope (750 nm SLD). Connectivity includes system computer with up to 24 TB storage. Software version 1.0 utilizes OMAG complex processing for angiography.

Indications for Use

Indicated for in-vivo viewing, axial cross-sectional, and 3D imaging of posterior ocular structures, including retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous, and choroid. Angiography feature indicated as an aid in visualization of retinal and choroidal vascular structures.

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 (K150977)

Reference Devices

• IOL Master 700 (K143275)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 26, 2016

Carl Zeiss Meditec, Inc. Ms. Christine Dunbar Manager, Regulatory Submissions 5160 Hacienda Drive Dublin, CA 94568

Re: K161194

Trade/Device Name: Plex Elite 9000 SS-OCT Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: September 12, 2016 Received: September 13, 2016

Dear Ms. Dunbar:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

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

Enclosure

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### Indications for Use

510(k) Number (if known) K161194

Device Name PLEXTM Elite 9000 SS-OCT

Model 9000

Indications for Use (Describe)

The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retinal nerve fiber layer, ganglion cell plus inner plexiform laver, macula, optic nerve head, vitreous and choroid.

The PLEX™ Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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510(K) SUMMARY

## 510(K) SUMMARY

#### 510(k) SUMMARY (Per 21 CFR §807.92)

PLEXTM Elite 9000 Swept-Source OCT With Software Version 1.0

### GENERAL INFORMATION

| Manufacturer: | Carl Zeiss Meditec, Inc.<br>5160 Hacienda Drive<br>Dublin, California 94568<br>[phone] (phone)<br>[phone] (fax)<br>Est. Reg. No. 2918630 |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christine Dunbar<br>Manager, Regulatory Affairs Submissions<br>Carl Zeiss Meditec, Inc.<br>5160 Hacienda Drive<br>Dublin, California 94568<br>[phone] (phone)<br>[phone] (fax) |
| Date Summary Prepared: | October 21, 2016 |
| Classification name: | Tomography, Optical Coherence; Ophthalmoscope |
| Classification: | Class II (acc. 21 CFR 886.1570) |
| Product Code: | OBO |
| Trade/Proprietary name: | PLEX Elite 9000 SS-OCT |
| Common Name | Swept Source Optical Coherence Tomography System |
| Substantial Equivalence Claimed To (21 CFR §807.92(a)(3)) | |
| Company:<br>Device: | Carl Zeiss Meditec, Inc.<br>CIRRUS™ HD-OCT (K150977) |
| Reference Predicate: | |
| Company: | Carl Zeiss Meditec AG |
| Device: | IOL Master 700 (K143275) |

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The PLEX Elite 9000 SS-OCT system as described in this premarket notification has the similar intended use, indications for use, and fundamental scientific technical characteristics as the predicate and reference devices listed above.

#### INTENDED USE / INDICATIONS FOR USE (21 CFR §807.92(a)(5))

Intended Use Statement:

The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures.

Indications for Use Statement:

The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing. axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid.

The PLEX™ Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

#### DEVICE DESCRIPTION SUMMARY (21 CFR §807.92(a)(4))

The PLEX™ Elite 9000 SS-OCT is a computerized instrument that acquires cross-sectional tomograms of the posterior ocular structures (including cornea, retinal nerve fiber laver, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, the PLEX Elite SS-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye) and non-contrast angiographic imaging of the retinal microvasculature.

The PLEX Elite 9000 SS-OCT is offered in one model, the Elite 9000 in a new compact desktop system. The PLEX Elite SS-OCT contains a swept source, Class 1 Laser system operating at 1060 nm and includes a new system computer and archive with up to 24 TB storage capacity. The PLEX Elite also contains an iris viewer, fixation system and the fundus camera is a similar line-scanning ophthalmoscope (LSO) as used on the CIRRUS HD-OCT system, model 4000.

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New Features consist of the following:

- . New -> Swept Source OCT system in a compact, desktop system.
- . New → Swept Source Laser system, operating at 1060 nm wavelength, acquiring 100,000 A-Scans a second. The new PLEX Elite 9000 system utilizes the same OEM swept source laser system as the IOLMaster 7001 and is a computerized instrument that acquires and analyzes cross-sectional tomograms of anterior and posterior ocular structures (including cornea, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain highresolution images. It produces images of the retina and layers of the retina from an en face perspective and supports the acquisition of angiographic data to evaluate the microvasculature of the retina without the use of intravenous contrast agents.
- New -> High Definition Scan: ●
- HD 1 Line 10 x 100 Spotlight Scan, a 1 high-definition single line scan o This scan generates a single ultra-high definition scan at a depth of 2.0 mm by averaging from 10 to 100 B-scans, each composed of 1536 A-scans. The scan can be positioned anywhere on the fundus image
- Updated → FastTrac™ 2.0 Retinal Tracking Technology The PLEX Elite 9000 uses . multiple channels of concurrent imaging and proprietary algorithms to monitor and correct for the motion of the eye in real-time. The motion of the retina is observed at a high rate to ensure higher efficiency in reducing the effects of motion; FastTrac ensures faster data acquisition by only re-scanning selective data that might be affected by motion. FastTrac also allows precise scanning at follow-up visits to acquire data at the same region of the eye.
- . Updated -> En Face Analysis and Macular Cube Scans: Automatically finds and displays retinal layers in existing 12x12 mm macular cube scans, including the optic nerve head (512x512 or 800x800 or 1024x1024) scans. The user can visualize en face (cscan), or partial en face, views of the same data. The user can choose any of the three surfaces as the basis for the partial en face images. A partial en face image is formed by the summation of image intensities based on one or more retinal contours.
- Updated -> OCT Angiography: PLEX Elite SS-OCT Angiography images are processed . to provide detailed images of ocular blood flow without the use of intravenous dyes to visualize microvasculature structures of the eye. The flow data that is generated by processing OCT images with OMAG has the same resolution and axial and transverse

¹ Note, due to differences in the intended use of the IOLMaster 700 (Biometry for anterior structures and OCT imaging for Axial length and Fixation) and the PLEX Elite 9000 (OCT imaging for posterior ocular structures and angiography) the implementation of the SS-OCT Engine is different.

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# 510(K) SUMMARY

extent as the OCT intensity and phase data, and therefore depth resolved flow images can be generated and displayed.

#### Updated -> Angio PLEX™ OCT Angiography .

(Market name for PLEX Elite 9000, SS-OCT Angiography)

A series of studies were performed comparing CIRRUS OCT angiography scans of 3x3 mm and 6x6 mm with the PLEX Elite SS-OCT angiography scans of the same dimensions. The findings demonstrate that the PLEX Elite Angiography, in combination with OCT OMAG Complex (intensity and phase) processing, can produce non-invasive three-dimensional information regarding retinal microvasculature with a higher signal-to-noise ratio and an increased depth of penetration as compared to the CIRRUS OCT angiography with intensity only processing.

AngioPLEX Angiography is not intended as a substitute for fluorescein angiography. Vascular findings on fluorescein angiography may be absent, poorly defined, or variably defined on AngioPLEX Angiography. Additionally, leakage, staining, and pooling are not features of AngioPLEX Angiography.

#### Risk Management and General Safety and Effectiveness

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

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

#### Technological Characteristics and Substantial Equivalence (21 CFR §807.92(a)(6)):

It is the opinion of Carl Zeiss Meditec. Incorporated that the proposed device, the PLEX Elite 9000 SS-OCT system, is substantially equivalent to the CIRRUS HD-OCT with Software Version 8.0 supported by the IOLMaster 700 with an internal SS-OCT system.

The indications for use for the PLEX Elite 9000 is similar to the indications for the primary predicate device CIRRUS HD-OCT with Software Version 8.0.

#### Summary of Verification and Validation Activity (21 CFR §807.92(b)):

#### Bench Testing (21 CFR §807.92(b)(1))

Bench testing in the form of Unit, Integration and System Integration testing was performed to evaluate the performance and functionality of the software version 1.0. The System level

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# 510(K) SUMMARY

software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the Test Plans.

#### Non-Clinical Test Results (21 CFR §807.92(b)(2))

Non-clinical testing-has been performed for the purpose of supporting technological claims for the improved signal-to-noise and penetration of the swept source laser system using a 1060 nm wavelength as compared to the same scans acquired on the predicate CIRRUS HD-OCT system using a SLD at 840 nm.

#### Testing to Consensus Standards (21 CFR §807.92(b)(1))

The PLEX Elite 9000 SS-OCT system has been tested (as needed) to meet the requirements for conformity (where applicable) to multiple industry standards. The R&D evaluation of the relevant testing to consensus standards is documented.

#### Substantial Equivalence to Predicates (21 CFR §807.92(b)(1))

Verification testing to the system requirements (SRS) for the PLEX Elite 9000 SS-OCT system and the validation of the intended use is intended to support the claim of substantial equivalence to the following primary predicate supported by the reference predicate:

| Product<br>Indications for Use | 510(k)<br>Clearance /<br>Date | Claim of Equivalence for: |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (Primary predicate)The CIRRUSTM HD-<br>OCT is a non-contact, high resolution<br>tomographic and biomicroscopic imaging<br>device 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, retina, retinal nerve fiber layer,<br>ganglion cell plus inner plexiform layer,<br>macula, and optic nerve head. | K150977 /<br>September<br>01, 2015 | The PLEXTM Elite 9000 Swept-Source<br>OCT [SS-OCT] is a non-contact, high<br>resolution, wide field of view tomographic<br>and biomicroscopic imaging device<br>intended for in-vivo viewing, axial cross-<br>sectional and three-dimensional imaging<br>of posterior ocular structures. The device<br>is indicated for visualizing posterior<br>ocular structures including, but not limited<br>to, retina, retinal nerve fiber layer,<br>ganglion cell plus inner plexiform layer,<br>macula, optic nerve head, vitreous and<br>choroid. |
| The CIRRUS OCT Angiography is<br>indicated as an aid in the visualization of<br>vascular structures of the retina and<br>choroid. | | The PLEXTM Elite SS-OCT angiography<br>is indicated as an aid in the visualization<br>of vascular structures of the retina and<br>choroid. |
| The CIRRUS HD-OCT is indicated as a<br>diagnostic device to aid in the detection and<br>management of ocular diseases including,<br>but not limited to, macular holes, cystoid<br>macular edema, diabetic retinopathy, age-<br>related macular degeneration, and<br>glaucoma. | | |

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## 510(K) SUMMARY

| Product<br>Indications for Use | 510(k)<br>Clearance /<br>Date | Claim of Equivalence for: |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (Reference predicate) ZEISS IOLMaster<br>700<br>The IOLMaster 700 is intended for<br>biometric measurements and visualization<br>of ocular structures. The measurements and<br>visualization assist in the determination in<br>the appropriate power and type of<br>intraocular lens.<br>The IOLMaster 700 employs non-invasive,<br>non-contact low coherence interferometry<br>(SS-OCT) to obtain cross-sectional images<br>of the eye. | K143275 /<br>July 10,<br>2015 | PLEXTM Elite SS-OCT with Software<br>Version 1.0 is a non-contact, high<br>resolution, wide field of view tomographic<br>and biomicroscopic imaging device<br>intended for in-vivo viewing, axial cross-<br>sectional and three-dimensional imaging<br>of posterior ocular structures. |

### Substantial Equivalence Table

### Comparison Table of Predicate CIRRUS HD-OCT v8.0 And Proposed PLEX Elite 9000

#### Highlighted areas are New or Modified Technology for PLEX Elite 9000

| Device | CIRRUSTM HD-OCT v8.0<br>(K150977) - Primary Predicate<br>Device | PLEXTM Elite 9000 SS-OCT<br>Proposed Device | Discussion |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The CIRRUS HD-OCT with Retinal<br>Nerve Fiber Layer (RNFL),<br>Macular, Optic Nerve Head and<br>Ganglion Cell Normative Databases<br>is indicated for in-vivo viewing,<br>axial cross-sectional, and three-<br>dimensional imaging and<br>measurement of anterior and<br>posterior ocular structures. | The PLEXTM Elite 9000 Swept-<br>Source OCT [SS-OCT] is a non-<br>contact, high resolution, wide field<br>of view tomographic and<br>biomicroscopic imaging device<br>intended for in-vivo viewing, axial<br>cross-sectional and three-<br>dimensional imaging of posterior<br>ocular structures. | Same intended use. |
| Indications<br>for Use | The CirrusTM HD-OCT is a non-<br>contact, high resolution tomographic<br>and biomicroscopic imaging device.<br>It is indicated for in-vivo viewing,<br>axial cross-sectional, and three-<br>dimensional imaging and<br>measurement of anterior and<br>posterior ocular structures, including<br>cornea, retina, retinal nerve fiber<br>layer, ganglion cell plus inner<br>plexiform layer, macula, and optic<br>nerve head.<br>The CIRRUS normative databases<br>are quantitative tools 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 of<br>normal subjects. | The PLEXTM Elite 9000 Swept-<br>Source OCT [SS-OCT] is a non-<br>contact, high resolution, wide field<br>of view tomographic and<br>biomicroscopic imaging device<br>intended for in-vivo viewing, axial<br>cross-sectional and three-<br>dimensional imaging of posterior<br>ocular structures.<br>The device is indicated for<br>visualizing posterior ocular<br>structures including, but not limited<br>to, retina, retinal nerve fiber layer,<br>ganglion cell plus inner plexiform<br>layer, macula, optic nerve head,<br>vitreous and choroid. | Similar Indications for use.<br>PLEX Elite does not contain<br>a normative database in the<br>R 1.0 release. |
| Device | CIRRUSTM HD-OCT v8.0<br>(K150977) - Primary Predicate<br>Device | PLEXTM Elite 9000 SS-OCT<br>Proposed Device | Discussion |
| | The CIRRUS OCT angiography is<br>indicated as an aid in the<br>visualization of vascular structures<br>of the retina and choroid.<br>The Cirrus HD-OCT is intended for<br>use as a diagnostic device to aid in<br>the 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. | The PLEXTM Elite SS-OCT<br>angiography is indicated as an aid in<br>the visualization of vascular<br>structures of the retina and choroid. | Same Indications for Use for<br>Angiography. |
| Device<br>Classification<br>Name | Optical Coherence Tomographer<br>(OCT) | Optical Coherence Tomographer<br>(OCT) | Same |
| Technology | Spectral Domain (Spatially encoded<br>Frequency Domain and Fourier<br>Domain Principle) OCT | Spectral Domain (Time encoded<br>Frequency Domain and Fourier<br>Domain Principle) OCT | Similar purpose, change<br>from spatial to time encoded<br>spectra with new light source<br>technology. |
| Illumination<br>Sources used<br>in<br>Instrument | Light Emitting Diode 700 nm - Iris Viewer Super Luminescent Diode 750 nm - LSO Super Luminescent Diode 840 nm - OCT Imager | Light Emitting Diode 700 nm - Iris Viewer Super Luminescent Diode 750 nm - LSO Swept Source Tunable Laser 1060 nm - OCT Imager | New laser light source and<br>longer wavelength for<br>similar imaging of the eye<br>using a non-invasive optical<br>technique produces high-<br>resolution cross-sectional<br>tomograms of the eye<br>without contacting the eye.<br>Swept Source Laser is Class<br>1. |
| Laser Class<br>Based on<br>IEC 60825-<br>1:2007 | N/A | Class 1 | |
| Optical<br>Power | <0.775 mW at the cornea | < 5.4 mW at the cornea*<br>*controlled by an electronic safety<br>interlock. | Different optical power<br>allowed due to longer<br>wavelength with the swept<br>source laser light<br>technology. |
| Scan Speed | 27,000 A-scan points per second<br>(Model 4000)<br>27,000 A-scans/sec (Model 500)<br>68,000 A-scans/sec:<br>Model 5000 only for OCT<br>Angiography scans | 100,000 A-scan points per second<br>for all scan types. | Similar purpose, increased<br>scan speed due to change in<br>detection technology (from<br>CCD to a single channel<br>detection). |
| Scan Speed<br>OCT<br>Angio-<br>graphy<br>feature | 68,000 A-scan points per second<br>(Model 5000) | 100, 000 A-scans points per second | Similar purpose, increased<br>scan speed due to change in<br>detection technology (from<br>CCD to a single channel<br>detection).<br>Higher density A-lines and B<br>scan per acquisition. |
| Axial Scan<br>Depth<br>(Max)-<br>Retina<br>Cube scan | 2.0 mm (in tissue), 1024 pixels per<br>A-scans. | 3.0 mm (in tissue), 1536 pixels per<br>A-scans* | Same acquisition feature<br>with same pixel size but<br>larger matrix (more pixels)<br>results in same pixel density |
| Device | CIRRUSTM HD-OCT v8.0<br>(K150977) - Primary Predicate<br>Device | PLEXTM Elite 9000 SS-OCT<br>Proposed Device | Discussion |
| Transverse<br>Scan Range<br>(Lateral<br>range in<br>degrees)<br>Retina | 10° x 0° on retina (Minimum)<br>31° x 31° on retina (Maximum) | 14° x 0° on retina (Minimum line<br>scan)<br>42° x 42° on retina (Cube)<br>56° x 0° on retina (Maximum line<br>scan) | Same acquisition feature<br>with an increased range due<br>to minor change in<br>technology. |
| Axial Scan<br>Depth<br>(Max)-<br>Retina | 2.0 mm (HD 1 Line (100x)) 1024<br>pixels (A-scans) | 3.0 mm -HD 1 Line (10 x 100x)<br>1536 pixels per A-scans | Same acquisition feature<br>with same pixel size but<br>larger matrix (more pixels)<br>results in same pixel density<br>and larger depth range. |
| Axial<br>Resolution | 5 µm (in tissue) | 5.5 µm (in tissue) | Similar resolution, change<br>due to wavelength of<br>imaging beam. |
| Transverse<br>Resolution -<br>Retina | ≤ 15 µm (in tissue) | ≤ 20 µm (in tissue) | Similar resolution, change in<br>technology. |
| Scan Pixels<br>Axial and<br>Transverse<br>sampling | 1024 axial x<br>(200-4096*) transverse<br>*HD Raster Scans | 1536 axial x<br>(300-1024*) transverse<br>*HD Spotlight and HD Cube scans | Similar imaging scans, |
| Acquisition<br>Time | Up to 8 seconds without tracking<br>(depending on number of pixels<br>scanned) | Up to 12 seconds without tracking<br>(depending on number of pixels<br>scanned) | Acquiring more data<br>(transverse density and axial<br>length) per scan. |
| Scan types<br>Non-Angio-<br>graphy | Macular Cube 512 x 128 = 6 mm x<br>6 mm<br>Macular Cube 200 x 200 = 6 mm x<br>6 mm<br>Optic Disc Cube 200 x 200=6 mm x<br>6 mm<br>HD (high-definition)<br>-HD 1 Line (100x)<br>-Enhanced Depth Imaging<br>mode (EDI) | NEW →Macular Cube 512 x 512 =<br>12 mm x 12 mm<br>NEW →Macular Cube 800 x 800 =<br>12 mm x 12 mm<br>NEW →Macular Cube 1024 x 1024<br>=12 mm x 12 mm<br>(All Mac Cube can include Optic<br>Nerve Head)<br>NEW →HD (high-definition)<br>NEW →HD Single Line Scan (10x-<br>100x)<br>-Enhanced Depth Imaging<br>mode (EDI) | Similar scan acquisition<br>types, increased field of<br>view due to change in<br>imaging technology. |
| OCT<br>Angio-<br>graphy<br>Cube | OCT Angiography:<br>Where the matrix along the z axis is<br>1024 pixels<br>Scans:<br>3x3 mm scans<br>6x6 mm scans | NEW →Where the matrix along the<br>z axis is 1536 pixels.<br>NEW →Scans:<br>3mmx3mm<br>6mmx6mm<br>9mmx9mm<br>12mmx12mm | Similar angiography scan<br>acquisition types, increased<br>field of view and density due<br>to change in imaging<br>technology. |
| Retina<br>Tracking | FastTrac Feature<br>Track-to-prior to Scan Acquisition<br>tracking. | FastTrac Feature<br>Track-to-prior to Scan Acquisition<br>tracking. | Same |
| OCT<br>Angio-<br>graphy<br>(aka OCTA) | En Face Algorithm - Modified to<br>support Intensity and a flow cube<br>(Angiography) | Modification →En Face Algorithm<br>- Modified to support Intensity and<br>Phase and a flow cube.<br>NEW →Angiography OMAG<br>Complex and a structure cube.<br>Algorithm - Modified to support<br>OMAG reconstruction. | Improved angiography<br>algorithm, higher signal to<br>noise, density and field of<br>view due to change in<br>technology. |
| Device | CIRRUSTM HD-OCT v8.0<br>(K150977) - Primary Predicate<br>Device | PLEXTM Elite 9000 SS-OCT<br>Proposed Device | Discussion |
| ANALYSIS AND REPORTS | | | |
| Cube Scan<br>Display<br>Macula<br>Analysis | Cube Scan Display:<br>■ Analyses for the Macula:<br>Macular thickness<br>analysis<br>Macular 3D color<br>thickness map | Cube Scan Display:<br>■ Analyses for the Macula /<br>ONH:<br>Macular 3D color<br>thickness map<br>Macular Cube scans provide<br>information about optic disc and<br>fovea parameters including (but not<br>limited to):<br>• Size (calipers)<br>• Cup, disc, rim area and volume<br>• Nerve fiber layer thickness<br>• Ganglion cell layer thickness<br>(macular cube) | Same basic features. |
| Optic Nerve<br>Head (ONH)<br>analysis | ■ Optic Nerve Head (ONH)<br>analysis<br>Rim Area / Disc Area<br>Cup Volume<br>Neuro-retinal Rim<br>Thickness<br>B-scan cross section of the<br>ONH<br>B-scan slices and<br>segmentation | In turn, scan Results screens<br>(Review Scan Results) provide tools<br>such as calipers for RNFL and<br>Ganglion cell layer estimation. | |
| Advanced<br>Visualization<br>Display | ■ Advanced Visualization<br>Display<br>Fundus Image with en<br>face overlay<br>Slice navigators<br>Horizontal B-scan (X-<br>image)<br>Vertical slice - A-scan (Y-<br>image)<br>Top slab – C- scan (Z<br>image)<br>Segmentation line toggle<br>Measurement calipers<br>Zoom controls<br>Save Image options<br>Movie option | ■ Advanced Visualization<br>Display<br>Fundus Image with en<br>face overlay<br>Slice navigators<br>Horizontal B-scan (X-<br>image)<br>Vertical slice - A-scan (Y-<br>image)<br>Top slab-C- scan (Z<br>image)<br>Segmentation line toggle<br>Measurement calipers<br>Add Annotation<br>Zoom controls<br>Save Image options<br>Movie option<br>3-D color Thickness map<br>NEW →Alternate Depth<br>View<br>NEW →Thumbnail<br>images | ■ Same basic features. |
| HD Scans | HD 5-Line Raster<br>HD 1 Line 100x<br>HD 21 Line<br>HD Radial<br>HD Cross | Modification →HD Scan<br>HD 1 Line 10 to 100x averaging<br><br>See HD 1 Line 10 - 100x -<br>Spotlight | Same scan acquisition,<br>selectable averaging |
| Device | CIRRUSTM HD-OCT v8.0<br>(K150977) - Primary Predicate<br>Device | PLEXTM Elite 9000 SS-OCT<br>Proposed Device | Discussion |
| Normative<br>Database | Retinal Nerve Fiber Layer (RNFL)<br>Macular<br>Optic Nerve Head (ONH)<br>Ganglion Cell | The PLEX Elite 9000 does not<br>contain a Normative Database in<br>Release 1.0. | N/A |
| | CIRRUS HD-OCT<br>FUNDUS IMAGING<br>Models 4000 & 5000 | 1.1.1. PLEX ELITE SS-OCT<br>1.1.2. FUNDUS IMAGING<br>1.1.3. MODEL 9000…