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

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 layer, 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.

AI/ML Overview

The provided text describes the Carl Zeiss Meditec, Inc. K161194 submission for the PLEX Elite 9000 SS-OCT device. However, it does not explicitly detail a standalone study with acceptance criteria and reported device performance in the format requested. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technological comparisons, bench testing, non-clinical tests, and a clinical case series.

Here's an attempt to extract and synthesize the information based on the provided document, acknowledging the limitations regarding the specific details of a formal "acceptance criteria and study" as might be found in a performance study report:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific quantitative targets and corresponding reported performance for a standalone clinical study. Instead, it describes general claims of improved performance compared to the predicate device.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (PLEX Elite 9000 SS-OCT)
Image Quality	Images of posterior ocular structures should be "high quality" and visualize structures as well as or better than the predicate device.	"produce high quality images of the retina and choroid."
Signal-to-Noise Ratio	Improved signal-to-noise ratio compared to the predicate device (CIRRUS HD-OCT).	"higher signal-to-noise ratio and an increased depth of penetration as compared to the CIRRUS OCT angiography with intensity only processing."
Depth Penetration	Increased depth penetration compared to the predicate device (CIRRUS HD-OCT).	"higher signal-to-noise ratio and an increased depth of penetration as compared to the CIRRUS OCT angiography with intensity only processing." Also, axial scan depth is 3.0 mm (in tissue) for PLEX Elite 9000 vs. 2.0 mm for predicate.
Field of View	Wider field of view for imaging posterior ocular structures compared to the predicate device.	"wider field of view, increased depth penetration and with a higher signal-to-noise ratio as compared to the CIRRUS HD-OCT system." Also, transverse scan range up to 42°x42° (Cube) and 56°x0° (Max line scan) for PLEX Elite 9000, compared to 31°x31° (Max) for predicate.
Visualization of Vascular Structures	Ability to image vascular structures of the retina and choroid as well as the predicate device.	"The PLEX Elite 9000 angiography scans were shown to image the structures of the retina and choroid as well as the predicate CIRRUS HD- OCT device."
Scan Speed (OCT)	Higher scan speed than the predicate device.	100,000 A-scan points per second for all scan types, compared to 27,000-68,000 A-scans/sec for the predicate.
Axial Resolution	Similar axial resolution to the predicate.	5.5 µm (in tissue) for PLEX Elite 9000, compared to 5 µm (in tissue) for predicate. Described as "Similar resolution, change due to wavelength of imaging beam."
Transverse Resolution	Similar transverse resolution to the predicate.	≤ 20 µm (in tissue) for PLEX Elite 9000, compared to ≤ 15 µm (in tissue) for predicate. Described as "Similar resolution, change in technology."
Safety	Compliance with relevant international standards and risk mitigation.	"Risk management is ensured via a risk analysis... These potential hazards are controlled by software means, user instructions, verification of requirements and validation of the clinical workflow... To minimize electrical, mechanical and radiation hazards, ZEISS adheres to recognized and established industry practice and relevant international standards." Laser is Class 1. Controlled optical power < 5.4 mW at the cornea with electronic safety interlock.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions a "case series study" as part of the clinical report. However, it does not specify the exact sample size of patients or images used for this case series. It only states that the study included "subjects with varying retinal pathologies."

The data provenance is implicit: the clinical imaging was "performed on human eyes," indicating prospective data collection for the purpose of this submission, likely from clinical sites where the device was being evaluated. The document does not specify the country of origin of the data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions that a "clinical report is provided that includes clinical images" and compares PLEX Elite 9000 OCT angiography to "FA, ICGA, CIRRUS HD-OCT angiography, and color fundus photography." This implies that existing clinical imaging modalities and potentially expert interpretations of these modalities were used as a reference, but the process for establishing ground truth for the test set images is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for images or findings within the clinical report/case series. The comparison is made against other imaging modalities like FA and ICGA, suggesting these served as reference standards, but a formal adjudication process for a "test set" in the context of an algorithm's performance is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, where human readers analyze images with and without AI assistance to quantify the effect size of AI improvement, is not described in this document. The clinical evaluation focuses on demonstrating the device's ability to produce high-quality images and visualize structures similarly to or better than the predicate, mostly through direct comparison of image characteristics and content.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

While the device itself is a standalone imaging system (producing images without human real-time intervention for image generation), the submission does not describe a standalone algorithm performance study. The context is that of an imaging device. The document does refer to "En Face Algorithm," "Angiography OMAG Complex and a structure cube Algorithm," and algorithms for retinal tracking, but there are no standalone performance metrics specifically for these algorithms presented in this summary beyond their contribution to image quality.

7. The Type of Ground Truth Used

The ground truth implicitly used for the clinical report/case series appears to be a combination of established clinical imaging modalities (Fluorescein Angiography (FA), Indocyanine Green Angiography (ICGA), CIRRUS HD-OCT angiography, and color fundus photography) for validating the visualization capabilities of the new SS-OCT angiography. For the general imaging capabilities (posterior ocular structures), the ground truth is the ability to visualize these structures as demonstrated by the images themselves and comparison to the predicate. No specific "expert consensus," "pathology," or "outcomes data" are explicitly stated as ground truth for the clinical evaluation of the device in this summary, although ICGA and FA are considered gold standards for certain vascular pathologies.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This submission is for an imaging device, not explicitly for an AI/CADe/CADx algorithm that requires a distinct training set in the way a deep learning model would. While the device utilizes "proprietary algorithms" for features like FastTrac™ 2.0 Retinal Tracking Technology and OCT angiography processing, the document does not elaborate on their development or training methodology.

9. How the Ground Truth for the Training Set Was Established

Since a training set and its sample size are not mentioned, the method for establishing its ground truth is also not provided in this document.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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.5160 Hacienda DriveDublin, California 94568(925) 557-4100 (phone)(925) 557-4259 (fax)Est. Reg. No. 2918630
Contact Person:	Christine DunbarManager, Regulatory Affairs SubmissionsCarl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, California 94568(925) 560-5139 (phone)(925) 557-4259 (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:Device:	Carl Zeiss Meditec, Inc.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:

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.

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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:

ProductIndications for Use	510(k)Clearance /Date	Claim of Equivalence for:
(Primary predicate)The CIRRUSTM HD-OCT is a non-contact, high resolutiontomographic and biomicroscopic imagingdevice intended for in-vivo viewing, axialcross-sectional, and three-dimensionalimaging of anterior and posterior ocularstructures. The device is indicated forvisualizing and measuring anterior andposterior ocular structures, includingcornea, retina, retinal nerve fiber layer,ganglion cell plus inner plexiform layer,macula, and optic nerve head.	K150977 /September01, 2015	The PLEXTM Elite 9000 Swept-SourceOCT [SS-OCT] is a non-contact, highresolution, wide field of view tomographicand biomicroscopic imaging deviceintended for in-vivo viewing, axial cross-sectional and three-dimensional imagingof posterior ocular structures. The deviceis indicated for visualizing posteriorocular structures including, but not limitedto, retina, retinal nerve fiber layer,ganglion cell plus inner plexiform layer,macula, optic nerve head, vitreous andchoroid.
The CIRRUS OCT Angiography isindicated as an aid in the visualization ofvascular structures of the retina andchoroid.		The PLEXTM Elite SS-OCT angiographyis indicated as an aid in the visualizationof vascular structures of the retina andchoroid.
The CIRRUS HD-OCT is indicated as adiagnostic device to aid in the detection andmanagement of ocular diseases including,but not limited to, macular holes, cystoidmacular edema, diabetic retinopathy, age-related macular degeneration, andglaucoma.

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510(K) SUMMARY

ProductIndications for Use	510(k)Clearance /Date	Claim of Equivalence for:
(Reference predicate) ZEISS IOLMaster700The IOLMaster 700 is intended forbiometric measurements and visualizationof ocular structures. The measurements andvisualization assist in the determination inthe appropriate power and type ofintraocular lens.The IOLMaster 700 employs non-invasive,non-contact low coherence interferometry(SS-OCT) to obtain cross-sectional imagesof the eye.	K143275 /July 10,2015	PLEXTM Elite SS-OCT with SoftwareVersion 1.0 is a non-contact, highresolution, wide field of view tomographicand biomicroscopic imaging deviceintended for in-vivo viewing, axial cross-sectional and three-dimensional imagingof 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(K150977) - Primary PredicateDevice	PLEXTM Elite 9000 SS-OCTProposed Device	Discussion
IntendedUse	The CIRRUS HD-OCT with RetinalNerve Fiber Layer (RNFL),Macular, Optic Nerve Head andGanglion Cell Normative Databasesis indicated for in-vivo viewing,axial cross-sectional, and three-dimensional imaging andmeasurement of anterior andposterior ocular structures.	The PLEXTM Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide fieldof view tomographic andbiomicroscopic imaging deviceintended for in-vivo viewing, axialcross-sectional and three-dimensional imaging of posteriorocular structures.	Same intended use.
Indicationsfor Use	The CirrusTM HD-OCT is a non-contact, high resolution tomographicand biomicroscopic imaging device.It is indicated for in-vivo viewing,axial cross-sectional, and three-dimensional imaging andmeasurement of anterior andposterior ocular structures, includingcornea, retina, retinal nerve fiberlayer, ganglion cell plus innerplexiform layer, macula, and opticnerve head.The CIRRUS normative databasesare quantitative tools for thecomparison of retinal nerve fiberlayer thickness, macular thickness,ganglion cell plus inner plexiformlayer thickness, and optic nervehead measurements to a database ofnormal subjects.	The PLEXTM Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide fieldof view tomographic andbiomicroscopic imaging deviceintended for in-vivo viewing, axialcross-sectional and three-dimensional imaging of posteriorocular structures.The device is indicated forvisualizing posterior ocularstructures including, but not limitedto, retina, retinal nerve fiber layer,ganglion cell plus inner plexiformlayer, macula, optic nerve head,vitreous and choroid.	Similar Indications for use.PLEX Elite does not containa normative database in theR 1.0 release.
Device	CIRRUSTM HD-OCT v8.0(K150977) - Primary PredicateDevice	PLEXTM Elite 9000 SS-OCTProposed Device	Discussion
	The CIRRUS OCT angiography isindicated as an aid in thevisualization of vascular structuresof the retina and choroid.The Cirrus HD-OCT is intended foruse as a diagnostic device to aid inthe detection and management ofocular diseases including, but notlimited to, macular holes, cystoidmacular edema, diabeticretinopathy, age-related maculardegeneration, and glaucoma.	The PLEXTM Elite SS-OCTangiography is indicated as an aid inthe visualization of vascularstructures of the retina and choroid.	Same Indications for Use forAngiography.
DeviceClassificationName	Optical Coherence Tomographer(OCT)	Optical Coherence Tomographer(OCT)	Same
Technology	Spectral Domain (Spatially encodedFrequency Domain and FourierDomain Principle) OCT	Spectral Domain (Time encodedFrequency Domain and FourierDomain Principle) OCT	Similar purpose, changefrom spatial to time encodedspectra with new light sourcetechnology.
IlluminationSources usedinInstrument	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 andlonger wavelength forsimilar imaging of the eyeusing a non-invasive opticaltechnique produces high-resolution cross-sectionaltomograms of the eyewithout contacting the eye.Swept Source Laser is Class1.
Laser ClassBased onIEC 60825-1:2007	N/A	Class 1
OpticalPower	<0.775 mW at the cornea	< 5.4 mW at the cornea**controlled by an electronic safetyinterlock.	Different optical powerallowed due to longerwavelength with the sweptsource laser lighttechnology.
Scan Speed	27,000 A-scan points per second(Model 4000)27,000 A-scans/sec (Model 500)68,000 A-scans/sec:Model 5000 only for OCTAngiography scans	100,000 A-scan points per secondfor all scan types.	Similar purpose, increasedscan speed due to change indetection technology (fromCCD to a single channeldetection).
Scan SpeedOCTAngio-graphyfeature	68,000 A-scan points per second(Model 5000)	100, 000 A-scans points per second	Similar purpose, increasedscan speed due to change indetection technology (fromCCD to a single channeldetection).Higher density A-lines and Bscan per acquisition.
Axial ScanDepth(Max)-RetinaCube scan	2.0 mm (in tissue), 1024 pixels perA-scans.	3.0 mm (in tissue), 1536 pixels perA-scans*	Same acquisition featurewith same pixel size butlarger matrix (more pixels)results in same pixel density
Device	CIRRUSTM HD-OCT v8.0(K150977) - Primary PredicateDevice	PLEXTM Elite 9000 SS-OCTProposed Device	Discussion
TransverseScan Range(Lateralrange indegrees)Retina	10° x 0° on retina (Minimum)31° x 31° on retina (Maximum)	14° x 0° on retina (Minimum linescan)42° x 42° on retina (Cube)56° x 0° on retina (Maximum linescan)	Same acquisition featurewith an increased range dueto minor change intechnology.
Axial ScanDepth(Max)-Retina	2.0 mm (HD 1 Line (100x)) 1024pixels (A-scans)	3.0 mm -HD 1 Line (10 x 100x)1536 pixels per A-scans	Same acquisition featurewith same pixel size butlarger matrix (more pixels)results in same pixel densityand larger depth range.
AxialResolution	5 µm (in tissue)	5.5 µm (in tissue)	Similar resolution, changedue to wavelength ofimaging beam.
TransverseResolution -Retina	≤ 15 µm (in tissue)	≤ 20 µm (in tissue)	Similar resolution, change intechnology.
Scan PixelsAxial andTransversesampling	1024 axial x(200-4096) transverseHD Raster Scans	1536 axial x(300-1024) transverseHD Spotlight and HD Cube scans	Similar imaging scans,
AcquisitionTime	Up to 8 seconds without tracking(depending on number of pixelsscanned)	Up to 12 seconds without tracking(depending on number of pixelsscanned)	Acquiring more data(transverse density and axiallength) per scan.
Scan typesNon-Angio-graphy	Macular Cube 512 x 128 = 6 mm x6 mmMacular Cube 200 x 200 = 6 mm x6 mmOptic Disc Cube 200 x 200=6 mm x6 mmHD (high-definition)-HD 1 Line (100x)-Enhanced Depth Imagingmode (EDI)	NEW →Macular Cube 512 x 512 =12 mm x 12 mmNEW →Macular Cube 800 x 800 =12 mm x 12 mmNEW →Macular Cube 1024 x 1024=12 mm x 12 mm(All Mac Cube can include OpticNerve Head)NEW →HD (high-definition)NEW →HD Single Line Scan (10x-100x)-Enhanced Depth Imagingmode (EDI)	Similar scan acquisitiontypes, increased field ofview due to change inimaging technology.
OCTAngio-graphyCube	OCT Angiography:Where the matrix along the z axis is1024 pixelsScans:3x3 mm scans6x6 mm scans	NEW →Where the matrix along thez axis is 1536 pixels.NEW →Scans:3mmx3mm6mmx6mm9mmx9mm12mmx12mm	Similar angiography scanacquisition types, increasedfield of view and density dueto change in imagingtechnology.
RetinaTracking	FastTrac FeatureTrack-to-prior to Scan Acquisitiontracking.	FastTrac FeatureTrack-to-prior to Scan Acquisitiontracking.	Same
OCTAngio-graphy(aka OCTA)	En Face Algorithm - Modified tosupport Intensity and a flow cube(Angiography)	Modification →En Face Algorithm- Modified to support Intensity andPhase and a flow cube.NEW →Angiography OMAGComplex and a structure cube.Algorithm - Modified to supportOMAG reconstruction.	Improved angiographyalgorithm, higher signal tonoise, density and field ofview due to change intechnology.
Device	CIRRUSTM HD-OCT v8.0(K150977) - Primary PredicateDevice	PLEXTM Elite 9000 SS-OCTProposed Device	Discussion
ANALYSIS AND REPORTS
Cube ScanDisplayMaculaAnalysis	Cube Scan Display:■ Analyses for the Macula:Macular thicknessanalysisMacular 3D colorthickness map	Cube Scan Display:■ Analyses for the Macula /ONH:Macular 3D colorthickness mapMacular Cube scans provideinformation about optic disc andfovea parameters including (but notlimited to):• Size (calipers)• Cup, disc, rim area and volume• Nerve fiber layer thickness• Ganglion cell layer thickness(macular cube)	Same basic features.
Optic NerveHead (ONH)analysis	■ Optic Nerve Head (ONH)analysisRim Area / Disc AreaCup VolumeNeuro-retinal RimThicknessB-scan cross section of theONHB-scan slices andsegmentation	In turn, scan Results screens(Review Scan Results) provide toolssuch as calipers for RNFL andGanglion cell layer estimation.
AdvancedVisualizationDisplay	■ Advanced VisualizationDisplayFundus Image with enface overlaySlice navigatorsHorizontal B-scan (X-image)Vertical slice - A-scan (Y-image)Top slab – C- scan (Zimage)Segmentation line toggleMeasurement calipersZoom controlsSave Image optionsMovie option	■ Advanced VisualizationDisplayFundus Image with enface overlaySlice navigatorsHorizontal B-scan (X-image)Vertical slice - A-scan (Y-image)Top slab-C- scan (Zimage)Segmentation line toggleMeasurement calipersAdd AnnotationZoom controlsSave Image optionsMovie option3-D color Thickness mapNEW →Alternate DepthViewNEW →Thumbnailimages	■ Same basic features.
HD Scans	HD 5-Line RasterHD 1 Line 100xHD 21 LineHD RadialHD Cross	Modification →HD ScanHD 1 Line 10 to 100x averagingSee HD 1 Line 10 - 100x -Spotlight	Same scan acquisition,selectable averaging
Device	CIRRUSTM HD-OCT v8.0(K150977) - Primary PredicateDevice	PLEXTM Elite 9000 SS-OCTProposed Device	Discussion
NormativeDatabase	Retinal Nerve Fiber Layer (RNFL)MacularOptic Nerve Head (ONH)Ganglion Cell	The PLEX Elite 9000 does notcontain a Normative Database inRelease 1.0.	N/A
	CIRRUS HD-OCTFUNDUS IMAGINGModels 4000 & 5000	1.1.1. PLEX ELITE SS-OCT1.1.2. FUNDUS IMAGING1.1.3. MODEL 9000
Methodology	Model 4000 & 5000:Line Scanning OphthalmoscopeModel 400 & 500:Live OCT fundus imaging (generatefundus image using OCT imagingsystem)	Line Scanning Ophthalmoscope -reuse CIRRUSModel 5000Remains Unchanged from thePredicate Device.	Same
	CIRRUS HD-OCTIRIS IMAGING	1.1.4. PLEX ELITE SS-OCTIRIS IMAGINGRemains Unchanged from thePredicate Device.	1.1.5.
Methodology	CCD camera and LED illumination	CCD camera and LED illumination	Same
Live irisimage	Light emitting diode (LED), 700 nm	Light emitting diode (LED), 700 nm	Same
	CIRRUS HD-OCTFIXATION	1.1.6. PLEX ELITE SS-OCTFIXATION	1.1.7.
Internalfixationsource	LCD (green pixels), Models 400 /4000LED Array, 9 positions, Models 500/ 5000	LCD (green pixels), As cleared inCIRRUS HD-OCT, Model 4000	Same as Model 4000

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510(K) SUMMARY

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510(K) SUMMARY

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510(K) SUMMARY

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510(K) SUMMARY

Clinical Evaluation

Clinical imaging performed on human eyes for each scan type supported by the PLEX Elite system is provided to demonstrate the ability of the PLEX Elite 9000 to image the posterior element with a wider field of view, increased depth penetration and with a higher signal-to-noise ratio as compared to the CIRRUS HD-OCT system.

To demonstrate the ability of the PLEX Elite 9000 angiography scans to image a range of retinal vascular pathologies affecting different anatomic depths through the retina and choroid, a clinical report is provided that includes clinical images from a case series study comparing PLEX Elite 9000 OCT angiography to FA, ICGA, CIRRUS HD-OCT angiography, and color fundus photography from subjects with varying retinal pathologies including retinal ischemia, microaneurysms, choroidal neovascularization, and retinal neovascularization. In addition, the clinical report compares PLEX Elite 9000 OCT angiography with ICGA images for lesions of the choroid, such as choroidal polyps in polypoidal choroidal vasculopathy and choroidal neovascular membranes.

The case series presented in the clinical report demonstrated the ability of the new PLEX

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510(K) SUMMARY

Elite 9000 to produce high quality images of the retina and choroid. The PLEX Elite 9000 angiography scans were shown to image the structures of the retina and choroid as well as the predicate CIRRUS HD- OCT device.

Additionally, a literature review of peer-reviewed, journal studies were evaluated and several are provided to support the indications for use statement for the PLEX Elite 9000 SS-OCT with Software Version 1.0. The articles serve to support the clinical efficacy of the SS-OCT Laser system and to demonstrate substantial equivalence to the CIRRUS HD-OCT with software version 8.0 (K150977).

510(k) Summary (21 CFR §807.92(c))

A technological comparison and clinical testing demonstrate that the PLEX Elite 9000 SS-OCT system is functionally equivalent to the primary predicate CIRRUS HD-OCT (K150977), utilizing the similar SS Laser system of the reference predicate, the IOLMaster 700 system (K143275) and does not raise new questions regarding safety and effectiveness.

As described in this 510(k) Summary, all testing deemed necessary was conducted on the PLEX Elite 9000 SS-OCT with Software Version 1.0 to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use and substantially equivalent to, and performs as well as, the predicate and reference devices.

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
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.(b)
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.