(182 days)
No
The summary describes image processing techniques (OMAG) but does not mention AI or ML.
No.
The device is described as an "imaging device" intended for "in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures" and "visualization of vascular structures". It is used for diagnosis and monitoring, not for treating any condition.
Yes
Explanation: The device is indicated for "in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures" and "as an aid in the visualization of vascular structures of the retina and choroid." Imaging and visualization of anatomical structures are steps in the diagnostic process. The performance studies also mention its use in "imaging a range of retinal vascular pathologies."
No
The device description explicitly details hardware components such as a swept source laser system, system computer, archive storage, iris viewer, fixation system, and fundus camera. While it includes software for image processing and angiography, it is fundamentally a hardware device with integrated software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures." This means it is used to image structures within a living patient's eye.
- Device Description: The description reinforces this by stating it "acquires cross-sectional tomograms of the posterior ocular structures" using "non-invasive, non-contact, low-coherence interferometry."
- Anatomical Site: The anatomical sites listed are all structures within the eye.
IVDs, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. This device operates directly on the living patient's eye.
N/A
Intended Use / Indications for 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
OBO
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.
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 700 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
- 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 extent as the OCT intensity and phase data, and therefore depth resolved flow images can be generated and displayed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
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. Vascular structures of the retina and choroid.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three overlapping profiles facing to the right.
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
1
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
2
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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3
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.
5160 Hacienda Drive
Dublin, California 94568
(925) 557-4100 (phone)
(925) 557-4259 (fax)
Est. Reg. No. 2918630 |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christine Dunbar
Manager, Regulatory Affairs Submissions
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, 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) |
4
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.
5
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.
6
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
7
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
Indications for Use | 510(k)
Clearance /
Date | Claim of Equivalence for: |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (Primary predicate)The CIRRUSTM 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 and
posterior ocular structures, including
cornea, retina, retinal nerve fiber layer,
ganglion cell plus inner plexiform layer,
macula, and optic nerve head. | K150977 /
September
01, 2015 | The PLEXTM 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, retina, retinal nerve fiber layer,
ganglion cell plus inner plexiform layer,
macula, optic nerve head, vitreous and
choroid. |
| The CIRRUS OCT Angiography is
indicated as an aid in the visualization of
vascular structures of the retina and
choroid. | | The PLEXTM Elite SS-OCT angiography
is indicated as an aid in the visualization
of vascular structures of the retina and
choroid. |
| The 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. | | |
8
510(K) SUMMARY
| Product
Indications for Use | 510(k)
Clearance /
Date | Claim of Equivalence for: |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (Reference predicate) ZEISS IOLMaster
700
The IOLMaster 700 is intended for
biometric measurements and visualization
of ocular structures. The measurements and
visualization assist in the determination in
the appropriate power and type of
intraocular lens.
The IOLMaster 700 employs non-invasive,
non-contact low coherence interferometry
(SS-OCT) to obtain cross-sectional images
of the eye. | K143275 /
July 10,
2015 | PLEXTM Elite SS-OCT with Software
Version 1.0 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. |
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 Predicate
Device | PLEXTM Elite 9000 SS-OCT
Proposed Device | Discussion |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The CIRRUS HD-OCT with Retinal
Nerve Fiber Layer (RNFL),
Macular, Optic Nerve Head and
Ganglion Cell Normative Databases
is indicated for in-vivo viewing,
axial cross-sectional, and three-
dimensional imaging and
measurement of anterior and
posterior ocular structures. | The PLEXTM 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. | Same intended use. |
| Indications
for Use | The CirrusTM HD-OCT is a non-
contact, high resolution tomographic
and biomicroscopic imaging device.
It is indicated for in-vivo viewing,
axial cross-sectional, and three-
dimensional imaging and
measurement of anterior and
posterior ocular structures, including
cornea, retina, retinal nerve fiber
layer, ganglion cell plus inner
plexiform layer, macula, and optic
nerve head.
The CIRRUS normative databases
are quantitative tools for the
comparison of retinal nerve fiber
layer thickness, macular thickness,
ganglion cell plus inner plexiform
layer thickness, and optic nerve
head measurements to a database of
normal subjects. | The PLEXTM 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, retina, retinal nerve fiber layer,
ganglion cell plus inner plexiform
layer, macula, optic nerve head,
vitreous and choroid. | Similar Indications for use.
PLEX Elite does not contain
a normative database in the
R 1.0 release. |
| Device | CIRRUSTM HD-OCT v8.0
(K150977) - Primary Predicate
Device | PLEXTM Elite 9000 SS-OCT
Proposed Device | Discussion |
| | The CIRRUS OCT angiography is
indicated as an aid in the
visualization of vascular structures
of the retina and choroid.
The Cirrus HD-OCT is intended for
use as a diagnostic device to aid in
the detection and management of
ocular diseases including, but not
limited to, macular holes, cystoid
macular edema, diabetic
retinopathy, age-related macular
degeneration, and glaucoma. | The PLEXTM Elite SS-OCT
angiography is indicated as an aid in
the visualization of vascular
structures of the retina and choroid. | Same Indications for Use for
Angiography. |
| Device
Classification
Name | Optical Coherence Tomographer
(OCT) | Optical Coherence Tomographer
(OCT) | Same |
| Technology | Spectral Domain (Spatially encoded
Frequency Domain and Fourier
Domain Principle) OCT | Spectral Domain (Time encoded
Frequency Domain and Fourier
Domain Principle) OCT | Similar purpose, change
from spatial to time encoded
spectra with new light source
technology. |
| Illumination
Sources used
in
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
longer wavelength for
similar imaging of the eye
using a non-invasive optical
technique produces high-
resolution cross-sectional
tomograms of the eye
without contacting the eye.
Swept Source Laser is Class
- |
| Laser Class
Based on
IEC 60825-
1:2007 | N/A | Class 1 | |
| Optical
Power |