SOLIX

K222166 · Optovue, Inc. · OBO · Nov 9, 2022 · Ophthalmic

Device Facts

• Record ID: K222166
• Device Name: SOLIX
• Applicant: Optovue, Inc.
• Product Code: OBO · Ophthalmic
• Decision Date: Nov 9, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

SOLIX™ is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and the threedimensional imaging and measurement of anterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelium, corneal stroma, pachymetry, and anterior chamber of the eye. With the integrated reference database. SOLIX™ is also a quantitative tool for the comparison of the retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases. The SOLIX™ with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects with glaucoma and retinal diseases. The non-mydriatic color fundus camera of SOLIX™ is an integrated non-contact. high resolution digital imaging component which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The SOLIX™ fundus camera component is indicated for in-vivo viewing of the posterior and external area of the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

Device Story

Computer-controlled ophthalmic imaging system combining spectral-domain optical coherence tomography (SD-OCT) and non-mydriatic digital fundus camera; uses low coherence interferometry for cross-sectional tomograms and motion-contrast images (OCTA) of retinal microvasculature. Operated by clinicians in clinical settings; provides internal/external ocular images and quantitative measurements of ocular structures. Features include AngioVue for vascular visualization and AngioAnalytics for quantitative vascular/structural analysis. System uses IR fundus image and MCT for motion artifact reduction. Output aids clinicians in evaluation, diagnosis, and documentation of ocular health and disease management. Benefits include non-invasive, high-resolution imaging and quantitative comparison to normative databases.

Clinical Evidence

Prospective, observational studies evaluated repeatability and reproducibility (R&R) of anterior and posterior segment parameters and image quality. R&R assessed using random-effects ANOVA across 6 device-operator configurations. Results showed high agreement with predicate devices. Fundus photography study (n=112) showed 74-89% of SOLIX images were similar or better quality than iCam, with 97.3% clinical utility. Reference database study (n=427) established normative limits for structural parameters. Bench testing confirmed spatial performance, sensitivity, and software validation.

Technological Characteristics

SD-OCT system; 840nm SLD light source (1.45mW); CMOS sensor; 120kHz scan rate; 6.25mm scan depth (FullRange scans). Includes CAM (Cornea Anterior Module). Connectivity: Windows-based PC. Sterilization: Non-sterile. Software: Moderate level of concern. Compliant with IEC 60601-1, IEC 60601-1-2, ISO 10993, ISO 15004.

Indications for Use

Indicated for in vivo imaging and measurement of anterior and posterior ocular structures (retina, RNFL, GCC, optic disc, cornea, anterior chamber) in patients to aid in detection and management of ocular diseases. Includes visualization of retinal/choroidal vascular structures and measurement of vascular density, FAZ, and layer thickness in normal subjects and those with glaucoma or retinal diseases. Fundus camera indicated for non-mydriatic imaging of retina and external eye for documentation and diagnostic aid.

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

• Avanti (K180660)
• iCam Fundus Camera (K122572)

Submission Summary (Full Text)

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November 9 ,2022

Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Optovue, Inc. Robert Lundberg VP Regulatory/Quality 2800 Bayview Drive Fremont, California 94538

#### Re: K222166

Trade/Device Name: Solix Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HKI Dated: September 30, 2022 Received: October 3, 2022

#### Dear Robert Lundberg:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Elvin Y. I

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K222166

Device Name SOLIXTM

#### Indications for Use (Describe)

SOLIX™ is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and the threedimensional imaging and measurement of anterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelium, corneal stroma, pachymetry, and anterior chamber of the eye. With the integrated reference database. SOLIX™ is also a quantitative tool for the comparison of the retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.

The SOLIX™ with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects with glaucoma and retinal diseases.

The non-mydriatic color fundus camera of SOLIX™ is an integrated non-contact. high resolution digital imaging component which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The SOLIX™ fundus camera component is indicated for in-vivo viewing of the posterior and external area of the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

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

| <div> <span style="font-size:14px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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Image /page/3/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized, incomplete circle on the left side, rendered in shades of orange and yellow, resembling a sunrise or a lens flare. To the right of the circle is the word "OPTOVUE" in a simple, sans-serif font, colored in gray.

#### 510(k) Summarv

#### Submitter Information

| Company | Optovue, Inc.<br>2800 Bayview Drive<br>Fremont, CA 94538 |
|----------------|---------------------------------------------------------------------------------------------------|
| Contact Person | Robert Lundberg<br>VP Regulatory/Quality<br>Tel: [phone]<br>Email: [e-mail] |
| Date Prepared | 07 November 2022 |

#### Device Information

| Device Trade Name | SOLIXTM |
|---------------------------|------------------------------|
| Device Common Name | Optical Coherence Tomography |
| Classification Regulation | 21 CFR 886.1570 |
| Classification Name | Ophthalmoscope |
| Device Class | Class II |
| Device Regulation Panel | Ophthalmic |
| Product Code | OBO, HKI |

#### Predicate/Reference Devices

| Primary Predicate: | K180660: Avanti, cleared on June 8, 2018 |
|----------------------|----------------------------------------------------------|
| Secondary Predicate: | K122572: iCam Fundus Camera, cleared on January 11, 2013 |

#### Indications for Use

SOLIX is an optical coherence tomography system intended for the in vivo imaging, crosssectional, and the three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, corneal epithelium, corneal stroma, pachymetry, and anterior chamber of the eye. With the integrated reference database, SOLIX is also a quantitative tool for the comparison of the retina, retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.

The SOLIX with the AngioVue® software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects, and in subjects with glaucoma and retinal diseases. The AngioAnalytics™ software feature of AngioVue® is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and

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Image /page/4/Picture/1 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in gray, sans-serif font. To the left of the word is a partial circle that is orange and yellow. The circle is open on the right side.

nerve fiber laver, and measurement of optic disc parameters in normal subjects, and in subjects with glaucoma and retinal diseases.

The non-mydriatic color fundus camera of SOLIX, is an integrated non-contact, high resolution digital imaging component which is suitable for photographing, displaying and storing images of the retina and external areas of the eve to be evaluated under non-mvdriatic conditions. The SOLIX fundus camera component is indicated for in-vivo viewing of the posterior and external area of the eye and the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

#### Device Description

SOLIX is a computer-controlled, ophthalmic imaging system with combined spectral-domain optical coherence tomography (SD-OCT) and non-mydriatic, digital fundus camera. The SD-OCT employs non-invasive, non-contact, low coherence interferometry to acquire crosssectional tomograms of the anterior and posterior segment of the eye and motion-contrast images of the retinal microvasculature (i.e., OCT "angiography" [OCTA]). The fundus camera produces color internal and external ocular images.

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Image /page/5/Picture/0 description: The image shows the text 'K222166' in a simple, sans-serif font. The text is arranged horizontally, with the letter 'K' followed by a series of digits. The numbers are '222166'. The text is black against a white background.

Image /page/5/Picture/1 description: The image shows the logo for Optovue. The logo consists of a stylized orange circle on the left and the word "OPTOVUE" in gray on the right. The circle is not complete, with a gap at the top, and it appears to be made of brush strokes.

# Substantial Equivalence

## SOLIX vs Avanti

| Device | SOLIX<br>(Proposed Device) | Predicate Devices<br>Primary Predicate Avanti | Substantial Equivalence<br>Comparison |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number &<br>Classification | K222166<br>Class II | K180660<br>Class II | |
| Date of Clearance | TBD | June 8, 2018 | |
| Trade Name | SOLIX | Avanti | |
| Manufacturer | Optovue, Inc. | Optovue, Inc. | Same |
| Indications For Use | SOLIX is an optical coherence<br>tomography system intended for the <i>in</i><br><i>vivo</i> imaging, cross-sectional, and the<br>three-dimensional imaging and<br>measurement of anterior and posterior<br>ocular structures, including retina,<br>retinal nerve fiber layer, ganglion cell<br>complex (GCC), optic disc, cornea,<br>corneal epithelium, corneal stroma,<br>pachymetry, and anterior chamber of<br>the eye. With the integrated reference<br>database, SOLIX is also a quantitative<br>tool for the comparison of the retina,<br>retinal nerve fiber layer, and optic disc<br>measurements in the human eye to a<br>database of known normal subjects.<br><br>It is indicated for use as a diagnostic<br>device to aid in the detection and<br>management of ocular diseases.<br><br>The SOLIX with the AngioVue<br>software feature is indicated as an aid<br>in the visualization of vascular<br>structures of the retina and choroid in<br>normal subjects, and in subjects with<br>glaucoma and retinal diseases.<br><br>The AngioAnalytics software feature<br>of AngioVue is indicated for the<br>measurement of vascular density, the<br>foveal avascular zone, the thickness of<br>retinal layers, and nerve fiber layer,<br>and measurement of optic disc<br>parameters in normal subjects, and in<br>subjects with glaucoma and retinal<br>diseases. | The Avanti is an optical coherence<br>tomography system intended for the <i>in</i><br><i>vivo</i> imaging, cross- sectional, and the<br>three- dimensional imaging and<br>measurement of anterior and posterior<br>ocular structures, including retina,<br>retinal nerve fiber layer, ganglion cell<br>complex (GCC), optic disc, cornea,<br>corneal epithelia, corneal stroma,<br>pachymetry, corneal power, and<br>anterior chamber of the eye. With the<br>integrated normative database, Avanti<br>is also a quantitative tool for the<br>comparison of retina, retinal nerve<br>fiber layer, and optic disc<br>measurements in the human eye to a<br>database of a known normal subjects.<br><br>It is indicated for use as a diagnostic<br>device to aid in the detection and<br>management of ocular diseases.<br><br>The Avanti with the AngioVue<br>software feature is indicated as an aid<br>in the visualization of vascular<br>structures of the retina and choroid in<br>normal subjects, and in subjects with<br>glaucoma and retinal diseases.<br><br>The AngioAnalytics software feature<br>of AngioVue is indicated for the<br>measurement of vascular density, the<br>foveal avascular zone, the thickness of<br>retinal layers, and nerve fiber layer,<br>and measurement of optic disc<br>parameters in normal subjects, and in<br>subjects with glaucoma and retinal<br>diseases. | Same |
| Technological<br>Characteristics | Spectral-Domain Optical Coherence<br>Tomography (SD-OCT) | Spectral-Domain Optical Coherence<br>Tomography (SD-OCT) | Same |
| System Components | • Scanner<br>• Control Unit<br>• Chin and Head rest<br>• Joystick and base assembly<br>• Computer with Windows operating<br>system<br>• Monitor<br>• Keyboard and Mouse<br>• System Table<br>• CAM Lens FullRange<br>• CAM Lens | • Scanner<br>• Control Unit<br>• Chin and Head rest<br>• Joystick and base assembly<br>• Computer with Windows operating<br>system<br>• Monitor<br>• Keyboard and Mouse<br>• System Table<br>• CAM Lens | Same |
| Signal Type | Optical scattering from tissue for<br>OCT | Optical scattering from tissue for OCT | Same |
| Device | SOLIX<br>(Proposed Device) | Predicate Devices<br>Primary Predicate Avanti | Substantial Equivalence<br>Comparison |
| OCT Light Source | Superluminescent diode<br>(SLD) 840nm | Superluminescent diode<br>(SLD) 840nm | Same |
| OCT Optical Power | 1.45mW (at cornea) | 0.75mW (at cornea) | SLD power in SOLIX is<br>increased from 0.75mW to<br>1.45mW to compensate the<br>loss of photon energy due to<br>higher scanner speed. With<br>higher power, it achieves<br>similar level of Signal to<br>Noise Ratio (SNR) as Avanti. |
| OCT Optical Power | 1.45mW (at cornea) | 0.75mW (at cornea) | The light exposure safety<br>issue in SOLIX is analyzed<br>in Dr. David Sliney's report.<br>The near- infrared radiation<br>from an SLD in SOLIX is<br>below all of the applicable<br>exposure limits -including<br>the guidelines for<br>ophthalmic instrument<br>exposure. |
| Fixation Light Source | Blue LED | Blue LED | Same |
| IR Fundus Imaging<br>Light Source | NIR LED | NIR LED | Same |
| Iris Viewer<br>Illumination | IR LED | N/A | Iris imaging is added for<br>external visualization to<br>facilitate patient alignment.<br>No impact on the systems'<br>essential functions - OCT. |
| Working Distance | Retina imaging: 35 mm<br>With CAM (Cornea Anterior<br>Module) attached: 20mm | Retina imaging: 22 mm<br>With CAM (Cornea Anterior Module)<br>attached: 13mm | The longer working<br>distance in SOLIX<br>improves the system's<br>usability. |
| Ergonomic | • Chin and forehead rest<br>• Joystick for alignment on the eye | • Chin and forehead rest<br>• Joystick for alignment on the eye | Same |
| Electrical | Medical-grade power supply (IEC<br>60601 compliant) | Medical-grade power supply (IEC<br>60601 compliant) | Same |
| Cleaning and<br>Disinfection | Chin and forehead rest can be<br>cleaned with a disinfecting agent,<br>such as isopropyl alcohol wipes or a<br>germicide with a lint-free cloth. | Chin and forehead rest can be cleaned<br>with a disinfecting agent, such as<br>isopropyl alcohol wipes or a germicide<br>with a lint-<br>free cloth. | Same…