(259 days)
Unknown
The summary mentions "real-time image analysis to perform image focus adjustment automatically," which could potentially involve AI/ML, but the description is not detailed enough to confirm its use. The absence of explicit mentions of AI, ML, training sets, or performance metrics related to AI/ML models makes a definitive determination impossible based solely on this summary.
No.
The device is described as an imaging device for capturing, displaying, and storing images of the retina, intended as an aid to clinicians in the evaluation and documentation of ocular health, which indicates a diagnostic rather than therapeutic purpose.
No
The device is described as an "imaging device for capturing, displaying and storing images of the retina." Its intended use is "as an aid to clinicians in the evaluation and documentation of ocular health." While it provides images that clinicians may use for diagnosis, the device itself does not perform analysis or provide diagnostic output; it merely captures and stores images for a clinician to interpret. A diagnostic device typically provides analytical results or a diagnosis.
No
The device description explicitly details hardware components such as a base, head support, onboard computer, touch-screen display, optical head, joystick, and LEDs, and provides physical dimensions and weight. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the Zilia Ocular device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Zilia Ocular's Function: The Zilia Ocular is an imaging device that captures images of the retina directly from the patient's eye. It does not analyze samples taken from the body.
- Intended Use: The intended use is "as an aid to clinicians in the evaluation and documentation of ocular health," which aligns with an imaging device used for visual assessment, not laboratory testing of samples.
Therefore, the Zilia Ocular falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Zilia Ocular is a non-contact imaging device for capturing, displaying and storing images of the retina under mydriatic conditions.
Zilia Ocular is intended for use as an aid to clinicians in the evaluation and documentation of ocular health.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
The Zilia Ocular Fundus Camera (Zilia Ocular FC) is a non-contact, stand-alone device designed to image the eye fundus.
The device includes a base, a head support, an onboard computer with a 15.6'' touch-screen display and an optical head. A joystick, situated at the base of the device, controls the movements of the optical head to enable adequate positioning. The touch-screen display also includes a user interface allowing the user to control the device and acquire and display patient data and images.
The Zilia Ocular FC uses near-infrared (NIR) light-emitting diodes (LEDs) as illumination during alignment to the patient's pupil, and a white LED during focusing and imaging of the eye fundus. The region of the eye fundus being imaged can be modified by changing or moving the fixation target. The images are saved and stored on the onboard computer.
The dimensions of the Zilia Ocular FC are 620 mm (L) by 360 mm (W) by 500 mm (H) and it weighs about 32 kg.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retina, eye fundus
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)
All necessary performance testing was conducted on the Zilia Ocular FC and demonstrated that the subject device is substantially equivalent to the predicate device, the NFC-700, in terms of safety and effectiveness.
Electrical Safety and Electromagnetic Compatibility: It was verified that the Zilia Ocular FC complies with the standard ANSI/AAMI ES60601-1:2005/(R)2012+A1:2012 for electrical safety and with the standard IEC 60601-1-2:2014 for electromagnetic compatibility under the ASCA pilot program.
Recognized Consensus Standards For Ophthalmic Cameras: The Zilia Ocular FC was found to comply with the following recognized consensus standards:
- ISO 15004-1:2020 Ophthalmic instruments Fundamental requirements and test methods . - Part 1: General requirements applicable to all ophthalmic instruments;
- ISO 15004-2:2007 Ophthalmic instruments Fundamental requirements and test methods . - Part 2: Light hazard protection;
- ANSI Z80.36-2021 American National Standard: Ophthalmics Light Hazard Protection . for Ophthalmic Instruments;
- ISO 10940:2009 Ophthalmic instruments Fundus cameras; and .
- IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for . basic safety and essential performance - Collateral standard: Usability.
Risk-Based Approach: The risk management report was prepared to document the evaluation and the decisions made and all necessary safety measures in the design and manufacturing of the Zilia Ocular FC. All documentation in accordance with ISO 14971:2019 Medical devices - Application of risk management to medical devices was created including a Risk Management Plan, a Hazard and Risk Analysis, a Production Failure Mode and Effect Analysis (PFMEA), and a Risk Management Report. The risks related to all applicable hazards which were identified for the Zilia Ocular FC have been reduced to the acceptable level by mitigation.
The Zilia Ocular FC is shown to be at least as safe and effective as the predicate device and the inherent risks are believed to be overcome by the benefits of the device use as indicated. Therefore, all residual risks post-mitigation have been deemed acceptable for this design.
Biocompatibility: The intact skin from the chin and forehead of the patient is intended to contact the Zilia Ocular FC for a short period of time. The biocompatibility of the Zilia Ocular FC was assessed in accordance with ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Processing of Health Care Products: The Zilia Ocular FC Instructions for Use document was assessed to comply with ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
Software Evaluation: The Zilia Ocular FC software was evaluated in accordance with IEC 62304:2006/AMD 1:2015 Medical device software - Software life cycle processes. The software for this device is considered to be a "Moderate Level of Concern" since a failure or latent flaw in the software could directly result in minor injury to the patient or user and due to the use of Off-the-shelf Software.
Labeling: The Zilia Ocular labeling was assessed to verify compliance to ISO 15223-1:2021 and ISO 20417:2021 and all applicable local requirements.
Usability: Zilia applied the recommendations from the FDA's guidance Applying human factors and usability engineering to medical device:2016 and IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability:2010+AMD1:2013+AMD2:2020 to maximize the likelihood that the Zilia Ocular FC is safe and effective for the intended users, uses and use environments.
Clinical Performance Data: This section is not applicable because clinical data was not provided for this 510(k) submission.
Animal Studies: This section is not applicable as there is no data related to animal studies for this 510(k) submission.
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
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
November 20, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Zilia Inc. % Christina Henza Regulatory Consultant Ultra Life Science Solutions Inc. 2811 Milton Ave #409 Janesville, Wisconsin 53545
Re: K230627
Trade/Device Name: Zilia Ocular FC (ZIL-10002) Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: October 27, 2023 Received: October 27, 2023
Dear Christina Henza:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Elvin Y. Na -S
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230627
Device Name Zilia Ocular
Indications for Use (Describe)
Zilia Ocular is a non-contact imaging device for capturing, displaying and storing images of the retina under mydriatic conditions.
Zilia Ocular is intended for use as an aid to clinicians in the evaluation and documentation of ocular health.
| 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
Image /page/3/Picture/0 description: The image shows the word "zilia" in a sans-serif font. The color of the text is a light green, almost pastel. The background is a solid, light gray color, providing a subtle contrast to the text.
125 Charest Blvd. East, Suite 400 Quebec City, Quebec G1K 3G5
□ 1 833 501-6996
510(k) SUMMARY Zilia Inc. Zilia Ocular Fundus Camera (Zilia Ocular FC)
This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
| SUBMITTER | |
|---|---|
| Company Name | Zilia Inc. |
| Company Address | 125 Charest Boulevard East, Suite 400 |
| Quebec City, Quebec, Canada | |
| G1K 3G5 | |
| Contact Person | Patrick Sauvageau, O.D., M.Sc., CEO |
| Phone | 1 833 501-6996 |
| patrick.sauvageau@ziliahealth.com | |
| Website | ziliahealth.com |
| Date prepared | 2023-10-10 |
| DEVICE INFORMATION | |
| Trade Name | Zilia Ocular Fundus Camera |
| Common Name | Zilia Ocular FC |
| Classification Name | Ophthalmic Camera, AC powered |
| 510(k) Number | K230627 |
| Regulatory Class | Class II |
4
Image /page/4/Picture/1 description: The image shows the word "zilia" in a light green color. The font is sans-serif and appears to be a custom design. The letters are evenly spaced and the overall impression is clean and modern.
| Product Code | HKI |
|---|---|
| Regulation Number | 21 CFR 886.1120 |
| PREDICATE DEVICE | |
|---|---|
| Trade Name | NFC-700 Non-Mydriatic Auto Fundus Camera |
| Classification Name | Ophthalmic Camera, AC powered |
| 510(k) Number | K182199 |
| REFERENCE DEVICE | |
|---|---|
| Trade Name | Mydriatic Hyperspectral Retinal Camera |
| (MHRC-C1) | |
| Classification Name | Ophthalmic Camera, AC powered |
| 510(k) Number | K200254 |
DEVICE DESCRIPTION
The Zilia Ocular Fundus Camera (Zilia Ocular FC) is a non-contact, stand-alone device designed to image the eye fundus.
The device includes a base, a head support, an onboard computer with a 15.6'' touch-screen display and an optical head. A joystick, situated at the base of the device, controls the movements of the optical head to enable adequate positioning. The touch-screen display also includes a user interface allowing the user to control the device and acquire and display patient data and images.
The Zilia Ocular FC uses near-infrared (NIR) light-emitting diodes (LEDs) as illumination during alignment to the patient's pupil, and a white LED during focusing and imaging of the eye fundus. The region of the eye fundus being imaged can be modified by changing or moving the fixation target. The images are saved and stored on the onboard computer.
The dimensions of the Zilia Ocular FC are 620 mm (L) by 360 mm (W) by 500 mm (H) and it weighs about 32 kg.
5
Image /page/5/Picture/1 description: The image shows the word "zilia" in a light green color. The font is sans-serif and the letters are rounded. The word is written in lowercase.
The detailed technological characteristics and specifications of the Zilia Ocular FC are listed in the section Comparison Of Technological Characteristics With The Predicate Device located on page 6 of this summary.
INDICATIONS FOR USE
The Zilia Ocular FC is a non-contact imaging device for capturing, displaying, and storing images of the eye fundus under mydriatic conditions.
The Zilia Ocular FC is intended for use as an aid to clinicians in the evaluation and documentation of ocular health.
PERFORMANCE TESTING
All necessary performance testing was conducted on the Zilia Ocular FC and demonstrated that the subject device is substantially equivalent to the predicate device, the NFC-700, in terms of safety and effectiveness.
Electrical Safety and Electromagnetic Compatibility
It was verified that the Zilia Ocular FC complies with the standard ANSI/AAMI ES60601-1:2005/(R)2012+A1:2012 for electrical safety and with the standard IEC 60601-1-2:2014 for electromagnetic compatibility under the ASCA pilot program.
Recognized Consensus Standards For Ophthalmic Cameras
The Zilia Ocular FC was found to comply with the following recognized consensus standards:
- ISO 15004-1:2020 Ophthalmic instruments Fundamental requirements and test methods . - Part 1: General requirements applicable to all ophthalmic instruments;
- ISO 15004-2:2007 Ophthalmic instruments Fundamental requirements and test methods . - Part 2: Light hazard protection:
- ANSI Z80.36-2021 American National Standard: Ophthalmics Light Hazard Protection . for Ophthalmic Instruments;
- ISO 10940:2009 Ophthalmic instruments Fundus cameras; and .
- IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for . basic safety and essential performance - Collateral standard: Usability.
Risk-Based Approach
The risk management report was prepared to document the evaluation and the decisions made and all necessary safety measures in the design and manufacturing of the Zilia Ocular FC. All documentation in accordance with ISO 14971:2019 Medical devices - Application of risk management to medical devices was created including a Risk Management Plan, a Hazard and Risk Analysis, a Production Failure Mode and Effect Analysis (PFMEA), and a Risk Management Report. The risks related to all applicable hazards which were identified for the Zilia Ocular FC have been reduced to the acceptable level by mitigation.
6
The Zilia Ocular FC is shown to be at least as safe and effective as the predicate device and the inherent risks are believed to be overcome by the benefits of the device use as indicated. Therefore, all residual risks post-mitigation have been deemed acceptable for this design.
Biocompatibility
The intact skin from the chin and forehead of the patient is intended to contact the Zilia Ocular FC for a short period of time. The biocompatibility of the Zilia Ocular FC was assessed in accordance with ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Processing of Health Care Products
The Zilia Ocular FC Instructions for Use document was assessed to comply with ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
Software Evaluation
The Zilia Ocular FC software was evaluated in accordance with IEC 62304:2006/AMD 1:2015 Medical device software - Software life cycle processes. The software for this device is considered to be a "Moderate Level of Concern" since a failure or latent flaw in the software could directly result in minor injury to the patient or user and due to the use of Off-the-shelf Software.
Labeling
The Zilia Ocular labeling was assessed to verify compliance to ISO 15223-1:2021 and ISO 20417:2021 and all applicable local requirements.
Usabilitv
Zilia applied the recommendations from the FDA's guidance Applying human factors and usability engineering to medical device:2016 and IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability:2010+AMD1:2013+AMD2:2020 to maximize the likelihood that the Zilia Ocular FC is safe and effective for the intended users, uses and use environments.
Clinical Performance Data
This section is not applicable because clinical data was not provided for this 510(k) submission.
Animal Studies
This section is not applicable as there is no data related to animal studies for this 510(k) submission.
7
ZI IC
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE AND REFERENCE DEVICE
The proposed Zilia Ocular FC is substantially equivalent to the NFC-700 Non-Mydriatic Auto Fundus Camera (Crystalvue Medical Corporation) cleared in K182199 on 2019-01-02, certain technical differences are supported by the reference device Mydriatic Hyperspectral Retinal Camera (MHRC-C1) cleared in K200254 on 04/27/2020. The proposed indications for use are equivalent to the predicate and reference device, as the three devices are intended to capture, display, and store images of the eye fundus. The technological characteristics of the proposed Zilia Ocular FC encompass the functionalities of the NFC-700 and MHRC-C1.
| Feature | Zilia Ocular
Fundus Camera
(Zilia Ocular FC)
(K230627) | NFC-700
(K182199) | MHRC-C1
(K200254) |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation number | 21 CFR 886.1120 | 21 CFR 886.1120 | 21 CFR 886.1120 |
| Product code | HKI | HKI | HKI, NFJ |
| Regulation name | Ophthalmic
Camera | Ophthalmic
Camera | Ophthalmic
Camera |
| Regulatory class | Class II | Class II | Class II |
| Intended
Use /
Indication
for use | Zilia Ocular is a
non-contact
imaging device
for capturing,
displaying, and
storing images of
the eye fundus
under mydriatic
conditions.
Zilia Ocular is
intended for use
as an aid to
clinicians in the
evaluation and
documentation of
ocular health. | NFC-700 is an AC-
powered ophthalmic
camera to take
photographs of the
eye and the
surrounding area.
NFC-700 is a non-
contact, high
resolution digital
imaging device
which is suitable
for photographing,
displaying and
storing images of
the retina and
external areas of
the eye to be
evaluated under
non-mydriatic | The MHRC-C1 is
intended to capture
images of the retina
at multiple
wavelengths
(colors) under
mydriatic
conditions. |
| Feature | Zilia Ocular
Fundus Camera
(Zilia Ocular FC)
(K230627) | NFC-700
(K182199) | MHRC-C1
(K200254) |
| | | conditions.
NFC-700 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. | |
| Prescription
use | Rx Only | Rx Only | Rx Only |
| Fundus
image | Mydriatic, color
image | Non-mydriatic,
color image | Mydriatic,
monochrome |
| Record
media | Digital | Digital | Digital |
| Contact
areas with
the patients | Chin and
forehead | Chin and forehead | Chin and forehead |
| Mean for
alignment | Manual
positioning | Fully automatic 3D
tracking | Manual
positioning |
| Main
technology | AC-powered
ophthalmic camera
on a support frame
with: | AC-powered
ophthalmic camera
on a support frame
with: | AC-powered
ophthalmic camera
on a support frame
with: |
| | • A patient chin
and forehead rest
for patient head | • A patient chin
and forehead rest
for patient head | • A patient chin
and forehead rest
for patient head |
| Feature | Zilia Ocular
Fundus Camera
(Zilia Ocular FC)
(K230627) | NFC-700
(K182199) | MHRC-C1
(K200254) |
| | placement. | placement. | placement. |
| | • Visual fixation
target for patient
to maintain
patient's gaze
and the pupil's
alignment. | • Visual fixation
target for patient
to maintain
patient's gaze
and the pupil's
alignment. | • Visual fixation
target for patient
to maintain
patient's gaze
and the pupil's
alignment. |
| | • Camera optical
head alignment
features to allow
the user to
observe, align,
and target the
desired image of
the patient's eye
area. | • Camera optical
head alignment
features to allow
the user to
observe, align,
and target the
desired image of
the patient's eye
area. | • Camera optical
head alignment
features to allow
the user to
observe, align,
and target the
desired image of
the patient's eye
area. |
| | • NIR lighting
during alignment
and white LED
lighting during
focusing and
imaging. | • NIR lighting
during alignment
and initial
observation to
not cause pupil
constriction. | • Monochromatic
light (700 nm)
during alignment. |
| | • Camera to record
the given images
provides lighting
with mask to
illuminate the
selected area for
the imaging. | • Camera to record
the given images
provides lighting
with mask to
illuminate the
selected area for
the imaging. | • Camera to record
the given images
provides lighting
with mask to
illuminate the
selected area for
the imaging. |
| Feature | Zilia Ocular
Fundus Camera
(Zilia Ocular FC)
(K230627) | NFC-700
(K182199) | MHRC-C1
(K200254) |
| | · Software and
control user
interfaces to
operate the
device. | · Software and
control user
interfaces to
operate the
device. | · Software and
control user
interfaces to
operate device. |
| Operation
Principle | The optical design
of the fundus
camera is based on
the principle of
monocular indirect
ophthalmoscopy.
- Fundus
observation:
Alignment to the
pupil is made
using two NIR
LEDs. Indicators
shown on the
screen help the
user center the
device with the
pupil. A white
LED is used to
focus and image
the eye fundus. | The optical design
of the fundus
camera is based on
the principle of
monocular indirect
ophthalmoscopy. - Fundus
observation:
A built-in light
ray from the
infrared light
LED source to
illuminate the
fundus.
Alignment of
the device is
performed by
built-in eye
tracking
indicator and
working
distance
indicator to
automatically
adjust the
system to the
best XYZ
position
automatically. | The optical design
of fundus camera is
based on the
principle of
monocular indirect
ophthalmoscopy. - Fundus
observation:
A positioning
system is used to
align the camera
relative to the
patient's eye.
Monochromatic
light (700 nm) is
used during
alignment. The
fundus is
observed through
a video feed on
an LCD monitor. |
| Feature | Zilia Ocular
Fundus Camera
(Zilia Ocular FC)
(K230627) | NFC-700
(K182199) | MHRC-C1
(K200254) |
| 2. Image capture: | System uses real-
time image
analysis to
perform image
focus adjustment
automatically to
capture the best
quality of image.
White light
emitted from
LEDs irradiates
the eye fundus.
The light
reflected from the
eye fundus forms
an image, and the
image is captured
by a built-in color
CMOS camera
module for
fundus image
capture. | 2. Image capture:
System uses
split-image
technique to do
image focus
adjustment
automatically to
capture the best
quality of image.
White light from
LEDs Flash
module irradiates
the fundus. The
light reflected
from eye portions
forms an image,
and the image is
captured by a
built-in color
CMOS camera
module for
fundus image
capture. | 2. Image capture:
Focus is achieved
manually through
a focus wheel.
System uses a
tunable light
source that
sequentially
presents the
retina with
monochromatic
light in the
spectral range
905 nm to 450
nm in steps of 5
nm. |
| Alignment/
visualization
light source | Near-infrared LED
during pupil
alignment
White LED during
focusing and
imaging | Near-infrared LED
during alignment
White LED during
imaging | Monochromatic
light (700 nm)
during alignment
Monochromatic
light (sequential
from 905 nm to 450
nm in steps of 5 nm)
during imaging |
| Field of
view | 25° | 45° | 31.5° |
| Feature | Zilia Ocular
Fundus Camera
(Zilia Ocular FC)
(K230627) | NFC-700
(K182199) | MHRC-C1
(K200254) |
| Working
distance | 55 mm
from lens to
cornea | 25 mm
from lens to
cornea | 46.7 mm
from lens to
cornea |
| Minimum
pupil
diameter | 4 mm | 4 mm | 6 mm |
| Focus | Manual or
automatic | Manual or
automatic | Manual |
| Exposure | Manual | Automatic | Automatic |
| Compensation for
ametropia | -15D to +15D | -15D to + 10D
(without
compensation lens)
-30D to -10D or
+5D to +30D (with
compensation lens) | -15D to +15D |
| Internal
fixation
targets | 5 points | 10 points | None |
| External
fixation
target | 1 point,
mobile | None | 1 point,
mobile |
| Camera
resolution -
pixel
size/pitch | CMOS 5 MP -
3.45 $μ$ m (pixel
pitch) | CMOS 12 MP -
5.12 $μ$ m (pixel
pitch) | Not available |
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Zilia Ocular FC Premarket Notification
Image /page/8/Picture/1 description: The image shows the word "zilia" in a sans-serif font. The color of the text is a light green. There are two dots above the "i" letters, which are also light green.
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Image /page/9/Picture/1 description: The image shows the word "zilia" in a sans-serif font. The color of the text is a light green. The letters are lowercase and evenly spaced.
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Zilia Ocular FC Premarket Notification
zilia
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zilia
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Zilia Ocular FC Premarket Notification
zilia
Considering the above, the Zilia Ocular FC proposes an equivalent technology and methods as the predicate and reference devices to address the same indications. The noted differences in their detailed specifications do not present any new questions of safety or effectiveness, whereby the devices are substantially equivalent.
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Image /page/13/Picture/1 description: The image contains the word "zilia" in a sans-serif font. The color of the text is a light green. The letters are all lowercase.
CONCLUSION
As described in this 510(k) Summary, comprehensive testing and analysis was conducted on the Zilia Ocular FC to ensure that the device is equivalent to the predicate and reference devices cleared under K182199 and K200254 when used in accordance with its Instructions for Use.
Based on the information in this submission, Zilia Ocular FC has the same intended use, technological characteristics, and operation principles as its predicate and reference devices. Therefore, Zilia Ocular FC is substantially equivalent to the predicate device.