(141 days)
Not Found
No
The summary describes a digital imaging device with auto-focusing and tracking features, but there is no mention of AI or ML being used for image analysis, diagnosis, or any other function beyond basic image capture and processing. The performance study focuses on image quality, not the performance of an AI/ML algorithm.
No
The device is for imaging, displaying, and storing images of the eye to aid in diagnosis, not for treating any condition.
No
The device is described as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health, which captures images for diagnosis but does not perform the diagnosis itself.
No
The device description explicitly details hardware components such as a digital imaging device, touch screen, NIR LED, USB, HDMI, and Ethernet ports, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the NFC-700 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- NFC-700 Function: The NFC-700 is a non-contact imaging device that captures images of the retina and external areas of the eye in vivo (within the living body). It does not analyze specimens taken from the body.
- Intended Use: The intended use is for in-vivo viewing and providing images as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health. This involves direct imaging of the eye, not laboratory analysis of biological samples.
Therefore, the NFC-700 falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
The NFC-700 is a non-contact fundus camera for capturing, storing and displaying the color fundus images with 12MP. It was designed a non-contact, high resolution digital imaging device, auto 3D tracking, fast and easy to use retinal imaging system and provide images of the eye as an aid to clinicians in the diagnosis of diabetic retinopathy, AMD, glaucoma and other retinal diseases. NFC-700 was designed as an All-in-one system with full auto-focusing technique and easy operation. The large 10.1" touch screen makes it easy to control all of the operating procedures and makes the measurement and image check easily. NFC-700 uses NIR LED as illumination during alignment to the retina of patients' eyes, users can just touch the center of the pupil on the screen to capture the image. There also some interface located at the bottom of the device such as USB, HDMI, Ethernet make user to store, retrieve, archive and share the digital images by USB or LAN. The dimensions of NFC-700 is about 485mm (L) x 282mm (W) x 500mm (H) and the whole weight should be not more than 17kg.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retina and external areas of the eye, posterior and external area of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians, Hospital
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 Testing: This is a single-site study evaluating the non-inferiority of the auto-focus study device, NFC-700, relative to the predicate with regards to image quality. Consented subjects will undergo ophthalmic examination and a series of fundus photos on the study eye with the NFC-700 and the predicate device. The clinical testing of NFC-700 was study the 119 patient. Photos will be based upon image quality assessment for identification of clinically significant features using a 5-point grading scale.
Key results:
- Of 119 subjects, NFC-700 images cleared demonstrated optic disc (118), macula (118), and retinal vessels (117).
- Image quality evaluation by ophthalmologist: Good focus (116/119), Appropriate brightness (107/119), Good view field identification (110/119), No image defects (109/119), No small pupil interference (119/119), No ocular media opacity (111/119).
- The ratio of images with "sufficient for clinical interpretation" (3~5 points) quality taken by the investigational device (NFC-700) vs. by the reference device (FundusVue) is 97.5% and 96.6%, respectively; which proven that the performance of NFC-700 is equivalent to the listed medical device FundusVue.
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
January 2, 2019
Crystalvue Medical Corporation Oliver Lin Director of Quality Assurance No.116, Ln.956, Zhongshan Rd., Taoyuan Dist., Taoyuan, 33072 Tw
Re: K182199
Trade/Device Name: NFC-700 non-mydriatic auto fundus camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: September 21, 2018 Received: September 28, 2018
Dear Oliver Lin:
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/cfpmp/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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
Bradley S. Gunningham -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K182199
Device Name
NFC700 Non-Mydriatic Auto Fundus Camera
Indications for Use (Describe)
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 conditions. NFC-700 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)
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 logo for Crystalvue. The logo consists of the word "Crystalvue" in a sans-serif font. The "C" in "Crystal" is replaced by a circular design with a gradient of light blue to white, resembling a lens or crystal ball. The "vue" portion of the word is in a lighter shade of blue compared to the rest of the word.
NFC-700 510(K) Premarket Notification
510(k) Summary
Crystalvue Medical Corporation NFC-700 Non-Mydriatic Auto Fundus Camera
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
Submitter
| Company name: | Crystalvue Medical Corporation |
|---|---|
| Company Address: | No.116, Ln.956, Zhongshan Rd., |
| Taoyuan Dist., Taoyuan City 33072, Taiwan | |
| Contact Person: | Oliver Lin |
| Director of Quality Assurance | |
| Phone: | +886 3 360 7711 Ext.2051 |
| Fax: | +886 3 360 7722 |
| E-mail: | Oliver.Lin@crystalvue.com.tw |
| Date prepared: | 08/10/2018 |
Device Information
| Classification: | Class II |
|---|---|
| Trade Name: | NFC-700 Non-Mydriatic Auto Fundus Camera |
| Common Name: | Fundus Camera |
| Classification Name: | Ophthalmic Camera, AC power |
| Product Code: | HKI |
| Regulation Number: | 21 CFR § 886.1120 |
Predicate Devices
Trade Name: Optovue iCam Fundus Camera Classification Name: HKI, Ophthalmic Camera, AC power 510(k) Number: K122572
Intended Use
NFC-700 provides non-mydriatic, color posterior chamber and external images of the eye as an aid to clinicians in the evaluation and diagnosis of eye disease.
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Image /page/4/Picture/0 description: The image shows the word "Crystalvue" in a stylized font. The "C" in Crystal is a light blue circle with a white design inside. The rest of the word "Crystal" is in black, while "vue" is in a lighter blue color.
Indication for Use
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 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.
Device Description
The NFC-700 is a non-contact fundus camera for capturing, storing and displaying the color fundus images with 12MP. It was designed a non-contact, high resolution digital imaging device, auto 3D tracking, fast and easy to use retinal imaging system and provide images of the eye as an aid to clinicians in the diagnosis of diabetic retinopathy, AMD, glaucoma and other retinal diseases.
NFC-700 was designed as an All-in-one system with full auto-focusing technique and easy operation. The large 10.1" touch screen makes it easy to control all of the operating procedures and makes the measurement and image check easily. NFC-700 uses NIR LED as illumination during alignment to the retina of patients' eyes, users can just touch the center of the pupil on the screen to capture the image. There also some interface located at the bottom of the device such as USB, HDMI, Ethernet make user to store, retrieve, archive and share the digital images by USB or LAN.
The dimensions of NFC-700 is about 485mm (L) x 282mm (W) x 500mm (H) and the whole weight should be not more than 17kg.
The detailed technological characteristics and specifications please refer to the paragraph of the substantial equivalence of this section.
Safety
All safety related parameters of NFC-700, such as light hazard protection, material biocompatibility, and IEC-60601 certification, has been tested and certified by recognized laboratories. The NFC-700 has the same indication and analysis features as predicate device; and all related test report of safety are show the NFC-700 is as safe as to the Optovue iCam Fundus Camera.
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Image /page/5/Picture/0 description: The image shows the word "Crystalvue" in a stylized font. The "C" in "Crystal" is replaced with a graphic of a crystal. The word "Crystal" is in black, while the word "vue" is in a gradient of blue.
Biocompatibility Testing
The Biocompatibility test evaluation for NFC-700 was conducted in accordance with the ISO10993-1. The test result of biocompatibility test is complies the ISO 10993-1 standard.
Effectiveness
The validation of effectiveness of the NFC-700 has been analyzed in detail and the image quality is similar to the predicate device.
In clinical testing, the proportion of clinically useful images was tested by comparing the measured data to the reference device by physicians. The results provided that the NFC-700 is as effective as other devices which available on the market.
Substantial Equivalence
The NFC-700 is substantially equivalent to the predicate devices: Optovue iCam Fundus Camera (K122572).
After the detailed substantial equivalence comparison, besides the outer shape and the focus adjustment mode of NFC-700 are different from iCam Fundus Camera, the intended uses, technological, biological, and clinical performance of NFC-700 are equivalent with iCam Fundus Camera.
| Product | Crystalvue /
NFC-700 | Optovue /
iCam Fundus Camera | Comparison
Comments |
|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | | | |
| 510K number | K182199 | K122572 | -- |
| Intended Use | NFC-700 provides
non-mydriatic, color posterior
chamber and external images
of the eye as an aid to
clinicians in the evaluation
and diagnosis of eye disease. | The iCam takes digital
images of the posterior and
external structures of the eye
without the use of a mydriatic
agent and is intended for use
as an aid to clinicians in the
evaluation, diagnosis and
documentation of ocular
health. | There is slight
difference in the
description of
intended use, but the
meaning is exactly
the same with iCam
Fundus Camera. |
| Indication for Use | 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 | The iCam 100 is a
non-contact, high resolution
digital imaging device which
is suitable for photographing,
displaying and storing images
of the retina and external | Both are almost the
same. But we
removed the part of
content about what
the device does not
do (please see the |
| | areas of the eye to be
evaluated under
non-mydriatic 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. | areas of the eye to be
evaluated under
non-mydriatic conditions.
iCam 100 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.
iCam 100 provides images
only and does not provide any
diagnostic, pathological
analysis or classification of
ocular health or disease. | last paragraph of
iCam IFU) to
comply with 21 CFR
814.20 (3)(i). |
| Where Used | Hospital | Hospital | Exactly the same |
| Design | | | |
| -Shape | All in one | A camera head combine with
a Base | NFC-700 is an
All-In-One and fully
auto alignment
device. Based on the
two reasons, the
mechanical structure
is different to iCam.
It is reflects on the
appearance of
NFC-700.
Furthermore, the
main technological
of NFC-700 is same
as iCam. Thus, the
differences won't
make the safety
problems but as
effective as iCam. |
| -Dimensions(WxDxH) | 282 x 485 x 492 (mm) | Head :150 x 225 x 335(mm)
Base: 340 x 460 x 580 (mm) | |
| -Weight | 17 Kg | Camera Head: 2 Kg
Base: 10 Kg | |
| -Eye Fixation | Internal 10 points | Internal 6 point | The eye fixation
point of NFC-700 is
more than iCam, it
provides more |
| | | | different angle of |
| | | | fundus images. |
| -Power Supply | | AC100V to 240V, 50/60Hz (Auto selected) | Exactly the same |
| -Environment | | Temp.:10-35 °C / Humidity:30-90%RH | Exactly the same |
| -Light source
- Observation:
- Flash: | | 1. Infrared LED
- White LED | Exactly the same |
| -Type of Photography | | Color / Digital red-free / Anterior eye image | Exactly the same |
| Operation Principle | The optical design of fundus camera is based on the principle
of monocular indirect ophthalmoscopy. - Fundus observation:
A build in light ray from the infrared light LED source to
illuminate the fundus. Alignment of the device is
performed by build in eye tracking indicator and working
distance indicator to adjust system to best XYZ position
automatically. - Image capture:
System use 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 built-in color CMOS
camera module for fundus image capture. | | The NFC-700 and
iCam fundus camera
have exactly same
technology principle. |
| Material of Chinrest | | ABS | Exactly the same |
| Material of
Forehead Rest | | TPE | The biocompatibility
has been certified by
recognized lab, thus
the different material
do not affect the
safety. |
| Safety | | IEC60601-1 compliance
IEC 60601-1-2 compliance | Exactly the same |
| Performance | | | |
| -Image (resolution) | | 12 MP | The higher pixel
only provides high
resolution image, it |
| | ABS | FEP | |
| | IEC60601-1 compliance | IEC60601-1 compliance | |
| | 1.3 MP | | |
| | | | |
| | | | does not adversely
affect safety and
effectiveness. |
| | | Manual focus tracking | For the different of
alignment method,
We analyzed the
possible hazards and
then set the security
measures on the
appearance design of
camera head and the
distance of
camera-to-patient.
Thus, the difference
does not adversely
affect safety and
effectiveness. |
| -Alignment | Fully automatic 3D tracking | | |
| | | | |
| -Field of View | 45° | | Exactly the same |
| -Minimum Pupil Size | 4.0 mm | | Exactly the same |
| -Working Distance | 25 mm | | Exactly the same |
| -Operation Range (Focus
Adjustment Range): - Without compensation
lens: - With compensation
lens: | -15 to +10 D | | -15 to +10 D |
| | -30D to -10D or +5D to +30D | -35D to -10D or +5D to +30D | |
| Interface | USB2.0 / Ethernet / HDMI | USB 2.0 | The interface is more
diversified provides
user more easy and
convenient image
transfer method. |
6
Orystalvue
NFC-700 510(K) Premarket Notification
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Image /page/7/Picture/0 description: The image shows the word "Crystalvue" in a stylized font. The "C" is replaced with a circular design that resembles a lens or crystal. The word is written in a combination of black and blue colors, with "Crystal" in black and "vue" in blue.
8
Image /page/8/Picture/0 description: The image shows the word "Crystalvue" in a stylized font. The "C" in "Crystal" is designed to look like a lens or a crystal ball, with concentric circles inside. The word "Crystal" is in black, while "vue" is in a blue color, creating a visual distinction within the name.
9
Image /page/9/Picture/0 description: The image shows the word "Crystalvue" in a stylized font. The "C" in "Crystal" is replaced with a circular design that resembles a lens or a crystal ball. The word "Crystal" is in black, while "vue" is in a blue color.
Performance Data
(a) Software Validation
The Software verification and validation testing were conducted and documentation was provided as recommended by IEC-62304 "Medical Device Software – Software Life Cycle Processes". The software of NFC-700 is classified as Class A according to the classification criterion of IEC 62304:2015, and also as Minor Level of Concern in accordance with U.S. FDA Guidance since the failure usually will not cause the patient injury. Application of risk management to medical devices to show the software used in the NFC-700 is conform the safety principles.
(b) Bench Testing
The NFC-700 has undergone performance testing before release to ensure that the device and its software meet the functional requirements and to demonstrate equivalence to the predicated devices.
| Performance
Item | Requirements | Test
Result |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Resolving power | ≥60 line pairs/mm at the center of the field
≥40 line pairs/mm at the mid field (r/2)
≥25 line pairs/mm at the periphery of the field (r) | Pass |
| Field of view | 45 degrees | Pass |
| Pixel pitch | 5.12 μm | Pass |
| Alignment
illumination | The alignment illumination intensity by NIR-LED
should be able to adjust output level by SW control. | Pass |
| Flash illumination | The flash illumination intensity by White LED should
be able to adjust output level by SW control. | Pass |
| Range of focus | -15 to +10 D (Without compensation lens) | Pass |
| | -35D to -10D or +5D to +30D (With compensation lens) | Pass |
| Minimum pupil
size | 4.0 mm | Pass |
| Working distance | 25 mm | Pass |
| Alignment | With fully automatic 3D tracking. The average test | Pass |
A summary of the results of performance testing and the device requirements follows:
10
NFC-700 510(K) Premarket Notification
| time should≤30 seconds. | ||
|---|---|---|
| Image quality | The quality of Fundus images captured by NFC-700 | |
| should be same as predicate device on same people. | Pass |
- (c) Clinical Testing
This is a single-site study evaluating the non-inferiority of the auto-focus study device, NFC-700, relative to the predicate with regards to image quality. Consented subjects will undergo ophthalmic examination and a series of fundus photos on the study eye with the NFC-700 and the predicate device.
The clinical testing of NFC-700 was study the 119 patient. Photos will be based upon image quality assessment for identification of clinically significant features using a 5-point grading scale.
- (1). Significant clinical manifestation zone:
Among the 119 subjects, their fundus images taken by the NFC-700 can mostly and clearly demonstrate significant clinical manifestation zones such as the optic disc, macula and retinal vessels.
| Whether the image can clearly demonstrate the following
| significant clinical manifestations for interpretation? | Yes | No |
|---|---|---|
| (a) Optic disc | 118 | 1 |
| (b) Macula | 118 | 1 |
| (c) Retinal vessels | 117 | 2 |
(2). Image quality factors:
The ophthalmologist reviews all fundus images from the 119 subjects taken by the NFC-700 one-by-one. Most image quality is evaluated as good.
| Whether the image can clearly demonstrate the following
| significant clinical manifestations for interpretation? | Yes | No |
|---|---|---|
| (a). Good focus | 116 | 3 |
| (b). Appropriate brightness | 107 | 12 |
| (c). Good view field identification | 110 | 9 |
| (d). No image defects | 109 | 10 |
| (e). No small pupil interference | 119 | 0 |
| (f). No ocular media opacity | 111 | 8 |
(3). Results interpretation:
This study total examined 119 eyes, of which the fundus images were taken both by
11
| Grading Statistics | FundusVue (reference camera) | ||||||
|---|---|---|---|---|---|---|---|
| Grading | 1 | 2 | 3 | 4 | 5 | Total | |
| 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
| NFC-700 | |||||||
| (investigational | |||||||
| camera) | 2 | 0 | 3 | 0 | 0 | 0 | 3 |
| 3 | 0 | 1 | 1 | 0 | 0 | 2 | |
| 4 | 0 | 0 | 0 | 15 | 10 | 25 | |
| 5 | 0 | 0 | 0 | 11 | 78 | 89 | |
| Total | 0 | 4 | 1 | 26 | 88 | 119 |
the investigational camera (NFC-700) and the reference camera (FundusVue). The grading results are summarized in the following table:
According to the preliminary statistics (the primary endpoints based on the dichotomy) listed in the above table, the ratio of images with "sufficient for clinical interpretation" (3~5 points) quality taken by the investigational device (NFC-700) vs. by the reference device (FundusVue) is 97.5% and 96.6%, respectively; which proven that the performance of NFC-700 is equivalent to the listed medical device FundusVue.
Conclusion
As described in this 510(k) Summary, comprehensive testing and analysis was conducted on the NFC-700 to ensure that the device is safe and effective for its intended use when used in accordance with its instructions for use. The Performance Data demonstrate that NFC-700 is as safe and effective as predicate device, Optovue iCam Fundus Camera. Based on the information in this submission, the NFC-700 has the same intended use, technological characteristics, and operation principles as its predicate devices. Therefore, NFC-700 is substantially equivalent to the predicate device.