(188 days)
Not Found
No
The summary describes a standard digital imaging device for capturing fundus images. There is no mention of AI, ML, or any advanced image processing that would suggest the use of such technologies. The performance studies focus on functional and mechanical aspects, not algorithmic performance.
No
The device is described as an aid to clinicians in the evaluation and diagnosis of ocular health, which indicates a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section states that the device "is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health."
No
The device description explicitly details hardware components such as a camera, illumination systems (IR light, white LED), optical systems, image sensors, and a display panel, indicating it is a physical medical device, not software-only.
Based on the provided information, the HFC-1 fundus camera is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The HFC-1 fundus camera directly images the eye, which is part of the living human body, not a specimen taken from it.
- The intended use describes capturing images of the eye for clinical evaluation and diagnosis. This is a direct imaging and diagnostic aid function, not a test performed on a biological sample.
- The device description details an optical imaging system. This aligns with in-vivo imaging, not in-vitro testing.
The device is clearly an in-vivo imaging device used to visualize and aid in the diagnosis of conditions within the eye.
N/A
Intended Use / Indications for Use
HFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the eye without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.
HFC-1 Fundus camera is a non-contact, high-resolution bio-microscopic imaging device. It is indicated for in-vivo viewing, color fundus image using a color camera without the use of mydiatic agents. HFC-1 Fundus camera captures fundus image to assist a clinician for diagnostic examinations.
Product codes
HKI
Device Description
HFC-1 Fundus Camera captures, store and display color fundus images with built-in 20 Mega pixel colored channel up to 45-degree field of view. HFC-1 Fundus Camera is designed as a non-contact, non-invasive and high resolution digital imaging device. HFC-1 Fundus Camera has a retinal imaging system that provides digital images of the eyes to assist physicians in diagnostic examinations. The anterior of an eye is illuminated by IR light, the retina of an eye is illuminated by a white LED, emitted by the fundus illumination optical system. The fundus observation/photography optical system obtains an image with image sensors and images are observed and manipulated on the display panel.
The dimension of HFC-1 Fundus Camera is 330(W) x 542(D) x 521(H) mm. It weights about 28kg. The size of touch screen is 12.1 inch- touch panel color LCD with 1280 x 800 pixel. The user captures an image by pressing the button on the joystick. At the bottom of the device, there are USB, LAN and DP port to store, retrieve and share digital image data in a network environment.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior and retina segment of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians
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)
Performance testing including biocompatibility, service life, functional and mechanical testing and transportation were conducted in accordance with standards. Animal and clinical data were not submitted. Performance testing demonstrated that the device meets all the specific requirements and performs as intended.
Test list and results:
Resolution:
Center: 62 (6G3E) 70.23(-1G6E)
Middle: 41 (6G2E) 62.59(-1G5E)
Around: 28 (6G1E) 39.41(-1G1E)
Pass
Image Capture Angle:
43.1 ° ø (790) r 395
Pass
Pupil diameter:
Normal mode: Pass
Minimum pupil measurement mode: Pass
Pixel pitch of sensor in fundus:
3.53 um
Light intensity control:
Pass
Objective lens reflected light and black spot:
Pass
Working Distance:
Pass
Diopter adjustment range:
Pass
Moving range:
Front Back: 70 mm
Left Right: 102 mm
Up down: 30.5 mm
Pass
Top and bottom of chin rest:
65 mm
Pass
Auto Tracking:
Top and Bottom: 30 mm
Right Left: 11 mm
Front Back: 10 mm
Pass
Sleep mode:
Pass
LCD Tilting Angle:
Angle 71 °
Pass
Cornea Flare:
Pass
Lens Flare:
Pass
Image Quality Comparison Tests: The images from the predicate device and the HFC-1 were shown to the physician for comparison in image quality. The result was supportive of equivalence of HFC-1 to the predicate device with regard to image quality.
HFC-1 Performance Test in Resolving, Field of View and Panorama Function: This testing measures resolving power and field of view of HFC-1 compared to HFC-1. Based on the result, HFC-1 is as effective as AFC-330. Also, the test demonstrates that HFC-1 has panorama function like AFC-330.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
February 2, 2021
Image /page/0/Picture/1 description: The image shows 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.
Huvitz Co., Ltd. % Dave Kim CEO Mtech Group 7707 Fannin St. Ste 200 Houston. Texas 77054
Re: K202097
Trade/Device Name: Fundus Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: December 28, 2020 Received: December 28, 2020
Dear Dave Kim:
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 probibitions 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 (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-devices/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 (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).
Sincerely,
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) K202097
Device Name HFC-1 Fundus Camera
Indications for Use (Describe)
HFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis 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
510(k) Summary
General Information
- Manufacturer: Huvitz Co., Ltd.
38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055, Republic of Korea Phone: 82-31-428-9100 Fax: 82-31-477-8617
- Contact Person: Dave Kim Mtech Group. 7707 Fannin St. Ste 200-V111, Houston, TX 77054 Tel: +713-467-2607 E-mail: davekim(@mtech-inc.net
Device Information:
- Classification: Class II
- Proprietary Name: HFC-1
- Classification Name: Camera, Ophthalmic, ac-powered
- Regulation No: 21 CFR 886.1120 (HKI)
- Common Name: Fundus Camera
Predicate Device Information:
- Trade Name: Non-Mydriatic Auto Fundus Camera Nidek AFC-330
- Classification Name: HKI, Ophthalmic Camera, AC power
- 510(k) Number: K113451
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Indication for Use:
HFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the eye without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.
Intended Use:
HFC-1 Fundus camera is a non-contact, high-resolution bio-microscopic imaging device. It is indicated for in-vivo viewing, color fundus image using a color camera without the use of mydiatic agents. HFC-1 Fundus camera captures fundus image to assist a clinician for diagnostic examinations.
The Huvitz Fundus camera has the following features:
- Auto shoot-image is optimized and captured automatically when aligned and focused to the ● patient's eye properly.
- Auto tracking-alignment and focus is automatically accomplished in tracking region.
- Pupil mode- Normal mode is 4.0mm, Small pupil mode is 3.3 mm.
- Capture mode- Single Macular mode provides capturing one fundus image for macular. Single ● Disc mode provides capturing one fundus image for Optic Disc. Widefield-Panorama mode provides the stitching function for maximum 7 adjacent images captured individually.
- o 12 inch, color and touch screen provides high quality images and easy to operate GUI available to the operator.
- HUVITZ-Webviewer software of the Server-Client structure exchanges clinical image data with the software built-into HUVITZ'S ophthalmic devices. I Images filmed on the device are transmitted to the server and the user can view the image data from any personal PC through web browser without installing additional software. HUVITZ-Webviewer is compatible with Internet Explorer, Chrome, Safari and Firefox.
- HFC-1 Fundus Camara transfers image data to a server in dicom environment.
Description:
HFC-1 Fundus Camera captures, store and display color fundus images with built-in 20 Mega pixel colored channel up to 45-degree field of view. HFC-1 Fundus Camera is designed as a non-contact, non-invasive and high resolution digital imaging device. HFC-1 Fundus Camera has a retinal imaging system that provides digital images of the eyes to assist physicians in diagnostic examinations. The anterior of an eye is illuminated by IR light, the retina of an eye is illuminated by a white LED, emitted by the fundus illumination optical system. The fundus observation/photography optical system obtains an image with image sensors and images are observed and manipulated on the display panel.
The dimension of HFC-1 Fundus Camera is 330(W) x 542(D) x 521(H) mm. It weights about 28kg. The size of touch screen is 12.1 inch- touch panel color LCD with 1280 x 800 pixel. The user captures an image by pressing the button on the joystick. At the bottom of the device, there are USB, LAN and DP port to store, retrieve and share digital image data in a network environment.
5
Safety:
All necessary safety testing was conducted on the subject device and demonstrated that HFC-1 is substantially equivalent to the predicate device in terms of safety and effectiveness. The safety testing included the followings:
-
- Electrical and Mechanical Safety Testing (according to IEC 60601-1)
-
- Electromagnetic Compatibility (according to IEC 60601-1-2)
-
- Light Hazard Testing (according to IEC 15004-2)
-
- Disinfection (tests according to ISO 10993-1)
Cross-disinfection is informed in the user manual, so users are able to avoid risks.
-
- ANSI Z80.36-2016
American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
- ANSI Z80.36-2016
Effectiveness:
Concerning the validation of effectiveness of HFC-1 Fundus Camera, HFC-1 Fundus Camera has been tested in comparison with the predicate device according to the requirements of ISO 10940:2009 (Ophthalmic Instruments-Fundus Cameras) and it demonstrated a similar image quality to the predicate device. Furthermore, the subject device has same technical features with its predicate device with regard to resolving power, tolerance of angular field of view and range of focus. Also, the performance test shows that HFC-1 Fundus Camera corresponds to all the specifications described in the manual.
| Test list | Test standard | Pass or Fail Criteria | Test result |
|---|---|---|---|
| Resolution | ①Center: | ||
| 60 line pairs / mm or more | |||
| ②Middle: | |||
| more than 40 line pairs / mm | |||
| ③Around: | |||
| 25 line pairs / mm or more | |||
| Instrument and Jig Control #: | |||
| W2AUAA-17-00055, P-205, | |||
| P-223 | The Pass or Fail Criteria | ||
| for Resolution | |||
| is established based on | |||
| ISO 10940 Standard. | |||
| After HFC-1 focused on the USAF | |||
| chart located 1 m from the pupil and | |||
| took a picture, the chart displayed on | |||
| the LCD monitor was judged by | |||
| being read. | Center: 62 (6G3E) | ||
| 70.23(-1G6E) | |||
| Middle: 41 (6G2E) | |||
| 62.59(-1G5E) | |||
| Around: 28 (6G1E) | |||
| 39.41(-1G1E) | |||
| ■P, OF | |||
| Image | |||
| Capture Angle | 45° ± 5% (normal mode) | ||
| 42.75° | |||
| Instrument and Jig Control #: | |||
| W2AUAA-17-00054, P-205, | |||
| P-223 | The Pass or Fail Criteria | ||
| for Image Capture Angle | |||
| is established based on | |||
| ISO 10940 Standard. | |||
| After photographing the scale at a | |||
| distance of 1m away from the pupil, | |||
| divide the photographed distance by 2 | |||
| to calculate r in mm. | |||
| Calculated by the following formula: | |||
| $Field of View – 2 * arctan (r/1000)$ | |||
| Because image capture angle of | 43.1 ° | ||
| ø (790) | |||
| r 395 | |||
| ■P, OF | |||
| HFC-1 fell within the given range, | |||
| HFC-1 passed the test. | |||
| Pupil diameter | ① 4.0 mm or more (normal mode) | ||
| Instrument and Jig Control #: | |||
| W2AUAA-17-00043 | Because Minimum Pupil Diameter for | ||
| HFC-1 is 4.0mm on Normal Mode, | |||
| the test should verify that HFC-1 has | |||
| more than 4.0mm pupil diameter. | |||
| After setting to normal mode, HFC-1 | |||
| took a shot of model eye which had | |||
| 4.0mm pupil diameter. | |||
| Because it was possible for HFC-1 to | |||
| take a shot of the model eye whose | |||
| pupil diameter was 4.0mm, | |||
| HFC-1 passed the test. | ■P, □F | ||
| ② 3.3 mm or more | |||
| (Minimum pupil measurement | |||
| mode) | |||
| Instrument and Jig Control #: | |||
| W2AUAA-17-00064 | Because Minimum Pupil Diameter for | ||
| HFC-1 is 3.3mm on Minimum Pupil | |||
| Measurement Mode, the test should | |||
| verify that HFC-1 has more than | |||
| 3.3mm pupil diameter. | |||
| After setting to Minimum pupil | |||
| measurement mode, | |||
| HFC-1 took a shot of model eye | |||
| which had 3.3mm pupil diameter. | |||
| Because HFC-1 could take a shot of | |||
| the model eye whose pupil diameter | |||
| was 3.3mm, HFC-1 passed the test. | ■P, □F | ||
| Pixel pitch of | |||
| sensor in | |||
| fundus | 3.69um ± 7% (3.4317 ~ 3.9483) | ||
| Instrument and Jig Control #: | |||
| W2AUAA-17-00054 | According to ISO 10940, tolerance of | ||
| pixel pitch on fundus is ± 7 %. | |||
| After taking a shot of 100mm scale | |||
| located 1 m away, use Device | 3.53 um | ||
| Light intensity | |||
| control | Step 10 should be | Calibrator Software | |
| Because HFC-1 has light intensity | |||
| level from 1 to 10, the test attempted | |||
| to verify that each level of light | |||
| intensity was well-operated and well- | |||
| controlled. | ■P, □F | ||
| Since each level of light intensity for | |||
| HFC-1 was well-operated and well- | |||
| controlled, HFC-1 passed the test. | |||
| Objective lens | |||
| reflected light | |||
| and black spot | The difference between the | ||
| circumference and 10 should be | |||
| less. | The test standard is established | ||
| considering Huvitz senior engineer | |||
| and researcher's opinion. | |||
| Because the result met the test | |||
| standard, HFC-1 passed the test. | ■P, OF | ||
| Working | |||
| Distance | Capture fundus image: | ||
| 33mm± 1mm | |||
| Instrument and Jig Control #: | |||
| P-204, P-241 | After installing model eye with 4.0mm | ||
| aperture on the chinrest, move the body | |||
| with a joystick in fundus shooting mode | |||
| to align and focus. | |||
| The distance from the objective lens to | |||
| the model is measured with a ruler. | |||
| Because the result met the test standard, | |||
| HFC-1 passed the test. | ■P, OF | ||
| Diopter | |||
| adjustment | |||
| range | Total: -33D ~ + 33D to be adjusted | ||
| (1)Without correction lens: | |||
| -13D ~ + 13D should be adjusted | |||
| (2+ Corrected lens entrance: |
- 7D~ + 33D
(3)- When the compensation
lens is charged:
-33D ~ -7D should be adjusted
Instrument and Jig Control # :
W2AUAA-17-00032,
W2AUAA-17-00034,
W2AUAA-17-00035,
W2AUAA-17-00039,
W2AUAA-17-00040,
W2AUAA-17-00063, | After selecting the corrective lens by
pressing C.lens icon, mount the model
eye corresponding to the minimum /
maximum range of the correction lens
on the chinrest.
Move the focus lens to a position in the
maximum/minimum range.
Use the joystick to align and focus the
body, then shoot an image.
Check if the captured image is clear,
then record the result.
Since | ■P, OF |
| Moving range | Body front and back: 70mm ± 5mm
Body right and left: 100mm ± 5mm
Body top and bottom: 30mm ±5mm
Instrument and Jig Control #: P-204
P-241 | Move the body in direction of where
you want to measure with the joystick
then move the body in the opposite
direction.
Use the ruler to measure moving
distance.
Since moving distance in each direction
met the test standard, HFC-1 passed the
test. | Front Back: 70 mm
Left Right: 102 mm
Up down: 30.5 mm
■P, OF |
| | | Press Chinrest Button and move the | |
| | | chinrest to the top or bottom. Then, | |
| | Top and bottom of chin rest: | move the chinrest in the opposite | |
| | 62mm ± 5mm | direction. | Up down: 65 mm |
| | Instrument and Jig Control #: P-204 | Then measure the distance with the | ■P, OF |
| | P-241 | ruler. | |
| | | Since Chinrest moving distance in each
direction met the test standard, HFC-1
passed the test. | |
| | | Turn off Auto Tracking Function. | |
| | | After the model eye is mounted on the
chinrest, align and focus. | |
| Auto Tracking | Top and Bottom: 30mm ±1mm
Right and Left: 10mm ±1mm
Front and Rear: 10mm ±1mm | Use the joystick to move the body until
the limit mark appears in the direction
you want to measure. | Top and Bottom:
30 mm |
| | Instrument and Jig Control #: | Place the ruler on the body. | Right Left: 11 mm |
| | P-204,
P-241 | Turn on the Auto Tracking function,
move the body in the opposite direction
until the limit mark appears, and then
measure the distance traveled. | Front Back: 10 mm
■P, OF |
| Sleep mode | 5 Min ±5 Sec | The test standard is established
considering Huvitz senior engineer and
researcher's opinion.
Because the result met the test standard,
HFC-1 passed the test. | ■P, OF |
| LCD Tilting
Angle | 70° ± 5% (66.5~73.5)
Instrument and Jig Control #: P-207 | The test standard is established
considering Huvitz senior engineer and
researcher's opinion.
Because the result met the test standard,
HFC-1 passed the test. | Angle 71 °
■P, OF |
| Cornea Flare | The ring of light is located at the
center of the mask.
Equal width and upper and lower,
left, right sides should be constant
when rotated (2nd step)
Instrument and Jig Control #:
W2AUAA-17-00021 | The test standard is established
considering Huvitz senior engineer and
researcher's opinion.
Because the result met the test standard,
HFC-1 passed the test. | ■P, OF |
| | The ring of light is located at the
center of the mask. | The test standard is established
considering Huvitz senior engineer and
researcher's opinion. | |
| | Equal width and upper and lower,
left, right sides should be constant
when rotated (3rd step) | Because the result met the test standard,
HFC-1 passed the test. | |
| Lens Flare | Instrument and Jig Control #:
W2AUAA-17-00021 | | ■P, □F |
-
- Summary of Performance Test
6
7
8
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2. Image Quality Comparison Tests
The images from the predicate device and the HFC-1 were shown to the physician for comparison in image quality.
The result was supportive of equivalence of HFC-1 to the predicate device with regard to image quality. The test report can be found in Performance Testing: Bench folder.
3. HFC-1 Performance Test in Resolving, Field of View and Panorama Function
This testing measures resolving power and field of view of HFC-1 compared to HFC-1. Based on the result, HFC-1 is as effective as AFC-330. Also, the test demonstrates that HFC-1 has panorama function like AFC-330. The test report can be found in Performance Testing: Bench folder.
Substantial equivalence:
According to the detailed substantial equivalence comparison between HFC-1 and AFC-330, HFC-1 is equivalent with regards to intended use, technological function, and clinical performance to AFC-330 from Nidek. However, HFC-1 uses the different design and materials from AFC-330 which do not have any effects on HFC-1 's clinical function and characteristics.
● Technical/Clinical/ Biological Characteristics Similarities:
-
Technical Similarities: Type of Photography, Angle for view, Observable/photographable diameter of pupil, Principle Operation, Conditions of Use
-
Clinical Similarities: Indication for Use, Intended Use, Site in the body, Intended Patient Population, User profile
-
Biological Similarities: Parts of the body contacted by the device
● Technical/Clinical/Biological Characteristics Differences:
- Technical Differences: Design, Dimension, Operating Distance, Measurable range of dioptric power for the patient's eye in case without the diopter compensation lens and when the convex compensation lens is used, LED Light Source, Base Movement, Power specification for system main body.
10
- Clinical Differences: found no differences
- Biological Differences: found no differences
- Critical Performance Characteristics Similarities:
-Performance Characteristics: Fundus Image Resolution.
- HFC-1 and AFC-330 have the same Fundus Image Resolution
11
●● Comparison of features and specifications of the predicate devices and subject devices
| Characteristic | Predicate Device
Non-Mydriatic Auto Fundus Camera AFC-330 | Subject Device
Huvitz Fundus Camera
HFC-1 | Comparison Comments |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K113451 | K202097 | - |
| Manufacturer | Nidek Co., Ltd | Huvitz Co.,Ltd | - |
| Device Name | Non-Mydriatic Auto Fundus Camera AFC-330
with Image Filing Software NAVIS-EX
AFC-330 | HFC-1 Fundus Camera | - |
| Design | Image: Non-Mydriatic Auto Fundus Camera AFC-330 | Image: Huvitz Fundus Camera HFC-1 | Same |
| Indications for
Use | The Non-Mydriatic Auto Eundus Camera
AFC-330 with Image Filing Software
NAVIS-EX is intended to capture, display,
store and manipulate images of the retina and
the anterior segment of the eye, to aid in
diagnosing or monitoring diseases of the eye
that may be observed and photographed. | HFC-1 fundus camera is intended to capture digital
images for the anterior and retina segment of the eye
without the use of a mydriatic agent. It is intended
for use as an aid to clinicians in the evaluation and
diagnosis of ocular health. | There is a minor difference in the indications
for use statement but the meaning is similar. |
| Design &
Dimension | AFC-330 is composed of LCD, Forehead rest,
Chinrest, External LED, Base, Joystick
The dimension of AFC-330 is
316 (W) x 518 (D) x 579 (H) mm | HFC-1 is composed of LCD, Headrest, Chinrest,
External LED, Base, Joystick
The dimension of HFC-1
330(W) x 542(D) x 521(H) mm | The size of AFC-330 with LCD is smaller than
HFC-1 with LCD. These differences are about
operator convenience. The interaction with a
patient is same. This difference does not raise
any new issues of safety or effectiveness |
| Power Supply | AC 100 - 240V, 50/60Hz, 150VA | AC 100 - 240 V, 50/60 Hz, 1.6 - 0.7 A | HFC-1 is evaluated by IEC60601-1 and meet |
| Characteristic | Predicate Device
Non-Mydriatic Auto Fundus Camera AFC-330 | Subject Device
Huvitz Fundus Camera
HFC-1 | Comparison Comments |
| | for system main body | for system main body | the requirement. |
| Conditions
of
Use | Use environment
-. Temperature: 10°C to 35°C
-. Humidity: 30% to 90%
-. Pressure: 800hpa to 1060hpa
Storage environment
-. Temperature: -10°C to 55°C
-. Humidity: 10% to 95%
-. Pressure: 700hpa to 1060hpa | Use environment
-. Temperature: + 10°C to + 35°C
-. Humidity: 30% to 90%
-. Pressure: 800hPa to 1060hPa
Storage environment
-. Temperature: - 10°C to + 55°C
-. Humidity: 10% to 95%
-. Pressure: 700hPa to 1060hpa | Exactly the same |
| Principle
Operation
(Fundus) | The patient's eye is illuminated by near
infrared light, which is emitted by the fundus
illumination optical system. The fundus
observation/photography optical system
forms and image on the image pick-up
element(fundus observation camera), and the
image can be observed on the control panel | The anterior of an eye is illuminated by IR light, the
retina of an eye is illuminated by an infrared light
and a white LED, of which lightings are emitted by
the fundus illumination optical system.
The fundus observation/photography optical system
forms and makes an image with image sensors,
which images are observed and manipulated with the
display panel. | Exactly the same |
| Type
Of
Photography | Color, Red-free & IR | Color, Red-free & IR | Exactly the same |
| LED
Light Source | For observation: Halogen lamp 12V 50W
For capturing: Xenon flash lamp 300Ws | Max 50Vdc, 120 mW | The power of LED light source of HFC-1 is
lower than the model AFC-330. The LED is
used to illuminate patient's eye.
The photo biological safety is tested and
evaluated by manufacturer of LED according to
IEC 62471. The performance results meets the
requirement of ISO10940.
LED light is much brighter than halogen bulbs
of the same wattage.
The energy output of AFC-330 is larger than |
| Characteristic | Predicate Device
Non-Mydriatic Auto Fundus Camera AFC-330 | Subject Device
Huvitz Fundus Camera
HFC-1 | Comparison Comments |
| | | | HFC-1 but HFC-1 can be as bright as Halogen
bulb and last longer. |
| Material of
contact parts | Forehead rest: Silicone rubber
Chinrest: Acrylonitrile butadiene styrene
resin
Chinrest paper pin: Polyamide resin | Headrest rubber: Silicone rubber
▲ Chinrest: Acrylonitrile butadiene styrene resin
Chin-rest paper: paper | Parts that in contact with patient intact skin is
evaluated by ISO10993-5 and ISO 10993-10.
The results meet the requirement of Standards. |
| | Performance | | |
| Fundus
Image
Resolution | Central area: 60 lines pairs/mm or more
Middle area: 40 lines pairs/mm or more
Peripheral area: 25 lines pairs/mm
or more | Center: 60 lines/mm or more
Middle (r/2): 40 lines/mm or more
Middle (r) : 25 lines/mm or more | Exactly the same |
| Angle for View
(Field of View) | 45° (33° in Small pupil photography mode)
According to the bench test, FOV of AFC-330
was 43.1° | 45°
According to the bench test, FOV of HFC-1
was 43.6° | Difference in Angle for View between HFC-1
and AFC-330 was really small which indicates
that there would be no significant effect on
Fundus Camera performance. |
| Observable /
Photographable
Diameter of
Pupil | Normal pupil diameter: Φ4.0mm or more
Small pupil diameter: Φ3.3mm or more | Normal pupil diameter: Φ4.0mm or more
Small pupil diameter: Φ3.3mm or more | Exactly the same |
| Operating
Distance
(Working
Distance) | 45.7 mm | 33 mm | Operating distance is different for the subject
and predicate device according to their internal
structure. All performance outcomes meet the
requirement of ISO10940. |
| Characteristic | Predicate Device
Non-Mydriatic Auto Fundus Camera AFC-330 | Subject Device
Huvitz Fundus Camera
HFC-1 | Comparison Comments |
| Measurable
range of dioptric
power for the
patient's eye | Total Measureable Range:
-33D to +35D | Total Measurable Range:
-33D~+33D | Overall measurable range of dioptric power for
the patient's eye is very similar between the
model AFC-330 and HFC-1.
Actually measurable range was led by +/-
compensation lens which made by different lens
processing technology depending on each
manufacturer.
All requirement of performance meets the
requirement of ISO10940. |
| | Without the diopter compensation lens:
-12D to +15D | Without the diopter compensation lens:
-13D~+13D | |
| | When the convex compensation lens is used:
+11D to +35D | When the convex compensation lens is used:
+7D~+33D | |
| | When the concave compensation lens is used:
-33D to -7D | When the concave compensation lens is used:
-33D ~ -7D | |
| Base Movement | Back-and-forth 40mm,
Right-and-left 85mm | Back-and-forth 70mm,
Right-and-left 100mm | The range of movement of HFC-1 is wider than
AFC-330 excluding op/down movement.
The range of movement is sufficient to align
between device and patient. |
| Base up and
down movement | 32mm | 30mm | |
| Chin-rest
movement | 62mm | 62mm | Exactly the same |
| Auto Tracking
Range | 32 mm (up and down),
10 mm (right and left),
10 mm (back and forth) | 30mm (up and down),
10mm (right and left),
10mm (back and forth) | The performance of auto tracking range of
HFC-1 is wider than AFC-330.
does not affect safety. |
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Summary of Performance Test
- Performance testing including biocompatibility, service life, functional and mechanical testing and transportation were conducted in accordance with standards. Animal and clinical data were not submitted. Performance testing demonstrated that the device meets all the specific requirements and performs as intended.
Conclusion
- The device is substantially equivalent to the predicate device according to the comparison of intended use, indications for use, technological and clinical characteristics. HFC-1 fundus camera has the same resolving power as the predicate device which means that HFC-1 can produce the similar quality images as its predicate device, AFC-330. The sponsor believes that HFC-1 fundus camera is as safe and effective as the identified predicate devices. Any new issues of safety and effectiveness are not found. Therefore, HFC-1 fundus camera, the subject device, is substantially equivalent to AVC-330, the predicate device.