(188 days)
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 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 Huvitz Co., Ltd. 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, aiding clinicians in evaluating and diagnosing ocular health.
The device's performance was evaluated through a series of bench tests, including electrical and mechanical safety testing, electromagnetic compatibility, light hazard testing, and disinfection tests, all adhering to relevant international standards. The primary effectiveness study involved comparing the HFC-1's image quality and technical features against a predicate device, the Nidek AFC-330 Non-Mydriatic Auto Fundus Camera (K113451), and assessing its conformity to ISO 10940:2009 (Ophthalmic Instruments-Fundus Cameras).
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test list | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| Resolution | ①Center: 60 line pairs / mm or more②Middle: more than 40 line pairs / mm③Around: 25 line pairs / mm or more (Established based on ISO 10940 Standard) | Center: 62 (6G3E), 70.23(-1G6E)Middle: 41 (6G2E), 62.59(-1G5E)Around: 28 (6G1E), 39.41(-1G1E) | Pass |
| Image Capture Angle | 45° ± 5% (normal mode), i.e., 42.75° | 43.1 ° (ø 790, r 395) | Pass |
| Pupil diameter | ① 4.0 mm or more (normal mode)② 3.3 mm or more (Minimum pupil measurement mode) | ① Pass (Possible to shoot model eye with 4.0mm pupil diameter)② Pass (Possible to shoot model eye with 3.3mm pupil diameter) | Pass |
| Pixel pitch of sensor in fundus | 3.69um ± 7% (3.4317 ~ 3.9483) (According to ISO 10940) | 3.53 um | Pass |
| Light intensity control | Step 10 should be. (Each level of light intensity should be well-operated and well-controlled) | Pass (Each level of light intensity was well-operated and well-controlled) | Pass |
| Objective lens reflected light and black spot | The difference between the circumference and 10 should be less. (Established considering Huvitz senior engineer and researcher's opinion) | Pass (Result met the test standard) | Pass |
| Working Distance | Capture fundus image: 33mm± 1mm | Pass (Result met the test standard) | Pass |
| Diopter adjustment range | Total: -33D ~ + 33D(1)Without correction lens: -13D ~ + 13D(2)With Corrected lens entrance: + 7D~ + 33D(3)With compensation lens: -33D ~ -7D | Pass (Captured image was clear within ranges) | Pass |
| Moving range (Body) | Body front and back: 70mm ± 5mmBody right and left: 100mm ± 5mmBody top and bottom: 30mm ±5mm | Front Back: 70 mmLeft Right: 102 mmUp down: 30.5 mm | Pass |
| Moving range (Chin rest) | Top and bottom of chin rest: 62mm ± 5mm | Up down: 65 mm | Pass |
| Auto Tracking | Top and Bottom: 30mm ±1mmRight and Left: 10mm ±1mmFront and Rear: 10mm ±1mm | Top and Bottom: 30 mmRight Left: 11 mmFront Back: 10 mm | Pass |
| Sleep mode | 5 Min ±5 Sec (Established considering Huvitz senior engineer and researcher's opinion) | Pass (Result met the test standard) | Pass |
| LCD Tilting Angle | 70° ± 5% (66.5~73.5) (Established considering Huvitz senior engineer and researcher's opinion) | Angle 71 ° | Pass |
| 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). (Established considering Huvitz senior engineer and researcher's opinion) | Pass (Result met the test standard) | Pass |
| Lens 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 (3rd step). (Established considering Huvitz senior engineer and researcher's opinion) | Pass (Result met the test standard) | Pass |
| Image Quality Comparison Test (HFC-1 vs AFC-330) | "Supportive of equivalence of HFC-1 to the predicate device with regard to image quality." (Implicit acceptance criteria: comparable image quality to the predicate) | Result was supportive of equivalence of HFC-1 to the predicate device with regard to image quality. | Pass |
| Resolving Power, Field of View, and Panorama Function Comparison Test (HFC-1 vs AFC-330) | "HFC-1 is as effective as AFC-330." (Implicit acceptance criteria: comparable performance to the predicate in these aspects) | HFC-1 is as effective as AFC-330. Test demonstrates HFC-1 has panorama function like AFC-330. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a distinct "test set" in terms of patient images or clinical cases for the performance evaluation. Instead, the performance tests relied on model eyes, standardized targets (e.g., USAF chart, scales), and physical measurements of the device.
- Data Provenance: The testing appears to be prospective bench testing conducted by the manufacturer, Huvitz Co., Ltd., which is based in Gyeonggi-do, Republic of Korea. No patient data or clinical data from specific countries are mentioned for these performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- For the objective quantitative tests (e.g., resolution, image capture angle, pupil diameter, pixel pitch, working distance, moving range, auto tracking, sleep mode, LCD tilting angle, cornea flare, lens flare), the acceptance criteria were established based on ISO 10940 Standard or opinions of Huvitz senior engineers and researchers. There is no mention of external experts or their specific qualifications for establishing ground truth for these objective measurements.
- For the Image Quality Comparison Test, images from the HFC-1 and the predicate device were "shown to the physician for comparison in image quality." The document does not specify the number of physicians, their qualifications, or how their comparisons were aggregated to form a "ground truth" or judgment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- For the objective bench tests, the adjudication method was none in the sense of expert consensus. The results were compared directly against pre-defined numerical or descriptive criteria derived from ISO standards or internal expert opinion.
- For the Image Quality Comparison Test, the document states images were "shown to the physician for comparison," but it does not describe an adjudication method (e.g., majority vote, consensus meeting) for interpreting the physician's comparison.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. The device is a fundus camera, which is an imaging device, not an AI-powered diagnostic algorithm designed to assist human readers. The effectiveness study focused on the image capture capabilities and image quality of the camera itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the HFC-1 Fundus Camera is an imaging device, not an AI algorithm. Its performance is about its ability to capture images, not interpret them.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the objective performance tests, the "ground truth" was based on internationally recognized standards (ISO 10940) and internal engineering specifications/expert opinions.
- For the Image Quality Comparison Test, the "ground truth" was based on the direct visual comparison of images by an unnamed physician. This is closer to a subjective expert assessment rather than objective and independently verified ground truth like pathology.
8. The sample size for the training set
- No training set is mentioned or applicable, as the HFC-1 Fundus Camera is an imaging device, not a machine learning algorithm that requires training data.
9. How the ground truth for the training set was established
- Not applicable as there is no training set for this device.
{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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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
{4}------------------------------------------------
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 more②Middle:more than 40 line pairs / mm③Around:25 line pairs / mm or moreInstrument and Jig Control #:W2AUAA-17-00055, P-205,P-223 | The Pass or Fail Criteriafor Resolutionis established based onISO 10940 Standard.After HFC-1 focused on the USAFchart located 1 m from the pupil andtook a picture, the chart displayed onthe LCD monitor was judged bybeing read. | Center: 62 (6G3E)70.23(-1G6E)Middle: 41 (6G2E)62.59(-1G5E)Around: 28 (6G1E)39.41(-1G1E)■P, OF |
| ImageCapture Angle | 45° ± 5% (normal mode)42.75° | The Pass or Fail Criteriafor Image Capture Angleis established based onISO 10940 Standard.After photographing the scale at adistance of 1m away from the pupil,divide the photographed distance by 2to 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 forHFC-1 is 4.0mm on Normal Mode,the test should verify that HFC-1 hasmore than 4.0mm pupil diameter.After setting to normal mode, HFC-1took a shot of model eye which had4.0mm pupil diameter.Because it was possible for HFC-1 totake a shot of the model eye whosepupil diameter was 4.0mm,HFC-1 passed the test. | ■P, □F |
| ② 3.3 mm or more(Minimum pupil measurementmode)Instrument and Jig Control #:W2AUAA-17-00064 | Because Minimum Pupil Diameter forHFC-1 is 3.3mm on Minimum PupilMeasurement Mode, the test shouldverify that HFC-1 has more than3.3mm pupil diameter.After setting to Minimum pupilmeasurement mode,HFC-1 took a shot of model eyewhich had 3.3mm pupil diameter.Because HFC-1 could take a shot ofthe model eye whose pupil diameterwas 3.3mm, HFC-1 passed the test. | ■P, □F | |
| Pixel pitch ofsensor infundus | 3.69um ± 7% (3.4317 ~ 3.9483)Instrument and Jig Control #:W2AUAA-17-00054 | According to ISO 10940, tolerance ofpixel pitch on fundus is ± 7 %.After taking a shot of 100mm scalelocated 1 m away, use Device | 3.53 um |
| Light intensitycontrol | Step 10 should be | Calibrator SoftwareBecause HFC-1 has light intensitylevel from 1 to 10, the test attemptedto verify that each level of lightintensity was well-operated and well-controlled. | ■P, □F |
| Since each level of light intensity forHFC-1 was well-operated and well-controlled, HFC-1 passed the test. | |||
| Objective lensreflected lightand black spot | The difference between thecircumference and 10 should beless. | The test standard is establishedconsidering Huvitz senior engineerand researcher's opinion.Because the result met the teststandard, HFC-1 passed the test. | ■P, OF |
| WorkingDistance | Capture fundus image:33mm± 1mmInstrument and Jig Control #:P-204, P-241 | After installing model eye with 4.0mmaperture on the chinrest, move the bodywith a joystick in fundus shooting modeto align and focus.The distance from the objective lens tothe model is measured with a ruler.Because the result met the test standard,HFC-1 passed the test. | ■P, OF |
| Diopteradjustmentrange | Total: -33D ~ + 33D to be adjusted(1)Without correction lens:-13D ~ + 13D should be adjusted(2+ Corrected lens entrance:+ 7D~ + 33D(3)- When the compensationlens is charged:-33D ~ -7D should be adjustedInstrument 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 bypressing C.lens icon, mount the modeleye corresponding to the minimum /maximum range of the correction lenson the chinrest.Move the focus lens to a position in themaximum/minimum range.Use the joystick to align and focus thebody, 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 ± 5mmBody right and left: 100mm ± 5mmBody top and bottom: 30mm ±5mmInstrument and Jig Control #: P-204P-241 | Move the body in direction of whereyou want to measure with the joystickthen move the body in the oppositedirection.Use the ruler to measure movingdistance.Since moving distance in each directionmet the test standard, HFC-1 passed thetest. | Front Back: 70 mmLeft Right: 102 mmUp 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 eachdirection met the test standard, HFC-1passed the test. | |||
| Turn off Auto Tracking Function. | |||
| After the model eye is mounted on thechinrest, align and focus. | |||
| Auto Tracking | Top and Bottom: 30mm ±1mmRight and Left: 10mm ±1mmFront and Rear: 10mm ±1mm | Use the joystick to move the body untilthe limit mark appears in the directionyou 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 directionuntil the limit mark appears, and thenmeasure the distance traveled. | Front Back: 10 mm■P, OF | |
| Sleep mode | 5 Min ±5 Sec | The test standard is establishedconsidering Huvitz senior engineer andresearcher's opinion.Because the result met the test standard,HFC-1 passed the test. | ■P, OF |
| LCD TiltingAngle | 70° ± 5% (66.5~73.5)Instrument and Jig Control #: P-207 | The test standard is establishedconsidering Huvitz senior engineer andresearcher'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 thecenter of the mask.Equal width and upper and lower,left, right sides should be constantwhen rotated (2nd step)Instrument and Jig Control #:W2AUAA-17-00021 | The test standard is establishedconsidering Huvitz senior engineer andresearcher's opinion.Because the result met the test standard,HFC-1 passed the test. | ■P, OF |
| The ring of light is located at thecenter of the mask. | The test standard is establishedconsidering Huvitz senior engineer andresearcher's opinion. | ||
| Equal width and upper and lower,left, right sides should be constantwhen 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}------------------------------------------------
{9}------------------------------------------------
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 DeviceNon-Mydriatic Auto Fundus Camera AFC-330 | Subject DeviceHuvitz Fundus CameraHFC-1 | Comparison Comments |
|---|---|---|---|
| 510(k) number | K113451 | K202097 | - |
| Manufacturer | Nidek Co., Ltd | Huvitz Co.,Ltd | - |
| Device Name | Non-Mydriatic Auto Fundus Camera AFC-330with Image Filing Software NAVIS-EXAFC-330 | HFC-1 Fundus Camera | - |
| Design | Image: Non-Mydriatic Auto Fundus Camera AFC-330 | Image: Huvitz Fundus Camera HFC-1 | Same |
| Indications forUse | The Non-Mydriatic Auto Eundus CameraAFC-330 with Image Filing SoftwareNAVIS-EX is intended to capture, display,store and manipulate images of the retina andthe anterior segment of the eye, to aid indiagnosing or monitoring diseases of the eyethat may be observed and photographed. | HFC-1 fundus camera is intended to capture digitalimages for the anterior and retina segment of the eyewithout the use of a mydriatic agent. It is intendedfor use as an aid to clinicians in the evaluation anddiagnosis of ocular health. | There is a minor difference in the indicationsfor use statement but the meaning is similar. |
| Design &Dimension | AFC-330 is composed of LCD, Forehead rest,Chinrest, External LED, Base, JoystickThe dimension of AFC-330 is316 (W) x 518 (D) x 579 (H) mm | HFC-1 is composed of LCD, Headrest, Chinrest,External LED, Base, JoystickThe dimension of HFC-1330(W) x 542(D) x 521(H) mm | The size of AFC-330 with LCD is smaller thanHFC-1 with LCD. These differences are aboutoperator convenience. The interaction with apatient is same. This difference does not raiseany 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 DeviceNon-Mydriatic Auto Fundus Camera AFC-330 | Subject DeviceHuvitz Fundus CameraHFC-1 | Comparison Comments |
| for system main body | for system main body | the requirement. | |
| ConditionsofUse | Use environment-. Temperature: 10°C to 35°C-. Humidity: 30% to 90%-. Pressure: 800hpa to 1060hpaStorage 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 1060hPaStorage environment-. Temperature: - 10°C to + 55°C-. Humidity: 10% to 95%-. Pressure: 700hPa to 1060hpa | Exactly the same |
| PrincipleOperation(Fundus) | The patient's eye is illuminated by nearinfrared light, which is emitted by the fundusillumination optical system. The fundusobservation/photography optical systemforms and image on the image pick-upelement(fundus observation camera), and theimage can be observed on the control panel | The anterior of an eye is illuminated by IR light, theretina of an eye is illuminated by an infrared lightand a white LED, of which lightings are emitted bythe fundus illumination optical system.The fundus observation/photography optical systemforms and makes an image with image sensors,which images are observed and manipulated with thedisplay panel. | Exactly the same |
| TypeOfPhotography | Color, Red-free & IR | Color, Red-free & IR | Exactly the same |
| LEDLight Source | For observation: Halogen lamp 12V 50WFor capturing: Xenon flash lamp 300Ws | Max 50Vdc, 120 mW | The power of LED light source of HFC-1 islower than the model AFC-330. The LED isused to illuminate patient's eye.The photo biological safety is tested andevaluated by manufacturer of LED according toIEC 62471. The performance results meets therequirement of ISO10940.LED light is much brighter than halogen bulbsof the same wattage.The energy output of AFC-330 is larger than |
| Characteristic | Predicate DeviceNon-Mydriatic Auto Fundus Camera AFC-330 | Subject DeviceHuvitz Fundus CameraHFC-1 | Comparison Comments |
| HFC-1 but HFC-1 can be as bright as Halogenbulb and last longer. | |||
| Material ofcontact parts | Forehead rest: Silicone rubberChinrest: Acrylonitrile butadiene styreneresinChinrest paper pin: Polyamide resin | Headrest rubber: Silicone rubber▲ Chinrest: Acrylonitrile butadiene styrene resinChin-rest paper: paper | Parts that in contact with patient intact skin isevaluated by ISO10993-5 and ISO 10993-10.The results meet the requirement of Standards. |
| Performance | |||
| FundusImageResolution | Central area: 60 lines pairs/mm or moreMiddle area: 40 lines pairs/mm or morePeripheral area: 25 lines pairs/mmor more | Center: 60 lines/mm or moreMiddle (r/2): 40 lines/mm or moreMiddle (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-330was 43.1° | 45°According to the bench test, FOV of HFC-1was 43.6° | Difference in Angle for View between HFC-1and AFC-330 was really small which indicatesthat there would be no significant effect onFundus Camera performance. |
| Observable /PhotographableDiameter ofPupil | Normal pupil diameter: Φ4.0mm or moreSmall pupil diameter: Φ3.3mm or more | Normal pupil diameter: Φ4.0mm or moreSmall pupil diameter: Φ3.3mm or more | Exactly the same |
| OperatingDistance(WorkingDistance) | 45.7 mm | 33 mm | Operating distance is different for the subjectand predicate device according to their internalstructure. All performance outcomes meet therequirement of ISO10940. |
| Characteristic | Predicate DeviceNon-Mydriatic Auto Fundus Camera AFC-330 | Subject DeviceHuvitz Fundus CameraHFC-1 | Comparison Comments |
| Measurablerange of dioptricpower for thepatient's eye | Total Measureable Range:-33D to +35D | Total Measurable Range:-33D~+33D | Overall measurable range of dioptric power forthe patient's eye is very similar between themodel AFC-330 and HFC-1.Actually measurable range was led by +/-compensation lens which made by different lensprocessing technology depending on eachmanufacturer.All requirement of performance meets therequirement 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 thanAFC-330 excluding op/down movement.The range of movement is sufficient to alignbetween device and patient. |
| Base up anddown movement | 32mm | 30mm | |
| Chin-restmovement | 62mm | 62mm | Exactly the same |
| Auto TrackingRange | 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 ofHFC-1 is wider than AFC-330.does not affect safety. |
{12}------------------------------------------------
{13}------------------------------------------------
{14}------------------------------------------------
{15}------------------------------------------------
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.
§ 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.