(141 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study details for the NFC-700 non-mydriatic auto fundus camera, based on the provided text:
Acceptance Criteria and Device Performance
| Performance Item | Requirements (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| 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 (Without compensation lens) | -15 to +10 D | Pass |
| Range of focus (With compensation lens) | -35D to -10D or +5D to +30D | Pass |
| Minimum pupil size | 4.0 mm | Pass |
| Working distance | 25 mm | Pass |
| Alignment (Automatic 3D tracking) | The average test time should ≤ 30 seconds. | Pass |
| Image quality | The quality of Fundus images captured by NFC-700 should be the same as the predicate device on the same people. | Pass |
| Clinical Testing (Image Quality - Clinically Significant Features) [for interpretation] | ||
| (a) Optic disc | Clear demonstration for interpretation (Implicit acceptance: high "Yes" count) | 118 out of 119 ("Yes") |
| (b) Macula | Clear demonstration for interpretation (Implicit acceptance: high "Yes" count) | 118 out of 119 ("Yes") |
| (c) Retinal vessels | Clear demonstration for interpretation (Implicit acceptance: high "Yes" count) | 117 out of 119 ("Yes") |
| Clinical Testing (Image Quality Factors) | ||
| (a). Good focus | Good (Implicit acceptance: high "Yes" count) | 116 out of 119 ("Yes") |
| (b). Appropriate brightness | Appropriate (Implicit acceptance: high "Yes" count) | 107 out of 119 ("Yes") |
| (c). Good view field identification | Good (Implicit acceptance: high "Yes" count) | 110 out of 119 ("Yes") |
| (d). No image defects | No defects (Implicit acceptance: high "Yes" count) | 109 out of 119 ("Yes") |
| (e). No small pupil interference | No interference (Implicit acceptance: high "Yes" count) | 119 out of 119 ("Yes") |
| (f). No ocular media opacity | No opacity (Implicit acceptance: high "Yes" count) | 111 out of 119 ("Yes") |
| Clinical Testing (Overall Image Quality for Clinical Interpretation) | Ratio of images with "sufficient for clinical interpretation" (3~5 points) comparable to the reference device (FundusVue). | NFC-700: 97.5% FundusVue: 96.6% |
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: 119 patients (eyes).
- Data Provenance: The text does not explicitly state the country of origin. It describes a "single-site study" and mentions "Consented subjects will undergo ophthalmic examination." This suggests it was a prospective study.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One ophthalmologist.
- Qualifications: "The ophthalmologist reviews all fundus images..." (No further specific qualifications or years of experience are provided beyond "ophthalmologist").
-
Adjudication method for the test set:
- The text describes a single ophthalmologist reviewing and grading the images. There is no mention of an adjudication method for discrepancies, implying either none was used or no discrepancies requiring adjudication were present (unlikely in a subjective grading process).
-
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, an MRMC comparative effectiveness study was not done. This study compared the image quality of the investigational device (NFC-700) to a reference camera (FundusVue), not the performance of human readers with or without AI assistance. The NFC-700 is a camera, not an AI diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in spirit. The "Performance Data" section primarily details the standalone performance of the NFC-700 camera in terms of image quality and technical specifications. The "Clinical Testing" evaluated the camera's ability to produce diagnostically useful images, which is a standalone assessment of the camera itself. It's important to note this is for the camera's image output, not an AI algorithm's diagnostic output.
-
The type of ground truth used:
- Expert Consensus (Single Expert): The ground truth for image quality assessment was established by a single ophthalmologist's review using a 5-point grading scale and assessment against clinically significant features.
-
The sample size for the training set:
- The document does not provide information regarding a training set. This is a fundus camera, not an AI algorithm that typically requires a large training set for model development. The mentions of "Software verification and validation testing" relate to the camera's control software, not an image analysis AI.
-
How the ground truth for the training set was established:
- Since no training set information is provided, how its ground truth was established is not applicable here.
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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
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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
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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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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 LinDirector 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 | ComparisonComments |
|---|---|---|---|
| Item | |||
| 510K number | K182199 | K122572 | -- |
| Intended Use | NFC-700 providesnon-mydriatic, color posteriorchamber and external imagesof the eye as an aid toclinicians in the evaluationand diagnosis of eye disease. | The iCam takes digitalimages of the posterior andexternal structures of the eyewithout the use of a mydriaticagent and is intended for useas an aid to clinicians in theevaluation, diagnosis anddocumentation of ocularhealth. | There is slightdifference in thedescription ofintended use, but themeaning is exactlythe same with iCamFundus Camera. |
| Indication for Use | NFC-700 is a non-contact,high resolution digitalimaging device which issuitable for photographing,displaying and storing imagesof the retina and external | The iCam 100 is anon-contact, high resolutiondigital imaging device whichis suitable for photographing,displaying and storing imagesof the retina and external | Both are almost thesame. But weremoved the part ofcontent about whatthe device does notdo (please see the |
| areas of the eye to beevaluated undernon-mydriatic conditions.NFC-700 is indicated forin-vivo viewing of theposterior and external area ofthe eye and the images areintended for use as an aid toclinicians in the evaluation,diagnosis and documentationof ocular health. | areas of the eye to beevaluated undernon-mydriatic conditions.iCam 100 is indicated forin-vivo viewing of theposterior and external area ofthe eye and the images areintended for use as an aid toclinicians in the evaluation,diagnosis and documentationof ocular health.iCam 100 provides imagesonly and does not provide anydiagnostic, pathologicalanalysis or classification ofocular health or disease. | last paragraph ofiCam IFU) tocomply with 21 CFR814.20 (3)(i). | |
| Where Used | Hospital | Hospital | Exactly the same |
| Design | |||
| -Shape | All in one | A camera head combine witha Base | NFC-700 is anAll-In-One and fullyauto alignmentdevice. Based on thetwo reasons, themechanical structureis different to iCam.It is reflects on theappearance ofNFC-700.Furthermore, themain technologicalof NFC-700 is sameas iCam. Thus, thedifferences won'tmake the safetyproblems but aseffective 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 KgBase: 10 Kg | |
| -Eye Fixation | Internal 10 points | Internal 6 point | The eye fixationpoint of NFC-700 ismore than iCam, itprovides 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 source1. Observation:2. Flash: | 1. Infrared LED2. 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 principleof monocular indirect ophthalmoscopy.1. Fundus observation:A build in light ray from the infrared light LED source toilluminate the fundus. Alignment of the device isperformed by build in eye tracking indicator and workingdistance indicator to adjust system to best XYZ positionautomatically.2. Image capture:System use split-image technique to do image focusadjustment automatically to capture the best quality ofimage. White light from LEDs Flash module irradiates thefundus. The light reflected from eye portions forms animage, and the image is captured by built-in color CMOScamera module for fundus image capture. | The NFC-700 andiCam fundus camerahave exactly sametechnology principle. | |
| Material of Chinrest | ABS | Exactly the same | |
| Material ofForehead Rest | TPE | The biocompatibilityhas been certified byrecognized lab, thusthe different materialdo not affect thesafety. | |
| Safety | IEC60601-1 complianceIEC 60601-1-2 compliance | Exactly the same | |
| Performance | |||
| -Image (resolution) | 12 MP | The higher pixelonly provides highresolution image, it | |
| ABS | FEP | ||
| IEC60601-1 compliance | IEC60601-1 compliance | ||
| 1.3 MP | |||
| does not adverselyaffect safety andeffectiveness. | |||
| Manual focus tracking | For the different ofalignment method,We analyzed thepossible hazards andthen set the securitymeasures on theappearance design ofcamera head and thedistance ofcamera-to-patient.Thus, the differencedoes not adverselyaffect safety andeffectiveness. | ||
| -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 (FocusAdjustment Range):1. Without compensationlens:2. With compensationlens: | -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 morediversified providesuser more easy andconvenient imagetransfer method. |
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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.
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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.
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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.
| PerformanceItem | Requirements | TestResult |
|---|---|---|
| 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 |
| Alignmentillumination | The alignment illumination intensity by NIR-LEDshould be able to adjust output level by SW control. | Pass |
| Flash illumination | The flash illumination intensity by White LED shouldbe 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 pupilsize | 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:
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NFC-700 510(K) Premarket Notification
| time should≤30 seconds. | ||
|---|---|---|
| Image quality | The quality of Fundus images captured by NFC-700should 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 followingsignificant 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 followingsignificant 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
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| Grading Statistics | FundusVue (reference camera) | ||||||
|---|---|---|---|---|---|---|---|
| Grading | 1 | 2 | 3 | 4 | 5 | Total | |
| 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
| NFC-700(investigationalcamera) | 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.
§ 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.