NFC-700 non-mydriatic auto fundus camera

K182199 · Crystalvue Medical Corporation · HKI · Jan 2, 2019 · Ophthalmic

Device Facts

• Record ID: K182199
• Device Name: NFC-700 non-mydriatic auto fundus camera
• Applicant: Crystalvue Medical Corporation
• Product Code: HKI · Ophthalmic
• Decision Date: Jan 2, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended 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 images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

Device Story

NFC-700 is an all-in-one, non-contact digital fundus camera; captures 12MP color images of retina and external eye. Uses NIR LED for alignment and white LED flash for image capture; features auto-3D tracking and auto-focusing. Operated by clinicians in hospitals/clinics via 10.1-inch touch screen. Device provides digital images for visual inspection; aids clinicians in diagnosing retinal diseases (e.g., diabetic retinopathy, AMD, glaucoma). Data stored/transferred via USB, Ethernet, or HDMI. Benefits include non-mydriatic imaging, simplified operation via automation, and high-resolution documentation of ocular health.

Clinical Evidence

Single-site clinical study of 119 patients comparing NFC-700 to FundusVue reference device. Primary endpoint: image quality for clinical interpretation using a 5-point grading scale. Results showed 97.5% of NFC-700 images were sufficient for clinical interpretation (grades 3-5) compared to 96.6% for the reference device. Demonstrates non-inferiority in image quality.

Technological Characteristics

Non-contact fundus camera; monocular indirect ophthalmoscopy principle. 12MP CMOS sensor. Illumination: NIR LED (alignment), White LED (flash). 45-degree field of view. 4.0mm minimum pupil size. 25mm working distance. Focus range: -15 to +10D (standard), -35 to -10D or +5 to +30D (with compensation lens). Connectivity: USB 2.0, Ethernet, HDMI. 10.1-inch touch screen. Biocompatibility per ISO 10993-1. Safety compliance: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for in-vivo viewing of the posterior and external eye in patients requiring retinal imaging under non-mydriatic conditions to aid clinicians in the evaluation, diagnosis, and documentation of ocular health, including diabetic retinopathy, AMD, and glaucoma.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*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.

Predicate Devices

• Optovue iCam Fundus Camera (K122572)

Reference Devices

• FundusVue (referenced in clinical study)

Submission Summary (Full Text)

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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 [phone] 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.,<br>Taoyuan Dist., Taoyuan City 33072, Taiwan |
| Contact Person: | Oliver Lin<br>Director of Quality Assurance |
| Phone: | [phone] Ext.2051 |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| 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 /<br>NFC-700 | Optovue /<br>iCam Fundus Camera | Comparison<br>Comments |
|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | | | |
| 510K number | K182199 | K122572 | -- |
| Intended Use | NFC-700 provides<br>non-mydriatic, color posterior<br>chamber and external images<br>of the eye as an aid to<br>clinicians in the evaluation<br>and diagnosis of eye disease. | The iCam takes digital<br>images of the posterior and<br>external structures of the eye<br>without the use of a mydriatic<br>agent and is intended for use<br>as an aid to clinicians in the<br>evaluation, diagnosis and<br>documentation of ocular<br>health. | There is slight<br>difference in the<br>description of<br>intended use, but the<br>meaning is exactly<br>the same with iCam<br>Fundus Camera. |
| Indication for Use | NFC-700 is a non-contact,<br>high resolution digital<br>imaging device which is<br>suitable for photographing,<br>displaying and storing images<br>of the retina and external | The iCam 100 is a<br>non-contact, high resolution<br>digital imaging device which<br>is suitable for photographing,<br>displaying and storing images<br>of the retina and external | Both are almost the<br>same. But we<br>removed the part of<br>content about what<br>the device does not<br>do (please see the |
| | areas of the eye to be<br>evaluated under<br>non-mydriatic conditions.<br>NFC-700 is indicated for<br>in-vivo viewing of the<br>posterior and external area of<br>the eye and the images are<br>intended for use as an aid to<br>clinicians in the evaluation,<br>diagnosis and documentation<br>of ocular health. | areas of the eye to be<br>evaluated under<br>non-mydriatic conditions.<br>iCam 100 is indicated for<br>in-vivo viewing of the<br>posterior and external area of<br>the eye and the images are<br>intended for use as an aid to<br>clinicians in the evaluation,<br>diagnosis and documentation<br>of ocular health.<br>iCam 100 provides images<br>only and does not provide any<br>diagnostic, pathological<br>analysis or classification of<br>ocular health or disease. | last paragraph of<br>iCam IFU) to<br>comply with 21 CFR<br>814.20 (3)(i). |
| Where Used | Hospital | Hospital | Exactly the same |
| Design | | | |
| -Shape | All in one | A camera head combine with<br>a Base | NFC-700 is an<br>All-In-One and fully<br>auto alignment<br>device. Based on the<br>two reasons, the<br>mechanical structure<br>is different to iCam.<br>It is reflects on the<br>appearance of<br>NFC-700.<br>Furthermore, the<br>main technological<br>of NFC-700 is same<br>as iCam. Thus, the<br>differences won't<br>make the safety<br>problems but as<br>effective as iCam. |
| -Dimensions(WxDxH) | 282 x 485 x 492 (mm) | Head :150 x 225 x 335(mm)<br>Base: 340 x 460 x 580 (mm) | |
| -Weight | 17 Kg | Camera Head: 2 Kg<br>Base: 10 Kg | |
| -Eye Fixation | Internal 10 points | Internal 6 point | The eye fixation<br>point of NFC-700 is<br>more than iCam, it<br>provides more |
| | | | different angle of |
| | | | fundus images. |
| -Power Supply | | AC100V to 240V, 50/60Hz (Auto selected) | Exactly the same |
| -Environment | | Temp.:10-35 °C / Humidity:30-90%RH | Exactly the same |
| -Light source<br>1. Observation:<br>2. Flash: | | 1. Infrared LED<br>2. White LED | Exactly the same |
| -Type of Photography | | Color / Digital red-free / Anterior eye image | Exactly the same |
| Operation Principle | The optical design of fundus camera is based on the principle<br>of monocular indirect ophthalmoscopy.<br>1. Fundus observation:<br>A build in light ray from the infrared light LED source to<br>illuminate the fundus. Alignment of the device is<br>performed by build in eye tracking indicator and working<br>distance indicator to adjust system to best XYZ position<br>automatically.<br>2. Image capture:<br>System use split-image technique to do image focus<br>adjustment automatically to capture the best quality of<br>image. White light from LEDs Flash module irradiates the<br>fundus. The light reflected from eye portions forms an<br>image, and the image is captured by built-in color CMOS<br>camera module for fundus image capture. | | The NFC-700 and<br>iCam fundus camera<br>have exactly same<br>technology principle. |
| Material of Chinrest | | ABS | Exactly the same |
| Material of<br>Forehead Rest | | TPE | The biocompatibility<br>has been certified by<br>recognized lab, thus<br>the different material<br>do not affect the<br>safety. |
| Safety | | IEC60601-1 compliance<br>IEC 60601-1-2 compliance | Exactly the same |
| Performance | | | |
| -Image (resolution) | | 12 MP | The higher pixel<br>only provides high<br>resolution image, it |
| | ABS | FEP | |
| | IEC60601-1 compliance | IEC60601-1 compliance | |
| | 1.3 MP | | |
| | | | |
| | | | does not adversely<br>affect safety and<br>effectiveness. |
| | | Manual focus tracking | For the different of<br>alignment method,<br>We analyzed the<br>possible hazards and<br>then set the security<br>measures on the<br>appearance design of<br>camera head and the<br>distance of<br>camera-to-patient.<br>Thus, the difference<br>does not adversely<br>affect safety and<br>effectiveness. |
| -Alignment | Fully automatic 3D tracking | | |
| | | | |
| -Field of View | 45° | | Exactly the same |
| -Minimum Pupil Size | 4.0 mm | | Exactly the same |
| -Working Distance | 25 mm | | Exactly the same |
| -Operation Range (Focus<br>Adjustment Range):<br>1. Without compensation<br>lens:<br>2. With compensation<br>lens: | -15 to +10 D | | -15 to +10 D |
| | -30D to -10D or +5D to +30D | -35D to -10D or +5D to +30D | |
| Interface | USB2.0 / Ethernet / HDMI | USB 2.0 | The interface is more<br>diversified provides<br>user more easy and<br>convenient image<br>transfer 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…