Nexy

K180306 · Next Sight Srl · HKI · Jun 8, 2018 · Ophthalmic

Device Facts

• Record ID: K180306
• Device Name: Nexy
• Applicant: Next Sight Srl
• Product Code: HKI · Ophthalmic
• Decision Date: Jun 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.

Device Story

Nexy is an automatic non-mydriatic eye-fundus camera; captures 45° color retinal images. System comprises optical head, forehead/cheekbone rests, base, and tablet interface running dedicated software. User initiates automatic examination; device aligns to pupil center, performs autofocus, and captures image. Output is JPEG retinal photo saved to internal database. Used in hospitals and clinics by trained medical personnel, health professionals, or optometrists. Provides clinicians with retinal visualization to assist in screening for eye or systemic diseases; benefits patient through non-invasive, mydriatic-free imaging.

Clinical Evidence

Bench testing only. Testing included ophthalmic performance per ISO 15004-1/2 and ISO 10940, electrical safety per IEC 60601-1, electromagnetic compatibility per IEC 60601-1-2, and software verification/validation per IEC 62304.

Technological Characteristics

Non-mydriatic fundus camera; 45° field of view; CMOS image sensor (2.1 Mpixel); white LED flash (<50ms); IR LED focusing; polarized light; +15D/-15D diopter adjustment. Connectivity: DICOM standard. Standards: IEC 60601-1, IEC 60601-1-2, ISO 10940, ISO 15004-1/2, ISO 14971, ISO 62366, ISO 62304.

Indications for Use

Indicated for taking digital images of a human retina without the use of a mydriatic agent. Intended for use in hospitals, public/private health clinics, and environments where eye or systemic diseases are screened. Not for use on children or minors without adult assistance.

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

• Digital Retinography System DRS (K101935)
• MiiS Horus Scope DEC 100 (K120982)

Submission Summary (Full Text)

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June 8, 2018

Next Sight srl Arianna Dalla Bá Quality and Regulatory Affairs Specialist Via IV Novembre 6/E Limena (Padova), 35010 IT

Re: K180306

Trade/Device Name: Nexy Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: March 13, 2018 Received: March 15, 2018

Dear Arianna Dalla Bá:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 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

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Denise L. Hampton -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

510(k) Number (if known) K180306

Device Name Nexy

Indications for Use (Describe)

Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.

Type of Use (Select one or both, as applicable)

X 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 Nextsight. The word "next" is in orange, and the word "sight" is in gray. To the right of the words is a stylized X, with one side in orange and the other in gray. Below the logo is the phrase "SEEN THE DIFFERENCE ?"

Headquarters VIA IV NOVEMBRE, 6/E 35010 LIMENA (PD) - ITALY TEL. +39 049 - 76 99 33

# 510(K) Summary

# K180306

#### GENERAL INFORMATION:

| Company Name: | Next Sight srl |
|-----------------|-------------------------------------------|
| Address: | Via IV Novembre 6/E |
| | 35010 - Limena (Padova) |
| | Italy |
| Phone: | [phone] |
| Contact Person: | Arianna Dalla Bà |
| Title: | Quality and Regulatory Affairs Specialist |
| Address: | Via IV Novembre 6/E |
| | 35010 - Limena (Padova) |
| | Italy |
| Email: | [e-mail] |
| Phone: | [phone] |
| Date Prepared: | January 31, 2018 |

#### DEVICE IDENTIFICATION:

| Trade Name: | Nexy |
|----------------------|--------------------------------|
| Generic Device Name: | Camera, Ophthalmic, Ac-Powered |
| Review Panel: | Ophthalmic |
| Classification: | Class II |
| Regulation Number: | 21 CFR 886.1120 |
| Product Code: | HKI |

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Image /page/4/Picture/0 description: The image is a logo for a company called "next sight". The word "next" is in orange, and the word "sight" is in gray. To the right of the words is a symbol that looks like two overlapping X's, one in orange and one in gray. Below the words is the phrase "SEEN THE DIFFERENCE ?" in gray.

NEXT SIGHT SRL
WWW.NEXTSIGHT.INFO

Headquarters
VIA IV NOVEMBRE, 6/E
35010 LIMENA (PD) - ITALY
TEL. [phone]

## Device Description:

The Nexy medical device is an automatic eye-fundus camera without the use of a mydriatic agent, designed to take color photos of the retinal fundus with a 45° field.

The device consists of two fundamental components: the eye-fundus camera and the tablet which represents the user interface where running a dedicated software application.

The instrument body includes: optical head, forehead and cheekbones rests and a base. The device is provided also with a front lens cap, a power cord and AC/DC adaptor.

Through the tablet, the user starts the automatic examination that provides as output the photo of the patient's retina saved in the internal database of the device in JPEG format.

The device can be used in a hospital environment, public and private health clinics and in public and private environments where eye or systemic diseases are screened.

The device must be used by medical personnel in some cases assisted by health professionals and/or optometry professionals. Users must be adequately trained in the use of the device and informed about the risks and side effects as well as being in possession of the qualifications required by law.

#### Indications For Use:

Nexy device is an automatic eye-fundus camera intended for takinq digital imaqes of a human retina without the use of a mydriatic agent.

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Image /page/5/Picture/0 description: The image shows the logo for Next Sight. The word "next" is in orange, and the word "sight" is in gray. To the right of the words is a symbol that looks like two interlocking links of a chain, with one link in orange and the other in gray. Below the words is the phrase "SEEN THE DIFFERENCE ?" in gray.

Headquarters
VIA IV NOVEMBRE, 6/E
35010 LIMENA (PD) - ITALY
TEL. +39 049 - 76 99 33

#### Identification of predicate devices:

The predicate devices selected for comparison with the subject device are identified as follows:

| Predicate<br>Device | 510(k)<br>Holder<br>Name | 510(K) no. | Date<br>cleared |
|---------------------------------------|-----------------------------------------------------|------------|----------------------|
| Digital<br>Retinography<br>System DRS | CenterVue | K101935 | 27 October<br>2010 |
| MiiS Horus<br>Scope DEC<br>100 | Medimaging<br>Integrated<br>Solution Inc.<br>(MiiS) | K120982 | 28 September<br>2012 |

#### Bench tests

As the predicate device DRS (K101935), Nexy device complies with the following standards:

- IEC 60601-1:2005;
- IEC 60601-1-2:2007; .
- ISO 10940-2:2009; ●
- . ISO 15004-2 2007.

Nexy complies also with the following standards:

- . ISO 15004-1:2006
- ISO 14971: 2012
- ISO 62366:2007 ●
- ISO 62304: 2006 ●
- DICOM standard .

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Image /page/6/Picture/0 description: The image is a logo for Next Sight. The word "next" is in orange, and the word "sight" is in gray. To the right of the words is an orange and gray symbol that looks like two crossing lines. Below the words is the phrase "SEEN THE DIFFERENCE ?" in gray.

Headquarters VIA IV NOVEMBRE, 6/E 35010 LIMENA (PD) - ITALY TEL. +39 049 - 76 99 33

## Predicate Device comparison

Table 1 provides a comparison between the subject device and the predicate devices.

| Table 1 - Predicate device comparison table | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ATTRIBUTE /<br>CHARACTERISTICS | Nexy<br>Subject Device | Digital Retinography<br>System DRS<br>Predicate Device PD1 | MiiS Horus Scope DEC<br>100<br>Predicate Device PD2 |
| Device Name | Nexy | Digital Retinography<br>System DRS | MiiS Horus Scope DEC<br>100 |
| Device<br>Manufacturer | Next Sight srl | CentreVue | Medimaging<br>Integrated Solution<br>Inc. (MiiS) |
| FDA Product<br>Code | HKI | HKI | HKI |
| Comparison: Both predicate devices PD1 and PD2 have the same FDA product code as subject<br>device. | | | |
| 510k reference | K180306 | K101935 | K120982 |
| FDA<br>Classification<br>Name | Camera, Ophthalmic, Ac-<br>Powered | Camera, Ophthalmic,<br>Ac-Powered | Camera, Ophthalmic,<br>Ac-Powered |
| Comparison: Both predicate devices PD1 and PD2 have the same FDA Classification Name as<br>subject device. | | | |
| Classification | II | II | II |
| Comparison: Both predicate devices PD1 and PD2 have the same Classification as subject device. | | | |
| FDA Regulation<br>Number | 886.1120 | 886.1120 | 886.1120 |
| Comparison: Both predicate devices PD1 and PD2 have the same FDA Regulation Number as<br>subject device. | | | |
| Type of device | Fundus non-mydriatic<br>camera | Fundus non-mydriatic<br>camera | Fundus non-mydriatic<br>camera |
| Comparison: Both predicate devices PD1 and PD2 have the same Type of device as subject device. | | | |
| Indication for<br>Use | Nexy device is an<br>automatic eye-fundus<br>camera intended for taking<br>digital images of a human<br>retina<br>without the use of a<br>mydriatic agent. | The CenterVue Digital<br>Retinography System<br>DRS is intended for<br>taking digital images of<br>a human<br>retina without the use<br>of a mydriatic agent. | MiiS Horus Scope DEC<br>100 is a digital hand-<br>held eye-fundus<br>camera used to record<br>digital photographs<br>and video of fundus of<br>the human eye and<br>surrounding area. |
| Comparison: Predicate device PD1 has the same Indication for Use as subject device. The predicate<br>device PD2 has similar Indication for Use to the subject device. | | | |

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Image /page/7/Picture/0 description: The image shows the logo for Nextsight. The word "next" is in orange, and the word "sight" is in gray. To the right of the words is a graphic of two overlapping lines, one orange and one gray. Below the logo is the phrase "seen the difference ?"

Headquarters
VIA IV N0VEMBRE, 6/E 35010 LIMENA (PD) - ITALY
TEL. +39 049 - 76 99 33

| Table 1 - Predicate device comparison table | | | |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| ATTRIBUTE / CHARACTERISTICS | Nexy Subject Device | Digital Retinography System DRS Predicate Device PD1 | MiiS Horus Scope DEC 100 Predicate Device PD2 |
| Treatable areas | Eyes | Eyes | Eyes |
| | Comparison: Both predicate devices PD1 and PD2 have the same treatable areas as subject device. | | |
| Target Population | All population with some exceptions: the device cannot be used on children and in any case on minors, without the assistance of an adult. | Not Available | Not Available |
| | Comparison: This information is not available in the competitors' documentation. | | |
| Alignment and examination | Automatic - the device automatically aligns to the center of the pupil prior to autofocusing and capture. | Automatic - the DRS device automatically aligns to the center of the pupil prior to autofocusing and capture. | Manual - MiiS Horus Scope DEC 100 is a digital hand-held eye-fundus camera. |
| | Comparison: Predicate device PD1 has the same alignment and examination as subject device. The alignment of the predicate device PD2 is different from the subject device. | | |
| Field of horizontal vision | 45° | 45° | 40° |
| Field of vertical vision | 45° | 40° | 40° |
| | Comparison: | | |
| | Field of view represents the portion of the field of vision of the retina that can be framed with the device. The predicate device PD1 as the same filed of horizontal vision as the subjected device. The Field of horizontal vision of the predicate device PD2 is different from the subject device. | | |
| Minimum pupil size | 3.8mm | 4mm | 3.5mm |
| | Comparison: | | |
| | The minimum pupil size parameter represents the size of the smallest pupil in order to take the exam. | | |
| | Both predicate devices PD1 and PD2 have similar minimum pupil size as subject device. | | |
| Image sensor | CMOS | CMOS | CMOS |
| | Comparison: Both predicate devices PD1 and PD2 have the same image sensor as subject device. | | |

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Image /page/8/Picture/0 description: The image is a logo for a company called "next sight". The word "next" is in orange, and the word "sight" is in gray. To the right of the words is a symbol that looks like two intersecting orange and gray lines. Below the words is the phrase "SEEN THE DIFFERENCE ?" in gray.

Headquarters
VIA IV N0VEMBRE, 6/E
35010 LIMENA (PD) - ITALY
TEL. +39 049 - 76 99 33

| Table 1 - Predicate device comparison table | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| ATTRIBUTE /<br>CHARACTERISTICS | Nexy<br>Subject Device | Digital Retinography<br>System DRS<br>Predicate Device PD1 | MiiS Horus Scope DEC<br>100<br>Predicate Device PD2 |
| Sensor size | 2.1 Mpixel | 5 Mpixel | 2 Mpixel |
| Comparison:<br>Predicate device PD2 has a similar sensor size as subject device. The sensor size of the predicate device PD1 is different from the subject device. | | | |
| Image Format | JPEG, DICOM | JPEG, DICOM | JPEG and Video (AVI) |
| Comparison: Predicate device PD1 has the same image format as subject device. The image format of the predicate device PD2 is the same for JPEG and it is different for AVI from the subject device. | | | |
| Resolution on<br>retina | 14 $ \mu $ m | 15 $ \mu $ m | This information is not<br>available for this<br>predicate device. |
| Comparison: Predicate device PD1 has similar resolution on retina as subject device.<br>This parameter indicates the level of distinguishable detail, Nexy resolution on retina differs by 1 $ \mu $ m from the predicate device PD1. | | | |
| Light source | LEDs | LEDs | LEDs |
| Comparison: Both predicate devices PD1 and PD2 have the same light source as subject device. | | | |
| Type of fixation<br>light | Green and continuous<br>(during the exam time) | Green and continuous<br>(during the exam time) | Not Applicable |
| Comparison: Both predicate devices PD1 and PD2 have the same type fixation light as subject device. | | | |
| Focus on the<br>retina — type of<br>light | IR (infrared) LEDs and<br>continuous source (during<br>the focusing time) | IR (infrared) LEDs and<br>continuous source<br>(during the focusing<br>time) | This information is not<br>available for this<br>predicate device. |
| Comparison: Both predicate devices PD1 and PD2 use the infrared LEDs to perform the focus on the retina. | | | |
| Type of flash | White LEDs in the visible<br>range and pulsed (duration<br>less than 50ms) with<br>annular shape on the<br>cornea. | White LEDs in the<br>visible range and pulsed<br>(duration less than<br>50ms) with annular<br>shape on the cornea. | This information is not<br>available for this<br>predicate device. |
| Comparison: Both predicate devices PD1 and PD2 use and comparable (color, technology, shape on<br>the cornea type of light to flash the retina. | | | |
| Exposure<br>conditions | In accordance to the flash<br>duration time. | In accordance to the<br>flash duration time. | This information is not<br>available for this<br>predicate device. |
| Comparison: Both exposure conditions of predicate devices PD1 and PD2 are in accordance to the flash duration time. | | | |
| Light feature | Polarized | Not polarized | Polarized |
| Comparison: Predicate devices PD2 has the same light source as subject device. It is different for | | | |
| Table 1 - Predicate device comparison table | | | |
| ATTRIBUTE /<br>CHARACTERISTICS | Nexy<br>Subject Device | Digital Retinography<br>System DRS<br>Predicate Device PD1 | MiiS Horus Scope DEC<br>100<br>Predicate Device PD2 |
| the predicate device PD2. | | | |
| Diopter<br>adjustment | +15D / -15D | +15D / -15D | +20D / -20D |
| Comparison:<br>Predicate devices PD1 has the same diopter adjustment as subject device. It is different for the<br>predicate device PD2. | | | |
| Number of<br>Fixings | 7 | 7 | Not Applicable |
| Comparison:<br>Predicate devices PD1 has the same Number of Fixings as subject device. | | | |
| Fixation target | Internal LEDs | Internal LEDs | Not Applicable |
| Comparison: Predicate devices PD1 has the same Fixation target as subject device. | | | |
| DICOM<br>standard<br>compliance | Yes | Yes | This information is not<br>available for this<br>predicate device. |
| Comparison: Predicate devices PD1 complies to DICOM standard as subject device. | | | |
| Performance<br>Standard<br>Compliance | Nexy device complies with<br>the following standards:<br>● IEC 60601-1:2005;<br>● IEC 60601-1-2:2007;<br>● ISO 10940-2:2009;<br>● ISO 15004-2 2007.<br><br>Nexy complies also with<br>the following standards:<br>● ISO 15004-1:2006<br>● ISO 14971: 2012<br>● ISO 62366:2007<br>● ISO 62304: 2006<br><br>Comparison:<br>Predicate devices PD1 complies to the same standards as subject device. Furthermore the subject<br>device complies with other standards. | The DRS complies with<br>the following standards:<br>IEC 60601-1:2005;<br>IEC 60601-1-2:2007;<br>ISO 10940-2:2009;<br>ISO 15004-2 2007. | This information is not<br>available for this<br>predicate device. |

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Image /page/9/Picture/0 description: The image contains the logo for Next Sight. The logo has the word "next" in orange above the word "sight" in gray. To the right of the words is a graphic of two crossing lines, one orange and one gray. Below the logo is the phrase "SEEN THE DIFFERENCE ?" in gray.

Headquarters VIA IV NOVEMBRE, 6/E 35010 LIMENA (PD) - ITALY
TEL. +39 049 - 76 99 33

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Image /page/10/Picture/0 description: The image shows the logo for Nextsight. The word "next" is in orange, and the word "sight" is in gray. Below the words is the phrase "SEEN THE DIFFERENCE ?" in gray. To the right of the words is a stylized image of two crossing bars, one in orange and one in gray.

NEXT SIGHT SRL
WWW.NEXTSIGHT.INFO

Headquarters
VIA IV NOVEMBRE, 6/E
35010 LIMENA (PD) - ITALY
TEL. +39 049 - 76 99 33

# TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary bench testing was conducted on Nexy to support a determination of substantial equivalence to the predicate devices. The tests performed include:

- Ophthalmic Testing per ISO 15004-1, and ISO15004-2 ●
- Ophthalmic Testing about Fundus Cameras per ISO 10940 Ophthalmic Instruments --. Fundus Cameras
- Software Verification and Validation per AAMI/ANSI/IEC 62304 The software of this . device was considered as a "Moderate" level of concern based on the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on: May 11, 2005
- . Electrical Safety Testing per IEC60601-1 and Electromagnetic Compatibility Testing per IEC60601-1-2.

The collective performance testing demonstrates that the Nexy device does not raise any new questions of safety or effectiveness when compared to the predicate devices. The results of the performance testing demonstrate that the Nexy device performs as intended and does not raise any new questions of safety or effectiveness.

#### Conclusion

None of the differences highlighted in the Table 1 introduce new issues of safety and effectiveness compared to predicate devices.

The remaining technical aspects of the Nexy device compared with the predicate devices are identical or very similar.

Based on the information contained in this submission, it is concluded that the Nexy device is substantially equivalent to the identified predicate devices already in commerce within the USA and that any differences that do exist have no effect on the safety and effectiveness of the device.