(126 days)
Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.
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.
The provided document describes the Nexy device, an automatic eye-fundus camera, and its substantial equivalence to predicate devices, but does not contain specific acceptance criteria or a detailed study report proving the device meets acceptance criteria.
However, based on the information provided, we can infer some details related to performance testing and conformity.
Here's an analysis of the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it lists standards that the device complies with, implying that meeting these standards constitutes the acceptance criteria. The "reported device performance" is summarized as the device performing as intended and not raising new safety or effectiveness concerns.
| Acceptance Criteria (Inferred from Standards Compliance) | Reported Device Performance (Summary) |
|---|---|
| Ophthalmic Testing | |
| ISO 15004-1 | Complies |
| ISO 15004-2 | Complies |
| ISO 10940 (Fundus Cameras) | Complies |
| Software Verification and Validation | |
| AAMI/ANSI/IEC 62304 ("Moderate" level of concern) | Complies, performs as intended, no new safety/effectiveness concerns |
| Electrical Safety Testing | |
| IEC60601-1 | Complies |
| Electromagnetic Compatibility Testing | |
| IEC60601-1-2 | Complies |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench tests" and "Performance testing" but does not provide details about the sample size used for performance testing (test set) or the data provenance (e.g., country of origin of the data, retrospective or prospective). The testing seems to be laboratory-based rather than involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document provided. The testing appears to be primarily technical compliance rather than clinical validation involving expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not reported in this document. The submission focuses on demonstrating substantial equivalence through technical specifications and compliance with standards, not on comparative clinical effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is an "automatic eye-fundus camera" designed for taking images. The testing described (ophthalmic testing, software verification, electrical safety, EMC) would classify as standalone performance testing of the device's ability to capture images and meet technical specifications. There is no mention of an AI algorithm within the device that would typically undergo a separate "standalone" performance evaluation in the context of diagnostic aid performance. The "automatic" aspect refers to alignment and autofocusing for image acquisition, not AI-driven image interpretation.
7. The Type of Ground Truth Used
For the type of testing described (compliance with standards like ISO 15004-1/2, ISO 10940, IEC 60601-1/1-2), the "ground truth" would be the technical specifications and requirements outlined in those standards. For example, for ISO 15004, the ground truth would be the specific image quality metrics, field of view, resolution, etc., defined by the standard. It's not clinical "ground truth" like expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable or not provided. The document does not describe the development or training of an AI algorithm that would require a training set. The device is a camera and its associated software for image acquisition.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided, as there is no mention of an AI algorithm training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: | +39049769933 |
| Contact Person: | Arianna Dalla Bà |
| Title: | Quality and Regulatory Affairs Specialist |
| Address: | Via IV Novembre 6/E |
| 35010 - Limena (Padova) | |
| Italy | |
| Email: | arianna.dallaba@nextsight.info |
| Phone: | +39049769933 |
| 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. +39 049-76 99 33
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:
| PredicateDevice | 510(k)HolderName | 510(K) no. | Datecleared |
|---|---|---|---|
| DigitalRetinographySystem DRS | CenterVue | K101935 | 27 October2010 |
| MiiS HorusScope DEC100 | MedimagingIntegratedSolution Inc.(MiiS) | K120982 | 28 September2012 |
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 /CHARACTERISTICS | NexySubject Device | Digital RetinographySystem DRSPredicate Device PD1 | MiiS Horus Scope DEC100Predicate Device PD2 |
| Device Name | Nexy | Digital RetinographySystem DRS | MiiS Horus Scope DEC100 |
| DeviceManufacturer | Next Sight srl | CentreVue | MedimagingIntegrated SolutionInc. (MiiS) |
| FDA ProductCode | HKI | HKI | HKI |
| Comparison: Both predicate devices PD1 and PD2 have the same FDA product code as subjectdevice. | |||
| 510k reference | K180306 | K101935 | K120982 |
| FDAClassificationName | Camera, Ophthalmic, Ac-Powered | Camera, Ophthalmic,Ac-Powered | Camera, Ophthalmic,Ac-Powered |
| Comparison: Both predicate devices PD1 and PD2 have the same FDA Classification Name assubject device. | |||
| Classification | II | II | II |
| Comparison: Both predicate devices PD1 and PD2 have the same Classification as subject device. | |||
| FDA RegulationNumber | 886.1120 | 886.1120 | 886.1120 |
| Comparison: Both predicate devices PD1 and PD2 have the same FDA Regulation Number assubject device. | |||
| Type of device | Fundus non-mydriaticcamera | Fundus non-mydriaticcamera | Fundus non-mydriaticcamera |
| Comparison: Both predicate devices PD1 and PD2 have the same Type of device as subject device. | |||
| Indication forUse | Nexy device is anautomatic eye-funduscamera intended for takingdigital images of a humanretinawithout the use of amydriatic agent. | The CenterVue DigitalRetinography SystemDRS is intended fortaking digital images ofa humanretina without the useof a mydriatic agent. | MiiS Horus Scope DEC100 is a digital hand-held eye-funduscamera used to recorddigital photographsand video of fundus ofthe human eye andsurrounding area. |
| Comparison: Predicate device PD1 has the same Indication for Use as subject device. The predicatedevice 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 /CHARACTERISTICS | NexySubject Device | Digital RetinographySystem DRSPredicate Device PD1 | MiiS Horus Scope DEC100Predicate Device PD2 |
| Sensor size | 2.1 Mpixel | 5 Mpixel | 2 Mpixel |
| Comparison: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 onretina | 14 $ \mu $ m | 15 $ \mu $ m | This information is notavailable for thispredicate device. |
| Comparison: Predicate device PD1 has similar resolution on retina as subject device.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 fixationlight | Green and continuous(during the exam time) | Green and continuous(during the exam time) | Not Applicable |
| Comparison: Both predicate devices PD1 and PD2 have the same type fixation light as subject device. | |||
| Focus on theretina — type oflight | IR (infrared) LEDs andcontinuous source (duringthe focusing time) | IR (infrared) LEDs andcontinuous source(during the focusingtime) | This information is notavailable for thispredicate 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 visiblerange and pulsed (durationless than 50ms) withannular shape on thecornea. | White LEDs in thevisible range and pulsed(duration less than50ms) with annularshape on the cornea. | This information is notavailable for thispredicate device. |
| Comparison: Both predicate devices PD1 and PD2 use and comparable (color, technology, shape onthe cornea type of light to flash the retina. | |||
| Exposureconditions | In accordance to the flashduration time. | In accordance to theflash duration time. | This information is notavailable for thispredicate 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 /CHARACTERISTICS | NexySubject Device | Digital RetinographySystem DRSPredicate Device PD1 | MiiS Horus Scope DEC100Predicate Device PD2 |
| the predicate device PD2. | |||
| Diopteradjustment | +15D / -15D | +15D / -15D | +20D / -20D |
| Comparison:Predicate devices PD1 has the same diopter adjustment as subject device. It is different for thepredicate device PD2. | |||
| Number ofFixings | 7 | 7 | Not Applicable |
| Comparison: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. | |||
| DICOMstandardcompliance | Yes | Yes | This information is notavailable for thispredicate device. |
| Comparison: Predicate devices PD1 complies to DICOM standard as subject device. | |||
| PerformanceStandardCompliance | Nexy device complies withthe following standards:● IEC 60601-1:2005;● IEC 60601-1-2:2007;● ISO 10940-2:2009;● ISO 15004-2 2007.Nexy complies also withthe following standards:● ISO 15004-1:2006● ISO 14971: 2012● ISO 62366:2007● ISO 62304: 2006Comparison:Predicate devices PD1 complies to the same standards as subject device. Furthermore the subjectdevice complies with other standards. | The DRS complies withthe following standards:IEC 60601-1:2005;IEC 60601-1-2:2007;ISO 10940-2:2009;ISO 15004-2 2007. | This information is notavailable for thispredicate 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.
§ 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.