The VX650 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for:

· Measuring the refraction of the eye giving both lower and higher order aberrations
· Measuring the shape of the cornea
· Retro-illumination imaging of the eye
Measuring the intraocular pressure without contacting the eye for glaucoma evaluation
· Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea
Full cornea thickness map
· Scheimpflug imaging
· Anterior chamber imaging
· Pupil Image
· Image of the cornea relative to the iris
· Automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatio agent

Device Description

The VX650 is based on the VX130 (already cleared 510(k), number K162067) which is a combined wavefront aberrometer, corneal topographer, Scheimpflug pachymeter, non-contact tonometer and cataract screening device in a single platform that contains five different measurement units. The VX650 also contains a non-mydriatic fundus camera for retinal photography. The wavefront aberrometer uses the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the refraction of the eye.

The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea. The Scheimpflug pachymeter measures the thickness of the central cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique, there is also a scanning mode that allows measurement of the whole corneal surface and can provide detailed tomography maps of both corneal surfaces and the corneal thickness.

An air puff non-contact tonometer is included for measurement of the intraocular pressure and retro illumination is present for cataract screening.

The fundus camera contains an infra-red LED for alignment and focusing and a white LED flash for the photography to give colour images. The fundus image covers an angle of 45° on the retina so a regular image will contain both the macula and the optic nerve. The fundus camera also has a seven-position fixation target to increase the field of view as the patient can fixate in different directions.

The device is fully automated and a number of different measurements can be performed by a sinqle command including alignment and focusing. The fundus imaging function is also fully automatic including automatic alignment, focusing and image capture.

AI/ML Overview

The provided document describes the VX650, a multi-function diagnostic device. The bulk of the submission focuses on demonstrating substantial equivalence to predicate devices through comparison of technical characteristics and compliance with standards. However, the document does not describe specific acceptance criteria and a study proving the device meets those criteria for clinical performance.

Instead, it relies on:

Bench tests and compliance with recognized standards: This demonstrates the device's adherence to general safety and performance requirements for ophthalmic instruments and software.
Comparison to predicate devices: The manufacturer argues that the VX650 is substantially equivalent to existing devices (VX130 for core functions, and Nexy/CenterVue DRS for the fundus camera module) which are already cleared for market. The claim is that the differences are minor and do not raise new questions of safety or effectiveness.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and reported device performance (as no specific performance metrics with acceptance limits are defined and reported from a clinical study).
Sample size for the test set or data provenance (as no clinical test set is described).
Number and qualifications of experts for ground truth (as no ground truth establishment for a test set is described).
Adjudication method.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done or the effect size of human readers with/without AI assistance.
If a standalone (algorithm only) performance was done.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

Summary of what the document does provide regarding testing:

Bench Tests and Standard Compliance:
- Acceptance Criteria (Implicit): Compliance with various ISO and IEC standards related to medical devices, ophthalmic instruments, electrical safety, electromagnetic compatibility, and software verification/validation.
- Reported Device Performance: The device "complies with" and "meets" these standards. The collective performance testing "demonstrates that the VX650 device does not raise any new questions of safety or effectiveness when compared to the predicate devices" and "performs as intended."
- Specific Standards Mentioned:
  - ISO 14971 (Risk Management)
  - AAMI ANSI ES60601-1 (Electrical Safety)
  - IEC 60601-1-2 (EMC)
  - ISO 15004-1 (Ophthalmic instruments - Fundamental requirements and test methods)
  - ISO 10940 (Ophthalmic Instruments - Fundus Cameras)
  - IEC 62471 (Photobiological safety of lamps and lamp systems)
  - IEC 60825-1 (Safety of laser products)
  - ISO 10993-1 (Biological evaluation of medical devices)
  - IEC 62366-1 (Usability)
  - IEC 60601-1-6 (Usability for medical electrical equipment)
  - IEC 62304 (Medical device software - Software life cycle processes)
  - ANSI Z80.36-2016 (Light Hazard Protection)
  - ISO 8612:2009 (Tonometers)
  - ISO 10342:2010 (Eye refractometers)
  - ISO 10343:2014 (Ophthalmometers)
  - ISO 19980:2012 (Corneal topographers)
  - ISO 24157:2008 (Reporting aberrations of the human eye)
  - ISO 15004-2 (Ophthalmic Instruments - Requirements and test methods for fundus cameras)
Software Verification and Validation:
- Level of Concern: "Moderate" based on FDA's guidance for software in medical devices.
- Proof: Performed "per AAMI/ANSI/IEC 62304."

In conclusion, the document provides evidence of engineering and regulatory compliance testing rather than clinical performance studies with specific acceptance criteria. The substantial equivalence argument negates the need for new clinical performance studies by demonstrating that the new device is fundamentally similar to already cleared devices and performs as intended according to established technical standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

January 29, 2021

Luneau Technology Operations Yossi Constantinis Group Regulatory Affairs & Ouality Manager 2 rue Roger Bonnet Pont-de-l'Arche, Rouen 27340 France

Re: K202221

Trade/Device Name: VX650 Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKX, HKI, MXK Dated: December 21, 2020 Received: December 28, 2020

Dear Yossi Constantinis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202221

Device Name VX650

Indications for Use (Describe)

The VX650 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for:

· Measuring the refraction of the eye giving both lower and higher order aberrations
· Measuring the shape of the cornea
· Retro-illumination imaging of the eye
Measuring the intraocular pressure without contacting the eye for glaucoma evaluation
· Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea
Full cornea thickness map
· Scheimpflug imaging
· Anterior chamber imaging
· Pupil Image
· Image of the cornea relative to the iris
· Automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatio agent

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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GENERAL INFORMATION:

Company Name:	Luneau Technology Operations
Address	2 rue Roger Bonnet,27340 Pont-de-l'Arche - France
Phone:	+33232989132
Primary contactPerson:	Yossi ConstantinisGroup Regulatory AffairsEmail y.constantinis@luneautech.comPhone: +972 546 535 299
Second contactPerson:	Haggai HermanGeneral ManagerEmail: h.herman@luneautech.com
Address:	2 rue Roger Bonnet,27340 Pont-de-l'ArcheFrance
Date Prepared:	August 3rd, 2020

DEVICE IDENTIFICATION:

Trade Name:	VX650
Generic Device Name:	Tonometer, Ac-Powered
Review Panel:	Ophthalmic
Classification:	Class II
Regulation Number:	21 CFR 886.1930
Product Code:	HKX

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Image /page/4/Picture/1 description: The image shows the logo for Luneau Technology. The logo consists of a gray circle with a blue and red stripe across it, followed by the text "Luneau Technology" in a bold, sans-serif font. Below the text, there are three smaller logos: VISIOONIX, briot, and WECO.

Subsequent product codes, based on other device functions in Class II:

HKI Camera, Ophthalmic, Ac-Powered

MXK Device, Analysis, Anterior Segment

Device Description:

An air puff non-contact tonometer is included for measurement of the intraocular pressure and retro illumination is present for cataract screening.

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Image /page/5/Picture/1 description: The image shows the logo for Luneau Technology. The logo consists of a gray circle with a blue, white, and red stripe across it, followed by the words "Luneau Technology" in bold, black font. Below that, in a smaller font, are the words "VISIXONIX briot WECO".

Indications For Use:

The VX650 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for:

Measuring the refraction of the eye giving both lower and higher order aberrations
Measuring the shape of the cornea
Retro-illumination imaging of the eye
Measuring the intraocular pressure without contacting the eye for glaucoma evaluation
Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea
· Full cornea thickness map
· Scheimpflug imaging
· Anterior chamber imaging
· Pupil Image
Image of the cornea relative to the iris

• Automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent

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Identification of predicate devices:

The subject device is substantially equivalent to the following:

PrimarypredicateDevice	510(k)Holder	510(k) no.	Datecleared
VX130	Luneau	K162067	24 April 2017

The primary predicate refers to the one with indications for use and technological characteristics most similar to the subject device.

Additionalpredicatedevices relatedto funduscamera module	510(k)Holder	510(k) no.	Datecleared
Nexy	Next Sight	K180306	8 June 2018
CenterVue DigitalRetinographySystem DRS	CenterVue	K101935	27 October2010

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Bench tests

As the predicate device VX130 (K162067), VX650 device complies with the following standards:

ISO 14971 Third Edtion 2019-12 ●
AAMI ANSI ES60601- 1:2005/(R)2012 And A1:2012 ●
IEC 60601-1-2 Edition 4.0 2014-02 ●
ISO 15004-1 First edition 2006-06-01 ●
ISO 10940 Second edition 2009-08-01 ●
IEC 62471 First edition 2006-07 ●
IEC 60825-1 Edition 2.0 2007-03
ISO 10993-1 Fourth edition 2009-10-15
IEC 62366-1 Edition 1.0 2015-02 ●
IEC 60601-1-6 Edition 3.1 2013-10 .
IEC 62304 Edition 1.1 2015-06
ANSI Z80.36-2016 American National Standard for Ophthalmics Light Hazard ● Protection for Ophthalmic Instruments

VX650 device complies also with the following standards:

ISO 8612:2009 Ophthalmic instruments Tonometers .
ISO 10342:2010 Ophthalmic instruments Eye refractometers ●
ISO 10343:2014 Ophthalmic instruments Ophthalmometers ●
ISO 19980:2012 Ophthalmic instruments Corneal topographers ●
ISO 24157:2008Ophthalmic optics and instruments - Reporting aberrations of the human eye

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Predicate Device comparison

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

Table 1 - Predicate device comparison table with primary predicate device
ATTRIBUTE /CHARACTERISTICS	VX650Subject Device	VX130PD1
Device Name	VX650	VX130
Comparison: Not Applicable
Device Manufacturer	Luneau	Luneau
Comparison: The device manufacturer is the same.
FDA Product Code	HKX(main and primary code)	HKX
Comparison: Predicate device PD1 has the same FDA product code as subject device.
510k reference	K202221	K162067
Comparison: Not Applicable
FDA Classification Name	Tonometer, Ac-Powered(for the main and primary code)	Tonometer, Ac-Powered
Comparison: Predicate device PD1 has the same FDA Classification name of submitted product.
Classification	II	II
Comparison: Predicate device PD1 has the same FDA Classification as subject device.
FDA RegulationNumber	886.1930(according to main code)	886.1930
Comparison: Predicate device PD1 has the same regulation number of subject device.

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Table 1 - Predicate device comparison table with primary predicate device
ATTRIBUTE /CHARACTERISTICS	VX650Subject Device	VX130PD1
	including fundus non-mydriatic camera
	Comparison: Predicate device PD1 is a combination instrument including multi-function.The subject device is a combination instrument including also (as an addition of predicate device PD1) a non-mydriatic fundus camera.
Treatable areas	Eyes	Eyes
	Comparison: Predicate device PD1 has the same treatable areas as subject device.
Alignment andexamination	Automatic - the deviceautomatically aligns to thecenter of the pupil prior toautofocusing and capture.	Automatic - the deviceautomatically aligns to thecenter of the pupil prior toautofocusing and capture.
	Comparison: Predicate device PD1 has the same alignment and examination procedure as the subject device.
General Functionalities	The general functionalities of VX650 are:Wavefront Keratometry Retro illumination Corneal topography Tonometry Pachymetry (single slit) Pachymetry (multi slit) Fundus photography	The general functionalities of VX130 are:Wavefront Keratometry Retro illumination Corneal topography Tonometry Pachymetry (single slit) Pachymetry (multi slit)
	Comparison:The subjected device has in addition the fundus photography, all the other functions are the same of predicate device PD1.
Performance StandardCompliance	Complies with the following standards:IEC 60601-1:2005 IEC 60601-1-2:2014 ISO 10940-2:2009 ISO 60825-1:2014 ISO 62471-1:2006 ISO 8612:2010 ISO 10342:2010 ISO 24157:2008 ISO 19980:2012 ISO 10343-1:2014 ISO 15004-2 2007 ISO15004-1:2006 ISO 14971: 2012 ISO 62366:2007 ISO 62304: 2006	Complies with the following standards:IEC 60601-1:2005 IEC 60601-1-2:2014 ISO 60825-1:2014 ISO 62471-1:2006 ISO 8612:2010 ISO 10342:2010 ISO 24157:2008 ISO 19980:2012 ISO 10343-1:2014 ISO 15004-2 2007 ISO15004-1:2006 ISO 14971: 2012 ISO 62366:2007 ISO 62304: 2006

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Image /page/11/Picture/1 description: The image shows the logo for Luneau Technology. The logo consists of a gray sphere with a blue and red stripe across it, followed by the text "Luneau Technology" in a sans-serif font. Below the text is the text "VISIONIX briot WECO" in a smaller font.

Table 1 - Predicate device comparison table with primary predicate device
ATTRIBUTE /CHARACTERISTICS	VX650Subject Device	VX130PD1
Comparison:Subject device and predicate device PD1 comply with relevant standards, except forISO 10940-2:2009 that is applied specifically to VX650 since it includes funduscamera module.

Table 2 provides a comparison between the subject device additional predicate devices related to fundus camera module.

Table 2 - Additional predicate devices related to fundus camera module
ATTRIBUTE /CHARACTERISTICS	VX650Subject Device	NexyPredicate Device PD2	Digital RetinographySystem DRSPredicate Device PD3
Device Name	VX650	Nexy	Digital RetinographySystem DRS
Comparison: Not Applicable
DeviceManufacturer	Luneau	Next Sight srl	CenterVue
Comparison: Not Applicable
FDA Product Code	HKX (main code);subsequent codes forclass II functions areHKI and MXK	HKI	HKI
Comparison: Both predicate devices PD2 and PD3 have product code identical to one of subsequentcode of subject device.
510k reference	K202221	K180306	K101935
Comparison: Not Applicable
FDA ClassificationName	Tonometer, Ac-Powered(for the main code);for the subsequentcodes:HKI Camera,Ophthalmic, Ac-PoweredMXK Device, Analysis,Anterior Segment	Camera, Ophthalmic,Ac-Powered	Camera, Ophthalmic,Ac-Powered
Comparison: Both predicate devices PD2 and PD3 have the same FDA Classification name, that is thesame of one of the subsequent codes of the subject device (VX650).
Classification	II	II	II
Comparison: Both predicate devices PD2 and PD3 have the same FDA Classification as subjectdevice.
Type of device	Combination instument	Fundus non-mydriatic	Fundus non-mydriatic
ATTRIBUTE / CHARACTERISTICS	VX650 Subject Device	Nexy Predicate Device PD2	Digital Retinography System DRS Predicate Device PD3
	including fundus non-mydriatic camera	camera	camera
Comparison: Both predicate devices PD2 and PD3 are non-mydriatic fundus cameras. The subject device is a combination instrument including a non-mydriatic fundus camera module.
Treatable areas	Eyes	Eyes	Eyes
Comparison: Both predicate devices PD2 and PD3 have the same treatable areas as subject device
Alignment and examination	Automatic - the device automatically aligns to the center of the pupil prior to autofocusing and capture.	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.
Comparison: Both predicate devices PD2 and PD3 have the same alignment and examination procedure as the subject device.
Field of horizontal vision	45°	45°	45°
Field of vertical vision	45°	45°	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 PD2 has the same field of view as the subject device. The field of horizontal vision of the predicate device PD3 is the same as the subject device but the vertical field is 5° smaller.Regarding the field of vertical vision, a difference of 5º degrees does not bring a point of non-substantial equivalence between the VX650 device and a predicate device, as it does not influence the intended use, the performance, the safety and effectiveness of the system.
Minimum pupil size	3.5mm	3.8mm	4mm
Comparison:The minimum pupil size parameter represents the size of the smallest pupil that can be measured. Both predicate devices PD2 and PD3 have slightly larger minimum pupil sizes than the subject device. It does not bring a point of non-substantial equivalence between the submitted device and the predicate devices, as it does not influence the intended use, the performance, the safety and effectiveness of the system.
Image sensor	CMOS	CMOS	CMOS
Comparison: Both predicate devices PD2 and PD3 have the same image sensor type as the subject device.
Sensor size	6 M pixel	2.1 M pixel	5 M pixel
Comparison:Predicate device PD3 has a similar sensor resolution as the subject device. The sensor resolution of the predicate device PD2 is smaller than the subject device, the subject device therefore is slightly better.
Table 2 - Additional predicate devices related to fundus camera module
ATTRIBUTE /CHARACTERISTICS	VX650Subject Device	NexyPredicate Device PD2	Digital RetinographySystem DRSPredicate Device PD3
retina
Comparison: The subject device has better fundus resolution than the predicate devices.
Light source	LEDs	LEDs	LEDs
Comparison: Both predicate devices PD12 and PD3 have the same light source as subject device.
Type of fixationlight	Blue and continuous(during the exam time)	Green and continuous(during the exam time)	Green and continuous(during the exam time)
Comparison: Both predicate devices PD2 and PD3 have the same type of fixation light as the subjectdevice. The colour does not make any significant difference.
Focus on theretina - type oflight	IR (infrared) LEDs andcontinuous source(during the focusingtime)	IR (infrared) LEDs andcontinuous source(during the focusingtime)	IR (infrared) LEDs andcontinuous source(during the focusingtime)
Comparison: Both predicate devices PD2 and PD3 use infrared LEDs to perform the focus on theretina, similar to the subject device.
Type of flash	White LEDs in the visiblerange and pulsed(duration less than50ms) with annularshape on the cornea.	White LEDs in thevisible range andpulsed (duration lessthan 50ms) withannular shape on thecornea.	White LEDs in the visiblerange and pulsed(duration less than50ms) with annularshape on the cornea.
Comparison: Both predicate devices PD2 and PD3 have a similar flash to the subject device (color,technology, shape on the cornea type of light to illuminate the retina).
PerformanceStandardCompliance	Complies with thefollowing standards:• IEC 60601-1:2005• IEC 60601-1-2:2014• ISO 10940-2:2009• ISO 60825-1:2014• ISO 62471-1:2006• ISO 8612:2010• ISO 10342:2010• ISO 24157:2008• ISO 19980:2012• ISO 10343-1:2014• ISO 15004-2 2007• ISO15004-1:2006• ISO 14971: 2012• ISO 62366:2007• ISO 62304: 2006	Complies with thefollowing standards:• IEC 60601-1:2005• IEC 60601-1-2:2007• ISO 10940-2:2009• ISO 15004-22007• ISO 15004-1:2006• ISO 14971:2012• ISO62366:2007• ISO 62304:2006	Complies with thefollowing standards:• IEC 60601-1:2005• IEC 60601-1-2:2007• ISO 10940-2:2009• ISO 15004-22007
Comparison:
Table 2 - Additional predicate devices related to fundus camera module
ATTRIBUTE /CHARACTERISTICS	VX650Subject Device	NexyPredicate Device PD2	Digital RetinographySystem DRSPredicate Device PD3
Subject device and predicate devices PD2 and PD3 comply with relevant standards; the subjectdevice includes also the applicability of additional standards for the other functions, as describedabove on Table 1.

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Image /page/13/Picture/1 description: The image shows the logo for Luneau Technology. The logo consists of a gray sphere with blue, white, and red stripes, followed by the text "Luneau Technology" in black. Below the text, there are three smaller logos: VISIO<•>NIX, briot, and WECO.

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TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary bench testing was conducted on VX650 to support a determination of substantial equivalence to the primary predicate device and to additional predicate device for fundus camera module. The tests performed include also:

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 VX650 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 VX650 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 and 2 introduce new issues of safety and effectiveness compared to predicate devices.

The remaining technical aspects (fundus camera module) of the VX650 compared with the additional predicate devices are considered very similar.

Based on the information contained in this submission, it is concluded that the VX650 device is substantially equivalent to the identified primary predicate device already in commerce within the USA and that any differences that do exist have no effect on the safety and effectiveness of the device.

Regulation Number and Section

§ 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.