The iVue 500 with normative database is an optical coherence tomography system intended for in vivo imaging, axial crosssectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.

The iVue 500 with normative database is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population. (identical to predicate device)

Device Description

The iVue 500 is a modification of its predicate device iVue with Normative Database (NDB) (K121739). The intended use, system performance, sub-assemblies, and key components of the iVue with NDB are all the same as the iVue with NDB. The intent of this redesign was to make the iVue a more compact desktop device, so it is more convenient to use and set-up in a typical office. Additionally operation via touchscreen or mouse driven technology, makes it simpler for a technician to use.

The iVue 500 is a non-invasive device for imaging the cornea, anterior chamber, and retinal tissue structure with micrometer range resolution.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Optovue iVue 500 (K133892) based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Category	Acceptance Criteria	Reported Device Performance (Average)	Results
Retina Mode
Working Distance	+/- 1mm	21.3mm (Range: 20.3-22mm)	Pass
Centering	+/- 1mm	0-.2mm	Pass
Pupil Distance	+/- 1mm	66.1-66.6mm	Pass
Cornea Mode
Working Distance	+/- 1mm	16.7mm (Range: 16.4-17.3mm)	Pass
Centering	+/- 1mm	0-.1mm	Pass
Pupil Distance	+/- 1mm	65.7-66.8mm	Pass

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: The document mentions using "2 model eyes" for the bench testing. This is a very limited sample size, suggesting the testing was highly controlled and focused on mechanical and alignment capabilities rather than diverse clinical data.
- Data Provenance: Not explicitly stated, but given the use of "model eyes" and the nature of the bench test, it is not clinical data from human subjects. It represents a controlled laboratory environment. Retrospective or prospective study types are not applicable here as it's not a clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Given that the testing involved "model eyes" and focused on alignment within mechanical tolerances, it's unlikely that clinical experts were involved in establishing "ground truth" in the typical sense (e.g., diagnosing disease). The "ground truth" for this test was the predefined mechanical tolerances.
Adjudication method for the test set:
- This information is not provided and is not applicable given the nature of the bench test with model eyes. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish a clinical ground truth.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a modified version of an existing OCT device, focusing on mechanical and alignment performance rather than clinical diagnostic efficacy with human readers or AI assistance. The document does not describe any AI component or human reader performance evaluation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense, a "standalone" test of the device's alignment capabilities was performed. The "software assisted motorized iVue 500" was tested to ensure it could align to the appropriate working distance and pupil centering with model eyes. This is an evaluation of the device's automated functions without human diagnostic interpretation in the loop. However, it's not a standalone diagnostic algorithm performance test as might be seen for an AI-powered diagnostic tool. The device itself is the "algorithm only" in this context of automated alignment.
The type of ground truth used:
- The ground truth used was predefined mechanical tolerances (e.g., "±1mm tolerance") for working distance, centering, and pupil distance. This relates to the physical positioning and alignment capabilities of the device in a controlled setting, not clinical diagnosis.
The sample size for the training set:
- This information is not applicable/not provided. The iVue 500 is a modification of an existing OCT system (K121739), not an AI algorithm that typically requires a separate training set. The existing normative database mentioned in the indications for use would have been developed previously, but details on its training set size are not part of this 510(k) submission. The current submission focuses on verifying the mechanical integrity and performance of the modified hardware.
How the ground truth for the training set was established:
- This information is not applicable/not provided for this 510(k) submission. As mentioned above, this submission is for hardware modification. The existing "normative database" (which might be considered a form of a "training set" for comparison) would have had its ground truth established based on measurements from "known normal subjects," but the details of that establishment are not within the scope of this submission.

Summary

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510(k) Summary Optovue iVue 500 K133892

MAR 1 9 2014

This 510(k) summary for the iVue 500 is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Category	Comments
Sponsor:	Optovue, Inc.2800 Bayview PkwyFremont, CA 94538
Correspondents:	Michael Sarrasin, Esq.,VP, Regulatory Affairs and Quality Assurancemichael_sarrasin@optovue.com
Manufacturer:	Optovue, Inc.2800 Bayview ParkwayFremont, CA 94538
Device Common Name:	Optical Coherence Tomography (OCT) System
Device Proprietary Name:	iVue 500
Device Classification	CI II, HLI, 21 CFR §886.1570
Predicate Device	IVue with NDB, K121739
Predicate Device Manufacturer	Optovue, Inc.
Predicate Device Classification	CI II, HLI, 21 CFR §886.1570

Date Summary was Prepared: January 7, 2014

Device Description: The iVue 500 is a modification of its predicate device iVue with Normative Database (NDB) (K121739). The intended use, system performance, sub-assemblies, and key components of the iVue with NDB are all the same as the iVue with NDB. The intent of this redesign was to make the iVue a more compact desktop device, so it is more convenient to use and set-up in a lypical office. Additionally operation via touchscreen or mouse driven technology, makes it simpler for a technician to use.

Intended Use: The iVue 500 with normative database is an optical coherence tomography system intended for in vivo imaging, axial crosssectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.
Indications for Use: The iVue 500 with normative database is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures,

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including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVuc 500 with normative database is a quantitative tool for the comparison of retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVuc 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population. (identical to predicate device)

Technological Characteristics: The iVue 500 is a non-invasive device for imaging the cornea, anterior chamber, and retinal tissue structure with micrometer range resolution.
Comparison to Predicate Device: The iVue 500 is a modification of its predicate device iVue with Normative Database (NDB) (K121739). The intended use, system performance, sub-assemblies, and key components of the iVue 500 with NDB are all the same as the iVue with NDB.

Device	Predicate	Current
510(k) Reference:	K121739	K133892
Intended Use:	The iVue with NormativeDatabase is an opticalcoherence tomographysystem intended for in vivoimaging, axial cross-sectional, three-dimensional imaging andmeasurement of anteriorand posterior ocularstructures.	Same
Device Description:	Optical CoherenceTomography (OCT)System	Same
Device Common Name:	Optical CoherenceTomography (OCT)System	Same
Device Classification:	Class II HLI(21 CFR 886.1570)	Same
Manufacturer:	Optovue, Inc.	Same

Summary of Testing: Testing was performed to verify design, and showed there were no new questions of safety or effectiveness with the subject device, This testing included electrical safety testing, electrical emissions testing, as well as bench. Bench testing demonstrated that the

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iVue 500 is able to align to appropriate working distance on both left and right eyes within the predefined acceptance criteria.

The bench test of iVue 500 utilizing 2 model eyes provides evidence that the software assisted motorized iVue 500 is able to complete the initial alignment of moving the scanner head to working position and to align the scanner head with the pupil within ±1mm tolerance. These are the general requirements to align a scanner to be able to capture an OCT image. Also the iVue 500 is able to move scanner head between right and left eyes.

RetinaMode	Range	Average	Criteria	Results
Workingdistance	20.3-22mm	21.3	+/- 1mm	Pass
centering	0-.2mm	n/a	+/- 1mm	Pass
Pupildistance	66.1-66.6mm	n/a	+/- 1mm	Pass

CorneaMode	Range	Average	Criteria	Results
Workingdistance	16.4-17.3mm	16.7	+/- 1mm	Pass
centering	0-.1mm	n/a	+/- 1mm	Pass
Pupildistance	65.7-66.8mm	n/a	+/- 1mm	Pass

Conclusion:

As described in this 510(k) Summary, all necessary testing and analyses were completed on the iVue 500 to ensure that the device is substantially equivalent to the identified predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609

Silver Spring, MD 2093-0002

March 19, 2014

Optovuc, Inc. % Mr. Michael Sarrasin, Esq. Vice President, Regulatory Affairs & Quality Assurance 2800 Bayview Drive Fremont, CA 94538

Rc: K133892

Trade/Device Name: iVue 500 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HILI Dated: February 19, 2014 Received: February 20, 2014

Dear Mr. Sarrasin:

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, 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, F12A may publish further announcements concerning your device in the Eederal 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.

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Page 2 - Mr. Michael Sarrasin, Esg.

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Scctions 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Deborah L. Falls -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K133892

Device Name

iVue 500

Indications for Use (Describe)

The iVue 500 with normative database is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-diment of anterior and posterior and posterior ocular structures, including reinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normalive database is a quantitative tool for the comparison of retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Rahul K. Ram -S (Affiliate) 2014.03.13 15:02:55 -04'00'

FORM FDA 3881 (9/13)

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.