The iVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, optic disk, cornea, and anterior chamber of the eye as an aid in the diagnosis and management of ocular diseases. The iStand is an optional accessory to the iVue which allows qualitative in-vivo imaging in cooperative, supine patients.

Device Description

The iVue OCT with iStand is a mobile computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The computer has a graphic user interface for acquiring and analyzing the image.

iVue offers three scans: Retina, Glaucoma, and Cornea. For the Cornea scan, a lens must be attached to the front of the device for proper scanning. This lens is called the CAM-L (Cornea Anterior Module - Long).

The optional addition of the iStand is designed to provide effective transportation of the iVue OCT when used under normal operational conditions. The mobile floor stand (iStand) with boom arm allows the iVue OCT System the ability to operate in different locations and allows the patient to be in a supine position during examination.

AI/ML Overview

The K103266 submission describes the iStand, an optional accessory that provides mobility and supine patient accessibility to the Optovue iVue Optical Coherence Tomography (OCT) system. The effectiveness section of the 510(k) indicates that the iStand is an accessory and does not affect the energy level and safety of the device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Stability (IEC 60601-1)	The iVue OCT with iStand meets the stability requirements of IEC 60601-1.
Safety	The addition of the iStand accessory to the iVue OCT system is an accessory and does not affect the energy level and safety of the device
Effectiveness	The substantial equivalence comparison to the predicate device in terms of intended use, operating principle, function, material, and energy source are unchanged on the effectiveness of the device. Performance data demonstrates that the iVue OCT System with the iStand is as safe and effective as iVue OCT.

2. Sample Size Used for the Test Set and Data Provenance

The document reports performance data from a TUV Certification Testing and Report (ref: 30883520.011) that was performed in accordance with IEC 60601-1 Amendment 1 and 2. It does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The device is a physical accessory and not a diagnostic algorithm that processes clinical data, so a "test set" in the traditional sense of clinical data samples is not applicable for this particular type of submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this 510(k) submission. The iStand is a physical accessory for an existing medical device, and its performance criteria relate to safety and mechanical stability (e.g., IEC 60601-1 standards), not the diagnostic output of the OCT system itself. Therefore, "ground truth" established by clinical experts for a test set is not relevant here.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth for diagnostic or prognostic endpoints.

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. This type of study is typically performed for AI or diagnostic imaging algorithms to assess the impact on human reader performance. The iStand is a physical accessory, and its safety and effectiveness are evaluated based on engineering standards and substantial equivalence to a predicate device, not through comparative clinical reading studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the context of an algorithm or diagnostic capability was not done. The iStand is a mechanical accessory, not a standalone algorithm. The "effectiveness" mentioned in the submission refers to the accessory not diminishing the existing effectiveness of the predicate iVue OCT system.

7. The Type of Ground Truth Used

The "ground truth" for the iStand's performance is based on engineering standards and regulatory compliance. Specifically, the stability criteria were assessed against IEC 60601-1 Amendment 1 and 2. For "effectiveness," the ground truth is established through demonstrating substantial equivalence to the predicate iVue OCT system, meaning the iStand does not alter the fundamental operation, safety, or effectiveness of the iVue OCT system as an imaging device.

8. The Sample Size for the Training Set

This information is not applicable. The iStand is a physical accessory, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Summary

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K103266

Optovue, Incorporated

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

General Information

Manufacturer:	Optovue, Inc.45531 Northport Loop West,Fremont, CA 94538Phone: (510) 623-8868Fax: (510) 623-8668Registration No.: 3005950902
Contact Person:	John J. TalaricoVP Regulatory and Clinical AffairsOptovue, Inc.Phone: (510)623-8868 x209e-mail: john_talarico@optovue.com
Device Information

Classification:	Class II
Trade Name:	iStand
Common Name:	Optical Coherence Tomography (OCT)
Classification Name:	Ophthalmoscope, a-c powered (21 C.F.R. § 886.1570)

Predicate Devices

510(k) K091404 iVue 100 Optical Coherence Tomography (OCT)

Purpose of this Traditional 510(k) notice

The iVue OCT with optional is an optional accessory addition to the iVue OCT System. Its purpose is to provide mobility and patient exam accessibility for the system.

Intended Use

Technological Characteristics

The iVue is a non-invasive diagnostic device for imaging the cornea, anterior chamber, and retinal tissue structure with micrometer range resolution. The iVue OCT with iSland is based on the same Optical Coherence Tomography (OCT) technology used in its predicate device, iVue OCT.

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K103266

Safety

The addition of the iStand accessory to the iVue OCT system is to provide mobility and patient exam accessibility for the system; the energy level and safety of the device are not affected.

Effectiveness

The substantial equivalence comparison to the predicate device presented in this premarket notification with regard to intended use, operating principle, function, material, and energy source are unchanged on the effectiveness of the device.

Performance Data

TUV Certification Testing and Report (ref: 30883520.011) was performed in accordance to IEC 60601-1 Amendment 1 and 2. The iVue OCT with iStand meets the stability requirements of IEC 60601-1.

Substantial Equivalence

The iVue OCT with iStand has the same intended use and similar indications, principles of operation, and technological characteristics as the Vue OCT. The minor differences in the iVue OCT with iStand's mobility do not raise any new questions of safety or effectiveness. Performance data demonstrates that the iVue OCT System with the iStand is as safe and effective as iVue OCT. Thus, the iVue OCT with the iStand is substantially equivalent to its predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Optovue, Inc c/o Mr. John Talarico Vice President Regulatory and Clinical Affairs 45531 Northport Loop West Fremont, CA 94538

Re: K103266

Trade/Device Name: iStand Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLI Dated: May 27, 2011 Received: May 31, 2011

JUN 3 2011

Dear Mr. Talarico:

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, 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 (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.

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Page 2 - Mr. John Talarico

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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,

Debra Falls

Malvina B. Evdelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K103266

Device Name: iStand

Indications for Use:

Prescription Use × (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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Concurrence of

CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K103266
Phone: (866) 344 8948: (510) 623-8868

45531 Northport Loop W. Frents

Fax: (510) 623.8668

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.