(211 days)
Not Found
No
The document describes a standard OCT imaging system with a computer interface for image acquisition and analysis. There is no mention of AI, ML, or any related terms, nor is there any description of training or test sets typically associated with AI/ML development. The performance studies mentioned are related to electrical safety and stability, not algorithmic performance.
No
The device is described as an "imaging and measurement" system used to "aid in the diagnosis and management" of diseases, which indicates a diagnostic rather than a therapeutic function.
Yes
The device is indicated for "in vivo imaging and measurement...as an aid in the diagnosis and management of ocular diseases," which directly refers to its use in medical diagnosis.
No
The device description explicitly states it is an "optical coherence tomography system" and a "mobile computer controlled ophthalmic imaging system" that "scans the patient's eye using a low coherence interferometer." It also mentions a physical lens (CAM-L) and an optional physical stand (iStand). These are all hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The iVue is described as 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". "In vivo" means within a living organism.
- No Specimen Analysis: The description focuses on imaging and measuring structures within the eye, not analyzing samples taken from the eye or body.
Therefore, the iVue is an in vivo imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
HLI
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
Retinal nerve fiber layer, optic disk, cornea, and anterior chamber of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 94538
Phone: (510) 623-8868
Fax: (510) 623-8668
Registration No.: 3005950902 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John J. Talarico
VP Regulatory and Clinical Affairs
Optovue, Inc.
Phone: (510)623-8868 x209
e-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
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.
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.
1
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.
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.
2
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.
3
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:
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.
Prescription Use × (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
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