(83 days)
Not Found
No
The summary explicitly states the software modifications are minor and related to scan names, limits, conventions, and speed, with no mention of AI or ML.
No
The device aids in diagnosis and management of retinal diseases by imaging and measurement but does not directly treat or provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an aid in the diagnosis and management of retinal diseases." Additionally, the "Device Description" mentions its use "as an aid in the diagnosis and management of retinal disease." These phrases clearly indicate its role in the diagnostic process.
No
The device description explicitly states "The RTVue is a computer controlled ophthalmic imaging and measurement system that employs optical coherence tomography to image and measure the posterior segment of the eye." This indicates the device includes hardware components (the OCT system) in addition to the software. The submission is for minor software modifications to an existing hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The RTVue is described as an "optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disk". The term "in vivo" means "within the living body".
- Anatomical Site: The device images and measures structures within the eye, which is part of the living body, not a sample taken from the body.
Therefore, the RTVue is an in vivo imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RTVue with Software 5.0 is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disk as an aid in the diagnosis and management of retinal diseases.
Product codes
HLI
Device Description
The RTVue is a computer controlled ophthalmic imaging and measurement system that employs optical coherence tomography to image and measure the posterior segment of the eye. The device is currently cleared for in vivo imaging and measurement of the various retinal layers (K062552). Imaging and measurements include but are not limited to the internal limiting membrane (ILM), the retinal nerve fiber layer (RNFL), the ganglion cell complex (GCC), the retinal pigment epithelium (RPE), the outer retinal thickness, the total retinal thickness and optic disk structures including the cup and neuroretinal rim as an aid in the diagnosis and management of retinal disease. The measurements for the ILM and RPE are height measurements relative to the RPE reference plane. The RNFL, GCC, the outer retinal thickness and total retinal thickness are thickness measurements where RNFL is the thickness of the RNFL layer, the GCC is the thickness from the ILM to the inner plexiform layer (IPL), the outer retinal thickness is the thickness from the IPL to the RPE, and total retinal thickness is the thickness from the ILM to the RPE. The current submission, RTVue with Software 5.0, is for minor software modifications, such as such as scan name changes, scan length limits, marking and labeling conventions, and improved data acquisition/archiving speeds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
Retinal nerve fiber layer, optic disk, posterior segment of the eye, various retinal layers (internal limiting membrane (ILM), retinal nerve fiber layer (RNFL), ganglion cell complex (GCC), retinal pigment epithelium (RPE), outer retinal thickness, total retinal thickness), optic disk structures (cup and neuroretinal rim).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
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
K 100861
JUN 1 7 2010
510(k) SUMMARY
Optovue's RTVue with Software 5.0
General Information
Manufacturer: Optovue, Inc. 45531 Northport Loop West, Fremont, CA 94538 Phone: (510) 623-8868 (510) 623-8668 Fax: Registration No.: 3005950902
Azimun Jamal Contact Person: Regulatory Manager Optovue, Inc. Phone: (510)623-8868 x188 e-mail: azimun_jamal@optovue.com
Device Information
| Classification: | Class II |
|---|---|
| Trade Name: | RTVue with Software 5.0 |
| Common Name: | Optical Coherence Tomography (OCT) |
| Classification Name: | Ophthalmoscope, a-c powered (21 CFR§ 886.1570) |
Predicate Device
Purpose of the Special 510(k) notice.
The RTVue with Software 5.0 is a modification to RTVue.
1
Intended Use
The RTVue with Software 5.0 is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disk as an aid in the diagnosis and management of retinal diseases.
Device Description
The RTVue is a computer controlled ophthalmic imaging and measurement system that employs optical coherence tomography to image and measure the posterior segment of the eye. The device is currently cleared for in vivo imaging and measurement of the various retinal layers (K062552). Imaging and measurements include but are not limited to the internal limiting membrane (ILM), the retinal nerve fiber layer (RNFL), the ganglion cell complex (GCC), the retinal pigment epithelium (RPE), the outer retinal thickness, the total retinal thickness and optic disk structures including the cup and neuroretinal rim as an aid in the diagnosis and management of retinal disease. The measurements for the ILM and RPE are height measurements relative to the RPE reference plane. The RNFL, GCC, the outer retinal thickness and total retinal thickness are thickness measurements where RNFL is the thickness of the RNFL layer, the GCC is the thickness from the ILM to the inner plexiform layer (IPL), the outer retinal thickness is the thickness from the IPL to the RPE, and total retinal thickness is the thickness from the ILM to the RPE. The current submission, RTVue with Software 5.0, is for minor software modifications, such as such as scan name changes, scan length limits, marking and labeling conventions, and improved data acquisition/archiving speeds.
Substantial Equivalence
RTVue with Software 5.0 has the same intended use and indications, principles of operation, and technological characteristics as RTVue. The minor differences in the RTVue with Software 5.0 do not raise any new questions of safety or effectiveness. Thus, the RTVue with Software 5.0 is substantially equivalent to its predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JUN 1 7 2010
Optovue, Inc c/o Ms. Azimun Jamal Manager of Quality/Regulatory 45531 Northport Loop W. Fremont, CA 94538
Re: K100861
Trade/Device Name: RTVue with Software 5.0 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLI Dated: May 19, 2010 Received: May 20, 2010
Dear Ms. Jamal:
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
3
Page 2 - Ms. Azimun Jamal
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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
A _ Malvina B. Eydelman, M.D. 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):
Device Name: RTVue with Software 5.0
Indications for Use:
The RTVue with Software 5.0 is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disk as an aid in the diagnosis and management of retinal diseases.
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)
Deshn.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K100861