(37 days)
Not Found
No
The summary describes improvements in image acquisition speed and resolution based on Fourier Domain-OCT technology and a broader spectral bandwidth light source. It mentions image analysis via a graphic user interface but does not describe any AI/ML algorithms for image processing or interpretation.
No.
The device is described as a "non-invasive diagnostic device" that aids in "diagnosis and management" through imaging and measurement, rather than providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that the device is "an aid in the diagnosis and management of retinal diseases." Additionally, the "Device Description" explicitly refers to the RTVue as a "non-invasive diagnostic device."
No
The device description clearly states it is an "optical coherence tomography system" and a "non-invasive diagnostic device" that scans a beam into the patient's eye using hardware components like a light source, interferometer, and is mounted on a motorized patient table with a joystick for alignment. While it includes software for image acquisition and analysis, it is fundamentally a hardware-based imaging system.
Based on the provided text, the RTVue device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: 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.
- RTVue's Function: The RTVue is described as an "optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disk". It "scan a beam into patient's eye and use a low coherence interferometer to measure the reflectivity of the retinal tissue."
- In Vivo vs. In Vitro: The key phrase here is "in vivo imaging". This means the imaging is performed within the living body, not on a sample taken from the body (which would be "in vitro").
Therefore, the RTVue is an in vivo imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RTVue 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.
The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disk as an aid in the diagnosis and management of retinal diseases.
Product codes
OBO
Device Description
RTVue, based on the same Optical Coherence Tomography (OCT) technology that is using in the predicate device Humphrey® OCT3 (K012727), is a non-invasive diagnostic device for withing the ocular tissue structure with micrometer range resolution. A brochure of the OCT3 system is in appendices [1]
The RTVue, like its predicate device Humphrey® OCT3 (K012727), is a computer controlled ophthalmic imaging system. The device scan a beam into patient's eye and use 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 device is mounted on a motorized patient table. The patient will rest their head on the forehead and chin rest. Operator uses joystick to align the device to patient's eye. The computer has a graphic user interface for acquire and analysis image.
The RTVue has improvements in image acquisition speed and image resolution over its predecessor. RTVue uses non-mechanic moving part in the depth scan, a branch of OCT technology called Fourier Domain-OCT, so the scan speed improves about 65 times faster than the mechanical limited scan speed in previous devices. A detail description of the technology improvement from predicate device is published in Optics Express, May 2004 by Leitgeb et. al. Appendices [2, a].
The RTVue also uses the same light source SLD (super luminescent diode) as in its predicate device but with broader spectral bandwidth. The broad spectral bandwidth provides higher image resolution than a narrow one based on the Optical Coherence Tomography principle. A paper desertes the technology improvement from predicate device is published in Optics Express, May 2004 by Ko et. al. Appendices [2,6] and in American Journal of Ophthalmology, September 2004 by Wojtkowski et. al. Appendices [2. c]. Ocular pathologies imaged with the Fourier domain OCT and ultrahigh resolution light source also has been published in Investigative Ophthalmolgy & Visual Science , Spierban 2005 by Schmidt-Erfurtb et. al. Appendices [2,d] and in American Academy of Ophthy Implomy. October 2005 by Wojtkowski, et. al Appendices [2,e].
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, retina
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The RTVue has had accuracy tests, optical emission safety analysis, electrical safety, electromagnetic compatibility test, and software validation tests.
The predicate device has been routinely used in clinic. Numerous clinic paper and data has been published over last 10 years. The comparison between high resolution and regular readlution OCCT image produced by predicate device shows same and in some cases better clinic diagnonistan Oe produced by the higher resolution device. A clinic evaluation of high resolution OCT image in diagnosis retinal diseases has been published in SPIE Proceeding vol. 4956, 2003 by Ko et. al. Appendices [2,f]. The summary of the paper is "Intraretinal architectural morphology associated with macular diseases such as macular edema, epiretinal membranes, and macular holes can be isualized with unprecedented resolution. Ultrahigh resolution ophthalmic OCT promises to improve the early diagnosis of retinal diseases as well as enable monitoring of disease progression and the efficacy of therapeutic intervention.".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Humphrey® OCT3 (K012727)
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
Image /page/0/Picture/0 description: The image shows the word "optovue" in a simple, sans-serif font. The "o" in "optovue" is replaced with an image of an eye. There is a curved line above the word, giving the impression of an arc.
Optovue RTVue 510(K) Premarket Notification
510(k) Summary
OCT - 6 2006
Optovue, Incorporated RTVue
This 510(k) summary for the RTVue is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
General Information
| Manufacturer: | Optovue, Inc.
41752 Christy Street,
Fremont, CA 94538
Phone: (510) 623-8868
Fax: (510) 623-8668
Registration No.: |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jay Wei
CEO/President
Optovue, Inc.
Phone: (510)623-8868 x102
e-mail: jay_wei@optovue.com |
| Device Information | |
| Classification: | Class II |
| Trade Name: | RTVue |
| Common Name: | Optical Coherence Tomography (OCT) |
| Classification Name: | Ophthalmoscope, a-c powered (21 CFR§ 886.1570 |
Predicate Device
Humphrey® OCT3 (K012727)
Intended Use
. The RTVue 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.
Optovue, Inc.
1
Device Description
RTVue, based on the same Optical Coherence Tomography (OCT) technology that is using in the predicate device Humphrey® OCT3 (K012727), is a non-invasive diagnostic device for withing the ocular tissue structure with micrometer range resolution. A brochure of the OCT3 system is in appendices [1]
The RTVue, like its predicate device Humphrey® OCT3 (K012727), is a computer controlled ophthalmic imaging system. The device scan a beam into patient's eye and use 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 device is mounted on a motorized patient table. The patient will rest their head on the forehead and chin rest. Operator uses joystick to align the device to patient's eye. The computer has a graphic user interface for acquire and analysis image.
The RTVue has improvements in image acquisition speed and image resolution over its predecessor. RTVue uses non-mechanic moving part in the depth scan, a branch of OCT technology called Fourier Domain-OCT, so the scan speed improves about 65 times faster than the mechanical limited scan speed in previous devices. A detail description of the technology improvement from predicate device is published in Optics Express, May 2004 by Leitgeb et. al. Appendices [2, a].
The RTVue also uses the same light source SLD (super luminescent diode) as in its predicate device but with broader spectral bandwidth. The broad spectral bandwidth provides higher image resolution than a narrow one based on the Optical Coherence Tomography principle. A paper desertes the technology improvement from predicate device is published in Optics Express, May 2004 by Ko et. al. Appendices [2,6] and in American Journal of Ophthalmology, September 2004 by Wojtkowski et. al. Appendices [2. c]. Ocular pathologies imaged with the Fourier domain OCT and ultrahigh resolution light source also has been published in Investigative Ophthalmolgy & Visual Science , Spierban 2005 by Schmidt-Erfurtb et. al. Appendices [2,d] and in American Academy of Ophthy Implomy. October 2005 by Wojtkowski, et. al Appendices [2,e].
Safety
The power of the scan beam enter into patient's pupil is at same level as predicate device. The detail safety analysis Appendices [3] is completed by an international recognized expert in the fild of optical radiation hazards and safety Dr. Dave Sliney. The conclusion of the analysis is "The Optovue Retinal OCT system emits near-infrared radiation from an SLD that is below all of the applicable exposure limits-including the guidelines for ophthalmic instrument exposure"
Effectiveness
The predicate device has been routinely used in clinic. Numerous clinic paper and data has been published over last 10 years. The comparison between high resolution and regular readlution OCCT image produced by predicate device shows same and in some cases better clinic diagnonistan Oe produced by the higher resolution device. A clinic evaluation of high resolution OCT image in diagnosis retinal diseases has been published in SPIE Proceeding vol. 4956, 2003 by Ko et. al. Appendices [2,f]. The summary of the paper is "Intraretinal architectural morphology associated with macular diseases such as macular edema, epiretinal membranes, and macular holes can be isualized
Optovue, Inc.
2
with unprecedented resolution. Ultrahigh resolution ophthalmic OCT promises to improve the early diagnosis of retinal diseases as well as enable monitoring of disease progression and the efficacy of therapeutic intervention.".
Substantial Equivalence
The RTVue is substantially equivalent to the predicate device identified previously. The RTVue is substantially equivalent to the predicate device with regard to intended use, operating principle, function, material, and energy source. The only difference from the predicate device is that the RTVue has an increased scan rate and high image resolution. A comparison of ultrahigh resolution and Standard-resolution OCT (the predicate device) paper publish by Tony Ko et., appendices [2, al in Journal of Ophthalmology 2005 , concludes that "Ultrahigh-resolution OCT and standard resolution OCT exhibited comparable performance in differentiating thicker retinal layers, such as the retina nerve fiber, inner and outer plexiform, and inner and outer nuclear."
Performance Data
(a) Non-clinic tests:
The RTVue has had accuracy tests, optical emission safety analysis, electrical safety, electromagnetic compatibility test, and software validation tests.
(b)Clinic tests:
Not Required
Conclusion
As described in this 510(k) Summary, all testing and analysis were conducted on the RTVue to ensure that the device is safe and effective for its intended use when used in accordance with its instructions for use.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all caps and is evenly spaced around the circle.
JUN 1 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Optovue, Inc. c/o Mr. Tamas Borsai TUV Rheinland of North America 12 Commerce Road Newton, CT 06470
Re: K062552
Trade/Device Name: RTVue Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: September 19, 2006 Received: September 21, 2006
Dear Mr. Borsai:
This letter updates our substantially equivalent letter of January 26, 2007.
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 (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.
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
4
Page 2 - Mr. Tamas Borsai
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Evenette T. Beus PhD
Image /page/4/Picture/7 description: The image contains a handwritten word, "for", in cursive script. The letter "f" is larger and more elaborate, with a prominent loop extending above the rest of the word. The "o" and "r" are connected and smaller in size, completing the word. The writing appears to be done with a pen or marker, and the overall impression is casual and informal.
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
5
Indications for Use
510(k) Number (if known): K062552
Device Name:_RTVue
Indications For Use:
The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disk as an aid in the diagnosis and management of retinal diseases.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clay R. Buttner
510(k) Number K062552
Rev 09/15/06