(147 days)
Not Found
No
The description focuses on the hardware adapter and software modifications for anatomical labeling, not on AI/ML for image analysis or interpretation. There is no mention of AI, ML, or related concepts.
No.
The device is indicated for in vivo imaging and measurement, which are diagnostic functions, not therapeutic.
Yes
The device is indicated for "in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye," which involves gathering information about the patient's anatomical condition to aid in diagnosis or treatment planning. Furthermore, the performance studies include "Cornea Thickness Measurement Comparison" with other commercial pachymeters, which are diagnostic tools.
No
The device description clearly states it is an "auxiliary lens adapter" and describes hardware components like a motorized patient table, forehead and chin rest, and joystick, in addition to the software module.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye." This means the device is used to examine and measure structures within a living patient's body.
- Device Description: The description details how the device scans a beam into the patient's eye and measures reflectivity of ocular tissue. This is a direct interaction with the patient's body.
- Anatomical Site: The anatomical site is the cornea and anterior segment of the eye, which are parts of the living body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro). This device does not perform tests on such samples.
The device is an in vivo imaging and measurement device used for ophthalmic examinations.
N/A
Intended Use / Indications for Use
The CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicated for in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye.
Product codes (comma separated list FDA assigned to the subject device)
OBO
Device Description
The CA device uses the same Optical Coherence Tomography (OCT) technology that was previously reviewed by FDA in its clearance of premarket notification K062552 for RTVue. The CA adapter gives the user an option to use the RTUve device as previously approved for retina scans, or to use it for cornea and anterior eye scans. Aside from the CA auxiliary attachment, the RTVue is virtually unchanged for the CA use except the CA software module provides for menu selections in the graphical user interface, which are selected by the operator to label corresponding corneal landmarks instead of those of the retina. The system scans a beam into patient's eye and uses a low coherence interferometer to measure the reflectivity of the ocular tissue. The cross-sectional ocular tissue structure is composed of sequence of A-scans. RTVue 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. The operator uses joystick to align the device to patient's eye. The computer has a graphic user interface for acquiring, analyzing and displaying the acquired image. The RTVue image acquisition speed and image resolution remain the same when used in conjunction with CA.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
cornea and other ocular structures of the anterior segment of the eye
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)
Non-Clinical:
Image Resolution Test:
Objective: To measure the axial resolution of RTVue/CA
Result: The axial resolution of the tested RTVue/CA system is 5.1± 0.4um
Clinical:
-
Corneal Imaging Comparison:
Objective: To compare images of cornea obtained with the RTVue/CA and with the Visante OCT.
Result: The RTVue/CA is capable of providing images that compare well with the Visante OCT. Anatomic features of the anterior segment of the eye were visible to the physicians that assessed the RTVue/CA images; the same physicians could not identify these features in the Visante OCT images. -
Cornea Thickness Measurement Comparison:
Objective: To compare the cornea thickness measurement with other commercial available pachymeters.
Result: The cornea thickness measurement made by RTVue/CA is highly correlated with the ultrasound pachymetry system (Pearson correlation r = 0.9889), Orbscan II (Pearson correlation r = 0.9995), and Visante OCT (Pearson correlation r = 0.9924 at the vertex, r == 0.9939 over the central zone). The reproducibility of the RTVue/CA corneal measurement was 1.2 um root-mean-square for the difference between repeat pachymetry maps.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Axial resolution: 5.1 +/- 0.4 um
Pearson correlation r = 0.9889 (RTVue/CA vs. ultrasound pachymetry system)
Pearson correlation r = 0.9995 (RTVue/CA vs. Orbscan II)
Pearson correlation r = 0.9924 at the vertex, r = 0.9939 over the central zone (RTVue/CA vs. Visante OCT)
Reproducibility: 1.2 um root-mean-square
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image shows the word "opt.vue" in a simple, sans-serif font. A curved line arches over the word, connecting the "o" and "e". The dot between "opt" and "vue" is a solid black circle.
Optovue RTVue/CA 510(K) Premarket Notification
Ko 71250
510(k) Summary
Optovue, Incorporated CA Model: CAM
SEP 2 8 2007
This 510(k) summary for the CA 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: Trade Name:
Common Name: Classification Name: Class II CA Model: CAM Optical Coherence Tomography (OCT) Ophthalmoscope, a-c powered (21 CFR§ 886.1570)
Predicate Devices
RTVue (K062552) – Optovue Visante OCT (K051789) - Carl Zeiss Meditec Bioptigen (K063343) - Bioptigen Inc.
Intended Use
The CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicated for in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye.
1
Device Description
The CA device uses the same Optical Coherence Tomography (OCT) technology that was previously reviewed by FDA in its clearance of premarket notification K062552 for RTVue. The CA adapter gives the user an option to use the RTUve device as previously approved for retina scans, or to use it for cornea and anterior eye scans. Aside from the CA auxiliary attachment, the RTVue is virtually unchanged for the CA use except the CA software module provides for menu selections in the graphical user interface, which are selected by the operator to label corresponding corneal landmarks instead of those of the retina. The system scans a beam into patient's eye and uses a low coherence interferometer to measure the reflectivity of the ocular tissue. The cross-sectional ocular tissue structure is composed of sequence of A-scans. RTVue 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. The operator uses joystick to align the device to patient's eye. The computer has a graphic user interface for acquiring, analyzing and displaying the acquired image. The RTVue image acquisition speed and image resolution remain the same when used in conjunction with CA.
Safety
The energy level and all safety related design of the RTVue remains the same when used in conjunction with CA. The only difference is that the CA allows RTVue system to image the cornea instead of the retina. The addition of the CA does not change the safety.
Effectiveness
The image resolution of RTVue when used in conjunction with CA is 5um which is about 3 times better than the predicate device Visante OCT. The scan speed of RTVue when used in conjunction with CA is also 13 times faster than Visante OCT.
Substantial Equivalence
The RTVue/CA is substantially equivalent to the predicate devices presented within this premarket notification with regard to intended use, operating principle, function, material, and energy source, all of which are similar. The RTVue/CA can perform imaging on cornea and anterior segment by simply adding a lens in front the existing RTVue ocular lens. The indication of use on the cornea and anterior segment of the eye are equivalent to another predicate device, Visante OCT marketed by Carl Zeiss Meditec and to that of Bioptigen Inc. All these devices are based on the same Optical Coherence Tomography technology.
Performance Test Data
Non-Clinical:
Image Resolution Test:
Objective: To measure the axial resolution of RTVue/CA
Result: The axial resolution of the tested RTVue/CA system is 5.1± 0.4um
Optovue, Inc.
2
Clinical:
1. Corneal Imaging Comparison:
Objective: To compare images of cornea obtained with the RTVue/CA and with the Visante OCT.
Result: The RTVue/CA is capable of providing images that compare well with the Visante OCT. Anatomic features of the anterior segment of the eye were visible to the physicians that assessed the RTVue/CA images; the same physicians could not identify these features in the Visante OCT images.
2. Cornea Thickness Measurement Comparison:
Objective: To compare the cornea thickness measurement with other commercial available pachymeters.
Result: The cornea thickness measurement made by RTVue/CA is highly correlated with the ultrasound pachymetry system (Pearson correlation r = 0.9889), Orbscan II (Pearson correlation r = 0.9995), and Visante OCT (Pearson correlation r = 0.9924 at the vertex, r == 0.9939 over the central zone). The reproducibility of the RTVue/CA corneal measurement was 1.2 um root-mean-square for the difference between repeat pachymetry maps.
Conclusion
As described in this 510(k) Summary, all testing and analysis were conducted on the RTVue/CA 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the 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 symbol that resembles an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Optovue, Inc. c/o Jay Wei 41752 Christy Street Freemont, CA 94538
SEP 2 8 2007
Re: K071250
Trade/Device Name: CA Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: August 22, 2007 Received: August 23, 2007
Dear Mr. Wei:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
4
This letter will allow you to begin 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.
Sincerely vours.
M.B. Egerlton, mD
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):
Device Name: CA Model:CAM
Indications for Use:
The CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicated for in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye.
Prescription Use X (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. Buttem
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K071250