(219 days)
No
The summary describes a normative database comparison, which is a statistical comparison to a pre-defined dataset of normal subjects, not a system that learns or adapts from data. There is no mention of AI, ML, or related technologies.
No.
The device is described as a non-invasive diagnostic imaging device intended to aid in the diagnosis, documentation, and management of ocular health and diseases by providing imaging and measurements of ocular structures. It does not provide treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The i Vue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population." Additionally, the "Device Description" calls it a "noninvasive diagnostic device."
No
The device is described as an optical coherence tomography system, which is a hardware-based imaging modality. While the submission focuses on software modifications (the normative database and analysis features), the core device is a physical OCT system.
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 anterior and posterior ocular structures." This means the device is used to image and measure structures within the living body, not to test samples taken from the body.
- Device Description: The description reinforces that it is a "noninvasive diagnostic device for viewing the ocular tissue structure." It describes scanning the patient's eye directly.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not involve the collection or analysis of such specimens.
The device is an in vivo diagnostic imaging device used to visualize and measure structures within the eye.
N/A
Intended Use / Indications for Use
The iVue with Normative Database is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.
The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The i Vue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Product codes
HLI
Device Description
iVue with Normative Database (NDB) is a modification of its predicate device iVue (K091404) through the inclusion of the database collected with the iVue. The intent of use, system performance, majority of sub-assemblies, and key components of the iVue with NDB are all the same as iVue and RTVue with NDB.
iVue with NDB, based on the same Optical Coherence Tomography (OCT) technology that is used in the predicate device iVue (K091404) and RTVue with NDB (K101505), is a noninvasive diagnostic device for viewing the ocular tissue structure with micrometer range resolution. Both iVue and RTVue with NDB are designed and manufactured by Optovue, Inc.
The device is currently cleared for in vivo imaging and measurement of the various retinal layers (K091404). The current submission is for a software modification through the addition of a normative database feature, similar to the NDB feature on the cleared predicate device RTV ue with NDB (K101505). With the addition of the normative database (NDB), the iVue can compare the measured data from the Retina Map scan, the Nerve Fiber scan, and the iWellness scan, to the normative database. The iVue/RTVue with Normative Database provide a comparison of the scanned measurements to a database of known normal subjects to provide a reference of where the patient's measurement stands in relation to the normative distribution. The iVue with normative database provides analysis information to be used as a clinical reference to aid in the diagnosis and management of ocular health and diseases. There is no hardware change from the 510(k) cleared iVue System (K091404). Additional scan patterns and acquisition of 3-D disc scan as ONH scan reference, optic disc analysis, and modification of the blood vessel extraction for the retina map scan are other software changes implemented in the current submission. These software changes are similar to features in the predicate RTVue device (K101505) and do not impact the safety and effectiveness of the system.
The device scans a patient's eye and uses a low coherence interferometer to measure the reflectivity of the retinal and corneal tissue. The cross sectional B-scan of the retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The patient will rest their head on the forehead and chin rest while the operator uses a joystick to align the device to the patient's eve. The computer has a graphic user interface for acquiring and analyzing the image.
iVue with NDB has similar scan patterns and analysis functions as the predicate device RTVue with NDB.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
anterior and posterior ocular structures, including retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye.
Indicated Patient Age Range
adult population.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
The iVue normative database collection was based on a similar study design, study protocol, and data collection method as those of predicate RTVue NDB data collection. The inclusion and exclusion criteria are identical in the two protocols. The image quality review criteria are similar for both devices. Both the iVue NDB and the RTVue NDB contain a mixture of ethnicities, and have similar age, gender, and refractive error range coverage. The total number of normal subjects is also similar in the two normative databases.
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)
A repeatability and reproducibility study was conducted with IRB approval to assess iVue precision. Fourteen (14) normal subjects, thirteen (13) patients with glaucoma, and thirteen (13) patients with retina disease were included in the study to evaluate the repeatability and reproducibility of iVue measurements. Only one eye per subject was included in the study. Each study eye was imaged 3 times with each of the 4 scan patterns (ONH, Retina. GCC, and iWellness) per iVue instrument and imaged across 3 instrument/operator pairs. The 3 iVue instruments were operated by different operators, and therefore, the combined effect of machine and operator was estimated for measurement reproducibility.
The precision of iVue measurements was estimated for these parameters (15 retinal parameters from the Retina scan, 5 GCC parameters from the GCC scan, 15 Retinal Nerve Fiber Layer (RNFL) parameters from ONH scan, 9 optic disc parameters from ONH scan, 11 retinal parameters from the iWellness scan, and 5 GCC parameters from the iWellness scan). The precision for each parameter is provided for the i) normal eyes, ii) the retinal disease eyes, and iii) the glaucoma eyes as follow: 1) repeatability standard deviation (SD), 2) reproducibility SD, 3) coefficient of variation (COV) based on reproducibility (Reproducibility SD/Mean100), and 4) 95% limits of reproducibility (2.8Reproducibility SD).
In addition, all 4 scan types and measurement parameters available in iVue with NDB are compared to the predicate RTVue with NDB device (K101505). Table 13 – 18 summarize the number of eyes in each study group, mean measurement for the new device and the predicate device, mean (& standard deviation) of the differences, 95% confidence interval for the mean differences, and 95% limits of agreement for each parameter and each scan type.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The iVue NDB study found that age was significantly associated with most study parameters, but the effect of age was small: The iVue NDB study found that SSI was significantly associated with most study parameters; the effect was small and at similar level to the age effect. The RNFL and ONH parameters were found to have strong association with disc area. Gender effect was not significant for most study parameters except for some retina thickness parameters where the retinal thickness was approximately 11 um thinner in female than in male on average.
The comparison of a scan result to the normative database is displayed in color-coded percentile categories as within normal', 'borderline', or 'outside normal' based on cut-off levels of 5% for 'borderline' and 1% for 'outside normal', same as in RTVue with NDB which was described in detail in the 510(k) submission (K101505), and received FDA clearance on September 15th 2010. The color categorization of a pixel presents the percentile with regard to the distribution of thickness at the specific location of a given pixel. This database takes into account several important covariates including age, signal strength, and optic disc size for the ONH scans, same as RTVue with NDB.
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.
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K12/739
Image /page/0/Picture/1 description: The image shows the word "optovue" in a stylized font. The "o" in "optovue" is drawn as an eye. There is a curved line above the word.
Optovue iVue NDB 510(K) Premarket Notification
JAN 1 8 2013
510(k) Summary Optovue, Incorporated iVue with NDB
This 510(k) summary for the iVue NDB is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
General Information
| Manufacturer: | Optovue, Inc.
2800 Bayview Drive
Fremont, CA 94538
Phone: (510) 623-8868
Fax: (510) 623-8668
Registration No.: 3005950902 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jay Wei
President & CEO
Optovue, Inc.
Phone: (510) 623-8868
e-mail: jay_wei@optovue.com |
| Summary Prepared: | Jan 17, 2013 |
| Device Information | |
| Trade Name: | iVue with Normative Database |
| Common Name: | Optical Coherence Tomography (OCT) |
| Classification Name: | Ophthalmoscope, a-c powered (21 CFR§ 886.1570) |
| Classification: | Class II (acc. 21 CFR 886.1570) |
| Product Code: | HLI |
Predicate Devices
(1) iVue® (K091404) - manufactured by Optovue, Inc. (2) RTVue® with Normative Database (K101505) - manufactured by Optovue, Inc.
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Intended Use
The iVue with Normative Database is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.
Indications For Use
The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The i Vue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Device Description
iVue with Normative Database (NDB) is a modification of its predicate device iVue (K091404) through the inclusion of the database collected with the iVue. The intent of use, system performance, majority of sub-assemblies, and key components of the iVue with NDB are all the same as iVue and RTVue with NDB.
iVue with NDB, based on the same Optical Coherence Tomography (OCT) technology that is used in the predicate device iVue (K091404) and RTVue with NDB (K101505), is a noninvasive diagnostic device for viewing the ocular tissue structure with micrometer range resolution. Both iVue and RTVue with NDB are designed and manufactured by Optovue, Inc.
The device is currently cleared for in vivo imaging and measurement of the various retinal layers (K091404). The current submission is for a software modification through the addition of a normative database feature, similar to the NDB feature on the cleared predicate device RTV ue with NDB (K101505). With the addition of the normative database (NDB), the iVue can compare the measured data from the Retina Map scan, the Nerve Fiber scan, and the iWellness scan, to the normative database. The iVue/RTVue with Normative Database provide a comparison of the scanned measurements to a database of known normal subjects to provide a reference of where the patient's measurement stands in relation to the normative distribution. The iVue with normative database provides analysis information to be used as a clinical reference to aid in the diagnosis and management of ocular health and diseases. There is no hardware change from the 510(k) cleared iVue System (K091404). Additional scan patterns and acquisition of 3-D disc scan as ONH scan reference, optic disc analysis, and modification of the blood vessel extraction for the retina map scan are other software changes implemented in the current submission. These software changes are similar to features in the predicate RTVue device (K101505) and do not impact the safety and effectiveness of the system.
2
Image /page/2/Picture/1 description: The image shows the word "optovue" in a simple, sans-serif font. The "o" in the middle of the word is stylized to resemble an eye, with concentric circles forming the iris and pupil. A curved line arches over the entire word, adding a subtle design element.
The device scans a patient's eye and uses a low coherence interferometer to measure the reflectivity of the retinal and corneal tissue. The cross sectional B-scan of the retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The patient will rest their head on the forehead and chin rest while the operator uses a joystick to align the device to the patient's eve. The computer has a graphic user interface for acquiring and analyzing the image.
iVue with NDB has similar scan patterns and analysis functions as the predicate device RTVue with NDB.
Safety
There is no change in safety from the iVue predicate device (K091404) since this is only a submission to address the addition of an established software database. There is no hardware change in the iVue with Normative Database; therefore, all safety related parameters, such as optical exposure power level, ergonomics, material biocompatibility, and IEC-60601 certification, remain the same as the 510(k) cleared device iVue (K091404). The addition of the NDB has the same indication and analysis features as the predicate device RTVue with NDB (K101505) and does not raise any safety concern.
Effectiveness
The validation of effectiveness of the iVue with NDB has been analyzed in detail. In general, the repeatability and reproducibility of the iVue measurements were reasonably similar to those of the predicate device. The iVue normative database is established using nearly identical methodology as that of the predicate RTVue with NDB. Therefore, the iVue with NDB is as effective as the predicate device, RTVue with NDB (K101505).
Substantial Equivalence
The iVue with NDB is substantially equivalent to the predicate iVue (K091404) and RTVue with NDB (K101505) with regard to intended use, operating principle, function, material, and energy source. Based on the types of measurements, comparisons made to the NDB, size and scope of the NDB, and method employed to establish the NDB limits, the iVue with NDB is substantially equivalent to the predicate device RTVue with NDB. With the exception of the software change associated with the NDB, the iVue with NDB is identical to the predicate 510(k) cleared iVue device (K091404) with regard to operating principle, function, material, and energy source. No mechanical or electrical change has been made. The method of comparing measurements to a normative database for glaucoma and retina pathologies in iVue with NDB is substantially equivalent to the method utilized by the predicate device RTVue with NDB (K101505).
Clinical Evaluation
The equivalence of iVue to RTVue in performing ocular imaging and measurements was established previously (K091409). The validity of the iVue with NDB and its equivalence to predicate devices were evaluated. The iVue normative database collection was based on a similar
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optovuè
study design, study protocol, and data collection method as those of predicate RTVue NDB data collection. The inclusion and exclusion criteria are identical in the two protocols. The image quality review criteria are similar for both devices. Both the iVue NDB and the RTVue NDB contain a mixture of ethnicities, and have similar age, gender, and refractive error range coverage. The iVue measurements were found to be as repeatable and reproducible as the corresponding measurements of the RTVue. Similar regression models were employed in iVue NDB analysis as those of RTVue with NDB to estimate normative limits. The measurements are similar in normal eyes for both devices. Furthermore, the total number of normal subjects is also similar in the two normative databases. In conclusion, the iVue normative database is substantially equivalent to the predicate device RTVue with NDB.
The iVue NDB study found that age was significantly associated with most study parameters, but the effect of age was small: The iVue NDB study found that SSI was significantly associated with most study parameters; the effect was small and at similar level to the age effect. The RNFL and ONH parameters were found to have strong association with disc area. Gender effect was not significant for most study parameters except for some retina thickness parameters where the retinal thickness was approximately 11 um thinner in female than in male on average.
The comparison of a scan result to the normative database is displayed in color-coded percentile categories as within normal', 'borderline', or 'outside normal' based on cut-off levels of 5% for 'borderline' and 1% for 'outside normal', same as in RTVue with NDB which was described in detail in the 510(k) submission (K101505), and received FDA clearance on September 15th 2010. The color categorization of a pixel presents the percentile with regard to the distribution of thickness at the specific location of a given pixel. This database takes into account several important covariates including age, signal strength, and optic disc size for the ONH scans, same as RTVue with NDB.
Performance Data
A repeatability and reproducibility study was conducted with IRB approval to assess iVue precision. Fourteen (14) normal subjects, thirteen (13) patients with glaucoma, and thirteen (13) patients with retina disease were included in the study to evaluate the repeatability and reproducibility of iVue measurements. Only one eye per subject was included in the study. Each study eye was imaged 3 times with each of the 4 scan patterns (ONH, Retina. GCC, and iWellness) per iVue instrument and imaged across 3 instrument/operator pairs. The 3 iVue instruments were operated by different operators, and therefore, the combined effect of machine and operator was estimated for measurement reproducibility.
The precision of iVue measurements was estimated for these parameters (15 retinal parameters from the Retina scan, 5 GCC parameters from the GCC scan, 15 Retinal Nerve Fiber Layer (RNFL) parameters from ONH scan, 9 optic disc parameters from ONH scan, 11 retinal parameters from the iWellness scan, and 5 GCC parameters from the iWellness scan). The precision for each parameter is provided for the i) normal eyes, ii) the retinal disease eyes, and iii) the glaucoma eyes as follow: 1) repeatability standard deviation (SD), 2) reproducibility SD,
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optovue
- coefficient of variation (COV) based on reproducibility (Reproducibility SD/Mean100), and 4) 95% limits of reproducibility (2.8Reproducibility SD).
Retina Scan
| Retina Scan | Mean | Repeatability
(SD) | Reproducibility
(SD) | Reproducibility
COV | Reproducibility
Limit* |
|--------------------------------------|-------|-----------------------|-------------------------|------------------------|---------------------------|
| Normal Eyes (14 subjects, 125 scans) | | | | | |
| Fovea (µm) | 259.8 | 3.68 | 3.78 | 1.45% | 10.5 |
| ParaFovea (µm) | 314.5 | 3.29 | 3.45 | 1.10% | 9.6 |
| Para S Hemisphere (µm) | 316.3 | 4.11 | 4.41 | 1.39% | 12.2 |
| Para I Hemisphere (µm) | 312.7 | 3.55 | 3.57 | 1.14% | 9.9 |
| Para Tempo (µm) | 308.0 | 3.57 | 3.73 | 1.21% | 10.3 |
| Para Superior (µm) | 316.9 | 4.52 | 4.92 | 1.55% | 13.6 |
| Para Nasal (µm) | 322.6 | 4.89 | 4.95 | 1.53% | 13.7 |
| Para Inferior (µm) | 310.5 | 3.97 | 3.97 | 1.28% | 11.0 |
| Perifovea (µm) | 285.9 | 2.61 | 2.82 | 0.99% | 7.8 |
| Peri S Hemisphere (µm) | 288.6 | 3.43 | 3.51 | 1.22% | 9.7 |
| Peri I Hemisphere (µm) | 283.2 | 3.23 | 3.50 | 1.24% | 9.7 |
| Peri Tempo (µm) | 278.1 | 4.13 | 4.54 | 1.63% | 12.6 |
| Peri Superior (µm) | 287.2 | 4.34 | 4.39 | 1.53% | 12.2 |
| Peri Nasal (µm) | 301.4 | 4.26 | 4.26 | 1.41% | 11.8 |
| Peri Inferior (µm) | 277.0 | 3.90 | 4.20 | 1.51% | 11.6 |
Table 1. Repeatability and Reproducibility of Retina Thickness (Normal Eyes)
- Repoducibility Limit is the 95% limit for the difference between measurements under the reproducibility Limi = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.
Table 2. Repeatability and Reproducibility of Retina Thickness (Retina Disease Eyes)
| Retina Scan | Retina Disease Eyes (13 subjects, 110 scans) | ||||
|---|---|---|---|---|---|
| Mean | Repeatability | ||||
| (SD) | Reproducibility | ||||
| (SD) | Reproducibility | ||||
| COV | Reproducibility | ||||
| Limit* | |||||
| Fovea (µm) | 286.0 | 7.74 | 8.12 | 2.86% | 22.5 |
| ParaFovea (µm) | 313.4 | 2.69 | 2.86 | 0.91% | 7.9 |
| Para S Hemisphere (µm) | 313.5 | 4.26 | 4.55 | 1.45% | 12.6 |
| Para I Hemisphere (µm) | 313.4 | 3.04 | 3.17 | 1.01% | 8.8 |
| Para Tempo (µm) | 303.6 | 4.22 | 4.28 | 1.41% | 11.9 |
| Para Superior (µm) | 313.1 | 5.83 | 6.05 | 1.94% | 16.8 |
| Para Nasal (µm) | 323.2 | 5.00 | 5.08 | 1.57% | 14.1 |
| Para Inferior (µm) | 313.9 | 3.85 | 3.91 | 1.25% | 10.8 |
| Perifovea (µm) | 280.2 | 1.58 | 1.66 | 0.59% | 4.6 |
| Peri S Hemisphere (µm) | 283.1 | 2.76 | 2.88 | 1.02% | 8.0 |
| Peri I Hemisphere (µm) | 277.4 | 3.57 | 3.94 | 1.42% | 10.9 |
| Peri Tempo (µm) | 268.3 | 3.37 | 3.62 | 1.35% | 10.0 |
| Peri Superior (µm) | 283.1 | 3.69 | 3.84 | 1.36% | 10.6 |
| Peri Nasal (µm) | 295.8 | 3.61 | 3.68 | 1.25% | 10.2 |
| Peri Inferior (µm) | 273.7 | 4.94 | 5.63 | 2.06% | 15.6 |
- Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility Limi = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.
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Table 3. Repeatability and Reproducibility of Retina Thickness (Glaucoma Eyes)
| Retina Scan | Glaucoma Eyes (13 subjects, 101 scans) | ||||
|---|---|---|---|---|---|
| Mean | Repeatability | ||||
| (SD) | Reproducibility | ||||
| (SD) | Reproducibility | ||||
| COV | Reproducibility | ||||
| Limit* | |||||
| Fovea (µm) | 255.9 | 5.18 | 5.64 | 2.18% | 15.6 |
| ParaFovea (µm) | 294.6 | 2.34 | 2.50 | 0.85% | 6.9 |
| Para S Hemisphere (µm) | 295.5 | 2.60 | 3.09 | 1.04% | 8.6 |
| Para I Hemisphere (µm) | 293.8 | 2.92 | 2.92 | 0.99% | 8.1 |
| Para Tempo (µm) | 289.5 | 2.79 | 2.99 | 1.03% | 8.3 |
| Para Superior (µm) | 295.4 | 3.03 | 3.66 | 1.23% | 10.1 |
| Para Nasal (µm) | 300.9 | 3.47 | 3.47 | 1.15% | 9.6 |
| Para Inferior (µm) | 292.7 | 3.52 | 3.52 | 1.20% | 9.8 |
| Perifovea (µm) | 267.4 | 1.76 | 2.21 | 0.82% | 6.1 |
| Peri S Hemisphere (µm) | 271.0 | 2.60 | 2.77 | 1.02% | 7.7 |
| Peri I Hemisphere (µm) | 263.9 | 3.08 | 3.99 | 1.51% | 11.1 |
| Peri Tempo (µm) | 262.6 | 4.34 | 4.40 | 1.67% | 12.2 |
| Peri Superior (µm) | 269.6 | 3.12 | 3.35 | 1.24% | 9.3 |
| Peri Nasal (µm) | 279.2 | 3.67 | 3.89 | 1.39% | 10.8 |
| Peri Inferior (µm) | 258.3 | 3.82 | 5.08 | 1.96% | 14.1 |
- Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility Limit = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.
GCC Scan
Table 4. Repeatability and Reproducibility of GCC (Normal Eyes)
| GCC Scan | Normal Eyes (14 subjects, 124 scans) | ||||
|---|---|---|---|---|---|
| Mean | Repeatability | ||||
| (SD) | Reproducibility | ||||
| (SD) | Reproducibility | ||||
| COV | Reproducibility | ||||
| Limit* | |||||
| GCC_Average (µm) | 95.4 | 1.49 | 1.52 | 1.59% | 4.2 |
| GCC_Superior_Avg (µm) | 95.5 | 1.83 | 1.87 | 1.96% | 5.2 |
| GCC_Inferior_Avg (µm) | 95.3 | 1.43 | 1.44 | 1.51% | 4.0 |
| GCC_FLV (%) | 1.213 | 0.438 | 0.438 | 35.97% | 1.214 |
| GCC_GLV (%) | 4.999 | 1.043 | 1.072 | 21.52% | 2.972 |
- Reproductibility Limit is the 95% imit for the difference between measurements under the reproducibility Limit = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.
** The high COV values for GCC_FLV is due to the highly skewed distribution near zero values of normal eyes and the denominator for the COV calculation has a low value. COV is not an appropriate measure of test-retest variability for such skeved distributions with a large portion of data at or near zero. Please interpret the data with this information in mind.
| Table 5. Repeatability and Reproducibility of GCC (Retina Disease Eyes) | ||
|---|---|---|
| ------------------------------------------------------------------------- | -- | -- |
| GCC Scan | Retina Disease Eyes (13 subjects, 98 scans) | ||||
|---|---|---|---|---|---|
| Mean | Repeatability | ||||
| (SD) | Reproducibility | ||||
| (SD) | Reproducibility | ||||
| COV | Reproducibility | ||||
| Limit* | |||||
| GCC_Average (µm) | 96.2 | 2.08 | 2.24 | 2.34% | 6.2 |
| GCC_Superior_Avg (µm) | 96.7 | 2.65 | 2.88 | 3.00% | 8.0 |
| GCC_Inferior_Avg (µm) | 95.7 | 2.15 | 2.22 | 2.33% | 6.2 |
| GCC_FLV (%) | 2.628 | 0.688 | 0.694 | 26.54% | 1.925 |
| GCC_GLV (%) | 5.557 | 1.066 | 1.116 | 19.02% | 3.093 |
- Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility Limit = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.
** The high COV values for GCC_FLV is due to the highly skewed distribution near zero values of normal eyes and the denominator for the COV calculation has a low value. COV is not an appropriate measure of test-retest variability for such skewed distributions with a large portion of data at or near zero. Please interpret the data with this information in mind.
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| GCC Scan | Glaucoma Eyes (13 subjects, 109 scans) | ||||
|---|---|---|---|---|---|
| Mean | Repeatability | ||||
| (SD) | Reproducibility | ||||
| (SD) | Reproducibility | ||||
| COV | Reproducibility | ||||
| Limit* | |||||
| GCC_Average (µm) | 83.2 | 1.91 | 1.91 | 2.29% | 5.3 |
| GCC_Superior_Avg (µm) | 84.6 | 2.21 | 2.21 | 2.62% | 6.1 |
| GCC_Inferior_Avg (µm) | 81.8 | 2.33 | 2.33 | 2.84% | 6.5 |
| GCC_FLV (%) | 4.273 | 1.116 | 1.116 | 26.99% | 3.094 |
| GCC_GLV (%) | 15.164 | 1.676 | 1.676 | 11.10% | 4.644 |
Reneatability and Ren aducibility of GCC (Glai
- Reproducibility Limit is the S5% limit for the difference between measurements under the reproducibility Limi = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.
** The high COV values for GCC_FLV is due to the highly skewed distribution near zero values of normal eyes and the denominator for the COV calculation has a low value. COV is not an appropriate measure of test-retest variability for such skeved distributions with a large portion of data at or near zero. Please interpret the data with this information in mind.
iWellness Scan
Note that 11 retina thickness parameters are provided for iWellness scan retinal measurements; the 4 hemisphere parameters (Para S Hemisphere, Para I Hemisphere, Peri S Hemisphere, and Peri I Hemisphere) are not included in the iWellness scan report.
| iWellness Scan | Normal Eyes (14 subjects, 125 scans) | ||||
|---|---|---|---|---|---|
| Mean | Repeatability (SD) | Reproducibility (SD) | Reproducibility COV | Reproducibility Limit* | |
| GCC Parameters | |||||
| GCC_Average (µm) | 94.6 | 1.15 | 1.17 | 1.24% | 3.2 |
| GCC_Superior_Avg (µm) | 94.7 | 1.42 | 1.45 | 1.53% | 4.0 |
| GCC_Inferior_Avg (µm) | 94.5 | 1.18 | 1.19 | 1.26% | 3.3 |
| GCC_FLV (%) | 1.029 | 0.458 | 0.458 | 44.43% | 1.269 |
| GCC_GLV (%) | 5.117 | 0.588 | 0.635 | 12.33% | 1.759 |
| Retina Parameters | |||||
| Fovea (µm) | 257.8 | 2.29 | 3.10 | 1.20% | 8.6 |
| ParaFovea (µm) | 316.3 | 3.62 | 3.71 | 1.17% | 10.3 |
| Para Tempo (µm) | 306.6 | 3.75 | 3.89 | 1.27% | 10.8 |
| Para Superior (µm) | 321.2 | 4.56 | 4.60 | 1.43% | 12.8 |
| Para Nasal (µm) | 320.8 | 4.75 | 4.75 | 1.48% | 13.2 |
| Para Inferior (µm) | 316.6 | 3.76 | 3.98 | 1.26% | 11.0 |
| Perifovea (µm) | 286.9 | 2.74 | 2.79 | 0.97% | 7.7 |
| Peri Tempo (µm) | 279.4 | 4.01 | 4.22 | 1.51% | 11.7 |
| Peri Superior (µm) | 290.2 | 3.87 | 3.92 | 1.35% | 10.9 |
| Peri Nasal (µm) | 301.4 | 4.16 | 4.16 | 1.38% | 11.5 |
| Peri Inferior (µm) | 276.6 | 2.99 | 3.09 | 1.12% | 8.6 |
Table 7. Repeatability and Reproducibility of GCC and Retina Thickness (Normal Eyes)
- Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility Limi = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.
** The high COV values for GCC_FLV is due to the highly skewed distribution near zero values of normal eyes and the denominator for the CV calculation has a low value of test-retest wariability for such size of test-retest wariability for such security of with a large portion of data at or near zero. Please interpret the data with this information in mind.
7
Table 8. Repeatability and Reproducibility of GCC and Retina Thickness (Retina Disease Eves)
| iWellness Scan | Retina Disease Eyes (13 subjects, 108 scans) | ||||
|---|---|---|---|---|---|
| Mean | Repeatability | ||||
| (SD) | Reproducibility | ||||
| (SD) | Reproducibility | ||||
| COV | Reproducibility | ||||
| Limit* | |||||
| GCC Parameters | |||||
| GCC_Average (µm) | 95.3 | 1.56 | 1.68 | 1.76% | 4.6 |
| GCC_Superior_Avg (µm) | 95.3 | 1.87 | 1.98 | 2.08% | 5.5 |
| GCC_Inferior_Avg (µm) | 95.3 | 1.67 | 1.75 | 1.84% | 4.9 |
| GCC_FLV (%) | 2.716 | 0.533 | 0.538 | 20.25% | 1.490 |
| GCC_GLV (%) | 5.972 | 0.811 | 0.845 | 14.11% | 2.343 |
| Retina Parameters | |||||
| Fovea (µm) | 280.6 | 4.17 | 4.37 | 1.55% | 12.1 |
| ParaFovea (µm) | 314.2 | 2.65 | 2.76 | 0.88% | 7.7 |
| Para Tempo (µm) | 305.2 | 3.79 | 4.21 | 1.38% | 11.7 |
| Para Superior (µm) | 317.0 | 3.71 | 3.91 | 1.23% | 10.8 |
| Para Nasal (µm) | 319.8 | 5.17 | 5.17 | 1.62% | 14.3 |
| Para Inferior (µm) | 314.8 | 3.16 | 3.24 | 1.03% | 9.0 |
| Perifovea (µm) | 281.1 | 1.73 | 1.92 | 0.69% | 5.3 |
| Peri Tempo (µm) | 272.5 | 3.48 | 4.01 | 1.48% | 11.1 |
| Peri Superior (µm) | 284.6 | 2.32 | 2.36 | 0.83% | 6.5 |
| Peri Nasal (µm) | 293.9 | 2.56 | 2.63 | 0.90% | 7.3 |
| Peri Inferior (µm) | 273.6 | 2.47 | 2.74 | 1.00% | 7.6 |
- Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility Limi = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.
** The high COV values for GCC_FLV is due to the highly skewed distribution near zero values of normal eyes and the denominator for the COV calculation has a low value. COV is not an appropriate measure of test-retest variability for such skeved distributions with a large portion of data at or near zero. Please interpret the data with this information in mind.
Table 9. Repeatability and Reproducibility of GCC and Retina Thickness (Glaucoma Eves)
| iWellness Scan | Glaucoma Eyes (13 subjects, 106 scans) | ||||
|---|---|---|---|---|---|
| Mean | Repeatability | ||||
| (SD) | Reproducibility | ||||
| (SD) | Reproducibility | ||||
| COV | Reproducibility | ||||
| Limit* | |||||
| GCC Parameters | |||||
| GCC_Average (um) | 82.4 | 1.14 | 1.14 | 1.38% | 3.2 |
| GCC_Superior_Avg (um) | 83.3 | 1.62 | 1.62 | 1.93% | 4.5 |
| GCC_Inferior_Avg (um) | 81.5 | 1.56 | 1.57 | 1.92% | 4.3 |
| GCC_FLV (%) | 3.943 | 0.913 | 0.929 | 23.28% | 2.575 |
| GCC_GLV (%) | 15.636 | 0.934 | 0.934 | 6.07% | 2.588 |
| Retina Parameters | |||||
| Fovea (um) | 254.6 | 2.87 | 3.01 | 1.18% | 8.3 |
| ParaFovea (um) | 296.4 | 2.24 | 2.30 | 0.77% | 6.4 |
| Para Tempo (um) | 289.5 | 2.64 | 2.75 | 0.95% | 7.6 |
| Para Superior (um) | 299.0 | 2.84 | 2.87 | 0.96% | 8.0 |
| Para Nasal (um) | 299.6 | 3.10 | 3.10 | 1.03% | 8.6 |
| Para Inferior (um) | 297.3 | 2.98 | 3.01 | 1.01% | 8.3 |
| Perifovea (um) | 267.6 | 1.63 | 1.78 | 0.67% | 4.9 |
| Peri Tempo (um) | 263.8 | 4.02 | 4.18 | 1.58% | 11.6 |
| Peri Superior (um) | 270.2 | 2.14 | 2.14 | 0.79% | 5.9 |
| Peri Nasal (um) | 278.5 | 2.99 | 2.99 | 1.07% | 8.3 |
| Peri Inferior (um) | 257.7 | 2.40 | 2.68 | 1.04% | 7.4 |
-
Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility Limit = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.
-
The high COV values for GCC_FLV and GCC_GLV is due to the highly skewed distribution near zero values of normal eyes and the denominator for the COV calculation has a low value. COV is not an appropriate measure of test-retest variability for such skewed distributions with a large portion of data at or near zero. Please interpret the data with this information in mind.
8
tovue
ONH Scan
Table 10. Repeatability and Reproducibility of Disc and RNFLThickness (Normal Eyes)
| ONH Scan | Normal Eyes (14 subjects, 123 scans) | ||||
|---|---|---|---|---|---|
| Mean | Repeatability | ||||
| (SD) | Reproducibility | ||||
| (SD) | Reproducibility | ||||
| COV | Reproducibility | ||||
| Limit* | |||||
| Disc Parameters | |||||
| discArea (mm²) | 1.929 | 0.084 | 0.086 | 4.42% | 0.237 |
| Area_C_D_ratio | 0.316 | 0.020 | 0.021 | 6.66% | 0.058 |
| H_C_D_ratio | 0.592 | 0.043 | 0.045 | 7.69% | 0.126 |
| V_C_D_ratio | 0.479 | 0.028 | 0.030 | 6.29% | 0.083 |
| CupArea (mm²) | 0.623 | 0.038 | 0.042 | 6.73% | 0.116 |
| RimArea (mm²) | 1.306 | 0.074 | 0.077 | 5.89% | 0.214 |
| RimVolume (mm³) | 0.157 | 0.014 | 0.015 | 9.23% | 0.040 |
| Nervehead_Volume (mm³) | 0.314 | 0.040 | 0.043 | 13.59% | 0.119 |
| CupVolume (mm³) | 0.129 | 0.021 | 0.023 | 17.91% | 0.063 |
| RNFL Parameters | |||||
| Avg_RNFL (µm) | 97.7 | 1.27 | 1.38 | 1.42% | 3.8 |
| Sup_RNFL (µm) | 99.1 | 1.47 | 1.47 | 1.48% | 4.1 |
| Inf_RNFL (µm) | 96.3 | 1.99 | 2.19 | 2.27% | 6.1 |
| Tempo (μm) | 74.3 | 3.95 | 3.95 | 5.33% | 10.9 |
| Superior (µm) | 116.2 | 3.27 | 3.38 | 2.91% | 9.4 |
| Nasal (µm) | 74.8 | 2.87 | 2.90 | 3.86% | 8.0 |
| Inferior (um) | 125.4 | 3.51 | 3.70 | 2.95% | 10.2 |
| TU (μm) | 82.2 | 5.31 | 5.36 | 6.53% | 14.8 |
| ST (μm) | 133.2 | 5.05 | 5.16 | 3.88% | 14.3 |
| SN (μm) | 99.3 | 4.83 | 4.83 | 4.87% | 13.4 |
| NU (μm) | 81.6 | 3.63 | 3.63 | 4.43% | 10.1 |
| NL (μm) | 68.0 | 2.82 | 3.07 | 4.50% | 8.5 |
| IN (μm) | 109.5 | 4.59 | 4.81 | 4.39% | 13.3 |
| IT (μm) | 141.3 | 5.22 | 5.26 | 3.72% | 14.6 |
2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.
| ONH Scan | Retina Disease Eyes (13 subjects, 101 scans) | ||||
|---|---|---|---|---|---|
| Mean | Repeatability | ||||
| (SD) | Reproducibility | ||||
| (SD) | Reproducibility | ||||
| COV | Reproducibility | ||||
| Limit* | |||||
| Disc Parameters | |||||
| discArea (mm²) | 2.226 | 0.068 | 0.068 | 3.14% | 0.189 |
| Area_C_D_ratio | 0.357 | 0.021 | 0.021 | 5.72% | 0.059 |
| H_C_D_ratio | 0.600 | 0.036 | 0.036 | 5.91% | 0.100 |
| V_C_D_ratio | 0.518 | 0.058 | 0.060 | 11.35% | 0.167 |
| CupArea (mm²) | 0.837 | 0.044 | 0.044 | 5.21% | 0.121 |
| RimArea (mm²) | 1.390 | 0.065 | 0.065 | 4.85% | 0.180 |
| RimVolume (mm³) | 0.144 | 0.013 | 0.013 | 9.30% | 0.035 |
| Nervehead_Volume (mm³) | 0.311 | 0.033 | 0.033 | 11.23% | 0.092 |
| CupVolume (mm³) | 0.139 | 0.020 | 0.020 | 14.81% | 0.057 |
| RNFL Parameters | |||||
| Avg_RNFL (μm) | 99.4 | 1.50 | 1.77 | 1.81% | 4.9 |
| Sup_RNFL (μm) | 100.1 | 2.12 | 2.55 | 2.59% | 7.1 |
| Inf_RNFL (μm) | 98.7 | 2.15 | 2.17 | 2.23% | 6.0 |
| Tempo (μm) | 74.0 | 3.27 | 3.62 | 4.95% | 10.0 |
| Superior (μm) | 116.2 | 4.35 | 4.63 | 4.05% | 12.8 |
| Nasal (μm) | 79.7 | 3.54 | 3.54 | 4.53% | 9.8 |
| Inferior (μm) | 127.6 | 3.30 | 3.32 | 2.65% | 9.2 |
| TU (μm) | 83.1 | 5.33 | 5.96 | 7.25% | 16.5 |
| ST (μm) | 126.9 | 6.51 | 7.06 | 5.68% | 19.6 |
| SN (μm) | 105.4 | 4.76 | 4.79 | 4.59% | 13.3 |
| NU (μm) | 84.7 | 4.37 | 4.37 | 5.32% | 12.1 |
| NL (μm) | 74.6 | 3.55 | 3.55 | 4.79% | 9.8 |
| IN (μm) | 126.1 | 4.88 | 4.88 | 4.01% | 13.5 |
| IT (μm) | 129.2 | 4.81 | 5.03 | 3.90% | 14.0 |
| TL (μm) | 64.9 | 3.42 | 3.42 | 5.33% | 9.5 |
Table 11. Repeatability and Reproducibility of Disc and RNFL Thickness (Retinal Disease Eyes)
9
- Reproducibility Limit is the 95% limit for the difference between measurements under the reproducibility Limit = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.
| ONH Scan | Glaucoma Eyes (13 subjects, 112 scans) | ||||
|---|---|---|---|---|---|
| Mean | Repeatability | ||||
| (SD) | Reproducibility | ||||
| (SD) | Reproducibility | ||||
| COV | Reproducibility | ||||
| Limit* | |||||
| Disc Parameters | |||||
| discArea (mm²) | 2.324 | 0.052 | 0.060 | 2.59% | 0.167 |
| Area C_D_ratio | 0.630 | 0.020 | 0.020 | 3.16% | 0.055 |
| H_C_D_ratio | 0.806 | 0.020 | 0.020 | 2.47% | 0.055 |
| V_C_D_ratio | 0.754 | 0.033 | 0.034 | 4.47% | 0.093 |
| CupArea (mm²) | 1.528 | 0.044 | 0.046 | 2.99% | 0.127 |
| RimArea (mm²) | 0.795 | 0.054 | 0.057 | 7.08% | 0.158 |
| RimVolume (mm²) | 0.053 | 0.010 | 0.010 | 18.23% | 0.027 |
| Nervehead_Volume (mm³) | 0.130 | 0.024 | 0.024 | 18.10% | 0.066 |
| CupVolume (mm³) | 0.443 | 0.043 | 0.048 | 10.79% | 0.133 |
| RNFL Parameters | |||||
| Avg_RNFL (µm) | 84.6 | 1.48 | 1.55 | 1.83% | 4.3 |
| Sup_RNFL (µm) | 89.1 | 1.95 | 1.99 | 2.24% | 5.5 |
| Inf_RNFL (µm) | 80.2 | 2.09 | 2.13 | 2.66% | 5.9 |
| Tempo (µm) | 66.4 | 2.93 | 3.15 | 4.77% | 8.7 |
| Superior (µm) | 104.5 | 3.01 | 3.13 | 2.99% | 8.7 |
| Nasal (µm) | 66.6 | 2.20 | 2.33 | 3.50% | 6.4 |
| Inferior (µm) | 101.1 | 2.54 | 2.56 | 2.52% | 7.1 |
| TU (µm) | 72.7 | 3.71 | 4.12 | 5.68% | 11.4 |
| ST (µm) | 117.4 | 4.17 | 4.52 | 3.85% | 12.5 |
| SN (µm) | 91.7 | 3.84 | 3.84 | 4.18% | 10.6 |
| NU (µm) | 74.8 | 3.55 | 3.71 | 4.98% | 10.3 |
| NL (µm) | 58.4 | 1.94 | 1.98 | 3.40% | 5.5 |
| IN (µm) | 91.9 | 3.08 | 3.08 | 3.32% | 8.5 |
| IT (µm) | 110.3 | 4.73 | 4.76 | 4.32% | 13.2 |
| TL (µm) | 60.0 | 4.70 | 4.76 | 7.97% | 13.2 |
| able 12. Repeatability and Reproducibility of Disc and RNFL Thickness (Glaucoma Eyes) | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | --------------------------------------------------------------------------------------- | -- |
- Reproducibility Limit is the SS% imit for the difference between measurements under the reproducibility Limi = 2.8 x Reproducibility SD per ISO 5725-1 and ISO 5725-6.
In addition, all 4 scan types and measurement parameters available in iVue with NDB are compared to the predicate RTVue with NDB device (K101505). Table 13 – 18 summarize the number of eyes in each study group, mean measurement for the new device and the predicate device, mean (& standard deviation) of the differences, 95% confidence interval for the mean differences, and 95% limits of agreement for each parameter and each scan type.
| iVue GCC
vs. RTVue GCC | Subjects
(n) | Mean_of
iVue | Mean_of
RTVue | mean_of
Differences | STDEV_of
Differences | 95%CI_of_mean_
of_Differences | LOA_
lower_bound | LOA_
upper_bound |
|---------------------------|-----------------|------------------|-------------------|-------------------------|--------------------------|----------------------------------|---------------------|---------------------|
| Normal Group | | | | | | | | |
| GCC_Average (µm) | 21 | 95.65 | 96.90 | -1.25 | 2.92 | (-2.577, 0.077) | -7.77 | 5.27 |
| GCC_Superior_Avg (µm) | 21 | 95.89 | 97.25 | -1.37 | 2.89 | (-2.681, -0.049) | -8.14 | 5.41 |
| GCC_Inferior_Avg (µm) | 21 | 95.41 | 96.55 | -1.13 | 3.21 | (-2.595, 0.325) | -8.10 | 5.83 |
| GCC_FLV (%) | 21 | 1.083 | 0.813 | 0.270 | 0.757 | (-0.074, 0.614) | -1.519 | 2.059 |
| GCC_GLV (%) | 21 | 3.964 | 4.146 | -0.182 | 1.857 | (-1.027, 0.662) | -4.266 | 3.901 |
| Glaucoma Group | | | | | | | | |
| GCC_Average (µm) | 24 | 79.10 | 80.44 | -1.34 | 1.50 | (-1.974, -0.709) | -5.31 | 2.62 |
| GCC_Superior_Avg (µm) | 24 | 79.75 | 80.76 | -1.01 | 2.66 | (-2.133, 0.114) | -7.35 | 5.34 |
| GCC_Inferior_Avg (µm) | 24 | 78.45 | 80.13 | -1.67 | 2.17 | (-2.591, -0.758) | -6.99 | 3.64 |
| GCC_FLV (%) | 24 | 4.641 | 4.854 | -0.213 | 1.328 | (-0.773, 0.347) | -3.445 | 3.019 |
| GCC_GLV (%) | 24 | 14.648 | 16.813 | -2.165 | 1.095 | (-2.626, -1.702) | -5.280 | 0.951 |
Table 13. iVue GCC vs. RTVue GCC in normal and glaucoma groups
10
optovué
| iVue ONH | ||||||||
|---|---|---|---|---|---|---|---|---|
| vs. RTVue ONH | Subjects | Mean_of | Mean_of | mean_of_ | STDEV_of_ | 95%CI_of_mean_ | LOA_ | LOA_ |
| (Disc Parameters) | (n) | _iVue | _RTVue | Differences | Differences | of_Differences | lower_bound | upper_bound |
| Normal Group | ||||||||
| discArea (mm²) | 21 | 1.916 | 2.090 | -0.174 | 0.180 | (-0.256, -0.092) | -0.528 | 0.179 |
| Area_C_D_ratio | 21 | 0.300 | 0.261 | 0.038 | 0.044 | (0.018, 0.0580) | -0.057 | 0.134 |
| H_C_D_ratio | 21 | 0.566 | 0.595 | -0.029 | 0.087 | (-0.068, 0.010) | -0.221 | 0.163 |
| V_C_D_ratio | 21 | 0.462 | 0.479 | -0.017 | 0.057 | (-0.042, 0.009) | -0.142 | 0.108 |
| CupArea (mm²) | 21 | 0.584 | 0.549 | 0.035 | 0.076 | (0.000, 0.069) | -0.136 | 0.205 |
| RimArea (mm²) | 21 | 1.332 | 1.541 | -0.209 | 0.187 | (-0.294, -0.124) | -0.586 | 0.167 |
| RimVolume (mm³) | 21 | 0.159 | 0.236 | -0.077 | 0.097 | (-0.121, -0.032) | -0.320 | 0.166 |
| Nervehead_Volume (mm³) | 21 | 0.334 | 0.409 | -0.075 | 0.094 | (-0.118, -0.032) | -0.320 | 0.169 |
| CupVolume (mm³) | 21 | 0.112 | 0.116 | -0.004 | 0.028 | (-0.016, 0.009) | -0.067 | 0.060 |
| Glaucoma Group | ||||||||
| discArea (mm²) | 23 | 2.035 | 1.952 | 0.083 | 0.246 | (-0.023, 0.189) | -0.399 | 0.566 |
| Area_C_D_ratio | 23 | 0.599 | 0.586 | 0.013 | 0.089 | (-0.025, 0.052) | -0.202 | 0.228 |
| H_C_D_ratio | 23 | 0.800 | 0.854 | -0.054 | 0.075 | (-0.086, -0.021) | -0.220 | 0.113 |
| V_C_D_ratio | 23 | 0.708 | 0.789 | -0.081 | 0.093 | (-0.120, -0.040) | -0.283 | 0.122 |
| CupArea (mm²) | 23 | 1.243 | 1.149 | 0.095 | 0.211 | (0.003, 0.186) | -0.375 | 0.565 |
| RimArea (mm²) | 23 | 0.792 | 0.802 | -0.011 | 0.222 | (-0.106, 0.085) | -0.503 | 0.482 |
| RimVolume (mm³) | 23 | 0.068 | 0.067 | 0.001 | 0.019 | (-0.006, 0.009) | -0.040 | 0.042 |
| Nervehead_Volume (mm³) | 23 | 0.151 | 0.128 | 0.023 | 0.038 | (0.006, 0.039) | -0.061 | 0.107 |
| CupVolume (mm³) | 23 | 0.341 | 0.328 | 0.013 | 0.095 | (-0.028, 0.054) | -0.212 | 0.237 |
Table 14. iVue ONH vs. RTVue ONH (Disc Parameters) in normal and glaucoma groups
Optovue iVue NDB 510(K)Premarket Notification
.
11
K12/739
| iVue ONH
vs. RTVue ONH
(RNFL Parameters) | Subjects
(n) | Mean_of
iVue | Mean_of
RTVue | mean_of
Differences | STDEV_of
Differences | 95%CI_of_mean_
of_Differences | LOA_
lower_bound | LOA_
upper_bound |
|------------------------------------------------|-----------------|------------------|-------------------|-------------------------|--------------------------|----------------------------------|---------------------|---------------------|
| Normal Group | | | | | | | | |
| Avg_RNFL (µm) | 21 | 100.42 | 104.85 | -4.43 | 3.15 | (-5.862, -2.991) | -11.56 | 2.70 |
| Sup_RNFL (µm) | 21 | 101.53 | 103.75 | -2.23 | 5.28 | (-4.630, 0.179) | -13.53 | 9.08 |
| Inf_RNFL (µm) | 21 | 99.31 | 105.94 | -6.63 | 4.54 | (-8.697, -4.562) | -16.73 | 3.47 |
| Tempo (µm) | 21 | 78.43 | 84.33 | -5.91 | 6.20 | (-8.728, -3.085) | -21.60 | 9.79 |
| Superior (µm) | 21 | 118.17 | 121.79 | -3.62 | 7.61 | (-7.083, -0.154) | -19.38 | 12.14 |
| Nasal (µm) | 21 | 74.99 | 78.76 | -3.77 | 6.60 | (-6.776, -0.765) | -20.26 | 12.71 |
| Inferior (µm) | 21 | 130.09 | 134.50 | -4.41 | 6.50 | (-7.369, -1.451) | -18.30 | 9.48 |
| TU (µm) | 21 | 87.96 | 86.81 | 1.15 | 9.26 | (-3.067, 5.362) | -20.61 | 22.90 |
| ST (µm) | 21 | 135.64 | 134.82 | 0.82 | 6.96 | (-2.352, 3.988) | -14.57 | 16.20 |
| SN (µm) | 21 | 100.70 | 108.76 | -8.05 | 10.89 | (-13.008, -3.096) | -30.71 | 14.60 |
| NU (µm) | 21 | 81.80 | 84.62 | -2.82 | 8.28 | (-6.583, 0.951) | -21.32 | 15.69 |
| NL (µm) | 21 | 68.18 | 72.97 | -4.80 | 6.11 | (-7.576, -2.016) | -22.89 | 13.30 |
| IN (µm) | 21 | 111.51 | 119.78 | -8.27 | 7.89 | (-11.864, -4.679) | -30.04 | 13.50 |
| IT (µm) | 21 | 148.68 | 149.21 | -0.54 | 8.71 | (-4.502, 3.430) | -21.51 | 20.44 |
| TL (µm) | 21 | 68.89 | 81.82 | -12.93 | 6.39 | (-15.837, -10.022) | -29.47 | 3.61 |
| Glaucoma Group | | | | | | | | |
| Avg_RNFL (µm) | 23 | 78.17 | 81.54 | -3.37 | 3.19 | (-4.750, -1.989) | -10.26 | 3.52 |
| Sup_RNFL (µm) | 23 | 79.49 | 81.45 | -1.96 | 3.89 | (-3.644, -0.283) | -10.63 | 6.71 |
| Inf_RNFL (µm) | 23 | 76.86 | 81.64 | -4.78 | 4.79 | (-6.847, -2.708) | -14.89 | 5.33 |
| Tempo (µm) | 23 | 59.48 | 63.83 | -4.36 | 4.82 | (-6.442, -2.275) | -16.20 | 7.48 |
| Superior (µm) | 23 | 93.17 | 96.03 | -2.86 | 6.37 | (-5.614, -0.105) | -16.47 | 10.75 |
| Nasal (µm) | 23 | 63.19 | 66.37 | -3.18 | 5.06 | (-5.369, -0.990) | -15.56 | 9.20 |
| Inferior (µm) | 23 | 96.87 | 99.96 | -3.08 | 7.63 | (-6.382, 0.214) | -18.88 | 12.71 |
| TU (µm) | 23 | 64.95 | 64.15 | 0.80 | 6.00 | (-1.796, 3.391) | -13.91 | 15.51 |
| ST (µm) | 23 | 102.82 | 99.61 | 3.21 | 7.73 | (-0.134, 6.547) | -13.74 | 20.16 |
| SN (µm) | 23 | 83.52 | 92.41 | -8.90 | 8.42 | (-12.534, -5.255) | -26.56 | 8.77 |
| NU (µm) | 23 | 66.67 | 69.61 | -2.94 | 5.05 | (-5.127, -0.757) | -15.74 | 9.86 |
| NL (µm) | 23 | 59.70 | 63.16 | -3.46 | 6.82 | (-6.409, -0.514) | -19.45 | 12.52 |
| IN (µm) | 23 | 88.54 | 96.69 | -8.14 | 9.29 | (-12.160, -4.128) | -27.44 | 11.15 |
| IT (µm) | 23 | 105.20 | 103.24 | 1.96 | 9.23 | (-2.035, 5.948) | -17.36 | 21.27 |
| TL (µm) | 23 | 54.00 | 63.49 | -9.49 | 6.48 | (-12.293, -6.689) | -24.65 | 5.67 |
Table 15. iVue ONH vs. RTVue ONH (RNFL Parameters) in normal and glaucoma groups
12
15121739
. .
| iVue Retina Map vs. | Subjects
(n) | Mean_of
iVue | Mean_of
RTVue | mean_of
Differences | STDEV_of
Differences | 95%CI_of_mean_
of_Differences | LOA_
lower_bound | LOA_
upper_bound |
|------------------------|-----------------|------------------|-------------------|-------------------------|--------------------------|----------------------------------|---------------------|---------------------|
| RTVue EMM5 | | | | | | | | |
| Normal Group | | | | | | | | |
| Fovea (µm) | 21 | 260.21 | 258.65 | 1.56 | 4.29 | (-0.395, 3.510) | -9.07 | 12.18 |
| ParaFovea (µm) | 21 | 314.79 | 319.40 | -4.61 | 6.87 | (-7.736, -1.485) | -18.68 | 9.45 |
| Para S Hemisphere (µm) | 21 | 316.34 | 322.04 | -5.70 | 7.97 | (-9.325, -2.071) | -22.09 | 10.69 |
| Para I Hemisphere (µm) | 21 | 313.25 | 316.82 | -3.57 | 6.38 | (-6.475, -0.667) | -16.87 | 9.73 |
| Para Tempo (µm) | 21 | 307.67 | 310.90 | -3.23 | 7.47 | (-6.625, 0.173) | -18.75 | 12.30 |
| Para Superior (µm) | 21 | 317.09 | 323.86 | -6.76 | 8.66 | (-10.704, -2.821) | -24.63 | 11.10 |
| Para Nasal (µm) | 21 | 322.71 | 325.90 | -3.18 | 8.01 | (-6.828, 0.463) | -20.19 | 13.82 |
| Para Inferior (µm) | 21 | 311.70 | 316.89 | -5.19 | 6.56 | (-8.177, -2.208) | -18.90 | 8.51 |
| Perifovea (µm) | 21 | 286.43 | 290.16 | -3.73 | 5.95 | (-6.441, -1.026) | -15.93 | 8.46 |
| Peri S Hemisphere (µm) | 21 | 289.58 | 291.01 | -1.43 | 6.26 | (-4.281, 1.419) | -14.45 | 11.58 |
| Peri I Hemisphere (µm) | 21 | 283.27 | 289.27 | -6.00 | 6.85 | (-9.115, -2.876) | -20.72 | 8.72 |
| Peri Tempo (µm) | 21 | 278.59 | 282.36 | -3.77 | 9.33 | (-8.012, 0.478) | -24.20 | 16.67 |
| Peri Superior (µm) | 21 | 288.50 | 287.40 | 1.11 | 6.14 | (-1.687, 3.903) | -12.38 | 14.59 |
| Peri Nasal (µm) | 21 | 301.59 | 308.02 | -6.43 | 6.15 | (-9.229, -3.629) | -19.75 | 6.89 |
| Peri Inferior (µm) | 21 | 277.02 | 282.75 | -5.73 | 7.98 | (-9.359, -2.094) | -22.92 | 11.46 |
| Retina Group | | | | | | | | |
| Fovea (µm) | 19 | 297.60 | 293.11 | 4.50 | 1.85 | (3.605, 5.386) | -4.94 | 13.93 |
| ParaFovea (µm) | 19 | 327.57 | 325.25 | 2.31 | 5.37 | (-0.276, 4.902) | -9.23 | 13.85 |
| Para S Hemisphere (µm) | 19 | 330.69 | 327.29 | 3.40 | 9.61 | (-1.233, 8.026) | -16.89 | 23.69 |
| Para I Hemisphere (µm) | 19 | 324.45 | 323.31 | 1.14 | 3.67 | (-0.628, 2.911) | -7.77 | 10.06 |
| Para Tempo (µm) | 19 | 328.04 | 324.88 | 3.16 | 7.11 | (-0.266, 6.588) | -12.07 | 18.39 |
| Para Superior (µm) | 19 | 330.69 | 327.51 | 3.18 | 13.22 | (-3.189, 9.551) | -24.66 | 31.02 |
| Para Nasal (µm) | 19 | 331.07 | 327.80 | 3.27 | 7.18 | (-0.195, 6.729) | -13.08 | 19.62 |
| Para Inferior (µm) | 19 | 320.48 | 320.95 | -0.47 | 4.62 | (-2.699, 1.755) | -11.96 | 11.02 |
| Perifovea (µm) | 19 | 291.19 | 288.67 | 2.52 | 5.05 | (0.089, 4.954) | -7.76 | 12.81 |
| Peri S Hemisphere (µm) | 19 | 294.75 | 290.30 | 4.45 | 10.48 | (-0.595, 9.504) | -16.69 | 25.60 |
| Peri I Hemisphere (µm) | 19 | 287.62 | 287.08 | 0.55 | 5.49 | (-2.101, 3.192) | -11.16 | 12.25 |
| Peri Tempo (µm) | 19 | 288.82 | 285.95 | 2.87 | 6.29 | (-0.161, 5.902) | -11.91 | 17.65 |
| Peri Superior (µm) | 19 | 292.12 | 286.32 | 5.80 | 14.20 | (-1.046, 12.638) | -22.99 | 34.58 |
| Peri Nasal (µm) | 19 | 303.39 | 301.97 | 1.42 | 8.79 | (-2.816, 5.653) | -17.15 | 19.99 |
| Peri Inferior (µm) | 19 | 280.42 | 280.37 | 0.06 | 7.52 | (-3.568, 3.678) | -15.59 | 15.70 |
Table 16. iVue Retina Map vs. RTVue EMM5 in normal and retina groups
| iVue iWellness | ||||||||
|---|---|---|---|---|---|---|---|---|
| vs. RTVue GCC | Subjects | Mean_of | Mean_of | mean_of_ | STDEV_of_ | 95%CI_of_mean_ | LOA_ | LOA_ |
| (GCC Parameters) | (n) | _iVue | _RTVue | Differences | Differences | of_Differences | lower_bound | upper_bound |
| Normal Group | ||||||||
| GCC_Average (µm) | 21 | 95.01 | 96.86 | -1.86 | 2.65 | (-3.062, -0.650) | -7.73 | 4.02 |
| GCC_Superior_Avg (µm) | 21 | 95.30 | 97.14 | -1.85 | 2.72 | (-3.085, -0.608) | -8.15 | 4.46 |
| GCC_Inferior_Avg (µm) | 21 | 94.73 | 96.59 | -1.86 | 2.83 | (-3.150, -0.573) | -8.01 | 4.29 |
| GCC_FLV (%) | 21 | 0.976 | 0.784 | 0.193 | 0.652 | (-0.104, 0.489) | -1.351 | 1.736 |
| GCC_GLV (%) | 21 | 3.871 | 4.259 | -0.389 | 1.802 | (-1.208, 0.431) | -4.118 | 3.340 |
| Glaucoma Group | ||||||||
| GCC_Average (µm) | 23 | 79.13 | 81.11 | -1.98 | 1.78 | (-2.752, -1.208) | -6.21 | 2.25 |
| GCC_Superior_Avg (µm) | 23 | 79.14 | 81.42 | -2.27 | 2.47 | (-3.340, -1.206) | -8.05 | 3.51 |
| GCC_Inferior_Avg (µm) | 23 | 79.10 | 80.79 | -1.69 | 1.72 | (-2.429, -0.944) | -6.11 | 2.73 |
| GCC_FLV (%) | 23 | 5.056 | 4.504 | 0.552 | 1.085 | (0.082, 1.020) | -2.249 | 3.352 |
| GCC_GLV (%) | 23 | 12.672 | 16.125 | -3.453 | 1.645 | (-4.164, -2.741) | -7.353 | 0.447 |
Table 17. iVue iWellness vs. RTVue GCC (GCC Parameters) in normal and glaucoma groups
13
pt@vue
| i Vue iWellness | ||||||||
|---|---|---|---|---|---|---|---|---|
| vs. RTVue EMM5 | Subjects | Mean_of | Mean_of | mean_of | STDEV_of_ | 95%CI_of_mean_ | LOA_ | LOA_ |
| (Retina Parameters) | (n) | _iVue | _RTVue | Differences | Differences | of_Differences | lower_bound | upper_bound |
| Normal Group | ||||||||
| Fovea (um) | 21 | 258.40 | 258.61 | -0.20 | 5.55 | (-2.730, 2.323) | -12.05 | 11.64 |
| ParaFovea ( $\mu$ m) | 21 | 317.10 | 317.75 | -0.65 | 7.15 | (-3.902, 2.611) | -15.20 | 13.91 |
| Para S Hemisphere ( $\mu$ m) | 21 | 318.63 | 319.73 | -1.10 | 8.64 | (-5.032, 2.837) | -18.60 | 16.41 |
| Para I Hemisphere ( $\mu$ m) | 21 | 315.57 | 315.64 | -0.08 | 6.40 | (-2.988, 2.838) | -13.30 | 13.15 |
| Para Tempo ( $\mu$ m) | 21 | 307.71 | 310.16 | -2.45 | 8.43 | (-6.290, 1.387) | -19.70 | 14.79 |
| Para Superior ( $\mu$ m) | 21 | 322.94 | 321.44 | 1.50 | 8.64 | (-2.433, 5.432) | -16.16 | 19.16 |
| Para Nasal ( $\mu$ m) | 21 | 320.39 | 323.54 | -3.15 | 8.15 | (-6.857, 0.563) | -20.23 | 13.94 |
| Para Inferior ( $\mu$ m) | 21 | 317.36 | 315.58 | 1.78 | 7.16 | (-1.482, 5.039) | -12.95 | 16.50 |
| Perifovea ( $\mu$ m) | 21 | 287.25 | 288.26 | -1.02 | 6.08 | (-3.783, 1.749) | -13.32 | 11.28 |
| Peri S Hemisphere ( $\mu$ m) | 21 | 290.94 | 289.63 | 1.31 | 7.14 | (-1.941, 4.555) | -13.26 | 15.87 |
| Peri I Hemisphere ( $\mu$ m) | 21 | 283.55 | 286.92 | -3.37 | 6.53 | (-6.342, -0.401) | -17.02 | 10.27 |
| Peri Tempo ( $\mu$ m) | 21 | 278.40 | 279.97 | -1.57 | 8.95 | (-5.646, 2.506) | -20.47 | 17.33 |
| Peri Superior (um) | 21 | 290.76 | 286.32 | 4.44 | 7.79 | (0.896, 7.989) | -11.65 | 20.53 |
| Peri Nasal (um) | 21 | 302.44 | 306.66 | -4.22 | 7.97 | (-7.850, -0.593) | -20.64 | 12.20 |
| Peri Inferior ( $\mu$ m) | 21 | 277.38 | 280.06 | -2.68 | 7.61 | (-6.144, 0.787) | -18.80 | 13.45 |
| Retina Group | ||||||||
| Fovea (um) | 16 | 278.96 | 276.71 | 2.24 | 3.71 | (0.269, 4.218) | -6.09 | 10.57 |
| ParaFovea ( $\mu$ m) | 16 | 318.55 | 315.23 | 3.32 | 4.94 | (0.684, 5.953) | -6.77 | 13.41 |
| Para S Hemisphere ( $\mu$ m) | 16 | 320.32 | 317.10 | 3.22 | 6.65 | (-0.325, 6.757) | -10.42 | 16.85 |
| Para I Hemisphere ( $\mu$ m) | 16 | 316.78 | 313.46 | 3.32 | 5.40 | (0.442, 6.193) | -7.83 | 14.47 |
| Para Tempo ( $\mu$ m) | 16 | 311.60 | 308.58 | 3.02 | 7.33 | (-0.885, 6.922) | -12.85 | 18.88 |
| Para Superior ( $\mu$ m) | 16 | 323.57 | 319.10 | 4.47 | 8.32 | (0.037, 8.901) | -12.51 | 21.45 |
| Para Nasal ( $\mu$ m) | 16 | 322.46 | 321.10 | 1.36 | 5.41 | (-1.523, 4.242) | -10.37 | 13.08 |
| Para Inferior ( $\mu$ m) | 16 | 316.55 | 312.29 | 4.26 | 6.37 | (0.869, 7.655) | -9.11 | 17.64 |
| Perifovea ( $\mu$ m) | 16 | 285.46 | 283.14 | 2.33 | 5.60 | (-0.658, 5.313) | -8.99 | 13.65 |
| Peri S Hemisphere ( $\mu$ m) | 16 | 289.42 | 285.44 | 3.99 | 10.05 | (-1.367, 9.338) | -16.35 | 24.32 |
| Peri I Hemisphere ( $\mu$ m) | 16 | 281.50 | 280.84 | 0.66 | 3.97 | (-1.458, 2.775) | -7.95 | 9.27 |
| Peri Tempo ( $\mu$ m) | 16 | 275.39 | 271.74 | 3.65 | 4.65 | (1.171, 6.128) | -8.39 | 15.69 |
| Peri Superior ( $\mu$ m) | 16 | 288.93 | 283.61 | 5.31 | 12.99 | (-1.607, 12.231) | -20.95 | 31.57 |
| Peri Nasal ( $\mu$ m) | 16 | 301.53 | 301.41 | 0.12 | 7.71 | (-3.990, 4.228) | -16.20 | 16.44 |
| Peri Inferior ( $\mu$ m) | 16 | 276.01 | 275.66 | 0.35 | 5.87 | (-2.776, 3.484) | -12.11 | 12.82 |
Table 18. iVue iWellness vs. RTVue EMM5 (Retina Parameters) in normal and retina groups
In general, the repeatability and reproducibility of the iVue measurements were reasonably similar to those of the predicate device. The iVue normative database measurements are similar to the predicate device in normative values, and have similar behavior with respect to the effects of patient age, signal strength, and optic disc size. In conclusion, based on the studies and tests performed, the iVue with normative database is substantially equivalent to the predicate devices, RTVue with NDB (K101505).
Conclusion
As described in this 510(k) Summary, all necessary testing and analyses were completed on the iVue with Normative Database to ensure that the device is substantially equivalent to the identified predicate devices.
14
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/14/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract representation of a human figure or symbol.
January 18, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Optovue, Inc. % Mr. Jay Wei President & CEO 45531 Northport Loop W Fremont, CA 94538
Re: K121739
Trade/Device Name: iVue with Normative Database Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope · Regulatory Class: Class II Product Code: HLI Dated: January 7, 2013 Received: January 9, 2013
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. 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
15
Page 2 - Mr. Jay Wei
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.
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 note the 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,
Kesia Y. Alexander
for Malvina B. Eydelman, M.D. Director Division of Opthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
16
Image /page/16/Picture/0 description: The image shows the word "optovue" in a stylized font. A curved line is drawn above the word. The "o" in "optovue" is replaced with a symbol resembling an eye.
Statement of Indications for Use
510(k) Number (if known): K121739
Device Name: iVue with Normative Database
Indications for Use:
The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
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)
CLCY
(Division Sign-Off)
(Division Sign-C Division of Ophthalmic Optovue iVue with Normative Database 510(r િત ૧૧માસની છે. ૧૯૪૮ 510(k) Number