(345 days)
The iVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, optic disk, cornea, and anterior chamber of the eye as an aid in the diagnosis and management of ocular diseases.
iVue is a modification of its predicate device RTVue (K062552). The intent of use, system performance, majority sub-assemblies, and key components of the iVue are all the same as RTVue. The intention of this redesign is to make the size of the iVue more compact and more affordable.
iVue also has a cornea lens adapter, like the predicate device CA (K071250), which can be attached to the front of the instrument to enable the iVue to image the cornea and anterior chamber of the eye.
i Vue, based on the same Optical Coherence Tomography (OCT) technology that is using in the predicate device RTVue (K062552) and CA (K071250), is a non-invasive diagnostic device for viewing the ocular tissue structure with micrometer range resolution. Both iVue and RTVue are designed and manufactured by Optovue Inc. A brochure of the RTVue and CA system is in appendices [1].
Like RTVue, iVue is a computer controlled ophthalmic imaging system. RTVue uses a desktop computer while i Vue uses a laptop computer. The device scans a patient's eye and uses 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 patient will rest their head on the forehead and chin rest while the operator uses joystick to align the device to patient's eye. The computer has a graphic user interface for acquiring and analyzing the image.
i Vue also has similar scan patterns and analysis functions as used in RTVue.
The provided text describes a 510(k) summary for the Optovue iVue, an Optical Coherence Tomography (OCT) system. The document focuses on demonstrating substantial equivalence to predicate devices (RTVue and CA) rather than establishing new performance criteria for a novel device. Therefore, instead of "acceptance criteria," the document presents "precision results" and "agreement results" to show that the iVue performs comparably to its predicates.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined "acceptance criteria" with numerical thresholds against which the iVue was measured. Instead, it presents precision results (repeatability and reproducibility standard deviations) and agreement results (mean differences and standard deviations of differences compared to the predicate RTVue). The implicit acceptance criteria are that these precision and agreement metrics demonstrate substantial equivalence to the predicate device.
Since there are no explicit acceptance values, I will present the reported device performance for several key measurements from the Glaucoma, Retina, and Cornea scans. Each section below represents a comparison between the iVue and the predicate RTVue.
Glaucoma Scan Performance (Avg RNFL thickness, Normal Patients)
| Metric | iVue Reported Performance (Mean Differences, Min-Max, SD) |
|---|---|
| Mean Difference (iVue vs RTVue) | -0.55 (-0.61, -0.49) |
| Estimated STDEV (iVue vs RTVue) | 2.25 (2.12, 2.38) |
Retina Scan Performance (Full Retina Fovea thickness, Normal Patients)
| Metric | iVue Reported Performance (Mean Differences, Min-Max, SD) |
|---|---|
| Mean Difference (iVue vs RTVue) | 2.64 (1.91, 3.37) |
| Estimated STDEV (iVue vs RTVue) | 3.79 (3.39, 4.20) |
Cornea Scan Performance (Central Cornea 0-2mm thickness, Normal Patients)
| Metric | iVue Reported Performance (Mean Differences, Min-Max, SD) |
|---|---|
| Mean Difference (iVue vs RTVue) | -0.44 (-0.64, -0.23) |
| Estimated STDEV (iVue vs RTVue) | 5.25 (4.86, 5.63) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: A total of 48 subjects were included in the study. This comprised:
- 4 normal subjects for each of the 3 pairs of iVue/RTVue devices (12 total normal subjects across all pairs and operators).
- 4 cornea patients for each of the 3 pairs.
- 4 retina patients for each of the 3 pairs.
- 4 glaucoma patients for each of the 3 pairs.
- The document also states varying "number of scans" for different measurements after quality review: e.g., 72 scans for normal patients in Glaucoma scans, 70 for normal patients in Cornea scans. This indicates that while 48 subjects were enrolled, the actual number of analyzed scans varied due to quality control.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the study was conducted at two clinical sites. No specific country is mentioned.
- Retrospective or Prospective: The study was prospective. Subjects were enrolled and scanned for the purpose of this comparison study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: The ground truth for subject classification (normal, glaucoma, retina, cornea patients) was established by the Principal Investigator (PI) at each clinical site. The number of PIs is not explicitly stated, but since there were two clinical sites, there would be at least two PIs involved.
- Qualifications of Experts: The PIs diagnosed the patients' conditions (e.g., "glaucoma patients were diagnosed as having glaucoma by the PI at each site"). The specific qualifications (e.g., years of experience, subspecialty) of these PIs are not provided.
4. Adjudication method for the test set
- Adjudication Method: The document does not describe an explicit adjudication method for the test set in terms of multiple expert reviews and reconciliation. Subject inclusion criteria were reviewed by comparing the study protocol with the Case Report Forms (CRF) at the subject level. At the individual scan level, data was reviewed for quality (overall signal strength, localized weak signals, eye blink, data out of boundary, data off-center) and scans with poor image quality were excluded. This is more of a quality control process for the images than an adjudication of diagnostic outcomes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study as described: This document describes a comparison between two medical devices (iVue and RTVue, both OCT systems) for their measurement precision and agreement. It is not an AI diagnostic device or a study evaluating human readers with or without AI assistance. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focused on human reader improvement with AI assistance was not performed, and no effect size for such a scenario is provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not an AI algorithm. The "device" (iVue) itself is an Optical Coherence Tomography system, which is an imaging device that produces measurements. The study evaluates the precision and agreement of these measurements between the new device (iVue) and a predicate device (RTVue). Therefore, the concept of "standalone performance" of an algorithm without human-in-the-loop is not applicable in this context. The reported performance is the standalone performance of the device's measurement capabilities.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for classifying subjects into different patient groups (normal, glaucoma, retina, cornea) was based on clinical diagnosis by a Principal Investigator (PI) at each clinical site. The measurements generated by the OCT devices (RNFL thickness, retinal thickness, cornea thickness) were compared against each other, with the predicate device (RTVue) essentially serving as the reference for agreement. It's a comparison for substantial equivalence, not against a gold standard like pathology in all cases.
8. The sample size for the training set
- Not Applicable: This study is on a medical imaging device (OCT scanner), not an AI algorithm that requires a training set. The iVue is a modification of an existing device (RTVue), and the study aim is to demonstrate its measurement precision and agreement with the predicate. Therefore, there is no training set in the context of an AI/machine learning model.
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set for an AI algorithm, this question is not relevant to the described study.
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Image /page/0/Picture/1 description: The image shows the word "optovue" in a simple, sans-serif font. The "o" in "optovue" is stylized to resemble an eye. A curved line is drawn above the word, arching over the letters.
510(k) Summary
APR 2 2 2010
Optovue, Incorporated iVue
This 510(k) summary for the iVue is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
General Information
| Manufacturer: | Optovue, Inc.45531 Northport Loop West,Fremont, CA 94538Phone: (510) 623-8868Fax: (510) 623-8668Registration No.: 3005950902 |
|---|---|
| Contact Person: | Azimun JamalRegulatory ManagerOptovue, Inc.Phone: (510)623-8868 x188e-mail: azimun_jamal@optovue.com |
Device Information
| Classification: | Class II |
|---|---|
| Trade Name: | iVue |
| Common Name: | Optical Coherence Tomography (OCT) |
| Classification Name: | Ophthalmoscope, a-c powered (21 CFR§ 886.1570) |
Predicate Devices
(1) RTVue (K062552) (2) CA (K071250)
Intended Use
The iVue is an optical coherence tomography system indicated for the in vivo imaging and The I vac is an optical vehicles temself of the rayer, optic disc, cornea, and anterior chamber of the eye as an aid in the diagnosis and management of ocular diseases.
Optovue, Inc.
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Device Description
iVue is a modification of its predicate device RTVue (K062552). The intent of use, system performance, majority sub-assemblies, and key components of the iVue are all the same as RTVue. The intention of this redesign is to make the size of the iVue more compact and more affordable.
iVue also has a cornea lens adapter, like the predicate device CA (K071250), which can be attached to the front of the instrument to enable the iVue to image the cornea and anterior chamber of the eye.
i Vue, based on the same Optical Coherence Tomography (OCT) technology that is using in the predicate device RTVue (K062552) and CA (K071250), is a non-invasive diagnostic device for viewing the ocular tissue structure with micrometer range resolution. Both iVue and RTVue are designed and manufactured by Optovue Inc. A brochure of the RTVue and CA system is in appendices [1].
Like RTVue, iVue is a computer controlled ophthalmic imaging system. RTVue uses a desktop computer while i Vue uses a laptop computer. The device scans a patient's eye and uses 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 patient will rest their head on the forehead and chin rest while the operator uses joystick to align the device to patient's eye. The computer has a graphic user interface for acquiring and analyzing the image.
i Vue also has similar scan patterns and analysis functions as used in RTVue.
Safety
The power of the scanning beam entering into patient's pupil is at same level as predicate devices. There is no change in the safety from previously submitted devices, the RTVue (K062552) and CA (K071250). A copy of the previous safety analysis for RTVue is attached in the Appendix [2]. The analysis was completed by an international recognized expert in the field of optical radiation hazards and safety, Dr. Dave Sliney.
Effectiveness
The predicate device has been routinely used in clinic. Numerous clinical papers and data have been published over last 2 years. Since there is no performance change, the effectiveness in clinical use is the same as predicate devices. A clinical comparison report and the IRB approved test protocol are attached in the premarket notification.
Substantial Equivalence
The iVue is substantially equivalent to the predicate devices identified previously. The iVue is substantially equivalent to the predicate devices with regard to intended use, operating principle, function, material, and energy source. The only difference from the predicate device is that the iVue is more compact in size.
Performance Data
(a) Non-clinic tests:
Optovue, Inc.
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The iVue has had accuracy tests, optical emission safety analysis, electrical safety, electromagnetic compatibility test, and software validation tests.
(b) Clinical tests:
Description of Precision Study, Subject Selection Criteria and Pathologies
Instruments:
Two types of Fourier Domain OCT devices were used in the study. The iVue device is a new OCT device and is compared to the predicate device, the RTVue. For the study, three iVues were paired with three RTVues with three different operators and results were compared in normal eyes, and eyes with retina pathology, cornea pathology, and glaucoma.
Scans:
The iVue device has three scan patterns optimized to evaluate three ocular pathologies, namely, i) Cornea scan, ii) Retina scan, and iii) Glaucoma scan. These scan patterns were compared to three equivalent RTVue scans, i) Pachymetry scan, ii) EMM5 scan, and iii) ONH scan, respectively. The measurements and parameters calculated from these respective scans were the same. Both eyes were scanned in each subject.
Subjects:
Four types of subjects were enrolled in the study at two clinical sites, namely 1) normal healthy eyes with no ocular pathology, 2) glaucoma patients, 3) retina patients, and 4) cornea patients. Normal subjects were free from ocular pathology as determined by the Principal Investigator (PI) at each clinical site. Glaucoma patients were diagnosed as having glaucoma by the PI at each site. Retina patients included subjects with any type of retina pathology diagnosed by the PI. Retina pathologies included but were not limited to, AMD, DME, and ERM. Cornea patients included subjects with any type of cornea pathology as diagnosed by the PI, or cornea alteration including LASIK. There were 4 normal subjects, 4 cornea patients, 4 retina patients, and 4 glaucoma patients enrolled for each pair of iVue and RTVue devices. There were 3 pairs of iVue and RTVue devices at 2 clinical sites. At one site, there were 2 iVues systems, 2 RTVues systems and 2 operators at different times. In total, there were 16 subjects enrolled for each of the 3 pairs of iVue and RTVue devices; a total of 48 subjects were included in the study.
Selection Criteria:
All data was carefully reviewed for completeness and quality in two levels, namely, the subject level and the individual scan level. At the subject level, the CRF was carefully reviewed to qualify each subject against all inclusion and exclusion criteria by comparing the study protocol with the CRF. At the individual scan level, the data was reviewed for quality to ensure data meeting inclusion criteria was accepted.
In a clinical environment, only scans with acceptable quality should be used. In order to match our analysis with acceptable clinical results, we reviewed and excluded all scans in the study with poor image quality. Image quality is based on a number of factors, including overall signal strength, localized weak signals, eye blink, data out of boundary, and data off-center. Due to the selection criteria, the sample size for each scan type varies.
Precision Results
Optovue, Inc.
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The following tables provide the precision results for the iVue scans. The data in the table includes the number of scans per subject group, the overall mean, the standard deviation, the repeatability standard deviation (Median value of subfields with the minimum subfield value and the maximum subfield value), and reproducibility standard deviation (Median value of subfields with the minimum subfield value and the maximum subfield value).
Glaucoma Scan Results (Normals and Glaucoma Patients) i)
The following table shows the overall precision results with the Glaucoma scan for average RNFL thickness for normals and glaucoma patients.
| Avg RNFL | Normal Patients | Glaucoma Patients |
|---|---|---|
| # of Scans | 72 | 65 |
| Overall Mean (Overall SD) | 100.26 (8.32) | 85.94 (14.40) |
| Repeatability SD* (Min, Max) | 1.30 (1.30, 1.30) | 1.09 (1.09, 1.09) |
| Reproducibility SD** (Min, Max) | 1.30 (1.30, 1.30) | 7.03 (7.03, 7.03) |
*estimate of the standard deviation among measurements taken on the same subject using the same operator and device in the same testing session with repositioning.
** estimate of the standard deviation among measurements taken on different subjects using different operators and devices, including repeatability; in some cases the maximum reproducibility estimates were impacted by mean thickness difference between subjects in different sites.
The following table shows the overall precision results with the Glaucoma scan for the average of 16 sectors for normals and glaucoma patients.
| 16 RNFL Sectors | Normal Patients | Glaucoma Patients |
|---|---|---|
| # of Scans | 72 | 65 |
| Overall Mean (Overall SD) | 100.26 (16.33) | 85.94 (18.68) |
| Repeatability SD* (Min, Max) | 3.74 (3.74, 5.82) | 3.58 (3.58, 6.13) |
| Reproducibility SD** (Min, Max) | 5.29 (4.27, 14.04) | 7.56 (3.58, 17.32) |
*estimate of the standard deviation among measurements taken on the same subject using the same operator and device in the same testing session with repositioning
** estimate of the standard deviation among measurements taken on different subjects using different operators and devices, including repeatability; in some cases the maximum reproducibility estimates were impacted by mean thickness difference between subjects in different sites.
ii) Retina Scan Results (Normals, Retina Patients and Glaucoma Patients)
The following table shows the overall precision results with the Retina scan for full retinal thickness in the fovea for normals, retina patients, and glaucoma patients (since inner retinal layer is affected by the disease of glaucoma, the precision results of retina scan on glaucoma patients are produced below).
| Full Retina Fovea | Normal Patients | Retina Patients | GlaucomaPatients |
|---|---|---|---|
| # of Scans | 72 | 71 | 67 |
| Overall Mean (Overall SD) | 247.00 (26.03) | 269.28 (70.95) | 247.93 (21.20) |
| Repeatability SD* (Min, Max) | 2.54 (2.54, 2.54) | 4.41 (4.41, 4.41) | 3.33 (3.33, 3.33) |
| Reproducibility SD** (Min, Max) | 17.41 (17.41, 17.41) | 13.73 (13.73, 13.73) | 3.33 (3.33, 3.33) |
Optovue, Inc.
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*estimate of the standard deviation among measurements taken on the same operator and device in the same testing session with repositioning
** estimate of the standard deviation among measurements taken on different subjects using different operators and devices, including repeatability; in some cases the reproducibility estimates were impacted by mean thickness difference between subjects in different sites.
The following table shows the overall precision results with the Retina scan for full retinal thickness in the periphery (average over 8 sectors outside the fovea) for normals, retina patients, and glaucoma patients.
| Full Retina Peripheral | Normal Patients | Retina Patients | GlaucomaPatients |
|---|---|---|---|
| # of Scans | 72 | 71 | 67 |
| Overall Mean (Overall SD) | 295.03 (16.95) | 298.35 (30.99) | 281.55 (24.90) |
| Repeatability SD* (Min, Max) | 1.89 (1.89, 3.04) | 2.60 (2.60, 4.11) | 2.24 (2.24, 3.33) |
| Reproducibility SD** (Min, Max) | 2.65 (1.89, 10.10) | 3.18 (2.60, 4.11) | 2.99 (2.24, 8.95) |
*estimate of the standard deviation among measurements taken on the same subject using the same operator and device in the same testing session with repositioning
** estimate of the standard deviation among measurements taken on different subjects using different operators and devices, including repeatability; in some cases the maximum reproducibility estimates were impacted by mean thickness difference between subjects in different sites.
The following table shows the overall precision results with the Retina scan for inner retinal thickness in the fovea for normals, retina patients, and glaucoma patients.
| Inner Retina Fovea | Normal Patients | Retina Patients | GlaucomaPatients |
|---|---|---|---|
| # of Scans | 72 | 71 | 67 |
| Overall Mean (Overall SD) | 72.91 (14.36) | 77.88 (20.64) | 72.35 (10.28) |
| Repeatability SD* (Min, Max) | 2.94 (2.94, 2.94) | 3.14 (3.14, 3.14) | 1.99 (1.99, 1.99) |
| Reproducibility SD** (Min, Max) | 8.96 (8.96, 8.96) | 3.14 (3.14, 3.14) | 1.99 (1.99, 1.99) |
*estimate of the standard deviation among measurements taken on the same subject using the same operator and device in the same testing session with repositioning
** estimate of the standard deviation among measurements taken on different subjects using different operators and devices, including repeatability; in some cases the reproducibility estimates were impacted by mean thickness difference between subjects in different sites.
The following table shows the overall precision results with the Retina scan for inner retinal thickness in the periphery (average over 8 sectors outside the fovea) for normals, retina patients, and glaucoma patients.
| Inner Retina Peripheral | Normal Patients | Retina Patients | GlaucomaPatients |
|---|---|---|---|
| # of Scans | 72 | 71 | 67 |
| Overall Mean (Overall SD) | 118.01 (9.37) | 117.37 (13.83) | 106.73 (12.05) |
| Repeatability SD* (Min, Max) | 1.45 (1.45, 2.82) | 1.91 (1.91, 3.41) | 1.88 (1.88, 2.83) |
| Reproducibility SD** (Min, Max) | 3.19 (2.22, 5.32) | 3.26 (1.91, 5.20) | 2.37 (1.88, 2.83) |
*estimate of the standard deviation among measurements taken on the same operator and device in the same testing session with repositioning
**estimate of the standard deviation among measurements taken on different subjects using different operators and devices, including repeatability; in some cases the maximum reproducibility estimates were impacted by mean thickness difference between subjects in different sites.
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- iii) Cornea Scan Results (Normals and Cornea Patients)
The following table shows the overall precision results with the Cornea scan for central 0-2 mm cornea thickness for normals and cornea patients.
| Central Cornea 0-2 mm | Normal Patients | Cornea Patients |
|---|---|---|
| # of Scans | 70 | 72 |
| Overall Mean (Overall SD) | 549.83 (20.85) | 531.80 (48.20) |
| Repeatability SD* (Min, Max) | 1.71 (1.71, 1.71) | 3.58 (3.58, 3.58) |
| Reproducibility SD** (Min, Max) | 1.71 (1.71, 1.71) | 14.52 (14.52, 14.52) |
*estimate of the standard deviation among measurements taken on the same subject using the same operator and device in the same testing session with repositioning
**estimate of the standard deviation among measurements taken on different subjects using different operators and devices, including repeatability; in some cases the maximum reproducibility estimates were impacted by mean thickness difference between subjects in different sites.
The following table shows the overall precision results with the Cornea scan for 2-5 mm cornea thickness measurements for normals and cornea patients.
| Cornea 2-5 mm | Normal Patients | Cornea Patients |
|---|---|---|
| # of Scans | 70 | 72 |
| Overall Mean (Overall SD) | 569.23 (22.10) | 559.10 (49.50) |
| Repeatability SD* (Min, Max) | 2.42 (2.42, 5.44) | 5.27 (5.27, 7.79) |
| Reproducibility SD** (Min, Max) | 4.04 (2.42, 5.44) | 21.38 (14.29, 29.19) |
*estimate of the standard deviation among measurements taken on the same subject using the same operator and device in the same testing session with repositioning
** estimate of the standard deviation among measurements taken on different subjects using different operators and devices, including repeatability; in some cases the maximum reproducibility estimates were impacted by mean thickness difference between subjects in different sites.
The following table shows the overall precision results with the Cornea scan for 5-6 mm cornea thickness measurements for normals and cornea patients.
| Cornea 5-6 mm | Normal Patients | Cornea Patients |
|---|---|---|
| # of Scans | 70 | 72 |
| Overall Mean (Overall SD) | 590.93 (24.55) | 589.81 (49.69) |
| Repeatability SD* (Min, Max) | 3.63 (3.63, 7.55) | 6.50 (6.50, 11.72) |
| Reproducibility SD ** (Min, Max) | 5.77 (3.63, 7.55) | 24.31 (13.97, 38.47) |
*estimate of the standard deviation among measurements taken on the same subject using the same operator and device in the same testing session with repositioning
** estimate of the standard deviation among measurements taken on different subjects using different operators and devices, including repeatability; in some cases the maximum reproducibility estimates were impacted by mean thickness difference between subjects in different sites.
Agreement Results
The following tables provide the overall agreement results for the iVue scans compared to the RTVue scans. The data in the table includes the overall mean differences averaged across all measurements for that scan pattern (with the minimum and maximum differences provided in parentheses) and the
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standard deviation of the differences (with the minimum standard deviations provided in parentheses).
i) Glaucoma LOA Results
The following table shows the overall agreement results for average RNFL thickness measurement in the iVue Glaucoma scan and the RTVue ONH scan for normals and glaucoma patients.
| Avg RNFL | Normal Patients | Glaucoma Patients |
|---|---|---|
| Mean Differences (Min, Max) | -0.55 (-0.61, -0.49) | -0.52 (-0.87, -0.18) |
| Estimated STDEV (Min, Max) | 2.25 (2.12, 2.38) | 1.74 (1.71, 1.76) |
The following table shows the overall agreement results for the 16 sector RNFL thickness measurement in the iVue Glaucoma scan and the RTVue ONH scan for normals and glaucoma patients.
| 16 RNFL Sector Averages | Normal Patients | Glaucoma Patients |
|---|---|---|
| Mean Differences (Min, Max) | -0.55 (-8.00, 4.49) | -0.53 (-7.19, 4.25) |
| Estimated STDEV (Min, Max) | 8.16 (6.26, 11.01) | 7.61 (5.01, 10.39) |
ii) Retina LOA Results
The following table shows the overall agreement results for full retina fovea thickness measurement in the iVue Retina scan and the RTVue EMM5 scan for normals, glaucoma patients, and retina patients
| Full Retina Fovea | Normal Patients | Glaucoma Patients | Retina Patients |
|---|---|---|---|
| Mean Differences (Min, Max) | 2.64 (1.91, 3.37) | 1.99 (1.64, 2.35) | 2.14 (1.13, 3.14) |
| Estimated STDEV (Min, Max) | 3.79 (3.39, 4.20) | 4.88 (4.60, 5.16) | 6.00 (5.36, 6.64) |
The following table shows the overall agreement results for full retina peripheral thickness measurements in the iVue Retina scan and the RTVue EMM5 scan for normals, glaucoma patients, and retina patients.
| Full Retina Periphery | Normal Patients | Glaucoma Patients | Retina Patients |
|---|---|---|---|
| Mean Differences (Min, Max) | -0.27 (-3.48, 3.21) | -1.00 (-4.18, 2.40) | -0.41 (-2.83, 2.30) |
| Estimated STDEV (Min, Max) | 3.48 (2.28, 4.92) | 4.56 (3.66, 5.34) | 4.54 (3.70, 5.51) |
The following table shows the overall agreement results for inner retina fovea thickness measurement in the iVue Retina scan and the RTVue EMM5 scan for normals, glaucoma patients, and retina patients.
| Inner Retina Fovea | Normal Patients | Glaucoma Patients | Retina Patients |
|---|---|---|---|
| Mean Differences (Min, Max) | 2.64 (1.91, 3.37) | 1.70 (1.58, 1.82) | 2.39 (1.92, 2.86) |
| Estimated STDEV (Min, Max) | 3.79 (3.39, 4.20) | 4.15 (3.51, 4.79) | 4.73 (4.61, 4.86) |
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The following table shows the overall agreement results for inner retina peripheral thickness measurements in the iVue Retina scan and the RTVue EMM5 scan for normals, glaucoma patients, and retina patients.
| Inner Retina Periphery | Normal Patients | Glaucoma Patients | Retina Patients |
|---|---|---|---|
| Mean Differences (Min, Max) | -0.27 (-3.48, 3.21) | -0.50 (-3.22, 2.17) | -0.26 (-2.10, 2.18) |
| Estimated STDEV (Min, Max) | 3.48 (2.28, 4.92) | 4.05 (2.70, 5.94) | 4.28 (2.93, 5.91) |
iii) Cornea LOA Results
The following table shows the overall agreement results for the central 0-2mm cornea thickness measurement in the iVue Cornea scan and the RTVue Pachymetry scan for normals and cornea patients.
| 0-2 mm Central Cornea | Normal Patients | Cornea Patients |
|---|---|---|
| Mean Differences (Min, Max) | -0.44 (-0.64, -0.23) | -1.04 (-1.41, -0.67) |
| Estimated STDEV (Min, Max) | 5.25 (4.86, 5.63) | 5.70 (5.63, 5.78) |
The following table shows the overall agreement results for the central 2-5 mm cornea thickness measurement in the iVue Cornea scan and the RTVue Pachymetry scan for normals and cornea patients.
| 2-5 mm Cornea | Normal Patients | Cornea Patients |
|---|---|---|
| Mean Differences (Min, Max) | 1.27 (-0.74, 2.85) | 0.07 (-4.01, 3.72) |
| Estimated STDEV (Min, Max) | 7.93 (4.14, 11.71) | 12.35 (7.81, 16.64) |
The following table shows the overall agreement results for the central 5-6 mm cornea thickness measurement in the iVue Cornea scan and the RTVue Pachymetry scan for normals and cornea patients.
| 5-6mm Cornea | Normal Patients | Cornea Patients |
|---|---|---|
| Mean Differences (Min, Max) | 2.71 (-1.14, 5.05) | 1.79 (-3.15, 8.29) |
| Estimated STDEV (Min, Max) | 10.27 (5.39, 13.32) | 15.28 (8.99, 21.84) |
The evidence from the clinical performance data study demonstrates that the iVue is substantially equivalent to the predicate device, the RTVue.
Conclusion
As described in this 510(k) Summary, comprehensive testing and analysis was conducted on the iVue 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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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Optovue, Inc c/o Ms. Azimun Jamal Manager of Quality/Regulatory 45531 Northport Loop W. Fremont, CA. 94538
APR 2 2 2010
Re: K091404
Trade/Device Name: iVue Model iVue100 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLI Dated: April 19, 2010 Received: April 20, 2010
Dear Ms. Jamal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's fequirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Ms. Azimun Jamal
Enclosure
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ehturn for
Malvina B. Eydelman, M.D. Director
Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Statement of Indications for Use
510(k) Number (if known): K091404
Device Name: iVue
Indications for Use:
The iVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, optic disk, cornea, and anterior chamber of the eye as an aid in the diagnosis and management of ocular diseases.
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)
teon.
(Division Sign-೧೧) Division of Ophthalmic Newrological and Ear, Nose and Throat De vices
510(k) Number K091404
§ 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.