RTVUE MODEL RTVUE 100
Device Facts
| Record ID | K101505 |
|---|---|
| Device Name | RTVUE MODEL RTVUE 100 |
| Applicant | Optovue, Inc. |
| Product Code | HLI · Ophthalmic |
| Decision Date | Sep 15, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1570 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K101505 · Sep 15, 2010 | RTVUE MODEL RTVUE 100 | Optovue, Inc. | Multi-site clinical normative database (480 individuals/640+ eyes) | The normative database provides a statistical reference of retinal and optic disc measurements from known normal subjects to aid in the diagnosis and management of ocular diseases. | Normative Database; Clinical Reference; Diagnostic Aid |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Normative Database Collection; Multi-site clinical data collection | 480 healthy individuals (640+ eyes) aged 18-84, diverse ethnic backgrounds; Sample Size: 480 individuals; Number of Sites: 11 | Not applicable for this study | Retinal nerve fiber layer, optic disc, and retinal thickness measurements |
Indications for Use
The RTVue with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disk as an aid in the diagnosis and management of retinal disease. The RTVue with Normative Database is also a quantitative tool for the comparison of retina, retinal nerve fiber layer, and optic disk measurements in the human eye to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases.
Device Story
RTVue is a computer-controlled optical coherence tomography (OCT) system for posterior segment eye imaging. It captures cross-sectional images of retinal layers (ILM, RNFL, GCC, RPE, outer/total retinal thickness) and optic disc structures. The system uses optical coherence tomography to generate measurements; these are compared against an integrated normative database (NDB) of 480 healthy individuals (ages 18-84). Used in clinical settings by eye care professionals to assess retinal pathologies (e.g., AMD, DME, ERM) and glaucoma. Output includes statistical comparisons of GCC, RNFL, full retinal thickness, and optic disc parameters (cup/rim) against normal ranges. This aids clinicians in detecting and managing ocular diseases by providing quantitative reference data. The device utilizes blood vessel matching for image registration to ensure scan consistency.
Clinical Evidence
Clinical study evaluated precision and reproducibility of RTVue with Normative Database using 36 subjects (12 normal, 12 glaucoma, 12 retina pathology) across 2 sites. Scans included EMM5 (retina), ONH (optic disc/RNFL), and GCC. Primary endpoints were repeatability and reproducibility standard deviations for retinal thickness, cup/rim area, and GCC parameters. Results showed good precision across all groups. Image registration efficacy was validated via accuracy and precision tests. Literature references (Tan et al. 2009, Sehi et al. 2009, etc.) support the device's diagnostic ability and repeatability compared to other OCT systems.
Technological Characteristics
Computer-controlled OCT imaging system; posterior segment measurement. Features include EMM5, ONH, and GCC scan patterns. Software-based normative database (NDB) provides statistical reference for retinal/optic disc measurements. Connectivity: Standalone system. Energy source: Optical (OCT). Image registration: Blood vessel matching algorithm. Materials: Standard ophthalmic device components.
Indications for Use
Indicated for in vivo imaging and measurement of retina, retinal nerve fiber layer (RNFL), and optic disc in human eyes to aid diagnosis and management of retinal and ocular diseases. Used as a quantitative tool for comparing patient measurements against a normative database of healthy subjects.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
Submission Summary (Full Text)
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# 1101505
## 510(k) Summary
#### Optovue, Inc. RTVue with Normative Database
SEP 1 5 2010
This 510(k) summary for the RTVue with Normative Database is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
#### General Information
| Manufacturer: | Optovue, Inc.<br>45531 Northport Loop West,<br>Fremont, CA 94538<br>Phone: (510) 623-8868<br>Fax: (510) 623-8668<br>Registration No.: 3005950902 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Talarico<br>VP of Regulatory and Clinical Affairs<br>Optovue, Inc.<br>Phone: (510) 623-8868 x209<br>e-mail: john_talarico@optovue.com |
| Device Information | |
| Classification: | Class II |
| Trade Name: | RTVue with Normative Database |
| Common Name: | Optical Coherence Tomography (OCT) |
| Classification Name: | Ophthalmoscope, a-c powered (21 CFR§ 886.1570) |
#### Predicate Device
- (1) RTVue with CA (K071250) -- Manufactured by Optovue, Inc.
- (2) StratusOCT with RNFL & Macula Normative Database (K033123) manufactured by Carl Zeiss Meditec, Inc.
#### Intended Use
The RTVue with Normative Database is an optical coherence tomography system indicated for the in-The NY Tue With Norman of the retina, retinal nerve fiber layer, and optic disc as an aid in the diagnosis and management of retinal disease. The RTVue with Normative Database is also a
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quantitative tool for the comparison of retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases.
#### Device Description
The RTVue is a computer controlled ophthalmic imaging and measurement system that employs optical coherence tomography to image and measure the posterior segment of the eye. The device is currently cleared for in vivo imaging and measurement of the various retinal layers (K062552). Imaging and measurements include but are not limited to the internal limiting membrane (ILM), the retinal nerve fiber layer (RNFL), the ganglion cell complex (GCC), the retinal pigment epithelium (RPE), the outer retinal thickness, the total retinal thickness and optic disk structures including the cup and neuroretinal rim as an aid in the diagnosis and management of retinal disease. The measurements for the ILM and RPE are height measurements relative to the RPE reference plane. The RNFL. GCC. the outer retinal thickness and total retinal thickness measurements where RNFL is the thickness of the RNFL layer, the GCC is the thickness from the ILM to the inner plexiform layer (IPL), the outer retinal thickness is the thickness from the IPL to the RPE, and total retinal thickness is the thickness from the ILM to the RPE. The current submission is for a software modification to add a normative database. With the additional normative database (NDB), the RTVue can compare the measured data from the GCC, the RNFL, the full retinal thickness, optic disc cup and optic disc rim measurements to the normative database. The RTVue with Normative Database provides a statistical reference of the GCC, the RNFL, the full retinal thickness, optic disc cup and optic disc rim measurements to a database of known normal subjects. The RTVue with Normative Database will provide the analysis information to be used as a clinical reference to aid in the diagnosis and management of ocular diseases.
#### Substantial Equivalence
The RTVue with Normative Database is substantially equivalent to the predicate device identified previously. The RTVue is similar to the previously cleared RTVue device with regard to intended use, operating principle, function, material, and energy source. Technological comparisons and clinical testing demonstrate that the RTVue with Normative Database is functionally equivalent to the predicate devices.
#### Performance Data
Clinical data was collected and evaluated to support the intended use for the RTVue with Normative Database and to demonstrate substantial equivalence to the predicate devices.
#### Description of Precision Study, Subject Selection Criteria and Pathologies
#### Instrument:
Three RTVue (K062552) with three different operators were used in this study. Measurements results of various structures within the eye including retinal thickness, optic disc measurements, and Ganglion Cell Complex (GCC) measurements were compared in normal eyes, and eyes with retina pathology and glaucoma.
#### Scans:
The RTVue device has three scan patterns where measurements are compared to a normative database. These scans include the 1) EMM5 scan, 2) the ONH scan, and 3) the GCC scan. The
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EMM5 scan is centered on the fovea and provides measurements of the full retina thickness and the inner retina thickness. Only the full retina thickness measurements are compared to the normative database. This scan can be used to assess possible retina pathologies. The ONH scan is centered on the optic disc and provides measurements of the RNFL and optic disc. This scan can be used to assess possible glaucoma. The GCC scan is centered at 1 mm off from the fovea in order to cover more temporal retina area. It provides measurements of the inner retina layers that contain the ganglion cell axon (RNFL), cell body, and dendrite (inner plexiform layer). This scan can be used to assess glaucoma. Both eyes were scanned in each subject.
#### Subjects:
1) Normal healthy eyes with no ocular pathology, 2) glaucoma patients and, 3) retina patients were enrolled in the study at two clinical sites. Normal subjects were 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. There were 4 normal subjects, 4 retina patients, and 4 glaucoma patients enrolled for each RTVue devices. There were 3 RTVue devices at 2 clinical sites. At one site, there were 2 RTVues systems and 2 operators at different times. In total, there were 12 subjects enrolled for each of the 3 RTVue devices; a total of 36 subjects were used from 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
The following tables provide the precision results for the scans with RTVue with Normative Database with both eyes combined. The data in the tables include 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).
- EMM5 Scan Results (Normal and Retina Patients) i)
The following tables show the overall precision results with the EMM5 scan for full retinal thickness in the fovea for normals and retina patients.
| EMM5 | | | |
|-------------------|-----------------|-----------------|-------------------|
| Full Retina Fovea | | | |
| | Normal Patients | Retina Patients | Glaucoma Patients |
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| # of Scans | 71 | 71 | 71 |
|---------------------------------|--------------------|--------------------|------------------|
| Overall Mean (Overall SD) | 243.61 (26.00) | 267.15 (73.32) | 246.22 (22.14) |
| Repeatability SD* (Min, Max) | 2.57(1.66, 2.57) | 2.96(1.83, 3.15) | 3.01(1.95, 3.01) |
| Reproducibility SD** (Min. Max) | 17.72(1.66, 17.72) | 13.78(1.83, 13.78) | 3.01(2.05, 5.80) |
*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 tables show the overall precision results with the EMM5 scan for full retinal thickness in the periphery (average over 8 sectors outside the fovea) for normals and retina patients.
| EMM5<br>Full Retina Thickness Peripheral Results | | | |
|--------------------------------------------------|-------------------|-------------------|-------------------|
| | Normal Patients | Retina Patients | Glaucoma Patients |
| # of Scans | 71 | 71 | 71 |
| Overall Mean (Overall SD) | 295.05 (16.21) | 299.03 (30.70) | 282.30 (25.26) |
| Repeatability SD* (Min, Max) | 1.96(1.66, 2.57) | 2.69(1.83, 3.15) | 2.35(1.95, 3.01) |
| Reproducibility SD ** (Min, Max) | 2.01(1.66, 17.72) | 2.69(1.83, 13.78) | 2.66(2.05, 5.80) |
*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.
ii) ONH Scan Results (Normals and Glaucoma Patients)
The following tables show the overall precision results with the ONH scan for average RNFL thickness for normals and glaucoma patients.
| | ONH<br>Average RNFL | |
|---------------------------------|---------------------|-------------------|
| | Normal Patients | Glaucoma Patients |
| # of Scans | 72 | 72 |
| Overall Mean (Overall SD) | 100.82 (8.11) | 86.40 (14.99) |
| Repeatability SD* (Min, Max) | 1.76(1.76, 6.18) | 1.56(1.56, 5.86) |
| Reproducibility SD** (Min, Max) | 2.11(2.11, 9.78) | 7.87(3.92, 16.33) |
*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 tables show the overall precision results with the ONH scan for the average over 2 hemi-spheres, 4 quadrants, and 8 sectors for normals and glaucoma patients.
| | ONH | |
|---------------------------|----------------------------------------------------------|-------------------|
| | RNFL averaged over 2 Hemispheres, 4 Quadrants, 8 Sectors | |
| | Normal Patients | Glaucoma Patients |
| # of Scans | 72 | 72 |
| Overall Mean (Overall SD) | 100.82 (14.80) | 86.41 (18.55) |
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| Optovue RTVue with NDB 510(K) Premarket Notification | | |
|------------------------------------------------------|--|--|
|------------------------------------------------------|--|--|
| Repeatability SD* (Min, Max) | 3.92(1.76, 6.18) | 4.48(1.56, 5.86) |
|---------------------------------|------------------|-------------------|
| Reproducibility SD** (Min, Max) | 5.40(2.11, 9.78) | 7.84(3.92, 16.33) |
*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 tables show the overall precision results with the ONH scan for the cup area measurement for normals and glaucoma patients.
| ONH<br>Cup Area | | |
|---------------------------------|-------------------|-------------------|
| | Normal Patients | Glaucoma Patients |
| # of Scans | 72 | 72 |
| Overall Mean (Overall SD) | 0.39 (0.18) | 1.04 (0.53) |
| Repeatability SD* (Min, Max) | 0.02 (0.02, 0.03) | 0.07(0.07, 0.21) |
| Reproducibility SD** (Min, Max) | 0.02 (0.02, 0.03) | 0.07(0.07, 0.21) |
*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 tables show the overall precision results with the ONH scan for the rim area measurement for normals and glaucoma patients.
| | ONH | |
|---------------------------------|-------------------|-------------------|
| Rim Area | | |
| | Normal Patients | Glaucoma Patients |
| # of Scans | 72 | 72 |
| Overall Mean (Overall SD) | 0.69 (0.17) | 0.89 (0.66) |
| Repeatability SD* (Min, Max) | 0.03 (0.02, 0.03) | 0.18(0.07, 0.21) |
| Reproducibility SD** (Min, Max) | 0.03 (0.02, 0.03) | 0.18(0.07, 0.21) |
*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 tables show the overall precision results with the ONH scan for the vertical CD ratio measurement for normals and glaucoma patients.
| ONH<br>Vertical CD Ratio | | |
|---------------------------------|-------------------|-------------------|
| | Normal Patients | Glaucoma Patients |
| # of Scans | 72 | 72 |
| Overall Mean (Overall SD) | 2.15 (0.65) | 0.76 (0.23) |
| Repeatability SD* (Min, Max) | 0.01 (0.01, 0.04) | 0.05(0.05, 0.08) |
| Reproducibility SD** (Min, Max) | 0.01 (0.01, 0.04) | 0.05(0.05, 0.08) |
*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.
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** 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.
#### iii) GCC Scan Results (Normals and Glaucoma Patients)
The following tables show the overall precision results with the GCC scan for the inner retina average for normals and glaucoma patients.
| | GCC<br>Inner Retina Average | |
|----------------------------------|-----------------------------|-------------------|
| | Normal Patients | Glaucoma Patients |
| # of Scans | 72 | 71 |
| Overall Mean (Overall SD) | 98.28 (9.31) | 81.76 (8.90) |
| Repeatability SD* (Min, Max) | 1.86 (1.86, 2.07) | 1.18 (1.18, 1.59) |
| Reproducibility SD ** (Min, Max) | 7.56 (7.32, 7.92) | 2.55 (1.59, 3.36) |
*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.
The following tables show the overall precision results with the GCC scan for the FLV thickness measurement for normals and glaucoma patients.
| GCC<br>GCC FLV | | |
|---------------------------------|-------------------|-------------------|
| | Normal Patients | Glaucoma Patients |
| # of Scans | 72 | 71 |
| Overall Mean (Overall SD) | 0.60 (0.67) | 4.30 (3.47) |
| Repeatability SD* (Min, Max) | 0.37 (0.37, 0.37) | 0.88 (0.88, 0.88) |
| Reproducibility SD** (Min, Max) | 0.46 (0.46, 0.46) | 1.04 (1.04, 1.04) |
*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.
The following tables show the overall precision results with the GCC scan for the GLV thickness measurement for normals and glaucoma patients.
| GCC<br>GCC GLV | | | | | |
|----------------------------------|-------------------|-------------------|--|--|--|
| | Normal Patients | Glaucoma Patients | | | |
| # of Scans | 72 | 71 | | | |
| Overall Mean (Overall SD) | 3.99 (3.43) | 15.51 (7.81) | | | |
| Repeatability SD* (Min, Max) | 0.83 (0.83, 0.83) | 1.03 (1.03, 1.03) | | | |
| Reproducibility SD ** (Min, Max) | 2.44 (2.44, 2.44) | 1.71 (1.71, 1.71) | | | |
*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.
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** 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.
#### Registration Results
Image registration using blood vessel matching is used for both the EMM5 scan and the ONH scan. The image registration algorithm uses a reference image to register all scans based on matching detected blood vessel patterns. For this internal validation study, we performed both an accuracy test as well as a precision test in order to evaluate the efficacy of the blood vessel registration method.
The following tables show the values at 2 times the standard deviation values for each parameters for these two scan types.
| EMM5 | FRT Fovea | FRT Para Tempo | FRT Para Superior | FRT Para Nasal | FRT Para Inferior | FRT Peri Tempo | FRT Peri Superior | FRT Peri Nasal | FRT Peri Inferior |
|------|-----------|----------------|-------------------|----------------|-------------------|----------------|-------------------|----------------|-------------------|
| | 6.345 | 3.9121 | 4.6186 | 3.6347 | 2.795 | 5.568 | 5.669 | 4.772 | 3.63 |
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#### Normative Databases
The normative data was collected at 11 clinical sites following an IRB approved protocol and enrolled known healthy eyes from 480 individuals (over 640 eyes) with a wide age range (18-84) from various ethnic backgrounds including 33% Caucasians, 22% Asians, 20% African Americans, 12% Hispanics, 12% Indian, and 1% other, approximately. Normative databases are adjusted by age, signal strength and disc area (where applicable), not by axial length, refraction or any other parameters. The normative limits do not take into account differences that may be present due to ethnicity.
In our clinical studies, the repeatability and reproducibility were found to be very good and were found to be similar for normal groups and pathology groups. We believe the Normative Database is a good representation of the patient population because it was created from a large population of patients from 11 clinical sites worldwide. Ocular measurements taken by the RTVue have been compared to other OCT devices by renowned leaders in the field of Ophthalmology and found to have good repeatability and reproducibility 1-5.
#### Conclusion
As described in this 510(k) Summary, all testing and analysis were completed on the RTVue with Normative Database to ensure that the device is safe and effective for its intended.
Tan O, Chopra V, Lu A, Schunan J, Ishkawa H, Wollstein G, Varma R, Huang D. Detection of macular ganglion cell loss in glaucoma by Fourier l. Domain Optical Coherence Tomography. Ophthalmol. 2009; 116:2305-2314.
Donall Optical Collection Touristic 2007, 10:230, 10.230, 10.230, 10.12 Reproducibility of RTVer Layer Thickness 2. Optic Disc Measurements and Agreement with Straus Optical Coherence Tomography Measurements. Am J Ophthalment (1909 Mar 5
Opic Disc Measurements and Agreement Will Suatts Optical Contractions Frin Opiliations Print of Partin Province Province Printer Price Printer Print Province Price Portugio 3. tomography. Ophthalmol. 2010; 117: 738-746.
toniolality. Ophilimino. 2000, 11:17 Comparison of repeatability of retinal nerve fiber thickness measurement made with the RT 4. domain Optocal Collerence Tomograph and the GDx Scanning Laser Polarimeter with Variable or Enhanced Comea Compensation. J Glaucoma. Oct
Sehi M, Grewal DS, Sheets CW, Greenfield DS. Diagnostic ability of Fourier-domain optical coherence tomography for glaus 5. detection. Am J Ophthalmol. 2009; 148: 597-605.
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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 Mr. John Talarico VP Regulatory and Clinical Affairs 45531 Northport Loop W. Fremont, CA 94538
SEP 1 5 2010
Re: K101505
Trade/Device Name: RTVue with Normative Database Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLI Dated: August 12, 2010 Received: August 19, 2010
Dear Mr. Talarico:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. John Talarico
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,
Kevia Alexander
Malvina B. Eydelman, M.D. Director
Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Indications for Use
KI0ISOS
510(k) Number (if known):
SEP 1 5 2010
Device Name: RTVue with Normative Database
Indications For Use:
The RTVue with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disk as an aid in the diagnosis and management of retinal disease. The RTVue with Normative Database is also a quantitative tool for the comparison of retina, retinal nerve fiber layer, and optic disk measurements in the human eye to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection 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)
Sesn.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K101505 Page 18 of 922
