(262 days)
CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior ocular structures. The device is indicated for visualizing and measuring and posterior ocular structures, including corneal epithelium, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head.
CIRRUS' AngioPlex OCT Angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.
CIRRUS HD-OCT is indicated as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.
This device is Prescription Use (Rx) only.
The CIRRUS™ HD-OCT Model 6000 is indicated for in-vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of anterior and posterior ocular structures. The clinical purpose of this device has not been modified as compared to the predicate.
CIRRUS 6000 uses the same optical system, architecture, and principle of operation as the previously cleared CIRRUS 5000 (K181534). CIRRUS 6000 has a 100 kHz scan rate for all structural and angiography scans. The primary impact of the higher acquisition speed is its impact on signal-to-noise ratio. The signal-to-noise ratio m the subject device is calibrated to match the specifications of the CIRRUS 6000 uses the same segmentation algorithms as the predicate device and therefore the segmentation results will be equivalent.
In addition to the acquisition speed change, CIRRUS 6000 also has a wider field of view (FOV) and has increased the number of fixation points to 21.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the reported precision summaries (Repeatability %CV and Reproducibility %CV and Limits) for various measurements on the CIRRUS HD-OCT 6000 (C6000) and the qualitative image quality results. The studies aim to demonstrate that the C6000 performs comparably to the predicate device, the CIRRUS HD-OCT 5000 (C5000), and that its image quality is clinically acceptable.
Since explicit numerical acceptance criteria (e.g., "Repeatability %CV must be < X%") are not directly stated in the text, I will present the reported performance as the evidence that these implicit criteria have been met. The table below summarizes key metrics where direct quantitative comparison is available.
| Metric (Measurement and Population) | Acceptance Criterion (Implicitly demonstrated by achieving results comparable to predicate and within
clinically acceptable ranges) | Reported Device Performance (CIRRUS HD-OCT 6000) |
|---|---|---|
| Ganglion Cell Thickness (Normal Subjects) | | |
| Average Thickness (µm) Repeatability %CV | Should be low, indicating consistent measurements | 0.5% |
| Average Thickness (µm) Reproducibility %CV | Should be low, indicating consistent measurements | 0.6% |
| Macular Thickness (Normal Subjects) | | |
| Central Subfield (µm) Repeatability %CV | Should be low, indicating consistent measurements | 0.4% |
| Central Subfield (µm) Reproducibility %CV | Should be low, indicating consistent measurements | 0.7% |
| ONH (Rim Area, Normal Subjects) | | |
| Rim Area (mm2) Repeatability %CV | Should be low, indicating consistent measurements | 4.9% |
| Rim Area (mm2) Reproducibility %CV | Should be low, indicating consistent measurements | 6.6% |
| RNFL Thickness (Average, Normal Subjects) | | |
| Average RNFL Thickness (µm) Repeatability %CV | Should be low, indicating consistent measurements | 1.2% |
| Average RNFL Thickness (µm) Reproducibility %CV | Should be low, indicating consistent measurements | 1.8% |
| Epithelial Thickness (Central, Normal Subjects) | | |
| Central (µm) Repeatability %CV | Should be low, indicating consistent measurements | 1.8% |
| Central (µm) Reproducibility %CV | Should be low, indicating consistent measurements | 3.8% |
| Pachymetry Thickness (Central, Normal Subjects) | | |
| Central (µm) Repeatability %CV | Should be low, indicating consistent measurements | 0.2% |
| Central (µm) Reproducibility %CV | Should be low, indicating consistent measurements | 0.4% |
| Angiography Image Quality (Overall) | Clinically Acceptable Overall Images should be high | 0.98 or above (C6000) vs 0.94 or above (C5000) |
| Raster Image Quality (Overall) | Clinically Acceptable Overall Images should be high | 1.00 (C6000) and 1.00 (C5000) |
Studies Proving Acceptance Criteria were Met:
The document describes two main clinical performance studies:
-
CIRRUS 6000 Repeatability and Reproducibility (R&R) Study: This study quantified the precision of measurements from the C6000 for various ocular structures (Ganglion Cell Thickness, Macular Thickness, ONH, RNFL Thickness, Epithelial Thickness, Pachymetry Thickness) across different patient populations (Normal, Glaucoma, Retinal pathology, Cornea pathology). The results are presented in Tables 3 through 12, showing generally low %CV values for both repeatability and reproducibility, indicating good precision. The agreement between C5000 and C6000 was evaluated using Bland-Altman Limits of Agreement and Deming Regression analysis, suggesting that the measurements are comparable to the predicate device.
-
CIRRUS 6000 Angiography Image Quality Study: This study assessed the image quality of OCTA scans from the C6000. It reported a high proportion of clinically acceptable overall images (0.98 or above for C6000), which was comparable to or better than the predicate C5000 (0.94 or above).
-
CIRRUS 6000 Raster Image Quality Study: This study evaluated the image quality of raster B-scans from the C6000, reporting that the proportion of clinically acceptable overall images was 1.00 for all scan types, identical to the predicate C5000.
Detailed Information on the Studies:
2. Sample Sizes and Data Provenance
-
CIRRUS 6000 Repeatability and Reproducibility (R&R) Study:
- Total Subjects Enrolled: 117
- Subgroups: 27 normal, 37 with glaucoma, 30 with retinal pathology, 23 with status post refractive surgery or with corneal pathology.
- Disqualifications: 9 subjects (did not meet inclusion criteria or showed macular changes due to drusen).
- Valid Scans Analyzed: 96.0% of C6000 and 94.9% of C5000 scans were valid.
- Data Provenance: Prospective, multi-site study. Country of origin not specified, but typically multi-site studies for FDA submissions include US sites.
-
CIRRUS 6000 Angiography Image Quality Study:
- Total Subjects Enrolled: 110
- Subgroups: 103 retinal diseased subjects, 7 normal subjects.
- Disqualifications/Discontinuations: 7 normal subjects (did not meet inclusion/exclusion criteria), 11 (operator unable to acquire quality scans), 1 (unable to continue study visit), 2 (no C6000 scans acquired), 2 (did not return for second visit).
- Valid Subjects with at least one OCT scan/FA/ICGA: 93. Only 92 subjects had at least one valid OCT scan.
- Valid Scans Analyzed: 78.3% of C6000 and 77.2% of C5000 scans.
- Data Provenance: Prospective, multi-site study. Country of origin not specified, but typically multi-site studies for FDA submissions include US sites.
-
CIRRUS 6000 Raster Image Quality Study:
- Total Subjects Enrolled: 68
- Subgroups: 20 normal eyes, 48 with retinal disease.
- Valid Scans Analyzed: 92.3% of C6000 and 91.3% of C5000 scans.
- Data Provenance: Prospective, multi-site study. Country of origin not specified, but typically multi-site studies for FDA submissions include US sites.
3. Number of Experts and Qualifications for Ground Truth
- R&R Study: No external experts were used for establishing ground truth in the R&R study itself, as it focused on the device's internal precision metrics.
- Angiography Image Quality Study: Three independent reviewers from a reading center were used to grade OCTA scans on image quality and clinically relevant information. Their specific qualifications (e.g., years of experience, specific certifications) are not detailed in the provided text.
- Raster Image Quality Study: Three independent graders from a reading center were used to grade the raster B-scans on image quality and clinically relevant information. Their specific qualifications are not detailed in the provided text.
4. Adjudication Method for the Test Set
- R&R Study: Not applicable, as this study focused on precision of measurements rather than subjective grading requiring adjudication.
- Angiography Image Quality Study: The text mentions "three independent reviewers...graded...according to pre-determined grading criteria." It does not specify an adjudication method (e.g., 2+1, 3+1). It implies independent assessments were done, and the reported "Proportion of Clinically Acceptable Overall Images" likely reflects a consensus or majority opinion based on these independent grades, or an aggregate result.
- Raster Image Quality Study: Similar to the angiography study, "three independent graders...graded...according to pre-determined grading criteria." No explicit adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- The document describes "qualitative image grading and agreement" studies (Angiography and Raster Image Quality Studies) that involved multiple readers. However, these appear to be primarily for assessing image quality and clinical relevance of the device outputs, rather than a direct MRMC comparative effectiveness study where human readers' diagnostic performance with and without AI assistance is measured.
- The studies compare the C6000's image quality to the C5000, and human readers grade these images. There is no mention of an effect size for how much human readers improve with AI vs without AI assistance. The device itself, the Cirrus HD-OCT, is an imaging device, not an AI-based diagnostic tool providing interpretations to assist human readers in the traditional sense of AI studies.
6. Standalone (Algorithm Only) Performance Study
- The document implies that the device's segmentation algorithms are the same as the predicate device and that "the segmentation results will be equivalent." It also states "ZEISS demonstrated non-clinical equivalency between the CIRRUS 6000 and CIRRUS 5000 scan data using a phantom retina, which shows the equivalency of the segmentation results as the segmentation algorithms are the same in both instruments."
- This suggests that an assessment of the algorithm's performance (particularly segmentation) was conducted indirectly by verifying equivalency to the predicate device's algorithms and demonstrating that the acquired data from the C6000 results in equivalent segmentation on a phantom. However, a specific "standalone" study rigorously evaluating the algorithm's performance on clinical data separate from the device's overall output is not explicitly detailed. The R&R study focuses on the precision of measurements derived from segmentations, which implies good algorithm performance.
7. Type of Ground Truth Used
- R&R Study: The "ground truth" here is the assumed true anatomical measurement for the precision calculation. The study methodology evaluates the variability within the device's measurements, not against an independent gold standard for the measurements themselves. The "truth" for this study is essentially the consistency and reproducibility of the device's own measurements.
- Angiography and Raster Image Quality Studies: The ground truth for these studies was established by "three independent reviewers from a reading center" who "graded the OCTA scans on image quality and clinically relevant information according to pre-determined grading criteria." This is expert consensus/grading on image quality and clinical relevance.
8. Sample Size for the Training Set
- The document does not provide information about the training set size for the segmentation algorithms. It explicitly states that the C6000 uses the same segmentation algorithms as the predicate device (C5000). This implies that the algorithms were trained previously for the C5000, and no re-training or new training set was required for the C6000 because the algorithms themselves have not changed.
9. How Ground Truth for Training Set was Established
- As mentioned above, the document states that the C6000 uses the same segmentation algorithms as the predicate device, the CIRRUS HD-OCT 5000 (K181534). Therefore, the training for these algorithms would have been established during the development and clearance of the predicate device. The current submission does not describe the ground truth establishment for the original training of these algorithms.
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Carl Zeiss Meditec Inc % Tanesha Bland Senior Regulatory Affairs Specialist Carl Zeiss Meditec USA Inc 5300 Central Parkway Dublin, California 94568
Re: K222200
Trade/Device Name: Cirrus HD-OCT Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: March 2, 2023 Received: March 6, 2023
Dear Tanesha Bland:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elvin Y. Ng -S
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K22200
Device Name CIRRUS HD-OCT Model 6000
Indications for Use (Describe)
CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior ocular structures. The device is indicated for visualizing and measuring and posterior ocular structures, including corneal epithelium, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head.
CIRRUS' AngioPlex OCT Angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.
CIRRUS HD-OCT is indicated as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.
This device is Prescription Use (Rx) only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Page 1 of 41
In accordance with 21 CFR 807.92 the 510(k) Summary for the CIRRUS Model 6000 is provided below.
SUBMITTER 1. Applicant: Carl Zeiss Meditec, Inc. 5300 Central Parkway Dublin, CA USA Tanesha Bland Primary Correspondent Sr. Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5300 Central Parkway | Dublin, CA 94568 (925) 216-7963 Phone | (925) 557-4259 Fax E-mail: tanesha.bland(@zeiss.com (preferred) Development Center Contact Vidita Desai Sr. Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5300 Central Parkway | Dublin, CA 94568 (925) 413-1644 Phone | (925) 557-4259 Fax E-mail: vidita.desai@zeiss.com (preferred) April 12, 2023 Date Prepared:
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SUBJECT DEVICE 2.
| Device Trade Name: | CIRRUS HD-OCT Model 6000 |
|---|---|
| Classification: | 21CFR886.1570 Optical Coherence Tomography (OCT) |
| Regulatory Class: | II |
| Product Code: | OBO |
3. PREDICATE DEVICE
| Predicate Device: | CIRRUS HD-OCT Model 5000 (K181534) |
|---|---|
| Classification: | 21CFR886.1570 Optical Coherence Tomography (OCT) |
| Regulatory Class: | II |
| Product Code: | OBO, IYO, ITX |
4. DEVICE DESCRIPTION
The CIRRUS™ HD-OCT Model 6000 is indicated for in-vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of anterior and posterior ocular structures. The clinical purpose of this device has not been modified as compared to the predicate.
CIRRUS 6000 uses the same optical system, architecture, and principle of operation as the previously cleared CIRRUS 5000 (K181534). CIRRUS 6000 has a 100 kHz scan rate for all structural and angiography scans. The primary impact of the higher acquisition speed is its impact on signal-to-noise ratio. The signal-to-noise ratio m the subject device is calibrated to match the specifications of the CIRRUS 6000 uses the same segmentation algorithms as the predicate device and therefore the segmentation results will be equivalent.
In addition to the acquisition speed change, CIRRUS 6000 also has a wider field of view (FOV) and has increased the number of fixation points to 21.
INDICATIONS FOR USE న్.
CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior and posterior ocular structures. The device is indicated for visualizing and measuring anterior ocular structures, including cornea, corneal epithelium, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head.
CIRRUS' AngioPlex OCT Angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.
CIRRUS HD-OCT is indicated as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.
This device is Prescription Use (Rx) only.
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6. SUBSTANTIAL EQUIVALENCE TO PRIMARY PREDICATE
Table 1. Subject to Predicate Device Comparison Table – Indications for Use
| Device | Subject Device – CIRRUS 6000 | Predicate Device – CIRRUS 5000(K181534) | EquivalencyAnalysis |
|---|---|---|---|
| Indicationsfor Use | CIRRUS HD-OCT is a non-contact, high resolution tomographic andbiomicroscopic imaging deviceintended for in-vivo viewing, axialcross-sectional, and three-dimensional imaging of anterior andposterior ocular structures. Thedevice is indicated for visualizingand measuring anterior and posteriorocular structures, including cornea,corneal epithelium, retina, retinalerve fiber layer, ganglion cell plusinner plexiform layer, macula, andoptic nerve head. | CIRRUS HD-OCT is a non-contact, high resolutiontomographic and biomicroscopicimaging device intended for in-vivo viewing, axial cross-sectional,and three-dimensional imaging ofanterior and posterior ocularstructures. The device is indicatedfor visualizing and measuringanterior and posterior ocularstructures, including cornea,corneal epithelium, retina, retinalnerve fiber layer, ganglion cell plusinner plexiform layer, macula, andoptic nerve head. The CIRRUSnormative databases arequantitative tools indicated for thecomparison of retinal nerve fiberlayer thickness, macular thickness,ganglion cell plus inner plexiformlayer thickness, and optic nervehead measurements to a databaseof normal subjects. | Identical (exceptthe normativedatabase) |
| CIRRUS AngioPlex OCTAngiography with is indicated as anaid in the visualization of vascularstructures of the retina and choroid. | CIRRUS AngioPlex OCTAngiography with is indicated asan aid in the visualization ofvascular structures of the retinaand choroid. | ||
| CIRRUS HD-OCT is indicated as adiagnostic device to aid in thedetection and management of oculardiseases including, but not limited to,macular holes, cystoid macularedema, diabetic retinopathy, age-related macular degeneration, andglaucoma. | CIRRUS HD-OCT is indicated asa diagnostic device to aid in thedetection and management ofocular diseases including, but notlimited to, macular holes, cystoidmacular edema, diabeticretinopathy, age-related maculardegeneration. and glaucoma |
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Page 4 of 41
Table 2. Subject to Predicate Device Comparison Table – Technical Characteristics
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4 | CIRRUS™ HD-OCT 5000 v. 10.0 | Analysis |
|---|---|---|---|
| Subject Device | Predicate Device (K181534) | ||
| Device ClassificationName | Tomography, Optical Coherence | Tomography, Optical Coherence | Identical |
| Generic/Common Name | Optical Coherence Tomography (OCT) | Optical Coherence Tomography (OCT) | Identical |
| Classification ProductCode | OBO | OBO | Identical |
| Class | II | II | Identical |
| Technology | Spectral Domain (Spatially encodedFrequency Domain and FourierDomain Principle) OCT | Spectral Domain (Spatially encodedFrequency Domain and FourierDomain Principle) OCT | Identical |
| Illumination Sourcesused in Instrument | Light Emitting Diode 700 nm - IrisViewerLSO Super Luminescent Diode 750 nmOCT Super Luminescent Diode840 nm | Light Emitting Diode 700 nm - IrisViewerLSO Super Luminescent Diode 750 nmOCT Super Luminescent Diode840 nm | Identical |
| Models | 6000 | 5000 | N/A |
| OCT IMAGING | |||
| Methodology | Spectral domain OCT (SD-OCT) | Spectral domain OCT (SD-OCT) | Identical |
| K222200 - 510(k) Summary | Page 5 of 41 | ||
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4Subject Device | CIRRUSTM HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| OCT Optical Source | OCT Super Luminescent Diode,840 nm wavelength | OCT Super Luminescent Diode,840 nm wavelength | Identical |
| Optical Power | $1200 \mu W +/- 300 \mu W$ (0.9 - 1.5 mW)at the cornea | $< 775 \mu W$ at the cornea | Different |
| Scan Speed | 100,000 A-scans per second | 27,000 A-scans per second68,000 A-scans per second only forOCT Angiography | Different |
| Axial Scan Depth(Max)- Retina | • 2.9 mm for 12 mm 1 Line 100xHD Raster, HD Angio 8x8,Angio 8x8, and Angiography12x12• 2.0 mm for all other scans | 2.0 mm | Different |
| Axial Scan Depth(Max)- Retina | 2.0 mm (in tissue), 1024 pixels per A-scans for all other scan except for theones listed above | 2.0 mm (in tissue), 1024 pixels per A-scans. | Identical |
| Axial Scan Depth (Max)-Anterior Segment | 2.0 mm (Anterior 5-Line Raster) –1024 points2.0 mm (Anterior SegmentCube) – 1024 points | 2.0 mm (Anterior 5-Line Raster) –1024 points2.0 mm (Anterior SegmentCube) - 1024 points | Identical |
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4Subject Device | CIRRUS™ HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| 5.8 mm (Anterior Chamber) – 2048points | 5.8 mm (Anterior Chamber) – 2048points | ||
| 2.9 mm (Wide Angle-to-Angle) – 1024points | 2.9 mm (Wide Angle-to-Angle) – 1024points | ||
| 2.9 mm (HD Angle) – 1024 points | 2.9 mm (HD Angle) – 1024 points | ||
| 2.0 mm (HD Cornea) – 1024 points | 2.0 mm (HD Cornea) – 1024 points | ||
| 2.0 mm (Pachymetry) – 1024 points | 2.0 mm (Pachymetry) – 1024 points | ||
| External AnteriorSegment Lens | Anterior Chamber LensCornea Lens | Anterior Chamber LensCornea Lens | Identical |
| Transverse Scan Range(Lateral range indegrees)Retina | 10° x 0° on retina (Minimum)42° x 42° on retina (Maximum) | 10° x 0° on retina (Minimum)31° x 31° on retina (Maximum) | Different |
| Transverse Scan Range-Anterior Segment | 3 mm (Minimum)15 mm (Maximum) | 3 mm (Minimum)15 mm (Maximum) | Identical |
| Axial Resolution | 5 µm (in tissue) | 5 µm (in tissue) | Identical |
| Transverse Resolution –Retina | ≤ 15 µm (in tissue) | ≤ 15 µm (in tissue) | Identical |
| K222200 - 510(k) Summary | Page 7 of 41 | ||
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4Subject Device | CIRRUS™ HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| Transverse Resolution -Anterior Segment | 20 μm (in tissue)20 μm @ 6mm FOV25 μm @ 9mm FOV45 μm @ 15mm FOV | 20 μm (in tissue)20 μm @ 6mm FOV25 μm @ 9mm FOV45 μm @ 15mm FOV | Identical |
| Scan patternsNon-angiography | Line, circle, crosshair, raster (a seriesof closely spaced lines, aka cube scan),radial scans and combinations of theabove. | Line, circle, crosshair, raster (a seriesof closely spaced lines, aka cube scan),radial scans and combinations of theabove. | Identical |
| Scan typesNon-angiography | Macular Cube 512 x 128 = 6 mm x 6mm | Macular Cube 512 x 128 = 6 mm x 6mm | Identical |
| Macular Cube 200 x 200 = 6 mm x 6mm | Macular Cube 200 x 200 = 6 mm x 6mm | Identical | |
| Optic Disc Cube 200 x 200 = 6 mm x 6mm | Optic Disc Cube 200 x 200 = 6 mm x 6mm | Identical | |
| Not Available | 5-Line Raster | Different, scan type notavailable for CIRRUS 6000 | |
| HD (high-definition) RasterHD 1 Line 100x (2.9 mm depthand up to 12 mm in length) | HD (high-definition) RasterHD 1 Line 100x (2.0 mm depthand up to 9 mm in length) | Identical except for HD 1 Line100x scan depth and max length | |
| K222200 - 510(k) Summary | Page 8 of 41 | ||
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4Subject Device | CIRRUS™ HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| - HD 21 Line- HD Radial- HD Cross- HD 5-Line Raster | - HD 21 Line- HD Radial- HD Cross- HD 5-Line Raster | Identical | |
| Anterior Segment Cube 512 x 128 | Anterior Segment Cube 512 x 128 | Identical | |
| Anterior Segment 5-Line Raster | Anterior Segment 5-Line Raster | Identical | |
| HD Angle | HD Angle | Identical | |
| Anterior Chamber | Anterior Chamber | Identical | |
| Wide Angle-to-Angle | Wide Angle-to-Angle | Identical | |
| HD Cornea | HD Cornea | Identical | |
| Pachymetry | Pachymetry | Identical | |
| OCT Angiography scans | Scans: | Scans: | Scans: |
| AngioPlex 3x3 mm scan | AngioPlex 3x3 mm scan | Identical | |
| AngioPlex 6x6 mm scan | AngioPlex 6x6 mm scan | Identical | |
| K222200 - 510(k) Summary | Page 9 of 41 | ||
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4Subject Device | CIRRUS™ HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| AngioPlex 8x8 mm scan, (2.9mm scandepth) | AngioPlex 8x8 mm scan, (2.0mm scandepth) | Different | |
| AngioPlex 12x12 mm scan (2.9mmscan depth) | Not Available | Different | |
| AngioPlex HD 6x6 mm scan | Not Available | Different | |
| AngioPlex HD 8x8 mm scan (2.9mmscan depth) | Not Available | Different | |
| 6 x 6 mm Montage AngioPlex | Not Available | Different | |
| 8 x 8 mm Montage AngioPlex | Not Available | Different | |
| Retina Tracking | FastTrac Retinal TrackingTrack-to-prior to Scan Acquisitiontracking. | FastTrac Retinal TrackingTrack-to-prior to Scan Acquisitiontracking. | Identical |
| OCT AngiographyAlgorithms(OCTA) | - En face Algorithm- Segmentation Algorithm- Z-Motion Correction Algorithm- Flow Contrast Algorithm(intensity based + phase=complex-based OCTAngiography) | - En face Algorithm- Segmentation Algorithm- Z-Motion Correction Algorithm- Flow Contrast Algorithm(intensity based + phase=complex-based OCTAngiography) | Identical |
| ANALYSIS AND REPORTS | |||
| K222200 - 510(k) Summary | Page 10 of 41 | ||
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4Subject Device | CIRRUSTM HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| RNFL, Macula, AnteriorSegment | Analyses for the Optic Disc:• ONH/RNFL OU Analysis• Guided Progression Analysis• Advanced Visualization• En face• 3D Visualization• Panomap• Single Eye Summary | Analyses for the Optic Disc:• ONH/RNFL OU Analysis• Guided Progression Analysis• Advanced Visualization• En face• 3D Visualization• Panomap• Single Eye Summary | Identical |
| Analyses for the Macula:• Macular thickness• Macular change• Advanced RPE• PanoMap• Advanced visualization• High-definition image• En face Analysis• 3D Visualization | Analyses for the Macula:• Macular thickness• Macular change• Advanced RPE• PanoMap• Advanced visualization• High-definition image• En face Analysis• 3D Visualization | ||
| K222200 - 510(k) Summary | Page 11 of 41 | ||
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4 | CIRRUSTM HD-OCT 5000 v. 10.0 | Analysis |
| Subject Device | Predicate Device (K181534) | ||
| Ganglion Cell GuidedProgressionAnalyses for the Anterior Segment: | Ganglion Cell GuidedProgressionAnalyses for the Anterior Segment: | ||
| • Anterior Segment Analysis• High-Definition ImageAnalysis• Anterior Chamber ScanAnalysis• HD Angle Analysis• HD Cornea Analysis• Pachymetry Analysis withEpithelial Thickness• Wide Angle-to-Angle Analysis• 3D visualization | • Anterior Segment Analysis• High-Definition Image Analysis• Anterior Chamber ScanAnalysis• HD Angle Analysis• HD Cornea Analysis• Pachymetry Analysis withEpithelial Thickness• Wide Angle-to-Angle Analysis• 3D visualization | ||
| RNFL ThicknessAnalysis | • OCT Fundus image with RNFLCalculation circle• OCT Image Extracted fromCalculation Circle with RNFLSegmentation | • OCT Fundus image with RNFLCalculation circle• OCT Image Extracted fromCalculation Circle with RNFLSegmentation | Identical, except the normativedatabase. CIRRUS 6000 addsNSTIN display orientation toRNFL thickness chart andremoved normative database. |
| K222200 - 510(k) Summary | Page 12 of 41 | ||
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4Subject Device | CIRRUSTM HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| RNFL Thickness Map Average Thickness Quadrant Thicknesses Clock Hour Thicknesses Symmetry value TSNIT (or NSTIN format) RNFL thickness graph | RNFL Thickness Map Deviation from Normal Map Average Thickness Quadrant Thicknesses Clock Hour Thicknesses Symmetry value Normative database TSNIT RNFL thickness graph with color coding | ||
| Optic Nerve Head(ONH) analysis | Rim Area / Disc Area Average C/D Ratio Vertical C/D Ratio: Cup Volume Neuro-retinal Rim Thickness B-scan cross section of the ONH Automatic outline of disc margin | Rim Area / Disc Area Average C/D Ratio Vertical C/D Ratio: Cup Volume Neuro-retinal Rim Thickness B-scan cross section of the ONH Automatic outline of disc margin | Identical, except the normative database. Normative ONH database color coding functionality removed. |
| K222200 - 510(k) Summary | Page 13 of 41 | ||
| Device | CIRRUS™ HD-OCT 6000 v. 11.5.4 | CIRRUSTM HD-OCT 5000 v. 10.0 | Analysis |
| Subject Device | Predicate Device (K181534) | ||
| • Automatic outline of cup edge | • Automatic outline of cup edge | ||
| • ONH B-scan slices andsegmentation | • ONH B-scan slices andsegmentation | ||
| • Disc size | • Normative ONH database colorcoding | ||
| • Disc size | |||
| K222200 - 510(k) Summary | Page 14 of 41 | ||
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4 | CIRRUSTM HD-OCT 5000 v. 10.0 | Analysis |
| Subject Device | Predicate Device (K181534) | ||
| Guided ProgressionAnalysis (GPA) forRNFL | - Multiple RNFL Thickness Maps- OCT Fundus image withCalculation circle- Overall Average RNFL ThicknessGraph- Superior RNFL Thickness Graph- Inferior RNFL Thickness Graph- RNFL Thickness Profile- RNFL Summary:o RNFL Thickness MapProgressiono RNFL Thickness ProfilesProgressiono Average RNFL ThicknessProgressionManual selection option of scans toinclude in change analysis | - Multiple RNFL Thickness Maps- Multiple Deviation from NormalMaps- OCT Fundus image withCalculation circle- Overall Average RNFL ThicknessGraph- Superior RNFL Thickness Graph- Inferior RNFL Thickness Graph- RNFL Thickness Profile- RNFL Summary:o RNFL Thickness MapProgressiono RNFL Thickness ProfilesProgressiono Average RNFL ThicknessProgressionManual selection option of scans toinclude in change analysis | Identical, except the normativedatabase. Multiple deviationfrom Normal maps removed. |
| K222200 - 510(k) Summary | Page 15 of 41 | ||
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4Subject Device | CIRRUS™ HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| Guided ProgressionAnalysis (GPA) forGanglion Cell/IPL | - Sequential display of Macularimages in Guided ProgressionAnalysis (GPA) for Ganglion CellLayer/Inner Plexiform Layer(GCL/IPL)- Multiple GCL/IPL ThicknessMaps- Overall Average GCL/IPLThickness Graph- Superior GCL/IPL ThicknessGraph- Inferior GCL/IPL Thickness Graph- GCL/IPL Summary:- GCL Thickness MapProgression- GCL Thickness Progression | - Sequential display of Macularimages in Guided ProgressionAnalysis (GPA) for Ganglion CellLayer/Inner Plexiform Layer(GCL/IPL)- Multiple GCL/IPL ThicknessMaps- Overall Average GCL/IPLThickness Graph- Superior GCL/IPL ThicknessGraph- Inferior GCL/IPL Thickness Graph- GCL/IPL Summary:- GCL Thickness MapProgression- GCL Thickness Progression | Identical |
| Macular ThicknessAnalysis and Display | - Fundus Image with scan cubeoverlay- Average thickness and volumetable- ETDRS grid map- Slice navigators- Horizontal B-scan (X-image) | - Fundus Image with scan cubeoverlay- Average thickness and volumetable- ETDRS grid map withnormative database colorcoding- Slice navigators | Identical, except the normativedatabase. Normative databaseremoved from ETDRS grid mapwith color coding. |
| K222200 - 510(k) Summary | Page 16 of 41 | ||
| Device | CIRRUS™ HD-OCT 6000 v. 11.5.4 | CIRRUS™ HD-OCT 5000 v. 10.0 | Analysis |
| Subject Device | Predicate Device (K181534) | ||
| - Vertical slice - A-scan (Y-image)- 3-D color ILM-RPE thickness map- 3-D surface map of ILM- 3-D surface map of RPE- Segmentation line toggle- Measurement calipers- Automatic fovea finding and coordinates- Assorted controls for aligning ETDRS grid- High-Resolution Images option- Edit Layers (enhanced interface)- Zoom controls- Save Image options- Movie option | - Horizontal B-scan (X-image)- Vertical slice - A-scan (Y-image)- 3-D color ILM-RPE thickness map- 3-D surface map of ILM- 3-D surface map of RPE- Segmentation line toggle- Measurement calipers- Automatic fovea finding and coordinates- Assorted controls for aligning ETDRS grid- High-Resolution Images option- Edit Layers (enhanced interface)- Zoom controls- Save Image options- Movie option | ||
| K222200 - 510(k) Summary | Page 17 of 41 | ||
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4Subject Device | CIRRUSTM HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| High Definition Display | - Fundus image with OCT b-scanreference line (slice navigator)overlays- Enlarged B-scan image ofselected line- Up to 5 thumbnail images | - Fundus image with OCT b-scanreference line (slice navigator)overlays- Enlarged B-scan image ofselected line- Up to 5 thumbnail images | Identical |
| Ganglion Cell OUAnalysis | - GCA Thickness Map- Six sectors of average thickness- Horizontal Macular B-scan- Vertical Macular B-scan- Average GCL+IPL thickness(chart)- Minimum GCL+IPL thickness(chart)- Data available on screen & onprintout | - GCA Thickness Map- GCA Deviation Map- Six sectors of average thickness –color coded per NDB limits- Horizontal Macular B-scan- Vertical Macular B-scan- Average GCL+IPL thickness(chart)- Minimum GCL+IPL thickness(chart)- Data available on screen & on printout | Identical, except the normativedatabase. Removed color codedNDB limits for Six sectors ofaverage thickness. |
| K222200 - 510(k) Summary | Page 18 of 41 | ||
| Device | CIRRUS™ HD-OCT 6000 v. 11.5.4 | CIRRUS™ HD-OCT 5000 v. 10.0 | Analysis |
| Subject Device | Predicate Device (K181534) | ||
| Single Eye Summary(Data from macula scanand optic disc scan areshown in one report) | Macula Analysis:- en face image of macular cube- Macular Thickness map- ETDRS grid sector thicknesses- Macular B-scanONH/RNFL Analysis:- en face image of Optic Disc Cube- RNFL Thickness map- Data Table with RNFL and ONHdata- RNFL TSNIT Thickness graph- ONH B-scan- Data available on screen & on printout | Macula Analysis:- en face image of macular cube- Macular Thickness map- ETDRS grid sector thicknesses withcomparison to normative data- Macular B-scanONH/RNFL Analysis:- en face image of Optic Disc Cube- RNFL Thickness map- Data Table with RNFL and ONHdata- RNFL TSNIT Thickness graph- ONH B-scan- Data available on screen & on printout | Identical, except the normativedatabase. Removed color codedNDB for ETDRS grid sectorthickness. |
| Advanced RPE Analysis | - Advanced RPE Analysis | - Advanced RPE Analysis | Identical |
| PanoMap Analysis | - Macular Cube 512x128 or- Macular Cube 200x200 and- Optic Disc Cube 200x200 scan forthe same eye.- Montage of Macular Cube andOptic Disc Cube OCT en faceimages | - Macular Cube 512x128 or- Macular Cube 200x200 and- Optic Disc Cube 200x200 scanfor the same eye.- Montage of Macular Cube and- Optic Disc Cube OCT en faceimages | Identical |
| K222200 - 510(k) Summary | Page 19 of 41 | ||
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4Subject Device | CIRRUS™ HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| Wellness Exam Report | This is an OU wide field analysis thatcombines information from the macularthickness analysis. PanoMap analysis,RNFL and ONH analysis and ganglioncell OU analysis into one report. | Not Available | Different |
| OCT AngiographyReport / Analysis | OCT Angiography ReportOCT Angiography ChangeAnalysis | OCT Angiography ReportOCT Angiography ChangeAnalysis | Identical |
| ORCC & RPE-to-RPEFit Slabs (pre-set) inOCTA Analysis | ORCC (Outer Retina toChorioCapillaris), Sub-RPE, RPE-to-RPEFit slabs in OCTA Analysis | Not Available | Different, these slabs arecalculated from existing slabson the predicate.Sub-RPE in CIRRUS 6000v11.5.4 was formerly calledChoriocapillaris in CIRRUS5000 v10.0 |
| K222200 - 510(k) Summary | Page 20 of 41 | ||
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4Subject Device | CIRRUSTM HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| Anterior Segment -Analysis withQuantitativeMeasurement Tools | - Anterior 5-Line Raster- Thickness calipers- Anterior Segment Cube- 3D Visualization- Thickness calipers- Pachymetry Scan- Corneal thickness- Epithelial thickness | - Anterior 5-Line Raster- Thickness calipers- Anterior Segment Cube- 3D Visualization- Thickness calipers- Pachymetry Scan- Corneal thickness- Epithelial thickness | Identical |
| ONH AngiographyTwo-Visit Comparison | - visual side by side comparison oftwo angiography visits on theanalysis screen and correspondingreport print out. | - visual side by side comparison oftwo angiography visits on theanalysis screen and correspondingreport print out. | Identical |
| Normative Database,Diverse | - Not Available | - Retinal Nerve Fiber Layer (RNFL)- Thickness- Macular Thickness- Optic Nerve Head (ONH)- Parameters- Ganglion Cell/IPL Thickness | Different, CIRRUS 6000 doesnot include normative referencedatabase functionality for scansacquired from the CIRRUS6000. |
| FUNDUS IMAGING | |||
| Methodology | Line Scanning Ophthalmoscope | Line Scanning Ophthalmoscope | Identical |
| Optical Source | Super Luminescent Diode (SLD) | Super Luminescent Diode (SLD) | Identical |
| K222200 - 510(k) Summary | Page 21 of 41 | ||
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4Subject Device | CIRRUSTM HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| 750 nm | 750 nm | ||
| Optical Power | < 1.5 mW at the cornea | < 1.5 mW at the cornea | Identical |
| Field of View | 36 degrees W x 30 degrees H | 36 degrees W x 30 degrees H | Identical |
| Frame Rate | > 20 Hz | > 20 Hz | Identical |
| Transverse Resolution | 25 um (in tissue) | 25 um (in tissue) | Identical |
| IRIS IMAGING | |||
| Methodology | CMOS camera and LED illumination | CMOS camera and LED illumination | Identical |
| Optical source | 1280 x 1024 | 1280 x 1024 | Identical |
| Resolution | During alignment | During alignment | Identical |
| Live iris image | Light emitting diode (LED), 700 nm | Light emitting diode (LED), 700 nm | Identical |
| FIXATION | |||
| Internal fixation source | LED Array, 21 positions (Same 9positions as CIRRUS 5000 plus anadditional 12 positions) | LED Array, 9 positions | Different |
| Internal fixation focusadjustment | -20D to +20D (diopters) | -20D to +20D (diopters) | Identical |
| K222200 - 510(k) Summary | Page 22 of 41 | ||
| Device | CIRRUS™ HD-OCT 6000 v. 11.5.4Subject Device | CIRRUS™ HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| External fixation source | Mechanically adjustable arm with LEDat the tip | Mechanically adjustable arm with LEDat the tip | Identical |
| ELECTRICAL, PHYSICAL, ENVIRONMENTAL | |||
| Configuration | Patient module, computer, media andpower supply integrated into singlecompact module | Patient module, computer, media andpower supply integrated into singlecompact module | Identical |
| Computer | High performance multi-core processorCORE i7 @ 3.6 GHz, 32GB RAM,2TB Hard Disk, Windows 10, SSD | High performance multi-core processorCORE i7 @ 3.1GHz, 16GB RAM,2TB Hard Disk, Windows 10 | Different |
| Input Devices | Computer mouse/keyboard | Computer mouse/keyboard | Identical |
| Display | 22" Widescreen HD(Resolution 1920 x 1080) | 19" Color Flat Panel Display(Resolution 1280 x 1024) | Different |
| Network | Network and additional USBconnectors under rear cover. | Network and additional USBconnectors under rear cover. | Identical |
| Optical media formatssupported | 6 USB Media ports | 6 USB Media ports | Identical |
| Weight | 35 kg (77 lbs) (without monitor) | 36 kg (80 lbs) | Different |
| Dimensions | 62.2L x 42.5W x 49.4H (cm) | 62.2L x 42.5W x 49.4H (cm) | Identical |
| Electrical rating (115V) | 100-120 V~ 50-60 Hz 6.3A | 100-120 V~ 50-60 Hz 6.3A | Identical |
| Power rating (115V) | 500W | 350W | Different |
| Device | CIRRUSTM HD-OCT 6000 v. 11.5.4 | CIRRUSTM HD-OCT 5000 v. 10.0 | Analysis |
| Subject Device | Predicate Device (K181534) | ||
| Fuse rating (115V) | T 6.3 A 250V | T 5A 250V | Different, power consumptionfor enhanced speed andcapabilities push the powerbudget to the place where higherrated power supply is needed |
| Max amperage andvoltage rating | T 6.3A 250V | T 5A 250V | Different, Compliant with IEC60601 requirements. |
| EnvironmentalConditions:Transport and Storage | Temp. -40° to +70° C30% to 75% (excluding condensation) | Temp. -40° to +70° C30% to 75% (excluding condensation) | Identical |
| Atmospheric Pressure500 to 1060 hPa | Atmospheric Pressure500 to 1060 hPa | ||
| EnvironmentalConditions: Operation | Temperature:+10 to +35° C | Temperature:+10 to +35° C | Identical |
| Relative Humidity:30% to 75% (excluding condensation) | Relative Humidity:30% to 75% (excluding condensation) | ||
| Atmospheric Pressure:700 to 1060 hPa | Atmospheric Pressure:700 to 1060 hPa | ||
| Enclosure-FlammabilityRatings | UL 94V-0 | UL 94V-0 | Identical |
| UX | |||
| Device | CIRRUS™ HD-OCT 6000 v. 11.5.4Subject Device | CIRRUS™ HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| Protocol buttons | - Workflow buttons filter scanpatterns for acquisition | Not Available | Different |
| Scan Protocols | - user-selectable scan protocols onthe patient management screen thatdefine a specific set of scans to beacquired. | Not Available | Different |
| Preferred Analysis | - allows the user to preconfigure thepreferred analysis to auto load. Thisis a UI update that allows the userto see first 4 preferred analysesevery time | Not Available | DifferentThis is a workflowimprovement, not a technicalimprovement. This provides theuser a streamlined selectionbased on their preferencesand/or practices. |
| Anterior SegmentCaliper Tool | - This tool is able to snap to thesurfaces identified by the software,including anterior cornea andposterior cornea. | Not Available | DifferentUser interface improvements |
| Analysis switch eye | - allows the user to switch to the'other' eye for the same analyses | Not Available | Different, user interfaceimprovements |
| New Circle Tool forAngiography | - a manually placed circle tool forannotation purposes | Not Available | Different, user interfaceimprovements |
| K222200 - 510(k) Summary | Page 25 of 41 | ||
| Device | CIRRUS TM HD-OCT 6000 v. 11.5.4Subject Device | CIRRUS TM HD-OCT 5000 v. 10.0Predicate Device (K181534) | Analysis |
| New Freehand Tool forAngiography | A scalable circle and freeform measurement tools for the OCTAngiography and ONHAngiography enface image whichdisplays estimated values for areaand perimeter/diameter | Not Available | Different, user interfaceimprovements |
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Image /page/7/Picture/0 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and set against a solid blue background. The bottom of the blue background is curved.
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Image /page/8/Picture/0 description: The image shows the Zeiss logo. The logo consists of the word "ZEISS" in a bold, sans-serif font, stacked on top of a blue rectangle. The bottom of the blue rectangle is curved.
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Image /page/9/Picture/0 description: The image shows the ZEISS logo. The logo consists of the word "ZEISS" in a bold, sans-serif font, set against a solid blue background. The bottom of the blue background has a curved shape.
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Image /page/10/Picture/0 description: The image contains the word "ZEISS" in white text on a blue background. The word is written in a bold, sans-serif font. The blue background is a solid color and takes up most of the image. The word "ZEISS" is positioned at the top of the blue background.
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Image /page/11/Picture/0 description: The image shows the logo for ZEISS. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue background. The background is shaped like a rectangle with a curved bottom edge.
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. . . .
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Image /page/15/Picture/0 description: The image contains the word "ZEISS" in white text on a blue background. The word is written in a bold, sans-serif font. The blue background is a solid color and takes up most of the image. The word "ZEISS" is positioned at the top of the blue background.
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Image /page/16/Picture/0 description: The image shows the ZEISS logo. The logo consists of the word "ZEISS" in a bold, sans-serif font, stacked on top of a blue rectangle. The bottom of the blue rectangle is curved, giving it a slightly rounded appearance.
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Image /page/17/Picture/0 description: The image shows the logo for ZEISS. The logo is a blue square with the word "ZEISS" in white letters. The bottom of the square is curved.
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Image /page/18/Picture/0 description: The image shows the logo for ZEISS. The logo is white text on a blue background. The text is in all capital letters and is bolded. The background is a solid blue color and is in the shape of a rectangle with a curved bottom.
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Image /page/19/Picture/0 description: The image shows the logo for ZEISS. The logo consists of the word "ZEISS" in a bold, sans-serif font, stacked on top of a blue rectangle. The bottom of the blue rectangle has a curved shape.
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Image /page/20/Picture/0 description: The image shows the logo for ZEISS. The logo consists of the word "ZEISS" in a bold, sans-serif font, stacked on top of a blue rectangle. The bottom of the blue rectangle is curved, creating a subtle, convex shape.
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Image /page/21/Picture/0 description: The image contains the logo for ZEISS. The logo is a blue square with the word "ZEISS" in white letters. The bottom of the square is curved.
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Image /page/22/Picture/0 description: The image shows the ZEISS logo. The logo consists of the word "ZEISS" in a bold, sans-serif font, set against a solid blue background. The bottom of the blue background has a curved shape.
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Image /page/23/Picture/0 description: The image contains the word "ZEISS" in large, bold, white letters against a solid blue background. The word is stacked vertically, with each letter aligned on top of the other. The blue background is a solid rectangle with a curved bottom edge, giving it a slightly rounded appearance.
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Image /page/24/Picture/0 description: The image features the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue background. The background is shaped like a rectangle with a curved bottom edge, giving it a distinctive appearance.
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Page 23 of 41
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7. SUMMARY OF STUDIES
Non-Clinical Performance Testing
Non-clinical system testing provided an evaluation of the system relevant to each of the system specifications. The functional and system level that the system met the defined specifications. ZEISS demonstrated non-clinical equivalency between the CIRRUS 6000 and CIRRUS 5000 scan data using a phantom retina, which shows the equivalency of the segmentation results as the segmentation algorithms are the same in both instruments.
Sterility, Shelf-Life, Biocompatibility, and Animal testing was not required for this submission and thus not used in substantiation of equivalence.
Software verification and validation testing were conducted, and documentation was provided as recommended by the FDA's Guidance for Industry and Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". There have been no changes in level of concern or software architecture. All testing passed.
Due to changes to hardware stated in the device description section, updated IEC 60601-1-2 was provided to demonstrate that the changes did not have a negative impact on the device's electrical safety profile. All testing has passed.
Bench Testing followed FDA's 510(k) OCT Pilot Program Recommendations
- . Spatial performance
- Device sensitivity
- OCT angiography ●
- Auxiliary functions testing ●
- Safety and Essential Performance: IEC 60601-1 ●
- Electromagnetic Compatibility: IEC 60601-1-2
- Usability: IEC 62366-1 ●
- Optical resolution testing (lateral and axial resolution)
- Light Hazard Protection for Ophthalmic Instruments: ANSI Z80.36-2016 ●
- . Gage R&R segmentation comparison between CIRRUS 5000 and CIRRUS 6000
All the above testing passed. No additional safety or performance concerns have been raised during development or device testing.
Clinical Performance Testing
Clinical performance testing was performed to substantiate subject device's equivalence. These studies included repeatability and reproducibility, qualitative image grading and agreement.
CIRRUS 6000 Repeatability and Reproducibility (R&R)
This was a prospective. multi-site study. A total of 117 subjects were enrolled: 27 without ocular pathology (normal), 37 with glaucoma, 30 with retinal pathology, and 23 with status post refractive surgery or with corneal pathology. 9 subjects were disqualified because they did not meet the inclusion or were disqualified after scans due to the presence of macular changes due to drusen. The subject age range was 20-90, with a mean
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age of 53.9 ± 12.4 for the normal sub-group, 71.2 ± 10.0 for the glaucoma subgroup, 73.0 ± 11.3 for the retinal pathology subgroup, 66.9 ± 15.9 for the cornea subgroup. The study population was composed of 46 (42.6%) females and 62 (57.4%) male subjects. 18 (16.7%) subjects were Asian. 5 (4.6%) subjects were Black, 79 (73.1%) subjects were Caucasian, and 6 (5.6%) subjects were listed as "Other". 96.0% of CIRRUS 6000 and 94.9% of CIRRUS 5000 scans acquired were valid and analyzed. Acquired scans were invalidated due to poor image quality (1.2-1.3%), scan decentration (1.7-2.4%), eye did not meet inclusion criteria (1.1%), poor signal strength (0.1%), or algorithm failure (0.2%).
Three acceptable scans of each scan type were acquired on each of the study devices (three CIRRUS 6000 and three CIRRUS 5000 devices) with assigned operator/device pairs. Analysis of variance was performed to determine the repeatability and reproducibility as well as the variance associated with the combination of operator and device. Agreement between CIRRUS 5000 and CIRRUS 6000 was evaluated with Bland-Altman Limits of Agreement, and Deming Regression analysis methods.
The CIRRUS 6000 (C6000) R&R results are presented in the tables below:
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
|---|---|---|---|---|---|---|---|---|
| Ganglion Cell Thickness | ||||||||
| Average Thickness (µm) | 82.1 | 0.20 | 0.41 | 0.5% | 1.1 | 0.48 | 0.6% | 1.3 |
| Temporal Superior (µm) | 81.2 | 0.13 | 0.65 | 0.8% | 1.8 | 0.79 | 1.0% | 2.2 |
| Superior (µm) | 82.6 | 0.36 | 0.72 | 0.9% | 2.0 | 0.82 | 1.0% | 2.3 |
| Nasal Superior (µm) | 83.8 | 0.39 | 0.74 | 0.9% | 2.1 | 0.92 | 1.1% | 2.6 |
| Nasal Inferior (µm) | 81.9 | 0.25 | 0.70 | 0.8% | 1.9 | 0.80 | 1.0% | 2.2 |
| Inferior (µm) | 80.3 | 0.33 | 0.78 | 1.0% | 2.2 | 0.87 | 1.1% | 2.4 |
| Temporal Inferior (µm) | 82.8 | 0.12 | 0.69 | 0.8% | 1.9 | 0.85 | 1.0% | 2.4 |
| Minimum Thickness (µm) | 80.6 | 0.14 | 0.80 | 1.0% | 2.2 | 0.86 | 1.1% | 2.4 |
| Macular Thickness | ||||||||
| Central Subfield (µm) | 267.8 | 0.031 | 1.0 | 0.4% | 2.9 | 2.0 | 0.7% | 5.6 |
| Inner Temporal (µm) | 316.2 | 0.91 | 1.2 | 0.4% | 3.4 | 2.5 | 0.8% | 7.1 |
| Inner Superior (µm) | 329.3 | 0.76 | 1.3 | 0.4% | 3.8 | 2.4 | 0.7% | 6.6 |
| Inner Nasal (µm) | 331.4 | 0.81 | 1.2 | 0.4% | 3.3 | 2.3 | 0.7% | 6.5 |
| Inner Inferior (µm) | 325.4 | 0.24 | 1.2 | 0.4% | 3.3 | 2.3 | 0.7% | 6.5 |
| Outer Temporal (µm) | 265.3 | 1.3 | 1.3 | 0.5% | 3.6 | 2.4 | 0.9% | 6.9 |
| Outer Superior (µm) | 284.2 | 1.1 | 1.1 | 0.4% | 3.1 | 2.0 | 0.7% | 5.6 |
| Outer Nasal (µm) | 303.1 | 0.98 | 0.95 | 0.3% | 2.7 | 2.0 | 0.7% | 5.7 |
| Outer Inferior (µm) | 270.7 | 1.1 | 1.3 | 0.5% | 3.5 | 2.4 | 0.9% | 6.7 |
Table 3. C6000 Macular Cube 512x128 Macular Thickness scans, Normal Subjects (n=225 scans), Precision Summary
{30}------------------------------------------------
Image /page/30/Picture/0 description: The image shows the word "ZEISS" in white letters on a blue background. The word is in a bold, sans-serif font. Below the word is a curved white line, which gives the impression of a horizon. The logo is simple and modern.
| K222200 - 510(k) Summary Page 28 of 41 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
| Average Cube Thickness(μm) | 285.2 | 1.0 | 1.3 | 0.5% | 3.7 | 2.0 | 0.7% | 5.5 |
| Volume Cube (mm3) | 10.3 | 0.032 | 0.052 | 0.5% | 0.15 | 0.077 | 0.8% | 0.22 |
Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components.
Repeatability and reproducibility limits are 2.8 · SD.
%CV is calculated as 100*SD/Mean.
Table 4. C6000 Optic Disc Cube 200x200 RNFL Thickness scans, Normal Subjects (n=214 scans), Precision Summary
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
|---|---|---|---|---|---|---|---|---|
| ONH | ||||||||
| Rim Area (mm2) | 1.3 | 0.004 | 0.063 | 4.9% | 0.18 | 0.084 | 6.6% | 0.24 |
| Disc Area (mm2) | 1.8 | 0.000 | 0.11 | 6.4% | 0.32 | 0.16 | 8.7% | 0.43 |
| Average Cup/Disc Ratio | 0.51 | 0.000 | 0.018 | 3.6% | 0.052 | 0.022 | 4.3% | 0.061 |
| Vertical C/D Ratio | 0.48 | 0.005 | 0.024 | 5.0% | 0.067 | 0.028 | 5.7% | 0.078 |
| Cup Volume (mm3) | 0.15 | 0.000 | 0.007 | 4.5% | 0.018 | 0.008 | 5.2% | 0.022 |
| RNFL Thickness | ||||||||
| Average RNFL Thickness(μm) | 95.9 | 0.54 | 1.2 | 1.2% | 3.3 | 1.7 | 1.8% | 4.9 |
| Temporal (µm) | 64.9 | 0.24 | 2.1 | 3.3% | 5.9 | 2.6 | 4.0% | 7.3 |
| Superior (µm) | 118.6 | 1.7 | 2.7 | 2.3% | 7.6 | 4.3 | 3.7% | 12.2 |
| Nasal (µm) | 74.8 | 0.63 | 2.1 | 2.8% | 5.9 | 2.9 | 3.9% | 8.2 |
| Inferior (µm) | 125.2 | 0.55 | 2.8 | 2.2% | 7.8 | 3.3 | 2.6% | 9.3 |
| Clock hour 1 (μm) | 107.9 | 2.8 | 3.7 | 3.4% | 10.3 | 5.9 | 5.4% | 16.4 |
| Clock hour 2 (µm) | 92.7 | 0.000 | 3.6 | 3.9% | 10.2 | 5.2 | 5.6% | 14.6 |
| Clock hour 3 (μm) | 60.7 | 1.4 | 2.4 | 4.0% | 6.8 | 3.7 | 6.1% | 10.4 |
| Clock hour 4 (μm) | 70.9 | 0.66 | 2.9 | 4.1% | 8.1 | 4.1 | 5.8% | 11.6 |
| Clock hour 5 (μm) | 102.4 | 0.48 | 3.1 | 3.0% | 8.6 | 4.4 | 4.3% | 12.2 |
| Clock hour 6 (μm) | 139.2 | 0.000 | 4.8 | 3.4% | 13.3 | 5.6 | 4.0% | 15.6 |
| Clock hour 7 (μm) | 134.1 | 0.000 | 4.4 | 3.3% | 12.4 | 5.8 | 4.3% | 16.3 |
| Clock hour 8 (μm) | 63.6 | 0.000 | 2.6 | 4.1% | 7.3 | 3.3 | 5.1% | 9.1 |
| Clock hour 9 (μm) | 51.4 | 0.000 | 1.9 | 3.7% | 5.3 | 2.4 | 4.6% | 6.6 |
| Clock hour 10 (μm) | 79.7 | 0.55 | 2.7 | 3.4% | 7.7 | 3.9 | 4.9% | 10.9 |
{31}------------------------------------------------
Image /page/31/Picture/0 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue background. The logo is simple and recognizable, reflecting the company's focus on precision and quality.
| K222200 - 510(k) Summary | Page 29 of 41 | |||||||
|---|---|---|---|---|---|---|---|---|
| Variable | Mean | DevOp SD | Residual SD | Repeat. %CV | Repeat. Limit | Repro. SD | Repro. %CV | Repro. Limit |
| Clock hour 11 (μm) | 130.4 | 0.000 | 3.8 | 2.9% | 10.6 | 4.8 | 3.7% | 13.5 |
| Clock hour 12 (μm) | 117.5 | 2.1 | 4.1 | 3.5% | 11.4 | 6.5 | 5.6% | 18.3 |
Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components.
Repeatability and reproducibility limits are 2.8 · SD.
%CV is calculated as 100*SD/Mean.
Table 5. C6000 Pachymetry Thickness scans, Normal Subjects (n=207 scans), Precision Summary
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
|---|---|---|---|---|---|---|---|---|
| Epithelial Thickness | ||||||||
| Central (um) | 49.1 | 0.000 | 0.90 | 1.8% | 2.5 | 1.8 | 3.8% | 5.2 |
| Inner Nasal (um) | 48.1 | 0.22 | 1.2 | 2.6% | 3.5 | 2.2 | 4.6% | 6.2 |
| Inner SuperoNasal (um) | 47.6 | 0.55 | 1.2 | 2.5% | 3.4 | 2.1 | 4.4% | 5.8 |
| Inner Superior (um) | 46.6 | 0.26 | 1.2 | 2.7% | 3.5 | 2.0 | 4.2% | 5.5 |
| Inner SuperoTemporal(um) | 46.5 | 0.000 | 1.1 | 2.5% | 3.2 | 2.1 | 4.6% | 6.0 |
| Inner Temporal (um) | 47.0 | 0.000 | 1.1 | 2.4% | 3.1 | 2.1 | 4.5% | 5.9 |
| Inner InferoTemporal (um) | 47.9 | 0.000 | 1.1 | 2.3% | 3.1 | 2.3 | 4.9% | 6.6 |
| Inner Inferior (um) | 48.6 | 0.34 | 1.1 | 2.3% | 3.1 | 2.6 | 5.3% | 7.2 |
| Inner InferoNasal (um) | 48.5 | 0.47 | 1.1 | 2.2% | 3.1 | 2.5 | 5.1% | 7.0 |
| Middle Nasal (um) | 46.9 | 0.000 | 1.3 | 2.7% | 3.6 | 2.5 | 5.3% | 6.9 |
| Middle SuperoNasal (um) | 45.6 | 0.27 | 1.5 | 3.3% | 4.2 | 2.0 | 4.4% | 5.7 |
| Middle Superior (um) | 43.5 | 0.17 | 1.6 | 3.6% | 4.4 | 1.9 | 4.3% | 5.3 |
| Middle SuperoTemporal(um) | 43.8 | 0.30 | 1.4 | 3.2% | 3.9 | 1.9 | 4.4% | 5.4 |
| Middle Temporal (um) | 45.4 | 0.000 | 1.3 | 2.8% | 3.6 | 2.3 | 5.0% | 6.4 |
| Middle InferoTemporal(um) | 47.0 | 0.25 | 1.2 | 2.6% | 3.4 | 2.7 | 5.7% | 7.5 |
| Middle Inferior (um) | 47.3 | 0.45 | 0.99 | 2.1% | 2.8 | 2.5 | 5.2% | 6.9 |
| Middle InferoNasal (um) | 46.9 | 0.001 | 1.2 | 2.5% | 3.3 | 2.8 | 5.9% | 7.7 |
| Outer Nasal (um) | 47.5 | 0.000 | 1.5 | 3.2% | 4.3 | 2.5 | 5.4% | 7.1 |
| Outer SuperoNasal (um) | 44.1 | 0.000 | 2.4 | 5.5% | 6.9 | 2.8 | 6.3% | 7.7 |
| Outer Superior (um) | 40.9 | 0.000 | 1.8 | 4.5% | 5.2 | 2.0 | 4.9% | 5.6 |
| Outer SuperoTemporal(um) | 41.3 | 0.000 | 2.1 | 5.2% | 6.0 | 2.5 | 6.0% | 6.9 |
{32}------------------------------------------------
Image /page/32/Picture/0 description: The image shows the ZEISS logo. The logo consists of the word "ZEISS" in a bold, sans-serif font, set against a solid blue background. The letters are white, creating a strong contrast with the background.
| K222200 - 510(k) Summary | Page 30 of 41 | |||||||
|---|---|---|---|---|---|---|---|---|
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
| Outer Temporal (µm) | 44.5 | 0.000 | 1.4 | 3.1% | 3.8 | 2.4 | 5.4% | 6.7 |
| Outer InferoTemporal (µm) | 46.9 | 0.000 | 1.7 | 3.6% | 4.7 | 2.9 | 6.1% | 8.0 |
| Outer Inferior (µm) | 45.6 | 0.000 | 1.0 | 2.3% | 2.9 | 2.8 | 6.0% | 7.7 |
| Outer InferoNasal (µm) | 46.4 | 0.000 | 2.0 | 4.3% | 5.6 | 3.1 | 6.8% | 8.8 |
| Pachymetry Thickness | ||||||||
| Central (µm) | 543.3 | 0.000 | 1.2 | 0.2% | 3.2 | 2.0 | 0.4% | 5.5 |
| Inner Nasal (μm) | 566.0 | 0.27 | 2.5 | 0.4% | 6.9 | 3.1 | 0.5% | 8.7 |
| Inner SuperoNasal (µm) | 571.6 | 1.8 | 2.8 | 0.5% | 7.8 | 3.8 | 0.7% | 10.6 |
| Inner Superior (µm) | 570.9 | 2.4 | 3.2 | 0.6% | 9.1 | 4.4 | 0.8% | 12.3 |
| Inner SuperoTemporal(µm) | 559.1 | 1.4 | 2.3 | 0.4% | 6.4 | 3.2 | 0.6% | 8.8 |
| Inner Temporal (µm) | 547.6 | 0.000 | 1.6 | 0.3% | 4.4 | 2.4 | 0.4% | 6.8 |
| Inner InferoTemporal (µm) | 548.0 | 1.2 | 2.1 | 0.4% | 5.8 | 3.4 | 0.6% | 9.6 |
| Inner Inferior (µm) | 556.0 | 1.5 | 3.0 | 0.5% | 8.4 | 4.4 | 0.8% | 12.3 |
| Inner InferoNasal (µm) | 562.1 | 1.2 | 2.8 | 0.5% | 7.8 | 4.0 | 0.7% | 11.1 |
| Outer Nasal (µm) | 599.8 | 1.2 | 3.7 | 0.6% | 10.3 | 4.7 | 0.8% | 13.2 |
| Outer SuperoNasal (µm) | 609.6 | 3.3 | 4.9 | 0.8% | 13.8 | 7.1 | 1.2% | 20.0 |
| Outer Superior (µm) | 610.4 | 4.7 | 6.0 | 1.0% | 16.9 | 8.9 | 1.5% | 24.8 |
| Outer SuperoTemporal(µm) | 590.6 | 2.1 | 4.0 | 0.7% | 11.2 | 5.0 | 0.9% | 14.1 |
| Outer Temporal (µm) | 568.2 | 0.000 | 2.5 | 0.4% | 7.0 | 3.3 | 0.6% | 9.4 |
| Outer InferoTemporal (µm) | 570.4 | 0.000 | 3.6 | 0.6% | 10.0 | 8.5 | 1.5% | 23.9 |
| Outer Inferior (µm) | 585.2 | 1.7 | 4.4 | 0.8% | 12.4 | 7.9 | 1.3% | 22.0 |
| Outer InferoNasal (µm) | 594.7 | 1.6 | 4.0 | 0.7% | 11.3 | 5.5 | 0.9% | 15.5 |
Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components. Repeatability and reproducibility limits are 2.8 · SD.
%CV is calculated as 100*SD/Mean.
Table 6. C6000 Macular Cube 512x128 Macular Thickness scans, Glaucoma Subjects (n=271 scans), Precision Summary
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
|---|---|---|---|---|---|---|---|---|
| Ganglion Cell Thickness |
{33}------------------------------------------------
Image /page/33/Picture/0 description: The image shows the logo for ZEISS, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font, set against a solid blue background. Below the wordmark, there is a curved shape, also in blue, that suggests the lens or optical element. The overall design is clean and modern, reflecting the company's focus on precision and technology.
| K222200 - 510(k) Summary | Page 31 of 41 | |||||||
|---|---|---|---|---|---|---|---|---|
| Variable | Mean | DevOpSD | ResidalSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
| Average Thickness(μm) | 61.5 | 0.000 | 0.82 | 1.3% | 2.3 | 0.98 | 1.6% | 2.7 |
| Temporal Superior (µm) | 62.1 | 0.000 | 1.2 | 2.0% | 3.4 | 1.5 | 2.4% | 4.1 |
| Superior (µm) | 62.5 | 0.000 | 2.3 | 3.7% | 6.5 | 2.5 | 4.0% | 7.0 |
| Nasal Superior (µm) | 64.1 | 0.000 | 1.4 | 2.1% | 3.8 | 1.8 | 2.8% | 5.1 |
| Nasal Inferior (μm) | 61.5 | 0.000 | 0.86 | 1.4% | 2.4 | 1.1 | 1.7% | 3.0 |
| Inferior (µm) | 58.7 | 0.000 | 1.4 | 2.5% | 4.0 | 1.6 | 2.7% | 4.5 |
| Temporal Inferior (µm) | 60.1 | 0.056 | 0.93 | 1.6% | 2.6 | 1.1 | 1.8% | 3.0 |
| Minimum Thickness(μm) | 55.4 | 0.000 | 2.1 | 3.7% | 5.8 | 2.1 | 3.7% | 5.8 |
| Macular Thickness | ||||||||
| Central Subfield (µm) | 262.5 | 0.000 | 1.3 | 0.5% | 3.5 | 1.6 | 0.6% | 4.5 |
| Inner Temporal (µm) | 289.2 | 0.39 | 1.6 | 0.6% | 4.6 | 2.0 | 0.7% | 5.6 |
| Inner Superior (μm) | 300.4 | 0.34 | 1.8 | 0.6% | 4.9 | 2.0 | 0.7% | 5.7 |
| Inner Nasal (µm) | 308.1 | 0.40 | 1.5 | 0.5% | 4.2 | 1.8 | 0.6% | 5.1 |
| Inner Inferior (μm) | 292.2 | 0.000 | 1.7 | 0.6% | 4.8 | 2.0 | 0.7% | 5.6 |
| Outer Temporal (µm) | 242.7 | 0.56 | 1.6 | 0.6% | 4.4 | 2.0 | 0.8% | 5.5 |
| Outer Superior (µm) | 256.3 | 0.64 | 1.5 | 0.6% | 4.2 | 1.8 | 0.7% | 5.1 |
| Outer Nasal (μm) | 269.8 | 0.74 | 1.5 | 0.6% | 4.2 | 1.9 | 0.7% | 5.4 |
| Outer Inferior (µm) | 239.5 | 0.76 | 1.5 | 0.6% | 4.1 | 2.0 | 0.8% | 5.6 |
| Average CubeThickness (µm) | 256.8 | 0.8 | 1.4 | 0.6% | 4.0 | 2.1 | 0.8% | 6.0 |
| Volume Cube (mm3) | 9.2 | 0.026 | 0.057 | 0.6% | 0.16 | 0.075 | 0.8% | 0.21 |
Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components. Repeatability and reproducibility limits are 2.8 · SD. %CV is calculated as 100*SD/Mean.
| Table 7. C6000 Optic Disc Cube 200x200 RNFL Thickness scans, Glaucoma Subjects (n=260 scans) |
|---|
| Precision Summary |
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
|---|---|---|---|---|---|---|---|---|
| ONH | ||||||||
| Rim Area (mm2) | 0.81 | 0.000 | 0.062 | 7.6% | 0.17 | 0.063 | 7.7% | 0.18 |
| Disc Area (mm2) | 1.7 | 0.000 | 0.12 | 7.2% | 0.34 | 0.12 | 7.2% | 0.34 |
| Average Cup/Disc Ratio | 0.68 | 0.000 | 0.013 | 1.9% | 0.036 | 0.014 | 2.0% | 0.039 |
{34}------------------------------------------------
Image /page/34/Picture/0 description: The image shows the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue background. The bottom of the image has a curved white shape, possibly part of a logo.
| K222200 - 510(k) SummaryPage 32 of 41 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Variable | Mean | DevOp SD | Residual SD | Repeat. %CV | Repeat. Limit | Repro. SD | Repro. %CV | Repro. Limit |
| Vertical C/D Ratio | 0.71 | 0.003 | 0.021 | 2.9% | 0.058 | 0.023 | 3.2% | 0.063 |
| Cup Volume (mm3) | 0.37 | 0.000 | 0.029 | 7.8% | 0.082 | 0.029 | 7.8% | 0.082 |
| RNFL Thickness | ||||||||
| Average RNFL Thickness (μm) | 70.3 | 0.45 | 1.3 | 1.9% | 3.7 | 1.7 | 2.4% | 4.7 |
| Temporal (μm) | 50.1 | 0.30 | 1.6 | 3.1% | 4.4 | 1.8 | 3.7% | 5.2 |
| Superior (μm) | 83.6 | 0.96 | 2.5 | 3.0% | 7.0 | 3.0 | 3.6% | 8.4 |
| Nasal (μm) | 67.5 | 0.000 | 2.3 | 3.4% | 6.4 | 3.0 | 4.4% | 8.3 |
| Inferior (μm) | 80.3 | 0.73 | 2.6 | 3.2% | 7.3 | 3.3 | 4.1% | 9.1 |
| Clock hour 1 (μm) | 78.7 | 1.1 | 3.4 | 4.4% | 9.6 | 4.4 | 5.5% | 12.2 |
| Clock hour 2 (μm) | 75.0 | 0.000 | 3.5 | 4.6% | 9.7 | 4.0 | 5.4% | 11.3 |
| Clock hour 3 (μm) | 64.1 | 0.41 | 2.7 | 4.2% | 7.6 | 3.4 | 5.3% | 9.6 |
| Clock hour 4 (μm) | 63.3 | 0.000 | 2.9 | 4.5% | 8.0 | 3.6 | 5.7% | 10.1 |
| Clock hour 5 (μm) | 74.0 | 0.68 | 2.9 | 3.9% | 8.1 | 4.1 | 5.5% | 11.4 |
| Clock hour 6 (μm) | 87.9 | 0.94 | 4.4 | 5.0% | 12.4 | 5.2 | 6.0% | 14.7 |
| Clock hour 7 (μm) | 78.9 | 0.24 | 3.4 | 4.3% | 9.5 | 4.1 | 5.2% | 11.6 |
| Clock hour 8 (μm) | 49.0 | 0.39 | 2.6 | 5.3% | 7.3 | 3.2 | 6.5% | 8.9 |
| Clock hour 9 (μm) | 44.2 | 0.000 | 1.6 | 3.6% | 4.4 | 2.1 | 4.7% | 5.8 |
| Clock hour 10 (μm) | 56.9 | 0.41 | 2.5 | 4.4% | 7.0 | 2.5 | 4.4% | 7.1 |
| Clock hour 11 (μm) | 84.2 | 0.000 | 3.6 | 4.3% | 10.1 | 4.4 | 5.3% | 12.4 |
| Clock hour 12 (um) | 87.9 | 1.5 | 4.7 | 5.4% | 13.2 | 5.1 | 5.8% | 14.2 |
Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components. Repeatability and reproducibility limits are 2.8 · SD. %CV is calculated as 100*SD/Mean.
| Table 8. C6000 Pachymetry Thickness scans, Glaucoma Subjects (n=254 scans), Precision Summary | |||
|---|---|---|---|
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
|---|---|---|---|---|---|---|---|---|
| Epithelial Thickness | ||||||||
| Central (µm) | 47.0 | 0.000 | 1.5 | 3.2% | 4.2 | 1.9 | 4.1% | 5.3 |
| Inner Nasal (µm) | 45.3 | 0.000 | 1.6 | 3.5% | 4.5 | 2.3 | 5.0% | 6.3 |
| Inner SuperoNasal (µm) | 44.8 | 0.000 | 1.7 | 3.8% | 4.8 | 2.2 | 5.0% | 6.3 |
| Inner Superior (µm) | 44.2 | 0.21 | 1.5 | 3.4% | 4.2 | 2.0 | 4.5% | 5.5 |
| K222200 - 510(k) Summary | Page 33 of 41 | |||||||
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
| Inner SuperoTemporal(μm) | 44.2 | 0.000 | 1.7 | 3.8% | 4.7 | 2.1 | 4.7% | 5.8 |
| Inner Temporal (μm) | 44.8 | 0.000 | 1.9 | 4.3% | 5.3 | 2.5 | 5.5% | 6.9 |
| Inner InferoTemporal (μm) | 45.9 | 0.000 | 1.9 | 4.2% | 5.4 | 2.6 | 5.7% | 7.3 |
| Inner Inferior (μm) | 47.0 | 0.27 | 2.0 | 4.3% | 5.6 | 2.5 | 5.4% | 7.1 |
| Inner InferoNasal (μm) | 46.5 | 0.000 | 1.9 | 4.1% | 5.4 | 2.4 | 5.1% | 6.7 |
| Middle Nasal (μm) | 44.2 | 0.000 | 1.6 | 3.5% | 4.4 | 2.2 | 5.0% | 6.2 |
| Middle SuperoNasal (μm) | 43.5 | 0.000 | 2.7 | 6.2% | 7.5 | 3.1 | 7.0% | 8.6 |
| Middle Superior (μm) | 41.8 | 0.000 | 1.7 | 4.1% | 4.8 | 2.3 | 5.5% | 6.4 |
| Middle SuperoTemporal(μm) | 42.1 | 0.000 | 1.7 | 4.1% | 4.9 | 2.1 | 5.1% | 6.0 |
| Middle Temporal (μm) | 43.5 | 0.000 | 2.0 | 4.5% | 5.5 | 2.6 | 6.0% | 7.3 |
| Middle InferoTemporal(µm) | 45.5 | 0.000 | 2.0 | 4.5% | 5.7 | 2.7 | 6.0% | 7.7 |
| Middle Inferior (μm) | 46.4 | 0.000 | 1.9 | 4.2% | 5.4 | 2.4 | 5.3% | 6.8 |
| Middle InferoNasal (μm) | 45.7 | 0.000 | 2.1 | 4.5% | 5.8 | 2.4 | 5.4% | 6.9 |
| Outer Nasal (μm) | 45.4 | 0.43 | 2.7 | 5.8% | 7.4 | 3.0 | 6.6% | 8.4 |
| Outer SuperoNasal (μm) | 42.8 | 0.000 | 2.2 | 5.2% | 6.2 | 2.8 | 6.5% | 7.8 |
| Outer Superior (μm) | 40.5 | 0.000 | 2.4 | 6.0% | 6.8 | 3.1 | 7.6% | 8.6 |
| Outer SuperoTemporal(μm) | 40.6 | 0.000 | 2.2 | 5.4% | 6.1 | 2.5 | 6.1% | 6.9 |
| Outer Temporal (μm) | 43.6 | 0.001 | 2.4 | 5.4% | 6.6 | 2.7 | 6.1% | 7.5 |
| Outer InferoTemporal (μm) | 46.6 | 0.000 | 2.4 | 5.1% | 6.6 | 2.8 | 6.0% | 7.8 |
| Outer Inferior (μm) | 46.2 | 0.000 | 2.0 | 4.3% | 5.6 | 2.5 | 5.3% | 6.9 |
| Outer InferoNasal (μm) | 46.3 | 0.54 | 2.1 | 4.5% | 5.8 | 2.8 | 5.9% | 7.7 |
| Pachymetry Thickness | ||||||||
| Central (μm) | 507.5 | 0.35 | 1.8 | 0.3% | 5.0 | 2.4 | 0.5% | 6.6 |
| Inner Nasal (μm) | 526.5 | 0.24 | 2.9 | 0.5% | 8.0 | 3.6 | 0.7% | 10.1 |
| Inner SuperoNasal (μm) | 533.4 | 1.4 | 3.8 | 0.7% | 10.5 | 4.8 | 0.9% | 13.5 |
| Inner Superior (μm) | 534.8 | 1.9 | 4.1 | 0.8% | 11.6 | 5.3 | 1.0% | 14.9 |
| Inner SuperoTemporal(µm) | 524.1 | 1.4 | 3.0 | 0.6% | 8.5 | 4.1 | 0.8% | 11.4 |
| Inner Temporal (μm) | 512.2 | 0.000 | 2.1 | 0.4% | 6.0 | 2.8 | 0.5% | 7.8 |
| Inner InferoTemporal (µm) | 513.5 | 0.83 | 2.7 | 0.5% | 7.6 | 3.6 | 0.7% | 10.1 |
| K222200 - 510(k) Summary | Page 34 of 41 | |||||||
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
| Inner Inferior (μm) | 521.3 | 0.86 | 3.2 | 0.6% | 8.9 | 4.2 | 0.8% | 11.6 |
| Inner InferoNasal (μm) | 524.2 | 0.83 | 3.1 | 0.6% | 8.6 | 3.9 | 0.8% | 11.0 |
| Outer Nasal (μm) | 556.3 | 1.3 | 3.9 | 0.7% | 10.9 | 4.8 | 0.9% | 13.6 |
| Outer SuperoNasal (μm) | 569.0 | 3.2 | 5.4 | 0.9% | 15.1 | 7.6 | 1.3% | 21.4 |
| Outer Superior (μm) | 574.8 | 3.4 | 6.0 | 1.0% | 16.7 | 8.5 | 1.5% | 23.9 |
| Outer SuperoTemporal(μm) | 556.5 | 1.5 | 4.4 | 0.8% | 12.2 | 5.6 | 1.0% | 15.5 |
| Outer Temporal (μm) | 532.0 | 0.000 | 2.6 | 0.5% | 7.4 | 3.5 | 0.7% | 9.9 |
| Outer InferoTemporal (μm) | 536.6 | 1.1 | 3.7 | 0.7% | 10.3 | 5.5 | 1.0% | 15.4 |
| Outer Inferior (μm) | 552.7 | 1.9 | 4.1 | 0.7% | 11.6 | 6.0 | 1.1% | 16.9 |
| Outer InferoNasal (μm) | 554.9 | 1.7 | 3.8 | 0.7% | 10.6 | 5.6 | 1.0% | 15.6 |
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Image /page/35/Picture/0 description: The image shows the word "ZEISS" in a bold, sans-serif font. The word is white and is set against a solid blue background. The bottom of the image shows a curved white line, suggesting a partial circle or arc.
{36}------------------------------------------------
Image /page/36/Picture/0 description: The image shows the word "ZEISS" in bold, white letters against a solid blue background. The letters are stacked vertically, with the top of the "Z" aligned with the top of the image. The bottom of the image has a curved white line, creating a subtle contrast with the blue background. The overall design is simple and clean, emphasizing the brand name.
Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components.
Repeatability and reproducibility limits are 2.8 · SD.
Table 9. C6000 Macular Cube 512x128 Macular Thickness scans, Retina Subjects (n=260 scans), Precision Summary
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
|---|---|---|---|---|---|---|---|---|
| Ganglion Cell Thickness | ||||||||
| Average Thickness (µm) | 71.5 | 0.000 | 4.0 | 5.6% | 11.2 | 4.4 | 6.1% | 12.2 |
| Temporal Superior (µm) | 75.9 | 0.000 | 3.9 | 5.1% | 10.8 | 4.4 | 5.8% | 12.4 |
| Superior (µm) | 66.7 | 0.000 | 4.9 | 7.3% | 13.7 | 5.7 | 8.6% | 16.0 |
| Nasal Superior (µm) | 73.4 | 0.000 | 5.2 | 7.1% | 14.7 | 5.6 | 7.6% | 15.7 |
| Nasal Inferior (µm) | 73.1 | 0.000 | 4.2 | 5.8% | 11.9 | 4.6 | 6.3% | 13.0 |
| Inferior (µm) | 67.4 | 0.000 | 5.0 | 7.5% | 14.1 | 5.6 | 8.3% | 15.6 |
| Temporal Inferior (µm) | 72.2 | 0.000 | 4.6 | 6.3% | 12.8 | 4.7 | 6.6% | 13.3 |
| Minimum Thickness (µm) | 54.7 | 0.000 | 6.9 | 12.5% | 19.2 | 7.4 | 13.5% | 20.7 |
| Macular Thickness | ||||||||
| Central Subfield (µm) | 274.2 | 0.31 | 2.4 | 0.9% | 6.6 | 2.6 | 1.0% | 7.3 |
| Inner Temporal (µm) | 310.7 | 0.82 | 1.9 | 0.6% | 5.2 | 2.3 | 0.7% | 6.4 |
| Inner Superior (µm) | 315.3 | 0.42 | 2.2 | 0.7% | 6.3 | 2.4 | 0.8% | 6.8 |
| Inner Nasal (µm) | 326.0 | 0.71 | 1.8 | 0.6% | 5.1 | 2.3 | 0.7% | 6.5 |
| Inner Inferior (µm) | 312.4 | 0.32 | 1.6 | 0.5% | 4.5 | 2.0 | 0.7% | 5.7 |
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Image /page/37/Picture/0 description: The image contains the word "ZEISS" in large, bold, white letters against a solid blue background. The word is centrally aligned and takes up a significant portion of the image. Below the word, there is a curved white shape, possibly part of a logo, but the details are not fully visible.
| K222200 - 510(k) Summary | Page 35 of 41 | |||||||
|---|---|---|---|---|---|---|---|---|
| Outer Temporal (µm) | 269.4 | 1.1 | 1.4 | 0.5% | 4.0 | 2.1 | 0.8% | 5.8 |
| Outer Superior (µm) | 275.9 | 0.33 | 1.4 | 0.5% | 4.1 | 2.0 | 0.7% | 5.6 |
| Outer Nasal (μm) | 293.7 | 0.57 | 1.1 | 0.4% | 3.0 | 1.5 | 0.5% | 4.2 |
| Outer Inferior (µm) | 265.1 | 0.95 | 1.3 | 0.5% | 3.7 | 2.0 | 0.7% | 5.5 |
| Average Cube Thickness(μm) | 279.9 | 0.68 | 1.5 | 0.5% | 4.2 | 1.9 | 0.7% | 5.4 |
| Volume Cube (mm3) | 10.1 | 0.025 | 0.058 | 0.6% | 0.16 | 0.072 | 0.7% | 0.20 |
Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components.
Repeatability and reproducibility limits are 2.8 · SD.
{38}------------------------------------------------
Image /page/38/Picture/0 description: The image contains the logo for ZEISS. The logo is white text on a blue background. The text is the company name, ZEISS, in a stylized font.
Page 36 of 41
Table 10. C6000 Optic Disc Cube 200x200 RNFL Thickness scans, Retina Subjects (n=196 scans), Precision Summary
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
|---|---|---|---|---|---|---|---|---|
| ONH | ||||||||
| Rim Area (mm2) | 1.2 | 0.009 | 0.034 | 2.8% | 0.095 | 0.039 | 3.2% | 0.11 |
| Disc Area (mm2) | 1.8 | 0.014 | 0.046 | 2.7% | 0.13 | 0.056 | 3.2% | 0.16 |
| Average Cup/Disc Ratio | 0.50 | 0.001 | 0.012 | 2.4% | 0.034 | 0.013 | 2.5% | 0.036 |
| Vertical C/D Ratio | 0.51 | 0.000 | 0.022 | 4.4% | 0.062 | 0.023 | 4.6% | 0.065 |
| Cup Volume (mm3) | 0.16 | 0.001 | 0.008 | 5.1% | 0.023 | 0.009 | 5.4% | 0.025 |
| RNFL Thickness | ||||||||
| Average RNFL Thickness(μm) | 88.3 | 0.49 | 2.2 | 2.4% | 6.1 | 2.4 | 2.7% | 6.6 |
| Temporal (μm) | 64.7 | 0.31 | 2.8 | 4.3% | 7.7 | 3.0 | 4.6% | 8.3 |
| Superior (μm) | 106.7 | 0.80 | 3.5 | 3.3% | 9.8 | 4.3 | 4.0% | 11.9 |
| Nasal (μm) | 75.3 | 0.38 | 3.5 | 4.7% | 9.8 | 4.0 | 5.3% | 11.1 |
| Inferior (μm) | 106.7 | 0.000 | 4.4 | 4.1% | 12.3 | 4.9 | 4.6% | 13.6 |
| Clock hour 1 (μm) | 95.7 | 1.8 | 6.4 | 6.7% | 17.9 | 6.7 | 7.0% | 18.7 |
| Clock hour 2 (μm) | 88.6 | 0.000 | 4.5 | 5.1% | 12.7 | 5.5 | 6.2% | 15.3 |
| Clock hour 3 (μm) | 68.3 | 0.83 | 4.0 | 5.9% | 11.2 | 4.9 | 7.2% | 13.8 |
| Clock hour 4 (μm) | 68.9 | 0.65 | 5.6 | 8.1% | 15.7 | 5.8 | 8.4% | 16.2 |
| Clock hour 5 (μm) | 89.3 | 0.000 | 8.1 | 9.1% | 22.6 | 9.1 | 10.2% | 25.4 |
| Clock hour 6 (μm) | 119.5 | 1.0 | 5.3 | 4.5% | 14.9 | 5.9 | 4.9% | 16.4 |
| Clock hour 7 (μm) | 111.5 | 1.5 | 4.3 | 3.9% | 12.2 | 5.4 | 4.8% | 15.0 |
| Clock hour 8 (μm) | 64.0 | 1.4 | 4.2 | 6.6% | 11.8 | 4.4 | 6.9% | 12.4 |
| Clock hour 9 (μm) | 55.9 | 0.000 | 3.4 | 6.0% | 9.4 | 3.9 | 7.0% | 11.0 |
| Clock hour 10 (μm) | 74.2 | 0.000 | 2.4 | 3.3% | 6.8 | 2.9 | 3.9% | 8.1 |
| Clock hour 11 (μm) | 116.5 | 0.000 | 6.3 | 5.4% | 17.6 | 7.6 | 6.5% | 21.2 |
| Clock hour 12 (μm) | 107.9 | 1.4 | 4.9 | 4.6% | 13.8 | 5.9 | 5.5% | 16.6 |
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
| Epithelial Thickness | ||||||||
| Central (µm) | 48.5 | 0.25 | 1.7 | 3.6% | 4.9 | 2.2 | 4.5% | 6.1 |
| Inner Nasal (μm) | 47.3 | 0.49 | 1.9 | 4.1% | 5.4 | 2.4 | 5.2% | 6.8 |
| Inner SuperoNasal (µm) | 46.9 | 0.53 | 1.7 | 3.7% | 4.9 | 2.2 | 4.7% | 6.2 |
| Inner Superior (µm) | 45.7 | 0.25 | 1.6 | 3.4% | 4.4 | 2.0 | 4.3% | 5.6 |
| Inner SuperoTemporal(μm) | 45.9 | 0.000 | 1.7 | 3.8% | 4.9 | 2.2 | 4.8% | 6.2 |
| Inner Temporal (µm) | 46.9 | 0.18 | 1.9 | 4.1% | 5.4 | 2.5 | 5.3% | 6.9 |
| Inner InferoTemporal (µm) | 47.9 | 0.74 | 1.8 | 3.7% | 5.0 | 2.5 | 5.3% | 7.1 |
| Inner Inferior (μm) | 47.9 | 0.60 | 1.8 | 3.8% | 5.1 | 2.5 | 5.2% | 7.0 |
| Inner InferoNasal (µm) | 48.0 | 0.55 | 2.0 | 4.2% | 5.6 | 2.5 | 5.3% | 7.1 |
| Middle Nasal (µm) | 46.2 | 0.39 | 1.8 | 4.0% | 5.1 | 2.2 | 4.7% | 6.1 |
| Middle SuperoNasal (µm) | 45.2 | 0.66 | 1.7 | 3.8% | 4.9 | 2.1 | 4.7% | 6.0 |
| Middle Superior (µm) | 42.7 | 0.46 | 1.9 | 4.4% | 5.3 | 2.0 | 4.7% | 5.6 |
| Middle SuperoTemporal(μm) | 43.4 | 0.45 | 1.8 | 4.2% | 5.1 | 2.2 | 5.1% | 6.1 |
| Middle Temporal (µm) | 45.8 | 0.20 | 1.9 | 4.1% | 5.2 | 2.4 | 5.2% | 6.6 |
| Middle InferoTemporal(μm) | 46.6 | 0.66 | 2.0 | 4.2% | 5.5 | 2.8 | 6.0% | 7.8 |
| Middle Inferior (µm) | 46.7 | 0.50 | 1.7 | 3.5% | 4.6 | 2.4 | 5.1% | 6.7 |
| Middle InferoNasal (µm) | 46.7 | 0.61 | 1.6 | 3.4% | 4.4 | 2.2 | 4.7% | 6.2 |
| Outer Nasal (µm) | 47.0 | 0.000 | 1.7 | 3.6% | 4.7 | 1.8 | 3.8% | 4.9 |
| Outer SuperoNasal (µm) | 43.8 | 0.20 | 3.1 | 7.2% | 8.8 | 3.4 | 7.7% | 9.5 |
| Outer Superior (µm) | 40.1 | 0.000 | 1.9 | 4.7% | 5.3 | 2.0 | 5.0% | 5.6 |
| Outer SuperoTemporal(μm) | 41.0 | 0.27 | 2.0 | 5.0% | 5.7 | 2.2 | 5.3% | 6.1 |
| Outer Temporal (µm) | 44.9 | 0.000 | 1.9 | 4.3% | 5.4 | 2.3 | 5.0% | 6.3 |
| Outer InferoTemporal (µm) | 46.3 | 0.000 | 2.5 | 5.4% | 7.0 | 2.8 | 6.1% | 7.9 |
| Outer Inferior (µm) | 45.8 | 0.000 | 1.4 | 3.1% | 4.0 | 1.9 | 4.2% | 5.3 |
| Outer InferoNasal (µm) | 46.9 | 0.000 | 2.5 | 5.4% | 7.1 | 2.6 | 5.6% | 7.3 |
| Pachymetry Thickness | ||||||||
| Central (µm) | 537.4 | 0.000 | 1.9 | 0.3% | 5.2 | 2.2 | 0.4% | 6.1 |
| Inner Nasal (um) | 561.4 | 0.000 | 3.2 | 0.6% | 9.1 | 3.4 | 0.6% | 9.6 |
| K22200 - 510(k) Summary | Page 38 of 41 | |||||||
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
| Inner SuperoNasal (um) | 568.1 | 0.77 | 4.5 | 0.8% | 12.5 | 5.1 | 0.9% | 14.2 |
| Inner Superior (um) | 567.6 | 1.2 | 4.9 | 0.9% | 13.7 | 5.8 | 1.0% | 16.2 |
| Inner SuperoTemporal(um) | 554.0 | 0.61 | 3.9 | 0.7% | 11.0 | 4.5 | 0.8% | 12.5 |
| Inner Temporal (um) | 541.4 | 0.000 | 2.4 | 0.4% | 6.6 | 2.9 | 0.5% | 8.2 |
| Inner InferoTemporal (um) | 542.9 | 0.98 | 2.7 | 0.5% | 7.6 | 4.0 | 0.7% | 11.3 |
| Inner Inferior (um) | 550.9 | 1.3 | 3.8 | 0.7% | 10.7 | 4.7 | 0.9% | 13.3 |
| Inner InferoNasal (um) | 556.7 | 1.4 | 3.6 | 0.6% | 10.1 | 4.3 | 0.8% | 12.1 |
| Outer Nasal (um) | 598.9 | 0.73 | 4.6 | 0.8% | 12.8 | 5.3 | 0.9% | 14.9 |
| Outer SuperoNasal (um) | 611.3 | 1.7 | 6.1 | 1.0% | 17.0 | 7.4 | 1.2% | 20.7 |
| Outer Superior (um) | 612.6 | 2.4 | 6.6 | 1.1% | 18.4 | 9.0 | 1.5% | 25.2 |
| Outer SuperoTemporal(um) | 588.8 | 0.68 | 5.4 | 0.9% | 15.2 | 6.5 | 1.1% | 18.1 |
| Outer Temporal (um) | 563.2 | 0.78 | 3.4 | 0.6% | 9.7 | 4.2 | 0.7% | 11.6 |
| Outer InferoTemporal (um) | 567.6 | 2.3 | 4.4 | 0.8% | 12.3 | 6.3 | 1.1% | 17.6 |
| Outer Inferior (um) | 584.7 | 3.5 | 5.7 | 1.0% | 16.0 | 7.6 | 1.3% | 21.4 |
| Outer InferoNasal (um) | 592.2 | 2.2 | 5.1 | 0.9% | 14.2 | 6.0 | 1.0% | 16.7 |
Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components.
Repeatability and reproducibility limits are 2.8 · SD.
{39}------------------------------------------------
Image /page/39/Picture/0 description: The image shows the ZEISS logo. The logo consists of the word "ZEISS" in a bold, sans-serif font, set against a dark blue background. Below the word, there is a curved white line, adding a subtle design element to the logo.
Page 37 of 41
Table 11. C6000 Pachymetry Thickness scans, Retina Subjects (n=211 scans), Precision Summary
{40}------------------------------------------------
Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components.
Repeatability and reproducibility limits are 2.8 · SD.
%CV is calculated as 100*SD/Mean.
Table 12. C6000 Pachymetry Thickness scans, Cornea Subjects (n=204 scans), Precision Summary
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
|---|---|---|---|---|---|---|---|---|
| Epithelial Thickness | ||||||||
| Central (µm) | 48.2 | 0.29 | 1.6 | 3.3% | 4.5 | 2.3 | 4.8% | 6.5 |
| Inner Nasal (µm) | 47.8 | 0.39 | 1.9 | 4.0% | 5.4 | 2.7 | 5.6% | 7.5 |
| Inner SuperoNasal (µm) | 47.0 | 0.41 | 2.0 | 4.2% | 5.5 | 2.5 | 5.4% | 7.1 |
| Inner Superior (µm) | 46.1 | 0.28 | 1.8 | 3.9% | 5.1 | 2.4 | 5.2% | 6.7 |
| Inner SuperoTemporal(µm) | 46.7 | 0.000 | 1.9 | 4.1% | 5.4 | 2.4 | 5.0% | 6.6 |
| Inner Temporal (µm) | 47.2 | 0.086 | 2.1 | 4.4% | 5.8 | 2.4 | 5.1% | 6.7 |
| Inner InferoTemporal (µm) | 48.1 | 0.000 | 2.1 | 4.3% | 5.7 | 2.6 | 5.4% | 7.3 |
| Inner Inferior (µm) | 49.3 | 0.000 | 1.4 | 2.9% | 3.9 | 2.5 | 5.1% | 7.1 |
| Inner InferoNasal (µm) | 48.9 | 0.34 | 1.8 | 3.8% | 5.1 | 2.8 | 5.7% | 7.7 |
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
| Middle Nasal (µm) | 45.7 | 0.000 | 1.9 | 4.2% | 5.4 | 2.5 | 5.5% | 7.0 |
| Middle SuperoNasal (µm) | 44.2 | 0.38 | 2.2 | 5.0% | 6.2 | 2.7 | 6.0% | 7.5 |
| Middle Superior (µm) | 42.0 | 0.21 | 2.1 | 4.9% | 5.8 | 2.4 | 5.8% | 6.8 |
| Middle SuperoTemporal(µm) | 43.5 | 0.15 | 2.0 | 4.5% | 5.5 | 2.3 | 5.3% | 6.4 |
| Middle Temporal (µm) | 45.6 | 0.000 | 2.5 | 5.4% | 6.9 | 2.7 | 5.9% | 7.6 |
| Middle InferoTemporal(µm) | 46.7 | 0.000 | 2.3 | 5.0% | 6.6 | 2.7 | 5.7% | 7.5 |
| Middle Inferior (µm) | 47.9 | 0.000 | 1.7 | 3.5% | 4.7 | 2.7 | 5.6% | 7.6 |
| Middle InferoNasal (µm) | 46.8 | 0.26 | 2.1 | 4.6% | 6.0 | 2.8 | 5.9% | 7.8 |
| Outer Nasal (µm) | 45.2 | 0.000 | 2.1 | 4.6% | 5.8 | 2.6 | 5.7% | 7.2 |
| Outer SuperoNasal (µm) | 43.0 | 0.000 | 3.0 | 7.0% | 8.4 | 3.3 | 7.8% | 9.4 |
| Outer Superior (µm) | 39.6 | 0.000 | 2.4 | 6.2% | 6.8 | 2.7 | 6.8% | 7.6 |
| Outer SuperoTemporal(µm) | 41.1 | 0.000 | 2.4 | 5.9% | 6.8 | 2.5 | 6.1% | 7.0 |
| Outer Temporal (µm) | 44.4 | 0.70 | 2.3 | 5.2% | 6.4 | 2.6 | 5.9% | 7.4 |
| Outer InferoTemporal (µm) | 45.9 | 0.000 | 3.3 | 7.2% | 9.2 | 3.4 | 7.5% | 9.6 |
| Outer Inferior (µm) | 45.4 | 0.000 | 2.3 | 5.1% | 6.5 | 2.8 | 6.2% | 7.9 |
| Outer InferoNasal (µm) | 46.5 | 0.001 | 4.3 | 9.2% | 11.9 | 4.5 | 9.7% | 12.6 |
| Pachymetry Thickness | ||||||||
| Central (µm) | 517.5 | 0.000 | 2.2 | 0.4% | 6.1 | 2.4 | 0.5% | 6.8 |
| Inner Nasal (µm) | 547.3 | 0.95 | 3.4 | 0.6% | 9.6 | 3.9 | 0.7% | 10.9 |
| Inner SuperoNasal (µm) | 551.9 | 0.13 | 3.9 | 0.7% | 10.8 | 4.2 | 0.8% | 11.8 |
| Inner Superior (µm) | 553.2 | 0.89 | 5.4 | 1.0% | 15.0 | 6.0 | 1.1% | 16.8 |
| Inner SuperoTemporal(µm) | 542.4 | 0.89 | 4.9 | 0.9% | 13.8 | 5.6 | 1.0% | 15.7 |
| Inner Temporal (µm) | 527.2 | 0.43 | 3.0 | 0.6% | 8.4 | 3.8 | 0.7% | 10.5 |
| Inner InferoTemporal (µm) | 528.3 | 1.9 | 4.0 | 0.8% | 11.3 | 5.1 | 1.0% | 14.4 |
| Inner Inferior (µm) | 538.3 | 2.8 | 5.3 | 1.0% | 14.8 | 7.4 | 1.4% | 20.6 |
| Inner InferoNasal (µm) | 543.7 | 2.3 | 5.5 | 1.0% | 15.4 | 6.5 | 1.2% | 18.2 |
| Outer Nasal (µm) | 589.9 | 0.000 | 4.4 | 0.7% | 12.2 | 5.3 | 0.9% | 14.9 |
| Outer SuperoNasal (µm) | 597.5 | 2.8 | 6.5 | 1.1% | 18.1 | 8.1 | 1.4% | 22.8 |
| Outer Superior (µm) | 601.4 | 2.2 | 9.6 | 1.6% | 27.0 | 9.9 | 1.6% | 27.7 |
| K222200 - 510(k) Summary | Page 40 of 41 | |||||||
| Variable | Mean | DevOpSD | ResidualSD | Repeat.%CV | Repeat.Limit | Repro.SD | Repro.%CV | Repro.Limit |
| Outer SuperoTemporal(µm) | 582.0 | 0.28 | 7.7 | 1.3% | 21.5 | 8.3 | 1.4% | 23.1 |
| Outer Temporal (µm) | 555.8 | 1.3 | 3.8 | 0.7% | 10.7 | 4.5 | 0.8% | 12.7 |
| Outer InferoTemporal (µm) | 562.0 | 2.1 | 6.7 | 1.2% | 18.8 | 7.3 | 1.3% | 20.5 |
| Outer Inferior (µm) | 581.5 | 4.3 | 8.4 | 1.4% | 23.5 | 12.6 | 2.2% | 35.2 |
| Outer InferoNasal (µm) | 589.0 | 3.5 | 7.0 | 1.2% | 19.5 | 9.4 | 1.6% | 26.4 |
{41}------------------------------------------------
Image /page/41/Picture/0 description: The image shows the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue background. The logo is simple and modern, with the company name prominently displayed.
Page 39 of 41
{42}------------------------------------------------
Image /page/42/Picture/0 description: The image contains the word "ZEISS" in a bold, sans-serif font. The word is white and is set against a solid blue background. The background is a rectangle with a curved bottom edge.
Reproducibility is the sum of: Residual, DevOp, and Subject:DevOp variance components.
Repeatability and reproducibility limits are 2.8 · SD.
{43}------------------------------------------------
Image /page/43/Picture/0 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue background. The bottom of the blue background has a curved shape.
CIRRUS 6000 Angiography Image Quality Study
This was a multi-site prospective study. A total of 110 subjects aged 18 years or older were enrolled: 103 retinal diseased subjects. 7 normal subjects were disqualified because they did not meet the inclusion/exclusion criteria, eleven others were disqualified because the operator was unable to acquire quality study scans, and one subject was discontinued due to the inability to continue the study visit. Two subjects were disqualified due to lack of any CIRRUS 6000 scans acquired; and two subjects were discontinued because they did not return for their second study visit. 93 subjects had at least one valid OCT scan or valid FA/ICGA images. However, only 92 subjects had at least one valid OCT scan. The subject age range was 19-91, with a mean age of 66.0 ± 14.8. The study population was composed of 42 (45.2%) females and 51 (54.8%) male subjects. 15 (16.1%) subjects were Asian, 4 (4.3%) subjects were Black, 63 (67.7%) subjects were Caucasian, 1 (1.1%) subject was Native Hawaiian/ Pacific Islander, and 10 (10.8%) subjects were listed as "Other". 78.3% of CIRRUS 6000 and 77.2% of CIRRUS 5000 scans acquired were valid and analyzed. Acquired scans were invalidated due to duplicate scans (1.1-2.5%), eye did not meet inclusion criteria (2.9-4.7%), poor image quality (7.6-10.6%), scan decentration (1.8-3.2%), poor signal strength (0.5-0.9%), or missing comparison photos (3.8-4.8%). Three independent reviewers from a reading center graded the OCTA scans on image quality and clinically relevant information according to pre-determined grading criteria. The proportion of Clinically Acceptable Overall Images was 0.98 or above for the CIRRUS 6000 device and 0.94 and above for the CIRRUS 5000 device for all subjects.
CIRRUS 6000 Raster Image Ouality Study
This was a multi-site prospective study. A total of 68 subjects were enrolled: 20 subjects with normal eyes and 48 subjects with retinal disease. The subject age range was 27-92, with a mean age of 64.3 ± 15.4. The study population was composed of 36 (52.9%) females and 32 (47.1%) male subjects. 14 (20.6%) subjects were Asian, 6 (8.8%) subjects were Black, 39 (57.4%) subjects were Caucasian and 9 (13.2%) subjects were listed as "Other". 92.3% of CIRRUS 6000 and 91.3% of CIRRUS 5000 scans acquired were valid and analyzed. Acquired scans were invalidated due to duplicate scans (6.2-6.9%), eye did not meet inclusion criteria (1.4%), poor image quality or blur (0.1-0.3%), or scan decentration (0.1%). Three independent graders from a reading center graded the raster B-scans on image quality and clinically relevant information according to pre-determined grading criteria. The proportion of Clinically Acceptable Overall Images was 1.00 for all scan types across the CIRRUS 6000 and the CIRRUS 5000 device for all subjects.
8. CONCLUSION
The indications for use are identical except for the removal of normative database for CIRRUS 6000 to the indications for use of the predicate device; and therefore, are determined to be substantially equivalent.
The technological characteristics and risk profile of the subject device are equivalent to the predicate device; and therefore, are determined to be substantially equivalent.
Testing methods are equivalent to those of the predicate device; are determined to be substantially equivalent.
Therefore, the subject device meets the requirements for substantial equivalence as compared to the proposed predicate device.
§ 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.