The CIRRUS photo (Models 600 and 800) is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions.

These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc as well as imaging of anterior ocular structures, including the cornea.

It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

Device Description

The CIRRUS photo is a non-contact, high resolution digital, tomographic and biomicroscopic imaging device that merges fundus imaging and optical coherence tomography into a single device. To optimize the workflow, the system applies the same beam delivery system for imaging and scanning.

AI/ML Overview

Here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: CIRRUS photo Models 600 and 800 (Fundus Camera and Optical Coherence Tomography)

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CIRRUS photo are not explicitly listed as specific thresholds in the document (e.g., "accuracy > 90%"). Instead, the study aimed to demonstrate equivalence and repeatability/reproducibility of measurements between the CIRRUS photo and the predicate device (Carl Zeiss Meditec Cirrus HD-OCT Model 4000).

Therefore, the "acceptance criteria" are implicitly that the differences in measurements between the two devices should be small and within acceptable limits (as evidenced by confidence intervals and limits of agreement), and that the CIRRUS photo should demonstrate good repeatability and reproducibility.

The reported device performance section details the findings from these equivalence and repeatability studies.

Acceptance Criteria Category	Specific Metric (Implicit)	CIRRUS Photo Performance
Equivalence (Inter-device)	Mean Difference in RNFL, ONH, and Macular Thickness measurements between CIRRUS photo and Cirrus HD-OCT Model 4000.	Normal Eyes (N=33): The mean difference for 31 measurement parameters (17 RNFL, 5 ONH, 9 macular) between the two devices was generally small, with 95% Confidence Intervals for most parameters including or very close to zero. The 95% Limits of Agreement show a range within which differences are expected to fall. For example, Average RNFL Thickness showed a mean difference of 0.6 (1.2) µm with a CI of (0.2, 1.0) and LOA of (-1.7, 2.9).Diseased Eyes (Glaucoma N=17, Macular Disease N=19): Similar to normal eyes, mean differences were generally small, with 95% Confidence Intervals for many parameters including or near zero. For example, Average RNFL Thickness (glaucoma) showed a mean difference of 0.8 (1.3) µm with a CI of (0.1, 1.4) and LOA of (-1.7, 3.2).
Repeatability	Repeatability Standard Deviation (SD) and Limit	Normal Eyes: Repeatability SDs for RNFL (e.g., Average RNFL Thickness: 1.4634 µm), ONH (e.g., Cup Disc Ratio: 0.0236), and Macular Thickness (e.g., Central Subfield: 1.6398 µm) demonstrate the device's consistency when measurements are repeated under the same conditions.Diseased Eyes: Repeatability SDs for RNFL (e.g., Average RNFL Thickness: 1.4634 µm), ONH (e.g., Cup Disc Ratio: 0.0276), and Macular Thickness (e.g., Central Subfield: 5.6224 µm) were also reported.
Reproducibility	Reproducibility Standard Deviation (SD) and Limit	Normal Eyes: Reproducibility SDs for RNFL (e.g., Average RNFL Thickness: 2.1899 µm), ONH (e.g., Cup Disc Ratio: 0.0245), and Macular Thickness (e.g., Central Subfield: 2.7756 µm) demonstrate consistency when measurements are repeated under varying conditions (e.g., different operators).Diseased Eyes: Reproducibility SDs for RNFL (e.g., Average RNFL Thickness: 1.8796 µm), ONH (e.g., Cup Disc Ratio: 0.0278), and Macular Thickness (e.g., Central Subfield: 7.6068 µm) were also reported.
Qualitative Assessment	Overall conclusion regarding performance	"The mean values of the 31 thickness parameters were very similar for the two devices.""Cirrus photo showed good repeatability and reproducibility for both normal and diseased eyes."

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Normal Eyes Study:
  - Phase 1 (Inter-operator variability): 30 subjects
  - Phase 2 (Inter-device variability): 33 subjects
- Diseased Eyes Study:
  - Retinal disease (inter-device): 19 subjects
  - Retinal disease (inter-operator): 19 subjects
  - Glaucoma (inter-device): 17 subjects
  - Glaucoma (inter-operator): 18 subjects
- Total Test Set: 63 normal subjects, 73 diseased subjects (total of 136 subjects, though there's some overlap in eyes examined across phases/devices, but subjects did not participate in both phases of a study)
- Data Provenance: The document does not specify the country of origin of the data. The studies were prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The study design focused on comparing measurements from the new device (CIRRUS photo) to an existing, cleared device (Cirrus HD-OCT Model 4000), which itself presumably has established accuracy.
- The "ground truth" here is the measurement obtained from the predicate device. Therefore, no external experts were used to establish a separate "ground truth" beyond the measurements themselves.
- For the inter-operator variability phases, four operators were involved, implying expertise in operating OCT devices. However, their specific qualifications (e.g., years of experience, medical degree) are not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This was a quantitative measurement comparison study, not a diagnostic classification study requiring adjudication of expert opinions. The method involved calculating mean differences, confidence intervals, and limits of agreement between device measurements.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a MRMC comparative effectiveness study was not done. This study focuses on the technical equivalence and repeatability/reproducibility of a diagnostic imaging device (OCT) rather than evaluating human reader performance with or without AI assistance.
- The term "AI" is not mentioned in this document.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the primary studies described are standalone performance evaluations of the device, focusing on the measurements generated by the CIRRUS photo itself compared to a predicate device. While human operators are involved in acquiring the images, the analysis of the measurement data (31 parameters of RNFL, ONH, and macular thickness) is performed by the device's algorithms. The document does not describe a human-in-the-loop study to modify or interpret the device's measurements.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the measurement data obtained from the predicate device (Cirrus HD-OCT Model 4000). The study aimed to show that the CIRRUS photo provides comparable measurements. It's a device-to-device comparison rather than an evaluation against a clinical ground truth like pathology or patient outcomes.
The sample size for the training set
- The document implies that the CIRRUS photo uses a "normative database" (RNFL, ONH, and Macular Normative Database) which comes from the Cirrus HD-OCT Model 4000 and is adjusted based on regression analysis. However, it does not specify the sample size of this underlying normative database or detail a separate "training set" for the CIRRUS photo's algorithms in this context. The study described focuses on testing a new device's performance against an established device, not on training a new algorithm.
How the ground truth for the training set was established
- As noted above, a distinct "training set" for the CIRRUS photo's algorithms (other than the inherited normative database from the predicate device, K083291; K111157) is not explicitly described. For the normal subjects in the "Normative Database," the implicit "ground truth" would be their classification as "normal" based on clinical criteria and measurements from the original predicate device (Cirrus HD-OCT 4000). The method for establishing this original normative database's "ground truth" is not explained in this document.

Summary

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510(K) SUMMARY

JUN 1 8 2012

This 510(k) Summary information is being submitted in accordance with the requirements of 21 CFR 807.92(a).

SUBMITTER NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED

Applicant:

Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 07745 Jena 'Germany

Contact Person:

Judith A. Brimacombe, MA Director, Clinical/Regulatory Affairs Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 USA j.brimacombe@meditec.zeiss.com Tel: (925) 557-4616 Fax: (925) 557-4259

Summary Prepared:

June 14, 2012

Fundus Camera

NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME

Trade/Proprietary Name:

CIRRUS photo Models 600 and 800

Optical Coherence Tomography

Tomography, Optical coherence Camera, Ophthalmic, AC-powered

Common/Usual Name:

Classification Name:

Product Code and Class:

OBO - Class II HKI - Class II

Classification Number:

886.1570 886.1120

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PREDICATE DEVICES

The CIRRUS photo (Models 600 and 800) is substantially equivalent to the Carl Zeiss Meditec VISUCAM PRO NM Digital Camera (K052268), the Carl Zeiss Meditec Cirrus HD-OCT Optical Coherence Tomographer with Retinal Nerve Fiber Layer (RNFL), Macular and Optic Nerve Head Normative Databases, Model 4000 (K083291; K111157), the Carl Zeiss Meditec FF450 plus Fundus Camera (K011877), the Topcon TRC-NW8F (K100207), and the Topcon 3D Optical Coherence Tomography 3D OCT-2000 (K092470).

The CIRRUS photo is substantially equivalent to these cleared devices with regard to indications for use and technological characteristics.

DEVICE DESCRIPTION

INDICATIONS FOR USE

The CIRRUS photo is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The CIRRUS photo has very similar indications for use and operating characteristics as the predicate devices. The CIRRUS photo combines into a single system the functionalities and indications for use from each of the predicate devices.

The fundus camera unit of the CIRRUS photo utilizes the same imaging properties and technology as the cleared VISUCAM PRO NM Digital Camera to record morphologic images of the human retina under mydriatic and non-mydriatic conditions, respectively. The spectral domain optical coherence tomographer SD-OCT Module is the same optical coherence tomography system as in the cleared Cirrus HD-OCT Optical Coherence Tomographer, Model 4000 (K083291; K111157). The CIRRUS photo includes the fluorescein angiography (FA), and indocyanine green angiography (ICGA) functionalities of the Carl Zeiss Meditec FF450 plus Fundus Camera (K011877) and also contains filters for Fundus Autofluorescence. Filters for Fluorescein Angiography, ICG Angiography, and Fundus Autofluorescence are available in the Topcon TRC-NW8F (K100207). The Topcon 3D Optical Coherence Tornography 3D OCT-2000 (K092470), like the CIRRUS photo, incorporates a high resolution fundus camera with a Spectral Domain Optical Coherence Tomographer.

The CIRRUS photo is therefore substantially equivalent to the predicate devices. i.e., the Carl Zeiss Meditec VISUCAM PRO NM Digital Camera (K052268), the Carl Zeiss Meditec Cirrus HD-OCT, Model 4000 (K083291; K11157), the Carl Zeiss Meditec FF450 plus Fundus Camera (K011877), the Topcon TRC-NW8F (K100207), and the Topcon 3D OCT-2000 (K092470).

BRIEF SUMMARY OF NONCLINICAL AND CLINICAL TESTS AND RESULTS

The CIRRUS photo has been designed and tested to the applicable standards for electrical and optical safety and verified to established specifications. In addition, the following clinical testing, which includes repeatability and reproducibility, was performed.

CLINICAL TESTING

Two prospective studies were conducted to determine comparability, repeatability and reproducibility of the measurement data between the CIRRUS photo and Cirrus HD-OCT Model 4000 instruments.

NORMAL EYES STUDY

Sixty-three normal subjects were enrolled in a study to evaluate the equivalence of the means of 31 measurement parameters: retinal nerve fiber layer (RNFL) thickness (17 parameters), optic nerve head (ONH) (5 parameters), and macular thickness (9 parameters) between the CIRRUS photo and Cirrus HD-OCT Model 4000. The study was divided into two phases. Thirty subjects were enrolled in Phase 1 that evaluated inter-operator variability. Three Optic Disc Cube 200x200 scans were taken on one eye and three Macular Cube 512x128 scans were taken on the fellow eye by each of the four operators using one Cirrus HD-OCT Model 4000 and one CIRRUS photo instrument. Thirty-three subjects were enrolled in Phase 2 that evaluated interdevice variability. Three Optic Disc Cube 200x200 scans were taken on one eye and three

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Macular Cube 512x128 scans were taken on the fellow eye from each of the four Cirrus HD-OCT Model 4000 instruments and each of the four CIRRUS photo instruments by one operator. Subjects could not participate in both phases.

DISEASED EYES STUDY

Seventy-three subjects with either macular disease or glaucoma were enrolled in a study to evaluate the equivalence of the means of 31 measurement parameters: retinal nerve fiber layer (RNFL) thickness (17 parameters), optic nerve head (ONH) (5 parameters), and macular thickness (9 parameters) between the CIRRUS photo and Cirrus HD-OCT Model 4000. The study was divided into two study arms; study arm 1 enrolled subjects with retina disease and study arm 2 enrolled subjects with glaucoma. Each study arm had two phases; phase 1evaluated inter-device variability and phase 2 evaluated inter-operator variability. Subjects could not participate in both phases of the study.

Nineteen subjects with retinal disease were enrolled in the inter-device phase of the study. Three Macular Cube 512x128 scans were taken by one operator using four Cirrus HD-OCT Model 4000 and four CIRRUS photo instruments. Nineteen different subjects with retinal disease were enrolled in the inter-operator phase of the study. Three Macular Cube 512x128 scans were taken by four operators using one Cirrus HD-OCT Model 4000 and one CIRRUS photo instrument.

Seventeen subjects with glaucoma were enrolled in the inter-device phase of the study. Three Optic Disc Cube 200x200 scans were taken by one operator using four Cirrus HD-OCT Model 4000 and four CIRRUS photo instruments. Eighteen subjects with glaucoma were enrolled in the inter-operator phase of the study. Three Optic Disc Cube 200x200 scans were taken by four operators using one Cirrus HD-OCT Model 4000 and one CIRRUS photo instrument.

DATA ANALYSIS

For each of the two study devices and each measurement parameter, the mean of the available measurements was calculated for each study eye. The difference in each of the 31 measurement parameters between the CIRRUS photo and Cirrus HD-OCT Model 4000 were calculated for each study eye. The mean difference, the corresponding 95% confidence intervals, and 95% limits of agreement were calculated for each measurement parameter. As the inter-operator phase utilized only one device, only the results for the inter-device phase are presented in Tables 1 and 2 for the normal and diseased eye studies, respectively.

The mean values of the 31 thickness parameters were very similar for the two devices. The results of these two studies support the incorporation of the normative databases established with the Cirrus HD-OCT Model 4000 instrument into the CIRRUS photo instrument with an adjustment based on regression analysis.

Additionally, analysis of variance (ANOVA) with random effect models was used to evaluate the repeatability, inter-device variability and inter-operator variability of each measurement parameter for the CIRRUS photo. The repeatability standard deviation (SD) and limits for the CIRRUS photo are shown in Tables 3 and 4 for the normal and diseased eyes studies, respectively. Cirrus photo showed good repeatability and reproducibility for both normal and diseased eyes.

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TABLE 1

MEAN DIFFERENCE IN RNFL, ONH AND MACULAR THICKNESS MEASUREMENTS BETWEEN CIRRUS PHOTO AND CIRRUS HD-OCT OPTICAL COHERENCE TOMOGRAPHER, MODEL 4000 (NORMAL EYES)

	Cirrus 4000Cirrus photo		Difference	95%	95%
	Mean (SD)	Mean (SD)	Mean (SD)	ConfidenceInterval ofMeanDifference	Limits ofAgreement
RNFL Parameter	N = 33	N = 33	N = 33
Average RNFL Thickness (µm)	94.3 (9.7)	93.7 (9.8)	0.6 (1.2)	(0.2, 1.0)	(-1.7, 2.9)
Temporal (µm)	68.8 (13.1)	68.4 (12.3)	0.4 (1.9)	(-0.3, 1.0)	(-3.3, 4.1)
Superior (µm)	119.3 (12.2)	121.0 (12.7)	-1.7 (2.4)	(-2.5, -0.8)	(-6.3, 2.9)
Nasal (µm)	69.8 (15.9)	68.2 (16.8)	1.6 (3.0)	(0.6, 2.7)	(-4.3, 7.6)
Inferior (µm)	119.4 (17.4)	117.5 (16.8)	1.9 (2.9)	(0.9, 2.9)	(-3.7, 7.5)
Clock hour 9 (µm)	53.3 (9.8)	53.8 (8.9)	-0.5 (2.1)	(-1.2, 0.3)	(-4.6, 3.6)
Clock hour 10 (µm)	82.0 (18.7)	83.8 (17.6)	-1.7 (3.1)	(-2.8, -0.6)	(-7.9, 4.4)
Clock hour 11 (µm)	134.8 (24.2)	137.4 (23.5)	-2.6 (4.1)	(-4.0, -1.2)	(-10.6, 5.4)
Clock hour 12 (µm)	116.5 (20.8)	117.1 (21.4)	-0.6 (4.5)	(-2.2, 1.0)	(-9.3, 8.2)
Clock hour 1 (µm)	106.5 (15.0)	108.3 (15.8)	-1.8 (4.7)	(-3.5, -0.1)	(-11.1, 7.5)
Clock hour 2 (µm)	86.9 (21.3)	83.5 (21.7)	3.4 (3.9)	(2.0, 4.8)	(-4.2, 10.9)
Clock hour 3 (µm)	58.2 (12.3)	56.1 (13.0)	2.1 (3.5)	(0.9, 3.4)	(-4.8, 9.0)
Clock hour 4 (µm)	64.3 (18.1)	64.8 (19.2)	-0.5 (3.8)	(-1.8, 0.9)	(-8.0, 7.0)
Clock hour 5 (µm)	93.0 (18.8)	93.1 (18.9)	-0.2 (4.3)	(-1.7, 1.4)	(-8.6, 8.2)
Clock hour 6 (µm)	130.5 (31.2)	130.3 (29.2)	0.2 (5.6)	(-1.7, 2.2)	(-10.7, 11.1)
Clock hour 7 (µm)	134.8 (18.5)	129.1 (17.7)	5.7 (4.3)	(4.2, 7.2)	(-2.7, 14.1)
Clock hour 8 (µm)	71.0 (14.5)	67.6 (14.1)	3.4 (3.5)	(2.2, 4.7)	(-3.4, 10.2)
ONH Parameters	N = 33	N = 33	N = 33
Average Cup-to-Disc Ratio	0.455 (0.158)	0.466 (0.154)	-0.012 (0.012)	(-0.016, -0.007)	(-0.035, 0.011)
Vertical Cup-to-Disc Ratio	0.430 (0.153)	0.440 (0.152)	-0.010 (0.013)	(-0.015, -0.005)	(-0.036, 0.016)
Disc Area (mm2)	1.753 (0.294)	1.822 (0.310)	-0.068 (0.034)	(-0.081, -0.056)	(-0.135, -0.001)
Rim Area (mm2)	1.317 (0.177)	1.352 (0.186)	-0.034 (0.027)	(-0.044, -0.025)	(-0.088, 0.019)
Cup Volume (mm3)	0.1293 (0.1246)	0.1382 (0.1309)	-0.0089 (0.0104)	(-0.0126, -0.0052)	(-0.0292, 0.0114)
Macular Thickness Parameters	N = 33	N = 33	N = 33
Central Subfield (µm)	265.0 (23.7)	262.8 (23.4)	2.2 (2.1)	(1.5, 3.0)	(-1.8, 6.3)
Inner Temporal (µm)	310.2 (13.7)	308.6 (13.2)	1.6 (2.5)	(0.7, 2.5)	(-3.3, 6.6)
Inner Superior (µm)	324.6 (14.8)	323.6 (14.1)	1.1 (3.1)	(-0.0, 2.2)	(-5.1, 7.2)
Inner Nasal (µm)	328.8 (15.4)	326.6 (14.6)	2.2 (3.0)	(1.2, 3.3)	(-3.6, 8.1)
Inner Inferior (µm)	320.7 (15.7)	319.1 (14.9)	1.6 (2.8)	(0.6, 2.5)	(-3.9, 7.0)
Outer Temporal (µm)	260.5 (13.6)	261.0 (13.3)	-0.6 (1.9)	(-1.2, 0.1)	(-4.3, 3.2)
Outer Superior (µm)	279.7 (13.1)	279.7 (12.7)	-0.0 (2.1)	(-0.8, 0.7)	(-4.1, 4.0)
Outer Nasal (µm)	299.4 (16.1)	298.9 (15.2)	0.5 (2.2)	(-0.3, 1.3)	(-3.7, 4.7)
Outer Inferior (µm)	266.2 (14.0)	266.1 (13.4)	0.2 (2.2)	(-0.6, 0.9)	(-4.1, 4.4)

For the inter-device phase of the study, 33 subjects were enrolled.

For each of the two study devices, the average of measurements from different units were calculated for each eye and this average was treated as the measurement for the corresponding eye.

Difference = Cirrus-4000 - Cirrus-photo.

95% Confidence Interval of Mean Difference = mean ± 1.96 ×SE. 95% Limits of Agreement = mean ± 1.96 ×SD.

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TABLE 2

MEAN DIFFERENCE IN RNFL, ONH AND MACULAR THICKNESS MEASUREMENTS BETWEEN CIRRUS PHOTO AND CIRRUS HD-OCT OPTICAL COHERENCE TOMOGRAPHER, MODE + 4000 (DISEASED EYES)

	Cirrus 4000Mean (SD)	Cirrus photoMean (SD)	DifferenceMean (SD)	95%ConfidenceInterval ofMeanDifference	95%Limits ofAgreement
RNFL Parameter	N = 17	N = 17	N = 17
Average RNFL Thickness (µm)	63.8 (10.0)	63.1 (9.6)	0.8 (1.3)	(0.1, 1.4)	(-1.7, 3.2)
Temporal (µm)	47.1 (8.3)	48.1 (8.0)	-0.9 (1.7)	(-1.8, -0.1)	(-4.2, 2.4)
Superior (µm)	78.5 (16.7)	78.9 (17.7)	-0.3 (1.8)	(-1.3, 0.6)	(-3.9, 3.3)
Nasal (µm)	58.7 (7.3)	55.8 (5.8)	2.9 (2.9)	(1.3, 4.4)	(-2.9, 8.6)
Inferior (µm)	70.8 (18.1)	69.4 (16.9)	1.4 (2.3)	(0.2, 2.6)	(-3.1, 5.9)
Clock hour 9 (µm)	41.6 (8.7)	43.2 (8.8)	-1.6 (2.0)	(-2.6, -0.5)	(-5.6, 2.4)
Clock hour 10 (µm)	52.4 (12.8)	53.8 (14.2)	-1.3 (2.5)	(-2.6, -0.0)	(-6.3, 3.6)
Clock hour 11 (µm)	78.9 (20.9)	80.3 (21.5)	-1.4 (2.8)	(-2.9, 0.0)	(-7.0, 4.1)
Clock hour 12 (µm)	81.4 (23.1)	81.0 (24.6)	0.4 (4.0)	(-1.7, 2.5)	(-7.5, 8.3)
Clock hour 1 (µm)	75.3 (17.5)	75.4 (17.8)	-0.1 (1.9)	(-1.1, 0.8)	(-3.8, 3.6)
Clock hour 2 (µm)	66.5 (9.2)	63.8 (9.3)	2.7 (3.0)	(1.2, 4.2)	(-3.1, 8.5)
Clock hour 3 (µm)	55.2 (10.0)	51.1 (7.7)	4.1 (3.9)	(2.1, 6.1)	(-3.5, 11.7)
Clock hour 4 (µm)	54.4 (7.8)	52.8 (6.7)	1.6 (4.3)	(-0.5, 3.8)	(-6.7, 10.0)
Clock hour 5 (µm)	64.7 (16.7)	64.7 (17.4)	-0.1 (3.9)	(-2.0, 1.9)	(-7.6, 7.5)
Clock hour 6 (µm)	75.3 (20.5)	74.5 (18.6)	0.8 (5.5)	(-2.0, 3.6)	(-9.9, 11.5)
Clock hour 7 (µm)	72.6 (21.3)	69.0 (18.8)	3.5 (4.3)	(1.3, 5.8)	(-4.9, 12.0)
Clock hour 8 (µm)	47.5 (10.2)	47.4 (8.8)	0.1 (2.8)	(-1.3, 1.6)	(-5.4, 5.7)
ONH Parameters	N = 17	N = 17	N = 17
Average Cup-to-Disc Ratio	0.732 (0.097)	0.738 (0.093)	-0.006 (0.007)	(-.010, -.002)	(-.021, 0.008)
Vertical Cup-to-Disc Ratio	0.736 (0.094)	0.742 (0.088)	-0.006 (0.012)	(-.013, -.000)	(-.031, 0.018)
Disc Area (mm²)	1.758 (0.489)	1.853 (0.523)	-0.095 (0.045)	(-.118, -.072)	(-.184, -.006)
Rim Area (mm²)	0.770 (0.216)	0.795 (0.222)	-0.024 (0.016)	(-.032, -.016)	(-.055, 0.006)
Cup Volume (mm³)	0.4105 (0.2230)	0.4419 (0.2376)	-0.0315 (0.0181)	(-.0408, -.0222)	(-.0669, 0.0039)
Macular Thickness Parameters	N = 19	N = 19	N = 19
Central Subfield (µm)	343.8 (107.9)	341.4 (108.8)	2.4 (5.2)	(-0.1, 4.9)	(-7.9, 12.6)
Inner Temporal (µm)	366.4 (92.7)	365.0 (94.4)	1.4 (9.3)	(-3.1, 5.9)	(-16.8, 19.6)
Inner Superior (µm)	364.6 (86.3)	364.7 (87.9)	-0.1 (5.4)	(-2.7, 2.5)	(-10.7, 10.5)
Inner Nasal (µm)	366.1 (83.7)	366.5 (85.3)	-0.4 (6.8)	(-3.6, 2.9)	(-13.6, 12.9)
Inner Inferior (µm)	365.1 (85.7)	365.1 (86.5)	-0.0 (5.1)	(-2.5, 2.4)	(-10.0, 10.0)
Outer Temporal (µm)	283.7 (44.7)	285.3 (45.6)	-1.6 (2.3)	(-2.7, -0.5)	(-6.0, 2.8)
Outer Superior (µm)	299.6 (49.5)	301.7 (50.0)	-2.1 (2.8)	(-3.5, -0.7)	(-7.7, 3.5)
Outer Nasal (µm)	308.2 (45.7)	310.0 (46.6)	-1.8 (2.6)	(-3.0, -0.5)	(-6.8, 3.3)
Outer Inferior (µm)	285.7 (46.6)	288.1 (48.5)	-2.4 (3.8)	(-4.2, -0.5)	(-9.9, 5.1)

For the inter-device phase of the study, 17 glaucomatous eyes with retinal disease were enrolled. For each of the two study devices, the average of measurements from different units were calculated for each eye and this average was treated as the measurement for the corresponding eye.

Difference = Cirrus-4000 - Cirrus-photo.

95% Confidence Interval of Mean Difference = mean ± 1.96 ×SE. 95% Limits of Agreement = mean ± 1.96 ×SD.

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TABLE 3.

CIRRUS PHOTO REPEATABILITY AND REPRODUCIBILITY IN MEASURING RNFL, ONH AND MACULAR THICKNESS (NORMAL EYES)

	Repeatability		Reproducibility		COV %
	SD	Limit	SD	Limit	Based on Repeatability	Based on Reproducibility
RNFL Parameter
Average RNFL Thickness (µm)	1.4634	4.0974	2.1899	6.1319	1.5660	2.3436
Temporal (µm)	3.1109	8.7106	3.4480	9.6544	4.6498	5.1536
Superior (µm)	4.0906	11.4538	5.2156	14.6038	3.4418	4.3884
Nasal (µm)	2.9302	8.2045	3.7041	10.3714	4.2513	5.3742
Inferior (µm)	3.4906	9.7737	4.8547	13.5930	2.9296	4.0744
Clock hour 9 (µm)	2.9861	8.3610	3.5083	9.8232	5.5946	6.5730
Clock hour 10 (µm)	4.2639	11.9388	4.6703	13.0768	5.2313	5.7299
Clock hour 11 (µm)	4.6518	13.0249	6.5183	18.2512	3.5278	4.9434
Clock hour 12 (µm)	6.6529	18.6281	7.7500	21.7000	5.6827	6.6198
Clock hour 1 (µm)	5.9988	16.7968	7.5104	21.0291	5.5767	6.9818
Clock hour 2 (µm)	5.1422	14.3981	6.4081	17.9426	6.0570	7.5481
Clock hour 3 (µm)	2.8467	7.9707	3.6839	10.3149	5.0520	6.5378
Clock hour 4 (µm)	3.4901	9.7722	4.2787	11.9803	5.3322	6.5371
Clock hour 5 (µm)	5.3422	14.9581	7.2244	20.2284	5.5214	7.4668
Clock hour 6 (µm)	5.9229	16.5841	8.1056	22.6956	4.4538	6.0951
Clock hour 7 (µm)	5.4060	15.1368	7.5886	21.2480	4.2341	5.9435
Clock hour 8 (µm)	3.8676	10.8293	4.9749	13.9296	5.8758	7.5580
ONH Parameters
Cup Disc Ratio	0.0236	0.0660	0.0245	0.0685	5.1582	5.3539
Vertical CD Ratio	0.0277	0.0774	0.0289	0.0809	6.3477	6.6278
Disc Area (mm²)	0.0888	0.2486	0.1009	0.2825	4.8833	5.5498
Rim Area (mm²)	0.0483	0.1352	0.0626	0.1752	3.5837	4.6455
Cup Volume (mm³)	0.0105	0.0294	0.0124	0.0349	7.5869	9.0060
Macular Thickness Parameters
Central Subfield (µm)	1.6398	4.5914	2.7756	7.7718	0.6308	1.0677
Inner Temporal (µm)	2.0716	5.8006	3.4834	9.7536	0.6683	1.1238
Inner Superior (µm)	2.1805	6.1054	3.4096	9.5470	0.6732	1.0527
Inner Nasal (µm)	2.1538	6.0307	3.1998	8.9594	0.6591	0.9792
Inner Inferior (µm)	2.0770	5.8156	3.2125	8.9951	0.6484	1.0029
Outer Temporal (µm)	1.7440	4.8833	2.8387	7.9483	0.6648	1.0820
Outer Superior (µm)	1.9601	5.4884	2.7409	7.6744	0.6997	0.9784
Outer Nasal (µm)	1.9932	5.5811	2.9532	8.2689	0.6662	0.9871
Outer Inferior (µm)	2.2541	6.3115	3.2616	9.1325	0.8427	1.2194

Repeatability SD is the standard deviations. Repeatability conditions. Repeatability Limit is the upper 95 % limit for the difference between repeated results under repeatability conditions. Per ISO 5725-6, Repeatability Limit = 2.8 x Repeatability SD. Reproducibility SD is the standard deviation under reproducibility conditions. It was estimated by the sum of repeatability variance and the variance components of operator "subjects, device and device *subjects. Reproducibility Limit is the upper 95 % limit for the difference between repeated results under reproducibility conditions. Reproducibility Limit = 2.8 × Reproducibility SD.

COV = Coefficient of variation = SD +Mean. ×100. SD is either Repeatability SD or Reproducibility SD.

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TABLE 4

CIRRUS PHOTO REPEATABILITY AND REPRODUCIBILITY IN MEASURING RNFL, ONH AND MACULAR THICKNESS (DISEASED EYES)

	Repeatability		Reproducibility		COV %
	SD	Limit	SD	Limit	Based onRepeatability	Based onReproducibility
RNFL Parameter
Average RNFL Thickness (µm)	1.4634	4.0976	1.8796	5.2629	2.2840	2.9336
Temporal (µm)	2.2956	6.4276	2.5546	7.1529	4.7043	5.2351
Superior (µm)	2.8264	7.9140	3.5281	9.8787	3.5930	4.4850
Nasal (µm)	2.8991	8.1176	3.9553	11.0748	4.9599	6.7668
Inferior (µm)	2.5395	7.1106	2.9880	8.3664	3.6115	4.2493
Clock hour 9 (µm)	2.4813	6.9476	2.8941	8.1034	5.5483	6.4713
Clock hour 10 (µm)	3.4895	9.7705	3.9555	11.0755	6.4194	7.2768	Clock hour 11 (µm)	3.8494	10.7784	4.0928	11.4599	4.9950	5.3108	Clock hour 12 (µm)	4.4919	12.5774	5.7878	16.2060	5.4955	7.0809	Clock hour 1 (µm)	3.9406	11.0336	4.6576	13.0414	5.1041	6.0328	Clock hour 2 (µm)	3.4231	9.5848	3.9783	11.1394	5.1747	6.0140	Clock hour 3 (µm)	3.4882	9.7670	5.0632	14.1771	6.5627	9.5259	Clock hour 4 (µm)	3.8452	10.7666	4.7855	13.3993	6.8533	8.5291	Clock hour 5 (µm)	3.8818	10.8691	4.5783	12.8192	5.6594	6.6747	Clock hour 6 (µm)	3.9587	11.0845	4.3994	12.3182	5.3266	5.9195	Clock hour 7 (µm)	3.6302	10.1644	4.6261	12.9530	5.3360	6.7998	Clock hour 8 (µm)	2.5716	7.2005	3.0180	8.4503	5.4299	6.3724	ONH Parameters							Cup Disc Ratio	0.0276	0.0774	0.0278	0.0777	3.7279	3.7449	Vertical CD Ratio	0.0307	0.0860	0.0313	0.0877	4.0501	4.1308	Disc Area (mm²)	0.0584	0.1635	0.0624	0.1746	3.0618	3.2703	Rim Area (mm²)	0.0367	0.1027	0.0395	0.1106	4.5529	4.9033	Cup Volume (mm³)	0.0220	0.0615	0.0247	0.0692	4.8135	5.4138	Macular Thickness Parameters								Central Subfield (µm)	5.6224	15.7427	7.6068	21.2992	1.5989	2.1632	Inner Temporal (µm)	4.3574	12.2007	5.1083	14.3032	1.1857	1.3900	Inner Superior (µm)	4.5687	12.7923	5.3448	14.9653	1.2562	1.4696	Inner Nasal (µm)	4.1606	11.6498	6.3917	17.8968	1.1298	1.7356	Inner Inferior (µm)	5.4349	15.2178	5.7159	16.0046	1.5167	1.5951	Outer Temporal (µm)	2.9954	8.3870	3.3484	9.3755	1.0367	1.1588	Outer Superior (µm)	2.8585	8.0038	3.3155	9.2835	0.9475	1.0989	Outer Nasal (µm)	2.7562	7.7173	3.4669	9.7073	0.8862	1.1147	Outer Inferior (µm)	4.2730	11.9645	4.6956	13.1476	1.5132	1.6628
Clock hour 11 (µm)	3.8494	10.7784	4.0928	11.4599	4.9950	5.3108
Clock hour 12 (µm)	4.4919	12.5774	5.7878	16.2060	5.4955	7.0809
Clock hour 1 (µm)	3.9406	11.0336	4.6576	13.0414	5.1041	6.0328
Clock hour 2 (µm)	3.4231	9.5848	3.9783	11.1394	5.1747	6.0140	Clock hour 3 (µm)	3.4882	9.7670	5.0632	14.1771	6.5627	9.5259	Clock hour 4 (µm)	3.8452	10.7666	4.7855	13.3993	6.8533	8.5291	Clock hour 5 (µm)	3.8818	10.8691	4.5783	12.8192	5.6594	6.6747	Clock hour 6 (µm)	3.9587	11.0845	4.3994	12.3182	5.3266	5.9195	Clock hour 7 (µm)	3.6302	10.1644	4.6261	12.9530	5.3360	6.7998	Clock hour 8 (µm)	2.5716	7.2005	3.0180	8.4503	5.4299	6.3724	ONH Parameters							Cup Disc Ratio	0.0276	0.0774	0.0278	0.0777	3.7279	3.7449	Vertical CD Ratio	0.0307	0.0860	0.0313	0.0877	4.0501	4.1308	Disc Area (mm²)	0.0584	0.1635	0.0624	0.1746	3.0618	3.2703	Rim Area (mm²)	0.0367	0.1027	0.0395	0.1106	4.5529	4.9033	Cup Volume (mm³)	0.0220	0.0615	0.0247	0.0692	4.8135	5.4138	Macular Thickness Parameters								Central Subfield (µm)	5.6224	15.7427	7.6068	21.2992	1.5989	2.1632	Inner Temporal (µm)	4.3574	12.2007	5.1083	14.3032	1.1857	1.3900	Inner Superior (µm)	4.5687	12.7923	5.3448	14.9653	1.2562	1.4696	Inner Nasal (µm)	4.1606	11.6498	6.3917	17.8968	1.1298	1.7356	Inner Inferior (µm)	5.4349	15.2178	5.7159	16.0046	1.5167	1.5951	Outer Temporal (µm)	2.9954	8.3870	3.3484	9.3755	1.0367	1.1588	Outer Superior (µm)	2.8585	8.0038	3.3155	9.2835	0.9475	1.0989	Outer Nasal (µm)	2.7562	7.7173	3.4669	9.7073	0.8862	1.1147	Outer Inferior (µm)	4.2730	11.9645	4.6956	13.1476	1.5132	1.6628
Clock hour 3 (µm)	3.4882	9.7670	5.0632	14.1771	6.5627	9.5259
Clock hour 4 (µm)	3.8452	10.7666	4.7855	13.3993	6.8533	8.5291
Clock hour 5 (µm)	3.8818	10.8691	4.5783	12.8192	5.6594	6.6747
Clock hour 6 (µm)	3.9587	11.0845	4.3994	12.3182	5.3266	5.9195
Clock hour 7 (µm)	3.6302	10.1644	4.6261	12.9530	5.3360	6.7998
Clock hour 8 (µm)	2.5716	7.2005	3.0180	8.4503	5.4299	6.3724
ONH Parameters
Cup Disc Ratio	0.0276	0.0774	0.0278	0.0777	3.7279	3.7449
Vertical CD Ratio	0.0307	0.0860	0.0313	0.0877	4.0501	4.1308
Disc Area (mm²)	0.0584	0.1635	0.0624	0.1746	3.0618	3.2703
Rim Area (mm²)	0.0367	0.1027	0.0395	0.1106	4.5529	4.9033
Cup Volume (mm³)	0.0220	0.0615	0.0247	0.0692	4.8135	5.4138
Macular Thickness Parameters
Central Subfield (µm)	5.6224	15.7427	7.6068	21.2992	1.5989	2.1632
Inner Temporal (µm)	4.3574	12.2007	5.1083	14.3032	1.1857	1.3900	Inner Superior (µm)	4.5687	12.7923	5.3448	14.9653	1.2562	1.4696	Inner Nasal (µm)	4.1606	11.6498	6.3917	17.8968	1.1298	1.7356	Inner Inferior (µm)	5.4349	15.2178	5.7159	16.0046	1.5167	1.5951	Outer Temporal (µm)	2.9954	8.3870	3.3484	9.3755	1.0367	1.1588	Outer Superior (µm)	2.8585	8.0038	3.3155	9.2835	0.9475	1.0989	Outer Nasal (µm)	2.7562	7.7173	3.4669	9.7073	0.8862	1.1147	Outer Inferior (µm)	4.2730	11.9645	4.6956	13.1476	1.5132	1.6628
Inner Superior (µm)	4.5687	12.7923	5.3448	14.9653	1.2562	1.4696
Inner Nasal (µm)	4.1606	11.6498	6.3917	17.8968	1.1298	1.7356
Inner Inferior (µm)	5.4349	15.2178	5.7159	16.0046	1.5167	1.5951
Outer Temporal (µm)	2.9954	8.3870	3.3484	9.3755	1.0367	1.1588	Outer Superior (µm)	2.8585	8.0038	3.3155	9.2835	0.9475	1.0989	Outer Nasal (µm)	2.7562	7.7173	3.4669	9.7073	0.8862	1.1147	Outer Inferior (µm)	4.2730	11.9645	4.6956	13.1476	1.5132	1.6628
Outer Superior (µm)	2.8585	8.0038	3.3155	9.2835	0.9475	1.0989
Outer Nasal (µm)	2.7562	7.7173	3.4669	9.7073	0.8862	1.1147
Outer Inferior (µm)	4.2730	11.9645	4.6956	13.1476	1.5132	1.6628

Repeatbility SD is the standard deviations. Repeatability conditions. Repeatability Limit is the upper 95 % limit for the difference between repeated results under repeatability conditions. Per ISO 5725-6, Repeatability Limit = 2.8 x Repeatability SD. Reproducibility SD is the standard deviation under reproducibility conditions. It was estimated by the sum of repeatability variance and the variance components of operator*subjects, device *subjects. Reproducibility Limit is the upper 95 % limit for the difference between reproducibility conditions. Reproducibility Limit = 2.8 x Reproducibility SD.

COV = Coefficient of variation = SD +Mean. x100. SD is either Repeatability SD or Reproducibility SD.

SUMMARY

As described in this 510(k) Summary, all testing deemed necessary was conducted on the CIRRUS photo to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.

{8}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 18 2012

Carl Zeiss Meditec, Inc. c/o Ms. Judith A. Brimacombe, M.A. Director, Clinical/Regulatory Affairs 5160 Hacienda Drive Dublin, CA 94568

Re: K112184

Trade/Device Name: Cirrus photo: Model 600 and 800 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HKI Dated: June 14, 2012 Received: June 15, 2012

Dear Ms. Brimacombe:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{9}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Alexander

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Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{10}------------------------------------------------

510(k) Number (if known): K112184

Device Name(s): CIRRUS photo

Indications for Use:

These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula, and optic disc as well as imaging of anterior ocular structures, including the cornea.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

S. C.

Page 1 of of

510(k) Number K112184

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

Regulation Number and Section

§ 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.