An optical coherence tomography system indicated for the in vivo imaging and measurement of the retina as an aid in the diagnosis and management of retinal diseases.

Device Description

The SOCT Copernicus is an AC-powered device containing illumination and viewing optics intended to examine the retina of the eye. The SOCT Copernicus consists of a main unit, which houses the optical system used for imaging the retina, the light source, and a power supply. In addition, both systems utilize a chin rest/forehead rest assembly for patient interface and a computer with software for data analysis / image processing.

AI/ML Overview

Here's an analysis of the SOCT Copernicus device based on the provided 510(k) summary, detailing its acceptance criteria and the supporting studies:

Acceptance Criteria and Device Performance for SOCT Copernicus

The SOCT Copernicus is an Optical Coherence Tomography (OCT) system intended for in-vivo imaging and measurement of the retina as an aid in the diagnosis and management of retinal diseases. The device's acceptance criteria are implicitly derived from its comparison to a legally marketed predicate device (Carl Zeiss STRATUS OCT) and its demonstrated precision.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria (Implied)	Reported Device Performance
Precision (Repeatability & Reproducibility)	Good agreement across operators and devices.	Statistical analysis of the study data showed "good agreement" across devices and operators for measurements from normal and pathological eyes (diabetic macular edema, wet AMD, dry AMD, cystoid macular edema, vitreous hemorrhage, epiretinal membrane and/or vitromacular traction, and macular holes).
Clinical Equivalence to Predicate Device	No medically significant difference in measurements compared to the predicate device (STRATUS OCT).	A prospective case series comparing measurements from the SOCT Copernicus and the STRATUS OCT in 27 eyes (21 patients) with various vitreo-retinal disorders (including 5 normal eyes) found "no medically significant difference" based on statistical analysis of nine retinal fields (central subfield, temporal inner retina, superior inner retina, nasal inner retina, inferior inner retina, temporal outer retina, superior outer retina, nasal outer retina, and inferior outer retina).
Technological Characteristics	Similar fundamental technology and intended use, with potential improvements.	Uses Optical Coherence Tomography (OCT). Shares similar hardware components (main unit, optical system, light source, power supply, chin rest/forehead rest, computer with software). Differences: SOCT Copernicus uses Spectral/Fourier Domain OCT (faster, higher resolution) vs. STRATUS OCT's Time Domain OCT. SOCT Copernicus has higher A-scan rate (25,000/sec vs. 400/sec) and better depth resolution (6µm vs. 10µm).

2. Sample Sizes Used for the Test Set and Data Provenance

Precision Test:
- Sample Size: 10 normal eyes and 10 pathological eyes.
- Data Provenance: Not explicitly stated, but likely from a single study center given the description "structured study". It is prospective as operators were "unaware of patient pathology", suggesting a controlled, forward-looking data collection.
Clinical Comparison:
- Sample Size: 27 eyes from 21 patients.
- Data Provenance: Prospective case series conducted at the Cleveland Clinic Cole Eye Institute (USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Precision Test: The ground truth for this test was the measurements taken by the device itself under different operating conditions. There's no mention of external human experts establishing a separate "ground truth" for these measurements. The "3 operators" involved were observing and potentially performing the scans, but their role was in data collection for precision, not adjudication of pathology.
Clinical Comparison: The "ground truth" (or reference for comparison) in this study was the measurements obtained from the predicate device (Carl Zeiss Meditec Stratus™ Time Domain OCT). The study focused on comparing the measurements between the two devices, not on validating the absolute accuracy against a gold standard established by a panel of experts. The physicians performing the scans would implicitly be qualified, but their role in establishing a separate "ground truth" is not described as involving a consensus process.

4. Adjudication Method for the Test Set

Precision Test: No explicit adjudication method is described. The "good agreement" was determined through statistical analysis of measurements, not by expert consensus on image interpretation.
Clinical Comparison: No explicit adjudication method is described. The comparison was statistical, between measurements obtained from the two devices themselves.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an imaging device (an OCT scanner), not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here. The studies focused on the device's technical precision and its equivalence to a predicate device in terms of measurement output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, the studies describe a standalone performance evaluation of the device. The "SOCT Copernicus Precision Test" evaluated the device's inherent repeatability and reproducibility. The "SOCT Copernicus Clinical Comparison" evaluated its measurement capabilities in direct comparison to another device, without human interpretation of the images themselves being the primary endpoint, but rather the measurements derived from the images. While humans operate the device, the performance being assessed is the device's ability to produce consistent and comparable measurements.

7. The Type of Ground Truth Used

Precision Test: The ground truth was the measurements taken by the device itself, with the goal of showing consistency between repeated measurements and different operators.
Clinical Comparison: The ground truth for comparison was the measurements obtained from the predicate device (Carl Zeiss Meditec Stratus™ Time Domain OCT).

8. The Sample Size for the Training Set

No information about a "training set" is provided. This device is an imaging instrument (hardware and embedded software), not a machine learning or AI algorithm that typically requires a separate training set. The descriptions relate to validation/testing of the device's performance, not the training of a predictive model.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or applicable in the context of this device's validation, there is no information on how its ground truth would have been established.

Summary

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K071839 .

1. Submitter's Identification:

Reichert, Inc. c/o Sandra Brown Quality Regulatory Affairs Manager 3362 Walden Avenue Depew, NY 14043 Tel: (716) 686-4599

Date Summary Prepared: January 24, 2008

2. Name of the Device: SOCT Copernicus

3. Common or Usual Name: Optical Coherence Tomographer (OCT)

4. Predicate Device Information:

Trade Name: STRATUS OCT .
510(k) Number: K030433 .
Common Name: Optical Coherence Tomographer (OCT) •
Classification Name: Ophthalmoscope, AC-powered .
Classification: Class II .
Classification Panel: 86 .
Product Code: HLI .
Regulation Number: 886.1570 .

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న్. SOCT Copernicus Device Description:

The SOCT Copernicus is an AC-powered device containing illumination and viewing optics intended to examine the retina of the eye.

SOCT Copernicus Intended Use:

The SOCT Copernicus is an optical coherence tomography system indicated for the invivo imaging and measurement of the retina as an aid in the diagnosis and management of retinal diseases.

6. Technological Characteristics:

The Reichert SOCT Copernicus and the predicate device have similar technological characteristics. Both devices utilize Optical Coherence Tomography, which relies upon interferometry of superluminescent diode light, reflected from the fundus of the eye, to produce a cross-sectional image of the retina. Both devices have similar hardware components. Like the predicate device, the SOCT Copernicus consists of a main unit, which houses the optical system used for imaging the retina, the light source, and a power supply. In addition, both systems utilize a chin rest/forehead rest assembly for patient interface and a computer with software for data analysis / image processing.

A brief summary of major technological characteristics for both devices is presented below:

	Factor	Subject DeviceReichert “SOCT Copernicus”	Predicate DeviceCarl Zeiss “STRATUS OCT”
1	Method ofOperation	Optical Coherence Tomography:Spectral / Fourier Domain	Optical Coherence Tomography:Time Domain
2	ExposureParameters	750 μW at the cornea	750 μW at the cornea
3	Light Source	SLED. scan beam wavelength is840 nm.	SLED. scan beam wavelength is820 nm.
4	OCT Image	25,000 A-scan/second	400 A-scan/second
5	Depth Resolution(in tissue)	6 μm	10 μm
6	TransverseResolution	12 μm18 μm typical	20 μm

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7. Discussion of Clinical Tests Performed:

SOCT Copernicus Precision Test (Repeatability and Reproducibility)

A structured study was conducted with 3 operators (unaware of patient pathology) and 2 devices to determine repeatability and reproducibility precision values for the SOCT Copernicus. The test population consisted of 10 normal eves (with a wide range of media opacity and other parameters affecting image quality) and 10 pathological eyes including eyes with parameters affecting image quality such as diabetic macular edema, wet AMD, dry AMD, cystoid macular edema, vitreous hemorrhage, epiretinal membrane and/or vitromacular traction, and macular holes.

Statistical analysis of the study data showed good agreement across devices and operators.

SOCT Copernicus Clinical Comparison

A prospective case series comparing the Carl Zeiss Meditec Stratus™ Time Domain Optical Coherence Tomography (TDOCT) to the Reichert Copernicus™ Spectral Domain OCT (SDOCT) was performed at the Cleveland Clinic Cole Eye Institute.

A total of 27 eves from 21 patients with a variety of vitreo-retinal disorders, including five normal eves, were scanned with both machines and analyzed. All scans were analyzed to obtain values from nine fields: central subfield, temporal inner retina, superior inner retina, nasal inner retina, inferior inner retina, temporal outer retina, superior outer retina, nasal outer retina, and inferior outer retina.

Based on the results of the statistical analysis, no medically significant difference seems to exist between the measurements made by the two devices.

9. Conclusions:

· The SOCT Copernicus and Stratus OCT are both intended for in-vivo imaging and measurement of the retina as an aid in the diagnosis and management of retinal diseases.

• The SOCT Copernicus and Stratus OCT use similar technology with the exception that SOCT Copernicus utilizes Spectral Domain technology whereas the Stratus OCT uses Time Domain technology. Spectral Domain technology results in higher resolution retinal images. In addition, the SOCT Copernicus PC software is different from the Stratus OCT, but has been completely tested and validated.

· The devices are substantially equivalent based on the precision, repeatability and clinical testing described herein.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 27 2002

Reichert, Inc. c/o Ms. Sandra Brown Quality/Regulatory Affairs Manager 3362 Walden Avenue Depew, NY 14043

Re: K071839

Trade/Device Name: SOCT Copernicus Spectral Optical Coherence Tomographer Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: Undated Received: February 15, 2008

Dear Ms. Brown:

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.

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

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

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M. B. Egelston, m.D.

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

Enclosure

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Indications for Use

510(k) Number (if known): _ K071839

Device Name: Reichert SOCT Copernicus Spectral Optical Coherence Tomographer

Indications For Use:

An optical coherence tomography system indicated for the in vivo imaging and measurement of the retina as an aid in the diagnosis and management of retinal diseases.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Ophthalmic Ear,
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510(k) Number	K071839
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Prescription Use (Per 21 CFR 801.109)

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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.