HUMPHREY OCT3 by CARL ZEISS OPHTHALMIC SYSTEMS, INC.

The Humphrey OCT3 is a high resolution tomographic device for the viewing and axial measurement of posterior ocular structures. It is used in the detection and in the detection and disk. It is intended for use as a diagnostic aid as well as macular edema, central serous retinopathy and glaucoma.

Device Description

The Humphrey OCT employs the principle of low coherence interferometry based upon the Michelson interferometer. In a Michelson interferometer, the light from a source is split into a sample path and a reference path containing a mirror. Light reflected back from the sample path and the reference path will create an interference pattern on a detector if the optical path lengths between the reference and sample are identical. Adjusting the length of the reference path will allow a semi-transparent sample, such as the retina, to be cross-sectionally scanned. The Super-Luminescent Diode (SLD) used in the Humphrey OCT Scanner permits a short coherence length in air. Accounting for the index of refraction of the eye, this translates to an even shorter coherence length within the retina. The SLD emits near infrared light which is scattered by the various interfaces and structures of the retinal tissue. As the reference arm is moved, a depth profile of the retina is produced which is similar to ultrasound A-scan. The profile plots variations in optical reflectivity between the different layers of the retina. Two mirrors mounted to galvanometers deflect the SLD beam within the eye. Scanning the retina in this manner produces cross-sectional images similar to ultrasound Bscan but of much higher resolution. The tomographic images of the retina produced by the OCT scanner provide an important tool in the diagnosis of retinal disorders and diseases that manifest themselves in the posterior pole of the eye.

AI/ML Overview

The provided document describes a 510(k) Pre-market Notification for the Humphrey OCT 3 (Optical Coherence Tomography Model 3000), seeking substantial equivalence to existing devices. This type of submission generally doesn't include a new, comprehensive clinical study with clearly defined acceptance criteria and performance metrics in the way a PMA (Pre-market Approval) would.

Instead, the submission relies on demonstrating substantial equivalence by referencing existing literature and clinical studies that support the efficacy and safety of Optical Coherence Tomography (OCT) technology in general, and specifically the predecessors or similar devices. It highlights the device's technical specifications and how they align with or improve upon existing, legally marketed predicate devices.

Therefore, many of the requested fields cannot be directly extracted as the information is not presented in the format of a novel clinical trial for device approval. Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance (Not Applicable - See Explanation Below):

Explanation: The document does not explicitly state "acceptance criteria" and "reported device performance" in terms of specific numerical thresholds that the Humphrey OCT 3 had to meet in a new study. Instead, it asserts substantial equivalence by referencing prior studies and the known capabilities of OCT technology for imaging and measurement. The claims revolve around the device's ability to image and measure ocular structures, similar to predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Feature/Metric	Acceptance Criterion (Implicit/Referenced)	Reported Device Performance (Reference)
Safety	Not to exceed ACGIH/ICNIRP limits for human ocular exposure	"maximum output power of the IR LED is well below the continuous ACGIH/ICNIRP limit of 2mW."
Reproducibility of RNFL & Retinal Thickness	Qualitatively demonstrated in prior studies	"reproducibility of OCT measurements for RNFL and retinal thickness has been tested by numerous clinical trials." (e.g., Konno & Akiba et al (2001), Blumenthal et al (2000))
Early Glaucoma Detection	Improved detection compared to other methods	"increased detection of RNFL damage by the OCT, improves early glaucoma detection." (Zangwill 2000); "OCT was more sensitive than standard automated perimetry or scanning laser polarimetry" (Bowd and Zangwill 2001)
Differentiation of Glaucomatous Eyes	Ability to distinguish between non-glaucomatous and glaucomatous eyes	"able to differentiate between non glaucomatous and glaucomatous eyes using the OCT." (Hoh and Greenfield, et al 2000)
Discrimination of Normal vs. Glaucomatous Visual Field Loss	No significant difference in sensitivity compared to qualitative stereo photographs	"Qualitative assessments of stereo photographs and OCT measurements had no significant differences in sensitivities." (Zangwill and Bowd 2001)
Ability to Image and Measure Ocular Structures	Functional capability similar to predicate devices	"safe and effective tool for the imaging and measurement of ocular structures."
Scan Rate	Equivalent or improved compared to predicate	"increased scan rate for high resolution scanning."

Detailed Information on Studies (Where Applicable):

Sample Size Used for the Test Set and Data Provenance:
- Not applicable for a single new "test set" for this submission. The document refers to multiple studies.
- Examples from referenced studies:
  - Hoh and Greenfield et al. (2000): 78 patients (implied origin is clinical study, likely prospective within the context of the original research, but presented retrospectively in this 510(k)).
  - Zangwill and Bowd (2001): Studied "normal healthy eyes and eyes with early to moderate glaucomatous visual field loss". Sample size not explicitly stated in this summary, but would be from a clinical research setting.
  - Other studies (Konno & Akiba, Blumenthal, Zangwill 2000, etc.) are clinical trials. Data provenance generally implies clinical settings, likely multiple countries given the international scope of research. All referenced studies are retrospective in the context of this 510(k) submission, meaning previously published research.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable for a single new test set. For the referenced studies, ground truth would have been established by attending clinicians, ophthalmologists, and researchers at the institutions conducting those studies. The specific number and qualifications are not provided in this 510(k) document, but generally, ophthalmic studies involving glaucoma or retinal conditions would use qualified ophthalmologists.
- Independent safety analysis: "an internationally recognized expert in the field of optical radiation hazards and safety" performed this.
Adjudication Method for the Test Set:
- Not applicable for a single new test set. Adjudication methods would have been specific to each referenced clinical study, but are not detailed in this 510(k).
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study is not specifically mentioned as being conducted for this 510(k) submission. The document cites studies that compare OCT's effectiveness against other diagnostic methods (e.g., "OCT was more sensitive than standard automated perimetry or scanning laser polarimetry" or comparison with "retinal nerve fiber layer photography").
- Effect Size of Human Readers with vs. without AI Assistance: Not applicable, as this is a device for imaging and measurement, not an AI-assisted diagnostic algorithm in the sense of comparing human performance. The "AI" (algorithm) here is the OCT's inherent measurement and imaging capability.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, implicitly. The device itself, the Humphrey OCT 3, performs the imaging and provides measurements (e.g., RNFL thickness). The performance of these measurements and interpretations is what the referenced studies evaluate. While a human clinician interprets the OCT images and data, the "standalone" performance refers to the device's ability to produce those accurate and reproducible images and measurements. The studies cited, such as those on "reproducibility of nerve fiber layer thickness measurements by optical coherence tomography," directly assess this standalone capability.
Type of Ground Truth Used:
- For the referenced studies, ground truth varies:
  - Clinical Diagnosis: Differentiation between "non glaucomatous and glaucomatous eyes" (Hoh and Greenfield, et al 2000) implies a clinical diagnosis made by ophthalmologists using a suite of tests.
  - Visual Field Tests: Correlation with "visual field defect documented with visual field tests in glaucoma patients" (Shuman et al 1995).
  - ONH Photographs: Correlation with "RNFL drop out observed in ONH photographs" (Shuman et al 1995).
  - Pathology/Outcome data: Not explicitly mentioned, but the clinical diagnosis of glaucoma often involves an assessment of the optic nerve head (ONH) and visual field, which are surrogates for the underlying pathology.
Sample Size for the Training Set:
- Not applicable. This submission is for a medical device (hardware and software for imaging), not a machine learning model that requires a distinct "training set" in the modern AI sense. The development of the OCT technology itself, its algorithms for image processing and measurement, would have involved extensive engineering and validation, but not a formally defined "training set" in the context of this 510(k). The referenced clinical studies serve as validation of the technology's utility, not as training data for a new ML model.
How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as above. If there were internal software algorithms that learned from data, the ground truth would have been established by engineering teams against known physical principles and clinically relevant measurements. This is not detailed in the 510(k).

Summary

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JAN 3 1 2002

K012727

510 k Safety and effectiveness summary

Carl Zeiss Ophthalmic Systems, Inc. 1. Humphrey Division 5160 Hacienda Dr. Dublin, CA 94568 Contact Person - Melissa R. Horne November 2, 2001
JAN 18 10 31 AM '02

RECEIVED

Humphrey Optical Coherence Tomographer 3 2.
1. We are claiming substantial equivalence to the Humphrey Optical Coherence Tomographer, the Heidelberg Retinal Tomograph, and the GDx by Laser Diagnostic Technologies.
1. In order to understand the Humphrey version of the Optical Coherence Tomographer. You must understand how Optical Coherence Tomography works. In general OCT Scanners permit the user to obtain and analyze cross-sectional tomograms of ocular tissue in a non-contact and non-invasive manner. The Humphrey Optical Coherence Tomography Scanner measures optical reflectivity to obtain cross sectional tomograms of the eye.

The Super-Luminescent Diode (SLD) used in the Humphrey OCT Scanner permits a short coherence length in air. Accounting for the index of refraction of the eye, this translates to an even shorter coherence length within the retina. The SLD emits near infrared light which is scattered by the various interfaces and structures of the retinal tissue. As the reference arm is moved, a depth profile of the retina is produced which is similar to ultrasound A-scan. The profile plots variations in optical reflectivity between the different layers of the retina. Two mirrors mounted to galvanometers deflect the SLD beam within the eye. Scanning the retina in this manner produces cross-sectional images similar to ultrasound Bscan but of much higher resolution. The tomographic images of the retina produced by the OCT scanner provide an important tool in the diagnosis of retinal disorders and diseases that manifest themselves in the posterior pole of the eye.

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1. This device will be used in the same manner as all OCT scanner devices. The Humphrey OCT is a safe and effective tool for the imaging and measurement of ocular structures. Previous submissions to the FDA, various publications, and clinical studies from independent researchers have demonstrated the efficacy of the OCT scanner. Independent analysis by an internationally recognized expert is included in this report and previous FDA submissions have demonstrated its safety. The information summarized below refers directly to the ability of the OCT to image and measure ocular structures.
  The reproducibility of OCT measurements for RNFL and retinal thickness has been tested by numerous clinical trials. Among them, Konno and Akiba et al (2001) reported the ability of the OCT to reproduce quantitative information on foveal thickness and Blumenthal et al (2000) reported that RNFL measurements were reproducible for both normal and glaucomatous eyes.

Zangwill (2000) reports that the increased detection of RNFL damage by the OCT, improves early glaucoma detection. Shuman et al (1995) have reported their use of the OCT for monitoring glaucoma. Circular OCT scans at various radii centered around the optic nerve head (ONH) presented nerve fiber layer (NFL) thickness in the OCT image, which could be measured by analysis of the data. The NFL thickness measurement correlated with the RNFL drop out observed in ONH photographs and with visual field defect documented with visual field tests in glaucoma patients.

In a study of 78 patients, Hoh and Greenfield, et al (2000), correlated retinal nerve fiber layer structural measurements with visual function. They report that they were able to differentiate between non glaucomatous and glaucomatous eyes using the OCT. Bowd and Zangwill (2001) report the ability to detect early glaucoma by the assessment of retinal nerve fiber layer using the OCT. In the same study, comparing the ability of different methods of detecting early glaucoma by assessment of retinal nerve fiber layer thickness, concluded that the OCT was more sensitive than standard automated perimetry or scanning laser polarimetry.

Reporting in the Archives of Ophthalmology, Zangwill and Bowd (2001), studied the ability of the OCT to discriminate between normal healthy eyes and eyes with early to moderate glaucomatous visual field loss. Qualitative assessments of stereo photographs and OCT measurements had no significant differences in sensitivities.

A safety analysis was performed by an independent consultant, who is an internationally recognized expert in the field of optical radiation hazards and safety, in order to determine if the energy introduced into the eye by the OCT scanner poses any safety risk.

The safety analysis concludes that the device under normal operating circumstances would never exceed the limits for human ocular exposure.

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The maximum output power of the IR LED is well below the continuous ACGIH/ICNIRP limit of 2mW.

1. The OCT3 is substantially equivalent to the predicate device. One of the differences between the two devices are that the new OCT combines many of the separate components utilized into one more cohesive unit. The devices are very similar in materials and energy source. The new OCT has an increased scan rate for high resolution scanning.

References

Schuman JS, Hee MR, Puliafito CA, Wong C, Pedut-Kloizman T, Lin CP, Hertsmark E, Izatt JA, Swanson EA, Fujimoto JG. Quantification of nerve fiber thickness in normal and glaucomatous eyes using optical coherence tomography; a pilot study. Archives of Ophthalmology 1995; 1130:586-596

Konno S, Akiba J, Yoshida A. Retinal thickness measurements with optical coherence tomography and the scanning retinal thickness analyzer. Retina 2001; 21(1): 57-61

Blumenthal EZ, Williams JM, Weinreb RN, Girkin CA, Berry CC, Zangwill LM. Reproducibility of nerve fiber layer thickness measurements by optical coherence tomography. Ophthalmology 2000; Dec; 107(12): 2278-82

Hoh ST, Greenfield DS, Mistlberger A, Liebmenn JM, Ishikawa H, Ritch R. Optical coherence tomography and scanning laser polarimetry in normal, ocular hypertensive, and glaucomatous eyes. American Journal of Ophthalmology 2000; Feb; 129(2):129-35

Bowd C, Zangwill LM, Berry CC, Blumenthal EZ, Vasile C, Sanchez OC, Bosworth CF, Sample PA, Weinreb RN. Detecting early glaucoma by assessment of retinal nerve fiber layer thickness and visual function. Investigative Ophthalmology and Visual Science 2001 Aug;42(9):1993-2003

Zangwill LM, Williams J, Berry CC, Knauer S, Weinreb RN. A comparison of optical coherence tomography and retinal nerve fiber layer photography for detection of nerve fiber layer damage in glaucoma. Ophthalmology 2000 Jul;107(7):1309-15

Zangwill LM, Bowd C, Berry CC, Williams J, Blumenthal EZ, Sanchez-Galena CA, Vasile C, Weinreb RN. Archives of Ophthalmology 2001 Jul;119(7):985-93

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or abstract figures, often interpreted as representing the human form or the flow of life.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2002

Ms. Melissa R. Horne Associate Product Manger, OCT Carl Zeiss Ophthalmic Systems, Inc. 5160 Hacienda Drive Dublin, California 94568

Re: K012727

Trade/Device Name: Optical Coherence Tomography Model 3000 (OCT 3) Regulation Number: 21 CFR 892.1560; 886.1570 Regulation Name: Ultrasonic pulsed echo imaging system and Ophthalmoscope Regulatory Class: II Product Code: IYO; HLI Dated: October 31, 2001 Received: November 5, 2001

Dear Ms. Horne:

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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Page 2 - Ms. Melissa R. Horne

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 1 of 1

510(k) Number (if known): K012727

Device Name: Humphrey OCT 3 __________________________________________________________________________________________________________________________________________________

Indications For Use: The Humphrey OCT3 is a high resolution tomographic device for Indications I of OSC. The Humpmoy of posterior ocular structures. It is used the viewing and axial 0.000 0000.01.21145. for in VNO integring and model. Still in the detection and in the detection and disk. It is intended for use as a diagnoons as week as macular edema, central serous retinopathy and glaucoma.

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duych Hoang

ision of Oohthalmic Ear. Nose and Throat Devises

510(k) Number K012727

(Optional Format 3-10-98)

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.