HUMPHREY OCT SCANNER

• K Number: K961171
• Device Name: HUMPHREY OCT SCANNER
• Manufacturer: CARL ZEISS, INC.
• Date Cleared: 1996-06-21 ( 88 days)
• Product Code: HLI OBO
• Regulation Number: 886.1570

Intended Use

This device will be used in the same manner as all OCT scanner devices are used for two dimensional cross-sectional imaging of the posterior segment of the eye. It incorporates the original intended uses of our earlier claimed substantially equivalent products. It is used primarily for diagnosing and monitoring retinal diseases and disorders that manifest themselves in the posterior pole of the eye. Clinical studies with the OCT have demonstrated its effectiveness in detecting and quantifying the extent of macular edema, macular holes, retinal detachments and central serious chorioretinopathy.

Device Description

In general OCT Scanners permit the user to obtain and analyze crosssectional 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 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 B-scan 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.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical principles of OCT imaging (interferometry, light scattering) and does not mention any computational analysis or algorithms beyond basic image acquisition and display. There is no mention of AI, ML, or related terms.

Therapeutic

No
The device is described as an imaging tool used for diagnosing and monitoring retinal diseases, not for providing therapy or treatment.

Diagnostic

Yes

The document explicitly states that the device is "used primarily for diagnosing and monitoring retinal diseases and disorders" and "provide an important tool in the diagnosis of retinal disorders and diseases."

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components like a Super-Luminescent Diode (SLD), Michelson interferometer, mirrors, and galvanometers, which are integral to the device's function of obtaining cross-sectional images. This indicates it is a hardware-based medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device function: The description clearly states that this device is an OCT scanner used for non-contact and non-invasive imaging of the posterior segment of the eye. It works by measuring optical reflectivity within the eye itself.
• No mention of samples: There is no indication that this device analyzes any samples taken from the body. It directly interacts with and images the eye.

Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This device will be used in the same manner as all OCT scanner devices are used for two dimensional cross-sectional imaging of the posterior segment of the eye. It incorporates the original intended uses of our earlier claimed substantially equivalent products. It is used primarily for diagnosing and monitoring retinal diseases and disorders that manifest themselves in the posterior pole of the eye. Clinical studies with the OCT have demonstrated its effectiveness in detecting and quantifying the extent of macular edema, macular holes, retinal detachments and central serious chorioretinopathy.

Product codes

OBO

Device Description

The Humphrey Optical Coherence Tomography (OCT) Scanner measures optical reflectivity to obtain cross sectional tomograms of the eye. 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 B-scan 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical Coherence Tomography (OCT)

Anatomical Site

posterior segment of the eye, posterior pole of the eye, retina

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Clinical studies with the OCT have demonstrated its effectiveness in detecting and quantifying the extent of macular edema, macular holes, retinal detachments and central serious chorioretinopathy.

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

MAY 2 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carl Zeiss, Inc. c/o Mr. Kenneth M. Nicoll 1 Zeiss Drive Thornwood, NY 10594

Re: K961171

Trade/Device Name: Humphrey Optical Coherence Tomography (OCT) Scanner Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: Unknown Received: March 25, 1996

Dear Mr. Nicoll:

This letter updates our substantially equivalent letter of June 21, 1996.

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 (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 additional controls. Existing major regulations affecting your

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Page 2 - Mr. Kenneth M. Nicoll

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.

This letter will allow you to continue 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Evenette M. Beus Ph.D.

Malvina B. Eydelman, 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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UN 21 100

19611

510-k Summary

Pursuant to 21 CFR 807.92 the following summary is submitted.

• 1. Submitter's name-Carl Zeiss, Inc. 1 Zeiss Drive Thornwood, NY 10594 [phone] Contact Person-Kenneth M. Nicoll March 21, 1996
• 2. Humphrey OCT (Optical Coherence Tomography) Scanner Optical Coherence Tomography Scanner

3. We are claiming substantial equivalence to the OCT predicate device. which already has market clearance.

4. In order to properly understand the Humphrey version of Optical Coherence Tomography Scanners you must understand how an Optical Coherence Tomography Scanner works. In general OCT Scanners permit the user to obtain and analyze crosssectional 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 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 B-scan 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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510-k Summary Page 2

5. This device will be used in the same manner as all OCT scanner devices are used for two dimensional cross-sectional imaging of the posterior segment of the eye. It incorporates the original intended uses of our earlier claimed substantially equivalent products. It is used primarily for diagnosing and monitoring retinal diseases and disorders that manifest themselves in the posterior pole of the eye. Clinical studies with the OCT have demonstrated its effectiveness in detecting and quantifying the extent of macular edema, macular holes, retinal detachments and central serious chorioretinopathy.

6. The modified OCT 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 which were utilized into one more cohesive unit. The two devices are very similar in materials and energy source. The primary differences between the two are the way the exteriors are designed and their appearance. The new OCT has a redesigned delivery system. This improvement permits a greater field of view, a longer working distance, the introduction of the Landmark system and a new internal fixation system.

Clinical studies were mentioned above.