HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT

K063191 · Heidelberg Engineering · OBO · Oct 31, 2006 · Ophthalmic

Device Facts

• Record ID: K063191
• Device Name: HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT
• Applicant: Heidelberg Engineering
• Product Code: OBO · Ophthalmic
• Decision Date: Oct 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The OCT add-on to the HRA 2 is intended for use for the imaging of the retina and retinal structures, and for aiding in the assessment and management of various diseases of the posterior segment, such like age-related macula degeneration, diabetic retinopathy, and glaucoma.

Device Story

HRA 2 / OCT is an add-on module for the Heidelberg Retina Angiograph (HRA 2) for imaging posterior ocular structures. Device uses spectral-domain (Fourier-domain) optical coherence tomography (SD-OCT) to capture axial cross-sectional images and 3D volume scans of the retina. System directs light at the retina; back-reflected light interferes with reference light; optical interference is detected and analyzed via spectrometer. Intensity of back-reflected light is displayed as gray-values on a computer monitor. Operated by clinicians in a clinical setting; patient sits in front of device with headrest for stabilization. Images are processed, displayed, edited, and stored using Heidelberg Eye Explorer Software. Output allows clinicians to visualize retinal morphology, aiding in diagnosis and management of conditions like macular degeneration, diabetic retinopathy, and glaucoma.

Clinical Evidence

Bench testing only. Device tested for electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2). Laser safety verified per 21 CFR 1040.10 and IEC 60825-1. Substantial equivalence supported by comparison of acquired images and technical specifications against the predicate device.

Technological Characteristics

Spectral-domain (Fourier-domain) OCT; SLD light source (870 nm, Class 1); galvanometric scanning motor; lateral resolution 14 μm; depth resolution 6.9 μm; linear line array detector. Connectivity via PC-based workstation; custom image management software. Manually adjustable focus (-12 to +12 diopters).

Indications for Use

Indicated for imaging of retina and retinal structures to aid in assessment and management of posterior segment diseases, including age-related macular degeneration, diabetic retinopathy, and glaucoma in patients requiring ophthalmic diagnostic imaging.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Humphrey Optical Coherence Tomographer 3 (Humphrey OCT3) (K012727)

Submission Summary (Full Text)

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K063191

# 510(k) Summary of Safety and Effectiveness

# Manufacturer and Submitter

| Company Name: | Heidelberg Engineering GmbH |
|------------------------|------------------------------|
| Company Address: | Tiergartenstrasse 15 |
| | 69121 Heidelberg, Germany |
| | phone: +49 / 6221 / 64 643 0 |
| | fax: +49 / 6221 / 64 63 62 |
| Contact Person: | Dr. Gerhard Zinser |
| Date Summary Prepared: | September 11, 2006 |

#### Device

Trade/Device Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Classification Panel: Classification:

HRA 2 / OCT Heidelberg Retina Angiograph / Optical Coherence Tomograph Opthalmoscope, AC-powered 21 CR 886.1570 HLI Ophthalmic Class II device

### Substantial Equivalence

The OCT add-on to the HRA 2 is substantially equivalent to the Carl Zeiss Ophtalmic Systems Inc. Humphrey Octical Coherence Tomographer 3, Humphrey OCT3, a 510 (k) cleared device ( K012727 ).

### Device Description

The HRA 2 / OCT is an add-on to the Heidelberg Retina Angiograph (HRA 2). It is intended for the imaging of the retina and retinal structures.

With the additional HRA 2 / OCT it is possible to perform axial cross sectional images of the retina or 3-dimensional volume scans of the retina. The visible structures are distinguished on the basis of their varying optical characteristics at the light wavelength used. The intensity of the back-reflected light is measured and displayed as gray-values on a computer monitor.

The light sent to the probe interferes with the light that is back-reflected from the probe. The optical interference of both light beams is detected and the spectrum of the light is analyzed in an optical spectrometer. This technology is called spectral-domain optical coherence tomography (SD-OCT) or Fourier-domain OCT (FD-OCT).

The images acquired by the device can be displayed, edited and stored using the Heidelberg Eye Explorer Software.

OCT 3 1 2006

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### Intended Use

The OCT add-on to the HRA 2 is intended for use for the imaging of the retina and retinal structures, and for aiding in the assessment and management of various diseases of the posterior segment, such like age-related macula degeneration, diabetic retinopathy, and glaucoma.

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fechnological Characteristics Compared to Predicate Device

| Comparison items<br>k number | HRA 2 / OCT | OCT 3<br>K012727 | |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Indications for use | The OCT add-on to the HRA 2 is a device for the<br>optical imaging of posterior ocular structures. | The Humphrey OCT3 is a high resolution tomographic<br>device for the viewing and axial cross sectional imaging of<br>posterior ocular structures. | |
| | The Device uses Optical Low Coherence<br>Tomography technology for the axial cross<br>sectional imaging of the retina. | It is used for the in vivo imaging<br>and measurement of the retina, retina nerve fiber layer and<br>optic disk. It is intended for use as a diagnostic device to | |
| | The OCT add-on to the HRA 2 is intended for use<br>for the imaging of the retina and retinal structures,<br>and for aiding in the assessment and management<br>of various diseases of the posterior segment, such | aid in the detection and management of ocular diseases, | |
| | like age-related macula degeneration, diabetic<br>retinopathy, and glaucoma. | including but not limited to macular edema, central serous<br>retinopathy and glaucoma. | |
| Corneal contact | No | No | |
| Working distance cornea to<br>objective | Ca. 10 mm | No information | |
| Corneal contact sensing and<br>warning feature | No | No | |
| Pre-sterilized contact surface | No | No | |
| | HRA 2 / OCT | OCT 3 | |
| Comparison of similarities and differences continued:<br>Comparison items<br>k number | | K012727 | |
| Front surface area | 310 mm² | No information. | |
| Focus | Manually adjustable | Manually adjustable | |
| Focus adjustment range | Correction of patients refractive errors: -12 to +12<br>diopters | Correction of patients refractive errors: -12 to +12<br>diopters | |
| Alignment to patient | Device is adjusted horizontally and vertically while<br>the patient is sitting straight in front of the device. | Device is adjusted horizontally and vertically while the<br>patient is sitting straight in front of the device. | |
| Working position | The patient is sitting straight in front of the device.<br>The examiner is sitting opposite to the patient. | The patient is sitting straight in front of the device. The<br>examiner is sitting opposite to the patient. | |
| Optical setup | Frequency (Fourier) Domain OCT | Time Domain OCT | |
| Type of scanning aperture | Point scan. | Point scan. | |
| Scanning means | Galvanometric scanning motor. | Galvanometric scanning motor | |
| Light source | SLD, 870 nm, Class 1 | SLD 820 nm, Class 1 | |
| Optical resolution, lateral | 14 μm | 20 μm in tissue<br>(spot size in tissue) | |
| Optical resolution, depth | 6,9 μm | <10 μm in tissue | |
| Comparison of similarities and differences continued: | | | |
| Comparison items | HRA 2 / OCT | | OCT 3 |
| k number | | | K012727 |
| Detector | Linear line array | | Photodiode |
| Lateral field of view | 2D Scan:<br>3 mm to 9 mm, corresponding to 10° to 30° | | 2D Scan:<br>6 mm, corresponding to 20° |
| | 3D Scan:<br>1,5 mm x 1,5 mm to 9 mm x 9 mm, corresponding to<br>5° x 5° to 30° x 30° | | |
| Lateral digital resolution | 2D Scan:<br>high resolution mode: 5 μm<br>high speed mode:<br>10 μm | | 2D Scan:<br>8 μm<br>(768 A scan in 6 mm) |
| | 3D Scan:<br>high resolution mode: 5 μm<br>high speed mode:<br>35 μm<br>video mode:<br>25 μm to 150 μm | | |
| Depth digital resolution | 3 μm<br>(512 points in 1,5 mm in tissue) | | 2 μm<br>(1024 points in 2 mm in tissue) |
| Comparison of similarities and differences continued: | | | |
| Comparison items | HRA 2 / OCT | | OCT 3 |
| k number | | | K012727 |
| Image acquisition time | 2D Scan: | | 2D Scan: |
| | high resolution mode: | 6 to 20 ms | 0,32 s to 1,92 s |
| | high speed mode: | 12 to 40 ms | (depends on no. of A-scan) |
| | 3D Scan: | | |
| | high resolution mode: | 3,6 s | |
| | high speed mode: | 1,6 s | |
| | video mode: | 0,1 s | |
| Acquisition of three-dimensional images | Yes | | No |
| Image storage | Directly into PC RAM, then to PC hard disk drive | | No information |
| Image compression method | Yes (without information loss) | | No information |
| Operating and image management software | Custom | | Custom |

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| Comparison of similarities and differences continued: | | |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Comparison items | HRA 2 / OCT | OCT 3 |
| number | | K012727 |
| Physical layout | - Mount with headrest<br>- Optical head<br>- Power supply and laser unit<br>- Touchpanel<br>- Computer with monitor, keyboard,<br>- Mouse and printer<br>- Lift table | - Imaging device with integrated headrest<br>- Computer with monitor, keyboard,<br>- Mouse and printer<br>- Lift table |

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# Conclusions from Performance Testing

The HRA 2 / OCT has been tested according to IEC 60601-1 and IEC 60601-1-2, and was found to meet all requirements. The system is a laser product of Class 1 according to 21 CFR Part 1040 Section 1040.10 and IEC 60825-1:1993+A2:2001.

The evaluation of the device and comparison of acquired images resulted in substantial equivalence to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness.

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Image /page/8/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized human figure with three faces in profile, representing the department's focus on people. The figure is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the figure.

JUN 1 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Heidelberg Engineering GmbH c/o Mr. Morten Simon Christensen Underwriters Laboratories, Inc 455 E. Trimble Road San Jose, CA 95131-1230

Re: K063191

Trade/Device Name: Heidelberg Retina Angiograph 2/ Optical Coherence Tomograph (HRA 2/OCT) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: October 18, 2006 Received: October 20, 2006

Dear Mr. Christensen:

This letter updates our substantially equivalent letter of October 31, 2006.

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. Morten Simon Christensen

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 yours,

Eivenette R. Beens PhD

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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

#### Enclosure

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# Indication for Use

510(k) Number (if known):

Device Name:

Heidelberg Retina Angiograph 2 / Optical Coherece Tomograph (HRA 2 / OCT)

Indication for Use

The OCT add-on to the HRA 2 is intended for use for the imaging of the retina and retinal structures, and for aiding in the assessment and management of various diseases of the posterior segment, such like agerelated macula degeneration, diabetic retinopathy, and glaucoma.

Prescription Use

X

and / or

Over-The -Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Dennis L. McCarthy

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(Division Sign Off)

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

510(k) Numbe