HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)

K052935 · Heidelberg Engineering · MXK · Jan 13, 2006 · Ophthalmic

Device Facts

• Record ID: K052935
• Device Name: HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
• Applicant: Heidelberg Engineering
• Product Code: MXK · Ophthalmic
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The SL OCT is an add on for a slit lamp biomicroscope and is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used for diagnostic purposes. The SL-OCT is intended as an aid for the quantitative analysis of structures and the diagnosis and assessment of structural changes in the anterior segment of the eye. The SL-OCT examination system is not intended for the analysis of the cross-sectional images to obtain quantitative measured values. Neither the obtained measured values nor the qualitative evaluation of the images should be used as the sole basis for therapy-related decisions.

Device Story

SL-OCT is an add-on for slit-lamp biomicroscopes; enables non-contact in vivo imaging of anterior eye segment (chamber angle, anterior chamber). Uses 1310nm SLD laser (Class 1) and resonant/galvanometric scanning motor to capture optical coherence tomography data. Input: optical signals from eye structures; processed via custom software to generate cross-sectional images. Output: images displayed on PC monitor for qualitative assessment and quantification of anterior segment structures. Used in clinical settings by eye care professionals. Data stored on PC hard drive; printed for medical records. Benefits: provides non-destructive, in-depth visualization of anterior segment structures to aid diagnosis; does not provide automated quantitative analysis for therapy decisions.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 60825-1 (laser safety) confirmed. No clinical trial data provided.

Technological Characteristics

Class 1 1310nm SLD laser source; InGaAs photodiode detector; resonant and galvanometric scanning motor. Lateral resolution 20-100 μm; axial resolution <25 μm. PC-based image acquisition and management software. Horizontal working position; 50mm working distance. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60825-1.

Indications for Use

Indicated for eye examination of the anterior eye segment (corneal epithelium to posterior capsule) for diagnostic purposes in patients requiring assessment of structural changes.

Regulatory Classification

Identification

An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

Special Controls

*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, 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

• Optical Low Coherence Pachymeter Pachy-01 SL (K030393)

Submission Summary (Full Text)

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JAN I 3 2006

K052935

510(k) Summary of Safety and Effectiveness

# 510(k) Summary of Safety and Effectiveness

### Manufacturer and Submitter

| Company Name: | Heidelberg Engineering GmbH |
|------------------------|-----------------------------------------------------------|
| Company Address: | Gerhart-Hauptmann-Strasse 30<br>69221 Dossenheim, Germany |
| | phone: +49 / 6221 / 64 643 0 |
| | fax: +49 / 6221 / 64 63 62 |
| Contact Person: | Dr. Gerhard Zinser |
| Date Summary Prepared: | August 15, 2004 |

### Device

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

SL-OCT Slitlamp Optical Coherence Tomography AC-powered Slit-Lamp Biomicroscope 21 CR 886.1850 MXK Ophthalmic Class II device

### Substantial Equivalence

The SL-OCT is substantially equivalent to the Haag Streit AG Optical Low Coherence Pachymeter Pachy-01 SL

### Device Description

The SL-OCT enables non-destructive in-depth measurements of the structure and/or form of the anterior segment of the human eye. The visible structures are distinguished on the basis of their varying optical characteristics at the light wavelength used.

The information can be displayed, analysed and documented by the SL-OCT. To this end, a preinstalled software package - which may only be operated on this system - is supplied with the examination system.

This software records and displays the data and controls the measurement process. In addition. the software allows subsequent editing and saving of data to a database provides no permanent and secure archiving of OCT measurement data. For the documentation, the data are printed out and attached to the patient's medical record.

The images provided by the SL-OCT allow qualitative statements to be made about the dimensions and structures of the anterior segment and the dimensions of the identified structures to be quantified.

The SL-OCT is particularly suitable for non-contact in vivo imaging of the chamber angle and the anterior chamber.

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### Intended Use

The SL-OCT is intended as an aid for the quantitative analysis of structures and the diagnosis and assessment of structural changes in the anterior segment of the eye. The SL-OCT examination system is not intended for the analysis of the cross-sectional images to obtain quantitative measured values. Neither the obtained measured values nor the qualitative evaluation of the images should be used as the sole basis for therapy-related decisions.

### Technological Characteristics Compared to Predicate Device

Comparison of similarities and differences:

| Comparison items | SL-OCT | Optical Low Coherence<br>Pachymeter |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| k number | - | K030393 |
| Indications for use | Imaging and observation of the<br>anterior segment of the eye for<br>diagnostic purposes. | Biometric diagnose of the anterior<br>segment of the eye. |
| Corneal contact | No | No |
| Working distance cor-<br>nea to objective | Ca. 50 mm | ca. 50 mm |
| Corneal contact sens-<br>ing and warning fea-<br>ture | Not applicable. | Not applicable. |
| Pre-sterilized contact<br>surface | Not applicable. | Not applicable. |
| Front surface area | Not applicable | Not applicable. |
| Focus | Not applicable | Not applicable. |
| Focus adjustment<br>range | Not applicable | Not applicable. |
| Adjustment direction | Device is adjusted horizontally<br>while the patient is sitting straight<br>in front of the device. | Device is adjusted horizontally while<br>the patient is sitting straight in front<br>of the device. |
| Working position | Horizontal | Horizontal |
| Optical setup | Conventional microscope | Conventional microscope. |
| Type of scanning ap-<br>erture | Point. | Point. |
| Scanning means | Resonant and galvanometric<br>scanning motor. | Rotating mirror. |
| Light source | SLD 1310nm Laser Class 1 | Laser Light in the visible infrared<br>spectral regions |
| Microscope lens | Not applicable | Not applicable. |
| Lateral optical resolu-<br>tion | 20 μm - 100 µm | ca. 10 microns |
| Optical depth resolu-<br>tion | Axial optical resolution capacity:<br><25 µm | ca. 1 micron |
| Detector | InGaAs - photodiode. | Si-Photodiode |
| Lateral field of view | Up to 15 mm | Up to 15 mm. |
| Lateral digital resoluti-<br>on | 20 µm - 100 µm | |

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# 510(k) Summary of Safety and Effectiveness

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| Comparison items | SL-OCT | Optical Low Coherence Pachymeter |
|------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|
| | ity: 4 μm | Not applicable. |
| Image acquisition time | 1s | Not applicable. |
| Acquisition of three-dimensional images | No | No |
| Microscope lens magnification | Ca. 16x | ca. 16x |
| Magnification on screen (15", 1024x768 pixels) | 300x | ca. 100x |
| Image storage | Directly into PC RAM, then to PC hard drive. | Not applicable. |
| Image compression method | Not applicable | Not applicable. |
| Corneal profile measurement | Yes | Cornea thickness measurement. |
| Operating and image management software | Custom | Not applicable. |
| Physical layout | Lift table, mount with headrest, optical head are separate components. | Lift table, mount with headrest, optical head are separate components. |

### Conclusions from Performance Testing

The SL-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/3/Picture/2 description: The image is a black and white 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

MAY 2 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Heidelberg Engineering GmbH c/o Mr. Jeffrey D. Rongero Project Engineer Underwriters Laboratories, Inc 12 Laboratory Drive Research Triangle, NC 27709

Re: K052935

> Trade/Device Name: Heidelberg Retina Slitlamp-OCT (SL-OCT) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope, AC-powered Regulatory Class: II Product Code: OBO Dated: January 4, 2006 Received: January 10, 2006

Dear Mr. Rongero:

This letter updates our substantially equivalent letter of January 13, 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. Jeffrey D. Rongero

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.

Ewenette W. Beens Ph.D

Image /page/4/Picture/7 description: The image contains the word "for" written in cursive. The word is written in black ink on a white background. The "f" is capitalized and has a loop at the top. The "o" and "r" are connected.

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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Image /page/5/Picture/0 description: The image contains the words "HEIDELBERG" on the top line and "ENGINEERING" on the bottom line. The text is in a bold, sans-serif font and is black in color. The words are stacked on top of each other, with "ENGINEERING" directly below "HEIDELBERG". The image appears to be a logo or a sign.

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## Indication for Use

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| 510(k) Number (if known): | K052935 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | SL-OCT |
| Indication for Use: | The SL OCT is an add on for a slit lamp biomicroscope and is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used for diagnostic purposes. |

| Prescription Use | X | and / or | Over-The -Counter Use |
|-----------------------------|---|----------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) |

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

| 510(k) Number | K052935 |
|---------------|---------|
|---------------|---------|

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