OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER

K030393 · Haag-Streit Holding AG · MXK · Sep 25, 2003 · Ophthalmic

Device Facts

• Record ID: K030393
• Device Name: OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER
• Applicant: Haag-Streit Holding AG
• Product Code: MXK · Ophthalmic
• Decision Date: Sep 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The OLCR Pachy-01 SL is a device used with slit-lamp systems to measure corneal thickness. The OLCR Pachymeter includes the functional capability to perform calculations of residual stroma thickness and correction to intraocular pressure values from user input.

Device Story

OLCR Pachymeter Pachy-01 SL is an add-on module for slit-lamp biomicroscopes; enables non-contact corneal thickness measurement. System comprises base unit, light-delivery instrument, and touch screen pad. Device emits visible and infrared laser light; uses Optical Low Coherence Reflectometry (OLCR) to capture ocular signals. Operated by ophthalmology specialists in clinical settings. System performs automated calculations for residual stroma thickness and intraocular pressure correction based on user input. Output provides precise, real-time ocular measurements to assist clinicians in evaluating patient eye health and surgical planning.

Clinical Evidence

Clinical study evaluated in-vivo precision/reproducibility of 5 OLCR pachymeters mounted on 5 different slit lamps. Measured central corneal thickness of 3 healthy individuals over 5 consecutive measurements. Nonclinical lab testing performed on 9 pachymeters across 5 different slit lamp systems using calibration standards and glass check rods to document accuracy.

Technological Characteristics

Optical Low Coherence Reflectometry (OLCR) sensing; Class I laser source (visible/infrared); conforms to ISO EN 15004 and IEC EN 60825-1. Add-on form factor for slit-lamp biomicroscopes. User-controlled via touch screen pad. Performs automated calculations for corneal thickness, residual stroma, and IOP correction.

Indications for Use

Indicated for use with slit-lamp systems to measure corneal thickness and perform calculations of residual stroma thickness and intraocular pressure correction in patients requiring ocular measurements.

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

• IOLMaster (K993357)
• Documenting Laser Slit Lamp (K012873)

Submission Summary (Full Text)

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KO30393

# 510(k) Summary OLCR PACHYMETER: Pachy - 01 SL

General Information:

- . Submitter's Name and Address: Rene Ott, Managing Director Haag-Streit AG Gartenstadtstrasse 10 Koeniz, Bern, Switzerland CH-3098
- . Contact Name: Eduardo March, Senior Consultant

AAC Consulting Group Inc. 7361 Calhoun Place, Suite 500 Rockville, MD 20855 Phone- 301.838.3120 Fax- 301.838-.3182

| Trade Name: | Optical Low Coherence Reflectometry (OLCR)<br>Pachymeter : Pachy-01 SL |
|-------------------|------------------------------------------------------------------------|
| Regulatory Class: | Class II |
| Product Code: | 86 MXK, Device, analysis, anterior segment |
| Regulation: | 21 CFR 886.1850, AC-powered slit-lamp biomicroscope |

## Device Description:

The Haag-Streit OLCR Pachymeter Pachy-01 SL is a device used with slit-lamp biomicroscopes to measure corneal thickness without eye contact. The Pachymeter is an add-on to Haag-Streit slit-lamps, including the BC 900, and those of other manufacturers marketed in the US. The Haag-Streit slit lamp and pachymeter provide ophthalmology specialists with the means of performing ocular measurements without contact, anesthesia, and external indentation of the ocular surface. The Haag-Streit pachymeter system allows for instantaneous, precise/reproducible and real time measurements.

The OLCR Pachymeter consists of a base unit, a light-delivery instrument and a user touch pad. The Pachymeter's Base unit generates a computer-controlled laser/light signal that is delivered through a fiber-optic coupler cable and emitted from a light-delivery instrument attached to the slit-lamp biomicroscope. The instrument emits light in the visible and infrared spectral regions within limit values specified by the ISO standard for ophthalmic instruments, ISO EN 15004. The instrument provides two laser exit locations; a location for the axial aiming laser and the measuring laser and a location for the lower aiming laser. The OLCR Pachymeter functions and assessment are user-controlled by means of a touch screen pad.

## Intended Use:

The OLCR Pachy-01 SL is a device used with slit-lamp systems to measure corneal thickness. The OLCR Pachymeter includes the functional capability to perform

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calculations of residual stroma thickness and correction to intraocular pressure values from user input.

#### Substantial Equivalence:

The OLCR Pachymeter when used with a slit-lamp biomicroscope is substantially equivalent, generally, to ultrasound diagnostic ophthalmic instruments used to image the anterior eve segment, perform calculations and estimate anterior chamber depth, axial length measurements and corneal radius and thickness.

The OLCR Pachymeter is, specifically, substantially equivalent to the IOLMaster from Carl Zeiss Inc. (K993357) and the Documenting Laser Slit Lamp from Bausch & Lomb Inc. (K012873). The OLCR Pachymeter is substantially equivalent to the IOLMaster, Zeiss, because both use light technology to provide ocular measurements and perform calculations needed to allow an ophthalmology specialist to evaluate the patient's eye.

Haag-Streit's Pachymeter is a class II medical device using a class I laser light source that emits light in the visible and infrared spectral regions and is subject to the Performance Standard for Light-emitting Products, 21 CFR Part 1040.10. The OLCR Pachymeter's performance conforms to the voluntary standard (IEC EN 60825-1) for class I laser devices. The IEC 60825 standard has been recognized by FDA as a means of meeting many of the part 1004.10 requirements for laser products.

The equivalence, accuracy and precision of the OLCR are demonstrated by nonclinical and clinical studies. In lab tests with 5 different biomicroscope slit lamp systems and with 9 pachymeters, Haag-Streit demonstrated the OLCR Pachymeter's accuracy and precision by mounting the pachymeters on different slit lamps to measure the thickness of an accepted calibration standard and glass check rods. In clinical studies, Haag-Streit has demonstrated the in-vivo precision or reproducibility of 5 OLCR pachymeters mounted on five different slit lamps to measure the central corneal thickness of 3 healthy individuals over 5 consecutive measurements. The measured accuracies of the 9 pachymeters in the lab and in-vivo studies have documented the accuracy under laboratory conditions and precision or variability of in-vivo human measurements with the OLCR Pachymeter.

The nonclinical and clinical tests demonstrate the OLCR Pachymeter is substantially equivalent to the IOLMaster system and other diagnostic ultrasound system used to measure corneal thickness.

Date Prepared: 9 Sept. 2003

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2003

Haag-Streit International C/O Eduardo March Senior Consultant AAC Consulting Group 7361 Calhoun Place, Suite 500 Rockville, MD 20855

Re: K030393 Trade Name: Optical Low Coherence Reflectometry (OLCR) Pachymeter, Pachy-01 Regulation: 21CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: MXK Dated: September 9, 2003 Received: September 9, 2003

Dear Mr. March:

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 - Eduardo March

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 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,

A Palgi 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

Enclosure

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## INDICATIONS FOR USE

510(K) NUMBER (If known): K030393

OLCR PACHYMETER : PACHY-01 SL Device Name:

Indications for Use:

The OLCR Pachymeter Pachy-01 SL is a device used with slit-lamp systems to measure corneal thickness. The OLCR Pachy-01 SL includes the functional capability to perform calculations of residual stroma thickness and correction to intraocular pressure values from user input.

Oexiashin'

510(k) Number

9-12-2003

(Please do not write below this line - Continue on other page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the Counter Use