Imaging and observation of the cellular layers of the anterior segment of the human eye, for the diagnosis and management of anterior segment diseases.

Device Description

The system consists of the HRT II laser scanning camera, the Rostock Cornea Module optics, a mount with headrest, a power supply, and a personal computer. For an examination, the Rostock Cornea Module optics is placed on the laser scanning camera, positioned in front of the patient's eye, in contact with the cornea. The contact surface is a sterile PMMA plate. Images of the anterior segment are acquired, displayed on the computer monitor and stored on the hard drive of the computer from where the images can be retrieved at a later time.

The system operates by illuminating the cornea of the eye under examination and detecting the light reflected or backscattered from the cornea. The light detection system has a confocal optical arrangement, resulting in a shallow depth of focus. In consequence a two-dimensional image acquired with this system can be considered as an optical section through the corneal layer located at the current focal plane. In addition, by moving the focal plane step by step, a sequence of section images at different locations of the focal plane can be acquired. This sequence of section images provides a layer-by-layer three-dimensional image. The acquired images are displayed on the computer monitor and stored on the computer's hard disk for later use.

AI/ML Overview

I'm sorry, but no information about acceptance criteria or a study proving that the device meets acceptance criteria is available in the provided text. The document is a 510(k) summary for the Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM), primarily focusing on its device description, intended use, comparison to predicate devices, and regulatory clearance. It confirms that the device was tested according to IEC 60601-1 and IEC 60601-1-2 and met all requirements, and is a Class 1 laser product. However, it does not detail specific acceptance criteria or a study with performance metrics for clinical efficacy.

Summary

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JE 1 3 21114

510(k) Summary of Safety and Effectiveness

Manufacturer and Submitter

Company Name:	Heidelberg Engineering GmbH
Company Address:	Gerhart-Hauptmann-Strasse 30
	69221 Dossenheim, Germany
	phone: +49 / 6221 / 64 643 0
	fax: +49 / 6221 / 64 63 62
Contact Person:	Dr. Gerhard Zinser
Date Summary Prepared:	August 30, 2004
Device
Trade/Device Name:	Heidelberg Retina Tomograph II / Rostock Cornea Module
	(HRT II / RCM)
Common/Usual Name:	Corneal Microscope
Classification Name:	AC-powered Slit-Lamp Biomicroscope
Regulation Number:	21 CR 886.1850
Product Code:	MXK
Classification Panel:	Ophthalmic

Substantial Equivalence

Classification Panel:

Classification:

The HRT II / RCM is substantially equivalent to a slit-lamp biomicroscope, a preamend-The FIXT 11 / RONA is buondinations of Secon 2" device, a Class II device that received 510(k) market clearance on October 26, 2001, document control number K012416,

Class II device

Device Description

The system consists of the HRT II laser scanning camera, the Rostock Cornea Module optics, a mount with headrest, a power supply, and a personal computer. For an examinaoptivs, a modily with nead sollule optics is placed on the laser scaming camera, positioned in front of the patient's eye, in contact with the cornea. The contact surface is a sterile PMMA plate. Images of the anterior segment are acquired, displayed on the comsterner monitor and stored on the hard drive of the computer from where the images can be retrieved at a later time.

Iceric ved at a faror thire. the cornea of the eye under examination and detecting the light reflected or backscattered from the cornea. The light detection system has a confocal optical arrangement, scatched nom all depth of focus. In consequence a two-dimensional image acquired windness in sincer as an optical section through the corneal layer located at the current Can be considered as an option result in addition, by moving the focal plane step by step, a sequence of section images at different locations of the focal plane can be acquired. This sequence of seculor mages a layer-by-layer three-dimensional image. The acquired im-Sequence of mages provides a the computer monitor and stored on the computer's hard disk for later use.

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Intended Use

The intended use of the Heidelberg Retina Tomograph II / Rostock Cornea Module is to The intended use of the netotoorg results + cannogior ======================================================================================================================== of the anterior segment.

Comparison of similarities and differences
	HRT II / RCM	Nidek Confoscan 2 *	Slit-Lamp Biomicro-scope
Indications for use	Imaging and observationof the cellular layers ofthe anterior segment ofthe human eye, for thediagnosis and manage-ment of anterior segmentdiseases.	As a diagnostic tool forobservation of the celllayers of the anteriorparts of the eye.	Imaging and observationof the anterior segmentof the eye for diagnosticpurposes.
Corneal contact	Yes. Polymethyl-methacrylate (PMMA)plate.	Not in normal use; how-ever, corneal contactwith the microscope lensfront surface can occur.	No
Working distance corneato objective	0 (in contact)	1.98 mm	ca. 50 mm
Corneal contact sensingand warning feature	Not applicable.	Yes	Not applicable.
Pre-sterilized contactsurface	Yes. Single use PMMAplate.	No. Microscope lensdisinfected according toinstructions for use.	Not applicable.
Front surface area	75 mm2 (PMMA plate)	16.6 mm2 (microscopelens)	Not applicable.
Focus	Manually variable.	Fixed	Not applicable.
Focus adjustment range	1 mm	Not applicable.	Not applicable.
Adjustment direction	Device is adjusted hori-zontally while the patientis sitting straight in frontof the device.	Device is adjusted hori-zontally while the patientis sitting straight in frontof the device.	Device is adjusted hori-zontally while the patientis sitting straight in frontof the device.
Working position	Horizontal	Horizontal	Horizontal
Optical setup	Confocal microscope	Slit-confocal microscope	Conventional micro-scope.
Type of scanning aper-ture	Point	Slit	Not applicable.
Scanning means	Resonant and galvano-metric scanning motors.	Stepper motor.	Not applicable.
Light source	Class I diode laser, 670nm wavelength.	Halogen lamp.	Tungsten lamp (typical).
Microscope lens	63x water immersion	40x water immersion	Not applicable.
Lateral optical resolution	2 microns	1 micron	ca. 10 microns
Optical depth resolution	4 microns	10 microns	ca. 10 microns
Detector	Avalanche photodiode.	CCD camera, mono-chrome.	Examiner observes im-age through an ocular, orphotographic film, orCCD camera
Lateral field of view	0.4 mm x 0.4 mm	Not known; approxi-mately 0.4 mm x 0.4 mm	Up to 8 mm.
Lateral digital resolution	1 micron/pixel	(Not known.)	Not applicable.
Digital depth resolution	2 micron/pixel	Not applicable.	Not applicable.
Image acquisition time	24 msec	(Not known.)	Not applicable.
Acquisition of three-dimensional images	Yes	No	No
Microscope lens magni-fication	63x	40x	ca. 16x
Magnification on screen(15", 1024x768 pixels)	300x	500x	ca. 100x
Image storage	Directly into PC RAM,then to PC hard drive.	Directly into PC RAM,then to PC hard drive.	Not applicable.
Image compressionmethod	JPG, loss-free	(Not known.)	Not applicable.
Cell density measure-ment software	Yes	Yes	No
Corneal profile meas-urement	Optical sectioning, byshifting the focal planeof the confocal imagingsystem.	Optical sectioning, byrecording of averagescatter from differentdepth locations.	No
Operating and imagemanagement software	Heidelberg Eye Explorer	NAVIS	Not applicable.
Physical layout	Lift table, PC, mountwith headrest, opticalhead are separate com-ponents.	Lift table, PC, and opti-cal head integrated intoone piece.	Lift table, mount withheadrest, optical head andseparate components.

Technological Characteristics Compared to Predicate Device

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K042742

510(k) Summary of Safety and Effectiveness

Conclusions from Performance Testing

The HRT II / RCM has been tested according to IEC 60601-1 and EC 60601-1-2, and I he HKT 117 KCM has becirements. The system is a laser product of Class 1 according to
was found to meet all requirements. The system is a laser product of Class 1 according was found to moot an requent 1040.10 and IEC 60825-1:1993+A2:2001.

21 CFR Parl 1040 Section 1040.10 and ESC 80023 11491 images resulted in substantial I he evaluation of the devices with respect to intended use, technological characteristics, and safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 2004

Heidelberg Engineering GmbH c/o TUV America, Inc. Mr. Stefan Preiss 1775 Old Highway 8 New Brighton, MN 55112-1891

Re: K042742

: K042742
Trade/Device Name: Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM) Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered Slit-Lamp Biomicroscope Regulatory Class: Class II Product Code: MXK Dated: September 30, 2004 Received: October 4, 2004

Dear Mr. Preiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premainter is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Chelosure) to regars actiment date of the Medical Device Amendments, or to commerce prior to May 26, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassined in accessfire approval of a premarket approval application (PMA). and Cosment AC. (Act) that do not require appro the general controls provisions of the Act. The You may, merciole, market the devices, courses, coursements for annual registration, listing of general controls provisions of the 110 110 110 1100 1100 bitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) ins. Existing major regulations affecting your device can may be subject to such additional controller Linestigations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peachar Ing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- 3 issuates or wouldevice complies with other requirements of the Act that TDA has made a determinations administered by other Federal agencies. You must of any Federal statutes and regularions and limited to: registration and listing (21 Comply with an the 71ct 31equirements, need 801); good manufacturing practice requirements as set CTK I at 807); aboning (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Palgi Korenthol

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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U.S. Food and Drug Administration

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Indications for Use

510(k) Number (if known): KO4Z742

Device Name:

Heidelberg Retina Tomograph "" / Rostock Cornea Module

Indications for Use: Imaging and observation of the cellular layers of the anterior segment of the human eye, for the diagnosis and management of anterior segment diseases.

Evenette T. Beem

510(k) Number K042742

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

ア

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEWS (PLE NEW NEEDED) NEEDED)

Regulation Number and Section

§ 886.1850 AC-powered slitlamp biomicroscope.

(a)
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.(b)
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.