HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)

{0}------------------------------------------------ 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. {1}------------------------------------------------ ## 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-<br>scope | | Indications for use | Imaging and observation<br>of the cellular layers of<br>the anterior segment of<br>the human eye, for the<br>diagnosis and manage-<br>ment of anterior segment<br>diseases. | As a diagnostic tool for<br>observation of the cell<br>layers of the anterior<br>parts of the eye. | Imaging and observation<br>of the anterior segment<br>of the eye for diagnostic<br>purposes. | | Corneal contact | Yes. Polymethyl-<br>methacrylate (PMMA)<br>plate. | Not in normal use; how-<br>ever, corneal contact<br>with the microscope lens<br>front surface can occur. | No | | Working distance cornea<br>to objective | 0 (in contact) | 1.98 mm | ca. 50 mm | | Corneal contact sensing<br>and warning feature | Not applicable. | Yes | Not applicable. | | Pre-sterilized contact<br>surface | Yes. Single use PMMA<br>plate. | No. Microscope lens<br>disinfected according to<br>instructions for use. | Not applicable. | | Front surface area | 75 mm2 (PMMA plate) | 16.6 mm2 (microscope<br>lens) | Not applicable. | | Focus | Manually variable. | Fixed | Not applicable. | | Focus adjustment range | 1 mm | Not applicable. | Not applicable. | | Adjustment direction | Device is adjusted hori-<br>zontally while the patient<br>is sitting straight in front<br>of the device. | Device is adjusted hori-<br>zontally while the patient<br>is sitting straight in front<br>of the device. | Device is adjusted hori-<br>zontally while the patient<br>is sitting straight in front<br>of the device. | | Working position | Horizontal | Horizontal | Horizontal | | Optical setup | Confocal microscope | Slit-confocal microscope | Conventional micro-<br>scope. | | Type of scanning aper-<br>ture | Point | Slit | Not applicable. | | Scanning means | Resonant and galvano-<br>metric scanning motors. | Stepper motor. | Not applicable. | | Light source | Class I diode laser, 670<br>nm 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-<br>chrome. | Examiner observes im-<br>age through an ocular, or<br>photographic film, or<br>CCD camera | | Lateral field of view | 0.4 mm x 0.4 mm | Not known; approxi-<br>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-<br>dimensional images | Yes | No | No | | Microscope lens magni-<br>fication | 63x | 40x | ca. 16x | | Magnification on screen<br>(15", 1024x768 pixels) | 300x | 500x | ca. 100x | | Image storage | Directly into PC RAM,<br>then to PC hard drive. | Directly into PC RAM,<br>then to PC hard drive. | Not applicable. | | Image compression<br>method | JPG, loss-free | (Not known.) | Not applicable. | | Cell density measure-<br>ment software | Yes | Yes | No | | Corneal profile meas-<br>urement | Optical sectioning, by<br>shifting the focal plane<br>of the confocal imaging<br>system. | Optical sectioning, by<br>recording of average<br>scatter from different<br>depth locations. | No | | Operating and image<br>management software | Heidelberg Eye Explorer | NAVIS | Not applicable. | | Physical layout | Lift table, PC, mount<br>with headrest, optical<br>head are separate com-<br>ponents. | Lift table, PC, and opti-<br>cal head integrated into<br>one piece. | Lift table, mount with<br>headrest, optical head and<br>separate components. | # Technological Characteristics Compared to Predicate Device {2}------------------------------------------------ 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. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned above a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ U.S. Food and Drug Administration E Image /page/5/Picture/2 description: The image shows the logo for the Department of Health and Human Services. The logo consists of an emblem on the left and the text "Department of Health and Human Services" on the right. The emblem appears to be an eagle or similar bird-like figure. The text is in a sans-serif font and is stacked in three lines. FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH # 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)