PENTACAM SCHEIMPFLUG CAMERA

{0}------------------------------------------------ SEP 1 6 2003 K030719 ### 510(K) SUMMARY #### substantially equivalent ## General Information | Applicant's Name and Address: | OCULUS Optikgeräte GmbH<br>Münchholzhäuser Straße 29<br>D-35582 Wetzlar | |-------------------------------|-------------------------------------------------------------------------| | Date of Summary: | 04 March 2003 | | Owner/Operator Number: | 8010318 | | | Mr. Joerg Iwanczuk<br>Product Manager | | Device Name | | | Trade Name: | Pentacam Scheimpflug Camera | Class: Classification Name: Product Code: Regulation Number: Class II Scheimpflug Camera MXK Anterior Eye-Segment Analysis System 886.1850 ### Predicate Devices The Pentacam Scheimpflug Camera is claimed to be substantially equivalent to the following currently market device: NIDEK, EAS-1000 Anterior Eye-Segment Analysis System- K991284 ### Device Description: The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to take photographs of the anterior segment of the eye, table mounted and AC powered. The system is based on the Scheimpflug Principle for Slit Image photography. The device consists of a measurement unit, power supply and a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The measuring system offers the possibility of automatically rotation to get photographs of every part of the eye. The system calculates from the photos a 3D-modell of the eye. {1}------------------------------------------------ # Product Comparison ,。 | | New Device | Anterior Eye-Segment Analysis<br>System | |---------------------------|-----------------------------------------------------|-----------------------------------------------------| | Manufacturer | OCULUS Optikgeräte<br>GmbH | Nidek Inc. | | Measuring Principle | Scheimpflug Principle for<br>Slit Image photography | Scheimpflug Principle for Slit<br>Image photography | | Optical | Single Aperture | Single Aperture | | Viewing Optics | 15" Coloured Screen | 5.5" Black and White CRT | | Observation Illumination | Infrared LED 800nm | Infrared LED for Retro-<br>Illumination 800nm | | Flash Output Illumination | Blue LED Light (UV-free)<br>475nm, max. 2.5Wsec | Xenon Lamp 200Wsec | | Photography Camera | CCD-Camera | CCD-Camera | | Display | Data digital, displayed on a<br>CPU | Data digital and can be displayed<br>on a CPU | | Image resolution | 800 x 600 pixels | 640 x 400 pixels | | Image size | 5.6 x 4.5mm | 8mm x 6.6mm | | Photographic range | Eligible 0 to 180° | Offers Photographic angles from<br>0 to 180° | | Photographic Series | 1 to 50 photos | N/A | | Slit Length | 14mm | 2 – 14mm adjustable | | Power Consumption | 50VA | 150 VA | | Power requirement | 110/220 VAC, 50/60Hz | 100VAC, 50/60Hz | | Weight | 9 kg | 25 kg | {2}------------------------------------------------ ## Basics for Substantial Equivalence - > The systems utilize the same or similar Operating System. They contain: - > An optical system - > A source of illumination for observation and photography - > A CCD-Camera as photographic medium - Both systems have the same intended use to measure the eye and the anterior eve segment A - Both systems use the same device features like a 公 - > Head stabilizing device - > External fixation target - > Joy stick for control mechanism - > Both systems are considered "Non Invasive" as defined in 21 CFR §812.3(k) and considered not to be a "Significant Risk Device" as defined in 21 CFR §812.3(m) ## Indications for Use Intended Use: The Pentacam is designed to take photos of the anterior segment of the eye, which includes cornea, lens and anterior chamber. To evaluate: Corneal shape Analyse condition of the lens Densitometry, cataract degree and location using the Scheimpflug Image State of the lens (pre and post intraocular lens implant) Analyse anterior chamber (size, volume and angle) Pachymetry (thickness of the cornea) Scheimpflug Image Analysing center position of the cornea to iris and lens ### Safety The Pentacam is a non-invasive diagnostic system, which contacts the patient only on his/her chin and forehead. The Pentacam does not present or pose any new or additional effects for risk on the safety prescribed intended uses. The light output is of an eye safe intensity and wavelength. The electrical safety requirements for medical devices are met. The Pentacam is proven effective for its intended uses through internal company and independent clinical studies. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, with lines connecting them to form a single, abstract shape. SEP 1 6 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCULUS Optikgeräte GmbH c/o Tom Weatherby 18902 NE 150th St. Woodinville, WA 98072 Re: K030719 Trade/Device Name: Pentacam Scheimpflug Camera Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: MXK Dated: July 18, 2003 Received: July 21, 2003 Dear Mr. Weatherby: 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. {4}------------------------------------------------ ### Page 2 - Tom Weatherby 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 halepi 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo with the word "OCULUS" underneath a star-shaped design. The left side of the star is filled in with black, while the right side is outlined. There is a triangle shape in the middle of the star. The word "Page" is on the bottom left. 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Pentacam Scheimpflug Camera Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Pentacam is designed to take photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate: - • corneal shape, - analyse condition of the lens (opaque crystalline lens), ● - analyse the anterior chamber angle, ● - analyse anterior chamber depth, . - analyse the volume of the anterior chamber, . - . analyse anterior or posterior cortical opacity, - analyse the location of cataracts (nuclear, subcapsular and or cortical), using cross . slit imaging with densitometry, - corneal thickness. ● (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Dea/ Kriclmen 510(k) Number (Optional Format 3-10-98)