PACHYCAM

{0}------------------------------------------------ Description of the Pachycam Scheimpflug Camera JAN 2 8 2005 Image /page/0/Picture/2 description: The image shows a logo with a geometric design above the word "OCULUS". The geometric design features a stylized shape resembling a mountain or a stylized letter "M", with additional lines and shapes within it. The word "OCULUS" is written in a blocky, sans-serif font, with each letter clearly defined. # K041841 510(K) SUMMARY Substantially equivalent General Information | Applicant's Name and Address: | OCULUS Optikgeräte GmbH | |-------------------------------|---------------------------| | | Münchholzhäuser Straße 29 | | | D-35582 Wetzlar | | Date of Summary: | 17 June 2004 | | Owner/Operator Number: | 8010318 | | Contact person: | Mr. Joerg Iwanczuk | | | Product Manager | | Device Name | | |----------------------|------------------------------------------| | Trade Name: | Pachycam | | Class: | Class II | | Classification Name: | Scheimpflug Camera | | Product Code: | MXK Anterior Eye-Segment Analysis System | | Regulation Number: | 886.1850 | ### Predicate Devices The Pachycam is claimed to be substantially equivalent to the following currently market device: Pentacam, Scheimpflug Camera, OCULUS Optikgeraete GmbH, Germany; K 030179 ## Device Description: The Pachycam is a non-invasive, diagnostic system created to take photos of the anterior segment of the eye, portable 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 device takes a series of the anterior segment of the eye from one fixed location (180°) and analyses one, selected by software. {1}------------------------------------------------ # Product Comparison Image /page/1/Picture/2 description: The image shows a logo with a geometric design. The upper part of the logo features a stylized star-like shape with an eye-like symbol in the center. Below the geometric shape, the word "OCULUS" is written in a blocky, sans-serif font, with each letter clearly defined. | | OCULUS Pentacam | New device, Pachycam | |---------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------| | Manufacturer | OCULUS Optikgeräte GmbH | OCULUS Optikgeräte GmbH | | Measuring Principle | Scheimpflug Principle for Slit<br>Image photography | Scheimpflug Principle for<br>Slit Image photography | | Optical | Please refer to the detailed description | | | Observation<br>Illumination | Infrared LED 800nm for pupil<br>illumination | Infrared LED 800nm for<br>pupil illumination | | Flash Output<br>Illumination | Blue LED Light (UV-free)<br>475nm, max. 2.5W Power<br>Input | Blue LED Light (UV-free)<br>455nm, max. 2.5W Power<br>Input | | Camera | CCD-Camera | CCD-Camera | | Display | Data digital, displayed on a<br>CPU | Data digital, displayed on<br>a CPU | | Image resolution | 800 x 600 pixel | 640 x 480 pixel | | Measuring points | 500 per image | 600 per image | | Image size | 5.6 x 4.5mm | 4.8mm x 3.6mm | | Photographic range | Eligible 0 to 360°<br>automatically | Fixed slit position in 180° | | Photographic Series | 1 to 50 photos | 5 images | | Exposure Control | Fixed during calibration, max<br>2.5Wsec. Power input | Fixed during calibration,<br>max 2.5Wsec. Power<br>input | | Slit Length | 14mm fixed | 5mm fixed | | Illumination time during<br>alignment | Limited to 300 seconds | Limited to 300 seconds | | Where used | Hospital, ambulance | Hospital, ambulance | | Intended use | Please refer to the detailed description | | | Sterilisation | Please refer to the detailed description | | | Materials | Housing is made of steel, the<br>back is made of Polyurethane,<br>specially treated, not | Housing is made of<br>Polyurethane, specially<br>treated, not inflammable | | | inflammable | OCULUS | | Mechanical safety | Please refer to the detailed description | | | Power supply | External, 110/220 VAC, 50/60Hz | External, 110/220 VAC, 50/60Hz | | Power Consumption | 50VA | 27 VA | | Power requirement | 25 VDC 2A / 5 VDC 2A | 9 VDC, 3A | | Weight | 9 kg | 1 kg | {2}------------------------------------------------ - {3}------------------------------------------------ ## Basics for Substantial Equivalence Image /page/3/Picture/2 description: The image shows a logo with the word "OCULUS" in block letters at the bottom. Above the word is a stylized symbol that resembles a star or crown shape. Inside the star shape is a design that looks like an eye or lens. The logo is simple and geometric in style. The systems utilize the same or similar Operating System. It 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 anterior eye segment Both systems use the same device features like a - . 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 Pachycam is designed to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea. The implanted keratometer measures the central radii of the cornea. ## Safety The Pachycam is a non-invasive diagnostic system, which contacts the patient only on his/her chin and forehead. The Pachycam 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 Pachycam is proven effective for its intended uses through internal company studies. {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 8 2005 OCULUS Optikgeräte GmbH c/o Mr. Joerg Iwanczuk Dutenhofen Münchholzhäuser Strasse 29 D-35582 Wetzlar Germany Re: K041841 Trade/Device Name: Pachycam Scheimpflug Camera Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: MXK Dated: December 23, 2004 Received: January 4, 2005 Dear Mr. Iwanczuk: 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ Page 2 - Mr. Joerg Iwanczuk 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 helyi 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 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo with the word "OCULUS" written in a blocky, sans-serif font. Above the word, there is a stylized graphic that resembles a star or a geometric shape with a curved line and a small circle inside, possibly representing an eye. The logo is simple and appears to be in black and white. Description of the Pachycam Scheimpflug Camera #### 10 Intended use 510(k) number: k_04/84/ Device name: Pachycam Scheimpflug Camera Indications For Use: The Pachycam is designed to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea. The implanted keratometer measures the central radii of the cornea. | Prescription Use<br>(Part 21 CFR 801 Subpart D) | ✓ | |-------------------------------------------------|---| |-------------------------------------------------|---| AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | | |------------------------------------------------|--| |------------------------------------------------|--| Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devices K041841 510 (k) Number_ (Optional Format 3-10-98)