XCEL 455 SLIT LAMP

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a stylized emblem. The emblem features three human profiles facing right, layered to create a sense of depth and unity. The profiles are rendered in a simple, elegant style, and the overall design is clean and professional. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 15, 2014 Reichert Inc. % Mr. Thomas M. Heckmann Quality Assurance/Regulatory Manager 3362 Walden Avenue Depew, NY 14043 Re: K141954 Trade/Device Name: Xcel 455 Slit Lamp Regulation Number: 21 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: September 12, 2014 Received: September 15, 2014 Dear Mr. Heckmann: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Deborah L. Falls -S for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K141954 Device Name Xcel 455 Slit Lamp Indications for Use (Describe) The Xcel 455 Slit Lamp is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for Reichert Technologies. The logo is blue and features the word "Reichert" in a bold, sans-serif font. Above the word "Reichert" is a curved line. Below the word "Reichert" is the word "TECHNOLOGIES" in a smaller, sans-serif font. # 510(k) Summary This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a). ### SUBMITTER | Submitter/Applicant Owner | Reichert, Inc.<br>3362 Walden Avenue<br>Depew NY, 14043 USA<br>716-686-4500 | |---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Thomas M. Heckmann, P.E.<br>Quality Assurance/Regulatory Manager<br>Reichert, Inc.<br>3362 Walden Avenue Depew<br>NY, 14043 USA<br>Tom.heckmann@ametek.com<br>Tel: 716-686-4503<br>Fax: 716-686-3027 | | Date Summary Prepared | July 3, 2014 | | NAME OF DEVICE | | | Proprietary Name | Xcel 455 Slit Lamp<br>also known as: Xcel® 455 Slit Lamp, Xcel™ 455 Slit Lamp, Xcel® 455,<br>Xcel™ 455, or Xcel 455. | | Common Name<br>Regulation Number<br>Classification Name<br>Regulatory Class<br>Product Code | Slit Lamp<br>21 CFR Part 886.1850<br>AC-powered slitlamp biomicroscope<br>II<br>HJO | Image /page/3/Picture/5 description: The image shows the logo for AMETEK Ultra Precision Technologies. The logo features the company name in bold, black letters, with a red triangle to the left of the word "AMETEK". Below the company name, the words "ULTRA PRECISION TECHNOLOGIES" are written in a smaller, black font. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products. Reichert, Inc. · 3362 Walden Avenue, Depew, New York 14043 USA Telephone: 716-686-4500 · Fax: 716-686-4545 · www.reichert.com · ISO-9001 Registered {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Reichert Technologies. The logo is blue and features a curved line above the word "Reichert" in a bold, sans-serif font. Below "Reichert" is the word "TECHNOLOGIES" in a smaller, sans-serif font. #### PREDICATE DEVICE #### Marketed device claiming equivalence to Reichert claims the Xcel 455 slit lamp is substantially equivalent to the Reichert Xcel 255 Slit Lamp, 510(k) # K063750. The proposed indications for use for the Xcel 455 are identical to the indications for use of the Reichert Xcel 255 Slit Lamp. #### DEVICE DESCRIPTION The Xcel 455 slit lamp is a general purpose examination instrument used in a wide range of eye care practices. Slit lamps are used for ophthalmic observation of the structures of the eye. By controlling the light source, nature of slit, and filters, physicians, optometrists, ophthalmologists and eye care technicians can observe various structures in the eye. The Xcel 455 can be used on any patient; there are no contraindications. Ophthalmic slit lamp design has not changed in decades, and like most, including the predicate Xcel 255, the Xcel 455 slit lamp consists of two fundamental subsystems, the illumination source to illuminate the eye to be examined, and the microscope to enable the practitioner to view the structures of the eye under magnification. The Xcel 455 uses a low voltage (6 Volt, 20 Watt) dimmable halogen lamp, and a selection of 4 color filters, or none, to illuminate the eye. The device uses a stereo microscope with 5 selections of magnification ranges, from 6.5x to 40x, to view the structure. There is a mount that allows other devices to attach in line with the optical path, such as a prism type contact tonometer. Like the predicate Xcel 255 device, the Xcel 455 device uses a steel body and glass lenses. The scientific principle of all slit lamps is to project light onto a patient's eye, so that a doctor may view the eye and its structures through a microscope. #### INDICATION FOR USE The Xcel 455 Slit Lamp is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye. #### TECHNOLOGICAL CHARACTERISTICS The manufacturing process for the Xcel 455 slit lamp is the same as the process used for the predicate Xcel 255 slit lamp. The fundamental configuration difference of the Xcel 455 slit lamp is that the light source is above the optical path, and reflected into the path from above. In comparison, the Xcel 255 slit lamp has the optical light source below the optical path, and is reflected into the path from below. The devices use the same technology of universal power supply rheostat to control the same halogen light source, use manual adjustment Image /page/4/Picture/14 description: The image shows the logo for AMETEK Ultra Precision Technologies. The logo consists of the word "AMETEK" in bold, black letters, with a red triangle to the left of the "A". Below the word "AMETEK" is the phrase "ULTRA PRECISION TECHNOLOGIES" in smaller, black letters. The logo is simple and modern, and it conveys a sense of precision and technology. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for Reichert Technologies. The logo is blue and features the word "Reichert" in large, bold letters with a curved line above it. Below "Reichert" is the word "TECHNOLOGIES" in smaller, sans-serif letters. of filters, optical settings, and X-Y position. All controls are manual. Neither the Xcel 455 nor its predicate Xcel 255 have data collection, display systems, motors, or software. # DETERMINATION OF SUBSTANTIAL EQUIVALENCE The determination of substantial equivalence was based upon nonclinical performance data. The determination of substantial equivalence did not include clinical data. # BRIEF SUMMARY OF NONCLINICAL TESTS AND RESULTS The Xcel 455 was evaluated to IEC 60601-1:2007 (3rd edition) for electrical safety, and passed. The Xcel 455 was evaluated to IEC 60601-1-2 for EMC compliance, and passed at Class A radiated emissions limits. The Xcel 455 was evaluated to ISO 10993-1 for biocompatibility of the forehead & chinrest materials and passed. The Xcel 455 was evaluated to ISO 15004-1 for environmental tolerance of ophthalmic devices and passed. The Xcel 455 was evaluated to ISO 15004-2 for assessment of photo-biological safety of light intensity limits, and passed. The Xcel 455 was evaluated to ISO 10939, which requires assessment to ISO 15004-1. 15004-2. and IEC 60601-1, and passed. These results support determination of substantial equivalence because they show that the Xcel 455 slit lamp, is a safe device, and an effective device, built to the norms of the industry, just like its predicate. ## CONCLUSION Based upon the test results, and the comparison to the long established predicate Reichert Xcel 255 slit lamp which uses the same technology and indication for use, Reichert believes the Xcel 455 slit lamp is as safe and effective, and performs as well as or better than the predicate device with respect to its intended use. Image /page/5/Picture/12 description: The image shows the logo for AMETEK Ultra Precision Technologies. The logo consists of the word "AMETEK" in large, bold, black letters, with a red triangle to the left of the "A". Below the word "AMETEK" is the phrase "ULTRA PRECISION TECHNOLOGIES" in smaller, black letters. The logo is simple and modern, and it conveys a sense of precision and technology.