KEELER SLIT LAMP H-SERIES

{0}------------------------------------------------ K131589 ## Ophthalmic Instruments # 3. 510(k) Summary # 3.1 Submitter's information The submitter of this pre-market notification is: Mr. Nickie Power (Quality Manager). Keeler limited Clewer hill Road, Windsor, Berkshire, SL4 4AA, UK Company Phone No: +44 (0) 1753 827153 Company Fax No: +44 (0) 1753 827145 Contact Person: Mr. Nickie Power Date summary prepared: January 14, 2013 ### 3.2 Device Identification | Device Trade Name: | Keeler Slit Lamp - H Series | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | AC Powered Slit lamp Biomicroscope | | Class: | ============================================================================================================================================================================== | | Classification Panel: | 86 | | Product Code: | HJO | | Regulation Number: | 886.1850 | # 3.3 Predicate Device | Predicate Device: | Slit Lamp BQ 900 | |-----------------------|------------------------------------| | 510(k) No: | K100202 | | Manufacturer: | Haag-Streit AG | | Common Name: | AC Powered Slit lamp Biomicroscope | | Class: | II | | Classification Panel: | 86 | | Product Code: | HJO | | Regulation Number: | 886.1850 | 510K Keeler H-Series Slit Lamp Project 210 Issue B JUN 2 7 2013 Page 5 of 53 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the words "Keeler Ophthalmic Instruments". The word "Keeler" is in a larger, bold font, and the words "Ophthalmic Instruments" are in a smaller font below it. The text is black and the background is white. ### 3.4 Device description An AC-powered slit lamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into the patient's eye through a control diaphragm a thin, intense beam of light. This Keeler Slit Lamp has an XYZ translation base that is either mounted onto a custom table top supplied by Keeler or can be mounted on a third parties table top (refraction unit) by suitably trained technicians. Fitted to the XYZ base is the illumination and observation system; fitted to the table top is the chinrest assembly with fixation target. The illumination system rotates around its mounting axis and has a number of filters and graticules allowing the user to control precisely the characteristics of the examination light. The magnification body has a magnification change systems and eyepieces adjustable for the user's individual pupillary distance and distance correction. The patient is seated in front of the slit lamp with his/her chin in the chin rest and forehead against the forehead rest. The chin rest can be adjusted in height to align the eyes of the patient with the optics/light beam. With the control lever the instrument can be moved back and forward until the slit appears in focus on the cornea. The image can be observed through the microscope. The base unit has a rheostat to control the illumination level. Various magnifications can be selected on the microscope. For different observations the slit width can be changed, the slit can be tilted horizontally, and the angle between the illumination unit and the microscope can also be varied horizontally. ### 3.5 Indications for Use The Keeler Slit Lamp is an AC-powered Slit lamp biomicroscope and is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment This device is intended to be used only by suitably trained and authorised healthcare professionals. Project 210 Issue B {2}------------------------------------------------ Keeler ### Ophthalmic Instruments # 3.6 Comparison of the device with the Predicate The Haag-Streit BQ900 has been chosen as the substantially equivalent device, it has the same intended use and classification. The Keeler Slit Lamp has the following similarities to those of the predicate device: -has the same indication for use, -uses the same operating principle, -incorporates the same basic optical design. Refer to the table below for comparison between Keeler and Haag Streit BQ 900 Slit Lamps (K100202). | Device | Predicate Device<br>Haag-Streit Slit Lamp<br>BQ 900 | Keeler Slit Lamp<br>H- Series | Discussion | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | An ac-Powered slit lamp<br>biomicroscope is an AC-<br>powered device that is a<br>microscope intended for use<br>in eye examination that<br>projects into the patient's eye<br>through a control diaphragm<br>a thin, intense beam of light | An ac-Powered slit lamp<br>biomicroscope is an AC-<br>powered device that is a<br>microscope intended for use<br>in eye examination that<br>projects into the patient's eye<br>through a control diaphragm<br>a thin, intense beam of light | Same | | Microscope | Galilean converging<br>binoculars | Galilean converging<br>binoculars | Same | | Type | AC Powered Biomicroscope<br>Slit Lamp | AC Powered Biomicroscope<br>Slit Lamp | Same | | Angle of<br>Convergence | 13° | 13° | Same | | Magnification | 6.3x / 10x / 16x / 25x / 40x | x6, x10, x16, x25 & x40 | The difference are not<br>significant and does not<br>affect the safety or<br>effectiveness of the<br>device | | Objective lens<br>working distance | 105mm | 107mm | The difference are not<br>significant and does not<br>affect the safety or<br>effectiveness of the<br>device | | Field of view | 32.0 @ 6.3x / 20.0 @ 10x /<br>12.7@ 16x / 8.0@ 25x /<br>5.1@ 40x | 34.0 @ 6x / 22.0 @ 10x / 14<br>@ 16x / 8.5 @ 25x / 5.5 @<br>40x | The difference are not<br>significant and does not<br>affect the safety or<br>effectiveness of the<br>device | | Range of PD<br>adjustment | 52 - 78 mm | 49.0 to 77mm | There is a difference in<br>the range of adjustment<br>however this does not<br>affect safe or<br>effectiveness on the<br>devices as both<br>conform to the<br>requirement of ISO<br>10939 | | Eyepiece dioptric<br>adjustment<br>range | + 8 to - 8 diopters | + 8 to - 8 diopters | same | | Slit Projection<br>Unit | | | | | Slit Length | 1-8 mm continuous | 12mm (1mm - 12mm<br>continuously variable) | The difference is not<br>significant<br>An Iris usually has a<br>diameter of 6mm max,<br>therefore a slit length of<br>12mm is more than<br>sufficient, meeting the<br>requirement specified<br>in ISO 10939 and does<br>not affect the safety or<br>effectiveness of the<br>device | | Slit Width | 0 - 8 mm continuous | 0-12mm continuously<br>variable | The difference is not<br>significant; this does<br>not affect safety or<br>effectiveness of the<br>devices as both<br>conform to the<br>requirement of ISO<br>10939.<br>Slit lamps are used to<br>examine the inner part<br>of the eye and usually<br>a narrow slit of less<br>than 1mm is needed.<br>For this reason the<br>maximum slit width is<br>not critical as long as it<br>is ≥ 8mm | | Light source | 7.5V, 38 W Halogen Lamp<br>24VDC 1A LED | 6V 20W Halogen lamp and<br>LED - As the slit lamp<br>conform to the relevant<br>standard<br>ISO 10939, there are no<br>issues of safety and<br>effectiveness. | There is a difference in<br>light sources used<br>however all light<br>sources must conform<br>to the requirements of<br>15004-2 Photo-toxicity<br>therefore there is no<br>affect on safety or<br>effectiveness | | Duration of<br>illumination | Maximum examination times<br>according to ISO 15004-2<br>and ISO 10939 | Maximum examination times<br>according to ISO 15004-2<br>and ISO 10939 | Same | | Light intensity<br>selection | Three selections: Full, 1/4<br>and 1/16 via neutral density<br>filter. | 0-100% continuous<br>potentiometer | The difference is not<br>significant as they allow<br>the user to select the<br>necessary light<br>intensity to perform the<br>relevant task | | Filter | Blue, red free (green), grey<br>(10%)<br>The UV filter and the heat<br>absorption filter are<br>permanently mounted | Clear; red free; neutral<br>density; diffuser; blue; IR<br>heat absorbing filter<br>permanently installed | The difference is not<br>significant and does not<br>affect safety or<br>effectiveness, both<br>devices have a<br>permanently installed<br>heat absorbing filter | | Electrical<br>ratings | | | | | Input voltage | AC 100-240 V, 50/60Hz | AC 100-240 V, 50/60Hz | Same | | Power output | 30VA | 30VA | Same | | Output Voltage | 12 V DC | 12 V DC | Same | | Compliance<br>with Safety<br>standards | IEC60601-1-2<br>IEC60601-1<br>ISO 15004-2 | IEC 60601-1-2<br>IEC 60601-1<br>ISO15004-2 | Same | 510K Keeler H-Series Slit Lamp Issue B {3}------------------------------------------------ # Keeler # Ophthalmic Instruments 510K Keeler H-Series Slit Lamp , ・ : Project 210 . 100 - 100 Issue B Page 8 of 53 {4}------------------------------------------------ ### Ophthalmic Instruments ## 3.7 Summary of Performance, EMC and Safety Testing The Keeler Slit Lamp (H - Series) was evaluated against the requirements of BS EN ISO 15004-2 and BS EN ISO 10939 for radiation hazards, to IEC 60601-1 for electrical safety and to IEC 60601-1-2 for electromagnetic compatibility. In all tests the slit lamp was in compliance with these FDA recognized standards. # 3.8 Conclusion In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this Premarket Notification, Keeler limited concludes that the H- Series Slit Lamp is safe and effective, and substantially equivalent to the predicate device. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle. ### DEPARTMENT OF HEALTH & HUMAN SERVICES June 27, 2013 Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Keeler Limited % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories Inc. I 2 Laboratory Drive Research Triangle Park, NC 27709 Re: K131589 Trade/Device Name: Keeler Slit Lamp - H Series Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slit Lamp Regulatory Class: Class II Product Code: HJO Dated: June 4, 2013 Received: June 13, 2013 Dear Mr. Rongero: 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 includions for use stated in the enclosure) to legally marketed predicated vices marked 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, Drig. 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, nsand adulteration. Please note: CDRH does not evaluate information related to contractling allie warranties. We remind you, however, that device labeling must be truthful and not miolesaling. 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, TDA coul 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 not the Act or any Federal statutes and regulations administered by other Federal agencies. You most 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 {6}------------------------------------------------ Page 2 - Mr. Jeff D. Rongero device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor Yow/Industry/default.htm. Sincerely yours, # Kesia Y. Alexander -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 {7}------------------------------------------------ Keeler Ophthalmic Instruments ### 2. Indications for Use Form 510(k) Number (if known): Device Name: Keeler Slit Lamp H-Series. Indications for Use: The Keeler Slit Lamp is an AC-powered Slit lamp biomicroscope and is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment This device is intended to be used only by suitably trained and authorised healthcare professionals. Prescription Use _v (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) | | Concurrence of CDRH, Office of Device Evaluation (ODE) | |--------------------------------|-------------------------------------------------------------------------------------------| | | <img alt="Signature" src="signature.png"/> Andrew Yang -5 2013.06.27 16:08:34 -04'00' | | 510K Keeler H-Series Slit Lamp | Project 210 | | | Division of Ophthalmic and Ear, Nose and Throat Devices | | | 510(k) Number K131589 | | | Issue B |