SLIT LAMP, Model: YF-100

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 16, 2017 Chongqing Yeasn Science-Technology Co., Ltd. % Ms. Iris Fung Official Correspondent SGS-CTSC Standards Technical Services Co., Ltd. 198 Kezhu Road, Scientech Park Guangzhou Economic & Technology Development District Guangzhou, CN Guangdong Re: K161764 Trade/Device Name: Slit Lamp, Model: YF-100 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: December 3, 2016 Received: January 3, 2017 Dear Ms. Fung: 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. {1}------------------------------------------------ Page 2 - Ms. Iris Fung 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 devicerelated 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 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" (21 CFR 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. Denise L. Hampton -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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K161764 Device Name SLIT LAMP Indications for Use (Describe) The 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 trauma, which affect the structural properties of the anterior segment of the eye. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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}------------------------------------------------ # 510(k) Summary This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. ## Date of the summary prepared: February 10, 2017 ## 1. Submitted Information - � 510(k) Owner's Name: CHONGQING YEASN SCIENCE-TECHNOLOGY CO., LTD - � Address: 5 Danlong Road, Nan An District, Chongqing Chongqing, CHINA 400060 - Phone:(86 23)62797666-8050 � - Fax:(8623)62766200 � - Contact Person: Bing Hu/Managing Director � - Email: tech@yeasn.com � #### 2. Application Correspondent: - � Company Name: SGS-CSTC Standards Technical Services Co., Ltd. - Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & � Technology Development District, Guangzhou, Guangdong, CHINA - Contact Person: Ms. Iris Fung � - Tel: +86-20-32136908 � - Email: Iris.Fung@sgs.com � ## 3. Subject Device Information - Trade Name: SLIT LAMP, Model: YF-100 � - Slit Lamp Common Name: � - AC Powered Slit Lamp Bio-microscope � Classification name: - Review Panel: Ophthalmic � - HJO Product Code: � {4}------------------------------------------------ - Regulation Class: II � - 21 886.1850 � Regulation Number: #### 4. Predicate Device Information | Sponsor | APPASAMY ASSOCIATES | |----------------------|-------------------------------------------------------| | Device Name | APPASAMY SLIT LAMP, model:A1A-11 AND A1A-12<br>SERIES | | 510(k) Number | K082031 | | Product Code | HJO | | Regulation<br>Number | 21 886.1850 | | Regulation Class | 2 | #### 5. Device Description The slit lamp is an instrument consisting of a high-intensity light source that can be focus to shine a thin sheet of light into the eye. The binocular slit-lamp examination provides a stereoscopic magnified view of the eye structure in detail, enabling diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye. The device consists of a base plate, chin rest, fixation light, illumination light, slit project, focusing ring and other accessories that in aid of examination. The patients can rest their chin and forehead on a support to keep the head steady. It is powered by the specified adapter (model: MDS-060BAS12A) which is certificated by ANSI/AAMI ES 60601-1 and considered as part of this equipment. Appliance coupled with US Plug. #### 6. Intended Use / Indications for Use The 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. {5}------------------------------------------------ It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye. ## 7. Test Summary for SLIT LAMP YF-100 has been evaluated the safety and performance by lab bench testing as following: - � The YF-100 was evaluated to IEC 60601-1:2005 (3rd edition) for electrical safety, and passed. - � The YF-100 was evaluated to IEC 60601-1-2 for EMC compliance, and passed at Class A radiated emissions limits. - � The YF-100 was evaluated to ISO 15004-1 for environmental tolerance of ophthalmic devices and passed. - � The YF-100 was evaluated to ISO 15004-2 for assessment of photo-biological safety of light intensity limits, and passed. - The YF-100 was evaluated to ISO 10939, which requires assessment to ISO 15004-1, � 15004-2, and IEC 60601-1, and passed. #### 8. Comparison to predicate device and conclusion The technological characteristics, features, specifications, materials, mode of operation, and intended use of SLIT LAMP is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate device do not raise new issues of safety or effectiveness. | Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Basic Unit Characteristics | | | | | Device Name and<br>Model | SLIT LAMP, Model: YF-100 | APPASAMY SLIT LAMP, model:A1A-11 AND A1A-12 SERIES | -- | | Elements of<br>Comparison | Subject Device | Predicate Device | Remark | | 510 (K) Number | K161764 | K082031 | -- | | Intended Use | The SLIT LAMP is intended<br>for use in eye examination of<br>the anterior eye segment,<br>from the cornea epithelium to<br>the posterior capsule. It is<br>used to aid in the diagnosis of<br>diseases or trauma which<br>affects the structural<br>properties of the anterior eye<br>segment. | Slit Lamp is an AC-powered<br>slit lamp biomicroscope<br>intended for use in eye<br>examination of the anterior<br>eye segment, from the cornea<br>epithelium to the posterior<br>capsule. It is used to aid in the<br>diagnosis of diseases or<br>trauma which affects the<br>structural properties of the<br>anterior eye segments. | SE | | Microscope type | Galileo binocular converging | Galilean type | SE | | Exposure<br>parameters | 1. Magnification Change:<br>Continuous by manual zoom<br>2. Eyepieces:12.5×<br>3. PD Range:55mm to 80mm<br>4. Slit Width:0mm to 14mm<br>continuous (become a circle at<br>14mm)<br>5. Slit Apertures: φ0.3mm、φ<br>5.5mm、φ9mm、φ14mm<br>6. Slit Angles: 0° to 180°<br>continuous adjustable from<br>vertical to horizontal direction<br>7. Diopter adjustment:-5.00D<br>to +5.00D<br>8. Working Distance: 100mm<br>9. Longitudinal(In/Out) :<br>Movement 100mm<br>10. Lateral(Left/Right) : | 1. Magnification Change:<br>Continuous by manual zoom<br>2. Eyepiece: 12.5x<br>3. PD Range: 55mm to 75mm<br>4. Slit Width: 0mm to 14mm<br>5. Slit Apertures: 0mm to 14mm,<br>φ0.2, φ1, φ3, φ4, φ6, φ10, φ<br>14mm<br>6. Slit Angles: 0° to 180°<br>7. Diopter adjustment: -6D to<br>+6D<br>8.Working Distance: 100mm<br>9. Longitudinal(In/Out) :<br>Movement 99mm<br>10. Lateral(Left/Right) :<br>Movement 118mm<br>11. Vertical(Up/Down) :<br>Movement 30mm<br>12. Chin Rest vertical:55mm | Note 1 | | Elements of<br>Comparison | Subject Device | Predicate Device | Remark | | Movement 100mm<br>11.Vertical(Up/Down) :<br>Movement 30mm<br>12. Horizontal:<br>Movement 10mm<br>13.Chin Rest Elevation :<br>70mm | | | | | Filters | Heat aborption, redfree, cobalt blue | Heat absorbing, Green,<br>Cobalt Blue | SE<br>Note 1 | | Total Magnification | $6.4 \times,10 \times,16 \times,25 \times,40 \times$ | 5.5x to 35.0x | SE<br>Note 1 | | Fixation Light | Red LED (620nm~720nm) | LED | SE<br>Note 1 | | Data collection<br>and/or display<br>system | N/A | N/A | SE | | Flammability of<br>materials | This instrument is not suitable<br>for use in a flammable<br>atmosphere. Do not use this<br>instrument if any flammable<br>gases are present. | This instrument is not suitable for<br>use in a flammable atmosphere.<br>Do not use this instrument if any<br>flammable gases are present. | SE | | Max. temperature<br>of parts of the<br>device held by the<br>operator or<br>accessible to the<br>patient | No parts of device with<br>patient/operator contact is<br>energized and remains at<br>ambient temperature. | No parts of device with<br>patient/operator contact is<br>energized and remains at<br>ambient temperature. | SE | | Brightness Control | 3V LED lamp | 12V 30W halogen bulb | SE<br>Note 1 | | Duration of<br>illumination | Maximum examination times<br>according to ISO 15004-2 and<br>ISO 10939 | Maximum examination times<br>according to ISO 15004-2 and<br>ISO 10939 | SE | | Compliance<br>with | IEC 60601-1-2 | IEC 60601-1 | -- | | Elements of<br>Comparison | Subject Device | Predicate Device | Remark | | Safety Standards | IEC 60601-1:2005 | ISO 10939:2007 | | | | ISO 15004-1 | ISO 15004-2:2007 | | | | ISO 15004-2 | | | | | ISO 10939 | | | | Input Voltage AC | 230 / 110V - 50 / 60 Hz | 230 / 110V - 50 / 60 Hz | SE | | Power Rating | 60W | 45W | SE<br>Note1 | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### Note 1: Although the Brightness Control, Power Rating, Filters, Total Magnification Light of subject device are a little different from the predicate devices, they are all compliant with requirements of IEC 60601-1, ISO 15004-2, ISO 10939 and Guidance for Slit Lamp. So the differences of the function specifications will not raise any safety or effectiveness issue. #### Finial Conclusion: The subject device "SLIT LAMP" is Substantially Equivalent to the predicate device.