Sunkingdom Slit Lamp

K182306 · Chongqing Sunkingdom Medical Instrument Co., Ltd. · HJO · Nov 22, 2018 · Ophthalmic

Device Facts

• Record ID: K182306
• Device Name: Sunkingdom Slit Lamp
• Applicant: Chongqing Sunkingdom Medical Instrument Co., Ltd.
• Product Code: HJO · Ophthalmic
• Decision Date: Nov 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The AC-powered slit lamp bio-microscope 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.

Device Story

Sunkingdom Slit Lamp LS-1A/LS-1B are portable, AC-powered biomicroscopes; used by clinicians for anterior eye segment examination. Device projects thin, intense LED light beam into patient eye via control diaphragm; clinician views eye structures through binocular microscope. Components include optical body, movement mechanism, illumination system, and handle. Used in clinical settings to aid diagnosis of ocular disease or trauma. Provides magnified visualization of cornea, iris, lens, and anterior chamber; assists physician in identifying structural abnormalities. Benefits include portable, high-intensity visualization for diagnostic assessment.

Clinical Evidence

Bench testing only. Biocompatibility testing (ISO 10993-5, ISO 10993-10) confirmed no cytotoxicity, skin irritation, or sensitization. Electrical safety and EMC testing (ANSI AAMI IEC 60601-1-2, ANSI AAMI ES60601-1) confirmed compliance. Optical performance testing (ISO 10939) and light hazard protection testing (ISO 15004-2) confirmed safety, with a defined 83-second exposure limit at maximum intensity.

Technological Characteristics

Portable binocular slit-lamp biomicroscope; LED light source; battery-powered (7.4V/680mAh). Features include 10X/16X magnification, variable slit width (0.1-12mm), and horizontal slit angle adjustment (±60°). Materials include patient-contacting forehead rest and chinrest. Complies with ISO 10939, ISO 15004-2, and IEC 60601-1 standards. Sterilization not applicable; device is a reusable ophthalmic instrument.

Indications for Use

Indicated for eye examination of the anterior eye segment (cornea epithelium to posterior capsule) to aid in the diagnosis of diseases or trauma affecting the structural properties of the anterior eye segment in patients requiring such examination.

Regulatory Classification

Identification

An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

Special Controls

*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• Suzhou 66 Vision Tech YZ Slit Lamp YZ3 (K131711)

Submission Summary (Full Text)

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November 22, 2018

Chongqing Sunkingdom Medical Instrument Co Ltd Joy Tse Sales Director 1012, Block A of China Resource Center No.55 of XieJiaWan,JiuLongPo Chongqing, 400050 Cn

Re: K182306

Trade/Device Name: Sunkingdom Slit Lamp Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: August 24, 2018 Received: August 24, 2018

Dear Joy Tse:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely yours.

Bradley S. Cunningham -A

for Malvina B. Evdelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K182306

Device Name Sunkingdom Slit Lamp LS-1A,LS-1B

#### Indications for Use (Describe)

The Chongqing Sunkingdom Slit Lamp LS-1A, LS-1B are AC --- powered slit lamp Biomicroscopes 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.

| Type of Use (Select one or both, as applicable) | <span> <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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# 510(k) Summary

This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92

| Submitter(510K Owner): | Chongqing Sunkingdom Medical Instrument Co.,Ltd<br>35-2,YingTian GuangDian GongGu,CaiJiaGang<br>Industry Zone,BeiBei District,ChongQing,China<br>Contact Person: Joy Tse<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail]<br>Registration # 3010610157 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official correspondent: | Amado DiazJr<br>6095 N.W. 167 Street,Unit D-9,<br>Hialeah, FL 33015<br>Phone: [phone]<br>Fax:[phone] |
| Dateof Preparation: | August 24,2018 |
| Proprietary Name: | Sunkingdom Slit LampLS-1A,LS-1B |
| Common or usual<br>name: | AC- Powered Slit-Lamp Biomicroscope |
| ClassificationName: | Biomicroscope, Slit-Lamp,AC-Powered<br>21 C.F.R. 886.1850<br>Class II |
| Productcode: | HJO |

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# Predicate Devices:

| Predicate devices | Suzhou 66 Vision Tech YZ Slit Lamp YZ3 |
|-------------------|----------------------------------------|
| Manufacturer | Suzhou 66 Vision-Tech Co.,Ltd |
| K# | K131711 |

# Device Description:

Sunkingdom slit lamp LS-1A, LS-1B are an AC-powered slit lamp biomicroscope 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.

An AC-powered Slit lamp Bio-microscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

Components: The optical body, movement mechanism, illumination system, portable handle, power supply.

# Intended Use/ Indication for use

The AC-powered slit lamp bio-microscope 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.

# Substantial Equivalence

The Portable slitlamp LS-1A,LS-1B is substantially equivalent to the predicate device Suzhou 66VisionTech YZ Slit LampYZ3 as they have the exactly same indication for use, which is to examine the anterior eye segment for diagnostic purposes. Also Sunkingdom slit lamp use similar technology and perform similar functions to provide the physician with the necessary information to make a diagnosis, the slit lamp project a beam of light into the patient's eve through a control diaphragm.

The Slit Lamp LS-1A,LS-1B has the same intended use and indications for use, technological characteristics, and principles of operation as the previously cleared predicates.

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# Comparation Table

| Descriptive<br>information | Proposed Device | Predicate Device | Description of differences<br>and discussion |
|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Chongqing<br>Sunkingdom<br>Medical Instrument<br>Co.,Ltd | 66 Vision Tech<br>Co.,Ltd. | |
| 510(k)Number | | K131711 | |
| Proprietary or<br>Model Name | LS-1A,LS-1B<br>Portable Slit Lamp<br>microscope | YZ3 Portable Slit<br>Lamp microscope | |
| Indications for<br>Use | The Sunkingdom<br>Portable Slit lamp is<br>an AC-powerslit<br>lamp biomicroscope<br>intended for use in<br>eye examination of<br>the anterior eye<br>segment, from the<br>cornea epithelium to<br>the posterior<br>capsule. It is used to<br>aid in the diagnosis<br>of diseases or<br>trauma which<br>affects the structural<br>properties of the<br>anterior eye<br>segment. | Same | |
| Flammability<br>of materials<br>near the light<br>source | None | None | |
| Descriprtive<br>information | Proposed Device | Predicate Device | Description of differences<br>and discussion |
| Maximum<br>temperature of<br>parts of the<br>device held by<br>the operator or<br>accessible to<br>the patient | Maximum<br>temperature of parts<br>of the device held<br>by the operator:<br>-Eyepiece:35 °<br>-Grip:35 °<br>-Slit width control<br>ring:35 °<br>Maximum<br>temperature of parts<br>of the device<br>accessible to the<br>patient:<br>Forehead rest 35 ° | Same | |
| Brightness<br>controls | Maximal<br>Illumination≥25000<br>0Lx | Maximal<br>Illumination≥30000Lx | The brightness controls are by a<br>variable continuous<br>potentiometer. It allow the user<br>to select a convenient<br>brightness to achieve optimum<br>results.<br>The maximum brightness is<br>significantly different.<br>The predicate device YZ3 has<br>a maximumbrightness<br>≥30000LUX, the LS-1A<br>and LS-1B has a maximum<br>brightness of 250000LUX.<br>For light hazard, test according<br>to ISO 15004-2 is proceed, LS-<br>1A and LS-1B are classified<br>into Group 2 intruments.<br>Exposure to light from this<br>instrument when operated at<br>maximum intensity will exceed<br>the safety guideline after 83<br>seconds. Manufacturer will<br>indicate this caution on label to<br>remind the practice.<br>LS-1A and LS-1B are conform<br>to the relevant electronic and<br>optical safety standard of ANSI<br>AAMI IEC60601-1-2,<br>AAMIES60601-1:2005, ISO<br>15004-2, and ISO10939.<br>It's approved to be safe, and no<br>issues of safety and<br>effectiveness. |
| Descriptive<br>information | Proposed Device | Predicate Device | Description of differences<br>and discussion |
| Slit Width | 0.1mm,0.2mm,0.8m<br>m, 1mm, 5mm,<br>12mm | 0 to 12mm<br>continuously<br>adjustable | LS-1A & LS-1B from SK<br>have 6 step of the slit<br>width, the maximum slit<br>width is 12mm which is<br>same like predict device of<br>66 vision, all other step<br>which is in the width area<br>of 66 vision.<br>The differences are not<br>significant, There are no<br>new issues of safety and<br>effectiveness. |
| Slit Length | 1mm,5mm,8mm,12<br>mm | 0.2mm,1mm,2mm,12<br>mm | The differences are not<br>significant. As the<br>illumination field is defined<br>by a circular aperture, the<br>slit length cannot be larger<br>than the slit width. The<br>maximum slit length of SK<br>MED is also the same as<br>predict device which is<br>12mm.<br>There are no new issues of<br>safety and effectiveness. |
| Radial<br>movement of<br>the slit light<br>illumination<br>relative to the<br>microscope<br>axis | Horizontal±60 ° | Horizontal ±30 ° | The predicate device has<br>horizontal±30 °Whereas,th<br>e LS-1A,LS-1B slit lamp<br>has horizontal±60.<br>When examing the conea,<br>the proposed device have<br>larger angle to ensure the<br>clear view of conea<br>formed.<br>SK MED's parameter is<br>better than the predicate<br>device.<br>There are no new issues of<br>safety and effectiveness. |
| Stereo angle | 13 ° | Same | The differences are not<br>significant<br>There are no new issues of<br>safety and effectiveness. |
| Descriprtive<br>information | Proposed Device | Predicate Device | Description of differences<br>and discussion |
| Light sources | LED | LED | LED is a safety light<br>source, it already filter the<br>IR and UV light which is<br>harmful to eye.<br><br>Image: Spectral Power Distribution Characteristics<br><br>Both SK MED and<br>predicate device are using<br>LED light source.<br><br>The differences are not<br>significant , There are no<br>new issues of safety and<br>effectiveness. |
| Pupil-distance | 49-75mm | 50 to 75mm | The differences are not<br>significant, There are no<br>new issues of safety and<br>effectiveness. |
| Eye piece | 12.5X | 10X,16X | The differences are not<br>significant, There are no<br>new issues of safety and<br>effectiveness. |
| Objective | 1X | Same | There are no new issues of<br>safety and effectiveness. |
| Total<br>magnifications | LS-1A:10X<br>LS-1B:10X,16X | 10X,16X(Optional) | The differences are not<br>significant.There are no<br>new issues of safety and<br>effectiveness. |
| Filter | Neutral density,<br>red-free, cobalt blue | Cobalt blue, Red-free,<br>Color Temperature<br>Compensation | The differences are not<br>significant. There are no<br>new issues of safety and<br>effectiveness. |
| Descriprtive<br>information | Proposed Device | Predicate Device | Description of differences<br>and discussion |
| Optical<br>Radiation<br>Emissions | Conform to ISO<br>15004-2 | Conform to ISO<br>15004-2 | The predict device and<br>LS-1A & LS-1B are all<br>conform toISO15004-2.<br>The differences are not<br>significant.<br>There are no new issues of<br>safety and effectiveness. |
| Working<br>distance | 100mm(10X),<br>80mm(16X) | 60mm | The differences are not<br>significant. There are no<br>new issues of safety and<br>effectiveness. |
| Power | 7.4V/680mAh,AA<br>Battery | 7.4V 2200mA Li<br>Battery, Rechargeable | The differences are not<br>significant.<br>Predicate device has 7.4V<br>2200mA Li Battery,<br>whereas the slit lamp<br>LS-1A,LS-1B has<br>7.4V/680mAh,AA Battery.<br>As all slit lamps conform to<br>the relevant standard ISO<br>10939. There are no new<br>issues of safety and<br>effectiveness. |
| Working time | 4 hours | 2.5 hours | The proposed device<br>working longer than<br>predicate device which is a<br>better performance. The<br>differences are not<br>significant.<br>There are no new issues of<br>safety and effectiveness. |
| Net Weight | 890g(with battery) | 900g | There are no new issues of<br>safety and effectiveness. |

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| Model | | LS-1B | LS-1A |
|-----------------------------------------------------------------------------------------------|-------------------------|--------------------------------------------|---------------|
| Micros<br>c ope<br>Type | Type | Binocular Convergence Biomicroscope | |
| | Eyepiece | 13° | |
| | Magnification | 10X, 16X | 10X |
| | Work distance | 16X:80mm,10X:100m<br>m | 10X:100m<br>m |
| | Pupil distance | 49mm~75mm | |
| | Diopter | -7D~+7D | |
| | Slit width | 0.1mm,0.2mm,0.8mm,1mm,5mm,12mm | |
| | Slit length | 1mm,5mm,8mm,12m<br>m | |
| Illumin<br>a tion<br>System | Slit angle | Horizontal ±60° | |
| | Filters | Neutral density,Redfree(green),Cobalt blue | |
| | Light source | LED | |
| | Brightness | ≥250000Lux | |
| | | | |
| Power<br>Suppl<br>y | LED<br>wor<br>k voltage | DC7.4V,680mAh | |
| | Battery | 7.4V/680mAh,AA Battery | |
| | | | |
| Slit lamp LS-1A,LS-1B are equivalent to each other, the devices all have the same indications | | | |
| for use and the devices are equivalent to the predicate devices. | | | |

# Difference between each model

# Performance Data

The following perfomance data were provided in support of the substantial quivalencedetermination.

# Biocompatibilitytesting

The biocompatibility evaluation for the Sunkingdom Slit Lamp LS-1A,LS-1B wasconductedinaccordancewiththe21CFR58GoodLaboratoryPracticefor Nonclinical Laboratory Studies,ISO 10993-10:2010 "Biological Evaluation of Medical Devices-Part 10:Tests For Irritation And Skin Sensitization",Jul,26,2016,and Standard ISO 10993-5:2009 "Biological Evaluation of Medical Devices-Part 5:Tests For In Vitro Cytotoxicity", Dec,23,2016,as recognized by FDA.The portable slit lamp of testing included the followingtests:

- . VitroCytotoxicity
- . SkinIrritation
- SkinSensitization

The test article Chinrest pat and Forhead band extract did not show potential toxicitytoL-929cells.TheextractofappliedsampleChinrestpatandForehead banddidnotinduceskinirritationinrabbitskin.ChinrestpatandForheadband extract showed no significant evidence of causing skin sensitization in the guineapig.

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The material of forhead rest bracket of Portable Slit Lamp LS-1A/LS-1B which is in contact with patient is the same material as the material of test report.

## Electrical safety and electromagnetic compatibility(EMC)

Electrical safety and EMC testing were conducted on the Sunkingdom Slit Lamp LS-1A, LS-1B. The system complies with the "ANSI AAMI IEC60601-1-2:2007/(R)2012,Jun,27,2016, standard for EMC and the ANSI AAMIES60601-1:2005/(R)2012AndA1:2012,Jul,09,2014,standardforsafety.

## Performance testing

The performance testing was conducted on the Sunkingdom Slit Lamp LS-1A.LS-1B. consisting of the optical body, movement mechanism, illumination system and portable handle. The system complies with Standard ISO 10939 "Ophthalmic instruments-Slit-Lamp microscopes",Dec,19,2017, in accordance with Slit lamp guidance - VI References.

# Light Hazard Protection

The light hazard protection for Ophthalmic Instruments was conducted on the Sunkingdom Slit Lamp LS-1A, LS-1B. The system complies with the ISO 15004-2:2007 Ophthalmic instruments -- Fundamental requirements and test methods --Part 2: Light hazard protection .

It is classified into Group 2 instruments according to the requirement of ISO 15004-2, The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum intensity will exceed the safety guideline after 83 seconds.

# Conclusions

In accordance to 21 CFR 807.92(d) and based on the technical characteristics and the results of the performance tests we conclude that Portable slit lamp LS-1A,LS-1B are substantially equivalent and as safe and effective as the predicate device 66 Vision Tech Co.,Ltd YZ3 Portable Slit Lamp.