Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard optical slit lamp with no mention of AI/ML capabilities, image processing, or data sets for training/testing.

Therapeutic

No
The device is used for diagnosis and examination of the anterior eye segment, not for treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device "is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment." This directly indicates its diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as "optical body, movement mechanism, illumination system, portable handle, power supply." This indicates it is a physical medical device with integrated hardware, not a software-only device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
Device Function: The description clearly states that the Chongqing Sunkingdom Slit Lamp is a biomicroscope used for eye examination of the anterior eye segment. It projects light into the patient's eye and is used to aid in the diagnosis of conditions affecting the structural properties of the eye. This is a direct examination of a living patient's body, not a test performed on a sample taken from the body.

Therefore, based on the provided information, the device is an ophthalmic examination device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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.

Product codes (comma separated list FDA assigned to the subject device)

HJO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anterior eye segment, from the cornea epithelium to the posterior capsule.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility testing: Conducted in accordance with 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies, ISO 10993-10:2010 "Biological Evaluation of Medical Devices-Part 10:Tests For Irritation And Skin Sensitization", and ISO 10993-5:2009 "Biological Evaluation of Medical Devices-Part 5:Tests For In Vitro Cytotoxicity". Tests included In Vitro Cytotoxicity, Skin Irritation, and Skin Sensitization. Results: "The test article Chinrest pat and Forhead band extract did not show potential toxicity to L-929 cells. The extract of applied sample Chinrest pat and Forehead band did not induce skin irritation in rabbit skin. Chinrest pat and Forhead band extract showed no significant evidence of causing skin sensitization in the guinea pig."
Electrical safety and electromagnetic compatibility (EMC): Complies with "ANSI AAMI IEC60601-1-2:2007/(R)2012" for EMC and "ANSI AAMIES60601-1:2005/(R)2012AndA1:2012" for safety.
Performance testing: Conducted on the optical body, movement mechanism, illumination system and portable handle. Complies with Standard ISO 10939 "Ophthalmic instruments-Slit-Lamp microscopes".
Light Hazard Protection: Complies with ISO 15004-2:2007 Ophthalmic instruments -- Fundamental requirements and test methods --Part 2: Light hazard protection. The device is classified into Group 2 instruments. "Exposure to light from this instrument when operated at maximum intensity will exceed the safety guideline after 83 seconds."

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K131711

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 886.1850 AC-powered slitlamp biomicroscope.

(a)
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.(b)
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.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (1-800-638-2041 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)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Form Approved: OMB No. 0910-0120

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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
35-2,YingTian GuangDian GongGu,CaiJiaGang
Industry Zone,BeiBei District,ChongQing,China
Contact Person: Joy Tse
Phone: +86 23 68643990
Fax: +86 23 68102793
E-Mail: joy.t@cqsunkingdom.com
Registration # 3010610157 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official correspondent: | Amado DiazJr
6095 N.W. 167 Street,Unit D-9,
Hialeah, FL 33015
Phone: 305-542-7556
Fax:(305)863-0122 |
| Dateof Preparation: | August 24,2018 |
| Proprietary Name: | Sunkingdom Slit LampLS-1A,LS-1B |
| Common or usual
name: | AC- Powered Slit-Lamp Biomicroscope |
| ClassificationName: | Biomicroscope, Slit-Lamp,AC-Powered
21 C.F.R. 886.1850
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
information | Proposed Device | Predicate Device | Description of differences
and discussion |
|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Chongqing
Sunkingdom
Medical Instrument
Co.,Ltd | 66 Vision Tech
Co.,Ltd. | |
| 510(k)Number | | K131711 | |
| Proprietary or
Model Name | LS-1A,LS-1B
Portable Slit Lamp
microscope | YZ3 Portable Slit
Lamp microscope | |
| Indications for
Use | The Sunkingdom
Portable Slit lamp is
an AC-powerslit
lamp biomicroscope
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. | Same | |
| Flammability
of materials
near the light
source | None | None | |
| Descriprtive
information | Proposed Device | Predicate Device | Description of differences
and discussion |
| Maximum
temperature of
parts of the
device held by
the operator or
accessible to
the patient | Maximum
temperature of parts
of the device held
by the operator:
-Eyepiece:35 °
-Grip:35 °
-Slit width control
ring:35 °
Maximum
temperature of parts
of the device
accessible to the
patient:
Forehead rest 35 ° | Same | |
| Brightness
controls | Maximal
Illumination≥25000
0Lx | Maximal
Illumination≥30000Lx | The brightness controls are by a
variable continuous
potentiometer. It allow the user
to select a convenient
brightness to achieve optimum
results.
The maximum brightness is
significantly different.
The predicate device YZ3 has
a maximumbrightness
≥30000LUX, the LS-1A
and LS-1B has a maximum
brightness of 250000LUX.
For light hazard, test according
to ISO 15004-2 is proceed, LS-
1A and LS-1B are classified
into Group 2 intruments.
Exposure to light from this
instrument when operated at
maximum intensity will exceed
the safety guideline after 83
seconds. Manufacturer will
indicate this caution on label to
remind the practice.
LS-1A and LS-1B are conform
to the relevant electronic and
optical safety standard of ANSI
AAMI IEC60601-1-2,
AAMIES60601-1:2005, ISO
15004-2, and ISO10939.
It's approved to be safe, and no
issues of safety and
effectiveness. |
| Descriptive
information | Proposed Device | Predicate Device | Description of differences
and discussion |
| Slit Width | 0.1mm,0.2mm,0.8m
m, 1mm, 5mm,
12mm | 0 to 12mm
continuously
adjustable | LS-1A & LS-1B from SK
have 6 step of the slit
width, the maximum slit
width is 12mm which is
same like predict device of
66 vision, all other step
which is in the width area
of 66 vision.
The differences are not
significant, There are no
new issues of safety and
effectiveness. |
| Slit Length | 1mm,5mm,8mm,12
mm | 0.2mm,1mm,2mm,12
mm | The differences are not
significant. As the
illumination field is defined
by a circular aperture, the
slit length cannot be larger
than the slit width. The
maximum slit length of SK
MED is also the same as
predict device which is
12mm.
There are no new issues of
safety and effectiveness. |
| Radial
movement of
the slit light
illumination
relative to the
microscope
axis | Horizontal±60 ° | Horizontal ±30 ° | The predicate device has
horizontal±30 °Whereas,th
e LS-1A,LS-1B slit lamp
has horizontal±60.
When examing the conea,
the proposed device have
larger angle to ensure the
clear view of conea
formed.
SK MED's parameter is
better than the predicate
device.
There are no new issues of
safety and effectiveness. |
| Stereo angle | 13 ° | Same | The differences are not
significant
There are no new issues of
safety and effectiveness. |
| Descriprtive
information | Proposed Device | Predicate Device | Description of differences
and discussion |
| Light sources | LED | LED | LED is a safety light
source, it already filter the
IR and UV light which is
harmful to eye.

Image: Spectral Power Distribution Characteristics

Both SK MED and
predicate device are using
LED light source.

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8

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Model		LS-1B	LS-1A
Micros
c ope
Type	Type	Binocular Convergence Biomicroscope
	Eyepiece	13°
	Magnification	10X, 16X	10X
	Work distance	16X:80mm,10X:100m
m	10X:100m
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
m
Illumin
a tion
System	Slit angle	Horizontal ±60°
	Filters	Neutral density,Redfree(green),Cobalt blue
	Light source	LED
	Brightness	≥250000Lux

Power
Suppl
y	LED
wor
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.