The proposed device, 308nm Excimer System is a new type of ultraviolet light therapy instrument, which could emit high levels of UV light. It has the following features:

High intensity UV light.
The instrument is suitable for small area treatment with good targeting.
8 inches Super Large color touch LCD screen which make the operation display more convenient;
Manual MED tests can also be performed according to the skin characteristics of the patient.
One-click Control light source Output.
Powerful user management capabilities.
Can realize the export and view of user information;
Multi-spec treatment handle light filter. The user can choose filter according to the size of the treatment area. Avoid excess radiation output.
Fingerprint entry makes it easy for doctors to quickly access patient information (for KN-5000D):
Accurate calibration system. Enhanced reliability of instrument dose output (KN-5000D applicable).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the 308nm Excimer System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for performance as one might expect for an AI/diagnostic device. Instead, it relies on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and performance standards. The "performance" being evaluated is the device's adherence to these standards and its operational characteristics being comparable to legally marketed devices.

Acceptance Criterion (Implicit)	Reported Device Performance (Proposed Device K200971)	Related Predicate Devices (K172273, K192642)
Product Code (FTC)	FTC	FTC
Regulation No. (21 CFR 878.4630)	21 CFR 878.4630	21 CFR 878.4630
Classification (Class II)	Class II	Class II
Intended Use (Treatment of psoriasis and vitiligo on intact skin)	The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.	Same intended use (K172273, K192642 includes atopic dermatitis, and leukoderma for K192642)
Prescription Required (Yes)	Yes	Yes
Mode of Operation (Continuous operation)	Continuous operation	Continuous operation (for K172273)
Wavelength (308 nm ± 2nm)	308 nm ± 2nm	308 nm ± 3nm (K172273), 308 ± 2 nm (K192642)
Light Source (Xenon-Chlorine (XeCl) excimer lamp produces monochromatic UVB light)	Xenon-Chlorine (XeCl) excimer lamp produces monochromatic UVB light	Xenon-Chlorine (XeCl) excimer lamp produces monochromatic UVB light
Irradiation mode (Handheld irradiation)	Handheld irradiation	Handheld irradiation
Cooling of light source (Air cooling)	Air cooling	Air cooling (for K172273), Cooling fan (for K192642)
Max. UV Irradiation Intensity (50 mW/cm²)	50 mW/cm²	50 mW/cm²
Electrical Safety/Performance (Compliance with IEC 60601-1 and IEC 60601-2-57)	Comply with IEC60601-1 and IEC 60601-2-57	Comply with IEC60601-1 and IEC 60601-2-57
EMC (Compliance with IEC 60601-1-2)	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2
Biocompatibility (Cytotoxicity, Irritation, Sensitization per ISO 10993)	Complies with requirements	Complies with requirements
Label and Labeling (Conforms to FDA Regulatory Requirements)	Conforms to FDA Regulatory Requirements	Conforms to FDA Regulatory Requirements

Note on "Analysis 1, 2, 3, 4" from the document: These sections discuss slight differences in specifications like Max Power Output, Treatment Area, Treatment Time, Maximum Dose, Power Source, MED Dose Determination, and Operating/Storage Environment. The conclusion for each is that these differences fall within the range of predicate devices or comply with relevant standards, and therefore do not raise any safety or effectiveness issues, thus meeting the implicit acceptance criteria of being substantially equivalent.

2. Sample size used for the test set and the data provenance:

No clinical test set was used for this submission. The document explicitly states: "No clinical study is included in this submission."
The device's substantial equivalence was determined based on non-clinical (lab bench) testing and comparison to predicate devices' specifications and compliance with international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As no clinical studies were performed and the evaluation relied on non-clinical testing and comparison to predicate devices, there was no ground truth for a test set established by experts in the context of diagnostic performance.

4. Adjudication method for the test set:

Not applicable. No clinical test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a medical equipment (ultraviolet lamp) for treatment, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device, not an algorithm. Its performance is evaluated based on its physical and operational specifications and compliance with safety standards, not an algorithm's output.

7. The type of ground truth used:

For non-clinical tests: The "ground truth" implicitly refers to the specified values, ranges, and requirements outlined in the international standards (e.g., IEC 60601-1, IEC 60601-2-57, IEC 60601-1-2, IEC 62471, ISO 10993-5, ISO 10993-10) that the device was tested against. Compliance with these standards served as the "truth" for safety and basic performance characteristics.
For substantial equivalence: The "ground truth" is the established safety and effectiveness of the legally marketed predicate devices, which the proposed device aims to demonstrate equivalence to based on technological characteristics and compliance with standards.

8. The sample size for the training set:

Not applicable. This device is a physical medical equipment, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. No training set was used.

Summary

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December 15, 2020

Xuzhou Kernel Medical Equipment Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K200971

Trade/Device Name: 308nm Excimer System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: October 15, 2020 Received: October 19, 2020

Dear Boyle Wang:

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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200971

Device Name 308nm Excimer System

Indications for Use (Describe)

The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

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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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

1.0 Submitter's Information

Name: Xuzhou Kernel Medical Equipment Co., Ltd. Address: Kernel Mansion, Economic Development District, Xuzhou City, Jiangsu Province, 221004 China Tel: +86-516-87732209 Fax: +86-516-87732210 Contact: Jing Wang Date of Preparation: Dec. 10th, 2020

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Address: Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: 308nm Excimer System Ultraviolet Lamp for Dermatologic Disorders Common name: Classification name: Light, Ultraviolet, Dermatological Model(s): KN-5000C; KN-5000D

3.0 Classification

Production code: FTC Regulation number: 21 CFR 878.4630 Classification: Class II Review Panel: General& Plastic Surgery

4.0 Predicate Device Information

Predicate Device Information 1: Manufacturer: Chongqing Peninsula Medical Technology Co.,Ltd. 308nm Excimer System Device:

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510(k) number: K172273

Predicate Device Information 2:

Manufacturer: Chongqing Peninsula Medical Technology Co.,Ltd. Device: 308nm Excimer System (Model: XECL-308E) 510(k) number: K192642

5.0 Indication for Use Statement

The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

6.0 Device Description

The proposed device, 308nm Excimer System is a new type of ultraviolet light therapy instrument, which could emit high levels of UV light. It has the following features:

High intensity UV light. -
The instrument is suitable for small area treatment with good targeting. -
-8 inches Super Large color touch LCD screen which make the operation display more convenient;
Manual MED tests can also be performed according to the skin characteristics of the patient.
One-click Control light source Output. -
Powerful user management capabilities. -
Can realize the export and view of user information; -
-Multi-spec treatment handle light filter. The user can choose filter according to the size of the treatment area. Avoid excess radiation output.
-Fingerprint entry makes it easy for doctors to quickly access patient information (for KN-5000D):
Accurate calibration system. Enhanced reliability of instrument dose output -(KN-5000D applicable).

Non-Clinical Test Conclusion

Non clinical tests were conducted by lab bench testing to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2012, Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance.

IEC 60601-2-57: 2011 Medical electrical equipment Part2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and

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cosmetic/ aesthetic use.

IEC 60601-1-2:2014, Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

IEC 62471:2006, Photobiological safety of lamps and lamp systems

ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity

ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity

7.0 Clinical Test Conclusion

No clinical study is included in this submission.

8.0 Substantial Equivalence Comparison

Table1-Technological Characteristic Comparison
Item	Proposed deviceK200971	Predicated device 1K172273	Predicated device 2K192642	Remark
ProductCode	FTC	FTC	FTC	SE
RegulationNo.	21 CFR 878.4630	21 CFR 878.4630	21 CFR 878.4630	SE
Class	II	II	II	SE
IntendedUse	The 308nm ExcimerSystem is intended to beused for the treatment ofpsoriasis and vitiligo. It isto be used on intact skinonly.	The 308nm ExcimerSystem is intended tobe used for thetreatment of psoriasisand vitiligo. It is to beused on intact skinonly.	The 308nm ExcimerSystem(model:XECL-308E) is anUltraviolet LightEmittingMedicalDevice.It is intendedto be used for thetreatment ofpsoriasis, vitiligo,atopic dermatitis, andleukoderma. It is tobe used on intact skinonly.	SE
PrescriptionRequired	Yes	Yes	Yes	SE
Weight	5kg (Treatmenthandle:1.4kg )	< 2.6 kg	Not publicly available	--
Dimensions(H x W x D)	34.1cm×29.7cm×22.1cm(For Host)	26 cm x 24 cm x 27cm(For lamp)5 cm x 9.5 cm x 18 cm	548.0mm253.6mm181.4mm	--
	28.0cm(After placing theTreatment handle)	cm(For Adapter)
Mode ofOperation	Continuous operation	Continuous operation	Not publicly available	SE
Wavelength	308 nm ± 2nm	308 nanometers (nm)±3nm	308±2 nm	SE
Light Source	Xenon-Chlorine (XeCI)excimer lamp producesmonochromatic UVB light	Xenon-Chlorine(XeCI)excimer lampproducesmonochromatic UVBlight	Xenon-Chlorine(XeCl) excimerlamp producesmonochromaticUVB light	SE
Irradiationmode	Handheld irradiation	Handheld irradiation	Handheld irradiation	SE
Cooling oflight source	Air cooling	Air cooling	Cooling fan	SE
TreatmentArea	$20cm^2±10%$	16 cm² (4 x 4 cm)	$6cm^2~28.8 cm^2$	Analysis1
Max.UVIrradiationIntensity	50 mW/cm²	50 mW/cm²	50 mW/cm²	SE
Max.IrradiationPower	1000 mW	800 mW	1440 mW	Analysis1
TreatmentTime	0~120s	1s to 40 s	1-140s	Analysis1
Maximumdose	5 J/cm²	2 J/cm²	7 J/cm²	Analysis2
PowerSource	AC100-240V, 50/60HzInput Power:KN-5000C: 160VAKN-5000D: 200VA	Adapter Input:100~240Vac, 50/60HzMain unit input: 48Vdc,2.94 A,135 VAmax	Not publicly available	Analysis3
PowerCalibrationMethod	KN-5000D:Automatic calibrationKN-5000C:NA	Internal, automatic	Not publicly available	SE
MED DoseDetermination	Manual MED test	Menu driven	Not publicly available	Analysis4
Display	8 inches touch LCDscreen	Touch Screen ControlPanel	Not publicly available	SE
SecurityType	Classification by type ofanti-electric shock: Class	Classification by typeof anti-electric shock:	Not publicly available	SE
		I; Classification accordingto the degree ofanti-electric shock: Type B.	Class I; Classificationaccording to thedegree of anti-electricshock: Type B.
	PatientLeakageCurrent	Complied with IEC60601-1 and IEC60601-2-57	Complied with IEC60601-1 and IEC60601-2-57	Complied with IEC60601-1 and IEC60601-2-57	SE
	OperatingEnvironment	Temperature: 5~~35℃Relative humidity: ≤85%Atmospheric pressure::700hPa~~1060hPa	Temperature:15~35°C,Humidity: ≤ 80%RH,AtmosphericPressure:86 ~ 106 kPa	Temperature:5℃~30℃Humidity: ≤80%RHAtmosphericPressure: 700 ~1060 hPa	Analysis4
	StorageEnvironment	Ambient temperature:-40 ~ 55 °CRelative humidity: ≤90%Atmospheric pressure:500 ~ 1060hpa	Temperature:-20~45°C,Humidity: 10-85%RHAtmosphericPressure:50 ~ 106 kPa	Temperature:0℃~40℃Humidity:≤85%RHAtmosphericPressure: 700 ~1060 hPa	Analysis4
	ElectricalSafety/Performance	Comply with IEC60601-1and IEC 60601-2-57	Comply withIEC60601-1 and IEC60601-2-57	Comply withIEC60601-1 and IEC60601-2-57	SE
	Sterile	N/A	N/A	N/A	SE
	Single Use	No	No	No	SE
	EMC	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Comply with IEC60601-1-2	SE
	Biocompatibility	Cytotoxicity (ISO10993-5:2009)Irritation (ISO10993-10:2010Sensitization (ISO10993-10:2010)	Under the conditionsof the study, Complywith the requirements	Under the conditionsof the study, Complywith the requirements	SE
	Label andLabeling	Conforms to FDARegulatory Requirements	Conforms to FDARegulatoryRequirements	Conforms to FDARegulatoryRequirements	SE

Table1 Tochnological Charactoristic Comparis

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Comparison Discussion:

Analysis1:

Although some output specifications as "Max Power Output", "Treatment area", and "Treatment time" of the proposed device are a little different from the predicate devices, but they are considered substantially equivalent, and they all comply with the standards: IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-57, and range between the predicate device K172273 and predicate

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device K192642. So the we can think that the slight differences in specification will not raise any safety or effectiveness issue.

Analysis 2:

The software limits the maximum dosage of the proposed device to no more than 5 J/cm²,it is different from the predicate devices, but the value range between the predicate device K172273 and predicate device K192642. So the we can think that the slight differences in specification will not raise any safety or effectiveness issue.

Analvsis 3:

The " Power Source" is a little different from the predicate devices, but they all comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57 requirements. So the differences will not raise any safety or effectiveness issue.

Analvsis 4:

The " Power Source", "MED Dose Determination" and "Operating and Storage Environment" are a little different from the predicate devices, but they all comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57 requirements. So the differences of function specification will not raise any safety or effectiveness issue.

Final Conclusion:

Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device. The proposed device "308nm Excimer System" is Substantial Equivalent to the predicate devices.

9.0 Conclusion

The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the leqally marketed predicated device and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.

Regulation Number and Section

§ 878.4630 Ultraviolet lamp for dermatologic disorders.

(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.