The UV Phototherapy is intended for use, by or under the direction of a physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use on all skin types (I-VI). It can be used in hospitals, clinics and households.

Device Description

The proposed device is a hand held ultraviolet phototherapy device, intended for partial treatment excluding eyes. Irradiation time can be adjusted from 0~30min and the treatment status can be controlled by the button on the device. The light comb equipped on the device is intended for easier treatment of target skin covered by hair, such as the scalp. The device is available in sixteen specifications. The device model KN-4003AL2S, KN-4003BL2S, KN-4003AL2DS, KN-4003BL2DS, KN-4006AL1S, KN-4006BL1S, KN-4006AL1DS and KN-4006BL1DS are designed with SD card. The recommended treatment can be written into the SD card by a physician. The device can be used in hospitals, clinics and households.

AI/ML Overview

This document is a 510(k) Summary for a UV Phototherapy device (K181805) and describes non-clinical testing for substantial equivalence, not a clinical study to prove the device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and clinical study details cannot be extracted.

However, I can provide the following based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a table format with corresponding device performance results in the typical sense of a clinical trial. Instead, it states that "Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards". These standards implicitly act as the acceptance criteria for non-clinical aspects.

Acceptance Criteria (Standard Compliance)	Reported Device Performance
ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity	"No cytotoxicity"
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity	"No irritation", "No sensitization"
ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Test for systemic toxicity	"No evidence of acute toxicity"
IEC60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance	"Comply with IEC60601-1" (for Electrical safety)
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 cosmetic/ aesthetic use	(Implicitly complied, as it is listed among standards for which testing was conducted to verify design specifications)
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	"Comply with IEC 60601-1-2" (for EMC)
IEC 60601-1-11 Medical electrical equipment-Part 1-11: General requirements for basic safety and essential performance-Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.	(Implicitly complied, as it is listed among standards for which testing was conducted to verify design specifications)
IEC 62133:2012 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications [Including: Corrigendum 1 (2013)]	(Implicitly complied, as it is listed among standards for which testing was conducted to verify design specifications)
Absence of pyrogen (Biocompatibility)	"No pyrogen"

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "No clinical study is included in this submission." Therefore, there is no clinical test set, sample size, or data provenance to report in this context. The document focuses on non-clinical testing for compliance with international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical study with a test set requiring expert ground truth was conducted or submitted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical study with a test set requiring adjudication was conducted or submitted.

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 is a phototherapy device, not an AI diagnostic tool, and no clinical comparative effectiveness study was conducted or submitted.

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

Not applicable. This is a phototherapy device, not an algorithm, and no clinical performance study was conducted or submitted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests conducted, the "ground truth" is compliance with the specified international standards and established test methods for biocompatibility and electrical safety. For example, for cytotoxicity, the "ground truth" is the determination of whether cytotoxicity is present according to ISO 10993-5.

8. The sample size for the training set

Not applicable, as no clinical study was conducted. There is no mention of a training set as this is not an AI/algorithmic device requiring training data.

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

Not applicable, as no training set was used.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Xuzhou Kernel Medical Equipment Co., LTD. Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CN

January 11, 2019

Re: K181805

Trade/Device Name: UV Phototherapy Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: November 30, 2018 Received: December 10, 2018

Dear Diana Hong:

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.

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

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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 (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 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.

Neil R	Digitally signed by Neil R
Ogden -S	Ogden -S
	Date: 2019.01.11
	09:28:12 -05'00'

Ogden -S
Date: 2019.01.11
09:28:12-05'00'
MD MRA FAC

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181805

Device Name UV Phototherapy

Indications for Use (Describe)

The UV Phototherapy is intended for use, by or under the direction for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use on all skin types (I-VI). It can be used in hospitals, clinics and households.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Tab #7 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K181805

1. Date of Preparation: 01/07/2019
1. Sponsor Identification

Xuzhou Kernel Medical Equipment Co., LTD. Kernel Mansion, Economic Development District, Xuzhou, Jiangsu Province, China

Establishment Registration Number: 3008393409

Contact Person: Jing Wang Position: Management Representative Tel: +86-516-87732208 Fax: +86-516-87732277 Email: wjkernel@126.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: UV Phototherapy Common Name: Ultraviolet lamp for dermatologic disorders

Regulatory Information

Classification Name: Light, Ultraviolet, Dermatological Classification: II Product Code: FTC Regulation Number: 21 CFR 878.4630 Review Panel: General& Plastic Surgery

Intended Use Statement:

Device Description

న్. Identification of Predicate Device

510(k) Number: K132643 Device Name: UV Phototherapy

6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

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ア 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
ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Test for systemic toxicity
IEC60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 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 cosmetic/ aesthetic use
A 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 60601-1-11 Medical electrical equipment-Part 1-11: General requirements for basic safety and essential performance-Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
IEC 62133:2012 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications [Including: Corrigendum 1 (2013)]
Clinical Test Conclusion 7.

No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 8.

Table 1 Comparison of Technology Characteristics
Item	Proposed Device	Predicate DeviceK132643
Product Code	FTC	FTC
Regulation Number	21 CFR 878.4630	21 CFR 878.4630
Intended Use	The UV Phototherapy is intended foruse, by or under the direction of aphysician for the treatment ofpsoriasis, vitiligo, and atopicdermatitis (eczema). It is intended foruse on all skin types (I-VI). It can beused in hospitals, clinics andhouseholds.	The UV phototherapy, modelKN-4001/KN-4002/KN-4003/KN-4004/KN4005/KN4006, deliver ultraviolet(UV) light to targeted affected skin. It isintended for use, by or under thedirection of a physician, for the treatmentof psoriasis, vitiligo, and atopicdermatitis (eczema) on all skin types(I-VI).
Single Use	No	No
Sterile	N/A	N/A
Mode of operation	Handheld	Handheld
Treatment area	Partial treatment excluding eyes	Partial treatment excluding eyes
Treatment Time	0~30min	0~30min
Treatment times	3~5 times per week	3~5 times per week
Lamp quantities	1 or 2	1 or 2
UV spectral	UVA or UVB	UVA or UVB
Biocompatibility	No cytotoxicityNo irritationNo sensitizationNo evidence of acute toxicityNo pyrogen	Comply with ISO 10993
Electrical safety	Comply with IEC60601-1	Comply with IEC60601-1
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2

Table 1 Comparison of Technology Characteristics

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.

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.