(189 days)
Not Found
No
The summary describes a standard UV phototherapy device with adjustable time and an SD card for physician-written treatment recommendations. There is no mention of AI, ML, image processing, or any data-driven decision-making or learning capabilities.
Yes
The device is described as "UV Phototherapy" and its intended use is for "treatment of psoriasis, vitiligo, and atopic dermatitis (eczema)," indicating a therapeutic purpose.
No
The device is described as a "hand held ultraviolet phototherapy device" intended for "treatment of psoriasis, vitiligo, and atopic dermatitis (eczema)". It delivers UV light for therapeutic purposes, rather than to diagnose or identify a medical condition.
No
The device description explicitly states it is a "hand held ultraviolet phototherapy device" and mentions physical components like a "button" and a "light comb," indicating it is a hardware device that utilizes software for control and functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a UV phototherapy device that applies ultraviolet light directly to the skin for the treatment of specific skin conditions (psoriasis, vitiligo, atopic dermatitis). It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "for the treatment of" these conditions, not for diagnosing them or analyzing samples from the body.
- Device Description: The description focuses on the physical characteristics and operation of the light-emitting device and its application to the skin.
- Performance Studies: The performance studies mentioned are related to safety and compliance with standards for medical devices, not studies evaluating the accuracy of diagnostic results from biological samples.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FTC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Partial treatment excluding eyes. Target skin, such as the scalp.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by or under the direction of a physician. It can be used in hospitals, clinics and households.
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)
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:
- 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
- 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)]
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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
-
- Date of Preparation: 01/07/2019
-
- 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
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
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
4
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:
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.
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:
5
- 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.
6
Substantially Equivalent (SE) Comparison 8.
| Table 1 Comparison of Technology Characteristics | ||
|---|---|---|
| Item | Proposed Device | Predicate Device |
| K132643 | ||
| Product Code | FTC | FTC |
| Regulation Number | 21 CFR 878.4630 | 21 CFR 878.4630 |
| Intended Use | 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. | The UV phototherapy, model | |
| KN-4001/KN-4002/KN-4003/KN-4004/ | ||
| KN4005/KN4006, deliver ultraviolet | ||
| (UV) light to targeted affected skin. It is | ||
| intended for use, by or under the | ||
| direction of a physician, for the treatment | ||
| of psoriasis, vitiligo, and atopic | ||
| dermatitis (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 cytotoxicity | |
| No irritation | ||
| No sensitization | ||
| No evidence of acute toxicity | ||
| No 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
-
- 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.
- Substantially Equivalent (SE) Conclusion