(246 days)
Not Found
No
The 510(k) summary describes a UV light therapy device with standard features like a touch screen, user management, and calibration. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of such technologies. The performance studies focus on compliance with electrical and safety standards, not algorithmic performance.
Yes
The device is intended for the "treatment of psoriasis and vitiligo," indicating a therapeutic purpose.
No
The device is described as a "treatment" system for psoriasis and vitiligo. The description focuses on its UV light emission for therapeutic purposes and indicates it performs "Manual MED tests," which measure the minimum erythema dose, relevant for determining treatment parameters rather than diagnosing a condition.
No
The device description clearly outlines hardware components such as a UV light source, touch LCD screen, treatment handles, and potentially a fingerprint reader, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of psoriasis and vitiligo on intact skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a "ultraviolet light therapy instrument" that emits UV light for treatment. It focuses on delivering light to the skin, not on analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no indication of measuring biomarkers or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver light therapy directly to the skin for treatment.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FTC
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intact skin only.
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)
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 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
No clinical study is included in this submission.
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.
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
§ 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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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3
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:
4
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
5
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 device | ||||
| K200971 | Predicated device 1 | ||||
| K172273 | Predicated device 2 | ||||
| K192642 | Remark | ||||
| Product | |||||
| Code | FTC | FTC | FTC | SE | |
| Regulation | |||||
| No. | 21 CFR 878.4630 | 21 CFR 878.4630 | 21 CFR 878.4630 | SE | |
| Class | II | II | II | SE | |
| Intended | |||||
| Use | 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. | 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. | The 308nm Excimer | ||||
| System(model: | |||||
| XECL-308E) is an | |||||
| Ultraviolet Light | |||||
| Emitting | |||||
| Medical | |||||
| Device.It is intended | |||||
| to be used for the | |||||
| treatment of | |||||
| psoriasis, vitiligo, | |||||
| atopic dermatitis, and | |||||
| leukoderma. It is to | |||||
| be used on intact skin | |||||
| only. | SE | ||||
| Prescription | |||||
| Required | Yes | Yes | Yes | SE | |
| Weight | 5kg (Treatment | ||||
| handle:1.4kg ) |