(237 days)
Not Found
No
The summary describes a standard UV radiation therapy device with basic components and features, and there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as a "therapeutic product" intended for the "treatment" of vitiligo, psoriasis, and eczema using UV radiation.
No
The device description explicitly states it is a "therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders" and is "intended for treatment of these conditions." It does not mention any diagnostic capabilities.
No
The device description explicitly states it consists of physical components like tubes, irradiator, and control circuit, and mentions using a Philips special UV lamp as a light source. This indicates it is a hardware device that emits UV radiation for treatment.
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 skin conditions (vitiligo, psoriasis, and eczema) using UV radiation. IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a "therapeutic product" that emits UV light for treatment. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or providing diagnostic information based on in vitro testing.
This device is clearly intended for therapeutic use, not diagnostic testing.
N/A
Intended Use / Indications for Use
The UV Radiation Treatment System models YK-6000A-T, YK-6000B, andYK-6000B-T, are intended for use under the direction of a physician, for the treatment of vitilizo, psoriasis, and eczema. The devices are intended for treatment of these conditions on Fitzpatrick Skin Types (I-VI).
Product codes
FTC
Device Description
The proposed device, UV Radiation Treatment System is a portable medical device that consists of tubes, irradiator, control circuit. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders. It is for the partial treatment. It has four models: YK-6000A,YK-6000A-T,YK-6000B,YK-6000B-T,in which the model YK-6000A and YK-6000A-T emit UVA light and the model YK-6000B and YK-6000B-T emit UVB light.
This product has the features are as follows:
A. Use Philips special UV lamp as light source, with high stability and long service life:
B. Small bulk, lightweight, operation simply, patients can take with themselves;
C. There is glisten board inner radiation unit, which can raise radiant efficiency.
The UV Radiation Treatment System only can be used in Hospital, Clinic, Medical Center, Private Medical Practice, or Other Professional Medical Environments under direction of physician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The UV Radiation Treatment System only can be used in Hospital, Clinic, Medical Center, Private Medical Practice, or Other Professional Medical Environments under direction of physician.
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
ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Test for systemic toxicity
No clinical study is included in this submission.
Key results:
The differences between both devices are insignificant in terms of safety and effectiveness. Based on the nonclinical and clinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
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 shows 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 Yongkang Electronic Science Technology Co., Ltd % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, 200120 Cn
Re: K191571
Trade/Device Name: UV Radiation Treatment System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: June 14, 2019 Received: June 14, 2019
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.
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
1
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 (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 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,
Jessica Mavadia-Shukla Acting 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) K191571
Device Name UV Radiation Treatment System
Indications for Use (Describe)
The UV Radiation Treatment System models YK-6000A-T, YK-6000B, andYK-6000B-T, are intended for use under the direction of a physician, for the treatment of vitilizo, psoriasis, and eczema. The devices are intended for treatment of these conditions on Fitzpatrick Skin Types (I-VI).
| 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
Tab #06 510(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 Yongkang Electronic Science Technology Co., Ltd Address: 4F Building C8, 40 Jingshan Road, Economic and Technological Development Zone, Xuzhou, Jiangsu,221000,China Tel: 86-516-87892766-601 Fax: 86-516-87892766-606 Contact: Kai Li Date of Preparation: Feb.5,2020
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: UV Radiation Treatment System Common name: Ultraviolet Lamp for Dermatologic Disorders Classification name: Light, Ultraviolet, Dermatological Model(s): YK-6000A,YK-6000A-T,YK-6000B,YK-6000B-T
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
Manufacturer: Xuzhou Kernel Medical Equipment Co., LTD. UV Phototherapy Device: 510(k) number: K181805
4
5.0 Indication for Use Statement
The UV Radiation Treatment System models YK-6000A, YK-6000A-T, YK-6000B, andYK-6000B-T, are intended for use under the direction of a physician, for the treatment of vitiligo, psoriasis, and eczema. The devices are intended for treatment of these conditions on Fitzpatrick Skin Types (I-VI).
6.0 Device Description
The proposed device, UV Radiation Treatment System is a portable medical device that consists of tubes, irradiator, control circuit. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders. It is for the partial treatment. It has four models: YK-6000A,YK-6000A-T,YK-6000B,YK-6000B-T,in which the model YK-6000A and YK-6000A-T emit UVA light and the model YK-6000B and YK-6000B-T emit UVB light.
This product has the features are as follows:
A. Use Philips special UV lamp as light source, with high stability and long service life:
B. Small bulk, lightweight, operation simply, patients can take with themselves;
C. There is glisten board inner radiation unit, which can raise radiant efficiency.
The UV Radiation Treatment System only can be used in Hospital, Clinic, Medical Center, Private Medical Practice, or Other Professional Medical Environments under direction of physician.
7.0 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 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
5
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
8.0 Clinical Test Conclusion
No clinical study is included in this submission.
9.0 Substantial Equivalence Comparison
| Item | Proposed device | Predicated device
K181805 | Remark |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Product Code | FTC | FTC | SE |
| Regulation No. | 21 CFR 878.4630 | 21 CFR 878.4630 | SE |
| Class | II | II | SE |
| Intended Use | The UV Radiation
Treatment System
models YK-6000A,
YK-6000A-T, YK-6000B,
andYK-6000B-T, are
intended for use under
the direction of a
physician, for the
treatment of vitiligo,
psoriasis, and eczema.
The devices are intended
for treatment of these
conditions on Fitzpatrick
Skin Types (I-VI). | 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. | SE |
| Prescriptive | Yes | Yes | SE |
| Mode of operation | Portable | Handheld | Analysis |
| Shell material | ABS | ABS | SE |
| Treatment Area | Partial treatment
excluding eyes | Partial treatment
excluding eyes | SE |
| Treatment Time | 520 min | 030min | Analysis |
| UV spectral output | UVA or UVB | UVA or UVB | SE |
| Lamp configuration | 1
9W UV tube | 1 or 2
9W UV tube | Analysis |
| Power Source | AC outlet | AC outlet or DC jack | Analysis |
| Wavelength range
(nm) | UVA:320400320 | UVA: 350
UVB: 300400315 | Analysis |
UVB: 310
Table1- Technological Characteristic Comparison
6
| IPX – Rating / water
| resistance | IPX0 | IP22 | Analysis |
|---|---|---|---|
| Application | |||
| Environment | Hospital, Clinic, Medical | ||
| Center, Private Medical | |||
| Practice, or Other | |||
| Professional Medical | |||
| Environments under | |||
| direction of physician | Hospital, Clinic, | ||
| Medical Center, | |||
| Private Medical | |||
| Practice, or Other | |||
| Professional Medical | |||
| Environments, | |||
| Household use under | |||
| direction of physician. | Analysis | ||
| Electrical | |||
| Safety/Performance | Comply with IEC60601-1 | ||
| and IEC 60601-2-57 | Comply with | ||
| IEC60601-1 and IEC | |||
| 60601-2-57 | SE | ||
| Home Use | Not applied | Comply with IEC | |
| 60601-1-11 | Analysis | ||
| Sterile | N/A | N/A | SE |
| Single Use | No | No | SE |
| EMC | Comply with IEC | ||
| 60601-1-2 | Comply with IEC | ||
| 60601-1-2 | SE | ||
| Biocompatibility | Cytotoxicity (ISO | ||
| 10993-5:2009) | Under the conditions of | ||
| the study, Comply with | |||
| the requirements | SE | ||
| Sensitization (ISO | |||
| 10993-10:2010) | |||
| Irritation (ISO | |||
| 10993-10:2010) | |||
| Pyrogen(ISO | |||
| 10993-11:2017) | |||
| Acute Systemic | |||
| Toxicity(ISO | |||
| 10993-11:2017) | |||
| Label and Labeling | Conforms to FDA | ||
| Regulatory | |||
| Requirements | Conforms to FDA | ||
| Regulatory | |||
| Requirements | SE |
Analysis:
The predicate device has the models which can support household use. The proposed device is not recommended household use, it just can be used in the professional medical environments under the guidance of doctors. In addition, the proposed device is substantially equivalent to the predicate device. The differences between both devices are insignificant in terms of safety and effectiveness. Based on the nonclinical and clinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
7
10.0 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 legally 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.