(157 days)
Not Found
Not Found
No
The summary describes a UV phototherapy device that delivers light via fluorescent lamps. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is intended for the "treatment of psoriasis, vitiligo, and atopic dermatitis (eczema)" by delivering UV light to affected skin, which directly aligns with the definition of a therapeutic device.
No
The device is described as a phototherapy system that delivers UV light for the treatment of skin conditions, not for diagnosing them.
No
The device description explicitly states it delivers UV light via fluorescent UV lamps and is a stationary base unit with a hand-held therapy wand or hand-held device, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device "delivers ultraviolet (UV) light to targeted affected skin." This is a therapeutic treatment applied directly to the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use is for the "treatment of psoriasis, vitiligo, and atopic dermatitis (eczema)." This is a therapeutic indication, not a diagnostic one.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The UV phototherapy, model KN-4001/KN-4002/KN-4003/KN-4004/KN-4005/KN-4006, delivers 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).
Product codes (comma separated list FDA assigned to the subject device)
FTC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
targeted affected skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
by or under the direction of a 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)
Not Found
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.
Not Found
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
K132643
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Section 3 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: _K132643
1 . Prepared Date: Aug. 23, 2013
Sponsor Identification 2.
:
Xuzhou Kernel Medical Equipment Co.,LTD. Kernel Mansion,Economic Development District, Xuzhou,Jiangsu Province,China
Establishment Registration Number: Not yet registered
Contact Person: Zhengjun ZHANG Position: General Manager Tel: +86(516)87732205 Email: kernelzzj@163.com
Submission Correspondent 3.
Ms. Diana Hong& Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
1
IEC60601-1:2005+CORR.1:2006+CORR.2:2007Medical equipment Part 1: requirements for basic safety and essential performance
IEC 60601-1-2:2007 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
Substantially Equivalent (SE) Conclusion 8.
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
| Item | Proposed Device(s) | Predicate Device(s) |
|---|---|---|
| Product Code | FTC | FTC |
| Regulation | ||
| Number | 21 CFR 878.4630 | 21 CFR 878.4630 |
| Intended Use | The UV phototherapy, model KN-4001/KN-4002/KN-4003/KN-4004/ | |
| KN-4005/KN-4006, delivers 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). | The DermaPal is a hand held | |
| ultraviolet light emitting fluorescent | ||
| lamp. 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). | ||
| Material | ABS | ABS |
| Sterile | N/A | N/A |
| Single Use | No | No |
| Energy Source | Fluorescent UV lamps | Fluorescent UV lamp |
| Safety | IEC 60601-1 / IEC 60601-1-2 | IEC 60601-1 / IEC 60601-1-2 |
| Biocompatibility | Non-Cytotoxicity | |
| Non-Irritation | ||
| Non-Sensitization | Non-Cytotoxicity | |
| Non-Irritation | ||
| Non-Sensitization | ||
| Mode of | ||
| operation | Stationary base unit with hand held therapy | |
| wand or hand held device | Stationary base unit with hand held | |
| therapy wand | ||
| Features | UV Radiation Treatment System model | |
| KN-4001/KN-4002/KN-4003/KN-4004/ | ||
| KN-4005/KN-4006 delivers ultraviolet | ||
| (UV) light to targeted affected skin, via | DermaPal is small enough to | |
| discreetly carry anywhere you go and | ||
| plugs into any standard electrical | ||
| outlet so you'll never miss a |
3-3
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2014
Xuzhou Kernel Medical Equipment Company, Ltd. % Ms. Diana Hong Mid-Link Consulting Company, Ltd. P.O. box 120-119 Shanghai, Shanghai 200120 CHINA
Re: K132643
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: December 25, 2013 Received: December 30, 2013
Dear Ms. 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. 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 (reporting of medical
3
Page 2 - Ms. Diana Hong
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 2 Indications for Use
510(k) Number: K132643 Device Name: UV phototherspy
Indications for Use:
The UV plastifierapy, model KN-4001/KN-4002/KN-4004/KN-4005/KN-4006, delivers ulturiolet (UV) light to rargeted affected skin. It is intended for use, by or under the direction of a physician, for the treatment of psociasis, vitiligo, and mopic dermatitis (ecrema) on all skin types (I - VI).
& FRESCRIPTION USE (Part 21 CFR 801 Subpart D)
OR
O OVER-THE-COUNTER USE (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NERDED)
,
Concurence of CDRH, Office of Device Evalustion (ODE)
Neil R Ogger 2014.01 10008
(Division Sign-off) foe BSA
Division of Surgical Devices
510(ld) Number_K132643
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