(90 days)
The Narrowband UV Phototherapy Light Lamp 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 proposed device, Narrowband UV Phototherapy Light Lamp is a portable medical device that consists of LED lamp, 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 excluding eyes. Irradiation time can be adjusted from 0~299s 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 two models: model HB-UPLL-01and model HB-UPLL-02.
The device can be used in hospitals, clinics and households.
Here's an analysis of the provided text regarding acceptance criteria and device performance:
Based on the provided text, the device is a "Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)". The submission is a 510(k) premarket notification, which means the manufacturer is asserting substantial equivalence to existing legally marketed devices, rather than seeking approval for a novel device.
In the context of 510(k) submissions, "acceptance criteria" for performance are typically demonstrated through non-clinical tests (e.g., adherence to recognized standards like IEC 60601-1) and comparisons to predicate devices, rather than through a traditional clinical study with defined performance metrics like sensitivity, specificity, or reader improvement. The goal is to show the new device performs as well as or similarly to the predicate, and does not raise new questions of safety or effectiveness.
Therefore, the information you're asking for, particularly concerning AI/imaging device-specific criteria (sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training sets, etc.), is not applicable to this specific device submission (a UV phototherapy lamp). This device is hardware that emits UV light for therapeutic purposes, not an AI or imaging diagnostic device.
The study proving the device meets the acceptance criteria is fundamentally a non-clinical engineering and comparison study against established standards and predicate devices.
Here's a breakdown of the information that is available in the provided text, and where the requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, the "acceptance criteria" are primarily adherence to safety, performance, and biocompatibility standards, and demonstrating comparable technological characteristics to predicate devices.
| Acceptance Criteria (from Non-Clinical Tests & Comparison) | Reported Device Performance (as stated in the submission) |
|---|---|
| Safety and Performance Standards Compliance: | |
| IEC 60601-1: General requirements for basic safety and essential performance (Electrical safety) | Complies with IEC60601-1 and IEC 60601-2-57 (Reported) |
| IEC 60601-1-2: Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 (Reported) |
| IEC 60601-1-11: Home healthcare environment requirements | Complies with IEC 60601-1-11 (Reported) |
| IEC 60601-2-57: Non-laser light source equipment (specific safety) | Complies with IEC60601-1 and IEC 60601-2-57 (Reported) |
| IEC 62471: Photobiological safety | Complies (Inferred from non-clinical test conclusion, though not explicitly stated "complies with IEC 62471" in the same way as others, it's listed under non-clinical tests performed.) |
| Biocompatibility: | |
| ISO 10993-5: In vitro cytotoxicity | Complies with the requirements (Reported, and implicitly by successful testing) |
| ISO 10993-10: Skin sensitization | Complies with the requirements (Reported, and implicitly by successful testing) |
| ISO 10993-23: Irritation | Complies with the requirements (Reported, and implicitly by successful testing) |
| Functional Equivalence to Predicate Devices: | |
| Product Code | FTC (Same as predicate) |
| Regulation No. | 21 CFR 878.4630 (Same as predicate) |
| Classification | Class II (Same as predicate) |
| Intended Use/Indications for Use | Same: treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I-VI), for use in hospitals, clinics, and households (Same as predicate). |
| Prescriptive use | Yes (Same as predicate) |
| Mode of operation | Handheld (Same as predicate) |
| Shell material | ABS (Same as predicate) |
| Treatment Area | Partial treatment excluding eyes (Same as predicate) |
| Test Frequency | 3~5 times per week (Same as predicate) |
| Working distance | HB-UPLL-01: 3cm; HB-UPLL-02: 2cm (Same as predicate's 3cm reference, note provided) |
| UV spectral output | UVB (Same as reference, predicate allows UVA or UVB) |
| Lamp configuration | 1 or 2 UV tube (Same as predicate) |
| Power Source | DC inlet (Similar to predicate's AC outlet or DC jack) |
| IPX - Rating / water resistance | IP22 (Same as predicate) |
| Application Environment | Hospitals, Clinics and Households (Same as predicate) |
| Sterile | Non-sterile (Same as predicate) |
| Single Use | No (Same as predicate) |
| Differences Acknowledged and Justified: | |
| Treatment Time | Proposed: 0 |
| Treatment Area | Proposed: HB-UPLL-01: 30 cm², HB-UPLL-02: 7 cm²; Predicate: 60cm²/100cm²/104cm²; Reference: 12.8 x 9.0 cm. Justification for differences: Not explicitly provided for this point, but generally implies that functionality remains similar despite size variations. |
| Irradiation Intensity | Proposed: HB-UPLL-01: UVB: 2.0 MW/cm², HB-UPLL-02: UVB: 1.2 MW/cm²; Predicate: UVA: 1 |
| Wavelength range | Proposed: UVB: 280 |
Specific Requested Information (and why it's mostly N/A):
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- N/A: No clinical test set data is provided or required for this type of submission. The "tests" are non-clinical engineering and bench validation against standards. The provenance for these would typically be the manufacturer's lab in China.
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)
- N/A: Not applicable as there is no test set in the clinical/diagnostic sense and no ground truth requiring expert adjudication. Acceptance is based on meeting technical specifications and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A: Not applicable. There is no test set for clinical performance that would require adjudication.
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
- N/A: This is a therapeutic device (UV lamp), not a diagnostic AI device. MRMC studies are completely irrelevant to its function or approval process.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: Not applicable. This is a hardware device; there is no algorithm or standalone performance in the sense of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A: Not applicable. The "ground truth" for this device's performance is adherence to established technical standards (e.g., wavelength output, intensity, safety checks) and demonstrating that its characteristics are substantially equivalent to legally marketed predicate devices.
8. The sample size for the training set
- N/A: Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- N/A: Not applicable. There is no training set.
In summary: The provided document is a 510(k) summary for a physical medical device (UV lamp). Its "acceptance criteria" revolve around demonstrating safety, adherence to international technical standards, and substantial equivalence to existing predicate devices based on non-clinical (bench) testing and comparative analysis of its specifications. The detailed clinical trial and AI/algorithm-specific metrics you've asked about are specific to a different class and type of medical device (e.g., diagnostic software or imaging AI) and are not presented or required for the approval of this UV phototherapy lamp.
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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.
March 27, 2023
Shenzhen Honpal Optoelectronic Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K223882
Trade/Device Name: Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: December 6, 2022 Received: December 27, 2022
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
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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 (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,
Jianting Wang -S
Jianting Wang 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
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Indications for Use
510(k) Number (if known) K223882
Device Name
Narrowband UV Phototherapy Light Lamp(Model:HB-UPLL-01, HB-UPLL-02)
Indications for Use (Describe)
The Narrowband UV Phototherapy Light Lamp 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.
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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510(k) Summary
K223882
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: | Shenzhen Honpal Optoelectronic Technology Co., Ltd. | ||||
|---|---|---|---|---|---|
| Address: | Room 505,Shenghui Building A,Xixiang Street,Baonan District,Shenzhen City,Guangdong Province,China | ||||
| Tel: | +86-15986705009 | ||||
| Contact: | Wang Tianming |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai,200120 China |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date of Preparation: Mar.21,2023
2.0 Device Information
| Trade/Device name: | Narrowband UV Phototherapy Light Lamp |
|---|---|
| Common name: | Ultraviolet Lamp for Dermatologic Disorders |
| Classification name: | Light, Ultraviolet, Dermatological |
| Model(s): | HB-UPLL-01, HB-UPLL-02 |
| Production code: | FTC |
| Regulation number: | 21 CFR 878.4630 |
| Classification: | Class II |
| Panel: | General & Plastic Surgery |
3.0 Predicate Device Information
Predicate Device#
Xuzhou Kernel Medical Equipment Co., LTD. Manufacturer:
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UV Phototherapy Device: 510(k) number: K181805
Reference Device # Manufacturer: ALLUX MEDICAL Device: RESOLVE UVB PHOTOTHERAPY SYSTEM 510(k) number: K072035
4.0 Indication for Use Statement
The Narrowband UV Phototherapy Light Lamp 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.
5.0 Device Description
The proposed device, Narrowband UV Phototherapy Light Lamp is a portable medical device that consists of LED lamp, 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 excluding eyes. Irradiation time can be adjusted from 0~299s 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 two models: model HB-UPLL-01and model HB-UPLL-02.
The device can be used in hospitals, clinics and households.
6.0 _Non-Clinical Test Conclusion
Non clinical tests were conducted 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: IEC60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 electrical equipment Part 1: General requirements for basic safety and essential performance. 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 60601-1-11:2015, 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 60601-2-57: 2011, Medical electrical equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source
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equipment intended for therapeutic, diagnostic, monitoring and cosmetic/ aesthetic use.
IEC 62471:2006, Photobiological safety of lamps and lamp systems
Biocompatibility Test
ISO 10993-5:2009,Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
ISO 10993-10:2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation
7.0 _Clinical Test Conclusion
No clinical study is included in this submission.
8.0 Technological Characteristic Comparison Table
Table1-General Comparison
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| Item | Subject DeviceK223882 | Predicate DeviceK181805 | Reference DeviceK072035 | Remark |
|---|---|---|---|---|
| Product Code | FTC | FTC | FTC | Same |
| Regulation No. | 21 CFR 878.4630 | 21 CFR 878.4630 | 21 CFR 878.4630 | Same |
| Class | II | II | II | Same |
| IntendedUse/Indication forUse | The Narrowband UVPhototherapy Light Lamp isintended for use, by or under thedirection of a physician for thetreatment of psoriasis, vitiligo,and atopic dermatitis (eczema). Itis intended for use on all skintypes (I-VI).It can be used in hospitals, clinicsand households. | The UV Phototherapy isintended for use, by or under thedirection of a physician for thetreatment of psoriasis, vitiligo,and atopic dermatitis (eczema).It is intended for use on all skintypes (I-VI). It can beused in hospitals, clinics andhouseholds. | The ResolveTM UVBPhototherapy System is anultraviolet light emittingmedical device for localizedphototherapeutic treatment ofdermatologic conditions suchas psoriasis, vitiligo, atopicdermatitis (eczema), andseborrheic dermatitis. TheResolveTM UVB PhototherapySystem is intended to be usedwith all Skin Types (I - VI). | Same |
| Prescriptive | Yes | Yes | Yes | Same |
| Mode of operation | Handheld | Handheld | Not Publicly Available | Same |
| Shell material | ABS | ABS | Not Publicly Available | Same |
| Treatment Area | Partial treatment excluding eyes | Partial treatment excluding eyes | Partial treatment excludingeyes | Same |
| Treatment Time | 0~299s | 0~180s | Not Publicly Available | Different |
| Test Frequency | 3~5 times per week | 3~5 times per week | Not Publicly Available | Same |
| Treatment Area | HB-UPLL-01: 30 cm² | 60cm²/100cm²/104cm² | 12.8 x 9.0 cm | Different |
| HB-UPLL-02: 7 cm² | ||||
| Irradiation Intensity | HB-UPLL-01: UVB: 2.0 MW/cm²HB-UPLL-02: UVB: 1.2 MW/cm² | UVA: 1 | 1 mW/cm² | Similar |
| Working distance | HB-UPLL-01:3cm;HB-UPLL-02:2cm | 3 cm | Not Publicly Available | Same |
| UV spectral output | UVB | UVA or UVB | UVB | Same |
| Lamp configuration | 1 or 2 UV tube | 1 or 29W UV tube | Not Publicly Available | Same |
| Power Source | DC inlet | AC outlet or DC jack | AC outlet | Same |
| Wavelength range(nm) | UVB: 280~320 | UVA: 350 | 300-320nm | Similar |
| IPX - Rating / waterresistance | IP22 | IP22 | Not Publicly Available | Same |
| ApplicationEnvironment | Hospitals, Clinics andHouseholds. | Hospitals, Clinics andHouseholds. | Hospitals, Clinics andHouseholds. | Same |
| ElectricalSafety/Performance | Comply with IEC60601-1 and IEC60601-2-57 | Comply with IEC60601-1 andIEC 60601-2-57 | Comply with IEC60601-1 andIEC 60601-2-57 | Same |
| Home Use | Comply with IEC 60601-1-11 | Comply with IEC 60601-1-11 | Comply with IEC 60601-1-11 | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Single Use | No | No | No | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009)Sensitization (ISO10993-10:2021)Irritation (ISO 10993-23:2021) | Under the conditions of thestudy, Comply with therequirements | Under the conditions of thestudy, Comply with therequirements | Same |
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Analysis:
The Irradiation Intensity of the proposed devices, but the value range of UVB is within that of the predicate device K181805 and between the value of the reference device K072035. So the we can think the slight differences will not affect the substantive equivalence.
The output specifications as "Treatment time" of the proposed device are a little different from the predicate devices, but they are considered substantially equivaled the performance tests in accordance with same standards: IEC 6001-1, IEC 60601-1-2 and IEC 60601-2-57,So there are no safety and effectiveness aspects concerned.
In conclusion, the technological characteristics, features, mode of the device substantially equivalent to the predicate devices quoted above. The subject device and predicate devices do not raise new issues of safety of effectiveness.
9.0 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 substantive equivalence to the predicate device.
§ 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.