(83 days)
The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face.
The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
The Shani Darden LED light therapy mask is a home use wearable light emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles and mild to moderate acne vulgaris of the face. The system consists of a hard-shell mask and a controller. The mask is worn on the face and is held in place by an adjustable Velcro strap. The LEDs produce blue, red and near infra-red (NIR) light in the visible spectrum (Blue: 415nm +/- 10nm, Red: 630nm +/- 10nm, NIR 830nm +/-10nm.). The device works by emitting the specified wavelengths into the skin in order to improve the appearance of wrinkles or to target bacteria that can cause acne vulgaris. The controller allows the user to select one of three treatment programmes (acne and wrinkles) and switches the LEDs ON/OFF, controlling power to the mask. The controller contains a simple graphical user interface (GUI) and three control buttons. The mask receives its power from a mains power adaptor.
The provided text describes the acceptance criteria and supporting studies for the Shani Darden LED light therapy mask, primarily focusing on non-clinical performance and a label comprehension study, rather than a clinical performance study.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria and reported device performance" as typically seen in clinical studies with specific endpoints. Instead, it relies on substantial equivalence to a predicate device and adherence to various safety and performance standards. The "performance" in this context refers to meeting those standards and demonstrating label comprehension.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Electrical Safety (Adherence to medical electrical equipment standards) | Conforms to IEC 60601-1:2005/AMD1:2012/AMD2:2020 |
| Electromagnetic Compatibility (EMC) (Adherence to standards for electromagnetic disturbances) | Conforms to IEC/EN 60601-1-2: 2015 (Including FCC 47 CFR Part 15, Sub Part B) |
| Home Healthcare Environment Safety (Adherence to specific safety requirements for devices used in home healthcare) | Conforms to IEC 60601-1-11:2015 |
| Non-Laser Light Source Equipment Safety (Adherence to particular requirements for therapeutic light sources) | Conforms to IEC 60601-2-57:2011 |
| Photobiological Safety (Adherence to standards for light source safety) | Conforms to IEC 62471:2008 |
| Biocompatibility (Evaluation and testing within a risk management framework for biological evaluation) | Conforms to ISO 10993-1: 2018 |
| Cytotoxicity (Tests for in vitro cytotoxicity) | Conforms to EN ISO 10993-5:2009 |
| Irritation and Skin Sensitization (Tests for irritation and skin sensitization) | Conforms to EN ISO 10993-10:2010 |
| Software Life Cycle Processes (Adherence to standards for medical device software) | Conforms to EN 62304: 2006 (ed. 1.0) |
| Risk Management (Application of risk management to medical devices) | Conforms to ISO 14971: 2019 |
| Label Comprehension and Safe/Effective Use by Lay Persons (Demonstrates that labeling can be used by lay persons to safely and effectively operate the device) | A label comprehension testing study was conducted. No new use errors, hazards, hazardous situations, or hazard-related use scenarios were discovered. The study concluded that the labeling could be used to safely and effectively operate the device for its intended use. |
| Similar Technical Characteristics to Predicate (K213184) | Intended Use: Same Energy Type: LED phototherapy Wavelength Spectrum: Similar (Blue: 415nm +/- 10nm, Red: 630nm +/- 10nm, NIR 830nm +/-10nm) Power Density & Dose: Similar to predicate Treatment Time & Protocol: Identical to predicate Software Control: Both use software for treatment duration |
2. Sample size used for the test set and the data provenance
- Test set for Label Comprehension Study: 19 subjects
- Data Provenance: The document does not explicitly state the country of origin. It mentions subjects identified as Hispanic, Asian, and Indian, and that 8 subjects identified English as their second language, suggesting a diverse, possibly multi-ethnic, participant group. The study type is prospective, as it involved actively testing subjects with the device and its labeling.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The text does not mention experts used to establish ground truth for the label comprehension study. The "ground truth" for this study was the subjects'
comprehension and ability to use the label safely and effectively, as observed during the test.
4. Adjudication method for the test set
The document does not describe an adjudication method for the label comprehension study, as it was directly observing user interaction and comprehension, which doesn't typically require expert adjudication in the same way clinical diagnoses do.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The device is an LED light therapy mask, not an AI-assisted diagnostic tool, so such a study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical LED light therapy mask, not an algorithm, and its use inherently involves a human user (applying the mask).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the LED light therapy performance: The ground truth is established through substantial equivalence to a legally marketed predicate device (K213184 MZ Skin LightMAX Supercharged LED Mask 2.0) and adherence to recognized performance and safety standards. There is no explicit "ground truth" for clinical efficacy described in this submission, as clinical testing was not conducted.
- For the Label Comprehension Study: The ground truth was the observable comprehension and safe/effective operation of the device by lay users based on the labeling, assessed directly through the study.
8. The sample size for the training set
The document explicitly states: "Clinical testing was not needed for this 510(k)." Therefore, there was no training set for clinical performance. The device relies on non-clinical performance testing and substantial equivalence to a predicate.
9. How the ground truth for the training set was established
As there was no clinical training set, this question is not applicable. The device's foundation for regulatory approval is based on substantial equivalence and non-clinical safety/performance standards.
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March 22, 2022
Harpar Grace International % Susan D'arcy Owner iSMART Developments Ltd 129 Green Lanes, Sutton Coldfield Birmingham, B735TR United Kingdom
Re: K214103
Trade/Device Name: Shani Darden LED light therapy mask Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OLP, OHS Dated: December 24, 2021 Received: December 29, 2021
Dear Susan D'arcy:
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.
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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 (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 mediation-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
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Indications for Use
510(k) Number (if known) K214103
Device Name Shani Darden LED light therapy mask
Indications for Use (Describe)
The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face.
The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
| 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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Section 5: 510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c). Submitter's Name: Harpar Grace International (HGI)
Submitter's Address: Unit 4 Imperial Court, Magellan Close, Walworth Business
Park, Hampshire. SP10 5NT
Contact Person: Alana Marie Chalmers
Telephone: +44 (0) 2038686242
Date Prepared: December 24th, 2021
Date amended: March 21st, 2022
Device Trade Name: Shani Darden LED light therapy mask
Device Classification Information:
| RegulationNumber | ClassificationName | Common name | DeviceClass | ProductCode | ClassificationPanel | Type |
|---|---|---|---|---|---|---|
| 21 CFR878.4810 | Laser SurgicalInstrument forUse in Generaland PlasticSurgery and InDermatology | Over-The-CounterLight-Basedtreatment forAcne and WrinkleReduction | Class 2 | OLPOHS | General &Plastic Surgery | Traditional510 (k) |
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5.1. Device Description
The Shani Darden LED light therapy mask consists of the following key components.
- Facemask 1.
-
- Controller
-
- Power supply and country specific adaptors
-
- Velcro strap
-
- User manual
-
- Carry Bag
The Shani Darden LED light therapy mask is a home use wearable light emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles and mild to moderate acne vulgaris of the face.
The system consists of a hard-shell mask (1) and a controller (2). The outer shell of the mask is manufactured from Acrylonitrile butadiene styrene (ABS) CHIMEI 757KF. The inner shell is a clear Polycarbonate CHIMEI PC115P. The Light emitting diodes are mounted behind the clear Polycarbonate. The LEDs generate the light.
The mask is worn on the face and is held in place by an adjustable Velcro strap (5). The LEDs produce blue, red and near infra-red (NIR) light in the visible spectrum (Blue: 415nm +/- 10nm, Red: 630nm +/- 10nm, NIR 830nm +/-10nm.). The device works by emitting the specified wavelengths into the skin in order to improve the appearance of wrinkles or to target bacteria that can cause acne vulgaris.
The controller (2) allows the user to select one of three treatment programmes (acne and wrinkles) and switches the LEDs ON/OFF, controlling power to the mask. The controller contains a simple graphical user interface (GUI) and three control buttons.
-
- Standby Button: wakes the device up from Sleep mode
-
- Mode Button: Allows the user to select treatment modes.
-
- Start button. Allows the user to start and pause a treatment
The GUI shows the treatment mode selected and a countdown timer that counts downs from 10 minutes in 1-minute increments.
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The mask receives its power from a mains power adaptor (Input 100v-240v. 50/60hZ. Rated at 0.7A) Output (12V, 1A).
The power adaptor is connected to the controller by a standard USB A connector.
The Shani Darden LED light therapy mask does NOT contain or does NOT rely on external wired and/or wireless communication interfaces (Wired: USB, ethernet, SD, CD, RGA, etc. or Wireless: Wi-Fi, Bluetooth, RF, inductive, Cloud, etc.).
The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent.
5.2. Intended Use
The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face.
The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and near infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
5.3. Predicate device
K213184 MZ Skin LightMAX Supercharged LED Mask 2.0
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5.3.1 Summary of Substantial Equivalence
| Description | Shani Darden LED light therapy mask | K213184MZ Skin LightMAX |
|---|---|---|
| Device Manufacturer | Harpar Grace International | MZ SKIN |
| Device Trade Name | Shani Darden LED light therapy mask | MZ Skin LightMAX Supercharged LED Mask2.0 |
| 510(K) Number | K214103 | K213184 |
| Device Product Code | OLP, OHS | OLP, OHS |
| Regulation Number | 878.4810Laser surgical instrument for use in general andplastic surgery and in dermatology. | 878.4810Laser surgical instrument for use in generaland plastic surgery and in dermatology |
| FDA DeviceClassification | Class II | Class II |
| Use | Over the Counter | Over the Counter |
| Intended use andIndications | The Shani Darden LED light therapy mask is anover-the-counter device intended to emit energyin the red and blue region of the light spectrum,specifically indicated to treat mild to moderateacne vulgaris of the face.The Shani Darden LED light therapy mask is anover-the-counter device intended to emit energyin the red and Near Infra-red spectrum and isintended for the use in the treatment of full-facewrinkles. | The MZ Skin LightMAX Supercharged LEDMask 2.0 is an over-the-counter deviceintended to emit energy in the red and blueregion of the light spectrum, specificallyindicated to treat mild to moderate acnevulgaris of the face.The MZ Skin LightMAX Supercharged LEDMask 2.0 is an over-the-counter deviceintended to emit energy in the red and NearInfra-red spectrum and is intended for theuse in the treatment of full-face wrinkles. |
| Description | Shani Darden LED light therapy mask | K213184 MZ Skin LightMAX |
| Intended Location of Use | Face | Face |
| Energy Type | Light emitting diodes | Light emitting diodes |
| Peak Wavelength(FWHM) | Blue: 415nm +/- 10nm,Red: 630nm +/- 10nm,NIR 830nm +/-10nm. | Blue: 415nm +/- 10nm,Red: 630nm +/- 10nm,NIR 830nm +/-10nm. |
| Intensity (mW/cm²) | Blue 28 mW/cm²Red 16 mW/cm²Red 18 mW/cm²NIR 11 mW/cm² | Blue 28 mW/cm²Red 16 mW/cm²Red 18 mW/cm²NIR 11 mW/cm² |
| Total Intensity (mW/cm²) | Blue/Red 44 mW/cm²Red/NIR 29 mW/cm² | Blue/Red 44 mW/cm²Red/NIR 29 mW/cm² |
| Treatment time | 10 Minutes | 10 Minutes |
| Dose | Blue 16.8J/cm²Red 9.6J/cm² | Blue 16.8J/cm²Red 9.6J/cm² |
| Red 11J/cm²NIR 7J/cm² | Red 11J/cm²NIR 7J/cm² | |
| Treatment protocol | Acne: 4 x weekly, 6 weeks | Acne: 4 x weekly, 6 weeks |
| Wrinkles: 5 x weekly, 6 weeks | Wrinkles: 5 x weekly, 6 weeks | |
| Software Controlled | Device uses a timer and software to controltreatment duration | Device uses a timer and software tocontrol treatment duration |
| Description | Shani Darden LED light therapy mask | K213184 MZ Skin LightMAX |
| Power supply | 100-240V | Lithium-Ion Battery (rechargeable) |
| Power input/output | Electrical Input to power adaptor: 100v-240v.50/60Hz. Rated at 0.7A. | Electrical Input from power adaptor: 100-240Vac/47-63Hz. 0.6A |
| Electrical Output from power adaptor: 12V, 1A | Electrical Output; 5V, 9.62Wh or 2200mAH |
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5.3.2. Comparison of Technological Similarities & Differences
The key similarities are.
- i. The intended use of the Shani Darden LED light therapy mask is the same as the listed predicate; an over-the-counter device that is intended for the use in the treatment of mild to moderate acne vulgaris and full-face wrinkles.
- ii. The devices are phototherapy units utilizing light emitting diodes that emit in the red and blue spectrum for the treatment of mild to moderate acne vulgaris and the red and NIR spectrum for the treatment of full-face wrinkles.
- iii. The wavelength spectrum of the devices is similar.
- iv. The Shani Darden LED light therapy mask has similar power density and dose to the predicate device.
- v. The Shani Darden LED light therapy mask has an identical treatment time and treatment protocol compared to the proposed predicate.
- vi. Both devices use software to control the treatment time.
The key difference between the Shani Darden LED light therapy mask and predicate device is that the sponsor device uses a power adaptor to control power while the predicate device utilizes Lithium-lon batteries. This difference has been addressed by EMC and electrical safety testing. Where other differences exist, these have been addressed by non-clinical performance testing to applicable standards.
5.4. Non- clinical performance testing
The Shani Darden LED light therapy mask has been thoroughly evaluated for electrical safety and performance and has been found to conform to the following standards.
IEC 60601-1:2005/AMD1:2012/AMD2:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
IEC/EN 60601-1-2: 2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests including FCC 47 CFR Part 15, Sub Part B
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
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Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use IEC 62471:2008. Photobiological safety of lamps and lamp systems. ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management. EN ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity EN ISO 10993-10:2010 ISO 10993-10 Third Edition 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization EN 62304: 2006 (ed. 1.0) Medical Device Software - Software Life Cycle Processes. ISO 14971: 2019 Medical Devices - Application of Risk Management to Medical
Devices
In addition to the above standards the Shani Darden LED light therapy mask labelling was subject to label comprehension testing. With respect to medical devices available without the intervention of a physician, termed 'Over the Counter' (OTC).
To determine the effectiveness of labelling pertaining to a medical device, the labelling and device was tested with an appropriate sample of users.
A study was conducted and is appended to this submission, demonstrating comprehension of the Shani Darden LED light therapy mask labelling.
Nineteen subjects took part in the study, 8:11 M:F, average age 31.6 years (range 16-57). Eight subjects identified English as their second language. In terms of ethnicity 6 subjects identified as Hispanic, 3 Asian, and 1 Indian. The average number of words incorrect in the REALM reading test was 9, giving a mean reading ability of 57 (7th grade).
No new use errors, hazards, hazardous situations, or hazard-related use scenarios were discovered during testing. Further improvement of the user interface design as it relates to safety was deemed unnecessary and there were no suggested revisions to the version of the user manual or box packaging tested.
The comprehension and use test demonstrated that the Shani Darden LED light therapy mask labelling could be used by lay persons to safely and effectively operate the device to attain its intended use and purpose.
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Clinical Performance
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
Conclusion
The Shani Darden LED light therapy mask utilizes the same light-emitting technological characteristics as the predicate device, and the new device does not raise new types of questions regarding safety and efficacy when compared to the predicate device. The device has been tested as described above to show that the device can be used safely and effectively. The Shani Darden LED light therapy device is considered to be substantially equivalent to the predicate device K213184.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.