(24 days)
The Bright device is intended to be used for the treatment of wrinkles, rhytides and fine lines in the periorbital region.
The Bright is an over-the-counter device that uses light emitting diodes to emit red light (660 nm) during treatment. The device includes a control unit, a treatment surface and a protective cap that fits over the treatment surface area of the device when not in use. The device controls consist of a single on/off activation button. The rechargeable battery included in the device can be charged using a USB cable that is supplied.
The provided document is a 510(k) summary for the Bright device, a light-emitting diode (LED) therapy device intended for the treatment of wrinkles, rhytides, and fine lines in the periorbital region. The purpose of this 510(k) notice is to demonstrate substantial equivalence to a previously cleared device, the Tanda Max OTC (K110735), after modifications to create a smaller version.
Based on the provided text, the device is not an AI product, but rather a physical medical device (LED therapy device). Therefore, the specific questions related to AI device performance, sample sizes for test sets and training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models are not directly applicable or discussed in this document.
The document focuses on demonstrating that the modified Bright device maintains the same safety and effectiveness as its predicate device despite physical changes.
Here's a breakdown of the requested information based on the provided text, with an emphasis that this is for a physical device, not an AI model:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Methods/Standards) | Reported Device Performance |
|---|---|
| IEC 60601-1:2005 (General Safety) | Functioned as intended |
| IEC 60601-1-2 Ed 4.0 2014-02 (EMC) | Functioned as intended |
| IEC 62304 Ed 1.0 (Software Life Cycle) | Functioned as intended |
| ISO 10993-1 (Biocompatibility) | Functioned as intended |
| IEC 62471 (Photobiological Safety) | Functioned as intended |
| ISO 14971 (Risk Management) | Functioned as intended |
| Output Power (mW/cm²) | Identical to predicate |
| Treatment Cycle Time | Identical to predicate |
| Treatment Regimen | Identical to predicate |
| Skin Contact Sensor | Preserved |
| Temperature Sensor | Preserved |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable or provided for a physical device's performance testing in this context. The document describes engineering and safety standard compliance testing for hardware and software, not a clinical trial with a "test set" of patients in the way an AI model would be evaluated. The testing is focused on the device's physical and electrical characteristics and adherence to recognized standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable or provided. The "ground truth" for a physical device's safety and performance is established by its compliance with recognized engineering, safety, and biological standards, as well as its functional specifications. It does not involve expert consensus on medical images or diagnoses in the way an AI medical device would.
4. Adjudication Method for the Test Set
This information is not applicable or provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., radiology reads) where there can be disagreement among experts. This document describes compliance testing against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not pertinent to this physical LED therapy device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical LED therapy device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and performance is based on compliance with established international and national engineering, safety, and biocompatibility standards (e.g., IEC 60601-1, ISO 10993-1). Additionally, its functional characteristics (e.g., output power, treatment cycle, sensor operation) were compared to the cleared predicate device.
8. The Sample Size for the Training Set
This information is not applicable or provided. "Training set" refers to data used to train an AI model. This document describes the manufacturing and testing of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided as it relates to AI model training data, not a physical device.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2016
Tanda Beauty Canada Inc. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market St., 29th Floor Philadelphia, Pennsylvania 19103
Re: K161849
Trade/Device Name: Bright 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: OHS Dated: July 5, 2016 Received: July 5, 2016
Dear Janice Hogan:
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
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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 devicerelated 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Christopher J. Ronk -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
Device Name
Bright
Indications for Use (Describe)
The Bright device is intended to be used for the treatment of wrinkles, rhytides and fine lines in the periorbital region.
Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D)
Z Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY
Tanda Beauty Canada, Inc.'s Bright Device
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Tanda Beauty Canada, Inc. (formerly Pharos Life Corporation) 11-380 Jamieson Parkway Cambridge, Ontario, Canada N3C 4N4
Phone: +1 212 245 2999 X 202 Facsimile: +1-519-651-2277
Contact Person: Bobae Kim
Date Prepared: July 28, 2016
Name of Device and Name
Bright
Common or Usual Name
Light Emitting Diode Therapy Device
Classification Name
Laser surgical instrument for use in general and plastic surgery and in dermatology
Predicate Devices
Tanda Beauty Canada, Inc.'s (formerly known as Pharos Life Corporation) Tanda Max OTC (K110735)
Purpose of the Special 510(k) Notice
The Bright device is a modification to the previously cleared Tanda Max OTC (K110735) device to create a smaller version of the cleared device.
Intended Use
The Bright device is indicated for the treatment of wrinkles, rhytides and fine lines in the periorbital region.
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Device Description
The Bright is an over-the-counter device that uses light emitting diodes to emit red light (660 nm) during treatment. The device includes a control unit, a treatment surface and a protective cap that fits over the treatment surface area of the device when not in use. The device controls consist of a single on/off activation button. The rechargeable battery included in the device can be charged using a USB cable that is supplied.
Technological Characteristics
The Bright device is a smaller version of its predicate device (K110725). Both the predicate device and the Bright share the same technological characteristics. Both devices are handheld rechargeable battery operated units that use light emitting diodes (LEDs) to deliver red light at 660 nm to the treatment surface. The primary features of the Bright device are identical to the predicate device, and include sensors for skin contact and skin temperature, as well as a single on/off push button that activates the device. The performance specifications, such as the total output power (mW/cm2), the treatment cycle time and the treatment regimen also remain identical between the predicate (K110735) and the Bright device. The minor change of reducing the size and dimensions of the Bright compared to the predicate does not present changes to the fundamental scientific technology and essential parameters of the originally cleared predicate device.
Performance Data
A risk analysis was performed to assess the modifications to the Bright System, and confirmed that no new risks are raised. The following non-clinical performance testing was conducted to re-validate the modified device. The same test methods and criteria used on the predicate device cleared in K110735 were followed, and include:
- . IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. (General)
- . IEC 60601-1-2 Edition 4.0 2014-02. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances - requirements and tests. (General II (ES/EMC))
- IEC 62304 Ed. 1.0. Medical device software Software life cycle . processes. (Software/Informatics)
- ISO 10993-1 Fourth edition 2009-10-15, Biological evaluation of medical devices Part 1: . Evaluation and testing within a risk management process [including: technical corrigendum 1 (2010)]. (Biocompatibility)
- IEC 62471, Photobiological safety of lamps and lamp systems. (Radiology) 1.0 edition (2006) ●
- . ISO 14971, Medical devices - Application of risk management to medical devices. (General) (2010)
In all instances, the Bright functioned as intended.
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Substantial Equivalence
The Bright device has the same intended use and indications, principles of operation, and technological characteristics as the Tanda Max OTC (K110735) predicate device. The minor hardware differences implemented to create a smaller version of the addition of a vibration indicator in the Bright device do not present new or different questions of safety or effectiveness. Performance data demonstrates that the Bright device is substantially equivalent to the company's Tanda Max OTC predicate device.
Conclusions
In sum, the Bright device performs the same as the predicate device, the Tanda Max OTC system (K110735). The Bright device has identical intended use/indications for use and principles of operation as the predicate device. The main safety features in the predicate device, including the skin contact sensor and temperature sensor, are also preserved in the Bright device. Furthermore, the Bright device delivers the same total output power (mW/cm2) in the same treatment duration and regimen as the predicate device and therefore, no new or different questions of safety or efficacy are raised in the modified device. The smaller size and addition of a vibration indicator to improve user experience do not raise new issues of safety or effectiveness compared to the predicate. No new hazards were identified as a result of these modification and validation through software and performance testing, electrical safety and electromagnetic compatibility/interference testing demonstrate that the Bright device is substantially equivalent.
§ 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.