(83 days)
Not Found
No
The summary describes a light therapy device with no mention of AI/ML terms, image processing, or data training/testing.
Yes
The device is indicated for the "treatment of mild to moderate inflammatory acne" and "uses LEDs (light emitting diodes) to produce therapeutic blue light," which indicates a medical purpose.
No
Explanation: The device is indicated for the "treatment" of acne, not for diagnosis. It uses blue light for therapeutic purposes.
No
The device description explicitly states it is a "handheld, electrically powered device that uses LEDs," indicating it is a hardware device, not software-only.
Based on the provided information, the Tria Sapphire is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of mild to moderate inflammatory acne. This is a therapeutic application, not a diagnostic one.
- Device Description: The device uses LEDs to produce blue light for therapeutic purposes. It does not involve analyzing samples (like blood, urine, or tissue) outside of the body, which is the core function of an IVD.
- No mention of in vitro analysis: The description and performance studies focus on usability and safety in treating acne on the skin, not on analyzing biological samples.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Tria Sapphire does not fit this description.
N/A
Intended Use / Indications for Use
The Tria Sapphire is indicated for the treatment of mild to moderate inflammatory acne. It is intended for over-the-counter use.
Product codes
OLP
Device Description
The Tria Sapphire is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.
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
Over-The-Counter Use (21 CFR 801 Subpart C)
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:
Performance testing was conducted to demonstrate that the Tria Sapphire performs according to specifications and functions as intended. The Sapphire device was tested and found to be compliant with the following:
- . Electrical safety and essential performance (IEC 60601-1)
- . Electromagnetic compatibility (IEC 60601-1-2)
- . Biocompatibility (ISO 10993-5 & 10993-10)
- . Software verification and validation testing
Clinical:
A 60-subject, all-comers OTC usability study was conducted. Subjects demonstrated the ability to (a) make the correct self-selection (mild to moderate inflammatory acne), (b) use the device properly and (c) comprehend key directions and warnings according to the Sapphire labeling. No safety issues were identified. Usability results were consistent with the predicate ATS-1 OTC device and are appropriate for over-the-counter clearance.
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
§ 878.4810 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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2016
Tria Beauty, Inc. % Mr. Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K160821
Trade/Device Name: Tria Sapphire 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 Dated: March 24, 2016 Received: March 24, 2016
Dear Mr. Kahan:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Tria Sapphire
Indications for Use (Describe)
The Tria Sapphire is indicated for the treatment of mild to moderate inflammatory acne.
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)
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
Tria Beauty's Tria Sapphire
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Tria Beauty, Inc. 4160 Dublin Blvd, Ste 200 Dublin, CA 94568 Phone: 925-452-2500 Facsimile: 925-452-2597 Contact Person: Heather Tanner Date Prepared: March 23, 2016
Name of Device and Name/Address of Sponsor
Tria Sapphire Tria Beauty, Inc. 4160 Dublin Blvd, Ste 200 Dublin, CA 94568
Common or Usual Name
Light Therapy System
Classification Name
Laser Instrument, Surgical, Powered Regulation Number: 21 CFR§878.4810 Product Code: OLP
Predicate Devices
Tria Beauty, Inc., ATS-1 OTC (K090312)
Intended Use / Indications for Use
The Tria Sapphire is indicated for the treatment of mild to moderate inflammatory acne. It is intended for over-the-counter use.
Technological Characteristics
The Tria Sapphire is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.
Performance Data
Performance data was submitted with this 510(k) notification to support the determination of substantial equivalence for the Tria Sapphire relative to its predicate device.
4
Non-Clinical:
Performance testing was conducted to demonstrate that the Tria Sapphire performs according to specifications and functions as intended. The Sapphire device was tested and found to be compliant with the following:
- . Electrical safety and essential performance (IEC 60601-1)
- . Electromagnetic compatibility (IEC 60601-1-2)
- . Biocompatibility (ISO 10993-5 & 10993-10)
- . Software verification and validation testing
Clinical:
A 60-subject, all-comers OTC usability study was conducted. Subjects demonstrated the ability to (a) make the correct self-selection (mild to moderate inflammatory acne), (b) use the device properly and (c) comprehend key directions and warnings according to the Sapphire labeling. No safety issues were identified. Usability results were consistent with the predicate ATS-1 OTC device and are appropriate for over-the-counter clearance.
Substantial Equivalence
The Tria Sapphire is substantially equivalent to the legally marketed ATS-1 OTC blue light device (K090312). It has the same general intended use and indication for use, the same principles of operation and treatment method, and substantially similar technological characteristics as the predicate. The kev technical parameters effecting safety and efficacy are identical to the predicate. The performance and consumer usability data demonstrates that any technological differences or changes in labeling do not raise new questions of safety or efficacy or alter the device's intended therapeutic effect in comparison to the predicate. Therefore, Tria Sapphire is substantially equivalent.