(188 days)
TRIA is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. TRIA is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
TRIA is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm +/- 20%.
The provided document is a 510(k) summary for the TRIA Laser Hair Removal System. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K090820) rather than presenting a detailed clinical study for a new device with specific acceptance criteria and a new performance study.
Therefore, many of the requested details about acceptance criteria, detailed study design, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not explicitly provided in this 510(k) summary. The document states that "Clinical trials have been conducted to demonstrate the safety and efficacy of TRIA for over-the-counter use for hair removal sustained with periodic treatments and for permanent reduction in hair regrowth," but it refers to the previously cleared TRIA as the device used in the clinical study and its performance data for substantial equivalence.
Based on the information available in the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for this specific 510(k submission. It refers to the "permanent reduction in hair regrowth" as its intended effect, defined as "long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen." The performance for this submission is based on the substantial equivalence to the previously cleared TRIA, meaning its performance is considered to meet the same standards.
| Acceptance Criteria (Inferred from Indication) | Reported Device Performance (Inferred from Substantial Equivalence to K090820) |
|---|---|
| Permanent reduction in hair regrowth (long-term, stable reduction in hair counts at 6, 9, and 12 months post-treatment regimen). | Performance is effectively deemed equivalent to the previously cleared TRIA (K090820), which demonstrated this outcome in its clinical trials. |
| Hair removal sustained with periodic treatments. | Performance is effectively deemed equivalent to the previously cleared TRIA (K090820), which demonstrated this outcome in its clinical trials. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary for this submission. The document states, "The TRIA used in the clinical study is the previously cleared TRIA." This implies the clinical data refers to the study performed for K090820, not a new study.
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)
This information is not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided.
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
This is not applicable. The device is a laser hair removal system, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical laser system, not a software algorithm. Its performance is inherent to its physical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For hair removal devices, the clinical ground truth typically involves outcomes data such as direct hair counts, photographic assessment by experts, or patient self-assessment of hair reduction over time. While not explicitly stated here, it would have been established during the clinical trials for the previously cleared TRIA.
8. The sample size for the training set
This information is not provided, as the submission relies on previous clinical trials. The concept of a "training set" in the context of deep learning models is not relevant here; rather, the "training" refers to the clinical trials conducted for the predicate device.
9. How the ground truth for the training set was established
This information is not provided for this submission. For the predicate device's clinical trials, the ground truth would have been established through methodologies typical for dermatological studies focusing on hair reduction, likely involving:
- Hair counting: Expert technicians manually counting hair follicles in a defined area.
- Photography: Standardized photographs evaluated by blinded experts.
- Patient Diaries/Self-assessment: Recording perceived hair reduction.
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SEP
1 3
2012
K [20737
510(k) SUMMARY
TRIA Beauty's TRIA Laser Hair Removal System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
TRIA Beauty, Inc. 4160 Dublin Blvd., Suite 200 Dublin, CA 94568
Phone: 925-452-2539 Facsimile: 925-452-2595
Contact Person
Lisa Parr, Pharm.D.
Date Prepared
September 7, 2012
Name of Device and Name/Address of Sponsor
TRIA Laser Hair Removal System
TRIA Beauty, Inc. 4160 Dublin Blvd., Suite 200 Dublin, CA 94568
Common or Usual Name
Pulsed Diode Laser
Classification Name
Laser Instrument, Surgical, Powered Regulation Number: 21 C.F.R.§ 878.4810 Product Code: GEX
Predicate Devices
TRIA Laser Hair Removal System (K090820)
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Intended Use / Indications for Use
TRIA is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. TRIA is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
Technological Characteristics
TRIA is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm +/- 20%.
Performance Data
Clinical trials have been conducted to demonstrate the safety and efficacy of TRIA for overthe-counter use for hair removal sustained with periodic treatments and for permanent reduction in hair regrowth.
Substantial Equivalence
The TRIA used in the clinical study is the previously cleared TRIA. The TRIA has the same intended uses and similar indications, technological characteristics, and principles of operation as the previously cleared TRIA. Performance data demonstrate that the TRIA is as safe and effective as its predicate. Thus, the TRIA is substantially equivalent.
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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 stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
TRIA Beauty, Incorporated
% Hogan and Lovells US, LLP
Mr. Jonathan Kahan
Regulatory Counsel
Columbia Square
555 13th Street, Northwest
Washington, District of Columbia 20004
SEP 13 2012
Re: K120737
Trade/Device Name: TRIA Laser Hair Removal System (TRIA) 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: GEX Dated: August 28, 2012 Received: August 28, 2012
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.
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Page 2 -- Mr. Jonathan Kahan
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for A
Dan Darler.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: K120737
Device Name: TRIA Laser Hair Removal System (TRIA)
Indications for Use:
TRIA is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. TRIA is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ... . X .... (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil Reynolds for mxn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
§ 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.