(272 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.
TRIA is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.
1. Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC. Instead, it focuses on demonstrating safety and efficacy for its intended use. The performance is described in terms of achieving "hair removal sustained with periodic treatments" and "permanent reduction in hair regrowth."
However, based on the narrative, the implicit acceptance criteria are that the device effectively performs these functions, and the reported performance indicates that this was demonstrated through clinical trials.
The specific "acceptance criteria" are not detailed in a quantitative manner but are centered around the clinical outcomes of hair removal and permanent reduction in hair regrowth.
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states that "Clinical trials have been conducted to demonstrate the safety and efficacy of TRIA." However, it does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not specify the number of experts used to establish ground truth or their qualifications. Given the nature of the device (hair removal), ground truth might have been established through objective measurements (e.g., hair count, photographic evaluation) and/or patient self-assessment, rather than solely by expert consensus in the traditional sense of diagnostic imaging.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study evaluating the improvement of human readers with AI assistance. This is expected given that the TRIA device is a consumer- direct treatment device, not an AI diagnostic tool.
6. Standalone Performance Study:
The document describes "Clinical trials" that "demonstrate the safety and efficacy of TRIA." This implies a standalone performance study of the device itself (algorithm only, in the context of the device's function) without human adjudication in the loop during the treatment phase. The trials focused on the device's direct effect on hair reduction.
7. Type of Ground Truth Used:
The document states that clinical trials demonstrated "hair removal sustained with periodic treatments" and "permanent reduction in hair regrowth." While not explicitly defined, the ground truth would likely involve:
- Objective Measurements: Such as hair count comparisons before and after treatment, potentially using standardized photography.
- Patient Diaries/Self-Assessment: To track sustained hair removal and satisfaction.
- Clinical Assessments by Investigators: Assessing the visible reduction in hair.
8. Sample Size for the Training Set:
The document does not provide any information regarding a training set sample size. This is consistent with the device being a laser hair removal system, where "training a model" in the AI sense is not applicable. The development would involve engineering and physical testing, followed by clinical trials to validate the device's performance, not the feeding of data into an AI algorithm for learning.
9. How Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the context of an AI algorithm, the question of how its ground truth was established is not applicable. The "ground truth" in the development of the TRIA device would relate to the physical and biological principles of laser hair removal, established through scientific understanding and prior research, rather than a data-driven training process.
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TRIA Laser Hair Removal System (TRIA)
12090820
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
TRIA Beauty, Inc. 5880 W. Las Positas Blvd., Suite 52 Pleasanton, CA 94588-8552 Phone: 925-701-2549 Facsimile: 925-701-2598 Contact Person: Lisa D. Parr, Pharm.D. Date Prepared: December 7, 2009
Name of Device and Name/Address of Sponsor
TRIA Laser Hair Removal System (TRIA) TRIA Beauty, Inc. 5880 W. Las Positas Blvd., Suite 52 Pleasanton, CA 94588-8552
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
SpectraGenics Spectra Hair Removal Laser System (K053527) Star Medical Technologies LightSheer Pulsed Diode Array Laser System (K982940) Home Skinovations Flash N' Go (K082298)
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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.
Technological Characteristics
TRIA is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.
Performance Data
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.
Substantial Equivalence
TRIA has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. Any minor differences between the TRIA and its predicate devices raise no new questions of safety or effectiveness nor change the device's intended therapeutic effect in comparison to its predicates. Performance data demonstrate that TRIA is as safe and effective as its predicate devices for the stated indications. Thus, TRIA is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC 2 3 2009
TRIA Beauty, Inc. % Tobin C. Island, Ph.D. Executive Vice President 5880 W. Las Positas Boulevard, Suite 52 Pleasanton, California 94588
Re: K090820
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: December 7, 2009 Received: December 7, 2009
Dear Dr. Island:
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.
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 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
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Page 2 - Tobin C. Island, Ph.D.
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/ucm1.15809.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/cdrh/mdr/ 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 ne mber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Toh
Mark N. Melkerson
Daef D.M
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 (if known): K090820
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.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of Surgical, OrthopedicPage of and Restorative Devices
510(k) Number /K090820
\\DC - 028683/000001 - 2998146 v1
§ 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.