(333 days)
The ATS-1 OTC is generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris. It is intended for over-the-counter use.
The ATS-1 OTC is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices.
The key points from the document regarding performance are:
- Claim of Substantial Equivalence: TRIA Beauty claims that the ATS-1 OTC's performance data is substantially equivalent to predicate devices, especially their previously cleared ATS-1 (K060567).
- Performance and Consumer Usability Data: The submission states that "Performance and consumer usability data is submitted with this 510(k) notification." However, the details of this data, including specific metrics, sample sizes, or study methodologies, are not present in the provided excerpt.
- No New Questions of Safety or Efficacy: The document states that "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 predicates." This implies that the current device performs comparably to the predicates and does not introduce new risks or reduce effectiveness.
Given the information, a table of acceptance criteria and reported performance cannot be generated as those details are not explicitly provided. Similarly, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone studies, and ground truth methodologies for any explicit performance study are not detailed.
The document primarily relies on the concept of substantial equivalence to predicate devices. This means that instead of conducting a new study to meet specific, quantifiable acceptance criteria, the manufacturer aims to show that their new device is as safe and effective as a device already on the market.
Based on the provided text, the specific information requested in your prompt cannot be fully provided because the document focuses on demonstrating substantial equivalence rather than detailing a specific de novo performance study with explicit acceptance criteria.
The lack of this information is typical for devices seeking 510(k) clearance based on substantial equivalence, especially when the device is an iteration of an already cleared product from the same manufacturer. The FDA's 510(k) process often relies on comparative data and pre-existing knowledge about the safety and effectiveness of predicate devices, rather than requiring extensive new clinical trials with predefined performance metrics for every submission.
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KC090312
510(k) SUMMARY
ATS-1 OTC
JAN - 5 2010
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: Tobin C. Island, Ph.D. Date Prepared: February 5, 2009
Name of Device and Name/Address of Sponsor
TRIA Acne Treatment System (ATS-1 OTC) TRIA Beauty, Inc. 5880 W. Las Positas Blvd., Suite 52 -Pleasanton, CA 94588-8552
Common or Usual Name
Light Emitting Diode Therapy System
Classification Name
Laser Instrument, Surgical, Powered Regulation Number: 21 C.F.R.§ 878.4810 Product Code: GEX
Predicate Devices
ATS-1 by TRIA Beauty, Inc. (formerly SpectraGenics, Inc.) (K060567) ThermaClear by Therative, Inc. (K060653) Zeno by Tyrell, Inc. (K043377) Tanda by Pharos Life Corporation (K080591)
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Intended Use / Indications for Use
- The ATS-1 OTC is generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris. It is intended for over-the-counter use.
Technological Characteristics
The ATS-1 OTC is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.
Performance Data
न्न
TRIA Beauty claims that the ATS-1 OTC performance data is substantially equivalent to the predicate devices, including and especially the company's previously cleared ATS-1 (K060567). Performance and consumer usability data is submitted with this 510(k) notification.
Substantial Equivalence
The ATS-1 OTC has substantially the same intended use, indications for use, technological parameters, and mechanism of action as the predicate device(s). Furthermore, 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 predicates. Therefore, the ATS-1 OTC is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the 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 an eagle or bird with outstretched wings, facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN - 5 2010
TRIA Beauty, Inc. % Hogan and Hartson LLP Mr. Jonathan S. Kahan Columbia Square 555 13th Street, N.W. Washington, District of Columbia 20004
Re: K090312
Trade/Device Name: TRIA Acne Treatment System (ATS-1 OTC) 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 09, 2009 Received: December 09, 2009
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. Iisting 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
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Page 2 – Mr. Jonathan S. Kahan
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/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 number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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 (if known):
Device Name: ATS-1 OTC
Indications for Use:
The TRIA Beauty ATS-1 OTC is generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Q
Division Sign-Off) Division Sign-Off)
Division of Surgical ( rthopedic,
Division of Surgical ( res ിഴിടിന്ന് of Suid Restorative Dev 510(k) Number -
19
Page of of
§ 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.