(63 days)
The TriLumina Therapeutic Laser System is a non-heating infrared lamp and is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
The TriLumina Therapeutic Laser is an innovative, safe, easy to use, hand-held, battery operated, non-invasive, athermal low energy infrared laser device. The TriLumina Therapeutic Laser contains three gallium-aluminum-arsenide continuous wave diodes operating in the near infrared at a wavelength of 830 nanometers and a visible red light emitting diode is used as a quide beam. The device has a power output of 30 milliwatts for each GaAlAs diode with a noncollimating beam of dimensions of approximately 1 by 3 millimeters at the lens. The Laser has an "On / Off" switch to control the power to the device and two pressure switches that when pressed energize the laser diodes. A timer automatically times the 30 second activation cycle and the delivery of 3 Joules of energy.
The provided text is a 510(k) premarket notification summary for the TriLumina Therapeutic Laser System. It focuses on demonstrating substantial equivalence to predicate devices and detailing the device's technical characteristics and intended use.
However, the document does not contain information about a study proving the device meets specific acceptance criteria related to its performance in temporarily relieving hand and wrist pain associated with Carpal Tunnel Syndrome. Instead, it relies on the substantial equivalence principle, comparing its technical specifications and intended use to already cleared devices.
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I answer questions regarding sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies. These types of studies would typically be conducted to prove clinical efficacy, which is often not required for 510(k) submissions that demonstrate substantial equivalence to previously cleared devices.
The document essentially states:
- Intended Use: Adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
- Mechanism: Non-heating infrared lamp (low energy therapeutic laser) using gallium-aluminum-arsenide continuous wave diodes at 830 nm.
- Basis for Clearance: Substantial equivalence to predicate devices (MicroLight 830 Laser System, Acculaser Pro Low Level Laser System, MedX LCS System) that are also low-level therapeutic lasers.
Without a clinical study described in the provided text, I cannot generate the detailed acceptance criteria and study information you requested.
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023935
JAN 2 8 2003
510(k) PREMARKET NOTIFICATION SUMMARY
112
(per 21 CFR 807.92)
TriLumina Therapeutic Laser System
I. Applicant:
USALaser Therapeutics Inc. 10115 Merrimac Road Richmond, VA 23235 1 804 320-4616
Contact Person: M. Joyce Heinrich Texas Applied Biomedical Services, Inc. 713 / 777-5477 telephone 713 / 734-5671 facsimile Tabs1@netropolis.net e-mail
Date Prepared:
November 25, 2002
II. Device Name
| Proprietary Name: | TriLumina Therapeutic Laser System |
|---|---|
| Common / Usual Name: | Low Energy Therapeutic Laser |
| Classification Name: | Infrared Lamp (21 CFR 890.555) |
| Product Code: | NHN |
III. Predicate Device
The TriLumina Therapeutic Laser System is substantially equivalent to other low level therapeutic lasers currently in commercial distribution. These predicate devices include the MicroLight Corporation of America, Inc. MicroLight 830 Laser System (K010175), Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657) and the MedX LCS System (K021985). These devices were cleared for introduction into interstate commerce via the FDA's 510(k) Notification process. The Trilumina Therapeutic Laser has the same intended use as and similar technological characteristics to the predicate devices.
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K023935 2/2
IV. Intended Use of the Device
The TriLumina Therapeutic Laser System is a non-heating infrared lamp and is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
V. Description of the Device
The TriLumina Therapeutic Laser is an innovative, safe, easy to use, hand-held, battery operated, non-invasive, athermal low energy infrared laser device. The TriLumina Therapeutic Laser contains three gallium-aluminum-arsenide continuous wave diodes operating in the near infrared at a wavelength of 830 nanometers and a visible red light emitting diode is used as a quide beam. The device has a power output of 30 milliwatts for each GaAlAs diode with a noncollimating beam of dimensions of approximately 1 by 3 millimeters at the lens.
The Laser has an "On / Off" switch to control the power to the device and two pressure switches that when pressed energize the laser diodes. A timer automatically times the 30 second activation cycle and the delivery of 3 Joules of energy.
Summary of the technical characteristics of the TriLumina Therapeutic VI. Laser System to the referenced predicate devices.
The TriLumina Therapeutic Laser System and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared diodes to emit infrared photonic energy to the tissue.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the logo. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2003
USA Laser Therapeutics, Inc. c/o M. Joyce Heinrich Texas Applied Biomedical Service, Inc. 12101 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------Houston, Texas 77047-1601
Re: K023935
Trade/Device Name: TriLumina Therapeutic Laser System Regulation Number: 890.5500 Regulation Name: Lamp, non-heating for adjunctive use in pain therapy Regulatory Class: Class II Product Code: NHN Dated: November 25, 2002 Received: November 26, 2002
Dear Ms. Heinrich:
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 such 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 mav 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
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Page 2 - Ms. M. Joyce Heinrich
(21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
iriam C. Provost
Col Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Ko23931 Pending
Device Name:
TriLumina Therapeutic Laser System
Indications for Use:
The TriLumina Therapeutic Laser System is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: OR (Per 21 CFR 801.109)
Over the Counter Use: (Optional Format 1-2-96)
(Division Sign-Off)
510(k) Number
iriam C. Provost
livision of General, Restorative nd Neurological Devices
TriLumina Therapeutic Laser 510(k) Premarket Notification November 25, 2002
000013
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.