(120 days)
The Spectra Therapy Spectra A1000 is an infrared lamp intended to provide topical heating. The Spectra Therapy Spectra A1000 is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
The Spectra Therapy Spectra A1000 is an infrared lamp intended to provide topical heating. The Spectra A1000 is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle pain and/or the temporary relaxation of muscle.
The Spectra A1000 System houses multiple photo energy devices. The photo devices consist of 4 dual [infrared and RED visible] lasers combined with a cluster of 8 visible RED LED's, and 8 Infrared LED's and a yellow indicator lamp.
The Spectra A1000 Laser Therapy Device consists of a docking unit, a USB and laser port, a key port and a key. The laser and light therapy releases radiation with wing wavelengths, all of which fall within the infrared range as defined in 21 CFR 890.5500.
The provided text is a 510(k) Summary for the Spectra Therapy Spectra A1000 Laser Device. It details the device's name, sponsor, predicate device, description, intended use, and substantial equivalence to a legally marketed predicate device.
However, the document does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria in terms of analytical or clinical performance (e.g., sensitivity, specificity, accuracy, or reader performance). Instead, the submission focuses on demonstrating substantial equivalence primarily through technological characteristics and safety testing (Tissue Temperature and electrical safety and EMC/EMI testing).
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, ground truth, expert opinions, or MRMC studies because this information is not present in the provided 510(k) summary. These types of studies and criteria are typically associated with devices that have a more complex diagnostic or therapeutic function requiring performance validation against a defined clinical outcome or expert diagnosis, which is not the primary focus of this submission for an infrared lamp for topical heating.
The relevant sections of the document explicitly state that:
- "Tissue Temperature and electrical safety and EMC/EMI testing have been performed demonstrating that the Spectra A1000 Laser Device is safe and effective for its intended use." This points to safety and basic functionality testing, not performance criteria like sensitivity or reader improvement.
- The FDA's letter states: "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... to legally marketed predicate devices." Substantial equivalence in this context is based on comparing the device's technological characteristics and intended use to a predicate, not necessarily on a new clinical study proving performance against defined acceptance criteria for a diagnostic or complex therapeutic claim.
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1080689
UUL - 9 2008
510(k) Summary for Spectra Therapy Spectra A1000 Laser Device
1. SPONSOR
Premier Dynamics, Inc. 3863 Rochester Rd. Troy, MI 48083
Contact Person: John Stephan Telephone: 248-321-2029
Date Prepared: March 10, 2008
2. DEVICE NAME
| Proprietary Name: | Spectra A1000 Laser Device |
|---|---|
| Common/Usual Name: | Heating lamp |
| Classification Name: | Heating lamp for adjunctive use in pain therapy |
3. PREDICATE DEVICES
Escada TerraQuant MQ2000 Laser Therapy Device K043055
4. DEVICE DESCRIPTION
The Spectra Therapy Spectra A1000 is an infrared lamp intended to provide topical The Spectra A1000 is intended to emit energy in the visible and near heating. infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle pain and/or the temporary relaxation of muscle.
The Spectra A1000 System houses multiple photo energy devices. The photo devices consist of 4 dual [infrared and RED visible] lasers combined with a cluster of 8 visible RED LED's, and 8 Infrared LED's and a yellow indicator lamp.
The Spectra A1000 Laser Therapy Device consists of a docking unit, a USB and laser port, a key port and a key. The laser and light therapy releases radiation with wing wavelengths, all of which fall within the infrared range as defined in 21 CFR 890.5500.
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5. INTENDED USE
The Spectra Therapy Spectra A1000 is an infrared lamp intended to provide topical heating. The Spectra Therapy Spectra A1000 is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The proposed Spectra A1000 device and the predicate TerraQuant MQ2000 Laser Therapy System device are also substantially equivalent in technological characteristics in that they are both hand-held, heating laser diodes, and/or infrared lamps, that deliver low level laser light to various anatomic areas. Both the output power and output wavelength of the proposed device are within the range of the predicate device. Tissue Temperature and electrical safety and EMC/EMI testing have been performed demonstrating that the Spectra A1000 Laser Device is safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.
AUG 18 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Premier Dynamics, Inc. % Mr. John J. Stephan General Manager 3863 Rochester Road Troy, Michigan 48083
Re: K080689
Trade/Device Name: Spectra Therapy Spectra A1000 Laser Device Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: June 10, 2008 Received: June 11, 2008
Dear Mr. Stephan:
This letter corrects our substantially equivalent letter of July 9, 2008
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 (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); 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.
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Page 2 - Mr. John J. Stephan
This letter will allow you to continue 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Mark A. Milbern
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number No # K080689
Spectra Therapy Spectra A1000 Laser Device Device Name:
Indications for Use:
The Spectra Therapy Spectra A1000 is an infrared lamp intended to provide topical heating. The Spectra Therapy Spectra A1000 is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
| Prescription Use(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-the-Counter Use(21 CFR 807 Subpart C) |
|---|---|---|---|
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDEH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K080689 |
|---|---|
| --------------- | --------- |
N/A