(91 days)
The LUMIX CPS Series IR Lamp Systems are intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
The LUMIX CPS Series IR Lamp Systems are intended for use as therapeutic heat lamps. The Systems are non-invasive devices that emit light energy to the skin-surface of the human body for the purpose of causing the therapeutic elevation of tissue temperature. The LUMIX CPS Series IR Lamp Systems deliver visible and invisible laser light beams at wavelengths between 650 and 1064 nm using gallium arsenide (GaAs) diode sources. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers. The tissue to be treated is illuminated by a non-therapeutic red laser guide light with 3 mW of power. The Systems consist of 2 main hardware sub-systems: 1) the control console and 2) the treatment handpiece probe with its connecting cable. The control consoles are made of standard medical PVC material and are designed to be placed on a desktop or table in the vicinity of the patient to be treated. The console houses the user interface, which is a pressure activated membrane and an LCD display. The treatment probes are made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiber optic cables. The probes contain a protective lens at the aperture, which is made of glass suitable for medical applications.
This document is a 510(k) premarket notification for the LUMIX CPS Series IR Lamp Systems. It does not describe a study involving an algorithm or artificial intelligence, so many of the requested categories are not applicable.
Here's an analysis based on the provided text, focusing on what is applicable to this medical device submission:
1. Acceptance criteria and reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a numerical threshold for a study. Instead, it demonstrates compliance with recognized medical device standards and establishes "substantial equivalence" to predicate devices. The reported device performance is primarily described through its intended therapeutic action and compliance with safety and performance standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1:2006 (General Safety) | Systems are manufactured to comply with this standard. |
| Compliance with IEC 60825-1:2014 (Laser Safety) | Systems are manufactured to comply with this standard. |
| Compliance with IEC 60601-1-2:2010 (EMC) | Systems are manufactured to comply with this standard. |
| Compliance with IEC 60601-1-6:2013 (Usability) | Systems are manufactured to comply with this standard. |
| Compliance with IEC 60601-2-22:2012 (Laser Equipment Specific) | Systems are manufactured to comply with this standard. |
| Compliance with IEC 62304:2006 (Software Life Cycle) | Systems are manufactured to comply with this standard. |
| Compliance with ISO 14971:2012 (Risk Management) | Systems are manufactured to comply with this standard. |
| Functional performance as a therapeutic heat lamp | Non-invasive, emits light energy for topical heating to elevate tissue temperature. |
| Delivers visible and invisible laser light at 650-1064 nm | Specifies use of gallium arsenide (GaAs) diode sources. |
| Achieves therapeutic elevation of tissue temperature | Stated purpose for temporary relief of various pains/spasms, and temporary increase in local blood circulation/muscle relaxation. |
| Substantial equivalence to predicate devices | Determined by FDA to be substantially equivalent. |
| Does not raise new safety or efficacy issues | Explicitly stated in conclusions. |
2. Sample size used for the test set and the data provenance
Not Applicable. This submission focuses on demonstrating substantial equivalence through compliance with recognized standards and comparison to predicate devices, rather than a clinical trial with a "test set" of patient data. The "testing" mentioned refers to engineering and performance testing of the device itself (functional, electrical safety).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. As there was no clinical test set of patient data, there was no need for expert adjudication of ground truth for medical conditions.
4. Adjudication method for the test set
Not Applicable. No test set requiring adjudication was used.
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
Not Applicable. This device is an infrared lamp, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a physical infrared lamp system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable. The "ground truth" for this submission revolves around engineering specifications, safety standards, and the established therapeutic principles of infrared heating, rather than clinical outcome "ground truth" in an AI context. The document states that "The use of light energy to generate heat for therapeutic use has been well documented and is a generally accepted alternative treatment modality for the temporary relief of pain," implying reliance on existing medical literature and accepted practices.
8. The sample size for the training set
Not Applicable. This is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. No training set was used.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 5, 2016
USA Laser Biotech Inc. % Ms. M. Joyce Heinrich Texas Applied Biomedical Services, Inc. 1201 Cullen Boulevard, Suite A Houston, Texas 77047-2951
Re: K160947
Trade/Device Name: LUMIX CPS 1 IR Lamp System, LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System, LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: April 11, 2016 Received: April 12, 2016
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. 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160947
Device Name
LUMIX CPS 1 IR Lamp System; LUMIX CPS 2 IR Lamp System; LUMIX CPS 3 IR Lamp System; LUMIX CPS 4 IR Lamp System; LUMIX CPS 5 IR Lamp System
Indications for Use (Describe)
The LUMIX CPS Series IR Lamp Systems are intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary ( as per 21 CFR 807.92)
l. GENERAL INFORMATION
Device Generic Name: Infrared Lamp
Trade Name:
LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System
| Device Classification: | Class II, Performance Standards21CFR Part 890.5500 – Infrared Lamp |
|---|---|
| ------------------------ | ------------------------------------------------------------------------ |
Product Code: ILY
Applicant Name and Address:
USA Laser Biotech Inc. 9210 Forest Hill Avenue Richmond, VA 23235 USA Telephone: 877 / 423-6169
510(k) Number: K160947
II. Device Description
The LUMIX CPS Series IR Lamp Systems are intended for use as therapeutic heat lamps. The Systems are non-invasive devices that emit light energy to the skin-surface of the human body for the purpose of causing the therapeutic elevation of tissue temperature.
The LUMIX CPS Series IR Lamp Systems deliver visible and invisible laser light beams at wavelengths between 650 and 1064 nm using gallium arsenide (GaAs) diode sources. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers. The tissue to be treated is illuminated by a non-therapeutic red laser guide light with 3 mW of power. The Systems consist of 2 main hardware sub-systems: 1) the control console and 2) the treatment handpiece probe with its connecting cable.
The control consoles are made of standard medical PVC material and are designed to be placed on a desktop or table in the vicinity of the patient to
be treated. The console houses the user interface, which is a pressure activated membrane and an LCD display.
The treatment probes are made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiber optic cables. The probes contain a protective lens at the aperture, which is made of glass suitable for medical applications.
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== Indications For Use
The LUMIX CPS Series IR Lamp Systems are intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
IV. Predicate Devices
The LUMIX CPS Series IR Lamp Systems are substantially equivalent to other therapeutic heat lamps that are currently in commercial distribution. These predicate devices include, but are not limited to:
-
- USA Laser Biotech Inc. LUMIX 3 Series Infrared Heat Lamp Therapy Systems (K132016),
-
- USA Laser Biotech Inc. NEXUS Series IR Heat Lamp Systems (K101893),
-
- CYNOSURE 1064nm Diode Laser (K123971), and
-
- ELTECH s.r.l. K-Laser Cube 1, K-Laser Cube 2, K-Laser Cube 3, K-Laser Cube 4 (K120604).
V. Summary of the Technical Characteristics of the LUMIX CPS System as Related to the Referenced Predicate Devices
The LUMIX CPS Series IR Lamp Systems and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared and visible laser diodes to generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain.
VI. Testing
Testing of the LUMIX CPS Systems includes functional performance testing and electrical safety testing. The Systems are manufactured to comply with the following international standards:
| IEC 60601-1:2006 - Ed. 3 | Medical Electrical Equipment, Part 1:General Requirements for Basic Safetyand Essential Performance |
|---|---|
| IEC 60825-1:2014 - Ed. 2 | Safety of Laser Products - Part 1:Classification of laser devices andrequirements |
| IEC 60601-1-2:2010 - Ed. 3 | Medical Electrical Equipment - Part 1-2:Collateral Standard: Electromagneticdisturbances - Requirements and tests |
| IEC 60601-1-6:2013 - Ed. 3.1 | Medical Electrical Equipment - Part 1-6:Collateral Standard: Usability |
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| IEC 60601-2-22:2012 – Ed. 3.1 | Medical Electrical Equipment – Part 2-22:Particular requirements for basic andessential performance of surgical,cosmetic, therapeutic and diagnostic laserequipment |
|---|---|
| IEC 63204:2006 | Software for Medical Devices: Softwarelife cycle processes |
| ISO 14971:2012 – Ed. 2 | Risk Management to Medical Devices |
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VII. Conclusions
Pursuant to the testing and comparison to the predicate devices, the LUMIX CPS Series IR Lamp Systems have the same intended uses, with similar functional and performance characteristics. The LUMIX CPS Series IR Lamp Systems are designed to comply with applicable performance standards promulgated by the U.S. Food and Drug Administration. These Systems perform as intended and do not raise any new safety or efficacy issues.
Clinical Efficacy
The use of light energy to generate heat for therapeutic use has been well documented and is a qenerally accepted alternative treatment modality for the temporary relief of pain
§ 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.