(139 days)
The Nexus XPulse IR Lamp Systems are intended to emit energy in the 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 Nexus XPulse 805 and the Nexus XPulse 980 IR Lamp Systems are intended for use as infrared heat lamps. The Systems are noninvasive devices that emit light energy to the skin-surface of human body for the purpose of causing the therapeutic elevation of tissue temperature. The Nexus XPulse Systems deliver an invisible laser light beam in the infrared spectrum at wavelengths of 805 nm and 980 nm using a gallium aluminum arsenide (GaAlAs) source. 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 quide light. The Systems consist of 2 main hardware sub-systems: 1) he control console and 2) he treatment handpiece probe with its connecting cable. The control console is made of standard medical PVC material and is designed to be place 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 probe is made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probe contains a focusing lens at the aperture, which is made of glass suitable for medical applications.
This document describes the Nexus XPulse 805 and Nexus XPulse 980 IR Lamp Systems, intended for use as infrared heat lamps for therapeutic elevation of tissue temperature.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with EN 60601-1:2001 (Medical Electrical Equipment, Part 1, General Requirements for Safety) | Tested and Compliant: "The Systems are manufactured to comply with the following international standards: EN 60601-1:2001 Medical Electrical Equipment, Part 1, General . Requirements for Safety" |
| Compliance with EN 60601-1-2:2001 (Medical Electrical Equipment, General Requirement for Safety. Electromagnetic Compatibility) | Tested and Compliant: "The Systems are manufactured to comply with the following international standards: . EN 60601-1-2:2001 Medical Electrical Equipment, General Requirement for Safety. Electromagnetic Compatibility" |
| Compliance with ISO 14971 (Medical Devices: Application of Risk Management) | Tested and Compliant: "The Systems are manufactured to comply with the following international standards: ISO 14971 Medical Devices: Application of Risk Management ." |
| Intended uses are substantially equivalent to predicate devices | Determined Substantially Equivalent: "The Nexus XPulse IR Lamp Systems have the same intended uses, with similar functional and performance characteristics." and "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..." |
| Functional performance is similar to predicate devices | Determined Substantially Equivalent: "...similar functional and performance characteristics." |
| Performance characteristics are similar to predicate devices | Determined Substantially Equivalent: "...similar functional and performance characteristics." |
| No new safety issues | Determined No New Safety Issues: "The Systems perform as intended and do not raise any new safety or efficacv issues." |
| No new efficacy issues | Determined No New Efficacy Issues: "The Systems perform as intended and do not raise any new safety or efficacv issues." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document describes testing as "functional performance testing and electrical safety testing" against international standards and comparison to predicate devices. It does not mention a specific "test set" in terms of patient data or clinical trials. The evaluation is based on engineering and regulatory compliance rather than clinical performance data from a specific study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The document describes compliance with technical standards and comparison to predicate devices, not clinical studies requiring expert ground truth for a test set.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of a test set requiring adjudication in the context of clinical or image-based evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted or described in this document. This submission is for an infrared lamp, and the evaluation focuses on electrical safety, functional performance, and substantial equivalence to existing predicate devices, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is an infrared lamp, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is based on:
- International Standards Compliance: Verification that the device meets the safety and performance requirements outlined in EN 60601-1, EN 60601-1-2, and ISO 14971.
- Comparison to Predicate Devices: Assessment that the device's intended uses, functional, and performance characteristics are "substantially equivalent" to already legally marketed infrared lamps (e.g., USA Laser Biotech, Inc. LUMINA 1600, Avicenna Laser Technology, Inc. ALT Laser, Model VTR 75).
8. The Sample Size for the Training Set:
Not applicable. This document pertains to an infrared lamp device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is relevant to the information provided.
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8.0 510(k) Summary ( as per 21 CFR 807.92)
OCT 2 8 2009
| GENERAL INFORMATION | |
|---|---|
| Device Generic Name: | Infrared Lamp |
| Trade Name: | Nexus XPulse 805 IR Lamp SystemNexus XPulse 980 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 AvenueRichmond, VA 23235 USATelephone: 877 / 423-6169 |
| 510(k) Number: | Pending K091726 |
II. Device Description
I.
The Nexus XPulse 805 and the Nexus XPulse 980 IR Lamp Systems (Figure 1) are intended for use as infrared heat lamps. The Systems are noninvasive devices that emit light energy to the skin-surface of human body for the purpose of causing the therapeutic elevation of tissue temperature.
The Nexus XPulse Systems deliver an invisible laser light beam in the infrared spectrum at wavelengths of 805 nm and 980 nm using a gallium aluminum arsenide (GaAlAs) source. 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 quide light.
The Systems consist of 2 main hardware sub-systems: 1) he control console and 2) he treatment handpiece probe with its connecting cable.
The control console is made of standard medical PVC material and is designed to be place 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 probe is made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probe contains a focusing lens at the aperture, which is made of glass suitable for medical applications.
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III. Indications For Use
The Nexus XPulse 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.
Predicate Devices IV.
The Nexus XPulse 805 and 908 IR Lamp Systems are substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. These predicate devices include, but are not limited to, the USA Laser Biotech, Inc. LUMINA 1600 Infrared Heat Lamp Therapy System (K052814), and Avicenna Laser Technology, Inc. ALT Laser, Model VTR 75 (K031612).
Summary of the Technical Characteristics of the NET-1000 System as V. Related to the Referenced Predicate Devices.
The Nexus XPulse 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.
Testing VI.
Testing of the System includes functional performance testing and electrical safety testing. The Systems are manufactured to comply with the following international standards:
- EN 60601-1:2001 Medical Electrical Equipment, Part 1, General . Requirements for Safety
- . EN 60601-1-2:2001 Medical Electrical Equipment, General Requirement for Safety. Electromagnetic Compatibility
- ISO 14971 Medical Devices: Application of Risk Management .
VII. Conclusions
Pursuant to the testing and comparison to the predicate devices, the Nexus XPulse IR Lamp Systems have the same intended uses, with similar functional and performance characteristics. The System is designed to comply with applicable performance standards promulgated by Federal Food and Drug Administration. The Systems perform as intended and do not raise any new safety or efficacv issues.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
USA Laser BioTech, Inc. % Texas Applied Biomedical Services Ms. M. Joyce Heinrich 12101 Cullen Boulevard. Suite A Houston, Texas 77047-2951
OCT 2 8 2009
Re: K091726
Trade/Device Name: Nexus XPulse 805 and Nexus XPulse 980 IR Lamp Systems Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: September 11, 2009 Received: September 25, 2009
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 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 1 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. M. Joyce Heinrich
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/cdrl/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.
erely yours,
x N. Melkerson
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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510K Notification - K01726 S/1 Nexus XPulse 805 & 980 IR Lamp System September 11, 2009
ATTACHMENT II
Indications for Use Statement
510(k) Number (if known): K091726
Device Name:
Nexus XPulse 805 and Nexus XPulse 980 IR Lamp Systems
Indications for Use:
The Nexus XPulse IR Lamp Systems are intended to emit energy in the 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.
Prescription Use: X AND/OR Over the Counter Use: (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODDE)
Mil Reblin for mxn
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091726
§ 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.