The Nexus BioWave Series 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.

Device Description

The Nexus Series IR Lamp Systems are intended for use as infrared heat lamps. The Systems are non-invasive 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 Series IR Lamp Systems deliver an invisible laser light beam in the infrared spectrum at wavelengths of 810 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 guide light. 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 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 probes are made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probes contain a focusing lens at the aperture, which is made of glass suitable for medical applications.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nexus Series IR Lamp Systems:

The provided document is a 510(k) Notification Supplement for an Infrared Lamp. It describes the device, its intended use, and summarizes the testing performed. However, it's important to note that this document does not describe a study in the context of typical AI/ML medical device evaluations, which involve large datasets, expert ground truth, and statistical performance metrics like sensitivity, specificity, or AUC.

Instead, this document describes bench testing and limited human subject testing to demonstrate physical performance specifications of a medical device (an infrared lamp) and its compliance with relevant standards. The "acceptance criteria" here relate to the device's ability to achieve and maintain a specific therapeutic temperature range on tissue.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Capable of achieving therapeutic temperature range of 40 - 45 degrees Centigrade.	The device achieved a topical temperature range of 41 to 43 degrees Centigrade during exposure after a brief stabilization time. This meets the 40-45°C therapeutic range.
Increase in topical heating of the tissue level by at least 5 degrees Centigrade within one (1) minute.	An increase in topical heating of at least 5 degrees Centigrade was reached within one (1) minute. (Pre-exposed temperature ranged from 30-32°C, and exposed temperature ranged from 41-43°C, indicating an average increase of 10-13°C, well above 5°C).
Therapeutic temperature range maintained for the 10-minute testing time.	The therapeutic temperature range (41-43°C) was maintained for the 10-minute testing time.
Compliance with international standards: EN 60601-1, EN 60601-1-2, ISO 14971.	The Systems are manufactured to comply with these standards. (The document states compliance, but specific test results for each standard are not detailed in this summary).
Primary Goal: Substantial equivalence to predicate devices for intended use, functional, and performance characteristics.	Demonstrated through comparison of technical characteristics and the successful physical performance testing (temperature achievement and maintenance). The FDA concurred with the substantial equivalence determination.

Study Details and Data Provenance

Sample size used for the test set and the data provenance:
- Sample Size: 3 human subjects.
- Data Provenance: The document does not specify the country of origin of the data, but the applicant (USA Laser Biotech Inc.) is based in the USA. The testing appears to be prospective bench testing and limited human subject testing, not a retrospective or prospective clinical trial with a large patient cohort.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this type of device (infrared lamp) and the specific testing described (temperature achievement on skin), there are no "experts" establishing a diagnostic "ground truth" in the way one would for an imaging or AI diagnosis device. The "ground truth" is the objective measurement of temperature using calibrated equipment, conforming to generally accepted physiological temperature ranges for therapeutic heat. The document refers to "generally accepted topical temperature range for therapeutic heat of 40 - 45 degrees centigrade" as the standard.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on ambiguous medical cases in AI/ML performance studies. This is not reported as such a study. The data appears to be direct physical measurements (temperature readings).
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:
- No. An MRMC study is not relevant or applicable to this device or the described testing. This device is an infrared heat lamp, not an AI-powered diagnostic tool intended to assist human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit, but not as an "algorithm." The core "performance" tested was the device's inherent ability to generate and maintain heat. This is a standalone device function, independent of human interpretation or AI algorithms. The measurements of temperature were objective, not subjective "readings."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is objective physical measurement (temperature) against established physiological and therapeutic thresholds. Specifically, reaching and maintaining a topical tissue temperature of 40-45 degrees Centigrade, and increasing pre-exposed temperature by at least 5 degrees Centigrade within one minute. There is no expert consensus, pathology, or outcomes data used to establish this specific "ground truth."
The sample size for the training set:
- Not Applicable. This device does not employ an AI/ML algorithm that requires a training set. The "testing" described is for functional and electrical safety performance of a physical medical device.
How the ground truth for the training set was established:
- Not Applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

Summary

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510K Notification Supplement K101893 S/1 December 31, 2011

510k SUMMARY [as per 21 CFR 807.92(b) (1)]

FEB 1 7 2011

I. GENERAL INFORMATION

Device Generic Name:	Infrared Lamp
Trade Name:	Nexus 7W Lite IR Lamp SystemNexus 10W Lite IR Lamp SystemNexus 30W Pro IR Lamp SystemNexus 60W IR Lamp System
Device Classification:	Class II, Performance Standards21CFR Part 890.5500 - Infrared Lamp
Product Code:	ILY
Applicant Nameand Address:	USA Laser Biotech Inc.9210 Forest Hill AvenueRichmond, VA 23235 USATelephone: 877 / 423-6169
510(k) Number:	K101893

II. Device Description

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510K Notification Supplement K101893 S/1 December 31, 2011

glass suitable for medical applications.

III. Indications For Use

The Nexus 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 Nexus Series 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. Nexus XPulse IR Heat Lamp Systems (K091726), the LUMINA 1600 Infrared Heat Lamp Therapy System (K052814), and ICL 60 Plus HFPL System (Models 40, 100, 250) K042256

Summary of the Technical Characteristics of the Nexus IR Lamp V. Systems as Related to the Referenced Predicate Devices.

The Nexus 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 Systems include 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, GeneralRequirements for Safety
EN 60601-1-2:2001	Medical Electrical Equipment, General Requirementfor Safety. Electromagnetic Compatibility
ISO 14971	Medical Devices: Application of Risk Management

The Nexus Series IR Lamp Systems are capable of achieving therapeutic temperature range of 40 - 45 degrees centigrade as accepted by the FDA. An increase in topical heating of the tissue level by at least 5 decrees centigrade was reached within one (1) minute as demonstrated in the bench testing that was conducted on each handheld probe. The therapeutic temperature range was maintained for the 10 minute testing time. The temperatures versus time measurements were conducted on 3 subjects at 2 physical locations, i.e., shoulder, neck, knee or lower back areas. On an average, the pre-exposed topical skin temperature ranged from 30 to 32 degrees centigrade. The topical temperature during exposure following brief stabilization time ranged from 41 to 43 degrees centigrade. These data demonstrate the System meets the generally accepted topical temperature range for therapeutic heat of 40 - 45 degrees centigrade during the recommended treatment time of 10 minutes.

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Conclusions VII.

Pursuant to the testing and comparison to the predicate devices, the Nexus Series IR Lamp Systems have the same intended uses, with similar functional and performance characteristics. The Nexus Series IR Lamp Systems are designed to comply with applicable performance standards promulgated by Federal Food and Drug Administration. These Systems perform as intended and do not raise any new safety or efficacy issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three overlapping wings, symbolizing health, human services, and the pursuit of well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002

USA Laser Biotech Inc. % Texas Applied Biomedical Services Ms. M. Joyce Heinrich 12101 Cullen Boulevard, Suite A Houston, Texas 77047

Re: K101893

Trade/Device Name: Nexus BioWave 7W Lite IR Lamp System Nexus BioWave 10W Lite IR Lamp System Nexus BioWave 30W Pro IR Lamp System Nexus BioWave 60W Pro IR Lamp System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II

Product Code: ILY Dated: December 31, 2010 Received: January 14, 2011

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.

FEB 1 7 2011

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Page 2 - Ms. M. Joyce Heinrich

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 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/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 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

A.S. vs. Rh
for

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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7.0 Indications for Use Statement

K101893 pg 1 of 1

Indications for Use Statement

510(k) Number (if known): Pending

Device Name:

Nexus BioWave 7W Lite IR Lamp System Nexus BioWave 10W Lite IR Lamp System Nexus BioWave 30W Pro IR Lamp System Nexus BioWave 60W Pro IR Lamp System

Indications for Use:

AND/OR Over the Counter Use: Prescription Use: X (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 (ODpE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

10(k) Number. K101893

Regulation Number and Section

§ 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.