BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief / reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.

Device Description

The PremIR 818 is an over-the-counter, infrared-therapy device, designed to emit energy at infe i reful o to is an over the osanton and one of the PremIR 818 provides infrared therapy through infrared frequencies to provide topical houng. In and that delivers infrared light for the purposes the use of an ennoicht und odor to acat living tissue in the body. Infrared light is delivered to the of elevating tissue tomporation to to a Arsenide (GaAlAs) Light Emitting Diodes (LEDs) distributed under the face plate of the PremIR 818. The LEDs used in the PremIR have average wavelengths of between 880 nm and 884 nm.

AI/ML Overview

The PremIR 818 is an infrared therapy device. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner typically seen for novel medical devices undergoing extensive clinical trials.

The document highlights the device's technical specifications and how they compare to predicate devices. The "Performance Data" section lists several measurements and compliance statements, which act as the de facto acceptance criteria and the results of the "study" (or testing) performed to meet them.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance
Delivered Energy	35 – 56 mW/cm²
Central Wavelength	884 nm
Mean Wavelength	881 nm
Minimum Wavelength	831 nm
Maximum Wavelength	937 nm
Electromagnetic Compatibility	Complies with IEC 601-1-2
General Electrical Safety	Complies with UL 60601-1
Skin (treatment) Temperatures	Maintains between 40 and 45 degrees C for greater than 10 minutes

Note: For a 510(k) submission, the "acceptance criteria" are largely established by demonstrating that the device operates within validated and safe parameters, similar to its predicate devices, without raising new questions of safety or effectiveness. The reported performance metrics are the results of testing conducted to show compliance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a "test set" in the context of a clinical study with human subjects or a statistical evaluation of device performance in a real-world scenario. The performance data provided (delivered energy, wavelength, temperature maintenance) appear to be results from technical bench testing of the device itself, likely on a single or a small batch of devices.

The data provenance is from technical testing of the device hardware. No human or patient data is mentioned, so no country of origin or retrospective/prospective distinction is applicable in this context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable. The "ground truth" here is based on objective physical measurements and engineering standards (e.g., wavelength measurements, power output, temperature, compliance with electrical safety standards). These do not typically require expert consensus in the same way clinical diagnostic studies do.

4. Adjudication Method for the Test Set

This section is not applicable. As the "test set" refers to physical device measurements and compliance with technical standards, there is no need for an adjudication method involving multiple observers or experts. The measurements are objective.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where human readers make assessments. This device is an infrared therapy device, and its performance evaluation focuses on physical output and safety, not on diagnostic accuracy or human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, implicitly. The "Performance Data" section represents standalone testing of the device's physical output and adherence to safety standards, independent of human operators (beyond setting up the test). This is not an "algorithm" in the typical sense of AI, but rather the device's inherent functional performance.

7. The Type of Ground Truth Used

The ground truth used is based on objective physical measurements (e.g., delivered energy, wavelength) and established engineering and safety standards (IEC 601-1-2 for EMC, UL 60601-1 for electrical safety). For temperature, the ground truth is the measured temperature range and duration.

8. The Sample Size for the Training Set

This section is not applicable. The PremIR 818 is an infrared therapy device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of model development. The device's design is based on established principles of infrared therapy, not on data-driven training.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reason as point 8.

Summary

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DEC 1 3 2004

9. 510(k) Summary

510(k) SUMMARY BIOCARE SYSTEMS, INC - PremIR 818

SUBMITTER INFORMATION

Company name / address:	Reglera LLC518 17th StreetSuite 1350Denver, CO 80202
510(k) contact name / numbers:	Clay AnselmoPhone: 800-341-4255 or 303.223.4303Fax: 303-832-6700anselmoc@reglera.com
Date summary prepared:	8/3/04

Trade names:

PremIR 818

PremIR 818 Infrared Therapy Device Common name:

Infrared Lamp Classification name:

PREDICATE DEVICES

Trade name: LightForce Super Nova 510(k) number: K022888 and K001179

Trade name: Quantum WARP 10 Light Delivery System 510(k) number: K032229

DEVICE DESCRIPTION

INDICATIONS FOR USE

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to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.

TECHNOLOGICAL CHARACTERISTICS COMPARISON

The following primary characteristics of the PremIR 818 device are substantially equivalent to the LightForce Super Nova device.

t Indications for Use
Wavelength of the light utilized .
Waveform .
Power supply and specifications ●
Energy source .
Number of LEDs .
. Device type

The following primary characteristics of the PremIR 818 device are substantially equivalent to the Quantum WARP 10 device.

Indications for Use .
. Wavelength of the light utilized
. Energy source
Energy delivery .
. Device type
Power Output .

PERFORMANCE DATA

35 – 56 mW/cm2 Delivered Energy: Central Wavelength: 884 nm Mean Wavelength: 881 nm Minimum Wavelength: 831 nm Maximum Wavelength: 937 nm

Complies with IEC 601-1-2, Electromagnetic Compatibility Complies with UL 60601-1, General Electrical Safety

Maintains skin (treatment) temperatures between 40 and 45 degrees C for greater than 10 minutes

CONCLUSION

The PremIR 818 is substantially equivalent to the LightForce Super Nova and the Quantum WARP 10 Light Delivery System.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2004

Reglera LLC C/o Mr. Clay Anselmo 518 17th Street Suite 1350 Denver, Colorado 80202

Re: K042532

Trade/Device Name: PremIR 818 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: August 2, 2004 Received: September 17, 2004

Dear Mr. Anselmo:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associou in the encreations of the enactment date of the Medical Device Amendments, or to conimered pror to may 20, 20, 2019 11:31 accordance with the provisions of the Federal Food, Drug, de nees that have been receasined require approval of a premarket approval application (PMA). and Cosmette (110) that to novice, 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 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. Clay Anselmo

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 (240) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milliken

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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510(k) Number (if known):	K042532
	Indications for Use

Device Name: PremIR 818

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use xxx (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE
for (Division Sign-Off)
Division of General, Restorative, Page _ of _
and Neurological Devices
(Posted November 13, 2003)
510(k) Number K042532

PremIR 818 510(k)

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.