Narrow Band, Near-IR Energy, Pain Therapy Devices emit energy in the Near-IR spectrum 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.

Device Description

The Narrow Band, Near-IR Energy, Pain Therapy Devices use LEDs to generate heat that alleviates pain. Two ranges are employed: 630 nm and 940 nm, depending on the product model, as well as a choice of continuous wave and pulse wave (BioBeam™ models only) modes. The units are available in handheld or mounted configurations.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information required to fill out all the fields in your request about acceptance criteria and a study proving device performance. The document is a 510(k) summary for a pain therapy device, focusing on its substantial equivalence to predicate devices rather than reporting on a specific clinical study with acceptance criteria.

Here's what I can extract and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of performance metrics. The document implies acceptance based on substantial equivalence to predicate devices and meeting electrical safety, electromagnetic compatibility, and biocompatibility tests.
Reported Device Performance: Not reported in quantitative terms in this summary. The device's intended use is for "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."

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not mentioned.
Data provenance: Not mentioned, as no specific clinical study data is reported.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical study with a ground truth assessment is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable.

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. The device is a pain therapy device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable.

8. The sample size for the training set:

Not applicable, as this is not an AI-based device and no training set is mentioned.

9. How the ground truth for the training set was established:

Not applicable.

The document primarily focuses on:

Device Name: Narrow Band, Near-IR Energy, Pain Therapy Devices (Models: BioBeam™ 660, BioBeam™ 940, MedLight™ 1630, and MedLight™ 2630)
Sponsor: Life Without Pain, LLC
Product Code: ILY
Regulation Number: 21 CFR 890.5500
Regulation Name: Infrared lamp
Predicate Devices: Quantum WARP 10 Light Delivery System (K032229), Light Force Therapy's SuperNova (K022888), and Diomedics' Pain-X-2000 (K982546).
Technological Characteristics: Uses LEDs to generate heat in two ranges (630 nm and 940 nm), with continuous wave and pulse wave modes. Available in handheld or mounted configurations.
Intended Use: 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.
Testing: Electrical safety, electromagnetic compatibility, and biocompatibility of materials in contact with the treatment site. These are general safety and performance tests, not clinical efficacy trials with specific acceptance criteria as you've outlined.

Summary

{0}------------------------------------------------

page 1 of 2

510(k) Summary for Narrow Band, Near-IR Energy, Pain Therapy Devices

1. SPONSOR

FEB 2 5 2005

Life Without Pain, LLC 1600 S. Federal Highway Suite 350 Pompano Beach, FL 33062

Contact Person: Irwin Newman, President Telephone: 954-786-0007

Submission Date: February 23, 2005

2. DEVICE NAME

The Narrow Band, Near-IR Energy, Pain Therapy Devices (Models: BioBeam™ 660, BioBeam™ 940, MedLight™ 1630, and MedLight™ 2630) are over-thecounter devices that use light-emitting diodes (LEDs) in the near-IR spectrum for the relief of pain. Pain-relief devices have been classified as Class II devices under the following classification name:

Name	Product Code	21 CFR Ref.	Panel
Infrared Lamp	ILY	890.5500	Physical Therapy

3. PREDICATE DEVICES

Narrow Band, Near-IR Energy, Pain Therapy Devices are substantially equivalent to the Quantum WARP 10 Light Delivery System, 510(k) No. K032229, Light Force Therapy's SuperNova, 510(k) No. K022888, and Diomedics' Pain-X-2000, 510(k) No. K982546.

4. DEVICE DESCRIPTION

The Narrow Band, Near-IR Energy, Pain Therapy Devices use LEDs to generate Two ranges are employed: 630 nm and 940 nm, heat that alleviates pain. depending on the product model, as well as a choice of continuous wave and

{1}------------------------------------------------

K042813 page 2 of 2

pulse wave (BioBeam™ models only) modes. The units are available in handheld or mounted configurations.

INTENDED USE ડ.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Narrow Band, Near-IR Energy, Pain Therapy Devices are similar to the predicate Naron Bankyon of principle of operation, wavelength, waveform, energy, recommended treatment time, target size.

7 TESTING

Narrow Band, Near-IR Energy, Pain Therapy Devices have been tested for electrical safety and electromagnetic compatibility. Materials that may come in contact with the treatment site have been tested for biocompatibility.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2005

Life Without Pain, LLC c/o Mr. Daniel J. Dillon Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Received: February 15, 2005

Re: K042813

K042015
Trade/Device Name: Name: Name: Name: Near-IR Energy, Pain Therapy Devices Natrow Band, Near II - Extress - ProBeam™ 940, MedLight™ 1630, and MedLight™ 2630) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: February 14, 2005

Dear Mr. Dillon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) presidentially equivalent (for the indications relerenced above and nave acterings acterificate devices marketed in interstate for use stated in the encrosure) to regally manifical Device Amendments. Or to commerce prior to May 20, 1770, the enaonance with the provisions of the Federal Food. Drug. devices mat have been recatismed in acceraapproval of a premarket approval application (PMA). and Cosmetic Act (Tec) that to not require for the general controls provisions of the Act. The You may, merelore, mance the act include requirements for annual registration, listing of general controls provisions of the fice, 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 If your device is classified (see above) and existing major regulations affecting your device can may be subject to such additional bentrelise Linking on Parts 800 to 898. In addition. FDA may be found in the Obas neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that i Dri- 3 resuarce complies with other requirements of the Act that TDA has made a determinations administered by other Federal agencies. You must of any Federal Statutes and regulations and admited to: registration and listing (21 comply with an the Act s requirements, mercessed on the practice requirements as set and CFK Part 807), labeling (21 OF Part 820), and if applicable, the clectronic (200), and if applicable, the clectronic (200 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Mr. Daniel J. Dillon

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 n you aton 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost

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

{4}------------------------------------------------

page 1 of 1

Indications for Use

510(k) Number (if known): K042813

Device Name:

Narrow Band, Near-IR Energy, Pain Therapy Devices (Models: BioBeam™ 660, BioBeam™ 940, MedLight™ 1630, and MedLight™ 2630)

Indications for Use:

Narrow Band, Near-IR Energy, Pain Therapy Devices emit energy in the Near-IR rantow Bana, 110a 100 - 100a - 100 minor muscle and joint pain, arthritis and muscle Spectrun for the temperary of moting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use __ X (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 (ODE)

Miriam C. Provost

Division of General, Restorative, and Neurological Devices

510(k) Number K042813

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.