The Painacea Model XR8 infrared heat lamp is intended to emit energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.

Device Description

The Painacea Model XR8 consists of a collection of near and infrared diodes [LEDs], packaged in a compact handheld device. The system emits light in the infrared spectrum to provide topical heating. The red diodes [LEDs], provide a visible indication that the unit is in operation. The battery and operating system is contained within the handheld device. The device has a cradle with wall power supply to recharge the battery.

AI/ML Overview

The provided text is a 510(k) summary for the Painacea Model XR8 Infrared Heat Lamp. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information (acceptance criteria, study design details like sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types for test/training sets, and training set sample size) is not present in this document.

The document mainly covers the device's description, intended use, and comparison to predicate devices. It states that the device was deemed "substantially equivalent" to existing infrared lamps on the market based on functional performance and electrical safety testing, not a clinical effectiveness study with defined acceptance criteria for clinical outcomes.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

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

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance
No explicit clinical acceptance criteria (e.g., pain reduction percentage, temperature delta) are stated in the document.	"The system performs as intended and does not raise any new safety or effectiveness issues."
Functional performance adherence	Functional performance testing was conducted. (No specific metrics or results detailed.)
Electrical safety adherence	Electrical safety testing was conducted. (No specific metrics or results detailed.)
Equivalence to predicate devices in intended use	"The Painacea Model XR8 has the same intended uses... as the predicate devices."
Equivalence to predicate devices in technological characteristics	"similar technological characteristics as the predicate devices." (e.g., "temperatures achieved by these devices are the same, using a similar number of diodes [LEDs], over a similar coverage area.")
OTC device labeling compliance	"The labeling, instructions, and User Operations... are designed for layman understanding and use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable/Not provided. This document describes testing for functional performance and electrical safety, not a clinical study with a "test set" of patients or data in the typical sense.
Data Provenance: Not applicable/Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. "Ground truth" in the context of clinical studies is not relevant to the functional and electrical safety testing mentioned.

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

Not applicable/Not provided.

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/Not provided. This is an infrared heat lamp, not an AI diagnostic device that would involve human readers or AI assistance.

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

Not applicable/Not provided. This is a physical device, not an algorithm. Its "standalone" performance would refer to its functional and electrical safety, which were tested.

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

Not applicable/Not provided. The "ground truth" for the functional and electrical safety testing would be objective measurements and adherence to engineering standards, not clinical outcomes data or expert consensus on a disease.

8. The sample size for the training set

Not applicable/Not provided. The device testing described does not involve machine learning or a "training set."

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

Not applicable/Not provided.

Summary

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MAY 1 0 2005

1021046

510(k) Submission, Painacea Model # XR8 Atlantis Luminescent Products, LLC, Lafayette, LA 70503

Summary

Date: April 11, 2005

This summary of 510(K)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Painacea Model XR8 Infrared Heat Lamp.

Company making the submission:

	This summary is submitted by:
Name:	Atlantis LuminescentProducts, LLC
Address:	1405 W. Pinhook Road,Ste. 205Lafayette, LA 70503
Telephone:	318-894-9490
Fax:	318-894-9505
Contact:	Jim CobbPresident
E-mail:	Jim@wnonline.net

1. Device Name:

Trade/Proprietary Name: Common/Usual Name: Classification Name:

Painacea Model XR8 Infrared Heat Lamp. infrared heat lamp. Infrared lamp, 21 CFR § 890.5500

2. Predicate Device:

The Painacea Model XR8 Infrared Heat Lamp is substantially equivalent to other infrared lamps on the market, such as the Light Wave (K024027) and Warp 10 (K032229).

3. Intended use of the Device:

Summary Rev B
DCG

510(k) Page #

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3. Description of the Device:

Summary of the technological characteristics of the device 4. Compared to predicate devices:

The Painacea Model XR8 and the above referenced predicate devices are infrared lamps as defined in 21 CFR § 890.5500. These devices utilize infrared diodes [LEDs], to provide topical heating for the temporary relief of muscle and/or joint pain. The temperatures achieved by these devices are the same, using a similar number of diodes [LEDs], over a similar coverage area. The devices are handheld, and intended to be placed directly on the skin or held just over the skin to provide the heating.

5. Testing:

Testing of the Painacea Model XR8 included functional performance testing and electrical safety testing.

1. Rx or OTC:
  The Painacea Model XR8 is an Over the Counter (OTC), device. The fabeling, instructions, and User Operations (21 CFR § 801.60 and 61), are designed for layman understanding and use. Both predicate devices are OTC. Predicate device labeling has been provided.
1. Conclusions:
  Based upon the testing and comparison to the predicate devices, the Painacea Model XR8 has the same intended uses, with similar technological characteristics as the predicate devices. The system performs as intended and does not raise any new safety or effectiveness issues.

510(k) Page #

ર્વ તા

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three stylized lines or stripes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2005

Atlantis Luminescent Products, LLC c/o Daniel W. Lehtonen Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01779

Re: K051046

Trade/Device Name: Painacea Model XR8 Infrared Heat Lamp Regulation Numbers: 21 CFR 890.5500 ﻴ Regulation Names: Infrared Lamp Regulatory Class: II Product Code: IL Y Dated: April 11, 2005 Received: April 25, 2005

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered pror to they 20, 1978, in accordance with the provisions of the Federal Food, Drug, de rices mat have ocen require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelove, manies of the Act include requirements for annual registration, listing of general controls pro resuring 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 IT your device is classified (600 world). Existing major regulations affecting your device can thay be subject to sach additions, 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 i lease oc actised that I Dr over device complies with other requirements of the Act that I Dri has made a astern regulations administered by other Federal agencies. You must or any it cachards and registments, including, but not limited to: registration and listing (21 Comply with an the Fee 81 cFR Part 801); good manufacturing practice requirements as set CFR I art 607), adoling (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Daniel Lehtonen

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of the pe premarket notification. The PDA inding of backantal equate 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
rs the regulation of the 1100 - All and and on a note the regulation entitl If you desire specific advice for your dovice of can associety of the regulation entitled,
contact the Office of Compliance at (240) 276-0120 . . (207 07) . Voy may obtain contact the Office of Comphalice at (240) 276 - 1240) Part 807.97). You may obtain "Misbranding by reference to premainer noutheadon (c) the Act from the Division of Small other general information on your responsion in the mumber (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrb/industry/support/index.html.
(301) 443-6597 or at its Internet address <http://www.fda.gov/cdrb/industry/support/ind

Sincerely yours,

Stat Curles

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number_K051046

Device Name:

Painacea Model XR8 Infrared Lamp

Indications for Use:

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

Over-The-Counter Use -- Yes (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)

Stupt Clurle

(Division Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.