The Pain Therapy Light, model: PTL, is an Over-The-Counter hand held device intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local and blood circulation, and the temporary relaxation of muscles.

Device Description

Pain Therapy Light Model 1301 is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide infra-red light to the skin. Physical components include an LED array emitting 630, 660, 855 and 940nm respectively in a handheld "wand" configuration containing a simple "in/out" integrated chip with external, manual on/off switch, a single electronic resistor, and a removable 9 volt AC-to-DC power supply. Treatment times are as required by the user, and specified by the User's Manuals for product code ILY indications.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Pain Therapy Light, Model 1301" (LightStim). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish efficacy or safety from scratch.

Therefore, the document does not contain the information requested regarding acceptance criteria studies, such as:

A table of acceptance criteria and reported device performance (as defined by specific metrics like sensitivity, specificity, accuracy).
Sample sizes for test sets, data provenance, or details about training sets.
The number or qualifications of experts for ground truth establishment.
Adjudication methods.
Details of multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance studies.
Specific types of ground truth used (e.g., pathology, outcomes data).

Instead, the submission relies on the concept of substantial equivalence to predicate devices that are already "in safe and effective commerce." The "study" proving the device meets acceptance criteria is implicitly the demonstration that its design, intended use, and performance characteristics are similar enough to existing, approved devices that no new clinical evidence is required.

Here's a breakdown of what the document does provide in relation to your request:

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

Acceptance Criteria (Implicit - Substantial Equivalence): The primary acceptance criterion for a 510(k) submission is demonstrating that the new device is "substantially equivalent" to a predicate device. This means it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the different characteristics do not raise new questions of safety and effectiveness and the device is as safe and effective as the predicate.
Reported Device Performance: The document states, "These products have been used safely and effectively in clinical testing applications within the United States, with no negative reports or claims submitted to FDA / CDRH, for over 7 years prior to the date of this submission." This acts as a general statement of performance and safety history rather than specific performance metrics from a controlled study. It also mentions compliance with performance standards for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act, and OSHA/NRTL listing for electrical and radiological products.

The document does NOT provide a table with specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) or the device's measured performance against such metrics.

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

No specific "test set" in the context of a performance study is mentioned. The submission relies on the historical safe and effective use of the device and its predicates.

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

Not applicable as there is no mention of a diagnostic performance study requiring expert-established ground truth.

4. Adjudication method for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No, an MRMC study was not done for this submission. The focus is on substantial equivalence.

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

Not applicable, as this is a physical light therapy device, not a software algorithm.

7. The type of ground truth used:

Not applicable in the context of a diagnostic performance study. The "ground truth" for the submission is the established safety and efficacy of the predicate devices for similar indications.

8. The sample size for the training set:

Not applicable, as there's no mention of a machine learning algorithm or a training set.

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

Not applicable.

In summary, this 510(k) submission for the "Pain Therapy Light, Model 1301" relies on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for a novel efficacy claim. The "study" mentioned is the historical use of the device and its predicates without negative reports, and compliance with applicable performance standards.

Summary

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K083580

510(k) Application Summary

K083580 - Revision IV, Submission Date: December 19th, 2010 JUN 2 2 2009

Submitter Information: AEGIS Regulatory, Inc. - Robert T. Wagner 1131 Anthem View Lane Knoxville. TN 37922 Tel.: 865-982-5552 Email: bob@bobwagner.net

For Manufacturer: LED Intellectual Properties, LLC Attn: Steve Marquese 9832 Chesterfield Circle Santa Ana. CA 92705 Tel .: (949) 394-2427

General Information 2.

2.1 Classification Name: ILY - Infrared Lamp, therapeutic heating (Dual Use)
2.2 Common/Usual Name: LightStim
2.3 Proprietary Names: Pain Therapy Light, Model 1301
2.4 Classification: Class II
2.5 Classification Number: 1.) 878.5500

3. Description:

4. Intended Use:

LightStim Pain Relief Light (handheld wand) Product Code - ILY

Indications for Use: The Pain Therapy Light, model: PTL, is an Over-The-Counter hand held device intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating

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tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local and blood circulation, and the temporary relaxation of muscles.

5. Substantial Equivalence to Predicate Device(s):

Pain Therapy Light: This device is substantially equivalent to the following predicate devices, which are currently in safe and effective commerce:

1. Quantum Warp 10 Light Delivery System K032229
1. Pain Relief Bio-Beam 660+940 & Med Light 1630+2630 K042813
1. Terra Quant MQ2000 V.5 & handy Rx MQ2007 K061614
1. Acubeam, Super Nova, Dio K022888

6. Performance Standards:

These devices have been tested under and are in compliance with performance standards that have been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act. All electrical and radiological products made by the applicant have been OSHA/NRTL listed, and have received constituent marks.

7. Labeling:

As attached and in User's Manuals (Attached Version 2.0) - Numerous technical warnings and advisements to insure proper use and maintenance.

8. Statement of Safety and Effectiveness:

These products have been used safely and effectively in clinical testing applications within the United States, with no negative reports or claims submitted to FDA / CDRH, for over 7 years prior to the date of this submission.

9. Over-The-Counter Variance Request:

As identical predicates of this device have been in safe and effective applications by layperson users, Over-The-Counter Variance is requested.

10. Design and Use of the Device(s):

Is the device intended for prescription use?	NO
Is the device intended for over-the-counter use?	YES
Are its components derived from a tissue or other biologic source?	NO
Is the device provided sterile?	NO
Is the device intended for single use?	NO

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Is the device a reprocessed single use device?	NO
Does the device contain a drug?	NO
Does the device contain a biologic?	NO
Does the device use software?	NO
Does the submission include clinical information	NO
Is the device implanted?	NO

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service .

Image /page/3/Picture/2 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing wings and a stylized body.

JUN 22 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LED Intellectual Properties, LLC % AEGIS Regulatory, Inc. Mr. Roberty Wagner 1131 Anthem View Lane Knoxville, Tennessee 37922

Re: K083580

Trade/Device Name: LED Intellectual Properties, LLC - Pain Therapy Light model: PTL Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: June 5, 2009 Received; June 17, 2009

Dear Mr. Wagner:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Roberty Wagner

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/cdrh/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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark N. Millman

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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K083580 p. 1 of 1

Indications for Use

510(k) Number: K083580

Device Name: LED Intellectual Properties, LLC - Pain Therapy Light model: PTL

Indications For Use:

Prescription Use AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Nolbert Ogden forman
Division Sign-Off

Concurrence of CDRH, Office of Device Evaluation (0)

Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of

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.