WARP-75 is a hand held device used for the treatment of chronic pain by emitting 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; to temporarily increase local blood circulation where applied.

Device Description

The Quantum WARP Light Delivery System (WARP-75) is used for applying therapy for the mitigation of chronic pain. Quantum Devices, Inc manufactures this light delivery system. These devices are solid state and hand held for . placement directly over the skin where the treatment is to occur.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Quantum WARP 75 Light Delivery System:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Temperature at the skin surface where the device is applied is acceptable per IEC 60601-1 Part 42.3 (UL2601-1).	"Testing for the Quantum WARP 75 Light Delivery Systems has been carried out to ensure that the temperature at the skin surface where the device is applied is acceptable per IEC 60601-1 Part 42.3 (UL2601-1)." (This statement indicates compliance, but no specific numerical performance data is provided in the summary.)

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

This information is not provided in the summary. The document only mentions "Testing for the Quantum WARP 75 Light Delivery Systems has been carried out."

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

This information is not applicable to this type of device and study. The testing for this device primarily involves physical compliance with safety standards (temperature at skin surface), not diagnostic accuracy requiring expert interpretation.

4. Adjudication Method

This information is not applicable as there is no diagnostic or interpretive element in the described testing that would require adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The device is for therapeutic use (chronic pain relief), not for diagnostic interpretation by human readers.

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

It appears that a standalone test was performed in the sense that the device's physical parameters (skin surface temperature) were evaluated independently against a standard. However, the term "standalone" typically refers to the performance of a diagnostic algorithm without human intervention in a medical imaging context. Given this device's nature, this question isn't directly applicable in the typical sense. The testing described focuses on the device's inherent safety performance, not an algorithm's diagnostic output.

7. The Type of Ground Truth Used

The ground truth used for the testing was adherence to a safety standard, specifically "IEC 60601-1 Part 42.3 (UL2601-1)" for acceptable skin surface temperature. This is a technical/engineering ground truth, not a clinical ground truth like pathology or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical light delivery system, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set mentioned or implied for this device.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS K113231

This summary of the 510(k) safety and effectiveness information is be submitted in accordance with the requirements of 21 CFR 807.92.

Applicant:	Quantum Devices, Inc.112 Orbison StreetBarneveld, WI 53507Phone: 608-924-3000FAX: 608-924-3007
Contact Person:	Glenn IgnatiusPresidentQuantum Devices, Inc.112 Orbison StreetBarneveld, WI 53507Phone: 608-924-3000FAX: 608-924-3007
Prepared on:	February 23, 2012
Model No./Name:	Quantum WARP 75 Light Delivery Systems
Classification:	Lamp, Infrared - 89 ILYPhysical Medicine Device, 21 CFR 890.5500

Description:

Statement of Intended Use for the WARP-75:

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Testing Summary:

Testing for the Quantum WARP 75 Light Delivery Systems has been carried out to ensure that the temperature at the skin surface where the device is applied is acceptable per IEC 60601-1 Part 42.3 (UL2601-1.

Substantial Equivalence:

The Quantum WARP 75 Light Delivery System is substantially equivalent to the Quantum WARP 10 Light Delivery System, K032229.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.

Public Health Service

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

FEB 2 7 2012

Quantum Devices, Inc. % Waxler Regulatory Consultancy, LLC Morris Waxler, Ph.D. 1920 Arlington Place Madison, Wisconsin 53726

Re: K113231

Trade/Device Name: Quantum WARP 75 Light Delivery Systems Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: February 15, 2012 Received: February 21, 2012

Dear Dr. Waxler:

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.

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

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Page 2 - Morris Waxler, Ph.D.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 vours.

erely yours,

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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Statement of Indication for Use

510(k) Number (if known): K113231

Quantum WARP 75 Light Delivery Systems Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109)

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

510(k) Number /<11323/

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.