QUANTUM WARP 10 LIGHT DELIVERY SYSTEM

K032229 · Quantum Devices, Inc. · ILY · Sep 12, 2003 · Physical Medicine

Device Facts

• Record ID: K032229
• Device Name: QUANTUM WARP 10 LIGHT DELIVERY SYSTEM
• Applicant: Quantum Devices, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Sep 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Quantum WARP 10 Light Delivery System 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; and to temporarily increase local blood circulation where applied.

Device Story

Handheld, solid-state device; emits non-coherent Near-IR energy (650-950nm) to skin surface; powered by 8 AA batteries. Used by patients (over-the-counter) for temporary relief of minor muscle/joint pain, arthritis, muscle spasms, and stiffness; promotes muscle relaxation and local blood circulation. Device applied directly to affected area for 60-300 seconds. Benefits include non-invasive pain management and improved local circulation.

Clinical Evidence

Bench testing only; no clinical data provided. Testing focused on ensuring skin surface temperature remains within acceptable limits.

Technological Characteristics

Solid-state infrared lamp; Near-IR wavelength 650-950nm; power density 30-80 mW/cm²; constant waveform; non-coherent multi-diode energy source; handheld probe form factor; battery-powered (8x 1.5V AA); 36mm diameter target area.

Indications for Use

Indicated for individuals suffering from chronic pain requiring temporary relief of minor muscle and joint pain, arthritis, muscle spasm, stiffness, and to increase local blood circulation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Light Force Therapy Inc., Super Nova (K022888)
• Bales Scientific Inc., Photomic Stimulator (K971468)
• DioMedics Inc., Pain-X-2000 Model 5700 (K982516)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle with three lines representing its wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 2003 NOV 3

Quantum Devices, Inc. C/o Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue SE Grand Rapids, MI 49548

Re: K032229

Trade/Device Name: Quantum WARP 10 Light Delivery System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: August 20, 2003 Received: August 28, 2003

### Dear Mr. Devine:

This letter corrects our substantially equivalent letter of September 11, 2003, regarding the overthe-counter notation on your Indications for Use enclosure.

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 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. Ned E. Devine, Jr.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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): ____________________________________________________________________________________________________________________________________________________

Quantum WARP 10 Light Delivery System Device Name:

Indications For Use:

The Quantum WARP 10 Light Delivery System 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; and to temporarily increase local blood circulation where applied.

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

レ

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use (Per 21 CFR 801.109)

for Mark N. Ahlken

(Division Sign-Off) Division of General, Restorative and Neurological Devices

:10(k) Number K032224

(Division Sign-Off) Division of Dental, Infection Control, And General Hospital Devices

Over -The-Counter Use

510(k) Number

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### SEP 1 2 2003

# KO32229

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

nimary of the 5104 -· 9.0

This summery of the 510(k) sufety and effectiveness information is being submitted in
accerdance with the requirements of 21 CRF 807.92. accordiance with the 510(k) safety and effectiveness
accordance with the requirements of 21 CRF 807.92.

Applicant:

Quantum Devices, Inc. 112 Orbison Street Barneveld, WI 53507

Phone: [phone] Fax: [phone]

Contact Person:

Prepared on:

Model No./Name:

Classification:

Predicate Devices:

Michele Vovolka Vantage Consulting International, Ltd.

July 18, 2003

Quantum WARP 10 Light Delivery System

Our Drug Delivery System

Lamp, Infrared -- 89 H. Y Physical Medicine Device, 21 CRF 890.5500 (Class II)
Physical Medicine Device, 21 CRF 890.5500 (Class II)
Light Forgo Tr

620.5500 (Class II)

Light Force Therapy Inc., Super Nova - K0225888
DioMadi Bales Scientific Inc., Photomic Stimulator - K022888
Bales Scientific Inc., Photomic Stimulator - K974468
DioMedics Inc., Pain-X-2000 Model 5700 press Scientifie Inc., Photomic Stimulator - K022888
DioMedics Inc., Pain-X-2000 Model 5700 - K9974468
DioMedics Inc., Pain-X-2000 Model 5700 - K9825-16

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Statement of Intended Use for Quantum WARP 10

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)

### Testing Summary

Testing for the Quantum WARP 10 Light Delivery System has been carried out to ensure that the temperature at the skin surface where the device is applied is acceptable per 10 Chance ma Part 42.3 (11.2601-1)

### Substantial Equivalence:

The Quantum WARP 10 Light Delivery System is substantially equivalent to the:

Light Force Therapy Inc., Super Nova - K022888 Bales Scientific Inc., Photomic Stimulator - K974468 DioMedics Inc., Pain-X-2000 Model 5700 – K982546

The Quantum Device, Inc. Quantum WARP 10 is substantially equivalent to these products in that it has the same intended use and similar technical characteristics. Technical characteristics comparison included power, wavelength, waveform, energy source, power supply, energy delivery, treatment time, indicated use, target population, and location for use.

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# K032229

## Table I

## Infrared Lamp Comparisons

| Company | Quantum<br>Devices, Inc. | Light Force<br>Therapy, Inc. | Bales<br>Scientific, Inc. | DioMedics, Inc. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--------------------------------------------|-------------------------------------------------------------|
| Device Name | Quantum WARP<br>10 | Super Nova<br>K022888 | Photomic<br>Stimulator<br>K971468 | Pain-X-2000<br>Model 5700<br>K982516 |
| Power<br>Wavelength | 30-80 mW/cm²<br>Near Infrared<br>650 to 950nm | 3.04 mW/cm²<br>550nm, 620nm,<br>and 890nm | 95 mW/cm²<br>Near Infrared<br>800 to 900mm | 16.25 mW/cm²<br>560nm, 590nm,<br>620nm, 670nm,<br>and 900nm |
| Waveform | Constant | Pulsed | Same as<br>Quantum<br>Device | 50% Duty<br>Cycle |
| Energy Source | Multi diode<br>dispersed over<br>treatment area<br>(noncoherent) | Same | Same | Same |
| Power Supply | 8 each, 1.5AA<br>Batteries | 24 Vdc - 500<br>mA | 115/220 Vac,<br>50/60Hz<br>electric outlet | Rechargable<br>Battery, AC<br>Adapter |
| Energy Delivery | Handheld<br>Treatment Probe | Same | Same | Same |
| Treatment Time | 60 - 300 seconds | 60 - 900<br>seconds | 0 - 594 seconds | 20 - 3000<br>seconds |
| Target Size | 36 mm diameter | 2-10 mm<br>diameter | 50 mm x 50 mm | 76 mm diameter |
| Indications for Use | To emit energy<br>in the Near-IR<br>spectrum for the<br>temporary relief<br>of minor muscle<br>and joint pain,<br>arthritis and<br>muscle spasm;<br>relieving<br>stiffness;<br>promoting<br>relaxation of<br>muscle tissue;<br>and to<br>temporarily<br>increase local<br>blood circulation<br>where heat is<br>indicated. | Same | Same | Same |
| Target Population | Individuals<br>suffering from<br>chronic pain | Same | Same | Same |
| Location for Use | Over-the-counter | Same | Same | Same |

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