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 Description

The Quantum WARP 10 Light Delivery System is used for applying therapy for the mitigation of chronic pain. These light delivery systems are manufactured by Quantum Devices, Inc. These devices are solid state and hand held for placement on the area where treatment is to occur.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Quantum WARP 10 Light Delivery System. It is a traditional medical device submission, not a submission for an AI/ML-driven device. As such, it does not include the typical information requested for AI/ML device studies.

Therefore, many of the requested fields cannot be filled. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and intended use, rather than presenting a detailed study with acceptance criteria and performance metrics in the way an AI/ML product would.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an AI/ML device, as this is a traditional medical device premarket notification. The "acceptance criteria" for a 510(k) are typically that the device is "substantially equivalent" to legally marketed predicate devices.

Acceptance Criteria (for AI/ML devices)	Reported Device Performance (N/A for this device)
N/A	N/A

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

No test set for AI/ML performance is mentioned. The document describes a "Testing Summary" focused on temperature at the skin surface, indicating safety testing rather than a clinical performance study.

Sample Size (Test Set): Not specified (likely not applicable for a "test set" in the AI/ML sense).
Data Provenance: Not specified. Testing was 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)". This refers to safety testing, not performance data provenance.

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

Not applicable. No ground truth establishment for a diagnostic or prognostic AI/ML output is mentioned.

4. Adjudication method 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. This device is a light delivery system for pain relief, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

For the safety testing mentioned (skin surface temperature), the "ground truth" would implicitly be the established safety limits for temperature. For substantial equivalence, the "ground truth" is the performance and safety characteristics of the predicate devices.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of AI/ML.

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

Not applicable.

Summary

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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 (301) 594-4659. 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/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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Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Quantum WARP 10 Light Delivery System Device Name:

Indications For Use:

(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: 608-924-3000 Fax: 608-924-3007

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

Description:

The Quantum WARP 10 Light-years

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of clarentic solid state and hand held for placems are manufactured by Quantum Devi of chinais pain. These light delivery System is used for applying the mitigate of the mitigate.
These devices are solid state and held for placenced by Quantum Devices, Inc. il be newters are solid sight delivery systems are manufactured by Quantum Devices. Mitge
These devices are solid sight delivery systems are manufactured by Quantum Devices. treatment is to occur.

Statement of Intended Use for Quantum WARP 10

The Quantum WARP 10 Light Delivery System is hand beview to emit energy in
the NearH spectrum for Light of miner muscle and joint min artheir 115 Quantini WARP 10 Light Delivery System is a hand he mit energy
the News-R spection for the loved on the musels and joint pain, arthris and n a from IN spection for the responsive is a hand held device used to emile nergy in
musels specificals; promoting relice of minor muscle and joint pain, arthritis and in te

Page 4 of 6

1/3

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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	QuantumDevices, Inc.	Light ForceTherapy, Inc.	BalesScientific, Inc.	DioMedics, Inc.
Device Name	Quantum WARP10	Super NovaK022888	PhotomicStimulatorK971468	Pain-X-2000Model 5700K982516
PowerWavelength	30-80 mW/cm²Near Infrared650 to 950nm	3.04 mW/cm²550nm, 620nm,and 890nm	95 mW/cm²Near Infrared800 to 900mm	16.25 mW/cm²560nm, 590nm,620nm, 670nm,and 900nm
Waveform	Constant	Pulsed	Same asQuantumDevice	50% DutyCycle
Energy Source	Multi diodedispersed overtreatment area(noncoherent)	Same	Same	Same
Power Supply	8 each, 1.5AABatteries	24 Vdc - 500mA	115/220 Vac,50/60Hzelectric outlet	RechargableBattery, ACAdapter
Energy Delivery	HandheldTreatment Probe	Same	Same	Same
Treatment Time	60 - 300 seconds	60 - 900seconds	0 - 594 seconds	20 - 3000seconds
Target Size	36 mm diameter	2-10 mmdiameter	50 mm x 50 mm	76 mm diameter
Indications for Use	To emit energyin the Near-IRspectrum for thetemporary reliefof minor muscleand joint pain,arthritis andmuscle spasm;relievingstiffness;promotingrelaxation ofmuscle tissue;and totemporarilyincrease localblood circulationwhere heat isindicated.	Same	Same	Same
Target Population	Individualssuffering fromchronic pain	Same	Same	Same
Location for Use	Over-the-counter	Same	Same	Same

Page 6 of 6

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.