(53 days)
Not Found
No
The summary describes a light delivery system for pain relief and does not mention any AI or ML capabilities, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is intended for the treatment of various pain-related conditions and temporary relief of symptoms, which aligns with the definition of a therapeutic device.
No
The device is described as a treatment device for chronic pain, not a diagnostic device. Its intended use and function are solely for emitting energy for pain relief and related therapeutic effects.
No
The device description explicitly states it is a "hand held device" and "solid state," indicating it is a physical hardware device that emits light. It is not solely software.
Based on the provided information, the Quantum WARP 10 Light Delivery System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the treatment of chronic pain by applying energy to the body. This is a therapeutic use, not a diagnostic one.
- Device Description: The description reinforces that it's a "light delivery system" for "applying therapy."
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, or tissue), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Quantum WARP 10 is a therapeutic device that delivers light energy to the body for pain relief.
N/A
Intended Use / 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.
Product codes
ILY
Device Description
The Quantum WARP 10 Light Delivery System is used for applying therapy for the mitigation 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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:
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
3
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
The Quantum WARP 10 Light Delivery System is used for applying therapy for the mitigation
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
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1/3
4
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.
5
K032229
Table I
Infrared Lamp Comparisons
| Company | Quantum
Devices, Inc. | Light Force
Therapy, Inc. | Bales
Scientific, Inc. | DioMedics, Inc. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--------------------------------------------|-------------------------------------------------------------|
| Device Name | Quantum WARP
10 | Super Nova
K022888 | Photomic
Stimulator
K971468 | Pain-X-2000
Model 5700
K982516 |
| Power
Wavelength | 30-80 mW/cm²
Near Infrared
650 to 950nm | 3.04 mW/cm²
550nm, 620nm,
and 890nm | 95 mW/cm²
Near Infrared
800 to 900mm | 16.25 mW/cm²
560nm, 590nm,
620nm, 670nm,
and 900nm |
| Waveform | Constant | Pulsed | Same as
Quantum
Device | 50% Duty
Cycle |
| Energy Source | Multi diode
dispersed over
treatment area
(noncoherent) | Same | Same | Same |
| Power Supply | 8 each, 1.5AA
Batteries | 24 Vdc - 500
mA | 115/220 Vac,
50/60Hz
electric outlet | Rechargable
Battery, AC
Adapter |
| Energy Delivery | Handheld
Treatment Probe | Same | Same | Same |
| Treatment Time | 60 - 300 seconds | 60 - 900
seconds | 0 - 594 seconds | 20 - 3000
seconds |
| Target Size | 36 mm diameter | 2-10 mm
diameter | 50 mm x 50 mm | 76 mm diameter |
| Indications for Use | To emit 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 heat is
indicated. | Same | Same | Same |
| Target Population | Individuals
suffering from
chronic pain | Same | Same | Same |
| Location for Use | Over-the-counter | Same | Same | Same |
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