The Quasar MD21 infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.

Device Description

The Quasar MD21 consists of a collection of both infrared and red diodes [LEDs], packaged in a compact plastic head. The system emits pulsed light in the infrared spectrum to provide topical heating. The red diodes [LEDs], provide a visible indication that the unit is in operation. For operation turn on LEDs for a time period of twenty-five (25) minutes prior to use.

AI/ML Overview

The provided document K032379 is a 510(k) summary for an infrared heat lamp, the Quasar MD21. This type of filing is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific clinical performance criteria from a clinical study. The document states that testing included "functional performance testing and electrical safety testing," but it does not describe a clinical study with acceptance criteria, sample sizes, ground truth establishment, or expert reviews for clinical effectiveness.

Therefore, many of the requested details about a study and acceptance criteria related to clinical performance cannot be extracted from this document, as such a study was not presented or required for this 510(k) submission.

Here's a breakdown of what can be inferred or explicitly stated from the document regarding the acceptance criteria and the "study" (referring to the testing mentioned):

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

Acceptance Criteria (Implied)	Reported Device Performance
Functional Performance:
Emit energy in infrared spectrum for topical heating.	The Quasar MD21 emits pulsed light in the infrared spectrum.
Provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm.	This is the stated intended use based on equivalence to predicate devices; no specific performance metrics or clinical trial results are provided to prove this relief.
Temporarily increase local blood circulation.	This is the stated intended use based on equivalence to predicate devices; no specific performance metrics or clinical trial results are provided to prove this increase.
Promote relaxation of muscle tissue.	This is the stated intended use based on equivalence to predicate devices; no specific performance metrics or clinical trial results are provided to prove this relaxation.
Achieve temperatures similar to predicate devices.	The document states "The temperatures achieved by these devices are the same, using a similar number of diodes [LEDs], over a similar coverage area" when compared to predicate devices.
Electrical Safety:
Comply with relevant electrical safety standards.	"Electrical safety testing" was performed. No specific standards or results are detailed in this summary.

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

Test Set Sample Size: Not applicable/Not provided. The "testing" mentioned refers to functional and electrical safety assessments of the device itself, not a clinical test set on human subjects.
Data Provenance: Not applicable/Not provided in relation to clinical data. The device itself was manufactured by Quantum Skincare, Inc. in Ringgold, LA, USA.

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

Number of Experts: Not applicable/Not provided. Ground truth in the context of clinical performance review by experts was not established since a clinical study on effectiveness was not described.
Qualifications of Experts: Not applicable/Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable/None mentioned. This concept applies to the resolution of discrepant readings in clinical studies, which were not conducted.

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

MRMC Study: No. This device is an infrared heat lamp, not an AI-powered diagnostic imaging device. An MRMC study is not relevant to this product.

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

Standalone Performance: Not applicable. This refers to AI algorithm performance, which is not relevant to an infrared heat lamp.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable. For the functional and electrical safety testing, the "ground truth" would be established engineering specifications and industry standards for electrical safety and infrared emission. No clinical ground truth (e.g., pathology, patient outcomes) was established or used for the purpose of this 510(k) submission's stated "testing."

8. The sample size for the training set

Training Set Sample Size: Not applicable. This concept applies to machine learning models, which are not involved in this device.

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

Ground Truth Establishment for Training Set: Not applicable.

In summary: The K032379 submission is for a medical device (infrared heat lamp) that achieves market clearance through substantial equivalence to predicate devices, rather than through extensive clinical trials demonstrating specific performance against rigorous acceptance criteria. The "testing" referred to in the document focuses on functional (e.g., infrared emission, temperature) and electrical safety aspects of the device itself, not on clinical effectiveness in human subjects in a manner that would generate the kind of data typically found in clinical studies for diagnostic or therapeutic devices requiring such evidence.

Summary

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K032379 (pg 1 of 2)

510(k) Submission, Infrared Lamp, 21 CFR 890.5500 Quantum Skincare, Inc., Ringgold, LA 71068

Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Quasar MD21 Infrared Heat Lamp.

Company making the submission:

Name:	This summary is submitted in behalf of:Quantum Skincare, Inc.	This summary is submitted by:
Address:	3157 Military RoadRinggold, LA 71068 .	Delphi Consulting Group11874 South Evelyn CircleHouston, Texas 770713404
Telephone:Fax:	1-318-894-9490	1-713-723-40801-775-429-9524
Contact:	Jim CobbPresident	J. Harvey KnaussConsultant
E-mail:	Jim@quantumskincare.com	harvey@delphiconsulting.com

1. Device Name:

・

Trade/Proprietary Name:	Quasar MD21 Infrared Heat Lamp.
Common/Usual Name:	Infrared heat lamp.
Classification Name:	Infrared lamp 21 CFR § 890.5500

2. Predicate Device:

The Quasar MD21 Infrared Heat Lamp is substantially equivalent to other infrared lamps on the market, such as the Mu Photonics Pain Therapist, K012598 manufactured by Nu Photonics, Inc., and Biolight PCD,

3. Intended use of the Device:

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4. Description of the Device:

5. Summary of the technological characteristics of the device Compared to predicate devices:

The Quasar MD21 and the above referenced predicate devices are infrared lamps as defined in 21 CFR § 890.5500. These devices utilize infrared diodes [LEDs], to provide topical heating for the temporary relied of muscle and/or joint pain. The temperatures achieved by these devices are the same, using a similar number of diodes {LEDs], over a similar coverage area. The devices are handheld, and intended to be placed directly on the skin or held just over the skin to provide the heating.

6. Testing:

Testing of the Quasar MD21 included functional performance testing and electrical safety testing.

7. Conclusions:

Based upon the testing and comparison to the predicate devices, the Quasar MD21 has the same intended uses, with similar technological characteristics. The system performs as intended and raises no new safety or effectiveness issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.

Public Health Service

NOV 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ouantum Skincare, Inc. c/o Mr. J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071-3404

Re: K032379

Trade/Device Name: Quasar MD21, Infrared Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: October 9, 2003 Received: October 14, 2003

Dear Mr. Knauss:

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. J. Harvey Knauss

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 on (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

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 KO32379

Quasar MD21, Infrared Lamp 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)

Prescription Use X

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Muriam C. Provost

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

510(k) Number K032379

Regulation Number and Section

N/A