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

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the Lumanosity, Inc. Celebrity 500 and Celebrity 7000 devices, which are infrared lamps for therapeutic heating.

Based on the provided document, the following information regarding acceptance criteria and a study to prove the device meets them cannot be fully extracted or is not present:

No specific acceptance criteria table is provided. The document focuses on regulatory approval based on "substantial equivalence" to a predicate device, rather than performance-based acceptance criteria for a new clinical study.
No specific study is described that "proves the device meets the acceptance criteria." The approval is based on equivalence to a predicate device.
No detailed information on sample sizes, data provenance, expert qualifications, or adjudication methods for a clinical study is present. This type of detail is typically found in a clinical study report, which is not provided here.
No information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance is present. This document discusses a physical medical device, not an AI or imaging algorithm.
No details on training set size or how ground truth for a training set was established. This refers to machine learning which is not addressed in this document.

However, based on the document's content, here's what can be inferred or directly stated:

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

Acceptance Criteria (Implied by Substantial Equivalence): The device (Lumanosity Celebrity 500, Celebrity 7000) must have the "same intended use and technological characteristics" as the predicate device (TERRAQUANT SOLO PRO) to be considered substantially equivalent.
Reported Device Performance: The document states that the Lumanosity Celebrity is intended to deliver photomodulation therapy for the purpose of temporarily improving pain in muscles and joints, and that it uses Infrared and Red photonic energy for this purpose. This implicitly means it performs similarly to the predicate for its intended use. No quantitative performance metrics are provided.

Here's a conceptual table based on the document's equivalence argument:

Acceptance Criteria Category	Specific Criteria (Based on Substantial Equivalence)	Reported Device Performance/Characteristics
Intended Use	Same as predicate device: 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.	Lumanosity Celebrity is intended to deliver photomodulation therapy for the purpose of temporarily improving pain in muscles and joints. This aligns with the predicate's use for temporary relief of various muscle/joint discomforts.
Technological Characteristics	Utilizes Infrared and Red photonic energy as the primary mechanism for its intended therapeutic effects.	Lumanosity Celebrity uses Infrared and Red photonic energy.
Safety	Complies with IEC 62471 Photobiological Safety of Lamps and Lamp Systems Part II Guidance on Mfg Requirements relating to non-laser optical radiation safety.	The submission references compliance with IEC 62471.
Minor Differences	Any differences from the predicate device should not raise new questions of safety or effectiveness.	The primary difference is the Lumanosity does not contain a magnet, whereas the TQ Pro does. The FDA's approval indicates this difference did not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable / Not provided. The document is a regulatory approval based on substantial equivalence, not a description of a specific clinical performance study for the Lumanosity devices themselves. Therefore, there is no "test set" in the context of a clinical trial described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable / Not provided. This information pertains to a clinical study with ground truth establishment, which is not detailed in this regulatory approval letter. The "ground truth" for this approval is essentially the FDA's determination of substantial equivalence based on the submitted technical characteristics and intended use compared to the predicate device.

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

Not applicable / Not provided. No clinical test set or adjudication method is described.

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:

No. This document pertains to a physical medical device (infrared lamp), not an AI or imaging diagnostic algorithm.

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

No. This document pertains to a physical medical device (infrared lamp), not an AI algorithm.

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

Regulatory "Ground Truth" for Equivalence: The "ground truth" in this context is the existing regulatory status and established safety and effectiveness profile of the predicate device (TERRAQUANT SOLO PRO). The Lumanosity device is deemed equivalent based on its comparison to the predicate's known characteristics and intended use. No new clinical ground truth was established for the Lumanosity device in this submission.

8. The sample size for the training set:

Not applicable / Not provided. This refers to machine learning algorithms, which are not described in this document.

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

Not applicable / Not provided. This refers to machine learning algorithms, which are not described in this document.

Summary

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Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three horizontal lines above it, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HU" is arranged in a circular fashion around the left side of the logo.

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

Lumanosity, Inc. % Mr. Jeff Provissiero, CFO 11271 Ventura Boulevard, Suite 212 Studio City, California 91604

TOCT 4 2010

Re: K100213

Trade/Device Name: Lumanosity, Inc. Celebrity 500, Celebrity 7000 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: September 29, 2010 Received: September 29, 2010

Dear Mr. Provissiero:

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 or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Jeff Provissiero, CFO

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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/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 yours.

For Mo. Mo.
Mark N. Molkerson Def. D.R.

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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luv213

Indications for Use

510(k) Number (if known): K 100213 / S1

Device Name: Lumanosity inc. Celebrity 500, Celebrity 7000

Indications for Use:

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil K. Oden for AKM

ivision Sigr Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number. K100213

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EXECUTIVE SUMMARY

501k Submission, Submission date: 1-10-2010

Submitter:

Lumanosity inc, 11271 Ventura Blvd, # 212 Studio City, CA 91604

Trade Name: The Celebrity 204

Class Name: Lamp, infra-red, therapeutic heating Closest Class: ll ILY Product code: Regulation #: 890.5500

Purpose

The purpose for this 501k is to register a new product for sale in the market which is a finished component

Predicate Devices

Device 1 Name: TERRAQUANT SOLO PRO 510(k) Number: K080102

Controls

IEC 62471 Photobiological Safety of Lamps and Lamps Systems Part II Guidance on Mfg Requirements relating to non- laser optical radiation safety, published 2006.

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Comparison Summary

A. Intended Use

The Lumanosity Celebrity is intended to deliver photomodulation therapy for the purpose of of temporarily improving pain in muscles and joints which is similar to the Terraquant Pro.

B. Technological Characteristics

Lumanosity Celebrity and Terraquant Pro both use Infrared and Red photonic energy for the purpose of temporarily improving pain in muscles and joints.

C. Differences

In addition to the LED's, the TQ Pro contains a magnet, which the Lumanosity does not.

D. Argument for Substantial Equivalence to Predicate Devices

The intended use and the technological characteristics of the Lumanosity Celebrity are the same as the predicate device and therefore we believe it is Substantially Equivalent to it.

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.