The Nutra Light Red is a non-invasive LED light device is intended/indicated for over- the -counter use for the treatment of periorbital wrinkles, and rhytides

Device Description

The NutraLuxe Red, Model NL-2212 is a device that utilizes Light Emitting Diodes to provide LED light to the body. The NutraLuxe Red is a visible light source of high spectral purity. They provide uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of Red is 650 +/- 5 at 80 mW. The NutraLuxe Red unit contains the power supply, internal NI-MH rechargeable battery and the control unit. The enclosure and LED lens are made of medical grade biocompatibility plastics via injection molding. It has the capabilities to deliver the light to the skin as the unit is moved over the STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Light Red does not use any software.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details for the Nutra Light Red device:

Important Note: The provided text does not describe acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/algorithm-based medical device. Instead, it details an OTC Usability Study and compliance with electrical, EMC, photobiological safety standards, and biocompatibility for a light-emitting diode (LED) device. This is a crucial distinction. The questions in your prompt are more aligned with the evaluation of algorithmic diagnostics, which this device is not.

However, I will extract the information as best as possible to align with your request, interpreting "acceptance criteria" here as the goals of the usability study and "reported device performance" as the outcome of that study.

Acceptance Criteria and Study Details for Nutra Light Red (Based on provided text)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Study Goals)	Reported Device Performance (Study Outcome)
To attract participants that represented the "intended users" of the device	Met
To determine if consumers could correctly self-select using the packaging labeling only	Met
To test consumer knowledge of the packaging labeling and user manual	Met
To accurately assemble, operate, and care for the device correctly	Met
Compliance with Electrical Safety (IEC 60601-1:2012)	Complies
Compliance with EMC (IEC 60601-1-2)	Complies
Compliance with Photobiological Safety (IEC 62471)	Complies
Compliance with Basic Safety and Performance of Non-Laser Light (IEC 60601-2-57)	Complies
Biocompatibility (ISO 10993)	Demonstrated compliance

2. Sample Size and Data Provenance for the Test Set

Sample Size: 80 participants
Data Provenance: Not explicitly stated, but the study was an "OTC Usability Study," implying it was conducted with representative consumers. No country of origin is specified. It is a prospective study as it involved participants performing tasks with the device.

3. Number of Experts and Qualifications for Ground Truth

Not applicable for this device and study. This device is an LED light therapy device, and the study was a usability study, not a diagnostic accuracy study requiring expert-established ground truth for a test set. The "ground truth" here was the successful completion of tasks by consumers.

4. Adjudication Method for the Test Set

Not applicable. There was no ambiguity in "ground truth" (i.e., whether tasks were performed correctly). The study aimed to see if participants could correctly perform actions and understand labeling, not to make a diagnostic determination that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This was not an AI/algorithm-based device, nor was it a diagnostic tool where human readers would be evaluated with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

No. The device does not contain an "algorithm" in the sense of an AI model that would have standalone performance. It is a hardware device. The "performance data" presented relates to its physical and usability characteristics. The document explicitly states: "The Nutra Light Red does not use any software."

7. Type of Ground Truth Used

For the usability study: The ground truth was the observed behavior and understanding of the 80 participants when interacting with the device, packaging, and user manual. Whether they could correctly perform actions (assemble, operate, care for) and understand labeling constituted the "ground truth" of usability.
For safety and compliance: The ground truth was established international standards and regulatory requirements (e.g., IEC, ISO).

8. Sample Size for the Training Set

Not applicable. This device does not use an AI or machine learning algorithm, therefore there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth for it.

Summary of Device and Study Type:

The Nutra Light Red is a non-invasive LED light device for treating periorbital wrinkles and rhytides, intended for over-the-counter use. The "study" described in the 510(k) summary is primarily an OTC Usability Study to ensure consumers can understand and safely operate the device without professional assistance. Other "performance data" relates to compliance with electrical, electromagnetic compatibility (EMC), photobiological safety, and biocompatibility standards, which are standard requirements for medical devices. This document does not describe the evaluation of an AI or algorithmic diagnostic device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three human profiles incorporated into its design, suggesting a connection between health, humanity, and government services.

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

August 20, 2014

Nutra Luxe MD, LLC Ms. Jill Creasy Regulatory & ISO Consulting 5575 Santa Rosa Court Sparks, Nevada 89436

Re: K141308 Trade/Device Name: Nutra Light Red Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OHS Dated: June 9, 2014 Received: June 13, 2014

Dear Ms. Creasy:

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 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

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K141308

Device Name Nutra Light Red

Indications for Use (Describe)

The Nutra Light Red is a non-invasive LED light device is intended/indicated for over- the -counter use for the treatment of periorbital wrinkles, and rhytides

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510K Summary of Safety and Effectiveness for Nutra Light Red

1. General Information

Submitter: NutraLuxe MD. LLC 6835 International Center Blvd Suite 4-5 Fort Myers, Florida 33912 Contact Person: C/O Jill Creasy RIC - Regulatory & ISO Consulting 5575 Santa Rosa Ct. Sparks, NV 89436 775-622-9591 info@@ricreq.com Summary Preparation Date: May 15, 2014

2. Device Name

Device Name: Nutra Light Red (Model: NL-2212) Classification Name: Laser Surgical Instrument, for use in General and Plastic Surgery and in Dermatology, Regulation Numbers: 21 CFR 878.4810 Requlatory Class: II Product Codes: OHS

3. Predicate Device

The Nutra Light Red is substantially equivalent to the Tanda Max OTC (K110735)), Light for Wrinkles (K101190).

4. Device Description

5. Intended Use and Indications:

The Nutra Light Red is a non-invasive LED light device is intended/indicated for over- the -counter use for the treatment of periorbital wrinkles, and rhytides

6. Substantial Equivalency & Comparison of Technological Similarities and Differences

The intended use and technological characteristics of the Nutra Light Red are equivalent to the listed predicates.

Has the same intended use as the predicates (i.e., Treatment of periorbital wrinkles, and rhytides

1. Has a similar output (i.e., 80 mW/cm2 ) as the predicates
1. Utilizes a similar wavelength (i.e., 650 nm) as the predicates
1. Utilizes a same treatment duration (i.e., 3 minutes per target area) as the predicates

{4}------------------------------------------------

Utilizes a similar treatment regimen (i.e., 2 treatments per week for 6 weeks)

Any differences between the Nutra Light Red and the predicates device are not significant to its safety or effectiveness for its intended use.

7. Clinical Performance Data

An OTC Usability Study was conducted with the following four goals in mind with 80 participants; 1. To attract participants that represented the "intended users" of the device;

1. To determine if consumers could correctly self-select using the packaging labeling only
1. To test consumer knowledge of the packaging labeling and user manual and actually assembly, operate and care for the device correctly. All four goal of the study were met.

8. Nonclinical Performance Data

The NutraLight Red device was tested and complies with Electrical Safety and EMC testing, which include the requirements of IEC 60601-1:2012 3« Edition "Medical Electrical Equipment Part 1 – General Requirements for Safety" IEC 60601-1-2 "Medical Electrical Equipment Part 1-2, General Requirements for Safety - Collateral Standard Electromagnetic Compatibility Requirements and Tests. IEC 60601-2-57, Medical Electrical Equip. - Part 2-57 Basic Safety and Performance of Non-Laser Light Cosmetic/Aesthetic use. IEC 62471 Photobiological Safety of lamps and lamp systems. In addition, testing and analysis have demonstrated compliance of the plastic within ISO 10993 (Biocompatibility).

9. Regulatory Requirements

NutraLuxe MD manufactures under strict quality assurance guidelines and US FDA Good Manufacturing Practice (GMP)

Nutra Luxe MD is fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations (QSR), Risk Analysis and Risk Management files (RMF) conforms to ISO 14971,

10. Substantial Equivalence

Based upon an analysis of the overall performance characteristics the Nutra Light Red device was found to have the same intended use and indication for use as the predicate devices. The device also has similar technological characteristics to its predicate devices. The minor technological differences between the Nutra Light Red and predicate devices do not raise any issues of safety or effectiveness. Therefore, Nutra Luxe MD, Inc. found the Nutra Light Red device to be substantially equivalent to the legally marketed predicate devices.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.