(209 days)
The Nutra Stim Hair Laser Comb is indicated to treat androgenetic alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, LL-1, LL-2, or frontal and Fitzpatrick Skin Types L to IV.
The Nutra Stim Hair Laser Comb is a hand-held low level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp.
The Nutra Stim Hair Laser Comb unit contains the power supply, internal NI-MH rechargeable battery and the control unit. The enclosure and laser lens are made of medical grade biocompatibility plastics via injection molding. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Stim Hair Laser Comb does not use any software.
The provided text describes the Nutra Stim Hair Laser Comb, a low-level laser device intended for promoting hair growth and treating androgenetic alopecia in specific female populations. However, the document does not contain a study that establishes acceptance criteria for device performance in terms of clinical efficacy (hair growth), nor does it provide performance data against such criteria.
The document focuses on demonstrating substantial equivalence to a predicate device (HairMax Pro 12 LaserComb, K112524) for regulatory clearance, rather than presenting a clinical trial for performance.
Here's an analysis based on the information provided, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not present in the document. The document discusses regulatory and safety testing but does not provide clinical performance acceptance criteria (e.g., minimum percentage increase in hair count, or specific visual improvement scores) or reported device performance against such criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Clinical): Not applicable for clinical efficacy. The document mentions an "OTC Usability Study" with "80 participants." This study was focused on usability and consumer understanding, not clinical performance for hair growth.
- Data Provenance: Not specified for any clinical performance data, as none is presented. For the OTC Usability Study, the provenance is not mentioned.
- Study Type: The OTC Usability Study was likely prospective, as it involved attracting participants to test the device's labeling and operation.
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)
This information is not present. The usability study did not involve establishing ground truth for efficacy using experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not present. No such adjudication method is mentioned, as there was no clinical performance data requiring expert adjudication.
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, an MRMC comparative effectiveness study was not done. The device is a physical laser comb, not an AI-assisted diagnostic or interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, the device is not an algorithm. What was done were non-clinical performance tests for electrical safety, EMC, and biocompatibility, as listed in Section 8. These are tests of the device's physical and electrical properties, not its clinical standalone efficacy for hair growth.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not present for clinical efficacy. For the OTC Usability Study, the "ground truth" was whether participants could correctly self-select, understand labeling, assemble, and operate the device. This "ground truth" would have been established by observing participant actions and responses against predefined correct answers or procedures.
8. The sample size for the training set
This information is not present. The document does not describe the development of an algorithm or model that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no mention of a training set or an algorithm being developed.
Summary of Device and Regulatory Context (based on the provided text):
- Device Name: Nutra Stim Hair Laser Comb Model NSL-6318
- Intended Use/Indications: Treats androgenetic alopecia and promotes hair growth in females with Ludwig (Savin) Scale I-4, LL-1, LL-2, or frontal, and Fitzpatrick Skin Types I to IV.
- Regulatory Class: Class II
- Product Code: OAP (Lamp, nonheating, for promotion of hair growth)
- Regulation Number: 21 CFR 890.5500
- Predicate Device: HairMax Pro 12 LaserComb (K112524)
- Basis for Clearance: Substantial Equivalence to the predicate device.
- Supportive Studies Mentioned:
- OTC Usability Study: 80 participants, focused on self-selection, understanding labeling/manual, assembly, and operation. All four goals of this study were reportedly met. This study did not assess clinical efficacy.
- Nonclinical Performance Data: Risk analysis, verification, and validation tests (specifics not detailed in the summary, but referenced as being in Section 10). Compliance with electrical safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11) and laser safety (IEC 60825-1) standards. Biocompatibility testing per ISO 10993.
In conclusion, the provided document is an FDA 510(k) clearance letter and its accompanying summary, which primarily establishes substantial equivalence for marketing purposes. It highlights compliance with safety and usability aspects but does not present a clinical study with acceptance criteria and performance data related to the device's efficacy in promoting hair growth. The efficacy is implicitly accepted based on the substantial equivalence to the predicate device, which would have had its own supporting data for clearance.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol of a stylized human figure in profile. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the circular seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2015
NutraLuxe MD, LLC % Jill Cleasy Regulatory and ISO Consulting 5575 Santa Rosa Court Sparks. Nevada 89436
Re: K141588
Trade/Device Name: Nutra Stim Hair Laser Comb Model NSL-6318 Regulation Number: 21 CFR 890.5500 Regulatory Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: December 03, 2014 Received: December 09, 2014
Dear Ms. Cleasy:
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
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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 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.
for
Sincerely yours,
David Krause -S
- Binita Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
cc: Enclosed
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Indications for Use
510(k) Number (if known): K
Device Name: Nutra Stim Laser Comb
Indications for Use:
The Nutra Stim Hair Laser Comb is indicated to treat androgenetic alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, LL-1, LL-2, or frontal and Fitzpatrick Skin Types L to IV.
Prescription Use (21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510K Summary Nutra Stim Hair Laser Comb
1. General Information
| Submitter: | NutraLuxe MD, LLC6835 International Center Blvd Suite 4-5Fort Myers, Florida 33912 |
|---|---|
| Contact Person: | C/O Jill CreasyRIC - Regulatory & ISO Consulting5575 Santa Rosa Ct.Sparks, NV 89436775-622-9591info@ricreg.com |
| Summary Preparation Date: | June 13, 2014 |
| Device Name | |
| Device Name: | Nutra Stim Hair Laser Comb Model NSL-6318 |
| Regulatory Name: | Lamp, nonheating, for promotion of hair growth |
| Regulation Numbers: | 21 CFR 890.5500 |
| Regulatory Class: | II |
| Product Codes: | OAP |
3. Predicate Device
The Nutra Stim Hair Laser Comb is substantially equivalent to the HairMax Pro 12 LaserComb (K112524)
4. Device Description
The Nutra Stim Hair Laser Comb is a hand-held low level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp.
The Nutra Stim Hair Laser Comb unit contains the power supply, internal NI-MH rechargeable battery and the control unit. The enclosure and laser lens are made of medical grade biocompatility plastics via injection molding. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Stim Hair Laser Comb does not use any software.
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5. Intended Use and Indications:
The Nutra Stim Hair Laser Comb is indicated to treat androgenetic alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, LL-1, LL-2, or frontal and Fitzpatrick Skin Types L to IV.
Substantial Equivalency & Comparison of Technological Similarities and Differences 6.
The Nutra Stim Hair Laser Comb are as safe and effective as the predicate device. The Nutra Stim Hair Laser Comb have the same indications. (i.e., treating androgenetic alopecia. promote hair growth in females who have Ludwig (Savin) Scale I-4, LL-1, LL-2, or frontal and Fitzpatrick Skin Types L to IV, as the predicate device.
The Nutra Stim Hair Laser Comb are identical in technological characteristics as the predicate, including its laser power, wavelength, laser delivery method, its comb component, its instructions for use and its audible timer.
The Nutra Stim Hair Laser Comb have the following similarities to the HairMax Pro
- Has the same indicated use 1.
- Same identical laser modules 2.
- Similar hair parting teeth 3.
- Uses the same operating principle 4.
- Similar device design and physical properties ર્ડ
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- Incorporates the same materials
- Utilizes a same treatment duration 7.
-
- Utilizes a similar treatment regimen
Any differences between The Nutra Stim Hair Laser Comb 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 80 participants;
- 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
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- 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
Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied for each are listed in Section 10
The Nutra Stim Hair Laser Comb device was also tested and complies with Electrical Safety and EMC testing, which include the requirements of IEC 60601-1:2012 3rd 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 60601-1-11 Home healthcare medical equipment and IEC 60825 Safety of laser products - Part 1: Equipment classification and requirements. In addition, testing and analysis have demonstrated compliance of the plastic within ISO 10993 (Biocompatibility).
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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 (OSR), Risk Analysis and Risk Management files (RMF) conforms to ISO 14971,
Conclusion: Nutra Luxe MD, Inc. found The Nutra Stim Hair Laser Comb device to be substantially equivalent to the legally marketed predicate devices.
§ 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.