The Grivamax Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II, males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

Device Description

The Grivamax Hair Growth System consists of 272 diode lasers configured within an outer cap helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head i.e., the area commonly covered with stylized hair. The Grivamax Hair Growth System is powered by a lithium-ion battery pack that contains an embedded controller chip.

AI/ML Overview

It appears there's a misunderstanding of the provided text. The document is an FDA 510(k) clearance letter for a medical device called the "Grivamax Hair Growth System," which is an infrared lamp to promote hair growth.

The document states very clearly in Performance Data section on page 4: "No clinical performance data was produced for this submission because the Grivamax Hair Growth System is the same device as the predicate, the Illumiflow Laser Cap, cleared under K162071. Both the Grivamax Hair Growth System and Illumiflow Laser Cap are the IDENTICAL same device offered for PRIVATE LABEL by the manufacturer, Cosmo Far East Technology Limited."

Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on its own clinical performance data within this submission. The clearance is based on its substantial equivalence to a predicate device for which performance data was previously submitted.

However, the document does describe an Over-The-Counter (OTC) Testing Program for consumer comprehension and usability. This is a study designed to meet acceptance criteria for informed self-selection, correct usage, and hazard comprehension for an OTC device. I will describe this study and its acceptance criteria as it is the only "study" described in the provided text.

OTC Testing Program: Acceptance Criteria and Study Details

The provided document describes an Over-The-Counter (OTC) Testing Program conducted to evaluate consumers' ability to understand and correctly use the Grivamax Hair Growth System without professional assistance. This is a crucial component for OTC medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Standard	Reported Device Performance
Pass Rate: 80% of subjects answer all questions correctly for correct self-selection, correct assembly and usage, and comprehension of hazards and maintenance procedures.	90% Pass Rate for the subject group.

Self-Selection: Making the correct decision to purchase the product or not, based on understanding the Intended Use.
Usability: Correctly assembling and using the product.
Comprehension: Understanding the hazards and maintenance procedures for the device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 40 subjects.
Data Provenance: Not explicitly stated regarding country of origin, but the context implies it was conducted within the jurisdiction where the FDA regulates, likely the USA. The study design ("volunteer subjects," "interview conducted by interviewer") suggests a prospective study for this specific OTC testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Ground Truth Establishment: The ground truth for this OTC test was based on the "correct" answers to 26 questions derived from the product's standard retail package and full owner's manual. The "experts" defining these correct answers would likely be the device manufacturer's design team and regulatory affairs personnel, who developed the manual and packaging, in conjunction with regulatory guidelines for consumer comprehension. No specific number or qualifications of "experts" are stated in this document for creating the questionnaire's correct answers, as it's assumed these would be inherent to the device's design and labeling.

4. Adjudication Method for the Test Set

Adjudication Method: "If the questions were answered correctly, they were given a P for PASS. If any questions were answered incorrectly, they were given an F for FAIL." This indicates a simple Pass/Fail adjudication per subject based on answering all questions correctly. No multi-reader, multi-expert consensus or 2+1/3+1 methods are described, as this was a direct consumer comprehension test against predefined correct answers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC study was done focusing on clinical effectiveness. The device is cleared based on substantial equivalence to a predicate device, not on new clinical performance data from a comparative effectiveness study within this submission.
The OTC testing was for consumer comprehension and usability, not for clinical efficacy or comparative effectiveness in promoting hair growth.

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

Not applicable. This device is a physical infrared lamp for hair growth. There is no "algorithm" in the sense of AI or image analysis being tested for standalone performance. The "standalone" aspect here relates to the consumer's ability to use the device without professional assistance, which was tested by the OTC program.

7. The Type of Ground Truth Used

Ground Truth: For the OTC testing, the ground truth was the correct answers to 26 questions derived from the device's retail packaging and owner's manual regarding its intended use, assembly, operation, hazards, and maintenance. This is a form of expert-defined truth based on the product's design and regulatory requirements for user comprehension.

8. The Sample Size for the Training Set

Not applicable. This document describes an OTC testing program involving human subjects, not an AI/machine learning model that requires a "training set."

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

Not applicable. As above, there is no AI/machine learning model or training set described in this document.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three people.

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

August 22, 2017

Leana Orders, Inc. % Raymond Blanche Managing Member NST Consulting, LLC 641 Shunpike Road Chatham, New Jersey 07928

Re: K171895

Trade/Device Name: Grivamax Hair Growth System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: June 1, 2017 Received: June 26, 2017

Dear Raymond Blanche:

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 Actinclude 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE) 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. Jennifer R. Stevenson -S

For Binita S. 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

Enclosure

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Indications for Use

K171895

510(k) Number (if known)

Device Name GrivaMax Hair Growth System

Indications for Use (Describe)

The GrivaMax Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II, in males with androgenetic alopecia who have Norwood-Hamilton IIa-V and for both, Fitzpatrick Classification of Skin Phototypes of I-IV.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

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510(k) Summary

Leana Orders, Inc.

Submitter's Contact Information

Name:	Raymond R. Blanche
Address	NST Consulting, LLC641 Shunpike Road, Suite 311Chatham, NJ 07928
Telephone:	(973-539-7444
Facsimile:	(973) 539-7445

Name of Device and Name/Address of Sponsor

Trade Name:	Grivamax Hair Growth System
Sponsor ContactInformation:	Leonid KritsLeana Orders, Inc.431 Travis AvenueStaten Island, NY 10314-6150
Telephone:	718-415-1901
Common or Usual Name:	Lamp, non-heating, for promotion of hair growth
Classification Name:	Infrared lamp per 21 CFR 890.5500
Classification Code:	OAP (Laser, comb, hair)

Predicate Devices:

Device Trade Name	Manufacturer
Illumiflow Laser Cap	Cosmo Far East Technology Limited

Reference Devices:

None

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Date Prepared:

August 17, 2017 Revised

Intended Use / Indications for Use

Technological Characteristics

Performance Data:

No clinical performance data was produced for this submission because the Grivamax Hair Growth System is the same device as the predicate, the Illumiflow Laser Cap, cleared under K162071. Both the Grivamax Hair Growth System and Illumiflow Laser Cap are the IDENTICAL same device offered for PRIVATE LABEL by the manufacturer, Cosmo Far East Technology Limited. They are the same device in optical, electronic, mechanical function and aesthetic appearance, as well as the same recommended clinical treatment regime.

Substantial Equivalence

Both the Grivamax Hair Growth System and Illumiflow Laser Cap which use red light diode lasers are classified as class IIIa/3R laser systems by the IEC standard for allowable emission levels, which is a recognized standard by the FDA as well, and the adverse event profile is the same. The sponsor believes that there is no difference in the physical appearance or in the method of delivering the radiant energy of the two systems and therefore, there are no variations in the therapeutic value or safety profile.

Finally, the summarized data contained in the Illumiflow Laser Cap in the 510(k) notice confirms the safety and efficacy of the device and accordingly, of the proposed Grivamax Hair Growth System for Over-the-Counter Use per Part 21 CFR 801 Subpart C. For these reasons, the Grivamax Hair Growth System overwhelmingly satisfies the FDA's substantial equivalence with respect to intended use, technological and design characteristics.

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Treatment Protocol

The Grivamax Hair Growth System and the Illumiflow Laser Cap igrow devices possess the same treatment regime of 30 minutes, every other day, on non-consecutive days, for the initial treatment regime of 16 weeks.

The following Comparison Chart in support of substantial equivalence is provided:

Grivamax Hair Growth System	Illumiflow Laser Cap
LLLT Device Type	Identical
OTC Application	Identical
Intended Use - Androgenetic Alopecia	Identical
Contain Laser Diodes-272 Class 3R	Identical
Helmet Design	Identical
650+/-5 NMS.	Identical
Marketing Clearance -Females & Males, OTC	Identical
Passive Use-Hands Free	Identical
OAP Classification	Identical
Classification Name -Infrared Lamp	Identical
Common Usage Name - Lamp, Non-Heating	Identical
General & Plastic Surgery Committee	Identical
Skin Phototypes - I- IV	Identical
Hamilton-Norwood IIa-V Hair Loss Classification	Identical
Ludwig-Savin I - II Hair Loss Classification	Identical
Efficacy Rates - High Compared to Placebo	Identical
Treatment- 16 weeks, every other day, for 30 minutes per session	Identical
Device Class II	Identical

With the data presented in the Comparison Chart, the sponsor believes that this data demonstrates that the two devices are identical and equivalent. PRIVATE LABEL devices from the same manufacturer and therefore are identical because the manufacturer ONLY produces one device.

Based on this comparison and determination, the sponsor requests the FDA to clear the device via the 510(k) notice.

Over - The - Counter Testing Program

To test volunteer subjects for the suitability of the Grivamax Hair Growth System, 40 subjects were asked twenty-six questions (see questionnaires) after being provided a standard retail package and a full owner's manual. The test subjects was given as long as they required to read and understand the product packaging and manual. No assistance was provided to them and they were not permitted to ask any questions of the interviewer. The interviewer then conducted the interview and filled in the responses

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from the subjects. The subjects were required to answer all questions correctly to be counted as PASS for the correct Self Selection or, to have made the correct decision to purchase the product or not; to assemble and use the product correctly and comprehend the hazards and maintenance procedures for the device. These decisions would be based upon their understanding of the Intended Use of the product and the manual.

If the questions were answered correctly, they were given a P for PASS. If any questions were answered incorrectly, they were given an F for FAIL. The number of subjects required to answer all questions correctly is 32 out of 40, for an 80% success rate.

The results of the Over-the-Counter testing demonstrate that the Grivamax Hair Growth System complies with the requirements the FDA determined to be applicable. The test revealed an overall 90% pass rate for the subject group of 40 male and female participants. The testing further demonstrates that age, education, socioeconomic group, race or medical hair loss status are not variants that prevent proper self-selection, usability and comprehension of hazards and maintenance procedures for the average consumer to successfully navigate the purchasing and use process of the Grivamax Hair Growth System.

Based on this data, the sponsor believes that the Grivamax Hair Growth System for male and female users should be granted the OTC intended use as requested.

Electrical Safety and Electromagnetic Compatibility Testing Performance

The Grivamax Hair Growth System was evaluated for conformance to recognized international standards. The following is a list of these evaluations and tests that were found to be in conformance:

1. IEC 60825-1 Edition 2.0 2007-03 Safety of Laser Products Part 1: Equipment Classification and Requirements.
1. IEC 60601-1-2 Edition 3.0 2007-03 Medical Electrical Equipment Part 1-2 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Part 1: Requirements and Tests.

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.