The igrow-II Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Phototypes I to IV.

Device Description

The Igrow-II Hair Growth System consists of 21 red visible light, diode lasers and 30 red light super-luminescent diodes configured within an outer helmet and protective inner liner. The use of diode lasers and non-laser LEDs provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down. by emitting an audible beep pattern.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the igrow-II Hair Growth System, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Promotion of hair growth in males with androgenetic alopecia, Norwood Hamilton Classifications IIa to V, and Fitzpatrick Skin Phototypes I to IV.	Subjects in the active group demonstrated 100% effectiveness (positive result for an increase in terminal hair counts).
Significant increase in terminal hair counts compared to placebo.	The active group showed a 39% positive variance over the placebo group from baseline.
Decrease in terminal hair counts in the active group should be zero or negligible.	The actual test group's decrease in terminal hair counts was zero, compared to a significant decrease in the placebo group.
No anticipated or reported adverse events related to the therapy.	No anticipated adverse events and none were reported from either therapy administered that were study related.
Device functions as anticipated.	In all instances, the igrow-II Hair Growth System functioned as anticipated.

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number, but the study refers to "subjects" and "all of the subjects" in the active group demonstrating effectiveness, implying a sufficiently powered sample for the observed effect.
- Data Provenance: Prospective, multi-center, randomized, double-blinded, placebo-controlled trial conducted at two sites in the United States.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the summary. The "ground truth" seems to be based on an objective measurement: "increase in terminal hair counts," which would likely be quantified measurements rather than expert consensus on images.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method is not explicitly stated. The "ground truth" is based on "increase in terminal hair counts" as a primary outcome.
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, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This study is evaluating the device itself, not AI assistance for human reading.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The device (igrow-II Hair Growth System) was tested on its own, with subjects self-administering treatments, and its efficacy was measured against a placebo device. There is no human-in-the-loop component mentioned for interpreting results or guiding the device's action, only for administering the treatment.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The primary ground truth used was outcomes data, specifically "increase in terminal hair counts."
The sample size for the training set:
- Not applicable / Not explicitly stated. This is a performance study of a physical device, not an AI/algorithm that requires a training set in the typical sense. The summary mentions "Adequate data, from prior testing, was already available to the sponsor, validating the efficacy of the igrow-II Hair Growth System." This likely refers to previous internal testing and development, not a formal training set for an algorithm.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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122248

510(k) Summary

Apira Science, Inc.

DEC 0 5 2012

Submitter's Contact Information

Name:

· Raymond R. Blanche

Address

NST Consulting, LLC 641 Shunpike Road, Suite 311 Chatham, NJ 07928

Telephone: Facsimile:

(973-539-7444 (973) 539-7445

Name of Device and Name/Address of Sponsor

Trade Name:

igrow-II Hair Growth System

Sponsor Contact Information:

Morgan Pepitone Apira Science, Inc. 2601 Main Street, Suite 530 Irvine, CA 92614

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

Hairmax Lasercomb

·Lexington International, LLC

Reference Devices:

MEP-90

Midwest RF

Date Prepared:

July 20, 2012 November 13, 2012 Revised

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K122248/ 2/4

Intended Use / Indications for Use

The igrow-II Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Phototypes I to IV.

Technological Characteristics

Performance Data:

A multi-center, randomized, double blinded, placebo controlled, prospective trial was conducted at two sites in the United States. Subjects received either the igrow-II Hair Growth System, unlabeled with any markings or an equivalent, red light, incandescent light system. Identical, helmet housings were used for both light sources to further mask the actual test device from the placebo device. Adequate data, from prior testing, was already available to the sponsor, validating the efficacy of the igrow-II Hair Growth System , obviating the need to test lasers versus LEDs, which the sponsor and the FDA consider equal in their tissue interaction profile. All subjects self-administered treatments, at home, for 16 weeks, with either the actual test device or the placebo device. Treatments were administered every other day, for 20 minutes. Subjects treated in the actual test laser group demonstrated a 100 % effectiveness; that is, all of the subjects showed a positive result for an increase in terminal hair counts. In the placebo group, there was some increment over baseline and some demonstrated a decrease over baseline. Overall, the active group demonstrated a 39% positive variance over the placebo group from baseline. Most significant was the actual test group's decrease in terminal hair counts which was zero compared to the placebo group which was highly significant. This points strongly to the hypothesis that red laser and LED light's characteristics for delivering precise,

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122248 3/4

controlled, consistent irradiance is essential in effecting a reproducible therapeutic outcome . There were no anticipated adverse events and none were reported from either therapy administered that were study related. In all instances the igrow-II Hair Growth System functioned as anticipated and hair re-growth was observed to be significantly greater than that of the incandescent placebo system.

Substantial Equivalence

The igrow -II Hair Growth System is as safe and effective as the other device in its class, the Hairmax Lasercomb. This is a unique distinction for the sponsor of the igrow-II Hair Growth System because the Food and Drug Administration has created a new classification for this device, effective January 18, 2007. It is called OAP. There are no other devices listed within this classification, which the sponsor believes serves to narrow down the predicate device issue to one key comparison. Does the igrow-II Hair Growth System demonstrate substantial equivalence to the Hairmax Lasercomb for the indicated use and to the MEP for the specific design characteristic? The sponsor believes that with the exception of the configuration of the predicate device, the Hairmax Lasercomb, which is a hair comb configuration and the igrow-II Hair Growth System , is a helmet, the devices are identical in the key areas that effect safety and efficacy. The MEP -90 is offered as a reference proof of the functionality and acceptability of a helmet design, both technically and clinically.

Both systems, which use red light diode lasers and/or the equivalent, super-luminescent, light emitting diodes 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 the difference in the physical appearance or in the method of delivering the radiant energy of the two systems is of no consequence and does not effect the therapeutic value or the safety profile. The sponsor believes that difference between a hand-held laser system (the Hairmax Lasercomb) and one that is a hands-free helmet design (the igrow-II Hair Growth System ) does not create a performance difference, but rather a physical appearance difference only. This design difference is mitigated by the marketing clearance issued to the MEP90, which is also a helmet design , demonstrating that a hair comb style device is not a performance requirement for efficacy. Finally, the clinical data summarized in the 510(k) notice confirms the safety and efficacy of the igrow-II Hair Growth System for OTC Use, according to Part 21 CFR 801 Subpart C). For these reasons, the igrow-II Hair Growth System satisfies the FDA 's substantial equivalence with respect to intended use, technological and design characteristics.

With the relatively new classification of OAP, the sponsor respectfully proposes that the FDA has acknowledged that Low-Level Laser/Light Therapy is a viable modality for treating androgenetic alopecia in the specified patient group and that the red light lasers in class IIIa/3R. used in the igrow-II Hair Growth System, are substantially equivalent to the Hairmax Lasercomb .

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K 122248 4/4

The clinical data presented by the sponsor for the igrow-II Hair Growth System further validates that red light lasers are effective in promoting hair growth and does not present any safety issues. Therefore, the igrow-II Hair Growth System satisfied the FDA's substantial equivalence criteria. Thus, the FDA should clear the device via the 510(k) notice containing clinical data.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

IGrow II Hair Growth System % NST Consulting, LLC Mr. Raymond R. Blanche 641 Shunpike Road, Suite 311 Chatham. New Jersey 07928

December 5, 2012

Re: K122248

Trade/Device Name: igrow-II Hair Growth System Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, Non-Heating for Hair Growth Regulatory Class: Class II Product Code: OAP Dated: November 16, 2012 Received: December 03, 2012

Dear Mr. 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 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 device-related 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.

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Page 2 - Mr. Raymond R. Blanche

Enclosure

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific advice 10. your as meets offices/CDRH/CDRHOffices/ucm115809.htm for go to mtp.//www.luagemal Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radionanding by reference to premarket notification" (21CFR Part note the regulation entired, "Misoranants 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 Tou may obtain other general miormational 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

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'INDICATIONS FOR USE

510(k) Number: K 122248

Device Name: igrow-II Hair Growth System

Indications for Use:

The igrow-II Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of Ila to V and Fitzpatrick Classification of Skin Phototypes I to IV.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED)

Concurrence of CDRH, Office of device Evaluation (ODE)

Prescription Use _ X (Part 21 CFR 801 Subpart D)

ੰ ਪ੍ਰ

Over-the -Counter Use (Part 21 CFR 801 Subpart C)

Neil R Ogden 2012.12.03 14:33:36 -05'00' (Division Sign-off) for MXM Division of Surgical Devices 510(k) Number K122248

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Premarket Notification for the igrow-II Hair Growth System, Revised 11/13/2012

and the comments of the comments of the comments of the comments of the comments of

the submit and the submit of the subscription of the sub-

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.