(238 days)
The igrow-II Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
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. 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.
The provided text is a 510(k) Summary for the iGrow-II Hair Growth System. It describes a clinical study to demonstrate the device's performance. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical thresholds in the typical sense for a diagnostic device. Instead, it describes efficacy in terms of hair growth and safety. The primary performance metric is the increase in terminal hair counts and effectiveness against a placebo.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Promotion of Hair Growth (Primary Efficacy) | 100% effectiveness: All subjects in the active group showed a positive result for an increase in terminal hair counts. |
| Demonstrated superiority/positive variance over placebo (Efficacy) | The active group demonstrated a 39% positive variance over the placebo group from baseline. |
| Safety (Adverse Events) | No anticipated adverse events and none were reported from either therapy administered that were study-related. |
| Decrease in terminal hair counts (Measure of stability/efficacy) | The actual test group's decrease in terminal hair counts was zero, compared to the placebo group which was highly significant (implying the placebo group had decreases in some subjects). This is highlighted as pointing to the importance of precise, consistent irradiance. |
| Overall functionality | In all instances, the iGrow-II Hair Growth System functioned as anticipated. |
| Hair re-growth comparison | Hair re-growth was observed to be significantly greater than that of the incandescent placebo system. |
| Indication | Promote hair growth in females with androgenetic alopecia (Ludwig-Savin Classifications I-II, Fitzpatrick Skin Phototypes I to IV). (The reported performance directly supports this indication by showing increased hair growth in the study population, which aligns with these classifications through the inclusion criteria of the study, though the specific classifications of the subjects in the results are not further detailed.) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the exact number of subjects in the test set or placebo group. It uses the phrase "All subjects self-administered treatments..." and "All of the subjects showed a positive result for an increase in terminal hair counts." indicating a cohort of subjects. It also mentions "a multi-center, randomized, double blinded, placebo controlled, prospective trial." Without a specific numerical count, the exact sample size remains unclear from this document alone.
- Data Provenance:
- Country of Origin: United States ("two sites in the United States").
- Study Design: Prospective, multi-center, randomized, double-blinded, placebo-controlled trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information about experts establishing ground truth for the test set. The efficacy assessment centers on objective measures such as "increase in terminal hair counts" and "decrease in terminal hair counts," implying quantitative measurement rather than subjective expert consensus on the images themselves.
4. Adjudication method for the test set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set. The assessment appears to be based on direct measurement of terminal hair counts.
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
This is not applicable. The iGrow-II Hair Growth System is a low-level light therapy device (infrared lamp) for promoting hair growth, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The iGrow-II Hair Growth System is a physical device used by individuals for hair growth, not an algorithm.
7. The type of ground truth used
The ground truth for evaluating device efficacy was based on objective measurement of "terminal hair counts." This implies a quantitative assessment of hair growth, likely through direct counting or imaging analysis, rather than expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic study.
8. The sample size for the training set
The document mentions "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." However, it does not specify a separate "training set" or its sample size in the context of a new clinical trial for this specific submission. The details provided pertain to the prospective controlled trial described.
9. How the ground truth for the training set was established
As there's no explicitly defined "training set" for the current submission's clinical trial, details on how its ground truth was established are not provided. The phrase "prior testing" suggests earlier studies, but their methodology for establishing ground truth is not elaborated upon in this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2014
Apira Science Incorporated % Mr. Raymand R. Blanche NST Consulting, LLC 641 Shunpike Road, Suite 311 Chatham, New Jersey 07928
Re: K140931
Trade/Device Name: iGrow II Hair Growth System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: August 21, 2014 Received: October 9, 2014
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
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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 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
510(k) Number (if known)
Device Name
iGrow-II Hair Growth System
Indications for Use (Describe)
The igrow-II Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
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510(k) Summary
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Apira Science, Inc.
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Submitter's Contact Information
| Name: | Raymond R. Blanche |
|---|---|
| Address | NST Consulting, LLC641 Shunpike Road, Suite 311Chatham, 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 ContactInformation: | Morgan PepitoneApira Science, Inc.2601 Main Street, Suite 530Irvine, 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 |
|---|---|
| igrow II Hair Growth SystemHairmax Lasercomb | Apira Science, Inc.Lexington International, LLC |
| Reference Devices: | |
| MEP-90 | Midwest RF |
Date Prepared: March 24, 2014
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510(k) Summary
Apira Science, Inc.
:
:
Submitter's Contact Information
| Name: | Raymond R. Blanche |
|---|---|
| Address | NST Consulting, LLC641 Shunpike Road, Suite 311Chatham, NJ 07928 |
| Telephone: | (973) 539-7444 |
| Telephone: | (973) 539-7444 |
| Facsimile: | (973) 539-7445 |
Name of Device and Name/Address of Sponsor
| Trade Name: | igrow-II Hair Growth System |
|---|---|
| Sponsor ContactInformation: | Morgan PepitoneApira Science, Inc.2601 Main Street, Suite 530Irvine, 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 |
|---|---|
| igrow II Hair Growth SystemHairmax Lasercomb | Apira Science, Inc.Lexington International, LLC |
| Reference Devices: | |
| MEP-90 | Midwest RF |
| Date Prepared: | March 24, 2014 |
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Intended Use / Indications for Use
The igrow-II Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I- II and Fitzpatrick Skin Phototypes I to IV.
Technological Characteristics
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. The use of diode lasers and non-laser LEDs prov.des 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.
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 incremental improvement 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,
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.
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Substantial Equivalence
The igrow -II Hair Growth System is the identical device known as the igrow II Hair Growth System cleared under 510(k) K122248 for males. It is as safe and effective as the predicate device and theother 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 Igrow II Hair Growth System for males and 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 .
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.
§ 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.