(70 days)
The igrow-II Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and Fitzpatrick Classification of Skin Phototypes of I-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 document is a 510(k) premarket notification for the igrow-II Hair Growth System. It describes the device, its intended use, and performance data related to its classification as an Over-The-Counter (OTC) device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Minimum of an 80% success rate for demonstrating comprehension of user instructions and warnings/precautions for Over-The-Counter (OTC) intended use. (Established during a Presubmission meeting with the FDA) | An 83.33% pass rate was achieved, satisfying the FDA's requirement for OTC Intended Use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 30 male subjects.
- Data Provenance: The document does not specify the country of origin. The study appears to be prospective, designed to assess the real-world capability of average male retail customers.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The study described refers to "comprehension of user instructions and warnings and precautions" for OTC use, not a clinical efficacy study with ground truth established by medical experts for hair growth. The ground truth here is the successful comprehension of the device's usage instructions by the test subjects. The document does not detail how this "successful comprehension" was measured or adjudicated beyond stating an 83.33% pass rate. No medical experts (e.g., dermatologists or radiologists) were involved in establishing this specific "ground truth."
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "pass rate" of 83.33% implies a direct assessment of each subject's comprehension against a predefined set of criteria, but the method of determining a "pass" or "fail" for each subject is not detailed.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a "Hair Growth System" (an infrared lamp), not an AI-powered diagnostic or assistive tool. The study described focuses on user comprehension for OTC classification, not a comparative effectiveness study involving human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical infrared lamp system, not an algorithm. The "performance data" refers to user comprehension of its operation for OTC classification, not an algorithm's performance.
7. The Type of Ground Truth Used
The "ground truth" for the performance data presented is the successful comprehension by test subjects of user instructions, warnings, and precautions related to the device's operation. This is in the context of obtaining an Over-The-Counter (OTC) classification, indicating the device can be used safely and effectively by consumers without professional medical guidance.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or algorithm development. The 30 male subjects were part of the testing for OTC comprehension.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no mention of a training set or associated ground truth establishment for an algorithm within the provided text. The study described is a human factors/usability assessment for OTC classification.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2014
Apira Science, Inc. % NST Consulting, LLC Raymond R. Blanche 641 Shunpike Road, Suite 311 Chatham, New Jersey 07928
Re: K141567
Trade/Device Name: igrow-II Hair Growth System Regulation Number: 21 CFR 890.5500 Regulatory Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: July 25, 2014 Received: July 31, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K141567
Device Name igrow-II Hair Growth System
The igrow-II Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and Fitzpatrick Classification of Skin Phototypes of I-IV
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 re garding 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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
{3}------------------------------------------------
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: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 |
|---|---|
| Hairmax Lasercomb | Lexington International, LLC |
Date Prepared:
February 10, 2014
{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 Classification 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 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.
Performance Data:
The data presented in this submission is restricted to Self -Selection and Usability to include comprehension of user instructions and warnings and precautions. The results of a Presubmission meeting provided the objectives that must be fulfilled for the igrow to be classified as an Over-the-Counter device. This guidance stipulated that a minimum of an 80% success rate must be achieved for the Intended Use of OTC to be granted. The testing was administered to 30 male subjects of any age, educational background, race, disease status present or pre-education about the testing to be performed. This was designed to provide for the broadest test criteria without any bias being imposed, thereby assessing the real world capability of the average male, "retail customer" who might wish to purchase a device without the benefit of a physician or other qualified health care provider to provide counsel as is the case with prescription devices.
{5}------------------------------------------------
The igrow testing demonstrated a pass rate of 83.33%, satisfying the FDA's requirements for an Over-the-Counter Intended Use.
Substantial Equivalence:
The requirements set for substantial equivalence in the traditional sense, do not have applicability in this process because the threshold for success has been set by the formal guidance provided to the sponsor by through the FDA's Presubmission Meeting process. However, The Hairmax Lasercomb has been cleared with the Intended Use of Over-the-Counter and therefore, the igrow Hair Growth System is substantially equivalent to the Hairmax Lasercomb by meeting or exceeding the minimum requirements set by the FDA's process of Presubmission Meeting guidance.
Revision.01. July 25, 2014
§ 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.