(70 days)
Not Found
No
The device description focuses on hardware components (lasers, LEDs) and basic automated functions (pausing therapy based on head position, audible signal). There is no mention of AI/ML terms, image processing, or data analysis that would suggest the use of such technologies. The performance studies are focused on usability and comprehension, not algorithmic performance.
Yes
The device is indicated to "promote hair growth" for a specific medical condition (androgenetic alopecia), which is a therapeutic purpose.
No
The device is indicated to promote hair growth, which is a therapeutic function, not a diagnostic one. It does not identify or detect a disease or condition.
No
The device description explicitly states it consists of hardware components: "21 red visible light, diode lasers and 30 red light super-luminescent diodes configured within an outer helmet and protective inner." This indicates it is a hardware device with integrated software for control and operation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The igrow-II Hair Growth System is a helmet that uses light therapy (lasers and LEDs) applied externally to the head. It does not involve testing samples from the body.
- Intended Use: The intended use is to promote hair growth in males with androgenetic alopecia, which is a therapeutic application, not a diagnostic one.
- Lack of IVD Indicators: The description does not mention any elements typically associated with IVDs, such as sample collection, analysis of biological markers, or diagnostic results.
Therefore, the igrow-II Hair Growth System is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
OAP
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The test subjects were "30 male subjects of any age." The indications for use specify males with androgenetic alopecia.
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data presented in this submission is restricted to Self -Selection and Usability to include comprehension of user instructions and warnings and precautions. The testing was administered to 30 male subjects. The igrow testing demonstrated a pass rate of 83.33%, satisfying the FDA's requirements for an Over-the-Counter Intended Use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pass rate of 83.33% for Over-the-Counter Intended Use based on self-selection and usability comprehension.
Predicate Device(s)
Hairmax Lasercomb
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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, 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 |
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.