(92 days)
The family of DermaScalp Laser Cap devices are indicated to treat Androgenetic Alpopecia and promote hair growth in Males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in Females who have Ludwig (Savin) Scale I-1 to I-4, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
The family of DermaScalp Laser Cap devices are a hands-free, portable, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Males and Females. The DermaScalp Laser Cap devices provide distributed red laser light dispersing from a "Concave" scalp covering utilizing laser modules with a 650 nm wavelength, <5 mW output power, producing a continuous wave "CW" output beam. The "Concave" scalp covering is designed to maximize the delivery of the coherent laser light to effectively cover the entire scalp of the user during treatment.
This document, a 510(k) Summary for the DermaScalp Laser Cap, describes performance data and criteria primarily in the context of demonstrating substantial equivalence to predicate devices, rather than a standalone evaluation against specific, quantitative acceptance criteria for its effectiveness in treating androgenetic alopecia and promoting hair growth.
The document focuses on comparing the DermaScalp Laser Cap's design, intended use, and general performance with existing FDA-cleared devices (predicates) to argue for substantial equivalence. It does not present a detailed study proving the device meets quantitative acceptance criteria for clinical efficacy through a direct clinical trial with a defined sample size and ground truth for efficacy.
However, it does describe a usability study with specific acceptance criteria.
Here's a breakdown of the information based on the provided document, addressing your specific questions to the best extent possible given the information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Usability Study) | Reported Device Performance (from Usability Study) |
|---|---|
| User comprehension of user instructions, warnings, and precautions resulting in a pass rate for self-selection | 93% pass rate (self-selection) |
| User comprehension of user instructions, warnings, and precautions resulting in a pass rate for user instruction questionnaire | 99.4% pass rate (user instruction questionnaire) |
| Compliance to design specifications for all functions | All functions verified to operate as designed. |
| Adherence to IEC 60601-1 and 60601-1-2 for LVD electrical and EMC safety requirements | Confirmed adherence. |
| Certification to Class 3R laser system according to IEC 60825-1 | Certified to classification 3R. |
| Compliance with IEC 60601-1-11:2015 for basic safety and essential performance in home use | Confirmed. |
| Same or similar Laser Wavelength as predicate devices | 650 nm (predicate devices range 635-678nm) |
| Same or similar Laser Power as predicate devices | <5 mW output power (continuous wave) |
| Same or similar Laser Energy Type as predicate devices | Not explicitly quantified, but generally "red laser light" |
| Same or similar Output Mode as predicate devices | "Continuous wave (CW)" output beam |
| Same or similar Treatment Time as predicate devices | 17 weeks, every other day (indefinite) |
| Same or similar Output Beam as predicate devices | Not explicitly quantified, but "coherent laser light" |
| Same or similar Laser Field Treatment Area as predicate devices | Designed to "effectively cover the entire scalp" |
| Same or similar Consumer Usage Focal Length as predicate devices | Not explicitly quantified |
| Biocompatibility adherence to ISO 10993-1:2009 and ISO 10993-5:2009 | Tested and adheres to requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Usability Study:
- Sample Size: 116 adult subjects
- Data Provenance: Not specified, but described as "diverse race, age, and educational background," suggesting a general population. This was a prospective study conducted by a "third party group."
- Performance Data (Technical): Not applicable for a typical "test set" in the context of clinical efficacy; this refers to technical compliance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Usability Study: The "ground truth" for the usability study was the actual user comprehension of instructions. It was evaluated via "user instruction questionnaire" and "self-selection" pass rates. This doesn't involve "experts" establishing ground truth in the clinical sense (e.g., diagnosing a condition). It's a measure of user understanding.
- Performance Data (Technical): The compliance was assessed against established standards (e.g., IEC standards), which represent accepted technical benchmarks. The document doesn't specify individual experts for establishing this ground truth, but rather adherence to recognized engineering and safety standards.
4. Adjudication Method for the Test Set
- Usability Study: This is not applicable in the typical sense of clinical adjudication (e.g., 2+1 for medical diagnoses). The pass rates were determined based on a questionnaire and self-selection criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. This document describes a medical device (laser cap) for hair growth, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant or reported here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm. The "performance data" refers to the device's technical specifications and safety compliance, not an algorithm's diagnostic performance.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- For Usability Study: User comprehension as measured by questionnaire responses and self-selection behavior.
- For Technical Performance: Adherence to international standards (e.g., IEC 60601-1, 60825-1, ISO 10993).
- For Clinical Efficacy (Implied): The document points to substantial equivalence to predicate devices that have prior FDA clearance, implying that the efficacy of low-level laser therapy (LLLT) for androgenetic alopecia has been established by those predicate devices. The current submission relies on the "same or similar Laser Wavelength, Laser Power, Laser Energy Type, Output Mode, Treatment Time, Output Beam, Laser Field Treatment Area, Consumer Usage Focal Length" as the predicates. This is a claim of equivalence based on shared technological characteristics rather than new clinical outcomes data from the DermaScalp device itself.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
In summary: The document primarily focuses on demonstrating substantial equivalence to pre-existing cleared devices based on technological characteristics and safety standards, along with a usability study. It does not present new, independent clinical efficacy data with a defined "ground truth" for hair growth established specifically for the DermaScalp Laser Cap in this 510(k) submission. The clinical efficacy is largely inferred from the equivalence to previously cleared predicate devices.
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March 21, 2018
DermaScalp LLC John Carullo Managing Member 190 E. Stacy Rd Suite 306-291 Allen, Texas 75002
Re: K173846
Trade/Device Name: D DermaScalp Laser Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: December 14, 2017 Received: December 19, 2017
Dear John Carullo:
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 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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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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -S3
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
510(k) Number (if known) K173846
Device Name DermaScalp Laser Cap
Indications for Use (Describe)
The family of DermaScalp Laser Cap devices are indicated to treat Androgenetic Alpopecia and promote hair growth in Males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in Females who have Ludwig (Savin) Scale I-1 to I-4, II-2, or frontal; both with Fitzpatrick Skin Types I to 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)
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ATTACHMENT 2
510(k) SUMMARY
| 510(k) Owner: | DermaScalp LLC190 E. Stacy Rd.Suite 306-291Allen, TX 75002Contact: John CarulloPhone: 214-683-0724 | ||||||
|---|---|---|---|---|---|---|---|
| Date Summary Prepared: | December 14, 2017 | ||||||
| Device: | Trade Name:DermaScalp Laser CapsCommon/Classification Name:Light Therapy Hair SystemProduct Code OAP21 C.F.R. § 890.5500 (Infrared lamp)Classification:Class II | Trade Name: | DermaScalp Laser Caps | Common/Classification Name: | Light Therapy Hair SystemProduct Code OAP21 C.F.R. § 890.5500 (Infrared lamp) | Classification: | Class II |
| Trade Name: | DermaScalp Laser Caps | ||||||
| Common/Classification Name: | Light Therapy Hair SystemProduct Code OAP21 C.F.R. § 890.5500 (Infrared lamp) | ||||||
| Classification: | Class II | ||||||
| Predicate Devices: | iGrow II Hair Growth System - Apira Science Inc - K152019Capillus82, Capillus202, Capillus272 Pro, 272 OfficePro, Capillus302, Capillus312, and Capillus352 – Capillus LLC – K163170Transdermal LaserCap80, LaserCap120, LaserCap224, LaserCap300 – K161875 | ||||||
| Reference Device: | DermaScalp Laser Cap - DermaScalp LLC - K152587 (Previously FDA cleared) |
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| DeviceDescription: | The family of DermaScalp Laser Cap devices are a hands-free, portable, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (HairLoss) and to promote hair growth in Males and Females. The DermaScalpLaser Cap devices provide distributed red laser light dispersing from a"Concave" scalp covering utilizing laser modules with a 650 nm wavelength,<5 mW output power, producing a continuous wave "CW" output beam. The"Concave" scalp covering is designed to maximize the delivery of the coherentlaser light to effectively cover the entire scalp of the user during treatment. |
|---|---|
| Intended Use: | The family of DermaScalp Laser Cap devices are indicated to treatAndrogenetic Alopecia and promote hair growth in Males who have NorwoodHamilton Classifications of IIa to V patterns of hair loss and to treatAndrogenetic Alopecia and promote hair growth in Females who have Ludwig(Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types Ito IV. |
| TechnologicalCharacteristics: | The family of DermaScalp Laser Cap devices are a hands-free portable devicethat produce red laser energy dispersed from a "Concave" scalp covering as itrests upon a user's head and creates a laser field that covers the users entirescalp area. The devices produce timed treatments of equally distributed laserenergy to the full scalp area. The treatment received from the laser energypromotes hair growth in both Males and Females and treats AndrogeneticAlopecia (Hair Loss) by the therapeutic modality of bio-stimulation. |
| BiocompatibilityData: | The construction of the family of DermaScalp Laser Cap devices do not raiseany biocompatibility issues. All the materials used in the construction of theDermaScalp devices were tested and adhere to the requirements of ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation andTesting within a Risk Management Process, as well as, adhere to therequirements of ISO 10993-5:2009 Biological Evaluation of Medical Devices --Part 5: Tests for in vitro cytotoxicity. |
| PerformanceData: | The evaluation of the perfomance data presented confirms that the family ofDermaScalp Laser Cap devices have the same or similar Laser Wavelength,Laser Power, Laser Energy Type, Output Mode, Treatment Time, OutputBeam, Laser Field Treatment Area, Consumer Usage Focal Length as the FDACleared predicate devices.Testing to IEC 60601-1 and 60601-1-2 confirm the devices adherence to LVDelectrical and EMC safety requirements. Testing to IEC 60825-1 certifies thelaser system to classifaction 3R, which is the same as the predicate devices.Testing to IEC 60601-1-11:2015 confirms the basic safety and essential |
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performance of medical electrical equipment and medical electrical systems for use in the home.
DermaScalp used a third party group to to administer a self-selection and usibility study to determine the user comprehension of user instructions, warnings, and precaustions. The testing was administered to 116 adult subjects of any age (>18) of diverse race, age, and educational background. The DermaScalp usibility test demonstrated a pass rate of 93% (self-selection) and 99.4% pass rate for the user instruction questionnaire, satisfying the FDA's requirements for clearance (sale) as Over-the-Counter Intended Use.
Performance Testing is conducted to confirm compliance to design specifications; all functions were verified to operate as designed. The DermaScalp devices met all acceptance criteria in the performance testing.
Substantial The family of DermaScalp Laser Cap devices referenced in this application are Equivalance: the same technology used by the LLLT devices cleared under device code OAP. The DermaScalp Laser Caps are as safe and effective as the predicate devices, as well as other reference devices in its class.
The sponsor believes that the difference in the physical appearance, number of diodes, or in the method of delivering the radiant energy of the systems is of no consequence and does not affect the therapeutic value or the safety profile. All compliant LLLT systems which use red light diode lasers are classified as class 3R laser systems according to 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.
| DermaScalp Devices | Capillus Devices | Transdermal Devices | iGrow | OAP Devices (General) |
|---|---|---|---|---|
| To Be Determined | K163170 | K161875 | K152019 | N/A |
| LLLT Device | LLLT Device | LLLT Device | LLLT Device | LLLT Device |
| OTC | OTC | Prescription | OTC | Prescription and OTC |
| Intended Use-Androgenetic Alopecia | Intended Use-Androgenetic Alopecia | Intended Use-Androgenetic Alopecia | Intended Use-Androgenetic Alopecia | Intended Use-Androgenetic Alopecia |
| Cap Design | Cap Design | Cap Design | Helmet Design | Helmet/Cap, Comb, Brush or Panel Design |
| 650nm | 650nm | 650nm | 655nm | 635-678nm |
| Marketing Clearance for Males & Females | Marketing Clearance for Males & Females | Marketing Clearance for Males & Females | Marketing Clearance for Males & Females | Marketing Clearance for Males & Females |
| Passive Use (hands free) | Passive Use (hands free) | Passive Use (hands free) | Passive Use (hands free) | Passive Use (hands free or comb) |
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| Diode Count- 50, 80,120, 148, 180, 202,224, 272 | Diode Count- 82,202, 272, 302, 312,352 | Diode Count- 80,120, 224, 300 | Diode Count- 51 | Diode Count- Rangesfrom1 to 352 |
|---|---|---|---|---|
| Classification: OAP | Classification: OAP | Classification: OAP | Classification: OAP | Classification: OAP |
| Fitzpatrick SkinPhototypes - I-IV | Fitzpatrick SkinPhototypes - I-IV | Fitzpatrick SkinPhototypes - I-IV | Fitzpatrick SkinPhototypes - I-IV | Fitzpatrick SkinPhototypes - I-IV |
| Ludwig-Savin I-II(females) | Ludwig-Savin I-II(females) | Ludwig-Savin I-II(females) | Ludwig-Savin I-II(females) | Ludwig-Savin I-II(females);Norwood HamiltonIIA-V (males);or both genders |
| Norwood Hamilton IIA-V (males) | Norwood HamiltonIIA-V (males) | Norwood HamiltonIIA-V (males) | Norwood HamiltonIIA-V (males) | |
| Treatment- 17weeks,every other day(indefinite) | Treatment- 17weeks,every other day(indefinite) | Treatment-17weeks, everyother day (indefinite) | Treatment-17weeks, everyother day(indefinite) | Treatment-approximately17weeks, everyother day (indefinite) |
| Total Laser EnergyOutput: <250mW,<400mW, <600mW,<740mW, <900mW,<1,010mW,<1,120mW,<1,360mW | Total Laser EnergyOutput: <410mW,<1,010mW,<1,360mW,<1,510mW,<1,560mW, and<1,760mW | Total Laser EnergyOutput: <400mW,<600mW,<1,120mW,<1,500mW | Total Laser EnergyOutput: <255mW | Total Laser EnergyOutput: Ranges from<5mW to <1,760mW |
| Device Class II | Device Class II | Device Class II | Device Class II | Device Class II |
For these reasons, the family of DermaScalp Laser Caps satisfy the FDA's substantial equivalence requirements with respect to intended use, technological and design characteristics. With reference to all devices cleared through the OAP device classification, the sponsor respectfully proposes that the FDA has acknowledged that Low-Level Laser/Light Therapy is a viable modality for treating androgenic alopecia in both genders and that the red light lasers in class 3R, used in the DermaScalp devices referenced in this application are substantially equivalent to the predicates. Additionally, no new safety or efficacy concerns are raised due to the minor differences present between devices.
- Conclusions: The family of DermaScalp Laser Cap devices are as safe and effective as the FDA Cleared predicate devices for male and female treatment, and is thefore Substantial Equivalent to the FDA Cleared predicate devices with respect to intended use, technological characteristics and safety characteristics.
§ 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.