(147 days)
The DermaScalp Laser Cap is indicated to promote hair growth in females with Androgenetic Alpopecia who have Ludwig-Savin Classifications I-II and who have Fitzpatrick Skin Types I to IV.
The DermaScalp MD Laser Cap and the DermaScalp MDX 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 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 describes the DermaScalp Laser Cap, a device for promoting hair growth in females with Androgenetic Alopecia. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance study with detailed acceptance criteria and a clinical trial.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of clinical efficacy endpoints (e.g., hair count increase, patient satisfaction). Instead, it relies on demonstrating that the new device has "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 FDA Cleared predicate devices."
The performance data listed confirms adherence to safety standards and comparison to predicate device specifications.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Clinical Efficacy (Not explicitly stated) | Similar to predicate devices' demonstrated efficacy in promoting hair growth in specified female population. | Not directly assessed with new clinical trials; deemed equivalent to predicate based on technological similarity. |
| Laser Wavelength | 650nm (as per predicate) | 650nm |
| Laser Power (each diode) | <5mW Per IEC 60825-1 (as per predicate) | <5mW Per IEC 60825-1 ED. 3.0 B:2014 |
| Laser Energy Type | Coherent Laser (as per predicate) | Coherent Laser |
| Output Mode | Continuous Wave "CW" (as per predicate) | Continuous Wave "CW" |
| Treatment Time | 30 minutes (as per predicate) | 30 minutes |
| Output Beam | Defined by "Concave" scalp covering (as per predicate) | Defined by "Concave" scalp covering |
| Laser Field Treatment Area | Entire Scalp Area (as per predicate) | Entire Scalp Area |
| Consumer Usage Focal Length | 0.5" - 1.5" from Emanating Diode Location (as per predicate) | 0.5" - 1.5" from Emanating Diode Location |
| Safety (Electrical/EMC) | Adherence to IEC 60601-1 and 60601-1-2 | Confirmed adherence |
| Safety (Laser Classification) | Classification 3R per IEC 60825-1 (as per predicate) | Certified to Classification 3R |
| Biocompatibility | Adherence to ISO 10993-1:2009 | All materials adhere to ISO 10993-1:2009 |
| Design Specifications | All functions operate as designed | Met all acceptance criteria in performance testing |
| Indications for Use (Female) | Ludwig (Savin) Classifications I-II, Fitzpatrick Skin Types I to IV | Same as predicate |
| Number of Laser Diodes | 80 for MD, 224 for MDX (as per predicate) | 80 for MD, 224 for MDX |
| Total Laser Energy Output | <400mW for MD, <1120mW for MDX (as per predicate) | <400mW for MD, <1120mW for MDX |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the context of a prospective clinical study directly comparing the new device's efficacy. The performance data presented refers to technical performance testing (e.g., electrical safety, EMC, laser classification, adherence to design specifications). Therefore, there's no clinical sample size or data provenance (country, retrospective/prospective) for a clinical test set in this submission. The device is cleared based on substantial equivalence to existing devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This is not applicable as there was no clinical test set for which ground truth needed to be established by experts for efficacy evaluation. The "ground truth" for the technical performance was based on engineering and safety standards (IEC, ISO).
4. Adjudication Method for the Test Set
Not applicable, as there was no clinical test set requiring adjudication.
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
Not applicable. This device is a laser therapy cap, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is also not applicable. The device is a physical therapeutic device, not an algorithm. The "performance data" section indicates engineering and safety tests were performed, which could be considered standalone performance for the device's technical specifications.
7. The Type of Ground Truth Used
For the technical performance of the device, the ground truth used was adherence to:
- International Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC safety), IEC 60825-1 (laser safety classification), and ISO 10993-1:2009 (biocompatibility).
- Design Specifications: The device was tested to confirm compliance to its design specifications.
For the clinical intended use, the "ground truth" for demonstrating substantial equivalence was effectively the clinical efficacy and safety profile of the predicate devices, which were already FDA cleared. The new device is argued to be safe and effective because its technological characteristics are the same or similar.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the traditional sense for algorithm development.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2016
Dermascalp LLC Mr. John Carullo Managing Member 1700 Alma Drive Suite 400 Plano, Texas 75075
Re: K152587
Trade/Device Name: DermaScalp Laser Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: November 20, 2015 Received: January 4, 2016
Dear Mr. 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 devicerelated 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.
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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/ResourcesforYou/Industry/default.htm. 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.
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,
Jennifer R. Stevenson -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152587
Device Name
DermaScalp Laser Cap Models: DermaScalp MD Laser Cap & DermaScalp MDX Laser Cap
Indications for Use (Describe)
The DermaScalp Laser Cap is indicated to promote hair growth in females with Androgenetic Alpopecia who have Ludwig-Savin Classifications I-II and who have 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 LLC1700 Alma Dr. Suite 400Plano, TX 75075Contact: John CarulloPhone: 214-683-0724 |
|---|---|
| Date Summary Prepared: | Sebtember 04, 2015 |
| Device: | |
| Trade Name: DermaScalp Laser Cap | |
| Common/Classification Name: Light Therapy Hair SystemProduct Code OAP | |
| 21 C.F.R. § 890.5500 (Infrared lamp) | |
| Classification: Class II | |
| Predicate Devices: | LaserCap Elite - Transdermal Cap Inc - K150613LaserCap PRO - Transdermal Cap Inc - K150613 |
| Device Description: | The DermaScalp MD Laser Cap and the DermaScalp MDX Laser Cap devicesare a hands-free, portable, non-invasive, low-level laser device intended totreat Androgenetic Alopecia (Hair Loss) and to promote hair growth inFemales. The DermaScalp Laser Cap devices provide distributed red laserlight dispersing from a "Concave" scalp covering utilizing laser modules witha 650 nm wavelength, <5 mW output power, producing a continuous wave"CW" output beam. The "Concave" scalp covering is designed to maximizethe delivery of the coherent laser light to effectively cover the entire scalp ofthe user during treatment. |
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| Intended Use: | The DermaScalp Laser Cap is indicated to promote hair growth in females withAndrogenetic Alpopecia who have Ludwig (Savin) Classifications I-II andwho have Fitzpatrick Skin Types I to IV. |
|---|---|
| TechnologicalCharacteristics: | The DermaScalp MD Laser Cap and the DermaScalp MDX Laser Cap devicesare a hands-free portable device that produce red laser energy dispersed from a"Concave" scalp covering as it rests upon a user's head and creates a laser fieldthat covers the users entire scalp area. The devices produce timed treatments ofequally distributed laser energy to the full scalp area. The treatment receivedfrom the laser energy promotes hair growth in Females and treats AndrogeneticAlopecia (Hair Loss) by the therapeutic modality of bio-stimulation. |
| BiocompatibilityData: | The construction of the DermaScalp MD Laser Cap and the DermaScalp MDXLaser Cap devices do not raise any biocompatibility issues. All the materialsused in the construction of the DermaScalp devices adhere to the requirementsof ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing within a Risk Management Process. |
| PerformanceData: | The evaluation of the perfomance data presented confirms that the DermaScalpMD Laser Cap and the DermaScalp MDX Laser Cap devices have the same orsimilar Laser Wavelength, Laser Power, Laser Energy Type, Output Mode,Treatment Time, Output Beam, Laser Field Treatment Area, Consumer UsageFocal Length as the FDA Cleared predicate devices.Testing to IEC 60601-1 and 60601-1-2 confirm the devices adherence to LVDelectrical and EMC safely requirements. Testing to IEC 60825-1 certifies thelaser system to classifaction 3R, which is the same as the predicate devices.Performance Testing is conducted to confirm compliance to designspecifications; all functions were verified to operate as designed. TheDermaScalp devices met all acceptance criteria in the performance testing. |
| Conclusions: | The DermaScalp MD Laser Cap and the DermaScalp MDX Laser Cap devicesare as safe and effective as the FDA Cleared predicate devices for femaletreatment and is thefore Substantial Equivalent to the FDA Cleared predicatedevices with respect to intended use, technological characteristics and safetycharacteristics. |
Substantial Equivalence Comparison Table
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| New Device | Predicate Device | |
|---|---|---|
| 510(k) # | K152587 | K150613 |
| Company | DermaScalp LLC | Transdermal Inc |
| Name | DermaScalp MD Laser Cap | LaserCap Elite |
| Indications for Use | The DermaScalp MD Laser Cap is indicatedto treat Androgenetic Alpopecia and topromote hair growth in Females who haveLudwig (Savin) I-II patterns of hair loss andwho have a Fitzpatrick Skin Types I to IV. | LaserCap Elite is indicated to treatAndrogenetic Alopecia and to promote hairgrowth in Females who have Ludwig(Savin) Hair Loss Classification of I to II,and who have a Fitzpatrick Skin Type ofI to IV. |
| Indicated Use On | Females | Females |
| Cleared Use for | Prescription Use | Prescription Use |
| Device Type | Scalp Covering Device | Scalp Covering Device |
| Laser Assembly | Red Laser Diodes mounted within a"Concave" scalp covering | Red Laser Diodes mounted within a"Concave" scalp covering |
| Wavelength | 650nm | 650nm |
| Output Beam | Continous Wave "CW" | Continous Wave "CW" |
| Laser Diode Power (each) | <5mW Per IEC 60825-1 ED. 3.0 B:2014 | <5mW Per IEC 60825-1 ED. 3.0 B:2014 |
| Number of LaserDiodes/Optics | Eighty (80) for Females | Eighty (80) for Females |
| Total Laser Energy Output | <400mW for Female use | <400mW for Female use |
| Light Energy Type | Coherent Laser | Coherent Laser |
| Laser Field | Entire Scalp Area | Entire Scalp Area |
| Laser Diode Array | Linear Rows within a"Concave" scalp covering | Linear Rows within a"Concave" scalp covering |
| Total Treatment Time | 30 minutes | 30 minutes |
| Device Application | Portable | Portable |
| Consumer UsageFocal Length | 0.5" - 1.5" from Emanating Diode Location | 0.5" - 1.5" from Emanating Diode Location |
| Ambient OperatingTemperature | 50° to 86°F (10° to 30°C) | 32° to 104°F (0° to 40°C) |
| Safety | CE Mark | CE Mark |
| User Manual | Yes | Yes |
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| Substantial Equivalence Comparison Table | ||
|---|---|---|
| ------------------------------------------ | -- | -- |
| New Device | Predicate Device | |
|---|---|---|
| 510(k) # | K152587 | K150613 |
| Company | DermaScalp LLC | Transdermal Inc |
| Name | DermaScalp MDX Laser Cap | LaserCap PRO |
| Indications for Use | The DermaScalp MDX Laser Cap isindicated to treat Androgenetic Alpopeciaand promote hair growth in Females whohave Ludwig (Savin) Hair LossClassification of I-II patterns of hair lossand Fitzpatrick Skin Types I to IV. | LaserCap PRO is indicated to treatAndrogenetic Alopecia and promote hairgrowth in Females who have Ludwig(Savin) Hair Loss Classification of I to II,and who have been determined to have aFitzpatrick Skin Type of I to IV. |
| Indicated Use On | Females | Females |
| Cleared Use for | Prescription Use | Prescription Use |
| Device Type | Scalp Covering Device | Scalp Covering Device |
| Laser Assembly | Red Laser Diodes mounted within a"Concave" scalp covering | Red Laser Diodes mounted within a"Concave" scalp covering |
| Wavelength | 650nm | 650nm |
| Output Beam | Continous Wave "CW" | Continous Wave "CW" |
| Laser Diode Power (each) | <5mW Per IEC 60825-1 ED. 3.0 B:2014 | <5mW Per IEC 60825-1 ED. 3.0 B:2014 |
| Number of LaserDiodes/Optics | Two hundred twenty-four (224)for Females | Two hundred twenty-four (224)for Females |
| Total Laser Energy Output | <1.120mW for Female use | <1,120mW for Female use |
| Light Energy Type | Coherent Laser | Coherent Laser |
| Laser Field | Entire Scalp Area | Entire Scalp Area |
| Laser Diode Array | Linear Rows within a"Concave" scalp covering | Linear Rows within a"Concave" scalp covering |
| Total Treatment Time | 30 minutes | 30 minutes |
| Device Application | Portable | Portable |
| Consumer UsageFocal Length | 0.5" - 1.5" from Emanating Diode Location | 0.5" - 1.5" from Emanating Diode Location |
| Ambient OperatingTemperature | 50° to 86°F (10° to 30°C) | 32° to 104°F (0° to 40°C) |
| Safety | CE Mark | CE Mark |
| User Manual | Yes | Yes |
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§ 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.