(402 days)
Tricoglam Home Use is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.
Tricoglam Home Use is a white and grey plastic helmet and inside is housed an electronic board with all the electrical components and a series of LED diodes on a wavelength, protected by a transparent plastic. The energy is distributed homogeneously. This Helmet is composed by 105 red LEDs arranged uniformly inside the helmet with a wavelength of 650 nm +/- 10 nm. The program consists of the lighting of all the red diodes for a duration of 20 min in continuous (every day). To start the treatment the user should press the button on the back and activate the program. All LEDs light up and, after the pre-set 20 minutes, all LEDs turn off.
The provided text is a 510(k) summary for the Tricoglam Home Use device, which is an infrared lamp for promoting hair growth. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information cannot be extracted directly from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria for clinical performance and corresponding reported device performance for the Tricoglam Home Use. Instead, it relies on demonstrating substantial equivalence to predicate devices which have already proven their safety and effectiveness.
The comparison table on page 5-6 primarily focuses on technical and operational characteristics between the new device and predicate devices, to show similarity for substantial equivalence. It does not list specific clinical acceptance criteria or performance metrics related to hair growth.
The closest to "acceptance criteria" for this device, based on the document, would be its intended use and indications, as well as compliance with safety standards.
| Criteria Type | Criteria (Implicitly from Indications for Use and Safety Standards) | Reported Device Performance (from "Substantial Equivalence" and "Performance Data" sections) |
|---|---|---|
| Clinical Performance | Promote hair growth in defined populations: - Females with androgenetic alopecia (Ludwig-Savin Classifications I - II) - Males with androgenetic alopecia (Norwood Hamilton Classifications IIa - V) - Both with Fitzpatrick Classification of Skin Phototypes I - IV. - Minimum duration of use: 16 weeks to achieve desired effect (inferred from predicate comparison) | No clinical trial data for the Tricoglam Home Use was submitted for this 510(k). The safety and effectiveness for its intended use are demonstrated via substantial equivalence to legally marketed predicate devices, which have similar indications and characteristics. The document states: "In addition all clinical data and all performance tests that have been performed in accordance with the Standards for the Software Evaluation and for the Electrical and Electromagnetic Safety test, in addition to the requirements for the laser products demonstrate that Tricoglam Home Use devices have safety and effectiveness for its intended use." Similarity to Predicate Devices: - Wearable Mounting: Helmet (same as most predicates). - Wavelength: 105 Red LEDs, 650 nm +/- 10nm (similar to predicates 620-660 nm or 650 nm). - Fluence: 1.2 J / cm² (similar to predicate 1 J/cm²). - Power output: 525 mW (similar range to predicates 400mW - 1.360mW). - Treatment Time: 20 minutes in continuous every day (similar to predicates, e.g., "Every other day 20-35 mins", "Every day 10 mins"). - Minimum duration of use: 16 weeks (same as some predicates, similar to 17 weeks for others). |
| Safety | Electrical Safety: Compliance with IEC 60601-1. Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2. General Safety Standards: Compliance with IEC 60601-1-11, IEC 60601-2-57, and IEC 62471 (for optical radiation safety, by inference from context). Biocompatibility: Materials (e.g., helmet plastic) compliant with ISO 10993-5 and ISO 10993-10. Human Factors: Evaluation following IEC 62366-1. | Non-clinical performance testing performed: - Evaluation to IEC 60601-1-2 (electrical safety and electromagnetic compatibility). - Conformance with IEC 60601-1-11, IEC 60601-2-57, and IEC 62471. - Material of the helmet are biocompatible according to ISO 10993-5 and ISO 10993-10. - Human factors evaluation of Tricoglam Home Use was considered following IEC 62366-1. - "Verification and validation data show that the device meets all product specifications." - "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical trial data for the Tricoglam Home Use was submitted for this 510(k)." Therefore, there is no "test set" in the context of a clinical performance study for this specific device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical trial data or associated "test set" was submitted for the Tricoglam Home Use device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical trial data or associated "test set" was submitted for the Tricoglam Home Use device.
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 an infrared lamp for hair growth, not an AI-assisted diagnostic tool involving "human readers."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an infrared lamp, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as "No clinical trial data for the Tricoglam Home Use was submitted for this 510(k)." The clearance is based on substantial equivalence to predicate devices that presumably demonstrated their efficacy through clinical data or known mechanisms of action.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/machine learning algorithm requiring a "training set."
Conclusion from document:
The FDA clearance (K193008) for the Tricoglam Home Use device is based on demonstrating substantial equivalence to several legally marketed predicate devices (Capillus 82, DermaScalp Laser Caps, Revian Red, Illumiflow Laser Cap), rather than new clinical trial data for the Tricoglam Home Use itself. The manufacturer submitted non-clinical performance data to confirm the device's electrical safety, electromagnetic compatibility, biocompatibility, and human factors compliance.
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December 3, 2020
Advihair S.R.L. Angleo D'Andrea Owner Via Benini 11 Zola Predosa, BO 40069 Italy
Re: K193008
Trade/Device Name: Tricoglam Home Use Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: September 25, 2020 Received: October 15, 2020
Dear Angleo D'Andrea:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193008
Device Name Tricoglam Home USE
Indications for Use (Describe)
Tricoglam Home Use is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, 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) |
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510 (k) SUMMARY K193008
SUBMITTER INFORMATION
| A. Company Name: | ADVIHAIR S.R.L. |
|---|---|
| B. Company Address: | Via Benini, 11, Zona industriale – 40069Zola Predosa (BO) |
| C. Company Phone:Company Fax:Company e-mail: | +39-0517554angelodandrea@cesareragazzi.it |
| D. Contact person: | Angleo D'AndreaOwnerADVIHAIR s.r.l. |
| E. Date Summary Prepared: | April 24th, 2019 |
DEVICE IDENTIFICATION
| A. Generic Device Name: | Physical Medicine Therapeutic Devices |
|---|---|
| B. Trade/Proprietary Name: | TRICOGLAM HOME USE |
| C. Classification: | Class II |
| D. Product Code: | OAP |
| E. Classification Panel: | 890 Physical Medicine Therapeutic Devices |
| F. Regulation Number: | 890.5500 |
LEGALLY MARKETED PREDICATE DEVICE
| Predicate device | 510 (k) Holder | 510 (k) No. | Date cleared |
|---|---|---|---|
| CAPILLUS 82 | Capillus LLC | K151516 | August 21st, 2015 |
| DermaScalp LaserCaps (Lasercap80,Lasercap 120) | Transdermal Cap, Inc. | K161875 | June 20th, 2018 |
| Revian Red | PhotonMD, Inc | K173729 | February 28th, 2018 |
| Illumiflow LaserCap | Eglobal, LLC | K162071 | January 23rd, 2017 |
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DEVICE DESCRIPTION
Tricoglam Home Use is a white and grey plastic helmet and inside is housed an electronic board with all the electrical components and a series of LED diodes on a wavelength, protected by a transparent plastic. The energy is distributed homogeneously.
This Helmet is composed by 105 red LEDs arranged uniformly inside the helmet with a wavelength of 650 nm +/- 10 nm
The program consists of the lighting of all the red diodes for a duration of 20 min in continuous (every day).
To start the treatment the user should press the button on the back and activate the program. All LEDs light up and, after the pre-set 20 minutes, all LEDs turn off.
Technical data
On the electronic board 105 LED diodes of the latest generation on one side and microelectronic components on the other are housed. The technology used is SMT (as in smartphones, computers, TV) that reduces size, weight and improves efficiency, thus ensuring lower thermal dissipation. On average, each LED produces an optical power of over 5 mW. The viewing angle is greater than 100° and the position of each LED on the electronic board is designed to make the irradiation more homogeneous, calculating the received energy exactly for each cm2 and avoiding the strongly illuminated areas. The total irradiated optical power is greater than 0.63 J. The total continuous energy dose for a 20-minute treatment time is about 1.2 J / cm2.
The power supply has a universal voltage input, so the device can be used anywhere without any intervention.
The home-use system is presented in a closed cardboard box without openings, on the four sides of the box are shown the images and texts of the product for the customer. Overall, the whole package is approximately 31 x 22 x 15 cm with a total weight of 1.20 kg.
The helmet is made of a white and smooth plastic and a colored border, weighs about 0.5 kg avoiding overloading the neck. The dimensions of the product are about 28x19x12 cm. 105 LED diodes equidistant on a flexible electronic board are arranged inside the helmet.
On the upper part of the helmet there are holes that allow the passage of air. During the treatment, the internal temperature undergoes a very modest increase, improving comfort for the user. On the back of the helmet there is the power button and a standard microUSB socket, through which you can power the helmet through any latest generation USB power supply.. Inside there is a rechargeable lithium ion battery that recharges using the same USB port. In this way, treatments can also be performed without connecting the helmet to an external power supply. Considering treatments lasting 20 minutes, the battery is able to ensure at least 2 complete treatments independently.
The maximum consumption of the helmet, considering also the recharge of the internal battery, is about 8W to 5V. The optimal operating temperature is between 16 ° C and 37 ° C.
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INDICATIONS FOR USE STATEMENT
Tricoglam Home Use is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.
SUBSTANTIAL EQUIVALENCE
All information provided with the present submission supports the substantial equivalence for the Tricoglam Home Use with the predicate device and its accessories that have identical characteristics and intended use and similar indication statement. In addition all clinical data and all performance tests that have been performed in accordance with the Standards for the Software Evaluation and for the Electrical and Electromagnetic Safety test, in addition to the requirements for the laser products demonstrate that Tricoglam Home Use devices have safety and effectiveness for its intended use.
The following matrix illustrates the equivalencies of the Tricoglam Home Use, as well as the substantial equivalent predicate devices.
| COMPARISON CHART TRICOGLAM HOME USE | females withandrogeneticalopecia whohave Ludwig-SavinClassifications I - II, inmales withandrogeneticalopecia whohaveNorwoodHamiltonClassifications IIa - V andfor both,FitzpatrickClassificationof SkinPhototypes ofI - IV. | have androgenicalopecia andLudwig-SavinClassificationsof I- II; and withFitzpatrickClassification ofSkin PhototypesI to IV. | hair growthin femaleswithandrogeneticalopecia whohaveLudwig-SavinClassifications of I- II,males withandrogeneticalopecia whohaveamilton-Norwoodclassifications IIa-Vand forboth genders,FitzpatrickClassificationof SkinPhototypes Ito IV | promote hairgrowth inmales whohaveNorwood-HamiltonClassificationsof IIa - Vpatterns of hairloss and totreatAndrogeneticAlopecia andpromote hairgrowth infemales whohave Ludwig-Savin Scale I-1to I-4, II-1, II-2 or frontalpatterns of hairloss; both withFitzpatrickSkin Types I -IV. | hair growth inmales withandrogenicalopecia whohaveNorwood-Hamiltonclassifications of IIa to Vor femaleswithandrogenicalopecia whohaveLudwig-SavinClassifications of I - IIand bothwithFitzpatrickSkinPhototypes Ito IV. | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ADVIHAIRS.R.L.TRICOGLAMHOME USENew Device | CAPILLUS LLCCapillus 82Predicate device | TRANSDERMAL CAP,INC.LaserCap80LaserCap120Predicatedevice | PHOTO MED,INCRevian RedPredicate device | EGLOBAL,LLCIllumiflowLaser CapPredicatedevice | WearableMounting | Helmet | Helmet/CapDesign | Helmet/CapDesign | Textile Cap | Helmet/CapDesign | |
| "K" NUMBERS | K193008 | K151516 | K161875 | K173729 | K162071 | Lasercap80: 80Red LaserDiode650 nmLasercap120:120 Red LaserDiode650 nm | |||||
| Proprietary name | TricoglamHome Use | Capillus 82 | LaserCap80LaserCap120 | Revian Red | IllumiflowLaser Cap | Wave-Length(s)and visible lightsource | 105 Red LEDs650 nm +/-10nm | 82 Red LaserDiode650 nm | 119 Red LEDs-620 - 660 nm | 272 Red LaserDiode650 nm | |
| CFR Section | 890.5500 | 890.5500 | 890.5500 | 890.5500 | 890.5500 | Fluence | 1,2 J / cm² | 1 J / cm² | |||
| Pro-code | OAP | OAP | OAP | OAP | OAP | Power output | 525 mW | 410 mW | 400mW | 1 J / cm² | 1.360mW |
| Classificationname | Infraredlampper 21CFR890.5500 | Infrared lamp per21 CFR 890.5500 | Infraredlampper 21CFR890.5500 | Infraredlampper 21CFR890.5500 | Infrared lampper 21 CFR890.5500 | ||||||
| Intended /Indications foruse | TricoglamHome Use isindicatedtopromote hair | The Capillus82is indicated topromote hairgrowth in | LaserCap120,andLaserCap80are indicated | Revian Red isindicatedtotreatAndrogeneticAlopeciaand | TheillumiflowLaser Cap isindicatedtopromote hair | Treatment Time | 20 minutes incontinuousevery day | Every other day20-35 mins | 2 times / week20 mins | Every day10 mins | Every otherday30 mins |
| Minimumduration of use | 16 weeks | 17 weeks | 17 weeks | 16 weeks | 16 weeks |
PREDICATE DEVICES COMPARISON CHART Table 1
Confidential
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| Battery | Rechargeable | Rechargeable | Rechargeable | Rechargeable | Rechargeable |
|---|---|---|---|---|---|
| battery | battery | battery | battery | battery | |
| Other DesignCharacteristics | aftercompletionof time, unitpowers downTricoglamHomeUsedoesnotcontaina'safetyinterlock'whichautomaticallypauses therapyif the subject'shead is in aless-than-optimalposition. | aftercompletionof time, unitpowers down | aftercompletionof time, unitpowers down | Cap pausestherapyifsubject'shead movesoutside zone ofradiation; aftercompletion oftreatment, unitpowers down,limits dailytreatment to 10mins, andprovidestreatmentreminders andmessages viamobile appcontroller | TheIllumiflowLaser Capdoes notcontain a'safetyinterlock'whichautomaticallypausestherapy if thesubject's headis in a less-than-optimalposition.TheillumiflowLaser Capdoes notutilize audibletones at thebeginning orend oftreatment. |
TECHNICAL CHARACTERISTICS
A comparison of the technological characteristics of Tricoglam Home Use and the predicate devices has been performed. The results of this comparison demonstrate that the technologic characteristics and the operating principle of the Tricoglam Home Use are the same or very similar to those of the claimed predicate devices. Where any differences arise from the analysis of the predicate device characteristics and those of the device subject of this submission, the clinical data evaluated from scientific publications give scientific evidence of the safety and the effectiveness of the Tricoglam Home Use devices. The system was evaluated and found compliant with IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMI/EMC, and 10993-1 for biocompatibility of the treatment tips. Verification and validation data show that the device meets all product specifications.
PERFORMANCE DATA
No clinical trial data for the Tricoglam Home Use was submitted for this 510(k).
To demonstrate substantial equivalence to the predicate device non clinical performance testing have been performed included evaluation to IEC 60601-1-2 to confirm the device's electrical safety and electromagnetic compatibility and conformance with IEC 60601-1-11, IEC 60601-2-57, and IEC 62471.
Material of the helmet are biocompatible according to ISO 10993-5 and ISO 10993-10. Performance verification and validation testing demonstrates that Tricoglam Home Use meets user needs and design inputs and met requirements for its intended use.
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Studies Related to Human Factors Evaluation: Human factors evaluation of Tricoglam Home Use was considered following IEC 62366-1.
Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.
CLINICAL DATA
The devices have been designed and validated in such a way that, when used under the conditions and for the purposes intended, it will not compromise the clinical condition or the safety of patients, or the safety and health of users or other people, provided that any risk which may be associated with its use constitute acceptable risks when weighed against the benefits to the patient and is compatible with a high level of protection of health and safety.
CONCLUSION
Based on the foregoing, the Tricoglam Home Use is substantially equivalent to the legally marketed, claimed predicate devices for the purposes of this 510 (k) submission. Safety and effectiveness were reasonably assured, justifying 510 (k) clearance.
§ 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.