(303 days)
iHelmet Hair Growth System (LTD88Lite, LTD36Air, LTD160Pro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
iHelmet Hair Growth System consists of laser diodes that are spread throughout the helmet. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. The product will pause automatically treatment if the sensor detects that the head is not in close proximity to the sensor, and will resume again once close enough. At the end of the treatment, an audible tone beeps to indicate the treatment is over and then the helmet automatically shut off.
Here's an analysis of the provided text regarding the iHelmet Hair Growth System's acceptance criteria and studies, organized according to your requested points.
It's important to note that this document is a 510(k) summary for a medical device aiming for substantial equivalence to existing devices. As such, the "studies" described primarily focus on bench testing and comparisons to predicates to demonstrate safety and performance under established standards, rather than formal clinical effectiveness trials with human subjects. There is no mention of a traditional algorithm-based AI system with ground truth development in the context of the provided document. The device is a physical product (infrared lamp for hair growth), not a diagnostic AI system.
Therefore, many of your requested points regarding AI-specific criteria (e.g., ground truth establishment for a test set, AI vs. human reader effectiveness, adjudication methods) are not applicable or cannot be extracted from this documentation.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on compliance with various international standards for medical electrical equipment, laser safety, and biocompatibility, as well as maintaining specific physical and operational parameters. The reported performance is the device's adherence to these standards and its performance within defined limits, making it "substantially equivalent" to predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 (General Requirements for Safety) | Complied with IEC 60601-1 (2005+A1:2012) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (EMC Requirements and tests) | Complied with IEC 60601-1-2 (Edition 4.0 2014-02) |
| Laser Safety | Compliance with IEC 60825-1 (Equipment classification and requirements) | Complied with IEC 60825-1 (2007-03); Classified as Class 3R (matching predicates) |
| Home Healthcare Environment Safety | Compliance with IEC 60601-1-11 (Requirements for Medical Electrical Equipment and Systems Used) | Complied with IEC 60601-1-11 (2010) |
| Biocompatibility (Cytotoxicity) | Compliance with ISO 10993-5 (Tests for In Vitro cytotoxicity) | All patient contacting materials are complied with ISO 10993-5 (2009) |
| Biocompatibility (Sensitization & Irritation) | Compliance with ISO 10993-10 (Tests for irritation and skin sensitization) | All patient contacting materials are complied with ISO 10993-10 (2010) |
| Temperature | Max. temperature between device and scalp not to exceed 43°C during operation (per IEC 60601-1) | Temperature test conducted; highest temperature between iHelmet and scalp would not exceed 43°C during operation. |
| Operational and Physical Parameters | Parameters (e.g., wavelength, power, treatment time, etc.) to be within clinically acceptable ranges and comparable to predicates to claim substantial equivalence. | Wavelength: 650nm±10nm (matches predicates) Energy per Laser Lamp: 4~5mW (matches predicates) Classification (Laser): Class 3R (matches predicates) Differences in Laser Lamp Amounts, Treatment Time, Treatment Area, Irradiance, Fluence: Acknowledged but "can be covered by predicate device's several models' range" and "will not raise any safety or effectiveness issue." |
| Mechanical/Environmental Parameters | Weight, Dimensions, Environment for Operation/Storage to be acceptable for intended use. | Differences from predicates acknowledged but "will not affect the main function and the intended use of the device as they all also comply with IEC 60601-1 requirements" and "will not affect the critical functions or the normal use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of human subjects or a data test set for an AI model. The "test set" in this document refers to the physical device undergoing various bench tests and comparisons against engineering specifications and predicate devices. No specific "sample size" of a dataset for algorithmic evaluation is mentioned because this is not an AI diagnostic or analytical device.
- Data Provenance: Not applicable. The "data" here comes from direct measurements and compliance testing of the physical iHelmet device itself, against pre-defined engineering standards and benchmarks set by predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This document does not describe the establishment of ground truth by experts for a dataset, as it pertains to a physical medical device (infrared lamp) for hair growth, not an AI system that interprets data or images. The "ground truth" for this device's performance is adherence to established engineering standards and safety limits, and demonstration of substantial equivalence to already cleared devices.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical trials or studies to resolve discrepancies among human readers or experts when establishing ground truth for diagnostic AI. This document describes bench testing and comparison studies of a physical 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
- No. An MRMC study is not mentioned as this device is not an AI-assisted diagnostic tool for human readers. It is a direct-to-consumer medical device for hair growth.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm. It is a physical device.
7. The Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on adherence to international consensus standards (e.g., IEC, ISO) for electrical safety, laser safety, biocompatibility, and performance, along with demonstrating substantial equivalence to previously cleared predicate devices.
- For biological parameters like hair growth, the ground truth for the predicate devices' effectiveness would have been established through clinical trials (but those trials are not part of this 510(k) submission, which relies on the predicate's prior clearance). The current submission focuses on demonstrating that the new device meets the same safety and performance profiles as the predicates.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI system that requires a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no AI training set, there's no ground truth establishment for it.
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December 23, 2019
Slinph Technologies Co., LTD % S K Manager SK Medical Device International Corp. Suite 52, Floor 16, No. 119 Xing Guang Ying Jing, Shui Ying Road Guangzhou, 51006 CN
Re: K190467
Trade/Device Name: iHelmet Hair Growth System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: November 21, 2019 Received: November 25, 2019
Dear S K:
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.
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
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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 (QS) 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,
Jessica Mavadia-Shukla Acting 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) K190467
Device Name
iHelmet Hair Growth System, Model: LTD88Lite, LTD36Air, LTD160Pro
Indications for Use (Describe)
iHelmet Hair Growth System (LTD88Lite, LTD36Air, LTD160Pro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Chapter 6. 510(k) Summary
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 890.5500.
1. Submitter Information
Sponsor Name: Slinph Technologies Co., Ltd. Address: Room 211, Building B, 1970 Cultural and Creative Industrial Park, Minzhi Street, Longhua, Shenzhen, China. Contact name: Zou Jian (General Manager) Tel: +86-158 1556 8501 Fax: 0755-83461353 Email: kevinzou@slinph.com
Application Correspondent:
Contact Person: Ms. SK Tel: +86-18620793542 Email: medical-device@qq.com
2. Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Lamp, non-heating, for promotion of hair growth |
| Trade Name: | iHelmet Hair Growth System |
| Classification Name: | Infrared lamp per 21 CFR 890.5500 |
| Review Panel: | General & Plastic Surgery |
| Product Code: | OAP |
| Regulation Number: | 21 CFR 890.5500 |
| Regulation Class: | 2 |
Predicate Device Information 3.
Predicate device 1
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Sponsor: Slinph Technologies Co., LTD Subject Device: iHelmet Hair Growth System, Model: LTD88Lite, LTD 36Air, LTD160Pro File No.: 510(k) submission report (V1.0), Chapter 6
| Sponsor | iHelmet Hair Growth System |
|---|---|
| Common Name | Lamp, non-heating, for promotion of hair growth |
| Trade Name | LTD200S |
| Classification Name | Infrared lamp per 21 CFR 890.5500 |
| 510(k) number | K162782 |
| Review Panel | General & Plastic Surgery |
| Product Code | OAP |
| Regulation Number | 21 CFR 890.5500 |
| Regulation Class | 2 |
| Predicate device 2 | |
|---|---|
| Sponsor | Capillus, LLC. |
| Common Name | Lamp, non-heating, for promotion of hair growth |
| Trade Name | Capillus272, Capillus202, Capillus82 |
| Classification Name | Infrared lamp per 21 CFR 890.5500 |
| 510(k) number | K153618, K160285, K163170 |
| Review Panel | General & Plastic Surgery |
| Product Code | OAP |
| Regulation Number | 21 CFR 890.5500 |
| Regulation Class | 2 |
Device Description 4.
iHelmet Hair Growth System consists of laser diodes that are spread throughout the helmet. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. The product will pause automatically treatment if the sensor detects that the head is not in close proximity to the sensor, and will resume again once close enough. At the end of the treatment, an audible tone beeps to indicate the treatment is over and then the helmet automatically shut off.
5. Intended Use
iHelmet Hair Growth System (Model: LTD88Lite, LTD36Air, LTD160Pro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
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Test Summary 6.
iHelmet Hair Growth System has been evaluated the safety and performance by lab bench testing according to the following standards:
| Standards No. | Standard Title | Version | Date |
|---|---|---|---|
| IEC 60601-1 | Medical Electrical Equipment - Part 1:General Requirements for Safety | 2005+A1:2012 | 07/09/2014 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2:General requirements for basic safetyand essential performance - Collateralstandard: Electromagneticcompatibility - Requirements and tests | Edition 4.0 2014-02 | 06/27/2016 |
| IEC 60825-1 | Safety of laser products - Part 1:Equipment classification andrequirements | 2007-03 | 07/09/2014 |
| IEC60601-1-11 | Medical Electrical Equipment - Part 1-11: General Requirements for BasicSafety and Essential Performance -Collateral Standard: Requirements forMedical Electrical Equipment andMedical Electrical Systems Used | 2010 | 06/27/2016 |
| ISO 10993-5(Cytotoxicity) | Biological evaluation of medicaldevices - Part 5: Tests for In Vitrocytotoxicity | 2009 | 12/23/2016 |
| ISO 10993-10(Sensitization andIrritation) | Biological evaluation of medicaldevices - Part 10: Tests for irritationand skin sensitization | 2010 | 07/26/2016 |
Except for the tests mentioned above, we have conducted the temperature test on the iHelmet Hair Growth System to prove that the highest temperature between iHelmet Hair Growth System and scalp would not exceed 43°C during operation, which is meet the requirement of safety standard IEC 60601-1.
7. Comparison to Predicate Device
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
|---|---|---|---|---|
| Company | Slinph TechnologiesCo., Ltd. | Slinph TechnologiesCo., Ltd. | Capillus LLC | -- |
| Trade Name | iHelmet Hair GrowthSystem | iHelmet Hair GrowthSystem | Capillus272,Capillus202,Capillus82 | -- |
| ClassificationName | Infrared Lamp | Infrared Lamp | Infrared Lamp | -- |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device2 | Verdict |
| 510(k) Number | Applying | K162782 | K153618,K160285, K163170 | -- |
| Product Code | OAP | OAP | OAP | SE |
| Intended Use /Indications forUse | iHelmet Hair GrowthSystem (Model:LTD88Lite,LTD36Air,LTD160Pro) isindicated to promotehair growth infemales withandrogeneticalopecia who haveLudwig-SavinClassifications I - II,in males withandrogeneticalopecia who haveNorwood HamiltonClassifications Ila - Vand for both,FitzpatrickClassification of SkinPhototypes of I - IV. | iHelmet Hair GrowthSystem (Model:LTD200S) isindicated topromote hair growthin females withandrogeneticalopecia who haveLudwig-SavinClassifications I - II,in males withandrogeneticalopecia who haveNorwood HamiltonClassifications Ila -V and for both,FitzpatrickClassification ofSkin Phototypes of I- IV. | The Capillus272,Capillus202,Capillus82 areintended to treatAndrogeneticAlopecia andpromote hairgrowth in maleswho have NorwoodHamiltonClassifications ofIla to V patterns ofhair loss and totreat AndrogeneticAlopecia andpromote hairgrowth in femaleswho have Ludwig(Savin) Scale I-1 to1-4, II-1, II-2, orfrontal; both withFitzpatrick SkinTypes I to IV. | SE |
| Waveform | Visible red laser | Visible red laser | Visible red laser | SE |
| Wavelength | 650nm±10nm | 650nm±10nm | 650nm | SE |
| Amounts of LaserLamp | LTD88Lite: 88LTD36Air: 36LTD160Pro: 160 | 200 | Capillus272: 272Capillus202: 202Capillus82: 82 | SENote 1 |
| Energy of perLaser Lamp | 4~5mW | 4~5mW | <5mW | SE |
| Classificationaccording toIEC60825-1 | Class 3R | Class 3R | Class 3R | SE |
| Treatment Time | Each Treatment: 20-35 minTotal Treatment:every other day, for16 weeks | Each Treatment:20-35 minTotal Treatment:every other day, for16 weeks | Each Treatment: 30minTotal Treatment:every other day, for17 weeks. | SENote 1 |
| Treatment Area | LTD88Lite: 220.61cm²LTD36Air: 86.3 cm²LTD160Pro: 338.42cm²Mathematically Max.derived | 424.93 cm²MathematicallyMax. derived | Capillus272:495.37 cm²Capillus202:449.51 cm²Capillus82: 194.42cm²MathematicallyMax. derived | SENote 1 |
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Sponsor: Slinph Technologies Co., LTD Subject Device: iHelmet Hair Growth System, Model: LTD88Lite, LTD 36Air, LTD160Pro File No.: 510(k) submission report (V1.0), Chapter 6
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| Sponsor: | Slinph Technologies Co., LTD |
|---|---|
| Subject Device: | iHelmet Hair Growth System, Model: LTD88Lite, LTD 36Air, LTD160Pro |
| File No.: | 510(k) submission report (V1.0), Chapter 6 |
| Elements ofComparison(per area) | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
|---|---|---|---|---|
| mW/cm²LTD36Air: 2.0857 mW/cm²LTD160Pro: 2.3639 mW/cm²Mathematically Max. derived | Mathematically Max. derived | 2.7454 mW/cm²Capillus202: 2.2469 mW/cm²Capillus82: 2.1088 mW/cm²Mathematically Max. derived | Note 1 | |
| Fluence | LTD88Lite: 4.1883 J/cm²LTD36Air: 4.3801 J/cm²LTD160Pro: 4.9642 J/cm²Mathematically Max. derived | 4.9420 J/ cm²Mathematically Max. derived | Capillus272: 4.9417 J/cm²Capillus202: 4.044 J/cm²Capillus82: 3.7920 J/cm²Mathematically Max. derived | SENote 1 |
| Dimension | 266mm x 196mm x 135mm(L x W x H) | 266mm x 196mm x 135mm(L x W x H) | -- | SENote 2 |
| Weight | LTD88Lite: about 550gLTD36Air: about 500gLTD36Air: about 600g | 600g | -- | SENote 2 |
| Environment forOperation | Temperature: 15 | Temperature: 15 | -- | SENote 2 |
| Environment forStorage | Temperature: - 20 | Temperature: - 20 | -- | SENote 2 |
| Safety Feature | Complied with IEC 60601-1 and IEC 60601-1-2 | Complied with IEC 60601-1 and IEC 60601-1-2 | Complied with IEC 60601-1 and IEC 60601-1-2 | SE |
| BiocompatibilityFeature | All patient contactingmaterials arecomplied with ISO10993-5, ISO 10993-10 | All patientcontacting materialsare complied withISO 10993-5, ISO10993-10 | All patientcontactingmaterials arecomplied with ISO10993-5, ISO10993-10 | SE |
Comparison in Detail(s):
Note 1:
Although the "Amounts of Laser Lamp", "Treatment Time", "Treatment Area", "Irradiance", and "Fluence" of subject device and predicate device are a little difference, the energy and power
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| Sponsor: | Slinph Technologies Co., LTD |
|---|---|
| Subject Device: | iHelmet Hair Growth System, Model: LTD88Lite, LTD 36Air, LTD160Pro |
| File No.: | 510(k) submission report (V1.0), Chapter 6 |
parameters' range of subject device can be covered by predicate device's several models' range; they are very similar. So these parameters' differences will not raise any safety or effectiveness issue.
Note 2:
Although the "Weight", "Dimensions", "Environment for Operation", "Environment for Storage" of subject device are different from the predicate device, it will not affect the main function and the intended use of the device as they all also comply with IEC 60601-1 requirements. Besides, the subtle changes of the physical characteristics will not affect the critical functions or the normal use.
8. Conclusion
The subject device iHelmet Hair Growth System has all features of the predicate devices. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate devices.
9. Summary Prepared Date 19 February 2019
§ 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.