iHelmet Hair Growth System (Model: LTD200S) 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.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the iHelmet Hair Growth System (Model: LTD200S). It focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria based on clinical outcomes.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies are not explicitly provided in this regulatory document. This document primarily addresses safety and performance through bench testing and comparison to a predicate device.

Here's a breakdown of the information that can be extracted or inferred from the provided text, addressing your points where possible:

1. A table of acceptance criteria and the reported device performance

The document does not present clinical acceptance criteria for hair growth or efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards. The "acceptance criteria" here are compliance with recognized safety standards and similarity to the predicate device.

Acceptance Criteria (Inferred from compliance)	Reported Device Performance (from "Test Summary" and "Comparison")
Safety Standards Compliance
IEC 60601-1 (General Safety)	Complied with IEC 60601-1
IEC 60601-1-2 (EMC)	Complied with IEC 60601-1-2
IEC 60825-1 (Laser Safety)	Class 3R (device classification per standard)
IEC 60601-1-11 (Home Healthcare Environment)	Complied with IEC 60601-1-11
ISO 10993-5 (Cytotoxicity)	Complied with ISO 10993-5 (Patient contacting materials)
ISO 10993-10 (Sensitization/Irritation)	Complied with ISO 10993-10 (Patient contacting materials)
Temperature between device & scalp	Highest temperature between iHelmet and scalp would not exceed 43°C during operation, meeting IEC 60601-1 requirement.
Functional/Technical Equivalence
Intended Use / Indications for Use	"Substantially Equivalent" to predicate device, indicated for promoting hair growth in females with Ludwig-Savin Class I - II and males with Norwood Hamilton Classifications IIa - V, both with Fitzpatrick Skin Phototypes I - IV.
Waveform	Visible red laser (identical to predicate)
Wavelength	650nm ± 10nm (very similar to predicate's 650nm)
Energy of per Laser Lamp	4~5mW (similar to predicate's <5mW)
Total treatment duration / frequency	Each Treatment: 20-35 min; Total Treatment: every other day, for 16 weeks (similar to predicate's 30 min, every other day, for 17 weeks)
Other parameters (Laser Lamp Amount, Treatment Area, Irradiance, Fluence)	Described as "a little difference" but within the range of the predicate device's several models and "will not raise any safety or effectiveness issue."

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 describes bench testing of the device for safety and compliance with standards. It does not mention a clinical test set of patients for efficacy evaluation in the way you might expect for an AI algorithm. Therefore, details about sample size, country of origin, or retrospective/prospective nature of a clinical efficacy study are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this document focuses on regulatory clearance via substantial equivalence and bench testing, not a clinical efficacy study relying on expert-established ground truth. Expert involvement would be for regulatory review, not for establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, for the same reasons as point 3.

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. The iHelmet Hair Growth System is a physical device (infrared lamp) for promoting hair growth, not an AI diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. The device's performance is standalone in its function as a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the safety aspects, the "ground truth" is compliance with international safety standards (e.g., IEC, ISO).
For the equivalence claim, the "ground truth" is the established safety and efficacy profile of the predicate devices.
There is no mention of a primary clinical efficacy study using patient outcomes data for the iHelmet itself to establish de novo "ground truth" for hair growth.

8. The sample size for the training set

Not applicable, as this is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI algorithm requiring a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" 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

April 4, 2017

Slinph Technologies Co., Ltd % Cecilia Ceng Manager Guangzhou Glomed Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, 510663 CN

Re: K162782

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: March 6, 2017 Received: March 9, 2017

Dear Cecilia Ceng:

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. Iisting 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

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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 (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.

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, 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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Indications for Use

510(k) Number (if known) K162782

Device Name

iHelmet Hair Growth System (Model: LTD200S)

Indications for Use (Describe)

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. Cecilia Ceng Guangzhou GLOMED Biological Technology Co., Ltd. Tel: +86-20-61099984 Email: regulatory@glomed-info.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

3. Predicate Device Information

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Sponsor: Slinph Technologies Co., LTD Subject Device: iHelmet Hair Growth System, Model: LTD200S File No.: 510(k) submission report (V1.0), Chapter 6

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

4. Device Description

5. Intended Use

iHelmet Hair Growth System, Model: LTD200S 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.

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	01/14/2014
IEC 60601-1-2	Medical electrical equipment - Part 1-2:General requirements for basic safetyand essential performance - Collateralstandard: Electromagneticcompatibility - Requirements and tests	2001+A1:2006	09/09/2008
IEC 60825-1	Safety of laser products - Part 1:Equipment classification andrequirements	2007	03/2007
IEC60601-1-11	Medical Electrical Equipment - Part 1-	2010	03/1/2011

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	11: General Requirements for BasicSafety and Essential Performance -Collateral Standard: Requirements forMedical Electrical Equipment andMedical Electrical Systems Used
ISO 10993-5(Cytotoxicity)	Biological evaluation of medicaldevices - Part 5: Tests for In Vitrocytotoxicity	2009	05/05/2010
ISO 10993-10(Sensitization andIrritation)	Biological evaluation of medicaldevices - Part 10: Tests for irritationand skin sensitization	2010	03/16/2010

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	Verdict
Company	Slinph Technologies Co., Ltd.	Capillus LLC	--
Trade Name	iHelmet Hair Growth System	Capillus272, Capillus202,Capillus82	--
ClassificationName	Infrared Lamp	Infrared Lamp	--
510(k) Number	K162782	K153618, K160285, K163170	--
Product Code	OAP	OAP	SE
Intended Use /Indications forUse	iHelmet Hair Growth System(Model: LTD200S) isindicated to promote hairgrowth in females withandrogenetic alopecia whohave Ludwig-SavinClassifications I - II, in maleswith androgenetic alopeciawho have Norwood HamiltonClassifications Ila - V and forboth, FitzpatrickClassification of SkinPhototypes of I - IV.	The Capillus272, Capillus202,Capillus82 are intended to treatAndrogenetic Alopecia andpromote hair growth in maleswho have Norwood HamiltonClassifications of Ila to Vpatterns of hair loss and totreat Androgenetic Alopeciaand promote hair growth infemales who have Ludwig(Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both withFitzpatrick Skin Types I to IV.	SE
Waveform	Visible red laser	Visible red laser	SE
Wavelength	650nm±10nm	650nm	SE
Amounts of	200	Capillus272: 272	SE

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Sponsor: Slinph Technologies Co., LTD Subject Device: iHelmet Hair Growth System, Model: LTD200S

Elements ofComparison	Subject Device	Predicate Device	Verdic
Laser Lamp		Capillus202: 202Capillus82: 82	Note 1
Energy of perLaser Lamp	4~5mW	<5mW	SE
Classificationaccording toIEC60825-1	Class 3R	Class 3R	SE
Treatment Time	Each Treatment: 20-35 minTotal Treatment: every otherday, for 16 weeks	Each Treatment: 30 minTotal Treatment: every otherday, for 17 weeks.	SENote 1
Treatment Area	424.93 cm2Mathematically Max. derived	Capillus272: 495.37 cm2Capillus202: 449.51 cm2Capillus82: 194.42 cm2Mathematically Max. derived	SENote 1
Irradiance(power per area)	2.3533 mW/cm2Mathematically Max. derived	Capillus272: 2.7454 mW/cm2Capillus202: 2.2469 mW/cm2Capillus82: 2.1088 mW/cm2Mathematically Max. derived	SENote 1
Fluence	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)	--	SENote 2
Weight	600g	--	SENote 2
Environment forOperation	Temperature: 15~~30°CHumidity: 30~~80% RHAtmosphere range:90~110kPa	--	SENote 2

dict te 1

Note 2

510(k) submission report (V1.0), Chapter 6 File No.:

Humidity: 0~ 80% RH

Complied with IEC 60601-1

materials are complied with

ISO 10993-5, ISO 10993-10

Atmosphere range:

and IEC 60601-1-2

All patient contacting

50~110kPa

Comparison in Detail(s):

Environment for

Safety Feature

Biocompatibility

Storage

Feature

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 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.

Complied with IEC 60601-1

All patient contacting materials

are complied with ISO 10993-

and IEC 60601-1-2

5, ISO 10993-10

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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

2 April 2017

Regulation Number and Section

§ 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.