Promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.

Device Description

Hair Up shares great similarities with predicate device which is currently market cleared for promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.

Both Hair Up and its predicate device both consist of 21 red visible laser diodes (LDs) and 30 red light emitting diodes (LEDs) configured within an outer helmet and protective inner liner. The use of LDs and LEDs provides for a full coverage of the upper 1/3 of the head where commonly covered with stylized hair. The system will automatically pause therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down.

AI/ML Overview

The provided document is a 510(k) summary for the "Hair Up" device, which is an infrared lamp for hair growth. This document primarily focuses on establishing substantial equivalence to a predicate device (iGrow-II Hair Growth System, K141567) based on technical characteristics and intended use.

However, the document does not contain the acceptance criteria or a study proving the device meets specific acceptance criteria related to its clinical efficacy (promotion of hair growth). The "Performance Data" section (number 6) only discusses non-clinical tests related to safety, electrical requirements, and risk management, which are typically standard compliance tests rather than clinical performance studies with acceptance criteria.

Therefore, most of the information requested in your prompt regarding acceptance criteria and studies proving the device meets them cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided. The document does not state specific clinical acceptance criteria (e.g., minimum percentage increase in hair count or density) nor does it report the device's performance against such criteria. The "Performance Data" section describes non-clinical engineering and safety compliance tests, not clinical efficacy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not describe any clinical study (test set) for evaluating the device's efficacy. The performance data mentioned refers to non-clinical technical tests, which do not typically involve patient "test sets."

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)

Cannot be provided. No clinical test set or ground truth establishment process is described in the document.

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

Cannot be provided. No clinical test set or adjudication method is described.

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

Cannot be provided. The "Hair Up" device is an infrared lamp for hair growth, not an AI-powered diagnostic imaging tool that would typically involve human readers or MRMC studies. This question is not applicable to the type of device described.

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

Cannot be provided. The "Hair Up" device is an infrared lamp, not an algorithm. This question is not applicable.

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

Cannot be provided. No clinical efficacy study or ground truth establishment for such a study is mentioned.

8. The sample size for the training set

Cannot be provided. The device is not an AI algorithm that requires a training set. If referring to a clinical training set for users, none is described.

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

Cannot be provided. This question is not applicable as there is no mention of a training set for an algorithm or a clinical study that would require a ground truth for a training set.

Summary of what the document does provide regarding performance (non-clinical):

The document states that non-clinical tests were performed to demonstrate that the device complies with relevant safety and performance standards. These include:

Measurement of wavelength and average output power: "Testing conducted on the Hair Up shows that it refers to the relevant mandatory performance standards for laser products 21 CFR 1040.10 and 1040.11."
Basic safety and essential performance: Tested and evaluated according to IEC 60601-1:2005.
Effect to the device by electromagnetic disturbances: Tested and evaluated according to IEC 60601-1-2:2014.
Safety of laser products: Evaluated according to IEC 60825-1:2014.
Biological evaluation of medical devices: Tested and evaluated according to ISO 10993-5:2009 and ISO 10993-10:2010.
Risk management: Recorded by referring to ISO 14971:2007.
Usability: Documented referring to IEC 62366.

These are compliance standards for device design and manufacturing, not clinical efficacy acceptance criteria. The basis for clearance is substantial equivalence to a predicate device, which implies that because the predicate device was cleared, and the new device shares similar technical characteristics and intended use, it is also considered safe and effective for the stated indications.

Summary

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January 5, 2018

Y&J BIO Co., Ltd. % Ms. Mina Joo Manager BT Solutions Incorporated Unit 502, 148 Yeoksam-ro Seoul, 06249 Kr

Re: K172968

Trade/Device Name: Hair Up Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: December 6, 2017 Received: December 7, 2017

Dear Ms. Joo:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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 medical devices and radiation-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.

David Krause -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) K172968

Device Name Hair Up

Indications for Use (Describe)

Promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary

1. General Information

Applicant/Submitter:	Y&J BIO Co., Ltd.
Address:	No. C-413, Munjeong Hyundai Knowledge Center 1,7, Beobwon-ro 11-gil, Songpa-gu, Seoul,Republic of KoreaTel) +82-3400-0325
Contact Person:	Mina Joo, BT Solutions, Inc.
Address:	Unit 502, 148 Yuksamro, Gangnam-gu, Seoul,Republic of KoreaTel) +82.2.538.9140Email) smanager@btsolutions.co.kr
Preparation Date:	September-22-2017

2. Device Name and Code

Device Trade Name:	Hair Up
Common Name:	Lamp, non-heating, for promotion of hair growth
Classification Name:	Infared lamp
Product Code:	OAP
Regulation Number:	890.5500
Classification:	Class II
Review Panel:	General & Plastic Surgery (ODE)

3. Predicate Devices

Hair Up is substantially equivalent to the following device

Table 5.1 Predicate devices
Applicant	Device Name	510(k) Number
Apira Science Inc.	igrow-II Hair Growth System	K141567

4. Device Description

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Hair Up

510(k) Summary

5. Indications / Intended Use

Promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.

6. Technical Characteristics in Comparison to Predicate Devices

	Predicate Device	Proposed Device
510(K) Number	K141567	Not Available
Manufacturer	Apira Science, Inc.	Y&J BIO Co., Ltd.
Device Name	igrow-II Hair Growth System	Hair Up
Clearance Date:		N/A
Classification /	Class 2 / 890.5500	Class 2 / 890.5500
Regulation
Product Code	OAP	OAP
Intended Use	Promotion of hair growth in males with	Promotion of hair growth in males with
	androgenetic alopecia who have	androgenetic alopecia who have
	Norwood Hamilton Classifications of IIa	Norwood Hamilton Classifications of IIa
	to V and Fitzpatrick Classification Skin	to V and Fitzpatrick Classification Skin
	Phototypes I to IV.	Phototypes I to IV.
Mode of	Low-level laser diodes and light emitting	Low-level laser diodes and light emitting
Operation	diodes	diodes
Wavelength	655 nm	655 nm
Electrical	Input: AC 100V ~ 240V (free voltage)	Input: AC 100V ~ 240V (free voltage)
Requirements	Frequency: 50Hz/60Hz	Frequency: 50Hz/60Hz
	Power: 5V 2A	Power: 5V 2A
Maximum Power	5 mW	5 mW
How to use	Helmet system	Helmet system
Treatment time	20-25 min	20-25 min

Hair Up is substantially equivalent to the following legally marketed predicate devices

6. Performance Data

Non-clinical tests: Measurement of wavelength and average output power, of treatment were performed. Testing conducted on the Hair Up shows that it refers to the relevant mandatory

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Hair Up

510(k) Summary

performance standards for laser products 21 CFR 1040.10 and 1040.11. Other performance, such as basic safety, etc, were tested using following consensus standards:

Basic safety and essential performance of the Hair Up is tested and evaluated according to -IEC 60601-1:2005.
-Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard, IEC 60601-1-2:2014.
Safety of laser products is evaluated according to FDA-recognized consensus standard, -IEC 60825-1: 2014.
Biological evaluation of medical devices is tested and evaluated according to ISO 10993--5: 2009 and ISO 10993-10:2010.
-Risk management was recorded by referring to ISO 14971:2007.
Usability was documented referring to IEC 62366. -

7. Substantial Equivalence

The intended use of the Hair Up is within the scope of the predicate devices. Hair Up, from both a design and clinical perspective, uses similar or identical technology as the cited predicate device and has the same intended uses. Based upon the predicted overall performance characteristics for the Hair Up, Y&J BIO Co., Ltd. believes that no significant differences exist in usage of its underlying technological principles between Hair Up and the cited predicate devices.

8. Conclusions

On the basis of the information provided in this Summary, Y&J BIO Co., Ltd. believes that the Hair Up is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.

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.