HEE HR Mini is an over-the-counter device intended for the removal of unwanted hair. The HEE HR Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.

Device Description

The HEE HR Mini devices are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The HR Mini devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the HR Mini devices is 3 cm². The device contains a lamp, a skin proximity sensor and a skin color sensor to detect appropriate skin tones. If the HR Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the HR Mini will not trigger a pulse.

The device has an on/off button, skin color sensor, light exit window, flash button, led indicator, two intensity button, socket for battery charging.

AI/ML Overview

The provided document does not contain detailed information about specific acceptance criteria related to a clinical study for the Hee Hr Mini device's effectiveness in hair removal or reduction. It primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons, safety, and regulatory compliance.

However, based on the Intended Use and the comparison table provided, we can infer the primary performance criteria the device is expected to meet, drawing parallels from its predicate devices which also claim "permanent reduction in hair regrowth."

Here's an analysis of the provided text in relation to your questions, noting where information is explicitly stated or can be inferred, and where it is not available.

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

The document does not explicitly state quantitative acceptance criteria for "permanent reduction in hair regrowth." However, the Intended Use for both the applicant device and its predicates defines this as:
"a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen."

The document states that the Hee Hr Mini passed all testing in support of the substantial equivalence determination, implying it met the expected performance for its intended use, which is aligned with the predicate devices. Since this is a 510(k) submission, the device is deemed "substantially equivalent" rather than proving superiority or achieving specific, novel clinical endpoints through a dedicated clinical trial for this submission.

Acceptance Criteria (Inferred from Intended Use)	Reported Device Performance (Inferred)
Primary: Permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.	The device passed all testing in support of the substantial equivalence determination, implying it is able to achieve the "permanent reduction in hair regrowth" as defined, similar to its predicate devices. No specific hair reduction percentage or count is provided.
Safety: Compliance with electrical safety, performance, and EMC standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 62471, and IEC 60601-1-2 for EMC). Biocompatibility (Cytotoxicity, Sensitization, Irritation). Software Verification and Validation (Moderate level of concern).	The device passed all specified safety and performance standards, biocompatibility testing, and software verification and validation.

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 does not provide details on a specific clinical test set for proving efficacy for this 510(k) submission. The performance data section focuses on "performance, software, electrical safety, EMC, biocompatibility and bench" testing, which are primarily technical and safety assessments, not an efficacy trial. It's common for 510(k) submissions to rely on substantial equivalence to predicate devices which have already established safety and efficacy, or on bench testing and limited human factor studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available in the provided text, as a clinical efficacy study with explicit ground truth establishment is not detailed for this 510(k) submission.

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

This information is not available in the provided text.

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

This is not applicable to the Hee Hr Mini device, which is an aesthetic light-based hair removal device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance effect size is mentioned or relevant.

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

This question is not directly applicable as the device is a hardware-based hair removal system, not an algorithm, per se. Its performance is inherent to its physical operation. The "Software Verification and Validation Testing" section mentions software, but this relates to the device's internal control and safety features, not a standalone diagnostic algorithm.

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

Given the lack of a detailed clinical efficacy study in this document, the type of ground truth used for efficacy (e.g., hair counts, photographic assessment by experts, patient self-assessment) for the Hee Hr Mini is not explicitly stated. For similar devices, ground truth for hair reduction efficacy is typically established through objective hair counts in a defined area, often by blinded assessors or using photographic analysis, over several months.

8. The sample size for the training set

The document does not mention a training set or provide details about any clinical trials or data used for training purposes, as this is not an AI/ML device in the context of typical "training sets."

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

As described in point 8, the concept of a "training set" in the context of AI/ML is not applicable here.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2017

Oriental Inspiration Limited Andy Wu Director Unit 607, The Lakeside 2, West Wing, No. 10 Science Park West Avenue Hong Kong, CN

Re: K170269

Trade/Device Name: Hee Hr Mini Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHT Dated: October 17, 2016 Received: January 27, 2017

Dear Andy Wu:

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

Image /page/0/Picture/11 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, with flowing lines representing hair or clothing.

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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.

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) K170269

Device Name HEE HR Mini

Indications for Use (Describe)

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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Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by section 21 CFR 807.92

1. Submitter of 510(K):

Company Name:	Oriental Inspiration Limited
Address:	Unit 607, The Lakeside 2, West Wing, No. 10 Science Park WestAvenue, Hong Kong Science Park, Shatin, N.T. Hong Kong.
Contact person:	Mr. Andy Wu
TEL:	+(852) 2687 3496
FAX:	+(852) 2687 4148
E-mail:	andy_wu@netop.com.hk
Date of Prepared:	10/20/2016

2. Proposed Device and code:

Device Trade Name:	HEE HR Mini
Regulation Medical	General & Plastic Surgery
Specialty
Product Code:	OHT
Regulation number	878.4810
Device Class	2

Predicate Device: 3.

510(K)	Trade or Proprietary or Model Name	Manufacturer
K140381	sensiLight (sensiLight and sensiLight Plus)	EL Global Trade Ltd.
K141242	Glide device	Home skinovations Ltd

4. Description of Proposed Device:

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sensor and a skin color sensor to detect appropriate skin tones. If the HR Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the HR Mini will not trigger a pulse.

The device has an on/off button, skin color sensor, light exit window, flash button, led indicator, two intensity button, socket for battery charging.

5. Intended for Use

6. Technical and Performance

The following table compares the device to the predicate device with basic technological

characteristics.
------------------

Parameter	New device	Predicate device	Predicate device	Remark
510(k)Number	(to be assigned)	K140381	K141242	--
Device Nameand Model	HEE HR Mini	sensiLight (sensiLight andsensiLight Plus)	Glide device	--
Manufacturer	Oriental InspirationLimited	EL Global Trade Ltd.	Home skinovations Ltd	--
RegulationNumber	878.4810	878.4810	878.4810	SE
Intend of use	HEE HR Mini is anover-the-counter deviceintended for the removalof unwanted hair. TheHEE HR Mini is alsointended for permanentreduction in hairregrowth, defined as along-term, stablereduction in the numberof hairs regrowing whenmeasured at 6, 9, and 12months after thecompletion of treatmentregimen.	The sensiLight is an overthe counter deviceintended for the removalof unwanted hair. ThesensiLight is also intendedfor permanent reductionin hair regrowth, definedas a long-term, stablereduction in the numberof hairs re-growing whenmeasured at 6, 9, and 12months after thecompletion of treatmentregimen.	The Glide device is an overthe counter deviceintended for the removal ounwanted hair. The Glidedevice is also intended forpermanent reduction inhair regrowth, defined as along-term, stable reductionin the number of hairsre-growing when measuredat 6, 9, and 12 months aftethe completion oftreatment regimen.	SE
Operation	Photothermolysis. Light	Photothermolysis. Light	Photothermolysis. Light	SE
Principle	energy is absorbed, heatsthe hair follicles andinterrupts the growth cycle.	energy is absorbed, heatsthe hair follicles andinterrupts the growth cycle.	energy is absorbed, heatsthe hair follicles andinterrupts the growth cycle.
Technology	Home Pulsed Light	Home Pulsed Light	Home Pulsed Light	SE
Comparisonof treatmentregime	• The 1-4 treatmentswill be approximatelytwo weeks apart• Followed by 5-7treatments plan fourweek time intervals.• Treatments 8 andafter: Treat as neededuntil decided results areachieved	• The 1-4 treatments willbe approximately twoweeks apart• Followed by 5-7treatments plan four weektime intervals.• Maintenance will beneeded from time to timeif growth is still visible	• The 1-4 treatmentswillbe approximately twoweeks apart• Followed by 5-7treatments plan fourweek time intervals.• Treatments 8 andafter: Treat as neededuntil decided results areachieved	SE
Safety	IEC 60601-1:2005IEC 60601-1-11:2010IEC 60601-2-57:2011IEC 62471:2006IEC 60601-1-2:2013	IEC 60601-1:2005IEC 60601-1-11:2010IEC 60601-2-57:2011IEC 62471:2006IEC 60601-1-2:2013	IEC 60601-1:2005IEC 60601-2-57:2011IEC 60601-1-2:2013IEC 62471:2006	SE
Performance Features
Opticalaperture	3 [cm²]	3 [cm²]	2.7 [cm²]	Same asK140381, anddifferent withK141242,Note 1
EmittedSpectrum	475-1200 [nm]	475-1200 [nm]	475-1200 [nm]	SE
Max energylevel(fluence)	5 [joules/cm²]	5 [joules/cm²]	5 [joules/cm²]	SE
UserselectableEnergy levels	8	3	5	DifferentwithK141242, andK140381,Note 1
Single pulseduration	500-800 [uSec]	500-800 [uSec]	500-800 [uSec]	SE
UseClassification	OTC	OTC	OTC	SE
	100-240 VAC, 50-60Hz	110-240 VAC, 50-60Hz	100-240 VAC, 50-60Hz	Note 1
	0.8A	to 19VDC, 1.8A	2A
Safety Features
Close contactdetector	Prevent the activation ofthe device while not inclose contact with theskin.	Prevent the activation ofthe device while not inclose contact with theskin.	Prevent the activation ofthe device while not inclose contact with theskin.	SE
Pigmentationlevel detector	Optical - does not allowactivation on dark skin	Optical - does not allowactivation on dark skin	Optical - does not allowactivation on dark skin	SE
Darkest skinallowed	Fitzpatrick 4	Fitzpatrick 4	Fitzpatrick 4	SE
Materials	Top, Side and Bottomshell - ABS/PC plastic(Acrylonitrile butadienestyrene/PolyCarbonate)	Top, Side and Bottom shell -ABS/PC plastic (Acrylonitrilebutadienestyrene/PolyCarbonate)	Device outer body -ABS/PC plastic(Acrylonitrile butadienestyrene/PolyCarbonate)	SE
	Optical Filter - Colorglass which purpose is ofan optical long passfilter tested forbiocompatibility	Optical Filter - Color glasswhich purpose is of anoptical long pass filter testedfor biocompatibility	Optical Filter - Color glasswhich purpose is of anoptical long pass filtertested forbiocompatibility
Overall Design	The HEE HR Mini deviceis light based hairremoval systemcomposed of ahand-held applicator.	The sensiLight device islight based hair removalsystem composed of ahand-held applicator.	The Glide device is lightbased hair removalsystem composed of ahand held applicator.	SE

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Note 1

Although it is a little different from the predicate devices, it will not affect the main function and the intended use of the device. They all also comply with safety and performance requirements. So the differences will not raise any safety or effectiveness issue.

7. PERFORMANCE DATA

The testing for HEE HR Mini included performance, software, electrical safety, EMC, biocompatibility and bench. HEE HR Mini passed all testing in support of the substantial equivalence determination:

7.1. Biocompatibility testing

The biocompatibility evaluation for the HEE HR Mini was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation

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and Testing Within a Risk Management Process." As dictated by the application and duration of contact with the intact skin, the enclosure of testing included the following tests:

Cytotoxicity
. Sensitization
Irritation

7.2. Electrical safety and electromagnetic compatibility

Electrical safety, performance and EMC testing were conducted on the HEE HR Mini. The device with compliance with the IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57 and IEC 62471 standards for safety and the IEC 60601-1-2 standard for EMC.

7.3. Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.

8. Conclusions:

The proposed device has the same intended use and similar characteristics as the predicate device, the sensiLight (sensiLight and sensiLight Plus) (K140381) and Glide device (K141242). Meanwhile, performance testing, bench testing, and safety report documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.

Based on performance testing, the proposed device is Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.