This devices adopts narrow band of low level Red 660nm and Blue light (415nm), the selected light can get about 3~5mm depth into skin. The BC-001+ Acne Purifier is a hand-held device consisting of a low intensity light emitting diode (LED) lamp that is intended/indicated for over-the-counter use in the treatment of mild to moderate acne. Finally, this product belongs to the low level light therapy, it is safe to use on acne treatment. The device has a power on/off switch, treatment button, battery status indicator, Micro- USB socket for battery charging.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called BC-001+ Acne Purifier. This type of document is for premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It typically focuses on safety and technological equivalence rather than detailed clinical effectiveness studies with specific performance metrics like sensitivity, specificity, or reader studies for AI-powered devices.

Therefore, the information requested, particularly regarding acceptance criteria, reported device performance in terms of diagnostic accuracy (e.g., sensitivity, specificity), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, is not available in this document. This is because the device described is a light-emitting device for acne treatment, not an AI-powered diagnostic tool.

The "Performance Data" section (7. PERFORMANCE DATA) in the document refers to a series of tests to demonstrate the device's safety and general performance, not its diagnostic accuracy or effectiveness in comparison to a gold standard as would be done for an AI device.

Here's why each point you requested is not applicable or not found:

A table of acceptance criteria and the reported device performance: Not applicable in the context of an AI-powered diagnostic device. The performance data listed (biocompatibility, electrical safety, software verification, usability) are safety and engineering performance criteria, not clinical outcome or diagnostic accuracy metrics.
Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to the actual device and its components undergoing engineering and safety tests, not a dataset for an AI algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no diagnostic ground truth being established for an AI algorithm.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is not an AI diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device relates to whether it passes safety and engineering standards.
The sample size for the training set: Not applicable, as this device does not involve an AI algorithm with a training set.
How the ground truth for the training set was established: Not applicable.

Summary of available information regarding "Performance Data" from the document:

The "PERFORMANCE DATA" section (Section 7) describes the following types of testing done for the BC-001+ Acne Purifier to support its substantial equivalence determination:

Biocompatibility testing: Conducted according to ISO 10993-1. Tests included cytotoxicity, sensitization, and irritation.
Electrical safety and electromagnetic compatibility (EMC) testing: Device complied with IEC 60601-1-11, IEC 60601-2-57, IEC 62471 standards for safety, EN 60601-1-2 for EMC, and IEC 62133 for battery safety.
Software Verification and Validation Testing: Conducted as per FDA guidance for "Moderate" level of concern software.
Usability Testing: Conducted according to FDA Guidance 1757, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design."

These tests confirm the device's safety and functional performance as a light therapy device, not its diagnostic accuracy.

Summary

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.

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

April 25, 2017

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

Re: K170260

Trade/Device Name: BC-001+ Acne Purifier 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: OLP Dated: November 10, 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

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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) K170260

Device Name BC-001+ Acne Purifier

Indications for Use (Describe)

BC-001+ Acne Purifier is intended/indicated for over-the-counter use in the treatment of mild to moderate acne.

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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001_510 (k) Summary Version: A/3

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

Submitter of 510(K): 1.

Company Name :	Oriental Inspiration Limited
Address :	Unit 607, The Lakeside 2, West Wing, No. 10 Science ParkWest Avenue, Hong Kong Science Park, Shatin, N.T. Hong Kong.
Contact person :	Mr. Andy Wu
TEL :	+(852) 2654 0872
FAX :	+(852) 2687 4148
E-mail :	andy_wu@netop.com.hk
Date Prepared :	25th April, 2017

Proposed Device and code: 2.

Device Trade Name	BC-001+ Acne Purifier
Regulation Medical Specialty	General & Plastic Surgery
Product Code	OLP
Regulation number	878.4810
Device Class	2

3. Predicate Device:

510(K)	Trade or Proprietary or Model Name	Manufacturer
K142246	LightStim for Acne/ LightStim for Acne Mini	LED Intellectual Properties, LLC
K153081	Clear Bi-Light	Michael Todd, LP
K152889	Sonilase Blue-UV Clean Plus Model-SL113BUV+	Biorenew Labs, LLC

4. Description of Proposed Device:

This devices adopts narrow band of low level Red 660nm and Blue light (415nm), the selected light

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001_510 (k) Summary Version: A/3

can get about 3~5mm depth into skin. The BC-001+ Acne Purifier is a hand-held device consisting of a low intensity light emitting diode (LED) lamp that is intended/indicated for over-the-counter use in the treatment of mild to moderate acne. Finally, this product belongs to the low level light therapy, it is safe to use on acne treatment. The device has a power on/off switch, treatment button, battery status indicator, Micro- USB socket for battery charging.

5. Intended Use

BC-001+ Acne Purifier is intended for over-the-counter use in the treatment of mild to moderate acne.

6. Technical and Performance

The following table compares the device to the predicate devices with basic technological characteristics.

Parameter	New Device	Predicate Device	Predicate Device	Predicate Device	Remark
510(k)Number	(to be assigned)	K142246	K153081	K152889	--
Device Nameand Model	BC-001+ Acne Purifier	LightStim for Acne/LightStim for Acne Min	Clear Bi-Light	Sonilase Blue-UV Clean Plus Model-SL113BUV+	--
Manufacturer	Oriental InspirationLimited	LED IntellectualProperties, LLC	Michael Todd, LP	Biorenew Labs, LLC	--
RegulationNumber	878.4810	878.4810	878.4810	878.4810	--
Classification	2	2	2	2	--
Intend of use	BC-001+ AcnePurifier isintended/indicatedfor over-the-counteruse in the treatmentof mild to moderateacne.	LightStim for Acne/LightStim for AcneMini is anover-the-counterhand-held deviceintended for the usein the treatment ofmild to moderateacne.	The Clear Bi-Light isindicated for thetreatment of mild tomoderate inflammatoryacne.	The Sonilase Blue-UVClean Plus is ahandheld OTC deviceintended to emitenergy in the blueregion of the lightspectrum for use in thetreatment of mild tomoderate acne vulgaris	SE
Over-the-counter use?	Yes	Yes	Yes	Yes	SE
Overall design	Lithium-ionrechargeable batteryAC charger: 100-240V at 50-60Hz, 500	Mains poweredhandheld deviceapplied to the faceproviding LED light	Lithium-ionrechargeable batteryAC charger: 100-240V at 50-60Hz, 500	One 7.4VrechargeableLithium-ion battery	Same asK153081 andK152889,butdifferent with
	mA	output.	mA
IEC 60601Compliant	Yes	Yes	Yes	Yes	K142246,Note 1SE
Handheld	Yes	Yes	Yes	Yes	SE
Dimensions	70mm70mm23mm	unknown	64 mm 35 mm 14.6 mm	Not stated	Different,Note 1
PerformanceData	Complies with applicable performance specifications and usability requirements				SE
Performance Features
TreatmentArea(cm^2)	9.1 [cm²]	16.6 [cm²]	20 [cm²]	Over 9.6cm²	Different withK153081,K152889 andK142246, butwithin thescope oftreatmentarea ofpredicatedevice. Note1
Wavelength(s)(nm)					Blue light issame as theK153081,K152889 andK142246, Andred light issame as theK153081
Blue	415 ± 5	411 ± 4	405-420	415 ± 5
Red	660 ± 5	640 ± 4	630-660
TreatmentTimer	Up to 1.5 minutes perarea	Up to 3 minutes perarea	Up to 3 minutes perarea	4 minutes per area,daily	Different withK141242, andK140381,Note 1,Blue dose
Dose rate(mW/cm2)					rate is sameas K152889.Red dose rateis within thescope ofK153081,Note 1
Blue	50 ( blue)	12.4 (blue)6.3 (red)	31.1 (blue)54.6 (red)	50 (blue)
Red	23 (red)

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Note 1

Although it is a little bit 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

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001 510 (k) Summary Version: A/3

safety or effectiveness issues.

7. PERFORMANCE DATA

The testing for BC-001+ Acne Purifier included performance, software, electrical safety, EMC, biocompatibility and bench. BC-001+ Acne Purifier passed all testing in support of the substantial equivalence determination:

7.1. Biocompatibility testing

The biocompatibility evaluation for the BC-001+ Acne Purifier was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation 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 BC-001+ Acne Purifier. The device with compliance with the IEC 60601-1-11, IEC 60601-2-57, and IEC 62471 standards for safety and the EN 60601-1-2 standard for EMC and the IEC 62133 standard for battery safety.

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.

7.4. Usability Testing

Usability testing according to following FDA Guidance 1757, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, was conducted.

8. Conclusions

The proposed device has the same intended use and similar characteristics as the predicate devices, the LightStim for Acne/ LightStim for Acne Mini device (K142246), Clear Bi-Light device (K153081) and Sonilase Blue-UV Clean Plus (K152889). Meanwhile, performance testing, bench testing, and safety report documentation supplied in this submission demonstrates that any differences in their

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001_510 (k) Summary Version: A/3

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 devices.

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.