Silkn Blue is a hand held device battery operated that uses low power light spectrum, LED, at wavelength of 415 ±15 nm, combine with tip temperature stabilizer at 41ºC. The emitting optical power is in a uniform distribution with no hot spots.

AI/ML Overview

The provided text describes a clinical study to demonstrate the performance and safety of the Silkn Blue device for treating mild to moderate acne. However, it does not specify pre-defined acceptance criteria (e.g., a minimum percentage improvement or reduction in lesion count that the device needed to achieve to be considered successful).

The study aims to determine the ability of the device to treat mild to moderate inflammatory acne and to assess if users can operate it correctly.

Here's the information parsed from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Not explicitly stated in the document)	Reported Device Performance
Implicit: Demonstrate efficacy in treating mild to moderate acne	Average improvement after one month: 56.7%
	Average improvement after three months: 57.7% ± 9.4%
Implicit: Demonstrate user usability	Users successfully operated the device according to labeling and filled out a questionnaire.
Implicit: Demonstrate safety	No immediate reactions or adverse effects associated with the treatment were observed.

2. Sample Size and Data Provenance:

Sample Size for Test Set: 50 subjects
Data Provenance: Not explicitly stated, but the company is based in Israel, so it's likely the study was conducted there or a similar region. The study is prospective as it involves subjects using the device over a specified period with follow-up visits.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set. It mentions "2 follow-up visits to evaluate the results," suggesting clinical evaluation, but doesn't detail who performed these evaluations.

4. Adjudication Method:

The document does not specify an adjudication method (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The study is a single-arm clinical trial evaluating the device's performance, not comparing human readers' performance with and without AI assistance. The Silkn Blue is a phototherapy device, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone study was not done. The Silkn Blue is a physical phototherapy device with human-in-the-loop (the user operating it). It does not involve an algorithm working independently.

7. Type of Ground Truth Used:

The ground truth used was based on clinical evaluation ("reduction in lesion count") performed during follow-up visits by unmentioned evaluators and self-reported usability via a questionnaire.

8. Sample Size for Training Set:

The concept of a "training set" is not applicable here as the Silkn Blue is a physical medical device, not an AI or machine learning algorithm that requires training data.

9. How Ground Truth for Training Set Was Established:

As above, the concept of a "training set" and establishing ground truth for it is not applicable for this device.

Summary

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Image /page/0/Picture/0 description: The image contains a sequence of handwritten alphanumeric characters. The characters are 'K121435'. The characters are written in a simple, legible style, with varying stroke thicknesses. The image appears to be a close-up of the characters, with a white background.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Home Skinovations Ltd. Silkn Blue

FEB 2 2 2 2013

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

Submitter's information

Name:	Home Skinovations Ltd.
Address:	Tavor building, POB 533, Yokneam 20692, Israel
Contact:	Dr. Amir Waldman VP Regulatory Affairs

Device information

Trade/Proprietary name:	Silkn Blue
Common/Usual name:	Acne Treatment device
Classification name:	Over the counter powered light based laser for Acne, 2CFR 878.4810
Product code:	OLP

Predicate devices

. ThermaClear by DermaCare Inc. K060653.
Quasar Blue Light Therapy System by Silver Bay LLC, K093963. .
Tanda Skincare System, by Pharos Life Corporation, K080591 .
. OmniLux New-U, by Photo Therapeutics Inc, K081307.

Intended use:

The Silkn Blue is indicated as an over the counter phototherapy device for the treatment of mild to moderate acne.

Device Description & technology comparison to predicate device:

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	Silkn Blue	ThermaClear	QuasarBlue	TandaSkincare	OmniLuxClear-U
EnergySource	LED + Tiptemperaturestabilizer	Tiptemperaturestabilizer	LED	LED	DualwavelengthsLED
Wavelengths(nm)	415	NA	415	415	415, 633
PowermW/cm2	50	NA	50	50	40(415 nm),70(633 nm)
Treatmentarea cm2	7	1	10	27	30
Targeted skintemperature°C	41±2	41-43	39-43	39-43	39-43
Patientcontactingmaterial	Stainlesssteels17-4PH, RigidABS	Stainless steels	RigidABS	RigidABS	Rigid ABS

Technology comparison of Silkn Blue with predicate devices:

Performance data:

The device complies with the following U.S. Food and Drug Administration performance standards: 21CFR § 1040.10 & 1040.11

Clinical study summary:

The clinical and usability research study performed to determine the ability of the Silkn Blue device to treat mild to moderate inflammatory acne, and to determine if the average person is able to use the device properly according to the labeling as describe in the operator manual.

The clinical study involves 50 subjects who used the Silk'n Blue twice a week over four weeks (a total of 8 treatments), and 2 follow-up visits to evaluate the results. All subjects demonstrated a reduction in lesion count.

The average improvement after one month was 56.7% and remained similar also after 3 months 57.7%±9.4%.

The users were asked to fill a questionnaire regarding the device use and labeling. Safety was evaluated by monitoring immediate reaction and adverse effects. There were no other adverse effects associated with the treatment.

Substantial Equivalence:

The Silkn Blue is substantial equivalent to its predicate device. The data in this 510(k) submission demonstrate that the Silkn Blue device has compatible output as the predicate devices, and identical intended use. Therefore is substantial equivalent to its predicate devices.

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Based upon an analysis of the overall performance characteristic for the device, Home Skinovations Ltd. believes that no significant differences exit. Therefore the Silkn Blue should raise no new issues of safety or effectiveness.

May 10, 2012

પ્રદર્ભ

Date

Dr. Amir Waldman, VP Regulatory Affairs Home Skinovations Ltd.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Public Health Service

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

February 22, 2013

Home Skinovations, Limited % Dr. Amir Waldman Vice President, Regulatory Affairs Tavor Building, POB 533 Yokneam Illit, Israel 20692

Re: K121435

Trade/Device Name: Silkn Blue 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: January 09, 2013 Received: February 13, 2013

Dear Dr. Waldman:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. Amir Waldman

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours, For:

Peter Di Rumm -S Mark

Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)_K_121435

Device Name_Silkn Blue

Indications For Use:

The Silkn Blue is indicated as an over the counter phototherapy device for the treatment of mild to moderate acne.

Prescription Use (Per 21 CFR 801.109) OR

Over The Counter Use X

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogder 2013.02.21 15 34:39 -05.00

(Division Sign-Off)

Division of Surgical Devices

510(k) Number _ K121435

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.