Strialite is an over-the-counter device in the temporary reduction of redness in striae rubra (red stretch marks). Strialite does not remove the stretch marks but may improve their appearance.

Device Description

The Strialite is an over the counter (OTC) device utilizing a combination of light emitting diode (LED) lights and a heating element as a phototherapy/thermal treatment for the end users' stretch marks (striae). It is a hand-held, compact, lightweight device, designed to specifically treat and reduce the visible appearance of an individual's red stretch marks. A stretch mark is a defect in the skin caused by damaged collagen that occurs from rapid skin stretching, that may have a red appearance. The red LED light and heat work together to stimulate the skin at the cellular level to produce and repair collagen. As the damaged collagen tissue is gradually replaced, over time the appearance of the stretch mark is reduced. Typical areas for treatment are the abdomen, breasts, back, hips, and thighs. The recommended treatment schedule is two (2) 20-minute sessions a week for at least four (4) weeks. Strialite is intended for home use by adults under the age of 50 years.

The Strialite device consists of a housing enclosure with an ergonomic handle, electronic circuit boards, treatment plate with a specific array of LED lights, thermal heating elements that generate temperature up to 105 degree F (40 degree C), touch control power button (On/Off), and a power cord. The flat LED panel, consisting of thirty-five (35) visible red LEDs in the 633 nm (±5nm) spectrum, is located on the base of the device, and directly contacts the area of skin to be treated. The device is provided non-sterile and reusable.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Strialite device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Study Design)	Reported Device Performance (Clinical Study)
Improvement in severity of redness of stretch marks (at least 2 grades on a 1-10 scale), self-assessed by subjects.	16 out of 30 subjects (53.3%) reported at least 2-grade improvement.
Improvement in severity of redness of stretch marks (blinded photographic assessment).	18 out of 30 subjects (60%) demonstrated improvement.
No adverse effects observed or reported.	No adverse effects were observed or reported during the study.
Ability of subjects to read and comprehend Instructions for Use and Quick Start Guide.	39 out of 40 subjects (97.5%) were able to read and comprehend the information.
Ability of subjects to correctly demonstrate critical steps in device use.	38 out of 40 subjects (95.0%) were able to correctly demonstrate the six critical steps.
Correct self-selection for device use based on carton labeling.	All responders (41 subjects) correctly determined the device use; all but one correctly self-selected.

Note: The document explicitly states "Strialite passed all testing stated in Table 5B below as shown by the acceptable results obtained," but Table 5B outlines non-clinical performance data (e.g., design verification, electrical safety, EMC, photobiological safety). The acceptance criteria for the clinical performance data are inferred from the outcomes presented in Section 10 ("Clinical Performance Data").

2. Sample Sizes Used for the Test Set and Data Provenance

Clinical Study Test Set:
- Sample Size: 33 subjects initially enrolled, with 30 completing the full series of 8 treatments.
- Data Provenance: Not explicitly stated, but clinical studies for FDA submissions are typically conducted in the US or in countries with equivalent regulatory standards. The document doesn't specify if it was retrospective or prospective, but clinical trials for regulatory submission are generally prospective.
Usability Study Test Set:
- Sample Size: 40 subjects.
- Data Provenance: Not explicitly stated, but likely prospective.
Self-Selection Study Test Set:
- Sample Size: 41 subjects.
- Data Provenance: Not explicitly stated, but likely prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Clinical Study: "blinded photographic assessment was performed." The number and qualifications of the individuals performing this blinded assessment are not specified in the provided text.
Usability Study: "observed and recorded by the trained interviewer." The number and qualifications of the trained interviewers are not specified.
Self-Selection Study: "When interviewed, all responders correctly determined..." The number and qualifications of the interviewers are not specified.

4. Adjudication Method for the Test Set

Clinical Study (blinded photographic assessment): The adjudication method is not specified. It only states "blinded photographic assessment was performed," not how discrepancies (if any) among assessors were resolved.
Other studies: Not applicable as ground truth was derived from direct observation or participant responses, not expert consensus on ambiguous cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done. The clinical study assessed the effect of the Strialite device on its own, without comparing human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone clinical study was done. The Strialite device is an over-the-counter device intended for direct user application. The clinical study directly assessed the device's performance based on subject self-assessment and blinded photographic assessment of the effects of the device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Clinical Study:
- Subjective Ground Truth: Subject self-assessment of "improvement of the severity of the redness of their stretch marks of at least 2 grades when graded on a scale of 1 to 10." This is a subjective outcome report from the users.
- Objective/Expert-Assessed Ground Truth: "blinded photographic assessment." While the experts are not explicitly defined, this implies an objective evaluation by trained individuals based on photographic evidence. This is a form of expert assessment of visual outcomes.
Usability Study: Ground truth was established by direct observation of subjects' actions (demonstrating correct simulated use) and their responses to survey questions (comprehension of instructions).
Self-Selection Study: Ground truth was established by subjects' responses to interview questions regarding their understanding of the device's indications for use.

8. The Sample Size for the Training Set

The document describes a clinical study to assess the device's effect and usability studies for its OTC claim. It does not mention any training set as this device is a physical light therapy device, not an AI/software algorithm that requires a training dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no mention of a training set for an AI/software algorithm.

Summary

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

February 24, 2016

Centre Light Solutions, LLC % Ms. Audrey Swearingen Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 August, Texas 78701

Re: K151337 Trade/Device Name: Strialite 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: ONE Dated: January 8, 2016 Received: January 12, 2016

Dear Ms. Swearingen:

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

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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 yours,

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) K151337

Device Name Strialite

Indications for Use (Describe)

Strialite is an over-the-counter device in the temporary reduction of redness in striae rubra (red stretch marks). Strialite does not remove the stretch marks but may improve their appearance

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

_ | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

for

Strialite™

1. Submission Sponsor

Centre Light Solutions, LLC 611 East Douglas Road Suite 108 Mishawaka Indiana, 46545 USA Phone: 574.612.3381 Contact: Ms. Carrie Colborn, Director of Operations

2. Submission Correspondent

Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: 512.818.3811 Office Phone: 512.327.9997 Fax: 512.327.9998 Contact: Audrey Swearingen, Director Regulatory Affairs Email: project.management@emergogroup.com

3. Date Prepared

February 19, 2016

4. Device Identification

Trade/Proprietary Name:	Strialite™
Common/Usual Name:	Light Emitting Diode (LED) device
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology.
Classification Regulation:	21 CFR 878.4810
Product Code:	ONE
Device Class:	Class II
Classification Panel:	General and Plastic Surgery

5. Legally Marketed Predicate Device(s)

Candela V Beam Pulse Dye Laser System, K013748

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6. Device Description

7. Indications for Use Statement

Strialite is an over-the-counter device indicated for use in the temporary reduction of redness in striae rubra (red stretch marks). Strialite does not remove the stretch marks but may improve their appearance.

8. Substantial Equivalence Discussion

As shown in Table 5A below, Strialite has the same intended use and similar technological characteristics and principles of operation as the predicate device, the Candela V Beam, and therefore is substantial equivalent to the predicate device.

Manufacturer	Centre Light Solutions	Candela Corporation
Trade Name	Strialite	Candela V Beam Pulse DyeLaser System	Comparison ofSignificant Differences
510(k) Number	N/A	K013748	N/A
Product Code	ONE	ONE	Same
Regulation Number	878.4810	878.4810	Same
Regulation Name	Laser surgical instrumentfor use in general andplastic surgery and indermatology	Laser surgical instrumentfor use in general andplastic surgery and indermatology	Same
Intended Use	Over the counter lightdevice for use indermatology	Prescription light devicefor use in dermatology	Strialite is for OTC use,which is supported bythe usability and self-selection studies, andclinical data.
Manufacturer	Centre Light Solutions	Candela Corporation
Trade Name	Strialite	Candela V Beam Pulse DyeLaser System	Comparison ofSignificant Differences
Indications for Use	An over the counter deviceindicated for use in thetemporary reduction ofredness in striae rubra.Strialite does not removethe stretch marks but mayimprove their appearance.	A prescription deviceindicated for use indermatology for thetreatment of striae.	The fundamentaltechnology and theintended use to treatstria rubra using andheat and red light arethe same.
Hand-Held	Yes	Yes	Same
Patient ContactMaterials	Anodized aluminumPlastic	Stainless steelPlastic	Both devices utilizematerials commonlyused in medical deviceshaving limited skincontact.
Sterile	No	No	Same
Single-Use	No	No	Same
Peak EmissionWavelength	633 ± 5nm	595 ± 5nm	Both devices utilizelight in the redspectrum.
Mechanism ofAction	Red light energy and dermalheating increases localcirculation and collagenproduction	Red light energy anddermal heating increaseslocal circulation andcollagen production	Both devices use acombination of redlight energy and heat
Software	No	Yes	To keep the userfunctions simple, nosoftware is used in theStrialite.
RecommendedOperatingConditions	Room temperature	Room temperature	Both operate withinnormal roomtemperatures
Electrical Safety /EMC Testing Passed	Yes	Yes	Same
Clinical Study	Yes	unknown	Strialite has beenshown to be safe andeffective for itsintended use.

Table 5A - Comparison of Characteristics

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9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of Strialite and to show substantial equivalence to the predicate device, Centre Light Solutions completed a number of tests. The Strialite passed all testing stated in Table 5B below as shown by the acceptable results obtained. These tests confirm that the output meets the design inputs and specifications and support Strialite's safety, performance and substantial equivalence to the predicate device.

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Testing Type	Test Performed / Standard	Result
Design Verification	Strialite Over-Temperature SensorVerification Study	The Strialite shuts off when the platetemperature exceeds 41 °C.
	Strialite Power Switch ReliabilityVerification	The power switch of the devicesuccessfully performed 500 ON/OFFcycles.
	Strialite Overtemperature Sensor withRunaway Resistors	In a single fault failure mode, the over-temperature protection sensor shut-offthe heat well before the treatmentplate reached a hazardous temperature(<51°C).
	Strialite Use Life – LED Specification	The LEDs exceeded the specification of1000 hours of continuous use.
	Strialite Temperature Verification	The temperature of the treatmentplate met the specification at 1 minuteand at 20 minutes after the device isturned on. The device operatedsuccessfully within the specifiedenvironmental temperature for thestated time period.
Electrical Safety	AAMI ES60601-1:2005/A1:2012 (Ed.3.1) - Medical electrical equipmentPart 1: General requirements for basicsafety and essential performance	Strialite complies with the statedperformance standard for electricalsafety for medical equipment used in ahome healthcare environment.
	IEC 60601-1-11: 2010, first ed. -Medical electrical equipment Part 1-2:General requirements for basic safetyand essential performance CollateralStandard: Requirements for medicalelectrical equipment and medicalelectrical systems used in the homehealthcare environment
	IEC 60601-2-57: 2011 - Medicalelectrical equipment Part 2-57:particular requirements for basicsafety and essential performance onnon-laser light source equipmentintended for therapeutic, diagnostic,monitoring and cosmetic/aesthetic use
	ElectromagneticCompatibility	IEC 60601-1-2: 2007, 3rd ed. - Medicalelectrical equipment Part 1-2: Generalrequirements for basic safety andessential performance CollateralStandard: ElectromagneticCompatibility
		Photobiological Safety

Table 5B – Summary of Non-clinical Performance Testing

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10. Clinical Performance Data

A clinical study was conducted to assess the effect of Strialite on the temporary reduction of redness of the subjects' red stretch marks. Thirty of the 33 subjects enrolled completed the full series of 8 treatments over 4 weeks. Sixteen out of 30 subjects reported, upon selfassessment, improvement of the severity of the redness of their stretch marks of at least 2 grades when graded on a scale of 1 to 10 from baseline to post-treatment. As a secondary endpoint blinded photographic assessment was performed and the blinded evaluation identified 18 of the 30 subjects as demonstrating improvement. Two subjects that selfassessed as having the worst appearing lesions (grade 10) did not show any improvement throughout the study. No adverse effects were observed or reported during the study.

As the Strialite is for OTC use, a usability study, designed in accordance with AAMI ANSI IEC 62366:2007, assessed whether subjects, after reading the labeling provided with the Strialite, were able to properly use the device without assistance. The usability test consisted of two components:

Demonstrating the ability to read and comprehend the information in the Instructions 1) for Use and Quick Start Guide, based on survey questions asked by an interviewer.
1. Demonstrating correct simulated use of the device by following the Instructions for Use and Quick Start Guide, as observed and recorded by the trained interviewer.

The study showed that 39 of 40 (97.5%) subjects were able to read and comprehend the information in the Instructions for Use manual, and that 38 of 40 (95.0%) subjects were able to correctly demonstrate the six critical steps in the use of the Strialite.

In addition, a Self-selection study was performed with forty-one (41) subjects who were each given the device carton labeling to read in private. When interviewed, all responders correctly determined from the carton labeling that the device is used for stretch marks, and all but one correctly self-selected.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when it has the same intended use and the same technological characteristics as the previously cleared predicate device; or the device has the same intended use and different technological characteristics, but it can be demonstrated that the differences do not raise different questions regarding its safety and effectiveness as compared to the predicate device.

Strialite is substantially equivalent to the predicate device, Candela V Beam Pulse Dye Laser, in that they both have the same intended use and share similar technological characteristics and principles of operation. Both devices are intended for the same use which is the treatment of striae rubra (red stretch marks) by combining heat and light to reduce the redness of the stretch mark. It has been shown in this 510(k) submission that the differences between the Strialite and the Candela V Beam predicate device do not raise new questions regarding Strialite's safety and effectiveness. The Strialite is determined to be substantially equivalent 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.