The iPulse is an intense pulsed light (IPL) system composed of a base unit housing the electrical and electronic sub-assembly and an umbilical cord which is connected to the applicator, located in which is the source of optical radiation, namely a Xenon flashlamp. The system is powered from AC power via an external power converter.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria	Reported Device Performance
Hair reduction	31.3% less hair at 6 months

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

Sample Size (Test Set): 61 subjects.
Data Provenance: The document does not explicitly state the country of origin. The study was prospective in nature, as subjects underwent 12 weekly treatments under clinical supervision and were followed for 6 months.

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)

Number of Experts: An "independent assessor" was used. The exact number of individuals is not specified, but the phrasing suggests at least one, and potentially more who reached a consensus.
Qualifications of Experts: Not specified.

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

The document states that "hair count before and after treatment was recorded from photographs and reviewed by independent assessor." It does not specify a formal adjudication method like "2+1" or "3+1." It implies a single or consensus review by an independent party.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This study is for a hair removal device, not an AI diagnostic/assessment tool.

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

No, a "standalone algorithm" performance was not done. The device is a physical intense pulsed light (IPL) system for hair removal, where the outcome is directly observed on the subjects, not by an algorithm processing data.

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

The ground truth was established by expert assessment of photographic evidence and subsequent calculation of hair density reduction. This falls under a form of expert consensus or independent assessment of objective data (hair counts from photographs).

8. The sample size for the training set

The document does not mention a "training set" in the context of an algorithm. The study described is a clinical trial to demonstrate the efficacy of the physical device itself.

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

Not applicable, as there is no mention of a training set for an algorithm. The clinical study directly evaluated the device's performance through observable outcomes on subjects.

Summary

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14130315

510(K) SUMMARY

Submission Date:	July 11th 2013	JUL 1 2 2013
Submitter Information
Company Name:Company Address:	CyDen, Ltd.Technium 2, Kings Road, Swansea, Wales, UK SA1 8PJ
Contact Person:	Dr Mike KiernanCyDen+44 1792 485682mkiernan@cyden.com
Device Information
Trade Name:	iPulse Hair Removal System
Common Name:	Light based over the counter hair removal system
Classification Name:	Laser surgical instrument for use in general and plastic surgery anddermatology
Device Class:	21 CFR 878.4810
Predicate Devices:	CyDen iPulse Smoothskin M100 series 2:	K122280
	Shaser IPL Hair Removal SystemShaser Inc,	K103560
	Flash 'N GoHome Skinovations Inc,	K082298
Device Description:	The iPulse is an intense pulsed light (IPL) system composed of abase unit housing the electrical and electronic sub-assembly and anumbilical cord which is connected to the applicator, located in whichis the source of optical radiation, namely a Xenon flashlamp. Thesystem is powered from AC power via an external power converter.
Intended Use:	The iPulse Hair Removal System is an over the counter deviceintended for the removal of unwanted hair.
Indications for Use:	The iPulse Hair Removal System is indicated for the removal ofunwanted hair.
Performance Data:	Nonclinical, clinical and usability testing has been completed for theiPulse Hair Removal System. Nonclinical testing includedbiocompatibility, electrical safety and software testing. The iPulseHair Removal System was tested in a clinical study of 61 subjects.Each subject had 12 weekly treatments under clinical supervision.Gel was used with all treatments. Treatment sites included the leg,arm, bikini and underarm. Hair counts were taken in a fixed arealocated using a template and skin landmarks. The hair count beforeand after treatment was recorded from photographs and reviewed byindependent assessor. The reduction in hair density was

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calculated. When used as directed, the clinical trial subjects showed on average 31.3% less hair at 6 months.

Comparison to Predicate Device:

The iPulse Hair Removal System has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the iPulse Hair Removal System and the listed predicate devices do not raise any issues of safety or efficacy. Performance data supports that the device is as safe and as effective as the predicate devices for its intended use. Therefore, the iPulse Hair Removal System may be found substantially equivalent to its predicate devices.

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Image /page/2/Picture/0 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 with three curved lines representing its wings or body. The bird is oriented towards the upper right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

DEPARTMENT OF HEALTH & HUM AN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20093-0002

July 12, 2013

Cyden Limited % Dr. Michael Kiernan Chief Scientific Officer Technium 2. Kings Road, Swansea. Wales, United Kingdom, SA1 8PJ

Re: K130315

Trade/Device Name: iPulse Hair Removal System 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: May 30, 2013 Received: June 05, 2013

Dear Dr. Kiernan:

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 10 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. Michael Kiernan

forth in 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/deliault:him 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,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K130315

I.T.

iPulse Hair Removal System

Indications for Use:

Device Name:

The iPulse Hair Removal System is an over-the-counter device intended for removal of unwanted hair.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.07.12 07:50:29 -04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Page 1 of _1

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.