(85 days)
The iPulse SmoothSkin Hair Removal System is an over the counter device intended for the removal of unwanted hair.
The iPulse SmoothSkin Hair Removal System is indicated for the removal of unwanted hair.
The iPulse SmoothSkin Hair Removal System 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.
The provided text describes a 510(k) premarket notification for the iPulse SmoothSkin Hair Removal System, a light-based over-the-counter hair removal system. The information is primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for performance against a defined standard.
Therefore, the requested information elements related to acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert involvement, and comparative effectiveness studies as typically found in AI/algorithm device submissions are not detailed in this document.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a table format with specific quantifiable thresholds for device performance. Instead, it reports the outcome of a clinical study aimed at demonstrating hair reduction efficacy.
| Performance Metric | Reported Device Performance |
|---|---|
| Hair Reduction | Mean hair count reduction of 54.7% at six months |
| Subjects experiencing hair reduction | 83.3% of subjects |
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 for the test set: 29 subjects for clinical testing.
- Data provenance: Not explicitly stated, but clinical testing is generally prospective. The country of origin for the data is also not stated, but the company is based in the UK.
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)
This information is not provided. The study design described focuses on quantifiable hair count reduction, which would be measured directly rather than requiring expert ground truth in the same way an AI diagnostic device would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. Hair count reduction measurements typically involve direct observation and measurement by study personnel rather than an adjudication process between experts.
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 MRMC comparative effectiveness study was done. This device is a direct-to-consumer hair removal system, not an AI diagnostic algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable as this is not an algorithm-only device. It's a physical hair removal system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for efficacy was based on quantitative hair count reduction observed at specified follow-up intervals (six months after the last treatment). This is an objective clinical outcome.
8. The sample size for the training set
This information is not applicable. The device is a physical system, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
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K12 2280 P 1/2
Traditional 510(k) Premarket Notification iPulse SmoothSkin Hair Removal System
3.0 510(K) SUMMARY
| Submission Date: | July 27, 2012 |
|---|---|
| Submitter Information | |
| Company Name: | CyDen, Ltd. |
| Company Address: | Technium 2, Kings Road, Swansea, Wales, UK SA1 8PH |
| Contact Person: | William CottonCyDen+44 1792 485 584wcotton@cyden.com |
| Device Information | |
| Trade Name: | iPulse SmoothSkin 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: | Shaser IPL Hair Removal SystemShaser Inc, K103560Flash 'N GoHome Skinovations Inc, K082298 |
| Device Description: | The iPulse SmoothSkin Hair Removal System is an intense pulsed light(IPL) system composed of a base unit housing the electrical andelectronic sub-assembly and an umbilical cord which is connected tothe applicator, located in which is the source of optical radiation,namely a Xenon flashlamp. The system is powered from AC power viaan external power converter. |
| Intended Use: | The iPulse SmoothSkin Hair Removal System is an over the counterdevice intended for the removal of unwanted hair. |
| Indications for Use: | The iPulse SmoothSkin Hair Removal System is indicated for theremoval of unwanted hair. |
| Performance Data: | Nonclinical, clinical and usability testing has been completed on theiPulse SmoothSkin Hair Removal System. Nonclinical testing includedbiocompatibility, electrical safety and software testing. Clinicaltesting was conducted in 29 subjects. Each subject underwent threeweekly treatments with SmoothSkin, with follow up reviews at fourweeks and six months after the last treatment. The majority of study |
CyDen Ltd.
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Traditional 510(k) Premarket Notification iPulse SmoothSkin Hair Removal System
subjects (83.3%) experienced hair reduction, with a mean hair count reduction of 54.7% at six months. Usability testing was completed in 47 subjects to evaluate device human factors and label comprehension.
The iPulse SmoothSkin Hair Removal System has the same intended Comparison to Predicate Device: use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the iPulse Smoothskin 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 SmoothSkin Hair Removal System may be found substantially equivalent to its predicate devices. A technical comparison to the predicates is provided below.
| PREDICATE DEVICES | DEVICE | ||
|---|---|---|---|
| Device Name | Flash N' Go | Shaser IPL | iPulse SmoothSkin Hair RemovalSystem |
| Manufacturer | Home Skinovations Itd | Shaser Inc | CyDen Limited |
| Energy Medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Wavelength Range | 475-1200nm | 650nm - 1100nm | 530 - 1100nm |
| Pulse Duration | 5 milliseconds | 30milliseconds | Setting I:Single pulse 25milliseconds.Setting II:Double pulse 15ms on, 10 ms off.Setting III:Double pulse 10 ms on, 40 ms off. |
| Energy Density | 5J/cm2 | 9J/cm2 | 7-10J/cm2 |
| Spot Size | 6cm2 (3cm by 2 cm) | 2cm2 (1cm by 2cm) | 3cm2 (1.3cm by 2.4 cm) |
| Delivery Device | Direct Illumination To Tissue | Direct Illumination toTissue | Direct Illumination To Tissue |
| Pulsing Control | Finger Switch | Finger Switch | Finger switch |
| Skin Tone Sensor | Optical MeasurementIntegral to HandpieceSensor moveable totreatment site | Optical MeasurementIntegral to Base UnitSensor fixed in base unit,treatment site moved tosensor | Optical MeasurementRemovable from Base UnitSensor moveable to treatment site |
| Specific Indicationsfor Use | The Flash N'Go is an Over-the-counter deviceintended for the removal ofunwanted hair. | The Shaser IPL is an Over-the-counter deviceintended for the removalof unwanted hair. | The iPulse SmoothSkin Hair RemovalSystem is indicated for the removalof unwanted hair. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cyden, Limited % Becker and Associates Consulting, Incorporated Mr. Austin Speier Managing Director 2001 Pennsylvania Avenue, Suite 950 Washington, District of Columbia 20006
OCT
23 2012
Re: K122280 Trade/Device Name: iPulse SmoothSkin 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: July 30, 2012 Received: July 31, 2012
Dear Mr. Speier:
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
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· Page 2 - Mr. Austin Speier
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Daniel Kraine
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K(228° p 1/1
Traditional 510(k) Premarket Notification iPulse SmoothSkin Hair Removal System
CyDen Ltd. Page 6
INDICATIONS FOR USE STATEMENT 2.0
510(k) Number (if known):
Device Name:
iPulse SmoothSkin Hair Removal System
Indications for Use:
The iPulse SmoothSkin Hair Removal System is indicated for the removal of unwanted hair.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (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.P. Odenin for mxm
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ision Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122280
§ 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.