(189 days)
The me is an over-the-counter device intended for the removal of unwanted hair. Me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.
The me device is a small over-the-counter, compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Syneron Beauty Ltd.'s mē Hair Removal System (K131649)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for "permanent reduction in hair growth" are explicitly stated as "at least 30% hair reduction measured at 12 months post-treatment compared to baseline." The study also reports on the percentage of subjects and body sites achieving this success.
| Acceptance Criteria | Reported Device Performance (No Maintenance Group) | Reported Device Performance (Maintenance Group) |
|---|---|---|
| Permanent reduction in hair growth defined as: - At least 30% hair reduction at 12 months post-treatment (Subject Success) | All Subjects (Table 1): 45% success observed in 44 subjects (those with long-term follow-up at 12 months) Subgroup of 21 Subjects (Table 3): 52% success observed in 21 subjects (those continuously followed for 6, 9, and 12 months) | All Subjects (Table 2): 59% success observed in 44 subjects (those with long-term follow-up at 12 months) Subgroup of 21 Subjects (Table 4): 62% success observed in 21 subjects (those continuously followed for 6, 9, and 12 months) |
| Permanent reduction in hair growth defined as: - At least 30% hair reduction at 12 months post-treatment (Body Site Success) | All Subjects (Table 1): 54% success observed in 72 sites (those with long-term follow-up at 12 months) Subgroup of 21 Subjects (Table 3): 68% success observed in 37 sites (those continuously followed for 6, 9, and 12 months) | All Subjects (Table 2): 72% success observed in 75 sites (those with long-term follow-up at 12 months) Subgroup of 21 Subjects (Table 4): 80% success observed in 40 sites (those continuously followed for 6, 9, and 12 months) |
| No serious adverse events | No serious adverse events observed | No serious adverse events observed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Initial Study (3-Month Group): 87 healthy participants.
- Sample Size for Long-Term Follow-up (Test Set):
- 6-Month Group: 40 participants
- 9-Month Group: 26 participants
- 12-Month Group: 44 participants
- Total Evaluated Long-Term: 58 participants were evaluated in at least one follow-up time point (6, 9, or 12 months). A subgroup of 21 participants completed continuous follow-up at 6, 9, and 12 months.
- Data Provenance: The study was a "medically supervised clinical study" conducted in "Israel" (based on the submitter's address). It appears to be a prospective study, as participants were enrolled and followed over time with specific treatment regimens and evaluation points.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Two independent evaluators.
- Qualifications: The document does not explicitly state the qualifications of these evaluators (e.g., dermatologists, trained technicians, etc.) beyond being "independent."
4. Adjudication Method for the Test Set
- The ground truth (hair reduction) was measured "by two independent evaluators through hair count on images taken from the treatment area that were subsequently averaged." This indicates a type of consensus by averaging rather than a formal adjudication method like "2+1" (where a third expert breaks ties) or "3+1."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the device's efficacy with and without maintenance treatments; it does not compare human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. The device is for user operation, and the study focuses on the clinical effectiveness of the device when used by participants. There is no mention of an AI algorithm operating independently to perform hair reduction.
7. Type of Ground Truth Used
- The ground truth used was expert consensus (through averaging) of hair count from images. These images were taken at baseline and subsequent follow-up visits, and the hair count reduction was calculated from these images.
8. Sample Size for the Training Set
- This information is not provided in the document. The document describes a "clinical study" which is typically considered the evaluation or test set for regulatory clearance. It does not elaborate on any prior "training" studies or datasets. Given the nature of this device (IPL technology), it is unlikely there was a "training set" in the context of machine learning, but rather prior clinical data for device development and predicate device clearances.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not explicitly mentioned or implied in the context of device development or machine learning, this information is not applicable/not provided. If the question refers to the development process for the device's underlying technology (IPL), then the ground truth for that would be established through a series of lab tests, animal studies, and initial human clinical trials to determine effective parameters for hair follicle targeting and destruction without excessive skin damage. However, these are not described as a "training set" for the present regulatory submission.
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DEC 11 2013
510(k) SUMMARY
Syneron Beauty Ltd.'s mē
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Syneron Beauty Ltd.
Kochav Yokneam Bldg. Yokneam Industrial Zone P.O. Box 14 Yokneam Illit 20692 lsrael
Phone: +972 (4) 9098 700 Facsimile: +972 (4) 9098 701
Contact Person: Omri Hayet
Date Prepared: December 11, 2013
Name of Device and Name/Address of Sponsor
m હૈ
Syneron Beauty Ltd. Kochav Yokneam Bldg. Yokneam Industrial Zone P.O. Box 14 Yokneam Illit 20692
Israel
Common or Usual Name
Light based hair removal system
Classification Name
ONF- Laser surgical instrument for use in general and plastic surgery and in dermatology, Class II, 21 CFR 878.4810
Predicate Devices
Syneron Beauty Ltd.'s me (K123845; K121598) Shaser Inc.'s IPL Hair Removal System (K120080; K103560) Tria Beauty, Inc's Tria Laser Hair Removal System (K090820; K 120737)
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Intended Use / Indications for Use
The me is an over-the-counter device intended for the removal of unwanted hair. Me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.
Device Description
The me device is a small over-the-counter, compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
Technological Characteristics
There are no technological differences between the me device presented in this submission and the previously cleared versions of the device (K123845, K121598). The device incorporates Intense Pulse Light (IPL) technology (output 2-4 J/cm²), like other OTC devices for hair removal.
The nonclinical evaluations of the me device were performed in support of clearance of the predicate me devices, and the information regarding sterilization, shelf life, biocompatibility, and electromagnetic compatibility and electrical safety remain unchanged.
Clinical Performance Data
In a medically supervised clinical study, the me was effective in the removal of unwanted hair, when used as directed. 87 healthy, dark haired participants of all skin types (I-VI) and between the ages of 18 to 65 years old, who were willing to refrain from any type of hair removal methods beyond shaving during the study duration, were enrolled. A treatment area (5x5 cm2) in the underarms, arms and legs were treated once a week for 7 treatments, over a period of 6 weeks, and were evaluated at 3 months after treatment also known as the "3-Month Group". Thereafter, 58 (54 females and 4 males with an average age of 34 years old) of these participants continued in long term clinical studies to evaluate permanent hair reduction at 6, 9 and 12 months with and without monthly maintenance treatments after the initial 7 treatments had been completed.
Table 1 presents the study data for subjects that did not receive monthly maintenance treatments after the initial regimen of 7 treatments ("No Maintenance" group), and Table 2 presents the data for subjects who received monthly treatment after the initial treatment period ("Initial and Maintenance Treatment" group). 72% of subjects were of light skin tone (Skin type I-IV) while the remainder were of darker skin tone (Skin Type V and VI). The "6-month Group" consisted of 40 participants. Each participant had a non-maintenance side and a maintenance side per body area (arms, legs and axilla) and monthly treatments were performed only on the maintenance side. Similarly, the "9-Month Group" consisted of 26 subjects and lastly the "12-Month Group" consisted of 44 subjects.
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The end point for the long term clinical studies was the overall hair reduction achieved at 6, 9 and 12 months following a basic treatment regimen (7 weekly treatments) as measured by two independent evaluators through hair count on images taken from the treatment area that were subsequently averaged. These images were taken just before the first treatment and at subsequent follow ups within the study period of up to 1 year. The effects of performing monthly maintenance following the Basic Treatment regimen of 7 weekly treatments were evaluated in participants of the various study groups at 6, 9 and 12 months from the start of the study and are summarized in the table below. A subject was considered a success if all treated body parts achieved greater than 30% hair reduction at that time point. A body site is considered a success if the treated site achieved greater than 30% hair reduction at that time point.
There were no serious adverse events observed during the entire course of all study evaluations conducted and any minor transient effects such as skin irritation or redness were documented by medical personnel and are described below.
*Table 1 below represents subjects who were evaluated in at least one follow up time point. Non maintenance body sites received only the initial (basic) treatment (7 weekly treatments) with the me device and no additional treatment during follow-up assessments at up to 12 months after end of basic treatment.
Note: There were 40 participants at the 6 month visit, 26 participants at the 9 month visit and 44 participants at the 12 month visit. A total of 58 participants were evaluated in at least one follow up time point 6, 9 or 12 months. Subjects were evaluated at 2, 3, or all follow up time points.
| Average Results | |
|---|---|
| Initial (Basic) Treatment (7 weeklytreatments) | 54% reduction observed in 87 participants (143 sites) |
| 3-Month Group | 44% reduction observed in 87 participants (139 sites) |
| Long Term (≥6 months) Follow-Up | |
| 6-Month Group | 48% reduction (40 participants, 65 sites) |
| 9-Month Group | 45% reduction (26 participants, 44 sites) |
| 12-Month Group | 37% reduction (44 participants, 72 sites) |
| % subjects met success (>30% hair reduction)on all body sites at 12 months post-treatmentSubject Success is defined as greater than30% hair reduction at all treatment sites at 12months. | 45% success observed in the 44 subjects withlong-term follow-up at 12 months |
| % body sites met success (>30% hairreduction) at 12 months post-treatmentBody site success is defined as greater than30% hair reduction on arm or leg or axilla at12 months | 54% success observed in the 72 sites with long-term follow-up at 12 months |
Table 1: Hair Reduction Data with Initial Treatment Regimen (No Maintenance*) (Return for Follow Up at Variable Time Points 6 or 9 or 12 Months)
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**Table 2 represents body sites where maintenance was performed throughout the study. Like Table 1 these subjects were evaluated in at least one follow up time point. For maintenance body sites, the subjects were assigned to perform maintenance treatments monthly after completing the initial (basic) treatment regimen.
Note: There were 40 participants at the 6 month visit, 26 participants at the 9 month visit and 44 participants at the 12 month visit. A total of 58 participants were evaluated in at least one follow up time point 6, 9 or 12 months. Subjects were evaluated at 2, 3, or all follow up time points.
| Average Results | |
|---|---|
| Initial (Basic) Treatment (7 weeklytreatments) | 57% reduction observed in 87 participants (143sites) |
| 3-Month Group | 58% reduction observed in 87 participants (142sites) |
| Long Term (≥6 months) Follow-Up | |
| 6-Month Group | 55% reduction (40 participants, 69 sites) |
| 9-Month Group | 56% reduction (26 participants, 46 sites) |
| 12-Month Group | 52% reduction (44 participants, 75 sites) |
| % subjects met success (>30% hair reduction)on all body sites at 12 months post-treatmentSubject Success is defined as greater than30% hair reduction at all treatment sites at 12months. | 59% success observed in the 44 subjects withlong-term follow-up at 12 months |
| % body sites met success (>30% hairreduction) at 12 months post-treatmentBody site success is defined as greater than30% hair reduction on arm or leg or axilla at12 months. | 72% success observed in the 75 sites with long-term follow-up at 12 months |
| Table 2: Hair Reduction Data with Initial and Maintenance** Treatment (Return for | |||
|---|---|---|---|
| Follow Up at Variable Time Points 6 or 9 or 12 Months) |
Tables 3 and 4 show data from the 21 of the 87 participants who completed non-maintenance (Table 3) and monthly maintenance (Table 4) treatments for up to 1 year continuously following their initial weekly basic treatments and returned for follow-up at 6, 9 and 12 months. As shown in the tables below, this subgroup of participants had slightly higher hair reduction at 12 months. Unlike Tables 1 and 2, the subjects in Tables 3 and 4 were evaluated at all follow up time points of 6, 9, and 12 months.
| Table 3: Hair Reduction Data with Initial Treatment (No Maintenance*) for Participants | |
|---|---|
| Returned for Follow Up at 6, 9 and 12 months |
| Average Results | |
|---|---|
| Basic Treatment (7 weekly treatments) | 54% reduction observed in 87 participants (143 body sites) |
| 3 Months after Initial Treatment | 44% reduction observed in 87 participants (139 body sites) |
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| Long Term (≥6 months) Follow-up | |
|---|---|
| 6 Months after Initial Treatment | 44% reduction observed in 21 participants (37body sites) |
| 9 Months after Initial Treatment | 45% reduction observed in 21 participants (37body sites) |
| 12 Months after Initial Treatment | 42% reduction observed in 21 participants (37body sites) |
| % subjects met success (>30% hair reduction)on all body sites at 12 months post-treatmentSubject Success is defined as greater than30% hair reduction at all treatment sites at 12months. | 52% success observed in the 21 subjects withlong-term follow-ups to 12 months |
| % body sites met success (>30% hairreduction) at 12 months post-treatmentBody site success is defined as greater than30% hair reduction on arm or leg or axilla at12 months. | 68% success observed in the 37 sites with long-term follow-up at 12 months |
- Non maintenance body sites received only the initial (basic) treatment (7 weekly treatments) with the me device and no additional treatment during follow-up assessments at up to 12 months after end of basic treatment.
Table 4: Hair Reduction Data with Initial and Maintenance Treatment** for Participants Returned for Follow Up at 6, 9 and 12 months
| Average Results | |
|---|---|
| Basic Treatment (7 weekly treatments) | 57% reduction observed in 87 participants (143body sites) |
| 3 Months after Initial Treatment | 58% reduction observed in 87 participants (142body sites) |
| Long Term (≥6 months) Follow-up | |
| 6 Months after Initial Treatment | 55% reduction observed in 21 participants (40body sites) |
| 9 Months after Initial Treatment | 59% reduction observed in 21 participants (40body sites) |
| 12 Months after Initial Treatment | 60% reduction observed in 21 participants (40body sites) |
| % subjects met success (>30% hair reduction) onall body sites at 12 months post-treatmentSubject Success is defined as greater than 30%hair reduction at all treatment sites at 12 months. | 62% success observed in the 21 subjects withlong-term follow-ups to 12 months |
| % body sites met success (>30% hair reduction)at 12 months post-treatmentBody site success is defined as greater than 30%hair reduction on arm or leg or axilla at 12 | 80% success observed in the 40 sites with longterm follow-up at 12 months |
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| months. | |
|---|---|
| --------- | -- |
**For maintenance body sites, the subjects were assigned to perform maintenance treatments monthly after completing the initial (basic) treatment regimen.
Actual results will vary from person to person and depending on body site being treated (arms, legs, or underarms). Hair re-growth may fluctuate (increase or decrease) over time, depending on the person, body area and whether the instructions were followed correctly. While permanent reduction of hair results can be achieved without monthly maintenance, it is recommended that user's perform monthly treatments following their basic treatments.
As noted above, there were no serious adverse events in the clinical study. In the clinical study, the majority (85%) of participants did not experience side effects with treatment. The most common side effect is redness after treatment that disappears within several hours without medical treatment. In addition, folliculitis may be observed in some cases.
The user may feel warmth, tingling, or itching. It is expected that the user may feel up to a moderate level of pain. If the pain is severe/intense or the pain persists for more than 24 hours after a treatment, consultation with a physician is recommended.
| Anticipated Effects on SkinAppearance | Number ofReports | Incidence (%) / of3,122 treatments | % Subjects (n/102)* |
|---|---|---|---|
| Redness | 20 | 0.6% | 4% (4/102) |
| Pruritis/itching | 2 | 0.06% | 1% (1/102) |
| Edema | 2 | 0.06% | 1% (1/102) |
| Inflammation | 2 | 0.06% | 1% (1/102) |
| Acne | 2 | 0.06% | 2% (2/102) |
| Total Anticipated | 28 | 0.9% | 9% (9/102)* |
| Device-relatedAdverse Events | |||
| Infection | 0 | 0% | 0% (0/87) |
| Blister | 2 | 0.06% | 1% (1/102) |
| Hyper/hypopigmentation | 0 | 0% | 0% (0/87) |
| Scarring | 0 | 0% | 0% (0/87) |
| Severe pain | 11 | 0.3% | 2% (5/102) |
| Total Adverse Events | 13 | 0.4% | 6% (6/102) |
| Overall anticipated effects +adverse events | 41 | 1% | 15% (15/102) |
In the clinical study, the following side effects of treatment were reported:
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- Safety evaluations were reported for a total of 102 subjects including the 87 subjects included in the efficacy data for up to 3 months post-treatment and an additional 15 subjects included in the long-term studies for >6 months follow-up after treatment.
Substantial Equivalence
The me is substantially equivalent to the Company's own previously cleared me device (K123845; K121598), Shaser's IPL System (K120080; K103560), and Tria Beauty, Inc's Tria Laser Hair Removal System (K090820; K120737).
The me has the same intended use and similar indications for use, technological characteristics, and principles of operation as its predicate devices. As noted above, the only principal change implemented in this submission compared to the previously cleared device version is to expand the indications for use of the device to include permanent hair reduction, based on longer-term clinical data through 12 months. Clinical data substantiates permanent hair reduction of at least 30% measured at 12 months post-treatment compared to baseline. This indication encompasses the same long term data (12 months) as other previously cleared predicates devices such as the Shaser's IPL System (K120080; K103560) and the Tria Laser Hair Removal System (K090820; K 120737). No changes to the device specifications were required to support the expanded indications for use. Thus, there are no technological differences between the me device presented in this submission and the previously cleared versions of the device (K 123845, K121598). Clinical data supports expansion of the indications for use to include permanent hair reduction. Thus, the me is substantially equivalent.
Conclusion
Therefore, the nonclinical and clinical evaluations of the me device demonstrate that the device performs as intended, and is substantially equivalent to the predicate devices.
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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or extensions reaching upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 11, 2013
Syneron Beauty Ltd. c/o Hogan Lovells US LLP Janice M. Hogan 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K131649
Trade/Device Name: më 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: ONF Dated: November 07, 2013 Received: November 07, 2013
Dear Ms. Hogan:
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 - Janice M. Hogan
.. . . . . . . . . . .
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Binita S. Asharaكرة
2013.12.11 17:34:24-05'00
Binita Ashar, MD, MBA, FACS Acting 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): K131649
Device Name: Syneron me
Indications For Use: The mẽ Is an over-the-counter device intended for the removal of unwanted hair. Me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.
| Prescription Use | AND/OR | Over-The-Counter Use | X |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden
2013.12.11 15:00:46 -05'00'
| (Division Sign-Off) for BSA | |
|---|---|
| Division of Surgical Devices | |
| 510(k) Number | K131649 |
Page 1 of _1
§ 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.