(29 days)
The Mini me is an over-the counter device intended for the removal of unwanted hair. The Mini 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 Mini mē is a smaller version of its predicate device (K131649) and consists of a handheld unit that operates with an external power supply. Identical to its predicate device, the miniaturized version also delivers Intense Pulse Light (IPL) technology (output up to 4 J/cm²) to the treatment area for removing unwanted hair and also uses a skin contact sensor via low RF energy signal to establish skin contact prior to the emission of a pulse.
The provided text is a 510(k) summary for the Mini mē device. It states that the Mini mē is a smaller version of its predicate device (Mē System, K131649) and shares the same technological characteristics, including the use of Intense Pulse Light (IPL) technology (output up to 4 J/cm²), a skin contact sensor, and safety features.
The document does not contain a clinical study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert adjudication as typically found for new device efficacy claims. Instead, it relies on substantial equivalence to a predicate device.
Here's the breakdown of what the document does provide and why it doesn't fit the requested format for a study proving acceptance criteria:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the document for the Mini mē regarding efficacy for hair removal. The document focuses on demonstrating that the Mini mē functions as intended based on non-clinical testing and that its performance is equivalent to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for efficacy. The document states "no new questions of efficacy are raised in the modified device" because it delivers energy within the same limits as the predicate device. | Not specified for efficacy. The document states that "in all instances, the Mini me device functioned as intended" for non-clinical tests (electrical safety, EMC, software, system V&V). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
No clinical test set data is provided. The performance data section refers to non-clinical testing: electrical safety, electromagnetic compatibility, software verification and validation, and system verification and validation. No sample sizes for these tests are mentioned, nor is data provenance in the context of clinical studies.
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 applicable as no clinical test set requiring expert ground truth establishment for efficacy is described. The document relies on engineering and system-level validation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as no clinical test set is described.
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:
This information is not applicable. The device is an IPL hair removal system, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a user-operated IPL hair removal system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable for clinical efficacy evaluations of the Mini mē, as no such evaluations are detailed in the provided text. For the non-clinical tests, the "ground truth" would be the engineering specifications and regulatory standards the device was tested against.
8. The sample size for the training set:
This information is not applicable. The Mini mē is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
In summary: The provided document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence. It highlights the technological characteristics and non-clinical performance testing (electrical safety, EMC, software, system V&V) to demonstrate that the Mini mē is as safe and effective as its predicate device (Mē System, K131649). It does not describe a clinical study with acceptance criteria, patient sample sizes, or expert adjudication for proving efficacy, as it leverages the prior clearance of the predicate device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Iluminage Ltd. (Formerly Syneron Beauty Ltd.) % Ms. Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K143339
Trade/Device Name: Mini mē 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 20, 2014 Received: November 20, 2014
Dear Ms. Janice M. 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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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 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/Resourcesfor You/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/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,
Binita S.Ashar -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known): K143339
Device Name: Mini me
Indications for Use (Describe)
The Mini me is an over-the counter device intended for the removal of unwanted hair. The Mini 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.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
XX Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/14)
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510(k) SUMMARY
Iluminage Ltd.'s Mini mē
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Iluminage Ltd.
Kochav Yokneam Bldg. Yokneam Industrial Zone P.O Box 14 Yokneam Illit 20692 Israel
Phone: +1 (212) 245-2999 X 202 Facsimile: +972 (4) 9098 701
Contact Person: Bobae Kim
Date Prepared: November 20, 2014
Name of Device and Name/Address of Sponsor
Mini mē
Iluminage 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
Predicate Devices
Iluminage Ltd's (Formerly Syneron Beauty Ltd)- Mē System (K131649)
Intended Use / Indications for Use
The Mini mē is an over-the counter device intended for the removal of unwanted hair. Mini mē 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.
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Technological Characteristics
The Mini mē is a smaller version of its predicate device (K131649) and consists of a handheld unit that operates with an external power supply. Identical to its predicate device, the miniaturized version also delivers Intense Pulse Light (IPL) technology (output up to 4 J/cm²) to the treatment area for removing unwanted hair and also uses a skin contact sensor via low RF energy signal to establish skin contact prior to the emission of a pulse. These essential output specifications remain unchanged from the cleared predicate device (K131649).
Performance Data
Risk analysis was performed to assess the modifications to the Mini me device, and confirmed that no new risks have been raised. The following non-clinical performance testing was conducted to re-validate the modified device, against the same test methods and criteria used on the predicate device cleared in K131469 that includes:
- Electrical safety
- Electromagnetic compatibility testing
- . Software verification and validation testing
- System verification and validation testing
In all instances, the Mini me device functioned as intended.
Substantial Equivalence
The Mini mē is as safe and effective as the predicate device, the mē System (K131649). The Mini me uses the same technology and wavelength of light and has the same intended and indications for use and principle of operation as the predicate device. The main safety features that include the skin contact sensor and cooling fan in the predicate device are also preserved in the Mini mē. Furthermore, the Mini mē delivers energy within the same limits as the predicate device including the rate and duration of each pulse emission and therefore no new questions of efficacy are raised in the modified device. Any minor differences in the dimensions and hardware of the Mini me device compared to its predicate device do not raise new issues of safety or effectiveness in the modified Mini mē device. Verification and validation testing demonstrated that the Mini me System is as safe and effective as the me System (K131649). There were no new hazards identified as a result of these minor modifications and therefore the Mini mē System is substantially equivalent.
§ 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.