(66 days)
For the removal of hair
The device works by emitting from the tweezer tips radio frequency energy that is transmitted down an individual hair grasped by the tweezers to the root and papilla of the hair. The tweezers may also be used to slide the hair out after treatment. The radio frequency energy destroys the papilla, with the result that the hair does not grow back. More than one treatment may be necessary.
The provided 510(k) summary for the Sonique™ Hair Remover does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria.
Instead, the summary relies on a Substantial Equivalence claim to an existing predicate device, the IGIÁ Hair Removal System. The core of the submission is that the Sonique™ Hair Remover is "substantially equivalent" to an already marketed device, meaning it has the same intended use and similar technological characteristics, and any differences do as not raise different questions of safety and effectiveness.
Here's a breakdown of what can be extracted from the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Hair removal | Yes, works by "emitting from the tweezer tips radio frequency energy that is transmitted down an individual hair grasped by the tweezers to the root and papilla of the hair." The "radio frequency energy destroys the papilla, with the result that the hair does not grow back." |
| Radio Frequency Signal: 27 MHz | Device emits a 27 MHz radio frequency signal. |
| Peak Radio Frequency Reading: Comparable to predicate | Sonique™: dBuV 107.15 (Target: Comparable to IGIA's dBuV 105.6) |
| Safety and Efficacy: Established for tweezer-type epilators | Referenced to Federal Register notice (June 11, 1997, 62 Fed. Reg. 31771-775) discussing safety and efficacy of this device type. |
| Electrical Operation: 4 "AAA" batteries, 6V | Device operates on 4 "AAA" batteries and uses 6V of electricity. |
Missing Information: The document does not specify quantitative acceptance criteria for efficacy (e.g., percentage of hair reduction over a certain period, permanence of hair removal) or safety (e.g., acceptable rates of skin irritation, burns). The "performance" is primarily described in terms of its mechanism and its similarity to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified, as no specific clinical study data is presented for this device. The submission relies on the established safety and efficacy of the predicate device type.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There is no described test set or ground truth establishment process for this device for efficacy or safety. The FDA's review for substantial equivalence makes a determination based on comparison to an existing, legally marketed device and existing literature (the Federal Register notice).
4. Adjudication Method for the Test Set
- Not applicable. No test set or human adjudication described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done. This device is a hair removal tool and not an imaging or diagnostic AI-assisted device where such a study would be relevant.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical hair removal device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the Sonique™ Hair Remover's clearance relies on the established regulatory precedent and published literature for tweezer-type epilators, specifically the finding of the FDA in the referenced Federal Register notice (62 Fed. Reg. 31771-775) which discusses the safety and efficacy of this device type generally, and the demonstrated safety and efficacy of its predicate device (IGIÁ Hair Removal System). There is no specific, independent "ground truth" established for this device in this submission beyond its technical specifications being comparable to the predicate.
8. The Sample Size for the Training Set
- Not applicable. This device does not use a "training set" in the artificial intelligence or machine learning sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable.
Summary of the "Study" Proving Acceptance:
The "study" proving the device meets the (implied) acceptance criteria is the demonstration of substantial equivalence to a predicate device, the IGIÁ Hair Removal System.
- The 510(k) submission argues that the Sonique™ Hair Remover shares the same intended use (hair removal) and technological characteristics (emitting a 27 MHz radio frequency signal via tweezers to destroy hair papillae) as the IGIÁ system.
- The key technical differences (battery vs. household power, 6V vs. 9V) are presented as not raising new questions of safety or effectiveness.
- The FDA's previous findings on the safety and efficacy of this class of devices, as published in the Federal Register, serve as the foundational justification for the device's acceptable performance and safety.
In essence, the device is cleared because it is functionally and technically similar enough to a device already deemed safe and effective by the FDA, rather than through independent prospective clinical trials for this specific product.
{0}------------------------------------------------
510 (k) SUMMARY
ni
OCT 30 1997
Sonique™ Hair Remover Trade name:
Global TV Concepts Ltd. Marketed by: 776 South Military Trail Deerfield Beach, Florida 33442 (954) 570-9998; fax (954) 570-9990 Contact: Ms. Laurie Braden
Date prepared: August 22, 1997
Sonic hair remover Common name:
Classification Tweezer-type epilator (per 21 C.F.R. § 878.5360) name :
Intended use: Hair removal
- The device works by emitting from the tweezer tips Description: radio frequency energy that is transmitted down an individual hair grasped by the tweezers to the root and papilla of the hair. The tweezers may also be used to slide the hair out after treatment. The radio frequency energy destroys the papilla, with the result that the hair does not grow back. More than one treatment may be necessary.
- The device is substantially equivalent to the Substantial IGIÁ Hair Removal System, another tweezer-type equivalence: epilator. Both devices emit a 27 MHz radio frequency signal, with a peak reading of dBuV 107.15 for the Sonique™ and dBuV 105.6 for the IGIA. The principal difference between the products is that the Sonique™ Hair Remover relies on 4 "AAA" batteries for its operation, whereas the IGIA Hair Removal System uses household electrical enerqy. Also the Sonique™ uses 6V of electricity to generate the radio frequency signal, whereas the IGIA uses 9V.
The safety and efficacy of tweezer-type epilators are discussed in the attached Federal Register notice published by the Food and Drug Administration (FDA) on June 11, 1997, 62 Fed. Reg. 31771-775.
Attachment
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Global TV Concepts, Ltd. c/o Ms. Samia N. Rodriguez Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, NW, Suite 1200 Washington, District of Columbia 20005
OCT 3 0 1997
Re: K973174
Trade Name: Sonique™ Hair Remover Regulatory Class: III Product Code: KCX Dated: August 22, 1997 Received: August 25, 1997
Dear Ms. Rodriguez:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{2}------------------------------------------------
Page 2 - Ms. Samia N. Rodriguez
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Asevedo
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
ri
، ﭘﺮ
510(k) Number (if known): K973174
Device Name: Sonique Hair Remover
Indications For Use:
For the removal of hair
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
coolo
(Division Sign-Off) Division of General Restorative Devices 6973174 510(k) Number J
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 878.5360 Tweezer-type epilator.
(a)
Identification. The tweezer-type epilator is an electrical device intended to remove hair. The energy provided at the tip of the tweezer used to remove hair may be radio frequency, galvanic (direct current), or a combination of radio frequency and galvanic energy.(b)
Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.