(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.
§ 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.