(64 days)
the removal of head lice and their eggs (nits) from hair
The kit consists of two components, the combing pretreatment shampoo. The comb is stainless steel with the teeth set to 0.3 mm (300 micron) spacing and capable of removing nits which are greater than 0.3 mm when attached to the hair. The second element is a shampoo that contains no pesticides but does facilitate lice removal and allows for rinsing and combing the nits out of the hair.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KIEL LABORATORIES, INC. KLOUT™ LICE COMB and PRETREATMENT SHAMPOO:
Summary of Device and Intended Use:
The KLOUT™ kit consists of a stainless steel comb with 0.3 mm tooth spacing and a pesticide-free shampoo. Its intended use is the removal of head lice and their eggs (nits) from hair.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or a controlled study with statistically reported device performance metrics (e.g., sensitivity, specificity, accuracy, removal rates, etc.) for the KLOUT™ kit itself.
Instead, the submission relies on a "Basis for Comparison" to predicate devices (CLEAR™ LICE EGG REMOVER SYSTEM - K981147 and LICEMEISTER™ COMB - K981250) to demonstrate substantial equivalence. The acceptance for this device is based on showing that its features and intended use are similar to those of legally marketed predicate devices, implying that if the predicates are safe and effective, then the KLOUT™ kit, with similar characteristics, also should be.
The table below reflects the comparison points used to establish substantial equivalence, which implicitly act as the "acceptance criteria" by aligning with the established performance/features of predicate devices.
| Acceptance Criteria (Derived from Predicate Comparison) | Reported Device Performance (KLOUT™ kit) |
|---|---|
| Comb included | Yes |
| Removal of nits | Yes |
| Ovicidal | No |
| Removal of lice | Yes |
| Pediculicidal | No |
| Where used (home setting) | Home |
| Active ingredient (none) | None |
| Anatomical site of use (hair/head) | Hair/head |
2. Sample Size Used for the Test Set and Data Provenance:
No specific test set or clinical study data is provided in this submission. The approach is based on demonstrating substantial equivalence to predicate devices, not on a new performance study with a distinct test set. Therefore, there is no sample size for a test set or data provenance to report.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. As no specific performance study with a test set was conducted for the KLOUT™ kit, there were no experts required to establish ground truth for such a study. The "ground truth" here is the established safety and effectiveness of the predicate devices.
4. Adjudication Method for the Test Set:
Not applicable. No test set or associated adjudication method is described in the submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document does not describe an MRMC comparative effectiveness study involving human readers or AI.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
No. This device is a physical product (comb and shampoo), not an algorithm or AI. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used:
The "ground truth" in this context is the established safety and effectiveness of the predicate devices (CLEAR™ LICE EGG REMOVER SYSTEM - K981147 and LICEMEISTER™ COMB - K981250) as accepted by the FDA. The submission demonstrates that the KLOUT™ kit is substantially equivalent to these devices based on its components, intended use, and functional characteristics.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set was used for this device.
§ 880.5960 Lice removal kit.
(a)
Identification. The lice removal kit is a comb or comb-like device intended to remove and/or kill lice and nits from head and body hair. It may or may not be battery operated.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.