(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.
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AUG 1 3 900
510 (k) NOTIFICATION KIEL LABORATORIES, INC. SUMMARY
KIEL LABORATORIES, INC. 2225 CENTENNIAL DRIVE GAINESVILLE, GA. 30504
CONTACT: TANYJA PORCHÁ PHONE: (770) 534-0079 FAX: (770) 534-0229
DATE PREPARED: 6/04/99
LICE COMB AND PRETREATMENT KIT DEVICE NAME: PROPRIETARY NAME: CLASS: 1 PANEL: PRODUCT CODE: LJL CLASSIFICATION NAME: PREDICATE DEVICE:
KLOUT™ LICE COMB and PRETREATMENT SHAMPOO GENERAL HOSPITAL DETECTORS AND REMOVERS, LICE (including combs) CLEAR™ LICE EGG REMOVER SYSTEM - K981147 LICEMEISTER™ COMB - K981250
DESCRIPTION AND INTENDED USE:
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.
intended use/indications: the removal of head lice and their eggs (nits) from hair
BASIS FOR COMPARISON:
| basis for comparison | KLOUT™ kit | CLEAR® system |
|---|---|---|
| comb included | yes | yes |
| removal of nits | yes | yes |
| ovicidal | no | no |
| removal of lice | yes | no |
| pediculicidal | no | no |
| where used | home | home |
| active ingredient | none | none |
| anatomical site of use | hair/head | hair/head |
section 5.wpd
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized human figure with three heads in profile, suggesting a sense of community and care. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 1999
Ms. Tanya Porcha Director of Requlatory Affairs Kiel Laboratories, Incorporated 2225 Centennial Drive Gainesville. Georgia 30504
Re : K991958 Klout Shampoo and Lice Combing Pretreatment Kit · Trade Name: Regulatory Class: I Product Code: LJL June 09, 1999 Dated: Received: July 30, 1999
Dear Ms. Porcha
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 obliqation 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 requlations.
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Page 2 - Mr. Porcha
This letter will allow you to begin marketing your device as Info iceeer wire as ( ) premarket notification. The FDA finding described in your sialence of your device to a legally marketed or babbtanded on a classification for your device and thus, permits your device to proceed to the market. enab/ Desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro regaractic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and (Jul, Joing 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 Other general information on your responsibilities CFR 807.97). under the Act may be obtained from the Division of Small under cho not maj 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,
Timothy A. Ulatowski
Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510 (k) NOTIFICATION KIEL LABORATORIES, INC.
intended use/indications: the removal of head lice and their eggs (nits) from hair
Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use.
Over the Moon...
Seulen Briler
Page 1 of 1
Sign-Off) ton control, (Division Sig of Dental, Infection Control Tospital Devices
section 1.wpd
§ 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.