(64 days)
Not Found
No
The device description and the absence of mentions of AI, ML, image processing, training/test sets, or performance metrics related to algorithmic analysis strongly indicate that this is a purely mechanical and chemical device for lice removal.
Yes
The device is intended for the removal of head lice and nits, which is a therapeutic purpose. It directly addresses a health condition (lice infestation) by removing the source of the problem, fitting the definition of a therapeutic device.
No
Explanation: The device is intended for the removal of head lice and their eggs, which is a treatment or management function, not a diagnostic one. It does not identify or detect a medical condition.
No
The device description explicitly states the kit consists of a stainless steel comb and a shampoo, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: This device is a physical tool (comb and shampoo) used to physically remove head lice and nits from hair. It does not perform any tests on bodily samples to diagnose a condition.
- Intended Use: The intended use is the physical removal of parasites, not the diagnosis of a disease or condition through analysis of biological samples.
Therefore, based on the provided information, this device clearly falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
the removal of head lice and their eggs (nits) from hair
Product codes
LJL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hair/head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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.
2
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