(64 days)
Not Found
No
The device description details a mechanical nit comb with no mention of software, algorithms, or any technology beyond its physical construction and tooth spacing.
No
The device is a nit comb used for detecting and removing lice eggs, which is a physical method of removal rather than a therapeutic treatment in the medical sense. It is substantially equivalent to other nit removal combs.
No
Explanation: The device is a nit comb designed for physical detection and removal of lice eggs. It does not perform any medical diagnosis or analysis of a condition.
No
The device description clearly states it is a "nit comb" constructed of "stainless steel teeth imbedded in a high density polyethylene handle," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is a physical comb used to detect and remove lice eggs (nits) from hair. It operates mechanically and does not involve testing biological samples in a laboratory setting.
- Intended Use: The intended use clearly states "For lice egg detection and removal," which is a physical process, not an in vitro diagnostic test.
- Device Description: The description details the physical construction of the comb and its mechanism of action (spacing of teeth), further supporting that it's a physical tool.
Therefore, this device falls under the category of a medical device, specifically a physical tool for the detection and removal of external parasites, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Lice egg detection and removal.
Product codes
LJL
Device Description
The product is a nit comb intended for use in detecting and removing lice eggs from the hair. It is constructed of closely spaced stainless steel teeth imbedded in a high density polyethylene handle. The points and edges of the teeth are rounded so as not to cut or damage hair or scalp. The comb can be cleaned with soap and water after use and can withstand boiling water disinfection. The product is substantially equivalent to other nit removal combs, including the Innocomb Lice Comb (K822421) and Innomed PD-1 Kit (K822574).
The technological characteristics of the Clear Special Nit Comb are the same as other marketed nit combs, including the predicate devices, which range from 100 to 200 microns of spacing between comb teeth. The minimum width of a lice nit adhering to a human hair is approximately 300 microns (0.3mm). The spacing between the teeth of the Clear Special Nit Comb is 200 microns (0.2mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K 981037
EXHIBIT 5 (05/18/98)
510(k) Summary
Submitted by: Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036 Telephone: 202-261-1000
On behalf of Care Technologies, Inc. 510(k) Submission: Clear™ Special Nit Comb
| Date Summary Prepared: | May 18, 1998 |
|---|---|
| Name of device: | Clear™ Special Nit Comb |
| Predicate Devices: | Innocomb Lice Comb |
| Innomed PD-1 Kit |
Description of Device:
The product is a nit comb intended for use in detecting and removing lice eggs from the hair. It is constructed of closely spaced stainless steel teeth imbedded in a high density polyethylene handle. The points and edges of the teeth are rounded so as not to cut or damage hair or scalp. The comb can be cleaned with soap and water after use and can withstand boiling water disinfection. The product is substantially equivalent to other nit removal combs, including the Innocomb Lice Comb (K822421) and Innomed PD-1 Kit (K822574).
The technological characteristics of the Clear Special Nit Comb are the same as other marketed nit combs, including the predicate devices, which range from 100 to 200 microns of spacing between comb teeth. The minimum width of a lice nit adhering to a human hair is approximately 300 microns (0.3mm). The spacing between the teeth of the Clear Special Nit Comb is 200 microns (0.2mm).
Intended use:
Lice egg detection and removal.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 22 1998
Care Technologies, Incorporated ·C/O Mr. Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036
K981037 Re : Trade Name: Clear™ Special Nit Comb Requlatory Class: Unclassified Product Code: LJL Dated: March 18, 1998 Received: March 19, 1998
Dear Mr. Manelli:
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 legally marketed predicate 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 Requlations, Title 21, Parts 800 to 895. ಗಳ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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
2
Page 2 - Mr. Manelli
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ----
3
Page_1_of_1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:___________________________________________________________
Indications For Use:
For lice egg detection and removal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Cucenite
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number `981037
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)