CLEAR (TM) LICE EGG REMOVER SYSTEM

K981147 · Care Technologies, Inc. · LJL · Jun 9, 1998 · General Hospital

Device Facts

• Record ID: K981147
• Device Name: CLEAR (TM) LICE EGG REMOVER SYSTEM
• Applicant: Care Technologies, Inc.
• Product Code: LJL · General Hospital
• Decision Date: Jun 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5960
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

To remove lice eggs from hair.

Device Story

Clear™ Lice Egg Remover System is a two-component kit for nit removal. Components include a glass-reinforced nylon fine-tooth comb and a non-toxic, water-based, vegetable-derived enzyme gel. The gel is applied to hair to facilitate the mechanical removal of lice eggs using the comb. The comb features a tooth spacing of 0.2 mm, designed to capture lice nits, which have a minimum width of approximately 0.3 mm. The system is intended for over-the-counter use by individuals to assist in the physical extraction of nits from hair.

Clinical Evidence

No clinical data provided; bench testing only. The device relies on physical dimensions (comb tooth spacing of 0.2 mm) relative to the known minimum width of lice nits (0.3 mm) to demonstrate efficacy.

Technological Characteristics

System consists of a glass-reinforced nylon fine-tooth comb and a water-based vegetable-derived enzyme gel. Comb tooth spacing is 0.2 mm. Mechanical removal principle. No energy source or software components.

Indications for Use

Indicated for the removal of lice eggs (nits) from human hair.

Regulatory Classification

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.

Predicate Devices

• Innocomb Lice Comb (K822421)
• Innomed PD-1 Kit (K822574)

Submission Summary (Full Text)

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K981147

EXHIBIT 5 (06/04/98)

## 510(k) Summary

Daniel J. Manelli Submitted by: Farkas & Manelli, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036 202-261-1000

> On behalf of Care Technologies, Inc. 510(k) Submission: Clear™ Lice Egg Remover System

June 4, 1998 Date Summary Prepared:

Clear™ Lice Egg Remover System Name of device:

Predicate Devices:

Innocomb Lice Comb Innomed PD-1 Kit

Description of Device:

The product is a system consisting of two components: (a) a glass reinforced nylon fine tooth nit comb; and (b) an enzyme gel cleansing agent intended to be used together with the comb to facilitate the combing out of lice eggs (nits) from the hair. The combing aid gel is a non-toxic water based vegetable derived enzyme composition. The product is substantially equivalent to other nit removal products, including the Innocomb Lice Comb (K822421) and the Innomed PD-1 Kit (K822574).

The technological characteristics of the nit comb component are the same as other marketed products, including the predicate devices, which range from 100 to 200 microns of spacing between comb teeth (0.1 to 0.2 mm). Spacing between the teeth of the comb component is 0.2 mm. The minimum width of a lice nit adhering to a human hair is approximately 300 microns (0.3 mm).

To remove lice eggs from hair Intended use:

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 1998

Care Technologies, Incorporated C/O Mr. Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street, NW (Suite 700) 20036 Washington, DC

Re : K981147 Clear™ Lice Egg Remover System Trade Name: Regulatory Class: Unclassified Product Code: LJL Dated: March 27, 1998 Received: March 30, 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 aqainst 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 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 obligation you might have under sections 531

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Page 2 - Mr. Manelli

through 542 of the Act for devices under the Electronic emoduct 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 ... ......

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EXHIBIT 2

1 1 of Page_

510(k) Number (if known): K981147

Clear(tm) Lice Egg Remover System Device Name:_

Indications For Use:

To remove lice eggs from hair.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pallina Cecchini

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K981147

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)