(71 days)
To remove lice eggs from hair.
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).
The provided document**K981147** is a 510(k) summary for a medical device called the "Clear™ Lice Egg Remover System." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria and performance metrics in the way a PMA submission might.
Therefore, the document does not contain the detailed acceptance criteria and a study proving device performance against those criteria as would be expected for a new technology requiring such validation. Instead, it focuses on comparing the new device's characteristics to existing, approved devices.
Here's a breakdown based on the information available in the document, and where information is missing:
The document describes the device as a system consisting of:
- A glass-reinforced nylon fine tooth nit comb.
- An enzyme gel cleansing agent, which is a non-toxic water-based vegetable-derived enzyme composition.
The intended use is "To remove lice eggs from hair."
The predicate devices identified are the Innocomb Lice Comb (K822421) and the Innomed PD-1 Kit (K822574).
Information from the document related to your request:
1. A table of acceptance criteria and the reported device performance
-
Acceptance Criteria (Implicit/Inferred from Predicate Equivalence): The primary acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device. For this specific device, the key technological characteristic that determines equivalence for the comb component is the spacing between the teeth.
- Criterion for Comb: Spacing between comb teeth should be within the range of 100 to 200 microns (0.1 to 0.2 mm), which is typical for other marketed products and predicate devices.
- Criterion for Effectiveness (Assumed): The comb, combined with the gel, should be effective at removing lice eggs (nits) that are larger than the comb's spacing.
-
Reported Device Performance:
Acceptance Criteria (Implicit) Reported Device Performance Spacing between comb teeth: 100 to 200 microns (0.1 to 0.2 mm) 0.2 mm (meets criterion) Lice nit minimum width: Approximately 300 microns (0.3 mm) (Implies that a 0.2 mm comb spacing is effective for removal, as the nit is larger than the gap)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The 510(k) summary does not mention any specific test set, clinical studies, or data provenance to prove performance against quantitative acceptance criteria in the way a clinical trial would. The submission relies on technological equivalence to predicate devices already on the market.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: As no specific test set or clinical study to establish ground truth is described, this information is not relevant to this submission type.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No test set described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This device is a physical nit comb and enzyme gel, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI effect sizes are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implicit Ground Truth (Technological Equivalence): The ground truth for this submission type is based on the established performance and safety of equivalent predicate devices and the physical characteristics of the nits being removed. The statement that "The minimum width of a lice nit adhering to a human hair is approximately 300 microns (0.3 mm)" serves as a foundational piece of information, implying that a comb with 0.2 mm spacing will physically remove nits effectively.
8. The sample size for the training set
- Not Applicable / Not Provided: There is no "training set" in the context of this 510(k) submission for a physical device.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: Refer to point 8.
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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 (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 ... ......
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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)
§ 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.