(64 days)
Lice egg detection and removal.
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).
This 510(k) submission (K981037) for the Clear™ Special Nit Comb does not contain a study that proves the device meets specific acceptance criteria in the manner typically expected for medical devices involving algorithmic performance or diagnostic accuracy.
Instead, this submission is based on substantial equivalence to predicate devices (Innocomb Lice Comb and Innomed PD-1 Kit). The "acceptance criteria" are implicitly met by demonstrating that the device has the same technological characteristics and intended use as legally marketed predicate devices, particularly regarding the spacing of its teeth.
Therefore, many of the requested categories (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Technological Characteristics:Tooth spacing (to effectively remove lice nits without damaging hair/scalp).Material and construction (closely spaced stainless steel teeth, high-density polyethylene handle, rounded points/edges, cleanable, autoclavable). | Tooth Spacing: The spacing between the teeth of the Clear™ Special Nit Comb is 200 microns (0.2mm). This falls within the range of predicate devices (100 to 200 microns). The minimum width of a lice nit adhering to a human hair is approximately 300 microns (0.3mm), indicating that a 200-micron spacing is sufficient to capture nits. Material and Construction: Constructed of closely spaced stainless steel teeth imbedded in a high-density polyethylene handle. Points and edges are rounded. Can be cleaned with soap and water and can withstand boiling water disinfection. |
| Intended Use:Lice egg detection and removal. | The device is intended for "Lice egg detection and removal." This matches the stated intended use of predicate devices as a nit comb. |
| Safety:No cutting or damaging of hair or scalp,Ease of cleaning/disinfection. | 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, indicating ease of maintenance and hygiene. |
1. Sample size used for the test set and the data provenance:
- Not applicable. This submission relies on substantial equivalence based on product design and published biological information (e.g., nit size), not a performance study with a test set of data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no "test set" in the context of an algorithmic or diagnostic performance study that required ground truth established by experts.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or expert adjudication was performed for this submission.
4. 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:
- No. This is a physical device (a comb), not an AI-powered diagnostic or assistive tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" implicitly relied upon is the biological size of lice nits (approximately 300 microns) and the known effectiveness of predicate nit combs with similar tooth spacing. This is more akin to established scientific understanding rather than a specifically generated "ground truth" for a performance study.
7. The sample size for the training set:
- Not applicable. This is a physical device, not an AI model requiring a training set.
8. How the ground truth for the training set was established:
- Not applicable. This is a physical device, not an AI model.
Summary Explanation:
The K981037 submission for the Clear™ Special Nit Comb sought 510(k) clearance based on substantial equivalence. This means the manufacturer demonstrated that their device is as safe and effective as legally marketed predicate devices without requiring new clinical trials or extensive performance studies typically associated with novel or high-risk devices, or those involving AI/diagnostic algorithms.
The key "evidence" presented was:
- Comparison of Technical Specifications: The tooth spacing (200 microns) was shown to be within the range of predicate devices and smaller than the minimum width of a lice nit.
- Description of Materials and Design: The construction (stainless steel teeth, polyethylene handle, rounded edges, cleanable) was presented as being similar to predicate devices and suitable for its intended use without causing harm.
- Intended Use Alignment: The stated intended use for lice egg detection and removal was identical to that of predicate devices.
The FDA's review concluded that the device was substantially equivalent, allowing it to be marketed. No performance studies with human subjects or data sets were required or cited in the provided documents for this type of submission.
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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 CombInnomed 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.
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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
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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 ----
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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)
§ 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.