The Nix® Ultra Lice Treatment Kit consists of two components: Nix® Ultra Lice Killing Solution and Nix® Ultra Lice Removal Comb. The kit also includes an Instructions for Use Leaflet.

Nix® Ultra Lice Killing Solution is a formulated device containing dimethicone and isoparaffin. The product kills lice and their eggs by physically coating the lice and clogging the spiracles through which they breathe and conduct water exchange; the solution also lubricates the hair to facilitate removal of dead lice and nits with the supplied comb. The Nix® Ultra Lice Treatment Kit is intended for over-the-counter use.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document for the Nix® Ultra Lice Treatment Kit:

Acceptance Criteria and Reported Device Performance

The FDA 510(k) submission for the Nix® Ultra Lice Treatment Kit does not explicitly state pre-defined quantitative acceptance criteria in the typical sense (e.g., "The device must achieve X% sensitivity and Y% specificity"). Instead, it focuses on demonstrating substantial equivalence to a predicate device, the Clear™ Lice Egg Remover System (K981147).

The closest equivalent to "acceptance criteria" and "reported device performance" in this document is the demonstration of effectiveness against lice and nits and safety through in-vitro studies and a clinical study. The primary endpoints in the clinical study focused on "cure rates" (no infestation) at different time points.

Here's a table summarizing the relevant performance metrics from the studies:

Acceptance Criteria (Implied)	Reported Device Performance (Nix® Ultra Lice Killing Solution)
In-vitro efficacy against Nits (lice eggs)	97% Mortality Rate (vs. 24% for drug comparator, 10% for water control)
In-vitro efficacy against Adult Lice	100% Mortality Rate (vs. 36.67% for drug comparator, 1% for water control)
In-vitro efficacy against Permethrin- and DDT-resistant lice	100% Mortality Rate (vs. 43.3% for drug comparator, 1.7% for water control)
Clinical Cure Rate - Day 10 (all baseline infestations)	92% - 96% of subjects free of infestation (depending on product in study)
Clinical Cure Rate - Day 7 (all baseline infestations)	88% - 88.46% of subjects free of infestation (depending on product in study)
Clinical Cure Rate - Day 1 (all baseline infestations)	92.31% - 96.15% of subjects free of infestation (depending on product in study)
Safety (Biocompatibility)	Not cytotoxic, non-irritating (human patch test), negligible irritation (rabbits), non-significantly/weakly sensitizing, mild corneal irritant.
Tolerability (Clinical Study)	Well tolerated (one mild, possibly related adverse event)
Post-marketing adverse events	5 cases involving 13 patients out of 518,095 units sold (non-serious and temporary)

Study Details

Sample size used for the test set and the data provenance:
- In-vitro studies: The document details the subjects as "adult lice, nits, and lice genetically confirmed to be permethrin- and DDT-resistant (BR-HL strain)". The exact numerical sample size (e.g., number of lice or nits per test) is not provided, only the resulting mortality rates.
- Clinical Study (Ref# NUHL001-10/15): The tables show results for 25-26 subjects for "Reference" and 25-26 subjects for "Test" in the "All baseline infestations" category. For "Mild and Moderate Baseline Infestation," it's 19 subjects for "Reference" and 17-18 subjects for "Test". The specific country of origin is not explicitly stated, but the mention of a European marketer for post-marketing data suggests the clinical trial could have been conducted in Europe. The study is described as a "randomized, controlled, investigator- and assessor-blinded study," indicating it was a prospective clinical trial.
- Post-marketing adverse event data: This involved 518,095 units sold in Europe from June 2007 to December 2015, making it retrospective observational data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- In-vitro studies: Not explicitly stated. The ground truth (live vs. dead lice/nits) would typically be assessed by laboratory technicians trained in entomology, potentially under the supervision of experts in parasitology. Specific qualification details are not provided.
- Clinical Study: The study involved an "investigator" to assess the baseline infestation and presumably monitor for cure or presence of lice. The document does not specify the number of investigators or their qualifications beyond the term "investigator." For Head Lice studies, these are often medical professionals or trained personnel experienced in examining scalps for lice and nits.
Adjudication method for the test set:
- In-vitro studies: Not specified, but generally, clear criteria for "mortality" in entomological studies are pre-defined and applied consistently by trained observers.
- Clinical Study: Not explicitly described. Given it was an "investigator- and assessor-blinded study," it implies that at least two independent parties were involved in assessments, one of whom was blinded. However, the specific adjudication process (e.g., if there were discrepancies between assessors) is not detailed.
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:

This is not an AI/imaging device. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is not applicable to this device. The clinical study was a comparison of the Nix® Ultra product against a "Reference" product in terms of cure rates.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not an AI/algorithm-driven device. Therefore, a standalone algorithm-only performance study is not applicable. The "device" in this context is a physical lice treatment kit.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- In-vitro studies: Biological endpoint (mortality/viability of lice and nits) observed directly by trained personnel. This could be considered a form of direct biological observation, which is highly objective.
- Clinical Study: Clinical outcome (presence or absence of head lice infestation), assessed by an "investigator" based on visual examination, likely aided by comb-out procedures. This would implicitly involve a form of expert assessment or consensus if multiple investigators were involved, but the document doesn't detail this.
- Post-marketing adverse event data: Self-reported adverse events from users and classified by the marketer. This is outcomes data based on user experience.
The sample size for the training set:

This device is a chemical and mechanical treatment for lice, not a machine learning model. Therefore, the concept of a "training set" for an algorithm is not applicable.
How the ground truth for the training set was established:

As this is not a machine learning device, the concept of a "training set" and its associated ground truth establishment is not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 21, 2017

Medtech Products Inc. c/o Vincent Argiro Prestige Brands Holdings 660 White Plains Road Tarrytown, New York 10591

Re: K163401

Trade/Device Name: Nix® Ultra Lice Treatment Kit Regulation Number: 21 CFR 880.5960 Regulation Name: Lice Removal Kit Regulatory Class: I Product Code: LJL Dated: February 7, 2017 Received: February 8, 2017

Dear Vincent Argiro:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Tina Kiang

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163401

Device Name Nix® Ultra Lice Treatment Kit

Indications for Use (Describe)

Nix® Ultra Lice Treatment Kit is intended to kill and remove head lice and their eggs from adults and children two years of age or older.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5 – 510(k) Summary

Nix® Ultra Lice Treatment Kit

K163401

1. Submitter

Name & Address:	Medtech Products Inc.660 White Plains RoadTarrytown, NY, 10591
Contact:	Jean Boyko, Ph.D.
Title:	Sr. Vice President, Science & Technology
Phone number:	(914) 524-6894

2. Official Correspondent

Name & Address:	Medtech Products Inc.
	660 White Plains Road
	Tarrytown, NY, 10591
Contact:	Vincent Argiro, RAC
Title:	Director, Regulatory Affairs
Phone number:	(914) 524-8721
Email:	vargiro@prestigebrands.com

3. Date Prepared

February 7th, 2017

4. Device Identification

Trade/Proprietary Name:	Nix® Ultra Lice Treatment Kit
Common/Usual Name:	Over-the-counter lice elimination product
Classification Name:	Lice removal kit
Regulation Number:	21 C.F.R. § 880.5960
Product Code:	LJL [Detectors and removers, lice (including combs)]
Device Class:	Class I, 510(k) exempt
Classification Panel:	General Hospital and Personal Use Devices

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5. Legally Marketed Predicate Device

Clear™ Lice Egg Remover System (K981147), Product Code LJL

6. Device Description

The Nix® Ultra Lice Treatment Kit consists of two components: Nix® Ultra Lice Killing Solution and Nix® Ultra Lice Removal Comb. The kit also includes an Instructions for Use Leaflet.

7. Indications for Use

Nix® Ultra Lice Treatment Kit is intended to kill and remove head lice and their eggs from adults and children two years of age or older.

8. Summary of the Technological Characteristics

The following table compares the Nix® Ultra Lice Treatment Kit to the predicate device with respect to intended use and technological characteristics. This comparison of the devices provides detailed information demonstrating the basis for the determination of substantial equivalence. The indications between the subject device and the predicate are not identical as the subject device has an additional action of killing lice and is intended for children 2 years and older. These minor differences between the subject and predicate do not raise different question of safety or effectiveness.

	Proposed Device	Predicate
Trade Name /Device Name	Nix® Ultra LiceTreatment Kit	Clear™ Lice EggRemover System
510(k) Number	TBD	K981147
REGULATORY CLASSIFICATION
Regulatory Class	Class I	Class I
Name of Generic Device Type	Lice Removal Kit	Lice Removal Kit
Regulation	21 CFR § 880.5960	21 CFR § 880.5960
Product Code	LJL	LJL
Applicable PerformanceStandards or Special Controls	N.A.	N.A.

		Table 5-1: Comparison of Characteristics
DEVICE DESCRIPTION
Intended Use	To remove lice and lice eggs, from head hair.	To remove lice and lice eggs, from head hair.
Indications for Use	Nix® Ultra Lice Treatment Kit is intended to kill and remove head lice and their eggs from adults and children two years of age and older.	To remove lice eggs from hair
OTC or Rx	OTC	OTC
Technology	Dimethicone and isoparaffin solution physically coats the lice/nits and clogs the spiracles through which they breathe and exchange moisture; the solution also lubricates the hair to facilitate removal of dead lice and nits with the supplied comb.	A lubricant gel that facilitates the combing out of lice eggs (nits) from the hair and a comb to remove lice and nits.
Energy	Mechanical	Mechanical
Presentation of Kit	Convenience kit consisting of two components: Nix Ultra Lice Killing Solution and Nix Ultra Lice Removal Comb	Convenience kit consisting of two components: a lubricating gel and a glass-reinforced nylon fine tooth comb
Mode of Action	Suffocation and interference with water exchange and removal by combing	Removal by combing
Duration of treatments	10 minutes for solution, plus comb out time	3 minutes for solution, plus comb out time
Target Population	2 years of age and	Minimum age not
	older	specified in available materials
Multiple Use Device	Yes (bottle contains multiple applications)	Yes (bottle contains multiple applications)
Sterile Device	No	No
Comb included	Yes	Yes
Gel/Solution included	Yes	Yes
Removal of nits	Yes	Yes
Ovicidal	Yes	No
Removal of lice	Yes	Yes
Pediculicidal	Yes	No
Use environment	Home	Home
Anatomical site of use	Hair/Head	Hair/Head

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9. Non-Clinical Performance Data

A series of in-vitro studies of Nix® Ultra Lice Killing Solution were conducted in adult lice, nits, and lice genetically confirmed to be permethrin- and DDT-resistant (BR-HL strain). In each of these investigations, the study subjects (i.e., adult lice, nits, or resistant lice) were exposed to the test articles for a duration matching the products' instructions for use, and then subjects were washed and periodically observed for signs of life. The results of these tests clearly demonstrate the claimed performance of Nix® Ultra Lice Killing Solution against adult lice, nits and resistant lice. The mortality rates calculated in each test appear in Table 5-2 below.

Table 5-2: In-vitro Mortality Rates
-------------------------------------	--	--

Study Subject	Test Article	Mortality Rate (%)
Nits (louse eggs)	Nix Ultra Lice Killing Solution	97
	Drug comparator	24
	Control (water)	10
Adult Lice	Nix Ultra Lice Killing Solution	100
	Drug comparator	36.67
	Control (water)	1
Permethrin- and DDT-resistant lice	Nix Ultra Lice Killing Solution	100
	Drug comparator	43.3
	Control (water)	1.7

Additionally, biocompatibility testing of Nix® Ultra Lice Killing Solution was conducted in accordance with the FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". This testing included evaluations of cytotoxicity, skin irritation (both in humans and rabbits), corneal irritation and sensitization. The results demonstrate that the formulation is not cytotoxic. Furthermore, the product

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was non-irritating in the human patch test, caused negligible irritation in rabbits, is non-significantly or weakly sensitizing and can be considered only a mild corneal irritant.

The results of the non-clinical testing support the substantial equivalence of the Lice Treatment Kit as compared to the predicate device.

10. Clinical Performance Data

A randomized, controlled clinical study supports the substantial equivalence of the Nix® Ultra Lice Treatment Kit. There is also post-marketing adverse event data from the product's European sales history.

Clinical Study (Ref# NUHL001-10/15)

A randomized, controlled, investigator- and assessor-blinded study was conducted to demonstrate the claimed performance of Nix® Ultra head lice lotion and comb (also called Nix Ultra™ 2-in-1 Lice Treatment) in subjects ranging in age from 2 to 63 years old with confirmed head lice infestation. (Note: Nix Ultra head lice lotion is identical in composition to Nix Ultra® Lice Killing Solution.) Assessments were conducted at baseline, one day after treatment, one week later (at which point a second treatment was given) and on Day 10. In this study, Nix Ultra™ met all pre-determined endpoints. The results are presented below in Table 5-3.

Primary Endpoint	Reference	Test	P-Value
Day 10 - All baseline infestations
No	24 (96%)	23 (92%)	>0.50001
Yes	1 (4%)	2 (8%)
Secondary Endpoint
Day 10 - For Mild and Moderate Baseline
Infestation
No	19 (100%)	16 (94.12%)	0.47221
Yes	0 (0%)	1 (5.88%)
Day 7 - All baseline infestations
No	22 (88%)	23 (88.46%)	>0.50001
Yes	3 (12%)	3 (11.54%)
Day 7 - For Mild and Moderate Baseline
Infestation
No	19 (100%)	17 (94.44%)	0.48651
Yes	0 (0%)	1 (5.56%)
Day 1 - All baseline infestations
No	25 (96.15%)	24 (92.31%)	>0.50001
Yes	1 (3.85%)	2 (7.69%)
Day 1 - For Mild and Moderate Baseline
Infestation
No	19 (100%)	17 (94.44%)	0.48651
Yes	0 (0%)	1 (5.56%)

Table 5-3: Analysis of Cure rate on Days- 10, 7 and 1 using Chi-Square Test (all baseline infestations)

No Significant difference between Reference and Test; T (Test Product) = Nix Ultra "" Lotion & Comb,

Note: The exact p-value is reported due to the small number of responses (less than five)

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Both products were considered well tolerated. There was one adverse event reported during the course of the study, dryness and redness behind the right ear, for a subject randomized to the test product (Nix Ultra); this event was judged by the investigator to be mild in severity and possibly related to the test product.

Post-Marketing Adverse Event Data

Finally, post-marketing adverse event (AE) data supplied by the product's European marketer, Oystershell Laboratories, described only five cases involving thirteen patients in relation to 518,095 units sold during the period from June 2007 to December 2015. These AEs involved scalp and ear irritation, skin redness, desquamation, and swollen ears or eyes. All AEs were classified by Oystershell Laboratories as non-serious and temporary.

In conclusion, the results of the clinical testing and European post-marketing data demonstrate the ability of the Nix® Ultra Lice Treatment Kit to kill and remove head lice without presenting a significant risk to the end user and therefore support the substantial equivalence of the device as compared to the predicate.

11. Statement of Substantial Equivalence

The Nix® Ultra Lice Treatment Kit has the same intended use as the following legally marketed lice removal device: the Clear™ Lice Egg Remover System. The non-clinical and clinical data provided in this submission demonstrate that the Nix® Ultra Lice Treatment Kit is as safe and as effective as the predicate device identified in this submission.

The Nix® Ultra Lice Treatment Kit is therefore substantially equivalent to the cited predicate device.

Regulation Number and Section

§ 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.