Nix Ultra Lice Treatment Kit

K163401 · Medtech Products, Inc. · LJL · Mar 21, 2017 · General Hospital

Device Facts

• Record ID: K163401
• Device Name: Nix Ultra Lice Treatment Kit
• Applicant: Medtech Products, Inc.
• Product Code: LJL · General Hospital
• Decision Date: Mar 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5960
• Device Class: Class 1
• Attributes: Therapeutic, Real-World Evidence, Pediatric

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K163401 · Mar 21, 2017	Nix Ultra Lice Treatment Kit	Medtech Products, Inc.	Post-marketing adverse event reports from European sales history	Post-marketing surveillance data was used to support the safety profile of the device by analyzing adverse event reports collected during routine commercial use.	post-marketing surveillance; adverse events; safety

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
European Post-Marketing Surveillance; Post-marketing surveillance / Adverse event reporting; Follow-up/Duration: June 2007 to December 2015; Study Period: 2007-2015	Users of the device in Europe; Sample Size: 518,095 units sold	Not applicable for this study	Incidence of adverse events

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.

Device Story

Kit consists of dimethicone/isoparaffin solution and fine-tooth removal comb; used at home by patients or caregivers. Solution physically coats lice/nits, clogging spiracles to induce suffocation and inhibit water exchange; lubricant facilitates mechanical removal of dead lice/nits via comb. Treatment duration 10 minutes plus combing time. Provides pediculicidal and ovicidal action. Benefits include effective lice/egg elimination, including permethrin- and DDT-resistant strains, without chemical neurotoxicity.

Clinical Evidence

Randomized, investigator-blinded study (n=52) compared Nix Ultra to reference product in subjects aged 2-63. Primary endpoint (Day 10 cure rate) showed 92% success for Nix Ultra vs 96% for reference (p > 0.5). Secondary endpoints at Days 1 and 7 showed comparable efficacy. Adverse events were rare, mild, and temporary. European post-marketing data (518,095 units) reported 5 non-serious AE cases.

Technological Characteristics

Formulated solution containing dimethicone and isoparaffin; mechanical removal via fine-tooth comb. Non-sterile. Biocompatibility per ISO 10993-1 (cytotoxicity, skin/corneal irritation, sensitization).

Indications for Use

Indicated for adults and children 2 years of age or older with head lice infestation.

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

• Clear™ Lice Egg Remover System (K981147)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.<br>660 White Plains Road<br>Tarrytown, NY, 10591 |
|-----------------|------------------------------------------------------------------------|
| Contact: | Jean Boyko, Ph.D. |
| Title: | Sr. Vice President, Science & Technology |
| Phone number: | [phone] |

#### 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: | [phone] |
| Email: | [e-mail] |

#### 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.

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-thecounter use.

#### 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 Lice<br>Treatment Kit | Clear™ Lice Egg<br>Remover 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 Performance<br>Standards 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.