Natureplex Warm Touch Warming Jelly

K180828 · Natureplex, LLC · NUC · Dec 20, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K180828
• Device Name: Natureplex Warm Touch Warming Jelly
• Applicant: Natureplex, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Dec 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Natureplex Warm Touch Warming Jelly is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene or polyurethane condoms

Device Story

Natureplex Warm Touch Warming Jelly is a non-sterile, viscous, clear, colorless personal lubricant. It is applied topically to penile and/or vaginal areas to supplement natural lubrication and enhance comfort during sexual activity. The device is packaged in an LDPE tube with a cap and peel seal. It is intended for over-the-counter use. The lubricant is formulated with propylene glycol, polyethylene glycol, hydroxypropyl cellulose, and lactic acid. It is compatible with natural rubber latex condoms but incompatible with polyisoprene or polyurethane condoms. The device provides physical lubrication to reduce friction, thereby potentially increasing comfort and reducing the risk of condom breakage during use.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted per ISO 10993-1 (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity). Condom compatibility testing performed per ASTM D7661-10. Shelf-life validated via real-time stability studies for 24 months. All specifications (pH 4.0-6.0, viscosity 60,000-155,000 cps, microbial limits) met.

Technological Characteristics

Non-sterile, viscous gel. Ingredients: propylene glycol, polyethylene glycol, hydroxypropyl cellulose, lactic acid. Physical specs: pH 4.0-6.0; viscosity 60,000-155,000 cps. Packaging: LDPE tube. Compatibility: Natural rubber latex condoms (ASTM D7661-10).

Indications for Use

Indicated for penile and/or vaginal application to moisturize and lubricate during intimate sexual activity; supplements natural lubrication. Compatible with natural rubber latex condoms; contraindicated for use with polyisoprene or polyurethane condoms.

Regulatory Classification

Identification

A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.

Special Controls

*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.

Predicate Devices

• Sheffield's Warming LubriGel Personal Lubricant (K052162)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 20, 2018

Natureplex, LLC Felicia Irons Director of Quality 11085 Airport Road Olive Branch, Mississippi 38654

Re: K180828

Trade/Device Name: Natureplex Warm Touch Warming Jelly Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: November 21, 2018 Received: November 23, 2018

Dear Felicia Irons:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael T. Bailey -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K180828

Device Name Natureplex Warm Touch Warming Jelly

#### Indications for Use (Describe)

Natureplex Warm Touch Warming Jelly is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene or polyurethane condoms

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

| Prescription Use (Part 21 CFR 801 Subpart D) | |
|----------------------------------------------|--------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> |

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#### 510(k) Summary-K180828

| Company Name: | Natureplex, LLC |
|---------------------------|---------------------------------------------------------|
| Company Address: | 11085 Airport Road Olive Branch, MS 38654-0221 |
| Contact Person: | Felicia Irons 901-825-8556 |
| Summary Preparation Date: | December 17, 2018 |
| Device Trade Name: | Natureplex Warm Touch Warming Jelly |
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (Lubricant, Personal) |
| Device Class: | Class II |
| Predicate Device: | Sheffield's Warming LubriGel Personal Lubricant K052162 |

The predicate device has not been subject to a design-related recall.

# Description of Device

Warm Touch Warming Jelly is a non-sterile, clear, colorless, viscous jelly for use as a personal lubricant. The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with natural rubber latex condoms during intimate sexual activity. The device is not compatible with polyurethane or polyisoprene condoms.

The primary packaging for the product is a low-density polyethylene (LDPE) tube with a cap, and peel seal for safety. Each tube is secondarily packaged in a cardboard carton.

The device specifications are listed in the table below:

| Parameter | Specification |
|------------|--------------------------|
| Appearance | Smooth clear gel |
| Odor | None to slight wax scent |

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| pH | 4.0-6.0 |
|--------------------------------------------------------------------------------------------------|--------------------|
| Viscosity | 60,000-155,000 cps |
| Total Aerobic Microbial<br>Count (TAMC) per USP<br><61> | <10 cfu/g |
| Total Yeast and Mold Count<br>(TYMC) per USP<61> | <10 cfu/g |
| Water Activity per USP<br><1112D> | \[le]0.023 aw |
| Absence of Pathogenic<br>Organisms (S. aureus, P.<br>aeruginosa, and C.<br>albicans) per USP<62> | Absent |

# Indications for Use

Natureplex Warm Touch Warming Jelly is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene or polyurethane condoms

| Feature | K1800828<br>Warm Touch<br>Warming Jelly<br>Subject Device | K052162<br>Sheffield's<br>Warming LubriGel<br>Personal Lubricant<br>Predicate Device |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Indication for Use | Natureplex Warm Touch<br>Warming Jelly is a<br>personal lubricant, for<br>penile and/or vaginal<br>application, intended to<br>moisturize and lubricate<br>to enhance the ease and<br>comfort of intimate<br>sexual activity and<br>supplement the body's<br>natural lubrication. This<br>product is compatible<br>with natural rubber latex<br>condoms. This product is<br>not compatible with<br>polyisoprene or<br>polyurethane condoms | Personal lubricant for<br>penile and vaginal use<br>only (compatible with<br>latex condoms) |

# Predicate Device Comparison

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| Formulation | Propylene glycol, polyethylene<br>glycol, hydroxypropyl<br>cellulose, lactic acid | Propylenecol,<br>polyethylene glycol,<br>hydroxypropyl cellulose,<br>lactic acid |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Condom Compatibility | Natural rubber latex<br>condoms | Natural rubber latex<br>condoms |
| pH | 4.0-6.0 | Not known |
| Viscosity | 60000-155000 cPs | Not known |
| Total Microbial | <10 cfu/g (USP <61>) | Not known |
| Fungal/Yeast/Mold | <10 cfu/g(USP <61>) | Not known |
| Absence of<br>Pathogenic<br>Organisms (S.<br>aureus, P.<br>aeruginosa,<br>and C.<br>albicans) | Absent | Not known |
| Shelf-Life | 2 years | Not known |

The subject and predicate devices have different indications for use statements; however, their intended uses are the same, i.e., lubrication during intimate sexual activity and compatibility with natural rubber latex condoms.

The subject and predicate devices have similar technological characteristics (e.g., condom compatibility, formulation ingredients, etc.); however, differences in specifications and concentrations of specific chemicals in the formulation exist.

The differences in technological characteristics described above between the subject and predicate devices do not raise different questions of safety and effectiveness. In addition, the specifications for the subject device are comparable to other devices of this type.

# Performance Data

# Biocompatibility:

Biocompatibility studies were performed in accordance with the 2016 FDA guidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993- 1:2009 as follows:

- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010) ●
- Vaginal Irritation (ISO 10993-10:2010) ●
- Acute Systemic Toxicity (ISO 10993-11:2006) ●

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The results of this testing demonstrated that the subject lubricants are biocompatible.

## Condom Compatibility:

Condom Compatibility testing was performed in accordance with ASTM D7661-10

"Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results based on the recognized standard demonstrate that the product is compatible with natural rubber latex condoms. No testing was performed on polyisoprene or polyurethane condoms. Therefore, the Warm Touch Warming Jelly is labeled as not compatible with polyisoprene and polyurethane condoms.

#### Shelf-Life:

The shelf-life of Warm Touch Warming Jelly is 24 months from the date of production. This is based on the results of real-time stability studies that demonstrated the device can maintain its specifications over the duration of its shelf-life.

#### Substantial Equivalence:

The results of the performance testing described above demonstrate that the Warm Touch Warming Jelly is as safe and effective as the predicate device and supports a determination of substantial equivalence.