Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry

K163674 · Neo Cosmetique · NUC · Sep 22, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K163674
• Device Name: Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry
• Applicant: Neo Cosmetique
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Sep 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Intended 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. These products are compatible with natural rubber latex condoms and polyisoprene male condoms. These products are not compatible with polyurethane condoms.

Device Story

Exsens Personal Lubricants are non-sterile, water-based gels designed for OTC use to provide lubrication during intimate sexual activity. Formulated with glycerin, water, propylene glycol, hydroxyethylcellulose, and various flavoring/preservative agents. Packaged in 70ml polyethylene tubes with flip-top caps. Applied topically by the user to the penis or vagina to enhance comfort and supplement natural lubrication. Device functions as a physical lubricant; does not involve electronic or mechanical processing. Benefits include reduced friction and increased comfort during sexual activity. Compatibility with specific condom types (latex, polyisoprene) is verified; incompatibility with polyurethane is noted in labeling to prevent condom degradation.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization, vaginal irritation), and ISO 10993-11 (acute systemic toxicity). Condom compatibility tested per ASTM D7661-10. Stability/shelf-life validated per ASTM F1980-07 (accelerated aging).

Technological Characteristics

Water-based gel; ingredients include glycerin, water, propylene glycol, hydroxyethylcellulose, and preservatives. pH 5.0-6.0; viscosity 7000-12,000 mPa; osmolality 600-700 mOsmol/kg. Packaged in polyethylene tubes. Shelf life 12 months. Non-sterile.

Indications for Use

Indicated for adults requiring personal lubrication during intimate sexual activity to moisturize and supplement natural lubrication. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use with 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

• K-Y Marilyn Pleasure Gel (K151884)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.

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

September 22, 2017

NEO COSMETIQUE % Gayle Lyne Official Correspondent Technic, Inc. 47 Molter Avenue Cranston, RI 02910

Re: K163674

Trade/Device Name: Exsens Personal Lubricant - Pure Aqua / Exsens Personal Lubricant - Aloe Vera / Exsens Personal Lubricant - Fresh Mint / Exsens Personal Lubricant - Candy Apple / Exsens Personal Lubricant - Raspberry

Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 10, 2017 Received: August 21, 2017

Dear Gayle Lyne:

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. Iisting 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,

# Charles Viviano -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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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K163674

#### Device Name

Exsens Personal Lubricant - Pure Aqua / Exsens Personal Lubricant - Aloe Vera /Exsens Personal Lubricant - Fresh Mint / Exsens Personal Lubricant - Candy Apple / Exsens Personal Lubricant - Raspberry

#### Indications for Use (Describe)

Intended 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. These products are compatible with natural rubber latex condoms and polyisoprene male condoms. These products are not compatible with polyurethane condoms.

| 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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cosm

A TECHNIC COMPANY

510(K) No : K163674

# 510(k) Summary

| Submitter name: | NEO COSMETIQUE<br>15, rue Montjoie<br>93212 Saint Denis<br>France |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Nathalie Vernin<br>President<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail]<br><br>Veronique Laroche<br>Regulatory Operations Lead<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date prepared: | 21 September 2017 |
| Device name: | Exsens Personal Lubricant - Pure Aqua<br>Exsens Personal Lubricant - Aloe Vera<br>Exsens Personal Lubricant - Fresh Mint<br>Exsens Personal Lubricant - Candy Apple<br>Exsens Personal Lubricant - Raspberry |
| Common name: | Personal lubricant |
| Classification Name: | Condom |
| Classification Number: | 21 CFR § 884.5300 |
| Product Code: | NUC (lubricant, personal) |
| Regulatory Class: | Class II |
| Panel: | Obstetrics/Gynecology |
| Predicate Device: | K-Y Marilyn Pleasure Gel, K151884 |
| | The predicate device has not been subject to a design-related recall. |
| Device Description: | Exsens Personal Lubricants are non-sterile, water-based personal<br>lubricants that provide personal lubrication during intimate sexual activity.<br>They are made up of Glycerin, Water, Propylene Glycol, Aroma (Flavor),<br>Aloe Barbadensis (aloe vera) leaf juice, Hydroxyethylcellulose, Sodium<br>Benzoate, Potassium Sorbate, Sodium Saccharin and citric acid. The<br>product is packaged in a 70ml polyethylene white tube with a flip-top cap<br>and protective sleeve. It is for over-the-counter (OTC) use. |

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Image /page/4/Picture/0 description: The image is a logo for Néo Cosmétique, a Technic Company. The word "néo" is in a bold, sans-serif font, with an accent mark over the "e". To the right of the "o" is a blue water droplet. Below "néo" is the word "cosmétique" in a smaller, sans-serif font. Below that is the text "A TECHNIC COMPANY" in a smaller, sans-serif font.

510(K) No : K163674

| Parameter | Specification |
|------------------------------------|---------------------------------------------------------|
| Appearance | Clear gel |
| Odor | Neutral, mint, candy<br>apple, raspberry |
| pH | 5.0 - 6.0 |
| Viscosity | 7000 - 12,000 mPa |
| Density | 1.14 |
| Osmolality | 600 - 700 mOsmol/kg |
| Antimicrobial Effectiveness | Meets acceptance<br>criteria for Category 2<br>products |
| Total Microbial Count | <100 cfu/g |
| Fungal/Yeast/Mold Limits | <10 cfu/g |
| Absence of Pathogenic<br>Organisms | Absent |

Indications for Use:

Intended 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. These products are compatible with natural rubber latex condoms and polyisoprene male condoms. These products are not compatible with polyurethane condoms.

# Predicate Device Comparison:

The table below lists the comparative intended use and technological characteristics of the subject and predicate device.

| 510(K) | Device Name | Intended Use | Ingredients | Physical<br>Features | Shelf life |
|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------|
| K163674 | Exsens Personal<br>Lubricant - Pure<br>Aqua<br>Exsens Personal<br>Lubricant - Aloe<br>Vera<br>Exsens Personal<br>Lubricant - Fresh<br>Mint<br>Exsens Personal<br>Lubricant - Candy<br>Apple<br>Exsens Personal<br>Lubricant -<br>Raspberry | Intended for penile<br>and/or vaginal<br>application, intended<br>to moisturize and<br>lubricate, to enhance<br>the ease and comfort<br>of intimate sexual<br>activity and<br>supplement the body's<br>natural lubrication.<br>These products are<br>compatible with natural<br>rubber latex condoms<br>and polyisoprene male<br>condoms. These<br>products are not<br>compatible with<br>polyurethane<br>condoms. | Glycerin, Water, Propylene<br>Glycol, Aroma (Flavor) /<br>Aloe Barbadensis (aloe<br>vera) leaf juice,<br>Hydroxyethylcellulose,<br>Sodium Benzoate,<br>Potassium Sorbate, Sodium<br>Saccharin and citric acid. | Homogeneous<br>Clear Gel, water<br>soluble | 1 year |
| K151884 | KY Marilyn Pleasure<br>Gel | Intended for penile<br>and/or vaginal<br>application, intended<br>to moisturize and<br>lubricate, to enhance<br>the ease and comfort<br>of intimate sexual<br>activity and<br>supplement the body's<br>natural lubrication.<br>This device is | Water, Glycerin, Propylene<br>Glycol,<br>Hydroxyethylcellulose, PEG-<br>40 Hydrogenated Castor Oil,<br>Flavor, Benzoic Acid, and<br>Sodium Hydroxide | Homogeneous<br>Clear Gel/<br>odorless | 9 months |

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Image /page/5/Picture/0 description: The image shows the logo for Néo Cosmétique, a Technic Company. The word "néo" is written in a bold, sans-serif font, with the accent mark over the "e" in black. To the right of "néo" is a blue water droplet. Below "néo" is the word "cosmétique" in a smaller, sans-serif font. Below that is the text "A TECHNIC COMPANY" in an even smaller, sans-serif font.

K163674 Page 3 of 3

510(K) No : K163674

| | compatible with natural<br>rubber latex and<br>Polyisoprene<br>condoms. This device<br>is not compatible with<br>polyurethane<br>condoms. | | | | |
|--|-------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
|--|-------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|

The subject and predicate device have the same intended use - for penile and/or vaginal application, intended to moisturize and lubricate, and to enhance the ease of comfort of intimate sexual activity and supplement the body's lubrication. The subject and predicate device have different technological characteristics, including different formulation and shelf life. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness.. Also, all personal lubricants must independently demonstrate that they are biocompatible with condoms, and can maintain their specifications for their expected shelf life.

## Summary of Performance Data:

## Biocompatibility

Biocompatibility studies were conducted on the subject device, including cytotoxicity, sensitization, irritation, and acute systemic toxicity. Each study was conducted in accordance with GLP requirements and requirements of 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)

The results of testing demonstrated the device materials to be biocompatible.

## Condom Compatibility:

The compatibility of the subject device with natural rubber latex, polyisoprene, and polyurethane male condoms was evaluated in accordance with ASTM D 7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber latex Condoms. The results of this test demonstrated that the subject device is compatible with natural rubber latex and polyisoprene male condoms. This product is not compatible with polyurethane condoms.

## Stability / Shelf-life:

Exsens Personal Lubricants are shown to have a 12 month shelf life according to ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Testing on samples at 3 months of accelerated aging showed that the subject device specifications as listed in this 510(k) summary.

## Conclusion:

The results of the performance testing described above demonstrate that the Exsens Personal Lubricants are as safe and effective as the predicate device and supports a determination of substantial equivalence.