JO H2O Flavored Personal Lubricants

K180219 · United Consortium · NUC · Apr 20, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K180219
• Device Name: JO H2O Flavored Personal Lubricants
• Applicant: United Consortium
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Apr 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

JO H2O Flavored Personal Lubricants are water-based personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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 and polyisoprene condoms. These products are not compatible with polyurethane condoms.

Device Story

Water-based, semi-viscous personal lubricant; intended for penile, anal, and/or vaginal application to enhance comfort during sexual activity. Supplied in PET bottles or laminated pouches; non-sterile. Used by consumers in home settings. Provides lubrication and moisture; supplements natural body fluids. Compatible with natural rubber latex and polyisoprene condoms; incompatible with polyurethane condoms. Enhances ease of intimate activity; benefits patient by reducing friction and discomfort.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), vaginal/penile irritation (ISO 10993-10), and acute systemic toxicity (ISO 10993-11). Results confirmed non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic. Condom compatibility tested per ASTM D7661-10. Shelf-life validated via real-time aging study over 3 years.

Technological Characteristics

Water-based, semi-viscous liquid. Ingredients: Glycerin, Water, Flavor, Sodium Carboxymethylcellulose, Methylparaben, Propylparaben, Masking Agent. pH 5.9-7.1; Viscosity 1200-2500 cps. Packaging: PET bottles or polyester-faced laminated pouches. Non-sterile. Tested per USP <51>, <61>, <62>, <1111>. Compatibility tested per ASTM D7661-10.

Indications for Use

Indicated for penile, anal, and/or vaginal application to lubricate and moisturize, enhancing comfort during intimate sexual activity and supplementing 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

• Astroglide Sensual Strawberry (K140590)

Submission Summary (Full Text)

{0}------------------------------------------------

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 20, 2018

United Consortium Stephanie Morris Regulatory Specialist 29000 N. Hancock Pkwy. Valencia, California 91355

Re: K180219

> Trade/Device Name: JO H2O Flavored Personal Lubricants Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: January 23, 2018 Received: January 25, 2018

Dear Stephanie Morris:

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.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

# Charles Viviano -S

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

Enclosure

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known)

#### K180219

Device Name JO H2O Flavored Personal Lubricants

#### Indications for Use (Describe)

JO H2O Flavored Personal Lubricants are water-based personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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 and polyisoprene 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) | ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K180219 - JO H2O Flavored Personal Lubricants

## 510(k) Summary

| 510(k) Owner: | United Consortium |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Street Address: | 29000 N. Hancock Parkway<br>Valencia, CA 91355 |
| Contact Person: | Stephanie Morris<br>Regulatory Specialist<br>Bruce Albert<br>Head of Technical Services |
| Contact Numbers: | Phone: [phone], ext. 232<br>Phone: [phone], ext. 231<br>FAX: [phone] |
| Summary Preparation<br>Date: | April 19, 2018 |
| Trade Names: | JO H2O Flavored Personal Lubricants<br>JO H2O Strawberry Kisses Flavored Personal Lubricant<br>JO H2O Cherry Burst Flavored Personal Lubricant<br>JO H2O Raspberry Sorbet Flavored Personal Lubricant<br>JO H2O Succulent Watermelon Flavored Personal Lubricant<br>JO H2O Lemon Splash Flavored Personal Lubricant<br>JO H2O Tropical Passion Flavored Personal Lubricant<br>JO H2O Juicy Pineapple Flavored Personal Lubricant<br>JO H2O Banana Lick Flavored Personal Lubricant<br>JO H2O Chocolate Delight Flavored Personal Lubricant<br>JO H2O Sweet Pomegranate Flavored Personal Lubricant<br>JO H2O Peachy Lips Flavored Personal Lubricant<br>JO H2O Tangerine Dream Flavored Personal Lubricant<br>JO H2O Red Licorice Flavored Personal Lubricant<br>JO H2O Black Licorice Flavored Personal Lubricant<br>JO H2O Vanilla Cream Flavored Personal Lubricant<br>JO H2O Green Apple Flavored Personal Lubricant<br>JO H2O Cotton Candy Flavored Personal Lubricant |
| Common Name: | Personal Lubricant |

{4}------------------------------------------------

# 219 - JO H2O Flavored Personal Lubricants

| Device Classification: | | |
|------------------------|--------------------------------|-------------------------------|
| | Regulation Name:<br>Regulation | Condom |
| | Number: | 21 CFR § 884.5300 |
| | Product Code: | NUC (lubricant, personal) |
| | Device Class: | Class II |
| Predicate Device: | Product Name: | Astroglide Sensual Strawberry |
| | 510(k) Number: | K140590 |
| | Manufacturer: | BioFilm, Inc. |
| | Product Code: | NUC |
| | Device Class: | Class II |

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

#### Device Description:

JO H2O Flavored Personal Lubricants are clear, semi-viscous personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

These products are provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps and the 4 oz. size bottles are capped with silver disc top dispenser caps. The individual bottles are hermetically sealed during the production process. These products are also available in polyester-faced laminated pouches.

The device specifications are listed in the table below:

| Property | Specification |
|--------------------------------------------------------------|-----------------------------------------------------------|
| Appearance | Clear, semi-viscous liquid |
| Color | Colorless to slightly yellow |
| Odor | Sweet/Characteristic |
| Viscosity (cps) | 1200 cps to 2500 cps |
| pH | 5.9 to 7.1 |
| Specific Gravity | 1.020 to 1.200 |
| Osmolality | 750 - 900 (1:5 dilution,) 1400 - 1650 (undiluted) mOsm/kg |
| Antimicrobial effectiveness per USP <51> | Meets US <51> acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per USP <61> and <1111> | Less than 10 cfu/g |

#### Table 1: Device Specifications for JO H2O Flavored Personal Lubricants

Image /page/4/Picture/10 description: The image shows a logo for United Consortium. The logo features a stylized letter "U" in blue, with a gray shape overlapping the top portion of the "U". Below the symbol, the words "UNITED CONSORTIUM" are written in a simple, sans-serif font.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in blue, with a gray shape behind it that suggests depth or a 3D effect. Below the 'U', the words 'UNITED CONSORTIUM' are written in a smaller, sans-serif font, with 'UNITED' stacked above 'CONSORTIUM'.

| Total yeast and mold count (TYMC) per USP <61><br>and <1111> | Less than 10 cfu/g |
|--------------------------------------------------------------|--------------------|
| Presence of Pathogens per USP <62> | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida Albicans | Absent |

#### Indications for Use:

JO H2O Flavored Personal Lubricants are water-based personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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 and polyisoprene condoms. These products are not compatible with polyurethane condoms.

#### Predicate Device Comparison:

The table below lists the comparative indication for use and technological characteristics of the subject and predicate devices.

| Feature | JO H2O Flavored Personal<br>Lubricants | Astroglide Sensual Strawberry<br>(K140590) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indication for Use | JO H2O Flavored Personal<br>Lubricants are water-based<br>personal lubricants for penile, anal<br>and/or vaginal application,<br>intended to lubricate and<br>moisturize, to enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the body's<br>natural lubrication. These products<br>are compatible with natural rubber<br>latex and polyisoprene condoms.<br>These products are not compatible<br>with polyurethane condoms. | The BioFilm, Inc. Astroglide<br>Sensual Strawberry is a personal<br>lubricant for penile and/or vaginal<br>application, intended to<br>moisturize and lubricate, to<br>enhance the ease and comfort of<br>intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is<br>compatible with natural rubber<br>latex, polyisoprene and<br>polyurethane condoms. |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Glycerin, Water (Aqua), Flavor<br>(Aroma), Sodium<br>Carboxymethylcellulose,<br>Methylparaben,<br>Propylparaben, Masking Agent | Water (Aqua), Glycerin, Propylene<br>Glycol, Hydroxyethylcellulose,<br>Natural and Artificial Strawberry<br>Flavor, Sodium Gluconate, Sodium<br>Saccharin, Methylparaben, Sodium<br>Benzoate, Citric Acid |

Table 2: Comparator Table for Subject Device – JO H2O Flavored Personal Lubricants and Predicate Device Astroglide Sensual Strawberry

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in two colors: a dark blue for the main part of the 'U' and a light gray for a curved element that wraps around the top and bottom of the 'U'. Below the 'U', the words 'UNITED CONSORTIUM' are written in a simple, sans-serif font.

| Feature | JO H2O Flavored Personal<br>Lubricants | Astroglide Sensual Strawberry<br>(K140590) |
|-------------------------|----------------------------------------|--------------------------------------------|
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Latex, Polyisoprene | Latex, Polyisoprene, Polyurethane |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 3 years | 2 years |

The subject and predicate devices have similar indications for use. The indication for the subject devices has been expanded to also include anal use. This change does not represent a new intended use as the intended use of these devices is the same as the predicate device, i.e., lubrication of an orifice during intimate sexual activity.. The subject and predicate devices have different technological characteristics, including differences in formulation, condom compatibility, and shelf-life. The different technological characteristics of the subject devices do not raise different types of safety and effectiveness questions.

#### Summary of Performance Data:

#### Biocompatibility

Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing 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) ●

- Penile Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2006) ●

The results of this testing demonstrated that the subject lubricants are noncytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.

#### Shelf-Life:

The subject devices are non-sterile personal lubricants with a three-year shelf-life in accordance with the results of a real time aging study. All device specifications listed in Table 1 were tested at 0, 1, 2 and 3 years. The subject devices met the device specifications at all time points.

#### Condom Compatibility:

The compatibility of the subject devices with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image features a logo for an organization called "UNITED CONSORTIUM". The logo consists of a stylized letter "U" in a dark blue color, with a gray ribbon-like element partially overlapping the top left portion of the "U". The text "UNITED CONSORTIUM" is written in a simple, sans-serif font below the "U" symbol. The overall design is clean and modern.

# K180219 - JO H2O Flavored Personal Lubricants

Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that JO H2O Flavored Personal Lubricants are compatible with natural rubber latex and polyisoprene condoms. These devices are not compatible with polyurethane condoms.

#### Conclusion:

The results of the performance testing described above demonstrate that the JO H2O Flavored Personal Lubricants are as safe and effective as the predicate device and supports a determination of substantial equivalence.