Silicone Personal Lubricant, ALL-IN-ONE

K180083 · United Consortium · NUC · Apr 9, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K180083
• Device Name: Silicone Personal Lubricant, ALL-IN-ONE
• Applicant: United Consortium
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Apr 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Silicone Personal Lubricant is a silicone-based personal lubricant 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. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms. ALL-IN-ONE is a silicone-based personal lubricant 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. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

Device Story

Silicone-based personal lubricant; clear, semi-viscous liquid; applied topically to penile, anal, or vaginal areas to supplement natural lubrication and enhance comfort during sexual activity. Packaged in PET bottles with disc top dispensers or lotion pumps, or polyester-faced laminated pouches. Used by consumers in home settings. Provides lubrication to reduce friction; compatible with natural rubber latex, polyurethane, and polyisoprene condoms. Benefits include improved comfort and ease of sexual activity.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (Cytotoxicity, Sensitization, Vaginal/Penile Irritation, Acute Systemic Toxicity) confirmed non-cytotoxic, non-irritating, and non-sensitizing properties. Condom compatibility tested per ASTM D7661-10. Shelf-life validated via real-time and accelerated aging studies over 2 years, meeting all physical and microbial specifications.

Technological Characteristics

Silicone-based lubricant (Dimethicone, Dimethiconol). Viscosity: 800-1075 cps. Specific Gravity: 0.850-1.020. Non-sterile. Packaging: PET bottles, polypropylene caps, polyester-faced laminated pouches. Biocompatibility per ISO 10993. Condom compatibility per ASTM D7661-10. Antimicrobial effectiveness per USP <51>.

Indications for Use

Indicated for individuals requiring lubrication and moisturization during intimate sexual activity; for penile, anal, and vaginal application; compatible with natural rubber latex, polyurethane, and polyisoprene 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

• JO Premium Personal Lubricant (K132954)

Submission Summary (Full Text)

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April 9, 2018

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

Re: K180083

Trade/Device Name: Silicone Personal Lubricant, ALL-IN-ONE Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 9, 2018 Received: January 11, 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.

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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); 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,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and is set against a white background. The letters are clearly legible, and the name is presented in a straightforward manner.

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)

#### K180083

Device Name Silicone Personal Lubricant ALL-IN-ONE

#### Indications for Use (Describe)

Silicone Personal Lubricant is a silicone-based personal lubricant for vaginal application, intended to lubricate and moisturize, 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, polyurethane and polyisoprene condoms.

ALL-IN-ONE is a silicone-based personal lubricant 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. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 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 a second "U" or a curved line. Below the symbol, the words "UNITED CONSORTIUM" are written in a simple, sans-serif font, with "UNITED" stacked above "CONSORTIUM".

K180083 - Silicone Personal Lubricant, ALL-IN-ONE Traditional Submission

# 510(k) Summary

510(k) Owner:

Street Address:

United Consortium

3005691625

29000 N. Hancock Parkway Valencia, CA 91355

Establishment Registration Number:

Contact Person:

Stephanie Morris Regulatory Specialist

Bruce Albert Head of Technical Services

Contact Numbers:

Phone: [phone], ext. 232 Phone: [phone], ext. 231 FAX: [phone]

Summary Preparation Date:

Trade Names:

ALL-IN-ONE

April 6, 2017

Common Name:

Personal Lubricant

Silicone Personal Lubricant

| Device Classification: | Common Name: | Personal Lubricant |
|------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| | Classification Name: | Condom |
| | Classification Number: | 21 CFR § 884.5300 |
| | Product Code:<br>Device Class: | NUC (lubricant, personal)<br>Class II |
| Predicate Device: | Product Name:<br>510(k) Number:<br>Manufacturer:<br>Product Code:<br>Device Class: | JO Premium Personal Lubricant<br>K132954<br>United Consortium<br>NUC<br>Class II |

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

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K180083 Page 2 of 5

## Device Description:

Silicone Personal Lubricant and ALL-IN-ONE are clear, semi-viscous personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. The 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 Polyethylene Terephthalate (PET) bottles capped with natural polypropylene disc top dispenser caps. The individual bottles are hermetically sealed during the production process. There is also 16 fl. oz./480 mL bottle with a different configuration for the Silicone Personal Lubricant. This consists of a clear Polyethylene Terephthalate (PET) bottle with a polypropylene lotion pump instead of the disc top dispenser used in all other sizes. This bottle is configured with a shrink wrap seal. 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 | Clear |
| Odor | Odorless |
| Viscosity (cps) | 800 cps to 1075 cps |
| Specific Gravity | 0.850 to 1.020 |
| Antimicrobial effectiveness per USP <51> | Meets US <51> acceptance criteria for Category 2<br>products |
| Total aerobic microbial count (TAMC) per USP <61><br>and <1111> | Less than 10 cfu/g |
| 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 | Absent |
| Escherichia coli | Absent |
| Candida albicans | Absent |

| Table 1: Device Specifications for Silicone Personal Lubricant and ALL-IN-ONE | | | | | |
|-------------------------------------------------------------------------------|--|--|--|--|--|
|-------------------------------------------------------------------------------|--|--|--|--|--|

### Indications for Use:

Silicone Personal Lubricant is a silicone-based personal lubricant 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. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

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Image /page/5/Picture/0 description: The image shows the logo for United Consortium. The logo features a stylized letter "U" in blue, with a gray ribbon-like element wrapping around the top portion of the "U". Below the symbol, the words "UNITED CONSORTIUM" are written in a simple, sans-serif font.

ALL-IN-ONE is a silicone-based personal lubricant 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. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

#### Predicate Device Comparison:

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

| Feature | Silicone Personal Lubricant and ALL-<br>IN-ONE | JO Premium Personal Lubricant<br>(K132954) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Intended Use | Silicone Personal Lubricant is a<br>silicone-based personal lubricant for<br>penile, anal and/or vaginal<br>application, intended to lubricate<br>and moisturize, to enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the body's<br>natural lubrication. This product is<br>compatible with natural rubber<br>latex, polyurethane and<br>polyisoprene condoms.<br>ALL-IN-ONE is a silicone-based<br>personal lubricant for penile, anal<br>and/or vaginal application, intended<br>to lubricate and moisturize, 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, polyurethane and<br>polyisoprene condoms. | JO Premium Personal Lubricant is a<br>silicone-based personal lubricant for<br>penile and/or vaginal application,<br>intended to lubricate and moisturize,<br>to 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 latex<br>and polyisoprene condoms. This<br>product is not compatible with<br>polyurethane condoms. |
| Water soluble | No | No |
| Contains water | No | No |
| Primary ingredients | Dimethicone, Dimethiconol | Dimethicone, Cyclopentasiloxane,<br>Cyclotetrasiloxane, Dimethiconol |

## Table 2: Comparator Table for Subject Devices – Silicone Personal Lubricant and ALL-IN-ONE and Predicate Device JO Premium Personal Lubricant

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Image /page/6/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter "U" in two shades. The left side of the "U" is a dark blue color, while the right side is a light gray color. Below the "U" is the text "UNITED CONSORTIUM" in a smaller font size.

| Feature | Silicone Personal Lubricant and ALL-<br>IN-ONE | JO Premium Personal Lubricant<br>(K132954) |
|-------------------------|-----------------------------------------------------|--------------------------------------------|
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Natural Rubber Latex, Polyisoprene,<br>Polyurethane | Natural Rubber Latex, Polyurethane |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 2 years | 2 years |

The subject and predicate device have similar indications for use. The indication for the subject device has been expanded to also include anal use. This change does not represent a new intended use as the intended use of this device is the same as the predicate device, i.e., lubrication of an orifice during intimate sexual activity. The subject and predicate devices have similar technological characteristics including similar formulation. 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 testing, Vaginal Irritation testing, Penile Irritation testing, Cytotoxicity and Sensitization testing were performed in accordance with the 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 non-cytotoxic, non-irritating, and non-sensitizing.

#### Shelf-Life:

The subject devices are non-sterile personal lubricants with a two-year shelf-life in accordance with the results of a real time and accelerated aging study. All device specifications listed in Table 1 were tested at 0, 1 and 2 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 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicated that the Silicone Personal

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Image /page/7/Picture/1 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in two shades of gray. The lower part of the 'U' is a darker gray, while the upper part is a lighter gray, creating a sense of depth. Below the 'U', the words 'UNITED CONSORTIUM' are written in a smaller, sans-serif font.

# K180083 - Silicone Personal Lubricant, ALL-IN-ONE Traditional Submission

Lubricant and ALL-IN-ONE are compatible with natural rubber latex, polyurethane and polyisoprene condoms.

## Conclusion:

The results of the performance testing described above demonstrate that the Silicone Personal Lubricant and ALL-IN-ONE are as safe and effective as the predicate device and supports a determination of substantial equivalence.