Love Liquid Personal Lubricant

K152168 · The Kama Sutra Company · NUC · Feb 5, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K152168
• Device Name: Love Liquid Personal Lubricant
• Applicant: The Kama Sutra Company
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Feb 5, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Love Liquid® 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 and Polyisoprene condoms. It is not compatable with polyurethane condoms.

Device Story

Love Liquid is a non-sterile, water-based personal lubricant; formulated as a clear, non-irritating, non-greasy, odorless liquid. Intended for OTC use to supplement natural lubrication during intimate sexual activity. Applied topically to penile or vaginal areas. Device is compatible with natural rubber latex and polyisoprene condoms; incompatible with polyurethane condoms. Product benefits include enhanced ease and comfort during sexual activity. Safety is established through biocompatibility, microbiology, and condom compatibility testing.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1:2009 included cytotoxicity, sensitization, vaginal mucosa irritation, and acute systemic toxicity, all showing no adverse effects. Condom compatibility tested per ASTM D7661-10. Microbiological safety confirmed via USP <51>, <61>, and <62>. Shelf-life stability demonstrated through real-time and accelerated testing.

Technological Characteristics

Water-based personal lubricant; non-sterile. Ingredients meet NF/USP standards or are GRAS. Compatibility testing performed per ASTM D7661-10. Biocompatibility testing performed per ISO 10993. No electronic or mechanical components.

Indications for Use

Indicated for individuals requiring penile and/or vaginal lubrication to enhance comfort during intimate sexual activity. 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

• ONE Personal Lubricant (K110691)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an image of three stylized human profiles facing to the right, with a wing-like shape above them.

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

February 5, 2016

The Kama Sutra Company Louie Goryoka Regulatory Consultant 5804 Rainbow Hill Rd. Agoura Hills, CA 91301

Re: K152168 Trade/Device Name: Love Liquid Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: January 6, 2016 Received: January 8, 2016

Dear Louie Goryoka,

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 yours,

# Benjamin R. Fisher -S

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) K152168

Device Name Love Liquid® Personal Lubricant

#### Indications for Use (Describe)

The Love Liquid® 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 and Polyisoprene condoms. It is not compatable with polyurethane condoms.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span></span> <svg height="12" width="12"> <path d="M1,1 L11,11 M11,1 L1,11" stroke="black"></path> </svg> |

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(K) SUMMARY K152168 Love Liquid® Personal Lubricant

| Company Name: | The Kama Sutra Company |
|---------------------------|---------------------------------------------------------------------|
| Company Address: | 2151 Anchor Court<br>Thousand Oaks, California 91320 |
| Contact Person: | Med-Device Consulting Inc.<br>Louie Goryoka – Regulatory Consultant |
| Contact Numbers: | Phone [phone]<br>[e-mail] |
| Summary Preparation Date: | February 3, 2016 |
| Trade Name: | Love Liquid® Personal Lubricant |
| Common Name: | Personal Lubricant |
| Classification Name(s): | Condom |
| Product Code: | NUC (lubricant, Personal)<br>21 CFR § 884.5300<br>Class II |
| Predicate Devices | ONE Personal Lubricant |
| 510 (k) Number: | K110691 |
| Manufacturer: | ONE Personal Lubricant |

### Device Description

The Love Liquid® Personal Lubricant is a non-sterile; water based personal lubricant, an over-the-counter personal lubricant, formulated to be a clear, non-irritating, non-greasy, liquid and odorless, aqueousbased.

The proposed device contains a blend of ingredients found in the predicate device. The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without a latex condom during intimate sexual activity as evidenced by condom compatibility testing. The device formula is neither a contraceptive nor a spermicide.

#### Indication for Use Statement

The Love Liquid® Personal Lubricant 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 and Polyisoprene condoms. It is not compatible with polyurethane condoms.

### Technological Characteristics

The technology involved in this product, Love Liquid® Personal Lubricant, has no exceptional technological characteristics.

The Love Liquid® Personal Lubricant contains mainly of ingredients that are substantially similar to other lubricants currently on the U.S. markets and substantially equivalent to the predicate device. All ingredients are either NF, USP, or are considered "generally recognized as safe for their intended use."

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# 510(K) SUMMARY K152168 Love Liquid® Personal Lubricant

#### Performance Data

Biocompatibility: The Love Liquid® Personal Lubricant is a mucosal membrane contacting device with limited contact duration (<24 hours) in accordance with ISO 10993-1:2009. Biocompatibility testing was performed in accordance with ISO 10993 standards. The results provided scientific evidence that this product is safe for its intended use.

| Test Performed | Results |
|-----------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Cytotoxicity (Direct Contact) | Product is Non-toxic |
| ISO GUINEA PIG MAXIMIZATION<br>SENSITIZATION TEST- (Method for Liquid<br>Test Articles) | Product does not elicit a sensitization<br>response |
| Vaginal Mucosa Irritation with<br>Histopathology | Product is considered a non-irritant to<br>vaginal tissue |
| Acute Systemic Toxicity | There is no evidence of system toxicity |

Condom Compatibility: The testing was performed in accordance with ASTM D7661-10 (Air Burst and Tensile); "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" on three marketed brands of Natural Rubber Latex condoms, one brand of Polyisoprene condoms, and one brand of Polyurethane condoms. The result showed that the product is compatible with natural rubber latex and Polyisoprene condoms and is not compatible with polyurethane condoms.

Microbiology: The Love Liquid® Personal Lubricant has passed the tests for Antimicrobial Effectiveness based on USP <51>, Total Microbial Count and Total Yeast and Mold Count based on USP <61>, and Absence of Pathogenic organism based on USP <62>.

Shelf-life: The real-time and accelerated shelf-life testing have been conducted on Love Liquid® Personal Lubricant. The results showed that the product maintained its appearance, color, odor, pH, osmolality, viscosity and microbiology specifications over a period of nine (9) months. Ongoing shelf-life testing will support extension of shelf-life to three years.

### Conclusion

Laboratory and safety testing conducted on the provided scientific evidence that this product is safe for its intended use, and that it is substantially equivalent to predicate devices.