O Glide Personal Lubricant

K142726 · Grafenberg Labs · NUC · Jul 24, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K142726
• Device Name: O Glide Personal Lubricant
• Applicant: Grafenberg Labs
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

O Glide 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 not compatible with condoms.

Device Story

O Glide Personal Lubricant is a non-sterile, oil-based personal lubricant formulated with plant-derived oils. It is intended for over-the-counter use by consumers to supplement natural lubrication and enhance comfort during intimate sexual activity. The product is supplied in an LDPE plastic tube. It is applied topically to the penis or vagina. The device is not compatible with condoms. It functions by providing physical lubrication to reduce friction during sexual activity. Safety is established through biocompatibility testing, including cytotoxicity, acute systemic toxicity, sensitization, and vaginal irritation studies, as well as shelf-life stability testing.

Clinical Evidence

No clinical data. Evidence consists of bench testing: ISO cytotoxicity (in vitro mammalian cell culture), ISO acute systemic toxicity (mice), ISO maximization sensitization (guinea pig), and ISO vaginal irritation with histopathology (rabbits). All tests showed no evidence of toxicity, sensitization, or irritation. Shelf life was validated via accelerated aging studies.

Technological Characteristics

Oil-based personal lubricant. Packaged in LDPE plastic tube with flip-top cap. Non-sterile. Specifications include appearance, odor, viscosity, and microbial limits (TAMC, yeast/molds, absence of pathogens). Osmolality, pH, and antimicrobial effectiveness are not applicable due to oil-based formulation.

Indications for Use

Indicated for individuals requiring penile and/or vaginal lubrication to enhance comfort during intimate sexual activity and supplement natural lubrication. Not compatible with 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

• Aloe Cadabra Personal Lubricant (K124044)

Submission Summary (Full Text)

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

July 24, 2015

Grafenberg Labs % Bosmat Friedman Regulatory Consultant MJRAC 1208-12 Rockford Road Toronto, Ontario M2R 3A2 Canada

Re: K142726 Trade/Device Name: O Glide Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 23, 2015 Received: June 25, 2015

Dear Bosmat Friedman,

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

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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.

for

Sincerely yours.

Herbert P. Lerner -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) K142726

Device Name O Glide Personal Lubricant

Indications for Use (Describe)

O Glide 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 not compatible with 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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# 510(K) SUMMARY [as required by section 807.92(c)] O Glide Personal Lubricant 510(k) Number K142726

#### 1. SUBMITTER

### Applicant's Name and Contact Information:

Grafenberg Labs 755 Second Avenue New York NY 10017 Tel: [phone] Ext. 143 212-599-5554 Fax:

### Contact Person:

Bosmat Friedman Regulatory Affairs Consultant; MJ RAC 1208-12 Rockford Rd. Toronto, ON, M2R 3A2, Canada Phone: [phone]; Fax: [phone]; [e-mail]

### Date Prepared:

September 15, 2014 (Revised July 23, 2015)

#### DEVICE NAME AND CLASSIFICATION 2.

Trade Name:

O Glide Personal Lubricant

### Common or Usual Name: Personal Lubricant

Classification Name: Condom Product Code: NUC Regulation No: 21 CFR 884.5300 Class: II Classification Panel: Obstetrics/Gynecology

#### 3. PREDICATE DEVICES

### Primary Predicate Device:

Aloe Cadabra Personal Lubricant - K124044

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#### 4. DEVICE DESCRIPTION

The O Glide Personal Lubricant is a non-sterile, oil-based personal lubricant designed to supplement the body's own natural lubrication fluids and to enhance the ease and comfort of intimate sexual activity.

The O Glide Personal Lubricant is specifically formulated with naturally occurring plant derived oils. The specifications for the subject lubricant include appearance, odor, viscosity, total microbial count (TAMC), total combined yeast and molds count, and absence of pathogenic organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Coliforms, and Clostridia). Osmolality, pH, and antimicrobial effectiveness are not applicable to the subject device because it is an oil-based lubricant.

The product is bottled in an LDPE white plastic tube with a white flip top cap. The tube is packaged in a carton for sale to consumers.

#### ട. INDICATIONS FOR USE

O Glide 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 not compatible with condoms.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6. PREDICATE DEVICE

The subject and predicate device have the same intended use. The subject and predicate devices do not have the same technological characteristics because the subject device is oil-based and the predicate is aloe-based. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions, as formulation differences are commonly addressed in personal lubricant 510(k) submissions. Accepted scientific methods exist to assess the effects of the different technological characteristics, including biocompatibility, condom compatibility, and stability testing.

#### 7. PERFORMANCE DATA

Below is a list of the tests that have been performed and successfully completed for the O Glide Personal Lubricant.

### Biocompatibility:

# Cytotoxicity Study Using the ISO Elution Method

The test article was evaluated for potential cytotoxic effects using an in vitro mammalian cell culture test. The test article extract showed no evidence of causing cell lysis or toxicity.

O Glide Personal Lubricant

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## ISO Acute Systemic Toxicity Study in Mice

The test article was evaluated for acute systemic toxicity in mice. There was no mortality or evidence of systemic toxicity from the extracts injected into mice.

### ISO Maximization Sensitization Study

The test article was evaluated for the potential to cause sensitization in a guinea pig maximization test. The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig.

### ISO Vaginal Irritation Study with Histopathology

The test article was evaluated for the potential to cause irritation to vaginal tissue in rabbits. The test article extracts were considered to be a non-irritant to vaginal tissue of the rabbit.

### Shelf Life:

The subject device has one-year shelf life based on the results of an accelerated aging study conducted in the proposed packaging. The subject device met its specifications over the duration of the proposed shelf life.

### Condom Compatibility:

The subject device is labeled not for use with condoms.

#### CONCLUSION 8.

The O Glide Personal Lubricant is substantially equivalent to the predicate device.