JO Gelato Flavored Personal Lubricants

K172447 · United Consortium · NUC · Oct 31, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K172447
• Device Name: JO Gelato Flavored Personal Lubricants
• Applicant: United Consortium
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Oct 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

JO Gelato Flavored Personal Lubricants are water-based personal lubricants for penile 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

Water-based, clear, semi-viscous personal lubricant; applied topically to penile and/or vaginal areas to supplement natural lubrication and enhance comfort during sexual activity. Provided in PET bottles or foil sachets; non-sterile. Compatible with natural rubber latex, polyurethane, and polyisoprene condoms. Used by consumers in home settings. Benefits include reduced friction and increased comfort during intimate activity.

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). Condom compatibility tested per ASTM D7661-10. Shelf-life validated via real-time and accelerated aging studies over two years.

Technological Characteristics

Water-based lubricant; viscosity 2000-3700 cps; pH 5.0-6.0; osmolality 1350-1550 mOsm/kg. Ingredients: Water, Glycerin, Potassium Sorbate, Hydroxyethylcellulose, Flavor, Sodium Chloride, Sucralose, Citric Acid. Packaging: PET bottles with Polypropylene caps or aluminized mylar foil sachets. Non-sterile. Complies with USP <51>, <61>, <62>, and <1111> for microbial effectiveness and safety.

Indications for Use

Indicated for adults requiring lubrication and moisturization for penile and/or vaginal application to enhance comfort during intimate sexual activity; 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

• Astroglide Sensual Strawberry (K140590)

Submission Summary (Full Text)

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October 31, 2017

United Consortium Stephanie Morris RA/QA Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355

Re: K172447

> Trade/Device Name: JO Gelato Flavored Personal Lubricants Regulation Number: 21 CFR\$ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 10, 2017 Received: August 14, 2017

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.

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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

### 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)

K172447

Device Name JO Gelato Flavored Personal Lubricants

#### Indications for Use (Describe)

JO Gelato Flavored Personal Lubricants are water-based personal lubricants for penile 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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### K172447 - 510(k) Summary

| 510(k) Owner: | United Consortium |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Street Address: | 29000 Hancock Parkway<br>Valencia, CA 91355 |
| Establishment Registration Number: | 3005691625 |
| Contact Person: | Stephanie Morris<br>RA/QA Specialist<br><br>Bruce Albert<br>Head of Technical Services |
| Contact Numbers: | Phone: [phone], ext. 232<br>Phone: [phone], ext. 231<br>FAX: [phone] |
| Summary Preparation Date: | October 27, 2017 |
| Trade Name: | JO Gelato Flavored Personal Lubricants<br>JO Gelato Salted Caramel Personal Lubricant<br>JO Gelato Crème Brulee Personal Lubricant<br>JO Gelato Hazelnut Espresso Personal Lubricant<br>JO Gelato Mint Chocolate Personal Lubricant<br>JO Gelato Tiramisu Personal Lubricant |
| Common Name: | Personal Lubricant |
| Device Classification: | Classification Name: Condom<br>Product Code: NUC (lubricant, personal)<br>Regulation: 21 CFR § 884.5300 (Condom)<br>Device Class: Class II |
| Predicate Device: | Product Name: Astroglide Sensual Strawberry<br>510(k) Number: K140590<br>Manufacturer: BioFilm, Inc.<br>Product Code: NUC<br>Device Class: Class II |

The predicate device has not been subject to a designrelated recall.

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#### Device Description:

JO Gelato Flavored Personal Lubricants are clear, semi-viscous personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. The device is a non-sterile lubricant for penile 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. The product is provided in Polyethylene Terephthalate (PET) bottles fitted with Polypropylene caps or foil sachets. The individual bottles are sealed using an induction seal constructed of aluminized mylar.

The device specifications are listed in the table below:

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

| Property | Specification |
|-----------------------------------------------------------------|--------------------------------------------------------------|
| Appearance | Clear, semi-viscous liquid |
| Color | Clear |
| Odor | Sweet/Characteristic |
| Viscosity (cps) | 2000 cps to 3700 cps |
| Specific Gravity | 0.900 to 1.050 |
| pH | 5.0 to 6.0 |
| Osmolality | 1350 to 1550 mOsm/kg |
| 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 |

#### Indications for Use:

JO Gelato Flavored Personal Lubricants are water-based personal lubricants for penile 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 subject and predicate device.

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| Feature | JO Gelato Flavored Personal Lubricants | Astroglide Sensual Strawberry<br>(K140590) |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Intended Use | JO Gelato Flavored Personal Lubricants<br>are water-based personal lubricants for<br>penile and/or vaginal application,<br>intended to lubricate and moisturize, to<br>enhance the ease and comfort of<br>intimate sexual activity and supplement<br>the body's natural lubrication. This<br>product is compatible with natural<br>rubber latex, polyurethane and<br>polyisoprene condoms. | The BioFilm, Inc. Astroglide<br>Sensual Strawberry is a personal<br>lubricant for penile and/or<br>vaginal 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 | Water (Aqua), Glycerin, Potassium<br>Sorbate, Hydroxyethylcellulose, Flavor<br>(Aroma), Sodium Chloride, Sucralose,<br>Citric Acid | Water (Aqua), Glycerin,<br>Propylene Glycol,<br>Hydroxyethylcellulose, Natural<br>and Artificial Strawberry Flavor,<br>Sodium Gluconate, Sodium<br>Saccharin, Methylparaben,<br>Sodium Benzoate, Citric Acid |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Latex, Polyisoprene, Polyurethane | Latex, Polyisoprene,<br>Polyurethane |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |

#### Table 2: Comparator Table for Subject Device – JO Gelato Flavored Personal Lubricants and Predicate Device Astroglide Sensual Strawherry

The subject and predicate device have the same intended use - for penile 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. The subject and predicate device have different technological characteristics, including different formulation. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions. All personal lubricants must independently demonstrate they are biocompatible, compatible with condoms, and can maintain their specifications for their expected shelf life.

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#### Summary of Performance Data:

#### Biocompatibility

Independent third-party laboratories conducted the biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing; each were performed in accordance with 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 Agarose Overlay Method, ISO 10993-5:2009) ●
- Sensitization (ISO Guinea Pig Maximization Sensitization, ISO 10993-10:2010) ●
- Vaginal Irritation (ISO Vaginal Irritation Study in Rabbits, ISO 10993-10:2010)
- Penile Irritation (ISO Penile Irritation Study in Rabbits, ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO Tests for Systemic Toxicity, ISO 10993-11:2006)

The results of this testing demonstrated that the subject lubricant is biocompatible.

#### Shelf-Life:

The proposed device, JO Gelato Flavored Personal Lubricant, is a non-sterile personal lubricant 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. In addition, both versions of the device packaging were evaluated. The subject device in both versions of its packaging met the device specifications at all time points.

#### Condom Compatibility:

The compatibility of the subject device, JO Gelato Personal Lubricant, was evaluated with natural rubber latex, polyisoprene and polyurethane condoms 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 indicate that the JO Gelato Flavored Personal Lubricants are compatible with natural rubber latex, polyurethane and polyisoprene condoms.

#### Conclusion:

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