JO H20 Water Based Personal Lubricant

K150480 · United Consortium, Inc. · NUC · Jul 8, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K150480
• Device Name: JO H20 Water Based Personal Lubricant
• Applicant: United Consortium, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 8, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

JO H2O Personal Lubricant is a water-based personal lubricant, for penile 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

JO H2O is a clear, colorless, semi-viscous water-based personal lubricant. It is applied topically to the penis and/or vagina to moisturize, lubricate, and enhance comfort during intimate sexual activity. The device supplements natural lubrication and is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. It is intended for over-the-counter use by consumers. The product is packaged in polyethylene (PET) bottles with polypropylene caps or lotion pumps, sealed with aluminized mylar. It functions as a physical lubricant to reduce friction during sexual activity, providing a benefit of increased comfort and ease of use.

Clinical Evidence

Bench testing only. Biocompatibility studies (acute systemic toxicity, vaginal irritation, cytotoxicity, guinea pig maximization sensitization) conducted per ISO 10993. Condom compatibility tested per ASTM D7661-10. Real-time aging study supports a three-year shelf life, evaluating appearance, pH, osmolality, viscosity, and microbial limits.

Technological Characteristics

Water-based personal lubricant. Materials: Polyethylene (PET) bottles, polypropylene caps, aluminized mylar induction seals. Compatibility: Natural rubber latex, polyurethane, polyisoprene condoms. Testing standards: ISO 10993 (biocompatibility), ASTM D7661-10 (condom compatibility).

Indications for Use

Indicated for adults seeking to moisturize and lubricate for 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

• I-D Glide Personal Lubricant (K051295)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.

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

July 8, 2015

United Consortium, Inc. Joe Mendoza Quality Assurance Manager 29000 Hancock Parkway Valencia, CA 91355

Re: K150480

Trade/Device Name: JO H2O Water Based Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 3, 2015 Received: June 5, 2015

Dear Joe Mendoza,

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,

**Herbert P. Lerner -S**

for 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) K150480

Device Name JO H2O Water Based Personal Lubricant

#### Indications for Use (Describe)

JO H2O Personal Lubricant is a water-based personal lubricant, for penile 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) | <input type="checkbox"/> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <input checked="" type="checkbox"/> |

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# 510(k) Summary

| 510(k) Owner: | United Consortium |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Street Address: | 29000 Hancock Parkway<br>Valencia, CA 91355 |
| Establishment Registration Number: | 3005691625 |
| Contact Person: | Joe Mendoza<br>Quality Assurance Manager |
| Contact Numbers: | Phone: [phone] ext. 209<br>FAX: [phone] |
| Summary Preparation Date: | July 6, 2015 |
| Trade Name: | JO H2O Water Based Personal Lubricant |
| Common Name: | Personal Lubricant |
| Device Classification: | Classification Name: Condom<br>Product Code: NUC (lubricant, personal)<br>Regulation: 21 CFR § 884.5300<br>Device Class: Class II |
| Predicate Device: | Product Name: I-D Glide Personal Lubricant<br>510(k) Number: K051295<br>Manufacturer: Westridge Laboratories, Inc.<br>Product Code: NUC<br>Device Class: Class II |

#### Device Description:

JO H2O Water Based Personal Lubricant is a clear, colorless, semi-viscous personal lubricant that is 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 moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is provided in Polyethylene (PET) bottles with Polypropylene caps. The individual bottles are sealed using an induction seal constructed of aluminized mylar. There is a 16 fl. Oz./480 mL bottle with a different configuration consisting of a clear Polyethylene (PET) bottle with a Polypropylene lotion pump. This bottle is fitted with a shrink band. The device specifications are listed in the table below:

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### Indications for Use:

JO H2O Water Based 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, polyurethane, and polyisoprene condoms.

### Summary of Technological Characteristics:

JO H2O Water Based Personal Lubricant contains water-soluble ingredients similar to ingredients found in the predicate device.

### Summary of Performance Data

Independent third-party laboratories conducted the biocompatibility studies including acute systemic toxicity, vaginal irritation, cyctotoxicity and guinea pig maximization sensitization testing according to FDA recognized ISO 10993 standards. The results of these tests demonstrate that JO H2O Water Based Personal Lubricant is safe.

Shelf Life: The subject device, JO H2O Water Based Personal Lubricant, has a three-year shelf life based on the results of a real time aging study. The shelf life study evaluated the following parameters of this product: appearance, color, odor, pH, osmolality, viscosity, specific gravity, total aerobic microbial count, total yeast and mold count, absence of pathogens, and antimicrobial effectiveness.

Condom Compatibility: The compatibility of the subject device, JO H2O Water Based Personal Lubricant, was evaluated with natural rubber latex, polyisoprene, and polyurethane condoms per 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 H2O Water Based Personal Lubricant is compatible with natural rubber latex, polyurethane, and polyisoprene.

| Feature | JO H2O Water Based Personal Lubricant | I-D Glide Water Based Lubricant |
|----------------------|---------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | Same as the predicate | Personal lubricant for penile and vaginal use<br>(enhance the comfort and ease of intimate) |
| Appearance | | Clear, colorless |
| Formulation | Comparable with the predicate | Water-based; ingredients include glycerin,<br>propylene glycol, cellulose polymer, etc. |
| Condom Compatibility | Latex, Polyurethane, Polyisoprene | Latex, Polyurethane |

### Predicate Device Comparison

#### Conclusion:

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JO H2O Water Based Personal Lubricant has the same intended use and comparable technological characteristics as the predicate device. therefore, the JO H2O Water Based Personal Lubricant is substantially equivalent to the predicate device.