JO Premium Jelly Original Personal Lubricant

K191214 · United Consortium · NUC · Aug 1, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K191214
• Device Name: JO Premium Jelly Original Personal Lubricant
• Applicant: United Consortium
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Aug 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

JO Premium Jelly Original 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

JO Premium Jelly Original Personal Lubricant is a non-sterile, viscous, clear gel personal lubricant; intended for penile, anal, and vaginal application to supplement natural lubrication and enhance comfort during sexual activity. Device is packaged in 4 oz. polyethylene (PE) tubes with polypropylene (PP) flip-top caps. It is an over-the-counter product for consumer self-use. The lubricant is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. It functions by providing a physical barrier to reduce friction. Safety is established through biocompatibility testing, condom compatibility testing per ASTM D7661-10, and shelf-life stability studies.

Clinical Evidence

No clinical data. Evidence consists of bench testing: biocompatibility (cytotoxicity, sensitization, vaginal/penile irritation, acute systemic toxicity per ISO 10993), condom compatibility (ASTM D7661-10), and shelf-life stability (real-time and accelerated aging).

Technological Characteristics

Viscous gel; non-sterile; water-insoluble (silicone-based). Ingredients: Dimethicone, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol. Packaging: PE tubes, PP caps. Shelf life: 2 years. Testing standards: USP <51> (antimicrobial), USP <61>/<1111>/<62> (microbial limits), ISO 10993 (biocompatibility), ASTM D7661-10 (condom compatibility).

Indications for Use

Indicated for adults requiring personal lubrication for penile, anal, or vaginal application to enhance comfort during 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 Diamond Silicone Gel Personal Lubricant (K163395)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 1, 2019

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

Re: K191214

Trade/Device Name: JO Premium Jelly Original Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: May 3, 2019 Received: May 6, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Sharon M. Andrews Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K191214

Device Name

JO Premium Jelly Original Personal Lubricant

#### Indications for Use (Describe)

JO Premium Jelly Original 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)Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510 (k) Summary - K191214

#### 1. Submitter Information

| Applicant: | United Consortium |
|------------|--------------------------------------------------|
| Contact: | Stephanie Morris<br>Global Regulatory Specialist |
| | Bruce Albert |
| | Head of Technical Services |
| Address: | 29000 N. Hancock Parkway |
| | Valencia, CA 91355 |
| Phone: | [phone], ext. 232 |
| Phone: | [phone], ext. 231 |
| FAX: | [phone] |

#### 2. Correspondent Information

| Contact: | Stephanie Morris |
|----------|------------------------------------------------|
| Address: | 29000 N. Hancock Parkway<br>Valencia, CA 91355 |
| Phone: | [phone], ext. 232 |
| Fax: | [phone] |
| Email: | [e-mail] |

#### 3. Date prepared: July 30, 2019

#### 4. Device Information

| Device Name: | JO Premium Jelly Original Personal Lubricant |
|--------------------|----------------------------------------------|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |

#### 5. Predicate Device Information

| Device Name: | Astroglide Diamond Silicone Gel Personal Lubricant |
|-------------------|----------------------------------------------------|
| 510(k) Number: | K163395 |
| Manufacturer: | BioFilm, Inc. |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |

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

#### 6. Device Description

JO Premium Jelly Original Personal Lubricant is a clear/water white, viscous gel-type personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This device is a non-sterile personal lubricant 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. This provided in clear, polyethylene (PE)

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tubes. These 4 oz. size tubes are capped with silver, glossy, polypropylene (PP) flip tops. The individual tubes are hermetically sealed during the production process. The device specifications are listed in the table below :

| | | | | Table 1: Device Specifications for JO Premium Jelly Original Personal Lubricant |
|--|--|--|--|---------------------------------------------------------------------------------|
|--|--|--|--|---------------------------------------------------------------------------------|

| Property | Specification |
|--------------------------------------------------------------|-----------------------------------------------------------|
| Appearance | Viscous gel |
| Color | Clear, water white |
| Odor | Odorless |
| Viscosity (cps) | 1375 cps to 1700 cps |
| Specific Gravity | 0.870 to 1.025 |
| Antimicrobial effectiveness per USP <51> | Meets US <51> acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per USP <61> and <1111> | Less than 10 cfu/g |
| Total yeast and mold count (TYMC) per USP <61> and <1111> | Less than 10 cfu/g |
| Presence of Pathogens per USP <62> | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida albicans | Absent |

#### 7. Indications for Use

JO Premium Jelly Original Personal Lubricant is a 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.

#### 8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The table below lists the comparative indications for use and technological characteristics of the subject and predicate device.

#### Table 2: Comparator Table for Subject Device - JO Premium Jelly Original Personal Lubricant and Predicate Device Astroglide Diamond Silicone Gel Personal Lubricant

| Feature | JO Premium Jelly<br>Original Personal<br>Lubricant | Astroglide Diamond<br>Silicone Gel Personal<br>Lubricant (K163395) |
|-------------------------------|----------------------------------------------------|--------------------------------------------------------------------|
| Device Classification<br>Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |

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| Feature | JO Premium Jelly<br>Original Personal<br>Lubricant | Astroglide Diamond<br>Silicone Gel Personal<br>Lubricant (K163395) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | JO Premium Jelly Original<br>Personal Lubricant is a<br>personal lubricant for penile,<br>anal and/or vaginal application,<br>intended to lubricate and<br>moisturize, to enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication. This<br>product is compatible with<br>natural rubber latex,<br>polyurethane and polyisoprene<br>condoms. | Astroglide® Diamond Silicone<br>Gel Personal Lubricant is a<br>personal lubricant for penile<br>and/or vaginal application,<br>intended to moisturize and<br>lubricate, to enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication. This<br>product is compatible with<br>natural rubber latex,<br>polyurethane and<br>polyisoprene condoms. |
| Water soluble | No | No |
| Contains water | No | No |
| Primary ingredients | Dimethicone,<br>Cyclopentasiloxane,<br>Cyclotetrasiloxane, Dimethicone<br>/ Vinyl Dimethicone<br>Crosspolymer, Dimethiconol | Dimethicone, Cyclomethicone<br>Dimethicone / Vinyl<br>Dimethicone Crosspolymer,<br>Cocos Nucifera (Coconut) Oil |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Natural Rubber Latex,<br>Polyurethane, Polyisoprene | Natural Rubber Latex,<br>Polyurethane, Polyisoprene |
| 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 device have similar technological characteristics, including similar formulation. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.

## 9. Summary of Non-Clinical Performance Testing

## Biocompatibility

Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing were performed in accordance with the 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 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- . Vaginal Irritation (ISO 10993-10:2010)

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- Penile Irritation (ISO 10993-10:2010) ●
- Acute Systemic Toxicity (ISO 10993-11:2006) ●

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

#### Shelf-Life

The subject device 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. The subject device met the device specifications at all time points.

#### Condom Compatibility

The compatibility of the subject device 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 JO Premium Jelly Original Personal Lubricant is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

#### 10. Conclusion

The results of the performance testing described above demonstrate that the JO Premium Jelly Original Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.