JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114

K230674 · CC Wellness, LLC · NUC · May 8, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K230674
• Device Name: JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114
• Applicant: CC Wellness, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: May 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

JO Water Based Anal Thick 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Story

JO Water Based Anal Thick Lubricant is a clear, semi-viscous, non-sterile personal lubricant intended for OTC use. It is applied topically to penile, anal, or vaginal areas to provide lubrication and moisture during intimate sexual activity. The device is supplied in PET bottles. It functions by providing a physical barrier/lubricant layer to reduce friction. It is compatible with natural rubber latex and polyisoprene condoms but not polyurethane. Users apply the lubricant manually as needed. The device benefits patients by enhancing comfort and ease of sexual activity. It is a chemical formulation consisting of water, glycerin, polysorbate 20, propylene glycol, hydroxyethyl cellulose, chlorphenesin, vitamin E acetate, and sodium hydroxide.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), vaginal irritation (ISO 10993-10), and acute systemic toxicity (ISO 10993-11). Results confirmed the device is non-cytotoxic, non-irritating, non-sensitizing, and not acutely systemically toxic. Condom compatibility tested per ASTM D7661-18. Shelf-life validated via real-time and accelerated aging studies for 18 months.

Technological Characteristics

Non-sterile, water-based, semi-viscous liquid. Ingredients: Water, Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethyl cellulose, Chlorphenesin, Vitamin E Acetate, Sodium Hydroxide. Specifications: Viscosity 6,500-9,000 cps (USP <911>), pH 6.50-7.50 (USP <971>), Osmolality 550-850 mOsm/kg (USP <785>). Packaging: PET bottles. Compatibility: Natural rubber latex and polyisoprene condoms (ASTM D7661-18).

Indications for Use

Indicated for individuals requiring personal lubrication for penile, anal, and/or vaginal application to enhance comfort during intimate sexual activity and supplement natural lubrication. 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

• The Sex Gel (K181078)

Submission Summary (Full Text)

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May 8, 2023

CC Wellness LLC Marlent Perez Regulatory Affairs Specialist II 29000 N. Hancock Pkwy. Valencia, CA 91355

Re: K230674

> Trade/Device Name: JO Water Based Anal Thick Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 7, 2023 Received: March 10, 2023

Dear Marlent Perez:

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 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-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,

# Monica D. Garcia -S

Monica D. Garcia, Ph.D. Assistant 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) K230674

Device Name JO Water Based Anal Thick Lubricant

Indications for Use (Describe)

JO Water Based Anal Thick 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 and polyisoprene condoms. This product is not compatible with polyurethane 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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Image /page/3/Picture/0 description: The image shows a logo for a wellness company. The logo features two stylized, cursive letters that appear to be "CC". To the right of the letters, the word "WELLNESS" is written in a smaller, sans-serif font. The overall design is simple and elegant, conveying a sense of sophistication and well-being.

510(k) Traditional Submission JO Water Based Anal Thick Lubricant

personal)

#### 510(k) Summary 8.

| 510(k) Owner: | CC Wellness LLC |
|------------------|---------------------------------------------------|
| Street Address: | 29000 N. Hancock Parkway<br>Valencia, CA 91355 |
| Contact Person: | Marlent Perez<br>Regulatory Affairs Specialist II |
| | Bruce Albert<br>Chief Scientific Officer |
| Contact Numbers: | Phone: [phone]<br>Phone: [phone] |

#### Subject Device Information:

Summary Preparation Date:

| Trade Name: | JO Water Based Anal Thick Lubricant | |
|----------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Common Name: | Personal Lubricant | |
| Regulation Name: | Condom | |
| Regulation Number: | 21 CFR 884.5300 | |
| Product Code: | NUC (lubricant, personal) | |
| Device Class: | Class II | |
| Predicate Device<br>Information: | Product Name:<br>510(k) number:<br>Manufacturer:<br>Product Code:<br>Device Class: | The Sex Gel<br>K181078<br>Necessaire, Inc<br>NUC (lubricant<br>Class II |

May 5, 2023

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

# Device Description:

JO Water Based Anal Thick Lubricant is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.

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Image /page/4/Picture/0 description: The image shows a logo with two stylized, cursive letters that appear to be 'CC'. Below the letters, the word 'WELLNESS' is written in a smaller, sans-serif font. The overall design is simple and elegant, with a focus on the flowing lines of the cursive letters and the clean typography of the word 'WELLNESS'.

# 510(k) Traditional Submission JO Water Based Anal Thick Lubricant

JO Water Based Anal Thick Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz./ 60 mL, 4 fl. oz./120 mL and 8 fl. oz./ 240 mL bottles. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle and capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

This device is composed of Water (Aqua), Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethyl cellulose, Chlorphenesin, Vitamin E Acetate and Sodium Hydroxide.

The device specifications are listed in the table below:

| Property | Specification |
|-----------------------------------------------------------------|----------------------------------------------------------------|
| Appearance | Semi-viscous liquid |
| Color | Clear |
| Odor | Odorless |
| Viscosity (cps) per USP <911> | 6,500 - 9,000 |
| pH per USP <971> | 6.50 to 7.50 |
| Specific Gravity per USP <841> | 0.950 to 1.100 |
| Osmolality per USP <785> | 550 - 850 mOsm/kg (1:1 dilution) |
| Antimicrobial effectiveness per USP <51> | Meets USP <51> acceptance criteria for Category 2<br>products. |
| Total aerobic microbial count (TAMC) per USP<br><61> and <1111> | Less than 100 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/Shigella | Absent |
| Escherichia coli | Absent |
| Candida albicans | Absent |

# Table 1: Device Specifications for JO Water Based Anal Thick Lubricant

# Indications for Use:

JO Water Based Anal Thick 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

# Comparison of Intended Use and Technological Characteristics with Predicate Device:

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

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Image /page/5/Picture/0 description: The image shows a logo for a company called "Wellness". The logo features a stylized, cursive font. The word "Wellness" is written in smaller letters below the main design. The overall design is simple and elegant.

# Table 2: Comparator Table for Subject Device – JO Water Based Anal Thick Lubricant and Predicate Device - The Sex Gel

| Feature | JO Water Based Anal Thick | The Sex Gel |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Lubricant | (K181078) |
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | JO Water Based Anal Thick<br>Lubricant is a personal lubricant<br>for penile, anal and/or vaginal<br>application, intended to lubricate<br>and moisturize, to enhance the<br>ease and comfort of intimate<br>sexual activity and supplement<br>the body's natural lubrication.<br>This product is compatible with<br>natural rubber latex and<br>polyisoprene condoms. This<br>product is not compatible with<br>polyurethane condoms. | The Sex Gel is a personal lubricant,<br>for penile and/or vaginal<br>application, intended to moisturize<br>and lubricate, to enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the body's<br>natural lubrication. This product is<br>compatible with natural rubber<br>latex, polyisoprene condoms and<br>polyurethane condoms. |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Water (Aqua), Glycerin, Polysorbate<br>20, Propylene Glycol,<br>Hydroxyethylcellulose,<br>Chlorphenisen, Vitamin E Acetate,<br>Sodium Hydroxide | Water, Aloe Barbadensis Leaf<br>Juice, Sorbitol,<br>Hydroxyethylcellulose,<br>Allantoin, Lactic<br>Acid/Tocopherols (Vitamin E),<br>Sodium Hyaluronate, Sodium<br>Benzoate & Potassium Sorbate |
| pH | 6.50 to 7.50 | 4.00 - 5.00 |
| Osmolarity | 550 - 850 mOsm/kg (1:1 dilution) | 435 - 535 mOsm/kg |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Latex and Polyisoprene | Latex, Polyisoprene, Polyurethane |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 18 months | 6 months |

The subject and predicate device have similar indications for use. The indications for the subject device has been expanded to include anal application. This additional application does not represent a new intended use as the primary 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 devices have different technological characteristics including different formulations and device specifications. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness.

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Image /page/6/Picture/0 description: The image shows a logo with two stylized letter C's in a cursive font. The letters are connected by a thin line that extends from the top of the first C to the top of the second C. Below the letters, the word "WELLNESS" is written in a smaller, sans-serif font. The logo is simple and elegant, and the use of cursive and sans-serif fonts creates a contrast that is both visually appealing and easy to read. The overall effect is one of sophistication and professionalism.

#### Summary of Non-Clinical Performance Data:

#### Biocompatibility

Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization Testing were performed in accordance with the 2020 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)
- Acute Systemic Toxicity (ISO 10993-11:2017)

The results of this testing demonstrated that the subject lubricant is non-cytotoxic, non-irritating, non-sensitizing, and not acutely systemically toxic.

#### Shelf-Life:

The subject device is a non-sterile personal lubricant with an 18 month shelf-life in accordance with the results of a real time and accelerated aging study. Results from this testing demonstrated that the device maintains its specifications as shown in Table 1 over the duration of its shelf life.

# Condom Compatibility:

The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicated JO Water Based Anal Thick Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

#### Conclusion:

The results of the performance testing described above demonstrate that JO Water Based Anal Thick Lubricant is safe and effective as the predicate device and supports a determination of substantial equivalence.