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 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.

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.

AI/ML Overview

The provided text describes the acceptance criteria and study for a medical device called "JO Water Based Anal Thick Lubricant." However, it is a 510(k) submission, which is for demonstrating substantial equivalence to a predicate device, not for a comparative effectiveness study with or without AI assistance, or for a standalone AI algorithm performance study.

Therefore, many of the requested categories in your prompt (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, ground truth type and training set information) are not applicable to this type of regulatory submission and information is not present in the provided document. This document focuses on the physical, chemical, and biological properties of the lubricant and its compatibility with condoms, as well as its shelf-life.

Here's the information that can be extracted from the provided text, primarily focusing on the device's specifications and performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The device specifications in Table 1 serve as the acceptance criteria for the JO Water Based Anal Thick Lubricant.

Property	Acceptance Criteria (Specification)	Reported Device Performance (Implied by "meets specification")
Appearance	Semi-viscous liquid	Semi-viscous liquid
Color	Clear	Clear
Odor	Odorless	Odorless
Viscosity (cps) per USP <911>	6,500 - 9,000	Within 6,500 - 9,000
pH per USP <971>	6.50 to 7.50	Within 6.50 to 7.50
Specific Gravity per USP <841>	0.950 to 1.100	Within 0.950 to 1.100
Osmolality per USP <785>	550 - 850 mOsm/kg (1:1 dilution)	Within 550 - 850 mOsm/kg
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products	Meets USP <51> acceptance criteria for Category 2 products
Total aerobic microbial count (TAMC) per USP <61> and <1111>	Less than 100 cfu/g	Less than 100 cfu/g
Total yeast and mold count (TYMC) per USP <61> and <1111>	Less than 10 cfu/g	Less than 10 cfu/g
Presence of Pathogens per USP <62>
Pseudomonas aeruginosa	Absent	Absent
Staphylococcus aureus	Absent	Absent
Salmonella/Shigella	Absent	Absent
Escherichia coli	Absent	Absent
Candida albicans	Absent	Absent

Performance Study Details:

Biocompatibility Studies:
- Tests Conducted: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Vaginal Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2017).
- Results: The lubricant was demonstrated to be non-cytotoxic, non-irritating, non-sensitizing, and not acutely systemically toxic.
Shelf-Life Study:
- Methodology: Real-time and accelerated aging study.
- Results: Demonstrated the device maintains its specifications (from Table 1) for an 18-month shelf-life.
Condom Compatibility Study:
- Methodology: Evaluated in accordance with ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
- Results: Compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane condoms.

Regarding the requested information that is not applicable or not present:

Sample size used for the test set and the data provenance: Not applicable. This is not a study involving human or image data for AI evaluation. The "test set" here refers to samples of the product for laboratory testing. The document does not specify the number of product samples used for each test (e.g., how many bottles were tested for viscosity). Data provenance is also not relevant in the context of these device characteristic tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for these tests would be the chemical and physical properties measured by standard laboratory methods.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not a diagnostic device or an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable.
The type of ground truth used: For the physical/chemical tests, the ground truth is established by validated laboratory measurement methods and standard testing protocols (e.g., USP and ASTM standards). For biocompatibility, it's based on animal testing results and established biological endpoints (e.g., non-cytotoxic).
The sample size for the training set: Not applicable. This involves product testing, not AI model training.
How the ground truth for the training set was established: Not applicable.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
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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 ParkwayValencia, CA 91355
Contact Person:	Marlent PerezRegulatory Affairs Specialist II
	Bruce AlbertChief Scientific Officer
Contact Numbers:	Phone: (661) 481-6390Phone: (661) 295-1700

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 DeviceInformation:	Product Name:510(k) number:Manufacturer:Product Code:Device Class:	The Sex GelK181078Necessaire, IncNUC (lubricantClass II

May 5, 2023

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

Device Description:

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

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 2products.
Total aerobic microbial count (TAMC) per USP<61> and <1111>	Less than 100 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

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

Indications for Use:

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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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 ThickLubricant is a personal lubricantfor penile, anal and/or vaginalapplication, intended to lubricateand moisturize, to enhance theease and comfort of intimatesexual activity and supplementthe body's natural lubrication.This product is compatible withnatural rubber latex andpolyisoprene condoms. Thisproduct is not compatible withpolyurethane condoms.	The Sex Gel is a personal lubricant,for penile and/or vaginalapplication, intended to moisturizeand lubricate, to enhance the easeand comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product iscompatible with natural rubberlatex, polyisoprene condoms andpolyurethane condoms.
Water soluble	Yes	Yes
Contains water	Yes	Yes
Primary ingredients	Water (Aqua), Glycerin, Polysorbate20, Propylene Glycol,Hydroxyethylcellulose,Chlorphenisen, Vitamin E Acetate,Sodium Hydroxide	Water, Aloe Barbadensis LeafJuice, Sorbitol,Hydroxyethylcellulose,Allantoin, LacticAcid/Tocopherols (Vitamin E),Sodium Hyaluronate, SodiumBenzoate & 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.

Regulation Number and Section

§ 884.5300 Condom.

(a)
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.(b)
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.