JO Classic Hybrid 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Description

JO Classic Hybrid Personal Lubricant is an off-white, semi-viscous, translucent gel type personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This product is not compatible with polyurethane condoms. 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 product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural polypropylene disc top dispenser caps. The 2 oz., 4 oz. and 8 oz. size bottles are capped with silver polypropylene disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.

AI/ML Overview

This document describes the premarket notification (510(k)) for the JO Classic Hybrid Personal Lubricant. Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Property	Acceptance Criteria (Specification)	Reported Device Performance (all time points within shelf-life study)
Appearance	Opaque thick liquid	Met
Color	Off-white	Met
Odor	Odorless	Met
Viscosity (cps)	15,000 cps to 34,000 cps	Met
pH	6.20 to 7.20	Met
Specific Gravity	0.950 to 1.075	Met
Osmolality (diluted 1:10)	350 - 599 mOsm/kg	Met
Osmolality (undiluted)	600 - 990 mOsm/kg	Met
Antimicrobial effectiveness per USP <51>	Meets US <51> acceptance criteria for Category 2 products	Met
Total aerobic microbial count (TAMC) per USP <61> and <1111>	Less than 10 cfu/g	Met
Total yeast and mold count (TYMC) per USP <61> and <1111>	Less than 10 cfu/g	Met
Presence of Pseudomonas aeruginosa	Absent	Met
Presence of Staphylococcus aureus	Absent	Met
Presence of Salmonella/Shigella	Absent	Met
Presence of Escherichia coli	Absent	Met
Presence of Candida albicans	Absent	Met
Biocompatibility (Cytotoxicity)	Pass (ISO 10993-5:2009)	Met
Biocompatibility (Sensitization)	Pass (ISO 10993-10:2010)	Met
Biocompatibility (Vaginal Irritation)	Pass (ISO 10993-10:2010)	Met
Biocompatibility (Penile Irritation)	Pass (ISO 10993-10:2010)	Met
Biocompatibility (Acute Systemic Toxicity)	Pass (ISO 10993-11:2006)	Met
Condom Compatibility (Natural Rubber Latex)	Compatible	Compatible
Condom Compatibility (Polyisoprene)	Compatible	Compatible
Condom Compatibility (Polyurethane)	Not Compatible	Not Compatible
Shelf-Life	3 years	3 years

2. Sample size used for the test set and the data provenance

The document does not explicitly state a "test set" in the context of a typical AI/software study. This is a medical device (personal lubricant), and the performance is evaluated through material properties and biocompatibility testing.

For Shelf-Life and Device Specifications: The "test set" would be samples of the lubricant tested at different time points (0, 1, 2, and 3 years). The specific number of samples tested at each time point is not provided. The data provenance is internal testing performed by the manufacturer (United Consortium).
For Biocompatibility: The "test set" involves biological models (in vitro and in vivo studies). The specific sample sizes for each biocompatibility test (e.g., number of cells in cytotoxicity, number of animals in sensitization/irritation/toxicity studies) are not provided in this summary. The data provenance is from studies conforming to ISO 10993 standards.
For Condom Compatibility: The "test set" would be lubricant samples tested with natural rubber latex, polyisoprene, and polyurethane condoms. The specific number of samples / tests is not provided. The data provenance is from studies conforming to ASTM D7661-10.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of medical device submission. "Ground truth" in this context is established by standardized material testing and biocompatibility protocols, not expert consensus on interpretations. Laboratories performing these tests would have qualified personnel, but they are not "experts establishing ground truth" in the same way radiologists might for an imaging AI.

4. Adjudication method for the test set

Not applicable as it's not an expert-based subjective assessment. The results are from objective laboratory tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a personal lubricant, not an AI-powered diagnostic or assistive device requiring human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical, chemical, and biological performance evaluation of a personal lubricant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on:

Standardized Material/Chemical Specifications: Adherence to defined physical and chemical properties (e.g., pH range, viscosity range, osmolality range, microbial limits).
International Standards: Compliance with recognized international standards for biocompatibility (ISO 10993 series) and condom compatibility (ASTM D7661-10). These standards define the test methods and acceptance criteria.
Defined Acceptance Criteria: The device must meet the predefined specifications for each tested property.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of software development.

9. How the ground truth for the training set was established

Not applicable.

Summary

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August 27, 2018

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

Re: K181408

Trade/Device Name: JO Classic Hybrid Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 25, 2018 Received: May 30, 2018

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.

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews -

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)

K181408

Device Name

JO Classic Hybrid Personal Lubricant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X 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 United Consortium. The logo features a stylized letter 'U' in dark blue, with a gray curved shape above it, creating a sense of depth. Below the symbol, the words 'UNITED CONSORTIUM' are written in a simple, sans-serif font, with 'UNITED' stacked above 'CONSORTIUM'.

K181408 - JO Classic Hybrid Personal Lubricant

510(k) Owner:		United Consortium
Street Address:		29000 N. Hancock ParkwayValencia, CA 91355
Contact Person:		Stephanie MorrisRegulatory Specialist
Contact Numbers:	Bruce AlbertHead of Technical Services
		Phone: (661) 295-1700, ext. 232Phone: (661) 295-1700, ext. 231FAX: (661) 295-1800
Preparation Date:		August 9, 2018
Trade Name:		JO Classic Hybrid Personal Lubricant
Common Name:		Personal Lubricant

Device Classification:	Regulation Name:Regulation Number:Product Code:Device Class:	Condom21 CFR § 884.5300NUC (lubricant, personal)Class II
Predicate Device:	Product Name:510(k) Number:Manufacturer:	TROJAN™ LUBRICANTS ContinuousSilkiness Personal LubricantK120751Church & Dwight Co., Inc.

K181408 - 510(k) Summary

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

Product Code:

Device Class:

Device Description:

NUC Class II

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Image /page/4/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in two colors. The left side of the 'U' is a dark blue, while the right side is a light gray. Below the 'U', the words 'UNITED CONSORTIUM' are written in a smaller, sans-serif font, also in dark blue. The overall design is simple and modern.

This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural polypropylene disc top dispenser caps. The 2 oz., 4 oz. and 8 oz. size bottles are capped with silver polypropylene disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.

The device specifications are listed in the table below:

Property	Specification
Appearance	Opaque thick liquid
Color	Off-white
Odor	Odorless
Viscosity (cps)	15,000 cps to 34,000 cps
pH	6.20 to 7.20
Specific Gravity	0.950 to 1.075
Osmolality	350 - 599 mOsm/kg (diluted 1:10 with purified water) and 600 -990 mOsm/kg (undiluted)
Antimicrobial effectiveness per USP <51>	Meets US <51> acceptance criteria for Category 2products
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>
Pseudomonas aeruginosa	Absent
Staphylococcus aureus	Absent
Salmonella/Shigella	Absent
Escherichia coli	Absent
Candida albicans	Absent

Table 1: Device Specifications for JO Classic Hybrid Personal Lubricant

Indications for Use:

Predicate Device Comparison:

The table below lists the comparative indications for 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 an organization called "UNITED CONSORTIUM". The logo features a stylized letter "U" in blue and gray. The blue portion of the "U" is more prominent, while the gray portion is in the background. The text "UNITED CONSORTIUM" is written in a smaller font below the "U" symbol.

Table 2: Comparator Table for Subject Device – JO Classic Hybrid Personal Lubricant and Predicate Device TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant

Feature	JO Classic Hybrid Personal Lubricant	TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant (K120751)
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC
Indications for Use	JO Classic Hybrid Personal Lubricantis a personal lubricant for penile,anal and/or vaginal application,intended to lubricate andmoisturize, to enhance the easeand comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product iscompatible with natural rubberlatex and polyisoprene condoms.This product is not compatible withpolyurethane condoms.	TROJAN™ LUBRICANTS ContinuousSilkiness Personal Lubricant is apersonal lubricant, for penileand/or vaginal application,intended to lubricate andmoisturize, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. Thisproduct is compatible with naturalrubber latex and polyisoprenecondoms. Not compatible withpolyurethane or other condoms.
Water soluble	Yes	Yes
Contains water	Yes	Yes
Primary ingredients	Propylene Glycol, Water (Aqua),Phenoxyethanol, Dimethicone,Cellulose Gum, Cyclopentasiloxane,Sodium Polyacrylate, Trideceth-6,PEG/PPG-18/18 Dimethicone	Propylene Glycol, Water,Dimethicone, Dimethicone/VinylDimethicone Crosspolymer,Hydroxyethyl Acrylate, SodiumAcryloyl Dimethyl TaurateCopolymer, Methylparaben,Propylparaben
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Natural Rubber Latex, Polyisoprene	Natural Rubber Latex,Polyisoprene
Biocompatibility Tested	Yes	Yes
Antimicrobial Tested	Yes	Yes
Shelf life	3 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 different technological characteristics, including differences in formulation and a different shelf life. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.

Summary of Performance Data:

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Image /page/6/Picture/1 description: The image features a stylized logo for "UNITED CONSORTIUM." The logo consists of a large, bold letter "U" in a deep blue color, with a subtle gray element behind it, creating a sense of depth. Below the "U," the words "UNITED CONSORTIUM" are printed in a smaller, sans-serif font, emphasizing the organization's name. The overall design is clean and modern, suggesting a professional and unified entity.

K181408 - JO Classic Hybrid Personal Lubricant

Biocompatibility

Biocompatibility studies 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)
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 three-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, 2 and 3 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 Classic Hybrid Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms.

Conclusion:

The results of the performance testing described above demonstrate that the JO Classic Hybrid Personal Lubricant is as 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.