JO H2O 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Description

JO H2O Jelly Original Personal Lubricant is a clear/water white, viscous 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 (PE) 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.

AI/ML Overview

This document is a 510(k) premarket notification for a personal lubricant (JO H2O Jelly Original Personal Lubricant), and as such, it does not contain the kind of detailed study information (like a multi-reader multi-case study, ground truth establishment for a large training set, or specific acceptance criteria for an AI algorithm's performance on a test set) that would be present for an AI/ML medical device.

The "acceptance criteria" discussed in this document refer to the physical and chemical specifications of the lubricant itself, as well as its biocompatibility and condom compatibility, and microbiological quality, not the performance of an AI model. Therefore, I cannot extract the information required by your prompt, such as:

A table of acceptance criteria and the reported device performance for an AI algorithm.
Sample size used for the test set and data provenance for AI evaluation.
Number of experts used to establish ground truth and their qualifications for AI evaluation.
Adjudication method for AI evaluation.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
If a standalone (algorithm only) performance study was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI evaluation.
The sample size for the training set for an AI algorithm.
How the ground truth for the training set was established for an AI algorithm.

Instead, the document details the following regarding the lubricant itself:

1. A table of device specifications (acceptance criteria for the product) and the measured or tested performance:

Property	Specification	Reported Performance (Implied by "met the device specifications")
Appearance	Viscous gel	Met specification (implied)
Color	Clear, water white	Met specification (implied)
Odor	Odorless	Met specification (implied)
Viscosity (cps)	15,500 cps to 35,000 cps	Met specification (implied)
pH	4.00 to 5.00	Met specification (implied)
Specific Gravity	1.000 to 1.200	Met specification (implied)
Osmolality	1050 to 1250 mOsm/kg	Met specification (implied)
Antimicrobial effectiveness per USP <51>	Meets US <51> acceptance criteria forCategory 2 products	Met USP <51> acceptance criteria (reported explicitly as "Meets US <51> acceptance criteria for Category 2 products")
Total aerobic microbial count (TAMC) perUSP <61> and <1111>	Less than 10 cfu/g	Met specification (reported explicitly as "Less than 10 cfu/g" in line with specification, implying it meets it)
Total yeast and mold count (TYMC) perUSP <61> and <1111>	Less than 10 cfu/g	Met specification (reported explicitly as "Less than 10 cfu/g" in line with specification, implying it meets it)
Presence of Pathogens per USP <62>
- Pseudomonas aeruginosa	Absent	Absent (implied by "device met the device specifications")
- Staphylococcus aureus	Absent	Absent (implied by "device met the device specifications")
- Salmonella/Shigella	Absent	Absent (implied by "device met the device specifications")
- Escherichia coli	Absent	Absent (implied by "device met the device specifications")
- Candida albicans	Absent	Absent (implied by "device met the device specifications")
Biocompatibility	Biocompatible	The results of testing demonstrated that the subject lubricant is biocompatible.
Shelf-Life	2 years at specified properties	Met device specifications at 0, 1, and 2 years during real-time and accelerated aging study. (Reported as "The subject device met the device specifications at all time points.")
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms	Compatible with natural rubber latex and polyisoprene condoms. (Reported as "The results of this test indicated that JO H2O Jelly Original Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms.")
Condom Compatibility	Incompatible with polyurethane condoms	Not compatible with polyurethane condoms. (Reported as "This device is not compatible with polyurethane condoms.")

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe the kind of "test set" or "data provenance" that would apply to an AI/ML device. The testing described is laboratory-based performance testing of the physical product. No geographic data provenance is mentioned. The studies (biocompatibility, shelf-life, condom compatibility) are prospective tests performed on the manufactured product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable to this type of device submission. Ground truth is established by standard laboratory testing methods (e.g., USP <51>, ASTM D7661-10) rather than expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable to this type of device submission.

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 physical lubricant, not an AI-based diagnostic or assistive device.

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

Not applicable; this is a physical lubricant, not an AI algorithm.

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

The "ground truth" for this product is based on established laboratory standards and test methods for material properties, sterility, biocompatibility, and compatibility with other medical devices (condoms). Examples include:
- USP <51> for antimicrobial effectiveness
- USP <61> and <1111> for microbial counts
- USP <62> for pathogen presence
- ISO 10993 series for biocompatibility (e.g., Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity)
- ASTM D7661-10 for condom compatibility

8. The sample size for the training set

Not applicable; this is a physical lubricant, not an AI algorithm.

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

Not applicable; this is a physical lubricant, not an AI algorithm.

In summary, the provided document describes the safety and effectiveness testing of a personal lubricant, focusing on its physical properties, biocompatibility, and compatibility with condoms, rather than the performance of an AI/ML medical device.

Summary

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April 17, 2019

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

Re: K183584

Trade/Device Name: JO H2O Jelly Original Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 15, 2019 Received: March 18, 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 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/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,

Jason Roberts -S 2019.04.17 15:32:11 -04'00'

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) K183584

Device Name JO H2O Jelly Original Personal Lubricant

Indications for Use (Describe)

polyisoprene condoms. This product is not compatible with polyurethane condoms.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510 (k) Summary - K183584

1. Submitter Information

Applicant:	United Consortium
Contact:	Stephanie Morris
	Global Regulatory Specialist

Bruce Albert Head of Technical Services Address: 29000 N. Hancock Parkway Valencia. CA 91355 Phone: (661) 295-1700, ext. 232 Phone: (661) 295-1700, ext. 231 FAX: (661) 295-1800

2. Correspondent Information

Contact:	Stephanie Morris
Address:	29000 N. Hancock ParkwayValencia, CA 91355
Phone:	(661) 295-1700, ext. 232
Fax:	(661) 295-1800
Email:	smorris@systemjo.com

3. Date prepared: April 16, 2019

4. Device Information

Device Name:	JO H2O 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:	JO Agapé Personal Lubricant
510(k) Number:	K171021
Manufacturer:	United Consortium
Regulatory Class:	Class II
Product Code:	NUC (lubricant, personal)

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

6. Device Description

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Property	Specification
Appearance	Viscous gel
Color	Clear, water white
Odor	Odorless
Viscosity (cps)	15,500 cps to 35,000 cps
pH	4.00 to 5.00
Specific Gravity	1.000 to 1.200
Osmolality	1050 to 1250 mOsm/kg
Antimicrobial effectiveness per USP <51>	Meets US <51> acceptance criteria forCategory 2 products
Total aerobic microbial count (TAMC) perUSP <61> and <1111>	Less than 10 cfu/g
Total yeast and mold count (TYMC) perUSP <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 H2O Jelly Original Personal Lubricant

7. Indications for Use

1. 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 H2O Jelly Original Personal Lubricant and Predicate Device JO Agapé Personal Lubricant

Feature	JO H2O Jelly OriginalPersonal Lubricant	JO Agapé PersonalLubricant (K171021)
Device ClassificationName	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC

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Feature	JO H2O Jelly OriginalPersonal Lubricant	JO Agapé PersonalLubricant (K171021)
Indications for Use	JO H2O Jelly Original PersonalLubricant 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.This product is not compatiblewith polyurethane condoms.	JO Agapé Personal Lubricant isa water-based personallubricant for penile and/orvaginal application, intended tolubricate and moisturize, toenhance theease and comfort of intimatesexual activity and supplementthe body's natural lubrication.This product is compatible withnatural rubber latex andpolyisoprene condoms. Thisproduct isnot compatible withpolyurethane condoms.
Water soluble	Yes	Yes
Contains water	Yes	Yes
Primary ingredients	Glycerine USP, Natrosol 250HHX, Aqualon SodiumCarboxymethyl Cellulose 7H35F, Water (Aqua), Norsene100, Sodium Benzoate,Potassium Sorbate, PREMIXCitricAcid 50% Blend	Propanedile,Hydroxyethylcellulose,Water (Aqua),Gluconolactone, SodiumBenzoate, Citric Acid
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Natural Rubber Latex,Polyisoprene	Natural RubberLatex, Polyisoprene
Biocompatibility Tested	Yes	Yes
Antimicrobial Tested	Yes	Yes
Shelf life	2 years	3 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:

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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 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 H2O Jelly Original Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms.

10. Conclusion

The results of the performance testing described above demonstrate that the JO H2O Jelly Original 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.