JO Premium Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, 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 Premium Personal Lubricant is a clear, colorless, semi-viscous silicone-based lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. The device is not compatible for use with polyurethane condoms. The device is a non-sterile lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is provided in Polyethylene (PET) bottles fitted with Polypropylene caps. The bottles are sealed using an induction seal constructed of aluminized mylar. There is a 16 fl. Oz./480 mL bottle with a different configuration. This consists of a clear Polyethylene (PET) bottle with a Polypropylene lotion pump. This bottle is also fitted with a shrink band.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "JO Premium Personal Lubricant." It details the device, its intended use, and various performance studies conducted to demonstrate its safety and effectiveness for substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds in a table format. However, it describes various tests performed and their outcomes, which serve as the implicit acceptance criteria for demonstrating safety and performance.

Test Property (Implicit Acceptance Criteria)	Reported Device Performance
Biocompatibility
Acute Systemic Toxicity (no biological reactivity)	All test group animals survived and exhibited no biological reactivity.
Vaginal Irritation (non-irritant or minimal irritant)	Considered a minimal irritant.
Cytotoxicity (non-cytotoxic)	Not considered to have a cytotoxic effect.
Sensitization (no sensitization reactions)	Did not elicit sensitization reactions.
Shelf Life
Shelf Life Duration (e.g., 3 years demonstrated)	Three-year shelf life based on real-time aging study.
Condom Compatibility
Compatibility with Natural Rubber Latex Condoms	Compatible.
Compatibility with Polyisoprene Condoms	Compatible.
Compatibility with Polyurethane Condoms	Not compatible.
Preservation Effectiveness
Antimicrobial Effectiveness (maintains effectiveness through shelf life)	Preservative effective through the proposed three-year shelf life.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of an AI/algorithm-based device. Instead, it describes various laboratory and in-vivo animal studies.

Acute Systemic Toxicity: Performed on "mice." The exact number of mice is not specified but usually involves a control group and multiple test groups.
Vaginal Irritation Testing: Performed on animals (not specified, but often rabbits or other suitable models). The exact number is not specified.
Cytotoxicity: Performed using "cell culture." No specific sample size (number of replicates or cell lines) is mentioned.
Sensitization: Performed on "Guinea Pig," referring to the ISO Guinea Pig Maximization Test. The exact number of guinea pigs is not specified.
Shelf Life: "Real time aging study." No specific number of product samples or batches are stated.
Condom Compatibility: Tested with various condom types (natural rubber latex, polyisoprene, and polyurethane). No specific number of condoms tested or replicates are mentioned.
Preservative Effectiveness Testing: "Samples of JO Premium Personal Lubricant samples that have been aged for 1-year, 2-years, and 3-years." No specific number of samples or batches are mentioned.

Data Provenance: The studies were conducted by "Independent third-party laboratories." The country of origin of the data is not explicitly stated. The studies are prospective in nature, as they involve testing the actual product under controlled conditions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the device is a personal lubricant, not an AI/algorithm-based diagnostic or prognostic device requiring expert ground truth for interpretation of images or other data. The "ground truth" for the performance studies is based on standardized laboratory test methods and animal models (e.g., observing biological reactivity, irritation scores, cell viability, antimicrobial effectiveness).

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Standardized protocols were followed for each test, and results were interpreted according to the specific methodology (e.g., ISO, ASTM, USP standards).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable as the device is a personal lubricant and not an AI-assisted diagnostic or imaging device that would involve human readers or comparative effectiveness studies with human-in-the-loop performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable as the device is not an algorithm or AI. All performance studies described are "standalone" in the sense that they evaluate the product's inherent properties and performance against established standards.

7. Type of Ground Truth Used

The "ground truth" for the various studies is established based on:

Standardized Biological Endpoints: For biocompatibility tests (systemic toxicity, irritation, cytotoxicity, sensitization), the ground truth is determined by observing specific biological reactions in live animals or cell cultures, interpreted against established criteria outlined in ISO 10993 or ASTM F895-11.
Physical and Chemical Properties: For shelf life, condom compatibility, and preservative effectiveness, the ground truth is determined by laboratory measurements and observations based on recognized standards such as ASTM D7661-10 and USP 36-2013.

8. Sample Size for the Training Set

This information is not applicable as the device is not an AI/machine learning model that requires a training set. The performance studies evaluate the manufactured product's inherent characteristics.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Summary

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K132954 pg 1 of 4

510(k) Summary

510(k) Owner:		United Consortium
Street Address:		29000 Hancock ParkwayValencia, CA 91355
Contact Person:		Joe MendozaQuality Assurance Manager
Contact Numbers:		Phone: (661) 295-1700 ext. 209FAX: (661) 295-1800
Summary Preparation Date:		May 1, 2014
Trade Name:		JO Premium Personal Lubricant
Common Name:		Personal Lubricant
Device Classification:	Classification Name:Product Code:Regulation:Device Class:		CondomNUC (lubricant, personal)21 CFR § 884.5300Class II
Predicate Device:	Product Name:510(k) Number:Manufacturer:Product Code:Regulation:Device Class:		LifeStyles Luxe Premium Personal LubricantK122477Ansell Healthcare Products, LLCNUC21 CFR § 884.5300Class II

Device Description:

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K132954

pg 2 of 4

.... pump. This bottle is also fitted with a shrink band. The device specifications are listed in the table below:

Property
Appearance
Color
Odor
Viscosity (cps)
Specific Gravity
Total aerobic microbial count (TAMC)
Total yeast and mold count (TYMC)
Absence of Pathogens
Pseudomonas aeruginosa
Staphylococcus aureus.
Candida albicans

Indications for Use:

Summary of Technological Characteristics:

JO Premium Personal Lubricant contains ingredients that are similar to those used in the manufacture of the predicate device. The table below compares the technological characteristics of JO Premium Lubricant to the predicate device LifeStyles Luxe Premium Personal Lubricant.

Feature	JO Premium Personal Lubricant	LifeStyles Luxe Premium Personal Lubricant
Contains Dimethicone	Yes	Yes - Cyclomethicone is a
Contains Cyclopentasiloxane	Yes	mixture of Dimethicones, and
Contains Cyclotetrasiloxane	Yes	various chain length cyclicsiloxanes such asCyclopentasiloxane andCyclotetrasiloxane
Contains Dimethiconol	Yes	Yes
Over-the counter use	Yes	Yes
Condom Compatible	Yes	Yes
Sterile	No	No

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Summary of Performance Data

Independent third-party laboratories conducted the Biocompatibility studies including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity, and Sensitization were performed according to FDA recognized ASTM and ISO 10993 standards.

Acute Systemic Toxicity: This test evaluated the systemic response in mice after injection of the subject lubricant JO Premium Personal Lubricant. This test was conducted according to ISO 10993-11: 2006 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity. All test group animals survived the test period and none of the test group animals exhibited any biological reactivity at any of the tested time points.

Vaginal Irritation Testing: The potential of the subject lubricant JO Premium Personal Lubricant to produce irritation of the vaginal mucosal tissue was assessed according to ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization. Results of the testing indicate that the JO Premium Personal Lubricant was considered a minimal irritant.

Cytotoxicity: The cytotoxicity potential of the JO Premium Personal Lubricant was determined according ASTM F895-11 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity. Results of the test show that the subject lubricant JO Premium Personal Lubricant was not considered to have a cytotoxic effect.

Sensitization: The ISO Guinea Pig Maximization Test was performed on the subject device JO Premium Personal Lubricant to determine to what extent the subject lubricant has the potential to act as a contact sensitizer. This test was conducted according to ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization. The results of this study indicate that the JO Premium Personal Lubricant did not elicit sensitization reactions in the animals involved in the study.

Shelf Life: The subject device JO Premium Personal Lubricant has a three-year shelf life based on the results of a real time aging study.

Condom Compatibility: The compatibility of the subject device JO Premium Personal Lubricant was evaluated with natural rubber latex, polyisoprene, and polyurethane condoms per ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that the JO Premium Personal Lubricant is compatible with natural rubber latex and polyisoprene but not compatible with polyurethane.

Preservative Effectiveness Testing: Preservative Effectiveness testing according to the protocols outlined in USP 36-2013 Antimicrobial Effectiveness Testing <51> was conducted on samples of JO Premium Personal Lubricant samples that have been aged for 1-year, 2-years, and 3-years. All samples were aged in real time. Results from this study indicate that the

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K132954

pg 4 of 4

preservative is effective in exerting its antimicrobial effectiveness through the proposed threeyear shelf life of the product.

Conclusion:

JO Premium Personal Lubricant has the same intended use and basic technological characteristics as the predicate device. The JO Premium Personal Lubricant is substantially equivalent to its proposed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 11, 2014

United Consortium Craig May General Manager 29000 Hancock Parkway Valencia, CA 91355

K132954 · Re:

Trade/Device Name: JO Premium Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: May 9, 2014 Received: May 12, 2014

Dear Craig May:

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. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Craig May

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

Beniamin 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: K132954

Device Name: JO Premium Personal Lubricant

Indications for Use:

JO Premium Personal Lubricant is a silicone based personal lubricant for penile 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herber P. Lerne 2014.06.11 14:32

Page 1 of 1

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.