JO Gelato Flavored Personal Lubricants by United Consortium

JO Gelato Flavored Personal Lubricants are water-based personal lubricants 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, polyurethane and polyisoprene condoms.

Device Description

JO Gelato Flavored Personal Lubricants are clear, semi-viscous personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. The device is a non-sterile lubricant for penile 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. The product is provided in Polyethylene Terephthalate (PET) bottles fitted with Polypropylene caps or foil sachets. The individual bottles are sealed using an induction seal constructed of aluminized mylar.

AI/ML Overview

The provided document describes the safety and effectiveness testing for "JO Gelato Flavored Personal Lubricants." However, this document is a 510(k) summary for a medical device (personal lubricant), not an AI/ML powered device. As such, the specific criteria requested for AI/ML devices (such as effect size of AI assistance, number of experts, adjudication methods, ground truth types for training) are not applicable to the information provided.

I can provide the acceptance criteria and the study descriptions for the device itself as presented in the document.

Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria	Reported Device Performance and Study
Physical/Chemical Specifications
Appearance	Clear, semi-viscous liquid	Met during shelf-life testing at 0, 1, and 2 years.
Color	Clear	Met during shelf-life testing at 0, 1, and 2 years.
Odor	Sweet/Characteristic	Met during shelf-life testing at 0, 1, and 2 years.
Viscosity (cps)	2000 cps to 3700 cps	Met during shelf-life testing at 0, 1, and 2 years.
Specific Gravity	0.900 to 1.050	Met during shelf-life testing at 0, 1, and 2 years.
pH	5.0 to 6.0	Met during shelf-life testing at 0, 1, and 2 years.
Osmolality	1350 to 1550 mOsm/kg	Met during shelf-life testing at 0, 1, and 2 years.
Antimicrobial Effectiveness	Meets USP <51> acceptance criteria for Category 2 products	Met. Tested per USP <51>.
Microbial Counts
Total aerobic microbial count (TAMC) per USP <61> and <1111>	Less than 10 cfu/g	Met. Tested per USP <61> and <1111>.
Total yeast and mold count (TYMC) per USP <61> and <1111>	Less than 10 cfu/g	Met. Tested per USP <61> and <1111>.
Presence of Pathogens per USP <62>	Absent (Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella, Escherichia coli, Candida albicans)	Met. Tested per USP <62>.
Biocompatibility	Lubricant is biocompatible	Demonstrated through independent third-party laboratory studies including: Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity, and Sensitization testing. Performed in accordance with 2016 FDA guidance document Use of International Standard ISO 10993-1 and ISO 10993-1:2009 for Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Vaginal Irritation (ISO 10993-10:2010), Penile Irritation (ISO 10993-10:2010), and Acute Systemic Toxicity (ISO 10993-11:2006).
Shelf-Life	Two-year shelf-life with specifications maintained	Demonstrated through a real-time and accelerated aging study. All device specifications (listed in Table 1) were tested at 0, 1, and 2 years for both PET bottles and foil sachets packaging. The device met specifications at all time points.
Condom Compatibility	Compatible with natural rubber latex, polyisoprene, and polyurethane condoms	Demonstrated through testing in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results indicated compatibility with all three types of condoms.

Due to the nature of this submission being for a personal lubricant and not an AI/ML medical device, the following specific questions are either not applicable or cannot be answered from the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a non-AI/ML device. Biocompatibility tests use animal models (e.g., rabbits, guinea pigs). Shelf-life and condom compatibility tests use samples of the product. Specific sample sizes are not explicitly mentioned but are inherent to the cited ASTM and ISO standards.
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. "Ground truth" in the context of AI/ML is not relevant here. The evaluation is based on scientific standards and laboratory testing by independent third-party laboratories.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Evaluation is based on meeting pre-defined scientific and regulatory specifications.
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 not an AI-powered device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML sense. "Ground truth" for this device comes from established scientific and regulatory standards (e.g., USP monographs, ISO standards, ASTM standards) and direct measurement of physical, chemical, and biological properties.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

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October 31, 2017

United Consortium Stephanie Morris RA/QA Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355

Re: K172447

Trade/Device Name: JO Gelato Flavored Personal Lubricants Regulation Number: 21 CFR$ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 10, 2017 Received: August 14, 2017

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. 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); 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Benjamin R. Fisher -S

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)

K172447

Device Name JO Gelato Flavored Personal Lubricants

Indications for Use (Describe)

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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K172447 - 510(k) Summary

510(k) Owner:	United Consortium
Street Address:	29000 Hancock ParkwayValencia, CA 91355
Establishment Registration Number:	3005691625
Contact Person:	Stephanie MorrisRA/QA SpecialistBruce AlbertHead of Technical Services
Contact Numbers:	Phone: (661) 295-1700, ext. 232Phone: (661) 295-1700, ext. 231FAX: (661) 295-1800
Summary Preparation Date:	October 27, 2017
Trade Name:	JO Gelato Flavored Personal LubricantsJO Gelato Salted Caramel Personal LubricantJO Gelato Crème Brulee Personal LubricantJO Gelato Hazelnut Espresso Personal LubricantJO Gelato Mint Chocolate Personal LubricantJO Gelato Tiramisu Personal Lubricant
Common Name:	Personal Lubricant
Device Classification:	Classification Name: CondomProduct Code: NUC (lubricant, personal)Regulation: 21 CFR § 884.5300 (Condom)Device Class: Class II
Predicate Device:	Product Name: Astroglide Sensual Strawberry510(k) Number: K140590Manufacturer: BioFilm, Inc.Product Code: NUCDevice Class: Class II

The predicate device has not been subject to a designrelated recall.

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Device Description:

The device specifications are listed in the table below:

Table 1: Device Specifications for JO Gelato Flavored Personal Lubricants

Property	Specification
Appearance	Clear, semi-viscous liquid
Color	Clear
Odor	Sweet/Characteristic
Viscosity (cps)	2000 cps to 3700 cps
Specific Gravity	0.900 to 1.050
pH	5.0 to 6.0
Osmolality	1350 to 1550 mOsm/kg
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>	Specification
Pseudomonas aeruginosa	Absent
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Candida albicans	Absent

Indications for Use:

Predicate Device Comparison:

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

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Feature	JO Gelato Flavored Personal Lubricants	Astroglide Sensual Strawberry(K140590)
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC
Intended Use	JO Gelato Flavored Personal Lubricantsare water-based personal lubricants forpenile and/or vaginal application,intended to lubricate and moisturize, toenhance the ease and comfort ofintimate sexual activity and supplementthe body's natural lubrication. Thisproduct is compatible with naturalrubber latex, polyurethane andpolyisoprene condoms.	The BioFilm, Inc. AstroglideSensual Strawberry is a personallubricant for penile and/orvaginal application, intended tomoisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubberlatex, polyisoprene andpolyurethane condoms.
Water soluble	Yes	Yes
Contains water	Yes	Yes
Primary ingredients	Water (Aqua), Glycerin, PotassiumSorbate, Hydroxyethylcellulose, Flavor(Aroma), Sodium Chloride, Sucralose,Citric Acid	Water (Aqua), Glycerin,Propylene Glycol,Hydroxyethylcellulose, Naturaland Artificial Strawberry Flavor,Sodium Gluconate, SodiumSaccharin, Methylparaben,Sodium Benzoate, Citric Acid
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Latex, Polyisoprene, Polyurethane	Latex, Polyisoprene,Polyurethane
Biocompatibility Tested	Yes	Yes
Antimicrobial Tested	Yes	Yes

Table 2: Comparator Table for Subject Device – JO Gelato Flavored Personal Lubricants and Predicate Device Astroglide Sensual Strawherry

The subject and predicate device have the same intended use - 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. The subject and predicate device have different technological characteristics, including different formulation. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions. All personal lubricants must independently demonstrate they are biocompatible, compatible with condoms, and can maintain their specifications for their expected shelf life.

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Summary of Performance Data:

Biocompatibility

Independent third-party laboratories conducted the biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing; each were performed in accordance with 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 Agarose Overlay Method, ISO 10993-5:2009) ●
Sensitization (ISO Guinea Pig Maximization Sensitization, ISO 10993-10:2010) ●
Vaginal Irritation (ISO Vaginal Irritation Study in Rabbits, ISO 10993-10:2010)
Penile Irritation (ISO Penile Irritation Study in Rabbits, ISO 10993-10:2010)
Acute Systemic Toxicity (ISO Tests for Systemic Toxicity, ISO 10993-11:2006)

The results of this testing demonstrated that the subject lubricant is biocompatible.

Shelf-Life:

The proposed device, JO Gelato Flavored Personal Lubricant, 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. In addition, both versions of the device packaging were evaluated. The subject device in both versions of its packaging met the device specifications at all time points.

Condom Compatibility:

The compatibility of the subject device, JO Gelato Personal Lubricant, was evaluated with natural rubber latex, polyisoprene and polyurethane condoms 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 indicate that the JO Gelato Flavored Personal Lubricants are compatible with natural rubber latex, polyurethane and polyisoprene condoms.

Conclusion:

The results of the performance testing described above demonstrate that the JO Gelato Flavored Personal Lubricants are 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.