Silicone Personal Lubricant is a silicone-based personal lubricant for 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.

ALL-IN-ONE is a silicone-based 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, polyurethane and polyisoprene condoms.

Device Description

Silicone Personal Lubricant and ALL-IN-ONE are clear, semi-viscous personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. The devices are non-sterile personal lubricants 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.

These products are provided in Polyethylene Terephthalate (PET) bottles capped with natural polypropylene disc top dispenser caps. The individual bottles are hermetically sealed during the production process. There is also 16 fl. oz./480 mL bottle with a different configuration for the Silicone Personal Lubricant. This consists of a clear Polyethylene Terephthalate (PET) bottle with a polypropylene lotion pump instead of the disc top dispenser used in all other sizes. This bottle is configured with a shrink wrap seal. These products are also available in polyester-faced laminated pouches.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: "Silicone Personal Lubricant, ALL-IN-ONE." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

The document does not describe an AI/ML-driven medical device, nor does it detail a study involving human readers, ground truth establishment by experts, or MRMC comparative effectiveness. The "acceptance criteria" discussed are for the physical and chemical properties of a personal lubricant, and the "study" involves laboratory testing to confirm these properties and biocompatibility.

Therefore, I cannot extract the information required to answer your questions regarding a device that uses AI/ML, human readers, or expert-established ground truth. The document describes a traditional medical device (a lubricant) and its physical, chemical, and biological testing for substantial equivalence.

Here's an analysis based on the document related to the lubricant's acceptance criteria and performance, as much as possible given the focus of the original request on AI/ML devices:

1. A table of acceptance criteria and the reported device performance:

The document describes the device specifications as performance criteria.

Property	Specification	Reported Device Performance (Implied from "met the device specifications")
Appearance	Clear, semi-viscous liquid	Clear, semi-viscous liquid
Color	Clear	Clear
Odor	Odorless	Odorless
Viscosity (cps)	800 cps to 1075 cps	Within 800 cps to 1075 cps range
Specific Gravity	0.850 to 1.020	Within 0.850 to 1.020 range
Antimicrobial effectiveness per USP <51>	Meets US <51> acceptance criteria for Category 2 products	Met USP <51> criteria
Total aerobic microbial count (TAMC) per USP <61> and <1111>	Less than 10 cfu/g	Less than 10 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	Absent	Absent
- Escherichia coli	Absent	Absent
- Candida albicans	Absent	Absent
Biocompatibility	Non-cytotoxic, non-irritating, non-sensitizing	Demonstrated as non-cytotoxic, non-irritating, non-sensitizing
Shelf-Life	2 years (with specifications met at 0, 1, 2 years)	Met specifications at 0, 1, and 2 years
Condom Compatibility	Compatible with natural rubber latex, polyurethane and polyisoprene condoms	Demonstrated compatibility with these condom types

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

Test set sample size: Not explicitly stated in terms of number of units or batches, but testing was performed according to Pharmacopeial standards (USP) and ISO standards. These standards typically specify the number of samples to be tested.
Data Provenance: Not specified in terms of country of origin. The studies appear to be laboratory-based (e.g., in vitro, animal irritation studies as per ISO 10993). The document states "real time and accelerated aging study" for shelf-life, which implies prospective testing.

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

This is not applicable as the studies are for a physical/chemical product, not an AI/ML device requiring human expert annotation or ground truth based on medical imaging or diagnostic outcomes. Testing was performed according to established international standards (ISO, ASTM, USP).

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

Not applicable. The "tests" are laboratory-based, objective measurements and biological assessments against predefined criteria. There is no human subjective assessment or adjudication process described as would be for an AI/ML system.

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 device is a personal lubricant, not an AI/ML diagnostic tool. No human reader study was conducted.

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

Not applicable. This is not an algorithm. The "standalone performance" refers to the lubricant's intrinsic properties as measured in a lab.

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

The "ground truth" for this device's performance is based on:

Established physical/chemical specifications (e.g., viscosity, specific gravity, appearance, odor).
Microbiological absence/presence thresholds per USP <61>,<62>,<1111>.
Biocompatibility criteria defined by ISO 10993 standards (e.g., lack of cytotoxicity, irritation, sensitization).
Condom compatibility per ASTM D7661-10.

These are objective, quantitative or qualitative laboratory results against predefined standards, not expert consensus on medical images or diagnostic outcomes.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable, as there is no training set for an AI/ML model.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out to the right of it.

April 9, 2018

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

Re: K180083

Trade/Device Name: Silicone Personal Lubricant, ALL-IN-ONE Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 9, 2018 Received: January 11, 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. 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.

{1}------------------------------------------------

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.

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.

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,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and is set against a white background. The letters are clearly legible, and the name is presented in a straightforward manner.

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K180083

Device Name Silicone Personal Lubricant ALL-IN-ONE

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter "U" in blue, with a gray shape behind it that suggests a second "U" or a curved line. Below the symbol, the words "UNITED CONSORTIUM" are written in a simple, sans-serif font, with "UNITED" stacked above "CONSORTIUM".

K180083 - Silicone Personal Lubricant, ALL-IN-ONE Traditional Submission

510(k) Summary

510(k) Owner:

Street Address:

United Consortium

3005691625

29000 N. Hancock Parkway Valencia, CA 91355

Establishment Registration Number:

Contact Person:

Stephanie Morris Regulatory Specialist

Bruce Albert Head of Technical Services

Contact Numbers:

Phone: (661) 295-1700, ext. 232 Phone: (661) 295-1700, ext. 231 FAX: (661) 295-1800

Summary Preparation Date:

Trade Names:

ALL-IN-ONE

April 6, 2017

Common Name:

Personal Lubricant

Silicone Personal Lubricant

Device Classification:	Common Name:	Personal Lubricant
	Classification Name:	Condom
	Classification Number:	21 CFR § 884.5300
	Product Code:Device Class:	NUC (lubricant, personal)Class II
Predicate Device:	Product Name:510(k) Number:Manufacturer:Product Code:Device Class:	JO Premium Personal LubricantK132954United ConsortiumNUCClass II

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

{4}------------------------------------------------

K180083 Page 2 of 5

Device Description:

Property	Specification
Appearance	Clear, semi-viscous liquid
Color	Clear
Odor	Odorless
Viscosity (cps)	800 cps to 1075 cps
Specific Gravity	0.850 to 1.020
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

Table 1: Device Specifications for Silicone Personal Lubricant and ALL-IN-ONE
-------------------------------------------------------------------------------	--	--	--	--	--

Indications for Use:

Silicone Personal Lubricant is a silicone-based 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, polyurethane and polyisoprene condoms.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for United Consortium. The logo features a stylized letter "U" in blue, with a gray ribbon-like element wrapping around the top portion of the "U". Below the symbol, the words "UNITED CONSORTIUM" are written in a simple, sans-serif font.

Predicate Device Comparison:

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

Feature	Silicone Personal Lubricant and ALL-IN-ONE	JO Premium Personal Lubricant(K132954)
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC
Intended Use	Silicone Personal Lubricant is asilicone-based personal lubricant forpenile, anal and/or vaginalapplication, intended to lubricateand moisturize, to enhance the easeand comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product iscompatible with natural rubberlatex, polyurethane andpolyisoprene condoms.ALL-IN-ONE is a silicone-basedpersonal lubricant for penile, analand/or vaginal application, intendedto lubricate and moisturize, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubberlatex, polyurethane andpolyisoprene condoms.	JO Premium Personal Lubricant is asilicone-based personal lubricant forpenile and/or vaginal application,intended to lubricate and moisturize,to enhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubber latexand polyisoprene condoms. Thisproduct is not compatible withpolyurethane condoms.
Water soluble	No	No
Contains water	No	No
Primary ingredients	Dimethicone, Dimethiconol	Dimethicone, Cyclopentasiloxane,Cyclotetrasiloxane, Dimethiconol

Table 2: Comparator Table for Subject Devices – Silicone Personal Lubricant and ALL-IN-ONE and Predicate Device JO Premium Personal Lubricant

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter "U" in two shades. The left side of the "U" is a dark blue color, while the right side is a light gray color. Below the "U" is the text "UNITED CONSORTIUM" in a smaller font size.

Feature	Silicone Personal Lubricant and ALL-IN-ONE	JO Premium Personal Lubricant(K132954)
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Natural Rubber Latex, Polyisoprene,Polyurethane	Natural Rubber Latex, Polyurethane
Biocompatibility Tested	Yes	Yes
Antimicrobial Tested	Yes	Yes
Shelf life	2 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 devices have similar technological characteristics including similar formulation. The different technological characteristics of the subject devices do not raise different types of safety and effectiveness questions.

Summary of Performance Data:

Biocompatibility:

Biocompatibility studies, including Acute Systemic Toxicity testing, Vaginal Irritation testing, Penile Irritation testing, Cytotoxicity and Sensitization testing were performed in accordance with the 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 lubricants are non-cytotoxic, non-irritating, and non-sensitizing.

Shelf-Life:

The subject devices are non-sterile personal lubricants 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 devices met the device specifications at all time points.

Condom Compatibility:

The compatibility of the subject devices 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 the Silicone Personal

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' in two shades of gray. The lower part of the 'U' is a darker gray, while the upper part is a lighter gray, creating a sense of depth. Below the 'U', the words 'UNITED CONSORTIUM' are written in a smaller, sans-serif font.

K180083 - Silicone Personal Lubricant, ALL-IN-ONE Traditional Submission

Lubricant and ALL-IN-ONE are compatible with natural rubber latex, polyurethane and polyisoprene condoms.

Conclusion:

The results of the performance testing described above demonstrate that the Silicone Personal Lubricant and ALL-IN-ONE are 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.