JO Agapé Personal Lubricant is a water-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.

Device Description

The JO Agapé Personal Lubricant is a clear, colorless, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. It is not compatible with polyurethane condoms. The device is a non-sterile lubricant for penile and/or vaginal application, 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 Terephthalate (PET) bottles fitted with Polypropylene caps. The individual bottles are sealed using an induction seal constructed of aluminized mylar.

AI/ML Overview

The provided document pertains to the 510(k) premarket notification for the JO Agapé Personal Lubricant. This is a Class II medical device (a personal lubricant) and the information presented primarily focuses on its physical and biological properties, as well as its compatibility with condoms, to establish substantial equivalence with a predicate device.

The questions regarding acceptance criteria and study design, training and test sets, expert involvement, and reader studies are typically applicable to AI/ML-driven diagnostic or medical imaging devices. This document describes a personal lubricant, which does not involve such AI components or diagnostic performance metrics. Therefore, many of the requested details are not applicable to this type of device.

However, I can extract the acceptance criteria and the information about the studies conducted to meet them as they relate to the properties of the lubricant.

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

Property	Acceptance Criteria (Specification)	Reported Device Performance (as stated in the document)
Device Specifications (Table 1)
Appearance	Clear, semi-viscous liquid	Met specification (implied, as the document states "The subject device met the device specifications at all time points" for shelf-life testing).
Color	Clear, colorless	Met specification (implied).
Odor	Odorless	Met specification (implied).
Viscosity (cps)	2400 cps to 3100 cps	Met specification (implied).
Specific Gravity	1.020 to 1.026	Met specification (implied).
pH	3.60 to 4.30	Met specification (implied).
Osmolality	250 to 350 mOsm/kg	Met specification (implied).
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products	"Meets USP <51> acceptance criteria for Category 2 products."
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."
- Candida albicans	Absent	"Absent."
Biocompatibility	Demonstrates biocompatibility per ISO 10993 standards	"The results of this testing demonstrated that the subject lubricant is biocompatible." (Studies included Cytotoxicity, Sensitization, Vaginal Irritation, Penile Irritation, Acute Systemic Toxicity).
Shelf-Life	Maintain all device specifications for 36 months	"The subject device met the device specifications at all time points" for a 36-month shelf-life, evaluated at 0, 1, 2, and 3 years in real-time and accelerated aging studies.
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms per ASTM D7661-10	"The results of this test indicate that the JO Agapé Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms." (Evaluated against ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms).

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

Sample Size: The document does not specify exact sample sizes for each test (e.g., number of lubricant units tested for viscosity, pH, etc., or number of condoms tested). It refers to the tests performed according to specific standards (e.g., USP, ISO, ASTM), which would implicitly define typical sample sizes for those methodologies.
Data Provenance: The studies were conducted by "independent third-party laboratories." The country of origin is not specified, but the use of international standards (ISO, USP, ASTM) suggests widely accepted scientific practices. The studies appear to be prospective in nature, as they involve testing the device against predefined specifications and standards.

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)

This question is not applicable. The device is a personal lubricant, not an AI/ML diagnostic. The "ground truth" for this device is defined by meeting physical, chemical, biological, and compatibility specifications outlined in recognized standards (e.g., USP, ISO, ASTM) and internal product specifications. There is no mention of human experts establishing ground truth in the context of diagnostic interpretation.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations in diagnostic studies, typically when establishing a ground truth for AI models. This type of device does not involve such expert adjudications. The results are based on objective laboratory measurements and standardized biological/chemical 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

This question is not applicable. MRMC studies are relevant for evaluating the performance of diagnostic imaging systems and AI-assisted interpretation, often involving multiple human readers. This device is a personal lubricant and does not involve human readers interpreting cases or AI assistance.

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

This question is not applicable. The device is a personal lubricant, which is a physical product, not an algorithm. Therefore, there is no "standalone" algorithm performance to evaluate.

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

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

Predetermined Specifications: Numerical ranges or qualitative descriptions for physical/chemical properties (viscosity, pH, osmolality, color, odor, appearance, specific gravity).
Regulatory Standards: Compliance with pharmacopeial standards for microbial limits and effectiveness (USP <51>, <61>, <62>, <1111>).
International Standards: Biocompatibility according to ISO 10993 standards and condom compatibility according to ASTM D7661-10.
Stability over Time: Maintaining the above specifications over a set shelf-life period.

These are established through objective laboratory testing, not human diagnostic interpretation.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML model and therefore does not have a "training set" in the context of machine learning. The "training" for the product development would involve chemical formulation and process optimization, but not AI model training with data sets.

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

This question is not applicable for the reasons stated above.

Summary

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

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 21, 2019

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

Re: K171021

Trade/Device Name: JO Agapé Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: June 29, 2017 Received: July 6, 2017

Dear Stephanie Morris:

This letter corrects our substantially equivalent letter of July 18, 2017.

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.

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

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Monica D. Garcia -S

Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K171021

Device Name

JO Agapé Personal Lubricant

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 with the letters 'U' and 'C' intertwined. The 'U' is purple and forms a curved shape, while the 'C' is gray and wraps around the top of the 'U'. Below the logo, the words 'UNITED CONSORTIUM' are written in small, sans-serif font.

510(k) Summary – K171021

510(k) Owner:	United Consortium
Street Address:	29000 Hancock ParkwayValencia, CA 91355
Establishment Registration Number:	3005691625
Contact Person:	Stephanie MorrisRA/QA Specialist
	Bruce AlbertHead of Technical Services
Contact Numbers:	Phone: (661) 295-1700, ext. 232Phone: (661) 295-1700, ext. 231FAX: (661) 295-1800
Summary Preparation Date:	July 18, 2017
Trade Name:	JO Agapé 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: Wet Original® Personal Lubricant510(k) Number: K160211Manufacturer: Trigg Laboratories, Inc.Product Code: NUCDevice Class: Class II

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

Image /page/4/Picture/0 description: The image features a stylized logo consisting of two overlapping shapes. The primary shape is a thick, curved line in a dark purple or blue hue, forming a 'U' or 'C' shape. Overlapping the top portion of this shape is a gray, curved element that adds depth and dimension to the logo. Below the logo, the words 'UNITED CONSORTIUM' are printed in a simple, sans-serif font, indicating that this is the symbol for a united group or organization.

Device Description:

The device specifications are listed in the table below:

Property	Specification
Appearance	Clear, semi-viscous liquid
Color	Clear, colorless
Odor	Odorless
Viscosity (cps)	2400 cps to 3100 cps
Specific Gravity	1.020 to 1.026
pH	3.60 to 4.30
Osmolality	250 to 350 mOsm/kg
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products
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
Candida albicans	Absent

Table 1: Device Specifications for JO Agapé Personal Lubricant

Indications for Use:

Predicate Device Comparison:

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

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

Image /page/5/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' formed by two curved lines. The left side of the 'U' is a dark purple color, while the top part is gray. Below the symbol, the words 'UNITED CONSORTIUM' are written in small, sans-serif font.

Table 2: Comparator Table for Subject Device – JO Agapé Personal Lubricant and Predicate Device Wet Original® Personal Lubricant

Feature	JO Agapé Personal Lubricant (K171021)	Wet Original® Personal Lubricant(K160211)
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC
Intended Use	JO Agapé Personal Lubricant is a water-based personal lubricant for penileand/or vaginal application, intended tolubricate and moisturize, to enhance theease and comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product iscompatible with natural rubber latex andpolyisoprene condoms. This product isnot compatible with polyurethanecondoms.	The Trigg Laboratories WetOriginal® Personal Lubricant is apersonal lubricant 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	Propanedile, hydroxyethylcellulose,water, gluconolactone, sodium benzoate,citric acid	Glycerin, water, pentylene glycol,potassium sorbate, sodiumcarboxymethylcellulose
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Latex, Polyisoprene	Latex, Polyisoprene, Polyurethane
Biocompatibility Tested	Yes	Yes
Antimicrobial Tested	Yes	Yes
Shelf life	3 years	2 years

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 and shelf life. 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.

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

Image /page/6/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter "U" formed by two overlapping shapes. The lower shape is a dark purple color, while the upper shape is gray. Below the shape is the text "UNITED CONSORTIUM" in a simple sans-serif font. The logo has a clean and modern design.

Summary of Performance Data:

Biocompatibility

Independent third-party laboratories conducted biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Skin 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 Agapé Personal Lubricant, is a non-sterile personal lubricant with a 36-month (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, 2, 2, and 3 years. The subject device met the device specifications at all time points.

Condom Compatibility:

The compatibility of the subject device, JO Agapé 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 Agapé Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Conclusion:

The results of the performance testing described above demonstrate that the JO Agapé 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.