JO Actively Trying Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

Device Description

JO Actively Trying Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This device is a non-sterile personal 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. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles are capped with silver disc top caps. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Propylene Glycol, Hydroxyethylcellose, Fructose, Arabinogalactan, Sodium Phosphate, Salt, Potassium Phosphate, Methylparaben.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the JO Actively Trying Personal Lubricant, based on the provided FDA 510(k) summary:

This device is a personal lubricant, and the studies performed are primarily non-clinical laboratory tests to demonstrate its safety, effectiveness, and compatibility for its intended use, rather than clinical studies in humans. Therefore, many of the typical categories for AI/medical device clinical studies (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria (Specification)	Reported Device Performance
Appearance	Clear, semi-viscous liquid	Clear, semi-viscous liquid
Color	Clear	Clear
Odor	Odorless	Odorless
Viscosity (cps)	6,500 cps to 12,000 cps	Met specifications
pH	7.25 to 7.80	Met specifications (compared to predicate pH 7.2 - 7.6)
Specific Gravity	0.900 to 1.000	Met specifications
Osmolality	800 to 1,000 mOsm/kg	Met specifications (compared to predicate 220 - 400 mOsm/kg)
Human Sperm Survival Assay (HSSA)	After exposure to 10% JO Actively Trying for 30 minutes, ≥ 80% of the control.	Passed (indicating compatibility with sperm, oocytes and embryos)
Limulus Amebocyte Lysate (LAL) Gel-Clot Method	<0.7 EU/mL	<0.7 EU/mL
Lubricant Barrier Assay	PASS	PASS
Antimicrobial effectiveness per USP <51>	Meets US <51> acceptance criteria for Category 2 products	Meets US <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
Presence of Pathogens per USP <62> (Staphylococcus aureus)	Absent	Absent
Presence of Pathogens per USP <62> (Salmonella/Shigella)	Absent	Absent
Presence of Pathogens per USP <62> (Escherichia coli)	Absent	Absent
Presence of Pathogens per USP <62> (Candida albicans)	Absent	Absent
Biocompatibility	Passed specific ISO 10993 tests	Passed (demonstrated biocompatibility, and compatibility with sperm, oocytes, and embryos)
Condom Compatibility	Compatible with natural rubber latex, polyurethane, and polyisoprene condoms	Compatible with natural rubber latex, polyurethane, and polyisoprene condoms
Shelf-life	2 years	Met device specifications at 0, 1, and 2 years based on real-time and accelerated aging study.

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

Not applicable in the context of a typical AI/ML clinical test set. The studies performed are non-clinical laboratory tests on the product itself.
For tests like HSSA, LAL, antimicrobial, and pathogen tests, the "sample size" would refer to the number of lubricant product samples tested, biological reagents used, or microbial cultures, which are not specified in this summary. The data provenance is from laboratory tests conducted presumably by or for the manufacturer.

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

Not applicable. This summary does not describe a study involving human experts establishing ground truth for a test set in the way it would for an AI diagnostic device. The "ground truth" for the lubricant's properties (e.g., pH, viscosity, sperm survival, microbial counts) is established by adherence to recognized laboratory standards and methods.

4. Adjudication method for the test set

Not applicable. No adjudication method is described as this is not a study requiring human interpretation or consensus.

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 product (personal lubricant), not an AI-based diagnostic or assistive device that would involve human readers or cases.

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

Not applicable. This is a physical product, not an algorithm.

7. The type of ground truth used

The "ground truth" for this product is based on objective measurements, quantitative laboratory assays, and adherence to established industry and regulatory standards as defined by:
- Device specifications (e.g., pH, viscosity, osmolality).
- Standardized microbiological tests (e.g., USP <51>, <61>, <62>, <1111>).
- Biocompatibility standards (e.g., ISO 10993 series).
- Specific performance assays (Human Sperm Survival Assay, Limulus Amebocyte Lysate Gel-Clot Method, Lubricant Barrier Assay, Condom Compatibility per ASTM D7661-10).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" for this type of product.

Summary

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April 26, 2019

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

Re: K182585

Trade/Device Name: JO Actively Trying Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated: March 22, 2019 Received: March 25, 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

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) K182585

Device Name JO Actively Trying Personal Lubricant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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 - K182585

1. Submitter Information

Applicant:	United Consortium
Contact:	Stephanie Morris
	Global Regulatory Specialist

	Bruce Albert
	Head of Technical Services
Address:	29000 N. Hancock Parkway Valencia, CA91355
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 Parkway Valencia, CA91355
Phone:	(661) 295-1700, ext. 232
Fax:	(661) 295-1800
Email:	smorris@systemjo.com

3. Date prepared: April 24, 2019

4. Device Information

Device Name:	JO Actively Trying Personal Lubricant
Common Name:	Personal Lubricant
Regulation Number:	21 CFR 884.5300
Regulation Name:	Condom
Regulatory Class:	Class II
Product Code:	PEB (lubricant, personal, gamete, fertilization and embryo compatible)

5. Predicate Device Information

Device Name:	Astroglide TTC Fertility Friendly Personal Lubricant
510(k) Number:	K141132
Manufacturer:	Biofilm, Inc.
Regulatory Class:	Class II
Product Code:	PEB (lubricant, personal, gamete, fertilization, and embryo compatible)

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

6. Device Description

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This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles are capped with silver disc top caps. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Propylene Glycol, Hydroxyethylcellose, Fructose, Arabinogalactan, Sodium Phosphate, Salt, Potassium Phosphate, Methylparaben. The device specifications are listed in the table below:

Property	Specification
Appearance	Clear, semi-viscous liquid
Color	Clear
Odor	Odorless
Viscosity (cps)	6,500 cps to 12,000 cps
pH	7.25 to 7.80
Specific Gravity	0.900 to 1.000
Osmolality	800 to 1,000 mOsm/kg
Human Sperm Survival Assay (HSSA)	After exposure to 10% JO Actively Trying for30 minutes, ≥ 80% of the control.
Limulus Amebocyte Lysate (LAL) Gel-ClotMethod	<0.7 EU/mL
Lubricant Barrier Assay	PASS
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 Actively Trving Personal Lubricant

7. Indications for Use

JO Actively Trying Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

8. 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.

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Table 2: Comparator Table for Subject Device – JO Actively Trying Personal Lubricant and Predicate Device Astroglide TTC Fertility Friendly Personal Lubricant

Feature	JO Actively TryingPersonal Lubricant	Astroglide TTC FertilityFriendly PersonalLubricant (K141132)
Device ClassificationName	Lubricant, Personal, Gamete,Fertilization, and EmbryoCompatible	Lubricant, Personal, Gamete,Fertilization, and EmbryoCompatible
Product Code	PEB	PEB
Indications for Use	JO Actively Trying PersonalLubricant is a personallubricant, for penile and/orvaginal application, intended tomoisturize and lubricate, toenhance the ease and comfortof sexual activity andsupplement the body's naturallubrication. This product iscompatible with sperm, oocytesand embryos and can be usedby couples trying to conceive.This product is compatible withnatural rubber latex,polyurethane and polyisoprenecondoms.	Astroglide TTC 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. Astroglide® TTC iscompatible with sperm, oocytes,and embryos and can be used bycouples trying to conceive.Astroglide® TTC is compatiblewith natural rubber latex,polyisoprene and polyurethanecondoms.
Water soluble	Yes	Yes
Contains water	Yes	Yes
Primary ingredients	Water (Aqua), Propylene Glycol,Hydroxyethylcellose, Fructose,Arabinogalactan, SodiumPhosphate, Salt, PotassiumPhosphate, Methylparaben,Propylparaben	Water, Propylene Glycol,Hydroxyethylcellulose,Fructose, Methylparaben,Sodium Phosphate, PotassiumPhosphate, Propyl Paraben,Galactose, Sodium Hydroxide
pH	7.25 - 7.80	7.2 - 7.6
Osmolarity	800 - 1000 mOsm/kg	220 - 400 mOsm/kg
Human Sperm SurvivalAssay (HSSA)	After exposure to 10% JOActively Trying for 30 minutes,> 80% of the control.	After exposure to 10% TTCfor 2hours, ≥80% of the control.
Limulus AmebocyteLysate (LAL) Gel-ClotMethod	<0.7 EU/mL	<0.7 EU/mL
Feature	JO Actively Trying Personal Lubricant	Astroglide TTC Fertility Friendly Personal Lubricant (K141132)
Lubricant Barrier Assay	Pass	Unavailable
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Natural Rubber Latex, Polyisoprene and Polyurethane	Natural Rubber, Latex, Polyisoprene and Polyurethane
Biocompatibility Tested	Yes	Yes
Antimicrobial Tested	Yes	Yes
Shelf life	2 years	8 months

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The subject and predicate device have the same indications for use. 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:

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.

The following additional biocompatibility testing was performed on the proposed device, JO Actively Trying Personal Lubricant:

Human Sperm Survival
Limulus Amebocyte Lysate (LAL) Gel-Clot Method ●
Lubricant Barrier Assay

The subject lubricant received passing scores for all of these tests, indicating that it is compatible with sperm, oocytes and embryos.

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 Actively

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Trying Personal Lubricant is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

10. Conclusion

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