Actively Trying Personal Lubricant Unfragranced 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 and polvisoprene condoms. This product is not compatible with polyurethane condoms.

Device Description

Actively Trying Personal Lubricant Unfragranced is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. Actively Trying Personal Lubricant Unfragranced is sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Hydroxyethylcellulose, Sodium Chloride, Sodium Phosphate, Potassium Phosphate, Propylene Glycol, Chlorphenisen, Fructose and Arabinogalactan.

AI/ML Overview

This document describes the regulatory submission for the Actively Trying Personal Lubricant Unfragranced (K212705). The information provided focuses on the device's characteristics and the non-clinical performance testing conducted to demonstrate its safety and effectiveness.

Here’s a breakdown as requested:

1. Table of Acceptance Criteria and the Reported Device Performance

Property	Acceptance Criteria	Reported Device Performance
Appearance	Semi-viscous liquid	Semi-viscous liquid
Color	Clear	Clear
Odor	Odorless	Odorless
Viscosity (cps) per USP <911>	8,500 - 13,000	Within range (actual value not reported, but stated to meet)
pH per USP <971>	7.25 - 7.80	Within range (actual value not reported, but stated to meet)
Specific Gravity per USP <841>	0.900 - 1.100	Within range (actual value not reported, but stated to meet)
Osmolality per USP <785>	300 – 410 mOsm/kg	Within range (actual value not reported, but stated to meet)
Human Sperm Survival Assay (HSSA)	≥ 80% of control motility at 24 hours after 30 minutes exposure to 10% of subject lubricant	≥ 80% of control motility at 24 hours after 30 minutes exposure to 10% of subject lubricant (reported as "compatible with sperm and does not inhibit sperm motility")
Limulus Amebocyte Lysate (LAL) Gel-Clot Method	<0.5 EU/mL	<0.5 EU/mL
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 100 cfu/g	Less than 100 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>	Absent for Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella/Shigella, Escherichia coli, Candida albicans	Absent for all listed pathogens
Biocompatibility (Acute Systemic Toxicity)	Non-toxic	Non-systemically toxic
Biocompatibility (Vaginal Irritation)	Non-irritating	Non-irritating
Biocompatibility (Cytotoxicity)	Non-cytotoxic	(Implied non-cytotoxic, stated "results of this testing demonstrated that the subject lubricant is... nonsensitizing")
Biocompatibility (Sensitization)	Non-sensitizing	Non-sensitizing
Condom Compatibility (Natural Rubber Latex)	Compatible	Compatible
Condom Compatibility (Polyisoprene)	Compatible	Compatible
Condom Compatibility (Polyurethane)	Not compatible	Not compatible
Shelf Life (2 years)	Meets device specifications at all time points (0, 1, and 2 years)	Met device specifications at all time points

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

The document does not specify the exact sample sizes for each non-clinical test (e.g., number of animals for toxicity, number of sperm samples for HSSA). The data provenance is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective, but they are described as "non-clinical performance testing" and "real time aging study", implying prospective testing for the shelf life.

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

Not applicable. This is a non-clinical device that does not involve human readers or interpretation of medical images. Ground truth is established through laboratory test results against predefined scientific and regulatory standards (e.g., USP, ISO, ASTM).

4. Adjudication method for the test set

Not applicable. As noted above, this device does not involve expert adjudication for ground truth.

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 document is for a personal lubricant, not an AI-powered diagnostic or interpretive device.

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

Not applicable. This is not an algorithm or AI device.

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

The ground truth for the performance criteria is established by:

Physical and Chemical Property Standards: USP (United States Pharmacopeia) standards for viscosity, pH, specific gravity, osmolality.
Biological Standards: ISO (International Organization for Standardization) standards for biocompatibility (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity), USP standards for LAL (endotoxin) and antimicrobial effectiveness, and HSSA guidelines.
Microbiological Standards: USP standards for total aerobic microbial count, total yeast and mold count, and presence of specific pathogens.
Material Compatibility Standards: ASTM (American Society for Testing and Materials) standards for condom compatibility.
Real-time aging study: to determine shelf life.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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February 9, 2022

CC Wellness LLC Marlent Perez Quality/Regulatory Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355

Re: K212705

Trade/Device Name: Actively Trying Personal Lubricant Unfragranced Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated: January 5, 2022 Received: January 10, 2022

Dear Marlent Perez:

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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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, Ph.D. 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

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Indications for Use

510(k) Number (if known) K212705

Device Name

Actively Trying Personal Lubricant Unfragranced

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 - K212705

1. Submitter Information

Applicant: CC Wellness LLC Contact: Marlent Perez Regulatory Affairs Specialist Bruce Albert Chief Scientific Officer Address: 29000 N. Hancock Parkway Valencia, CA 91355 Phone: (661) 481-6390 Phone: (661) 295-1700, ext. 231

2. Correspondent Information

Contact: Marlent Perez Address: 29000 N. Hancock Parkway Valencia, CA 91355 Phone: (661) 481-6390 Email: mperez@ccwellness.com

3. Date prepared: February 7, 2022

4. Device Information

Device Name: Actively Trying Personal Lubricant Unfragranced Common Name: Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB

5. Predicate Device Information

Device Name: Actively Trying Personal Lubricant 510(k) Number: K182585 Manufacturer: CC Wellness LLC 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

Actively Trying Personal Lubricant Unfragranced is sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The individual bottles are hermetically sealed during the production process.

This device is composed of Water (Aqua), Hydroxyethylcellulose, Sodium Chloride, Sodium Phosphate, Potassium Phosphate, Propylene Glycol, Chlorphenisen, Fructose and Arabinogalactan.

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The devices specifications are listed in the table below:

Property	Specification
Appearance	Semi-viscous liquid
Color	Clear
Odor	Odorless
Viscosity (cps) per USP <911>	8,500 - 13,000
pH per USP <971>	7.25 - 7.80
Specific Gravity per USP < 841>	0.900 - 1.100
Osmolality per USP <785>	300 – 410 mOsm/kg
Human Sperm Survival Assay (HSSA)	≥ 80% of control motility at 24 hours after 30minutes exposure to 10% of subject lubricant
Limulus Amebocyte Lysate (LAL) Gel-ClotMethod USP<85> and/or AAMI/ANSIST72:2011/(R) 2016	<0.5 EU/mL
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria forCategory 2 products.
Total aerobic microbial count (TAMC) per USP<61> and <1111>	Less than 100 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/Shigella	Absent
Escherichia coli	Absent
Candida albicans	Absent

Table 1: Device Specifications for Actively Trying Personal Lubricant Unfragranced
Feature	Actively Trying PersonalLubricant Unfragranced	Actively Trying PersonalLubricant (K1828585)
Device ClassificationName	Lubricant, Personal	Lubricant, Personal
Product Code	PEB	PEB
Indications for Use	Actively Trying PersonalLubricant Unfragranced is apersonal lubricant for penile,and/or vaginal application,intended to lubricate andmoisturize, to enhance the easeand comfort of sexual activityand supplement the body'snatural lubrication. This productis compatible with sperm,oocytes and embryos and can beused by couples trying toconceive. This product iscompatible with natural rubberlatex and polyisoprene condoms.This product is not compatiblewith polyurethane condoms.	Actively Trying PersonalLubricant is a personal lubricantfor penile, anal and/or vaginalapplication, intended to lubricateand moisturize, to enhance theease and comfort of intimatesexual activity and supplementthe body's natural lubrication.This product is compatible withnatural rubber latex, polyisoprenecondoms and polyurethanecondoms.
Water soluble	Yes	Yes
Contains water	Yes	Yes
Primary ingredients	Aqua, Propylene Glycol,Hydroxyethylcellulose, SodiumChloride, Sodium Phosphate,Potassium Phosphate, PropyleneGlycol, Chlorphenisen,Fructose, Arabinogalactan	Water (Aqua), Propylene Glycol,Hydroxyethylcellulose, Fructose,Arabinogalactan, SodiumPhosphate, Salta, PotassiumPhosphate, Methylparaben,Propylparaben
pH	7.25 - 7.80	7.25 - 7.80
Osmolarity	300 – 410 mOsm/kg	800 – 1000 mOsm/kg
Human Sperm SurvivalAssay (HSSA)	≥ 80% of control motility at 24hours after 30 minutes exposureto 10% of subject lubricant	After exposure to 10% JOActively Trying for 30 minutes, ≥80% of the control
Limulus AmebocyteLysate (LAL) Gel-ClotMethod	<0.5 EU/mL	<0.7 EU/mL
Lubricant Barrier Assay	Pass	Pass
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Natural rubber latex andPolyisoprene	Natural rubber latex,Polyisoprene, Polyurethane
Biocompatibility Tested	Yes	Yes
Antimicrobial Tested	Yes	Yes
Shelf life	2 years	2 years

7. Indications for Use:

Actively Trying Personal Lubricant Unfragranced is a personal lubricant for penile, and/or vaginal application, intended to lubricate and moisturize, 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Comparison of Intended Use and Technological Characteristics with the Predicate Device The table below compares the intended use and technological characteristics of the subject and predicate device.

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Table 2: Comparator Table for Subject Device – Actively Trying Personal Lubricant Unfragranced and Predicate Device – Actively Trying Personal Lubricant

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The subject and predicate device have similar indications for use statements and have the same intended use. The subject and predicate device have different technological characteristics, including different formulations and specifications. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity and Sensitization testing were performed in accordance with the 2020 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)
Acute Systemic Toxicity (ISO 10993-11:2006) ●

The results of this testing demonstrated that the subject lubricant is non-irritating, nonsensitizing, and not systemically toxic.

Non-clinical Performance Testing

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

Human Sperm Survival Assay
Endotoxin Testing per USP <85> and/or AAMI/ANSI ST72:2011/(R) 2016 (Limulus Amebocyte ● Lysate (LAL) Gel-Clot Method)
Lubricant Barrier Assay ●

The results indicate that the subject device is compatible with sperm and does not inhibit sperm motility.

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 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 indicate that Actively

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Trying Personal Lubricant Unfragranced is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

10. Conclusion

The results of the performance testing described above demonstrate that the Actively Trying Personal Lubricant Unfragranced 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.