Actively Trying Personal Lubricant Rose Scented 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 polvisoprene condoms. This product is not compatible with polyurethane condoms.

Device Description

Actively Trying Personal Lubricant Rose Scented 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 Rose Scented 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, Arabinogalactan, and Rose water (Damascena).

AI/ML Overview

This document describes the acceptance criteria and the study results for the "Actively Trying Personal Lubricant Rose Scented" to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria	Reported Device Performance
Physical/Chemical Properties
Appearance	Semi-viscous liquid	Semi-viscous liquid
Color	Clear	Clear
Odor	Rose Scented	Rose Scented
Viscosity (cps) per USP <911>	8,500 - 13,000	Met (within 8,500 - 13,000)
pH per USP <971>	7.25 - 7.80	Met (within 7.25 - 7.80)
Specific Gravity per USP <841>	0.900 - 1.100	Met (within 0.900 - 1.100)
Osmolality per USP <785>	300 — 410 mOsm/kg	Met (within 300 - 410 mOsm/kg)
Biocompatibility
Cytotoxicity (ISO 10993-5:2009)	Non-cytotoxic	Non-cytotoxic
Sensitization (ISO 10993-10:2010)	Non-sensitizing	Non-sensitizing
Vaginal Irritation (ISO 10993-10:2010)	Non-irritating	Non-irritating
Acute Systemic Toxicity (ISO 10993-11:2006)	Not systemically toxic	Not systemically toxic
Sperm Compatibility
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 (results indicate compatible and does not inhibit sperm motility)
Endotoxin Content
Limulus Amebocyte Lysate (LAL) Gel-Clot Method USP <85> and/or AAMI/ANSI ST72:2011/(R) 2016	<0.5 EU/mL	<0.5 EU/mL
Microbial Contamination
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	Absent
Pseudomonas aeruginosa	Absent	Absent
Staphylococcus aureus	Absent	Absent
Salmonella/Shigella	Absent	Absent
Escherichia coli	Absent	Absent
Candida albicans	Absent	Absent
Condom Compatibility
Lubricant Barrier Assay (ASTM D7661-10) with natural rubber latex and polyisoprene condoms	Pass	Pass (compatible)
Lubricant Barrier Assay (ASTM D7661-10) with polyurethane condoms	Fail (not compatible)	Not compatible
Shelf Life	Maintains all device specifications in Table 1 at 0, 1, and 2 years	Met all device specifications at 0, 1 and 2 years

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

The document does not specify a distinct "test set" in the context of clinical trials with human subjects. The testing described is primarily non-clinical, involving laboratory assays and material compatibility tests. Therefore, typical "sample size" for a clinical test set and "data provenance" (country of origin, retrospective/prospective) are not applicable in the way they would be for a diagnostic device or a drug.

For the biocompatibility studies and non-clinical performance testing (Human Sperm Survival Assay, Endotoxin Testing, Lubricant Barrier Assay), these are laboratory-based tests conducted under specific standards (e.g., ISO 10993, USP, ASTM D7661-10). The sample size would refer to the number of lubricant batches or test replicates used in each assay, which is not detailed in the document beyond stating that the tests were performed.

For shelf-life, tests were conducted at 0, 1, and 2 years. This is a prospective aging study performed on the device product itself.

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

This information is not applicable to the non-clinical performance and biocompatibility testing described. These studies rely on standardized laboratory protocols and measurement techniques rather than expert consensus on a "ground truth" derived from human data. The "ground truth" for these tests comes from the established scientific and regulatory standards themselves (e.g., ISO, USP, ASTM).

4. Adjudication method for the test set

Not applicable, as the tests are objective laboratory measurements against defined acceptance criteria, not subjective interpretations requiring adjudication.

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 not an AI-powered diagnostic device, but a personal lubricant undergoing non-clinical performance testing for substantial equivalence to a predicate device.

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

Not applicable, as this is not an algorithm or AI-based device.

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

The "ground truth" for the performance and safety of this device is established by adherence to internationally recognized standards and pharmacopoeial methods. These include:

ISO 10993 series: for biocompatibility (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity).
USP (United States Pharmacopeia) methods: for physical/chemical properties (Viscosity <911>, pH <971>, Specific Gravity <841>, Osmolality <785>), endotoxin <85>, antimicrobial effectiveness <51>, and microbial counts <61>, <1111>, <62>.
ASTM D7661-10 Standard Test Method: for condom compatibility (Lubricant Barrier Assay).
Human Sperm Survival Assay: an established method for evaluating sperm compatibility.

Meeting the predefined specifications and passing these standardized tests constitutes the "ground truth" for demonstrating the device's acceptable performance and safety.

8. The sample size for the training set

Not applicable, as this device does not involve machine learning or AI algorithms requiring a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The FDA logo is in blue.

February 11, 2022

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

Re: K212885

Trade/Device Name: Actively Trying Personal Lubricant Rose Scented Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated: January 7, 2022 Received: January 12, 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.

{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) 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

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

Indications for Use

510(k) Number (if known) K212885

Device Name

Actively Trying Personal Lubricant Rose Scented

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)

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}------------------------------------------------

K212885 Page 1 of 5

510(K) Summary - K212885

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 Rose Scented 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 Rose Scented 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, Arabinogalactan, and Rose water (Damascena).

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

The devices specifications are listed in the table below:

Property	Specification
Appearance	Semi-viscous liquid
Color	Clear
Odor	Rose Scented
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 Rose Scented
------------------------------------------------------------------------------------	--	--	--

7. Indications for Use:

Actively Trying Personal Lubricant Rose Scented 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.

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

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

Feature	Actively Trying PersonalLubricant Rose Scented	Actively Trying PersonalLubricant (K182585)
Device ClassificationName	Lubricant, Personal	Lubricant, Personal
Product Code	PEB	PEB
Indications for Use	Actively Trying PersonalLubricant Rose Scented 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, RoseWater	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

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

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-cytotoxic, 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 Rose Scented:

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

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

10. Conclusion

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