Actively Trying Personal Lubricant Rose Scented

K212885 · CC Wellness, LLC · PEB · Feb 11, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K212885
• Device Name: Actively Trying Personal Lubricant Rose Scented
• Applicant: CC Wellness, LLC
• Product Code: PEB · Obstetrics/Gynecology
• Decision Date: Feb 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

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.

Device Story

Actively Trying Personal Lubricant Rose Scented is a clear, semi-viscous, non-sterile personal lubricant. It is applied topically to the penis or vagina to provide lubrication and moisture during sexual activity. The device is intended for use by couples trying to conceive, as it is formulated to be compatible with sperm, oocytes, and embryos. It is sold over-the-counter in 4 fl. oz. PET bottles. The lubricant is applied by the user. It functions by providing a physical barrier and moisture to enhance comfort. The device is compatible with natural rubber latex and polyisoprene condoms, but not polyurethane condoms. Clinical benefit is derived from the enhancement of sexual comfort and the support of fertility-related activities without negatively impacting sperm motility.

Clinical Evidence

Bench testing only. Performance testing included biocompatibility (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity per ISO 10993), Human Sperm Survival Assay (≥80% motility at 24 hours), endotoxin testing (<0.5 EU/mL), and condom compatibility (ASTM D7661-10). Real-time aging studies confirmed a two-year shelf life.

Technological Characteristics

Semi-viscous liquid; pH 7.25-7.80; osmolality 300-410 mOsm/kg. Ingredients: Water, Hydroxyethylcellulose, Sodium Chloride, Sodium Phosphate, Potassium Phosphate, Propylene Glycol, Chlorphenisen, Fructose, Arabinogalactan, Rose water. Non-sterile. Packaged in PET cylinder bottles. Testing standards: USP <911> (viscosity), USP <971> (pH), USP <841> (specific gravity), USP <785> (osmolality), USP <85>/AAMI/ANSI ST72 (endotoxin), USP <51> (antimicrobial), ASTM D7661-10 (condom compatibility).

Indications for Use

Indicated for penile and/or vaginal application to lubricate and moisturize, enhancing comfort during sexual activity and supplementing natural lubrication. Compatible with sperm, oocytes, and embryos; intended for use by couples trying to conceive. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use with polyurethane condoms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Actively Trying Personal Lubricant (K182585)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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) K212885

Device Name

Actively Trying Personal Lubricant Rose Scented

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | <div> <span> <input type="checkbox"/> </span> <span> <input type="checkbox"/> </span> </div> |
|-------------------------------------------------|----------------------------------------------------------------------------------------------|
|-------------------------------------------------|----------------------------------------------------------------------------------------------|

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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## 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: [phone] Phone: [phone], ext. 231

#### 2. Correspondent Information

Contact: Marlent Perez Address: 29000 N. Hancock Parkway Valencia, CA 91355 Phone: [phone] Email: [e-mail]

#### 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 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).

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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 30<br>minutes exposure to 10% of subject lubricant |
| Limulus Amebocyte Lysate (LAL) Gel-Clot<br>Method USP<85> and/or AAMI/ANSI<br>ST72:2011/(R) 2016 | <0.5 EU/mL |
| Antimicrobial effectiveness per USP <51> | Meets USP <51> acceptance criteria for<br>Category 2 products. |
| Total aerobic microbial count (TAMC) per USP<br><61> and <1111> | Less than 100 cfu/g |
| Total yeast and mold count (TYMC) per USP<br><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.

8. 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 Rose Scented and Predicate Device – Actively Trying Personal Lubricant

| Feature | Actively Trying Personal<br>Lubricant Rose Scented | Actively Trying Personal<br>Lubricant (K182585) |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification<br>Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | PEB | PEB |
| Indications for Use | Actively Trying Personal<br>Lubricant Rose Scented is a<br>personal lubricant for penile,<br>and/or vaginal application,<br>intended to lubricate and<br>moisturize, to enhance the ease<br>and comfort of sexual activity<br>and supplement the body's<br>natural lubrication. This product<br>is compatible with sperm,<br>oocytes and embryos and can be<br>used by couples trying to<br>conceive. This product is<br>compatible with natural rubber<br>latex and polyisoprene condoms.<br>This product is not compatible<br>with polyurethane condoms. | Actively Trying Personal<br>Lubricant is a personal lubricant<br>for penile, anal and/or vaginal<br>application, intended to lubricate<br>and moisturize, to enhance the<br>ease and comfort of intimate<br>sexual activity and supplement<br>the body's natural lubrication.<br>This product is compatible with<br>natural rubber latex, polyisoprene<br>condoms and polyurethane<br>condoms. |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Aqua, Propylene Glycol,<br>Hydroxyethylcellulose, Sodium<br>Chloride, Sodium Phosphate,<br>Potassium Phosphate, Propylene<br>Glycol, Chlorphenisen,<br>Fructose, Arabinogalactan, Rose<br>Water | Aqua, Propylene Glycol,<br>Hydroxyethylcellulose, Fructose,<br>Arabinogalactan, Sodium<br>Phosphate, Salta, Potassium<br>Phosphate, Methylparaben,<br>Propylparaben |
| pH | 7.25 - 7.80 | 7.25 – 7.80 |
| Osmolarity | 300 – 410 mOsm/kg | 800 – 1000 mOsm/kg |
| Human Sperm Survival<br>Assay (HSSA) | ≥ 80% of control motility at 24<br>hours after 30 minutes exposure<br>to 10% of subject lubricant | After exposure to 10% JO<br>Actively Trying for 30 minutes, ≥<br>80% of the control |
| Limulus Amebocyte<br>Lysate (LAL) Gel-Clot<br>Method | <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 and<br>Polyisoprene | Natural Rubber Latex,<br>Polyisoprene, Polyurethane |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 2 years | 2 years |

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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-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.

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## 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.