Sensuva Premium Silicone Personal Lubricant

K212260 · Valencia Naturals, Inc. · NUC · Apr 13, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K212260
• Device Name: Sensuva Premium Silicone Personal Lubricant
• Applicant: Valencia Naturals, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Apr 13, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Sensuva Premium Silicone Personal Lubricant is a silicone-based personal lubricant for penile, anal and/or vaginal application, intended to moisturize and lubricate, 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, polyisoprene and polyurethane condoms.

Device Story

Sensuva Premium Silicone Personal Lubricant is a non-sterile, silicone-based liquid (dimethicone, dimethiconol, cyclopentasiloxane) used as a personal lubricant. It is applied topically to penile, anal, or vaginal areas to moisturize and enhance comfort during sexual activity. The device is sold over-the-counter in polyethylene terephthalate bottles with pump sprayers or lotion pumps. It is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The device functions by providing physical lubrication to supplement natural body fluids. It is intended for consumer self-use.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (Cytotoxicity, Acute Systemic Toxicity, Sensitization, Vaginal Irritation). Condom compatibility tested per ASTM D7661-18. Shelf-life validated via accelerated aging study.

Technological Characteristics

Silicone-based lubricant (dimethicone, dimethiconol, cyclopentasiloxane). Viscosity 300-630 cps. Packaged in polyethylene terephthalate bottles with polypropylene caps/pumps. Non-sterile. Biocompatibility per ISO 10993. Condom compatibility per ASTM D7661-18. Microbial limits per USP <61>, <1111>, and <62>.

Indications for Use

Indicated for penile, anal, and/or vaginal application to moisturize and lubricate during intimate sexual activity; compatible with natural rubber latex, polyisoprene, and 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

• Silicone Personal Lubricant (K180083)

Submission Summary (Full Text)

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April 13, 2022

Valencia Naturals, Inc. % Stephanie Morris Principal Consultant, Owner SLMCO, Inc. 19762 Steinway Street Canyon Country, CA 91351

Re: K212260

> Trade/Device Name: Sensuva Premium Silicone Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 11, 2022 Received: March 14, 2022

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/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,

for 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)

#### K212260

Device Name Sensuva Premium Silicone Personal Lubricant

Indications for Use (Describe)

Sensuva Premium Silicone Personal Lubricant is a silicone-based personal lubricant for penile, anal and/or vaginal application, intended to moisturize and lubricate, 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, polyisoprene and polyurethane condoms.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------|--|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | |

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## 510(k) Summary – K212260

### Sensuva Premium Silicone Personal Lubricant

| 510(k) Owner/Submitter: | Valencia Naturals, Inc. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Street Address: | 9731 Topanga Canyon Place<br>Chatsworth, CA 91311 |
| Contact Person(s): | Anthony Santoro<br>President, Valencia Naturals, Inc. |
| Contact Number(s): | Phone: [phone] |
| Summary Preparation Date: | April 11, 2022 |
| Trade Name: | Sensuva Premium Silicone Personal Lubricant |
| Common Name: | Personal Lubricant |
| Device Classification: | Regulation Name: Condom<br>Regulation Number: 21 CFR 884.5300<br>Product Code: NUC (lubricant, personal)<br>Regulatory Class: Class II |
| Predicate Device: | Product Name: Silicone Personal Lubricant<br>510(k) Number: K180083<br>Manufacturer: United Consortium<br>Product Code: NUC (lubricant, personal)<br>Regulatory Class: Class II |

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

#### Device Description:

Sensuva Premium Silicone Personal Lubricant is a non-sterile, clear, colorless, thin liquid, silicone-based personal lubricant. This device is for penile, anal, and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. It is compatible with natural rubber latex, polyisoprene and polyurethane condoms. Its formulation consists of dimethicone, dimethiconol, and cyclopentasiloxane.

Sensuva Premium Silicone Personal Lubricant is sold as an over-the-counter (OTC) device and is provided in polyethylene terephthalate bottles. The 1.93 fl. oz./57 mL bottles are fitted with 20/410 smooth black pump sprayers and clear polypropylene caps. The 4.23 fl. oz./125 mL and 8.12 fl. oz./240 mL bottles are capped with 24/410 smooth black lotion pumps.

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The device specifications are listed in the table below:

| Property | Specification |
|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Appearance | Thin liquid |
| Color | Clear, colorless |
| Odor | Characteristic |
| Viscosity (cps) | 300-630 cps |
| 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> ( <i>Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella/Shigella, Escherichia coli, Candida albicans</i> ) | Absent |

#### Table 1: Device Specifications for Sensuva Premium Silicone Personal Lubricant

### Indications for Use:

Sensuva Premium Silicone Personal Lubricant is a silicone-based personal lubricant for penile, anal and/or vaginal application, intended to moisturize and lubricate, 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, polyisoprene and polyurethane condoms.

### Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Devices:

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

| Feature | Sensuva Premium Silicone<br>Personal Lubricant<br>K212260<br>Subject Device | Silicone Personal<br>Lubricant<br>K180083<br>Predicate Device | Comparison |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Classification<br>Name | Lubricant, Personal | Lubricant, Personal | Same |
| Product Code | NUC | NUC | Same |
| Indications for Use | Sensuva Premium Silicone<br>Personal Lubricant is a silicone-<br>based personal lubricant for<br>penile, anal and/or vaginal<br>application, intended to<br>moisturize and lubricate, to<br>enhance the ease and comfort<br>ofintimate sexual activity and<br>supplement the body's natural | Silicone Personal Lubricant<br>is a silicone-based personal<br>lubricant for penile, anal<br>and/or vaginal application,<br>intended to lubricate and<br>moisturize, to enhance the<br>ease and comfort of<br>intimate sexual activity and<br>supplement thebody's | The subject and<br>predicate device<br>have the same<br>indications for use<br>and intended use. |
| | lubrication. This product is compatible with natural rubber latex, polyisoprene and polyurethane condoms. | natural lubrication. This product is compatible with naturalrubber latex, polyurethane and polyisoprene condoms. | |
| Water Soluble | No | No | Same |
| Contains Water | No | No | Same |
| Primary<br>Ingredients | Dimethicone,<br>Cyclopentasiloxane,<br>Dimethiconol | Dimethicone, Dimethiconol | Different: The subject and predicate devices have different formulations. These differences do not raise different questions of safety and effectiveness (S&E). |
| Appearance/Color | Clear, colorless thin liquid | Clear, semi-viscous liquid | Similar |
| Odor | Characteristic | Odorless | Different: The predicate and subject devices have differences in their odors. These differences do not raise different questions of S&E. |
| Viscosity | 300-630 cps | 800-1075 cps | Different: The predicate device has a higher viscosity than the subject device. Differences in viscosity do not raise different questions of S&E. |
| TAMC | <100 cfu/g | <10 cfu/g | Different: The subject device has a higher TAMC specification. This difference does not raise a different question of S&E. |
| TYMC | <10 cfu/g | <10 cfu/g | Same |
| Absence of<br>Pathogenic<br>Organisms | Absent | Absent | Same |
| Over the Counter<br>(OTC) Use | Yes | Yes | Same |
| Sterile | No | No | Same |
| Condom<br>Compatibility | Natural Rubber Latex,<br>Polyurethane, Polyisoprene | Natural Rubber Latex,<br>Polyurethane, Polyisoprene | Same |
| Biocompatibility<br>Tested | Yes | Yes | Same |
| Shelf-Life | 8.4 months | 2 years | Different: The<br>subject device has<br>a shorter shelf-life<br>than the predicate<br>device. Differences<br>in shelf-life<br>duration do raise<br>different questions<br>of S&E. |

## Table 2: Comparator Table for Subject Device – Sensuva Premium Silicone Personal Lubricant and Predicate Device Silicone Personal Lubricant

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The subject and predicate devices have the same indications for use and intended use. The subject and predicate devices have differences in technological characteristics, including different formulations, odor, viscosity, TAMC, and shelf-life duration. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

### Summary of Non-Clinical Performance Data:

### Biocompatibility

Biocompatibility studies 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." The following testing was conducted:

- Cytotoxicity (ISO 10993-5:2009)
- Acute Systemic Toxicity (ISO 10993-11:2017)
- Sensitization (ISO 10993-10:2010) ●
- Vaginal Irritation (ISO 10993-10:2010)

The results of testing support the biocompatibility of the device materials.

#### Shelf-Life:

The subject device has a shelf-life of 8.4 months. Results from an acceleratedaging study demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life.

## Condom Compatibility:

The compatibility of the subject device with condoms was evaluated in accordance with ASTM D7661-18 StandardTest Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this testing showed the Sensuva Premium Silicone Personal Lubricant is compatible with natural rubber latex, polyisoprene and polyurethane condoms.

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## Conclusion:

The results of the performance testing described above demonstrate that the Sensuva Premium Silicone Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.