Solevy Co. LLC Silicone Based Personal Lubricant

K203644 · Solevy Co., LLC · NUC · Apr 19, 2021 · Obstetrics/Gynecology

Device Facts

• Record ID: K203644
• Device Name: Solevy Co. LLC Silicone Based Personal Lubricant
• Applicant: Solevy Co., LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Apr 19, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Solevy Co. LLC Silicone Based Personal Lubricant is a silicone-based personal lubricant, for penile and/or vaginal application, intended 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 natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Story

Clear, colorless, semi-viscous silicone-based personal lubricant; intended for penile and/or vaginal application to moisturize and lubricate during intimate sexual activity. Supplied in polyethylene bottles (1-16 fl. oz.) with polypropylene caps or lotion pumps. Used by consumers in home settings. Enhances comfort and supplements natural lubrication. Compatible with natural rubber latex and polyisoprene condoms; incompatible with polyurethane condoms. Non-sterile.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity) demonstrated the device is non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic. Condom compatibility testing per ASTM D7661-10 confirmed compatibility with natural rubber latex and polyisoprene condoms, and incompatibility with polyurethane condoms. Shelf-life established at 3 years via real-time aging study.

Technological Characteristics

Silicone-based lubricant containing dimethicone, cyclopentasiloxane, cyclotetrasiloxane, and dimethiconol. Viscosity 750-950 cps (USP <912>). Packaging: polyethylene bottles, polypropylene caps/pumps, induction seals (aluminized mylar). Non-sterile. Biocompatibility per ISO 10993-1. Condom compatibility per ASTM D7661-10.

Indications for Use

Indicated for penile and/or vaginal application to lubricate and moisturize, enhancing comfort during intimate sexual activity and supplementing natural lubrication. 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

• JO Premium Personal Lubricant (K132954)

Submission Summary (Full Text)

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April 19, 2021

Solevy Co. LLC Joe Mendoza Ouality/Regulatory Manager 29017 Avenue Penn Santa Clarita, CA 91355

Re: K203644

> Trade/Device Name: Solevy Co. LLC Silicone Based Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 12, 2020 Received: December 14, 2020

Dear Joe Mendoza:

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) K203644

#### Device Name

Solevy Co. LLC Silicone Based Personal Lubricant

#### Indications for Use (Describe)

Solevy Co. LLC Silicone Based Personal Lubricant is a silicone-based personal lubricant, for penile and/or vaginal application, intended 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 natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary - K203644

| 510(k) Owner: | Solevy Co. LLC |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Street Address: | 29017 Avenue Penn<br>Santa Clarita, CA 91355 |
| Contact Person: | Joe Mendoza<br>Quality/Regulatory Manager |
| Contact Number: | Phone: [phone] |
| Summary Preparation Date: | April 16, 2021 |
| Trade Name: | Solevy Co. LLC Silicone Based Personal<br>Lubricant |
| Common Name: | Personal Lubricant |
| Device Classification: | Regulation Name: Condom<br>Regulation Number: 21 CFR 884.5300<br>Product Code: NUC (Lubricant, Personal)<br>Device Class: Class II |
| Predicate Device: | Product Name: JO Premium Personal Lubricant<br>510(k) Number: K132954<br>Manufacturer United Consortium, Inc.<br>Product Code: NUC<br>Device Class: Class II |

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

### Device Description:

Solevy Co. LLC Silicone-Based Personal Lubricant is a clear, colorless, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. The device is not compatible for use with polyurethane condoms. The device is a non-sterile lubricant, for penile and/or vaginal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is provided in volumes of 1, 2.5, 4.5, 8, and 16 fl. oz in polyethylene bottles. The 1-8 fl. oz. bottles are closed with polypropylene (PP) caps, while the 16 fl. oz. bottle includes a polypropylene lotion pump. The 16 fl. oz. bottle is sealed using tamper-resistant shrink wrap band. The 1-8 fl. oz. bottles are sealed using an induction seal constructed of aluminized mylar.

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The device specifications are listed in Table 1 below:

## Table 1: Device Specifications

| Property | Specification |
|-------------------------------------------------------------|----------------------------|
| Appearance | Clear, semi-viscous liquid |
| Color | Colorless |
| Odor | Odorless |
| Viscosity (cps) – USP<912> | 750 to 950 |
| Total aerobic microbial count (TAMC) –<br>USP<61>/USP<1111> | Less than 100 cfu/g |
| Total yeast and mold count (TYMC) –<br>USP<61>/USP<1111> | Less than 10 cfu/g |
| Presence of Pathogens | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Candida albicans | Absent |

## Indications for Use:

Solevy Co. LLC Silicone Based Personal Lubricant is a silicone-based personal lubricant, for penile and/or vaginal application, intended 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 natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

# Predicate Device Comparison:

A comparison of the indications for use and technological characteristics of the subject and predicate device is summarized in Table 2 below:

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Table 2: Predicate Device Comparison

| Feature | Solevy Co. LLC Silicone Based<br>Personal Lubricant (K203644) | JO Premium Personal<br>Lubricant (K132954) |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | Solevy Co. LLC Silicone Based<br>Personal Lubricant is a silicone-<br>based personal lubricant, for<br>penile and/or vaginal<br>application, intended to<br>lubricate and moisturize, to<br>enhance the ease and comfort<br>of intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is<br>compatible with natural rubber<br>latex and polyisoprene<br>condoms. This product is not<br>compatible with polyurethane<br>condoms. | Jo premium personal<br>lubricant is a silicone based<br>personal lubricant for penile<br>and/or vaginal application,<br>intended to lubricate and<br>moisturize, to enhance the<br>ease and comfort of intimate<br>sexual activity and<br>supplement the body's<br>natural lubrication. This<br>product is compatible with<br>natural rubber latex and<br>polyisoprene condoms. This<br>product is not compatible<br>with polyurethane condoms. |
| Product Code | NUC | NUC |
| Primary Ingredients | Dimethicone<br>Cyclopentasiloxane<br>Cyclotetrasiloxane<br>Dimethiconol | Dimethicone<br>Cyclopentasiloxane<br>Cyclotetrasiloxane<br>Dimethiconol |
| Silicone-Based | Yes | Yes |
| Over-the-Counter | Yes | Yes |
| Condom<br>Compatibility | Natural Rubber Latex,<br>Polyisoprene | Natural Rubber Latex,<br>Polyisoprene |
| Sterile | No | No |
| Biocompatibility | Yes | Yes |
| Tested | | |
| Shelf Life | 3 years | 3 years |

The indications for use for the subject and predicate devices are the same; therefore, they have the same intended use.

The subject and predicate devices have the same technological characteristics. As the technological characteristics of the subject and predicate device are the same, there are no differences raising different questions of safety and effectiveness.

# Summary of Performance Data:

Solevy Co. LLC Silicone Based Personal Lubricant has undergone biocompatibility testing in accordance with the 2020 FDA guidance document "Use of International Standard ISO 10993-1,

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Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process." Testing included:

- . Cytotoxicity
- . Sensitization
- . Vaginal Irritation
- Acute Systemic Toxicity .

The results of testing demonstrated the subject device is non-cytotoxic, non-sensitizing, nonirritating, and non-systemically toxic.

## Shelf-Life:

TheSolevy Co. LLC Silicone Based Personal Lubricant has a three-year shelf-life based on the results of a real-time aging study. The shelf-life study evaluated all device specifications listed above in Table 1, Device Specifications. The subject device specifications over the stated shelf-life duration.

## Condom Compatibility:

The compatibility of the Solevy Co. LLC Silicone Based Personal Lubricant was evaluated with natural rubber latex, polyisoprene, and polyurethane condoms per ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of testing demonstrated that the Solevy Co. LLC Silicone Based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms but is not compatible with polyurethane condoms.

# Conclusion:

The results of performance testing demonstrate that the Solevy Silicone Based Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.