K Number
K203654
Device Name
Solevy Co. LLC Water-Based Personal Lubricant
Manufacturer
Date Cleared
2021-04-19

(125 days)

Product Code
Regulation Number
884.5300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Solevy Co. LLC Water-Based Lubricant is a water-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, polyurethane, and polyisoprene condoms.
Device Description
Solevy Co. LLC Water-Based Lubricant is a clear, colorless, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane, and polyisoprene. 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.
More Information

Not Found

No
The device description and performance studies focus on the physical properties and biocompatibility of a personal lubricant, with no mention of AI or ML technologies.

No
The device is a personal lubricant intended to enhance comfort during sexual activity, not to treat or prevent a medical condition.

No

The device is a personal lubricant intended to enhance comfort during intimate sexual activity, not to diagnose any condition or disease.

No

The device is a physical product (a water-based lubricant) provided in bottles, not a software application.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is clearly stated as a personal lubricant for penile and/or vaginal application to enhance sexual activity and supplement natural lubrication. This is a topical application for physical comfort and function, not for diagnosing a condition or analyzing a sample from the body.
  • Device Description: The description details a lubricant applied externally.
  • Lack of Diagnostic Function: There is no mention of the device being used to test or analyze any biological sample (blood, urine, tissue, etc.) to provide diagnostic information.
  • Performance Studies: The performance studies focus on biocompatibility, shelf-life, and condom compatibility, which are relevant for a personal lubricant, not an IVD.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

N/A

Intended Use / Indications for Use

Solevy Co. LLC Water-Based Lubricant is a water-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, polyurethane, and polyisoprene condoms.

Product codes (comma separated list FDA assigned to the subject device)

NUC

Device Description

Solevy Co. LLC Water-Based Lubricant is a clear, colorless, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane, and polyisoprene. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Penile and/or vaginal application

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Biocompatibility: Solevy Co. LLC Water-Based Lubricant has undergone biocompatibility testing 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." Testing included:

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

Shelf-Life: The Solevy Co. LLC Water-Based 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 met all device specifications over the stated shelf-life duration.

Condom Compatibility: The compatibility of the Solevy Co. LLC Water-Based 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 Water-Based Lubricant is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K150480

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 19, 2021

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

Re: K203654

Trade/Device Name: Solevy Co. LLC Water-Based Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 11, 2020 Received: December 15, 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.

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,

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

2

Indications for Use

510(k) Number (if known) K203654

Device Name Solevy Co. LLC Water-Based Lubricant

Indications for Use (Describe)

Solevy Co. LLC Water-Based Lubricant is a water-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, polyurethane, and polyisoprene 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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3

510(k) Summary - K203654

510(k) Owner:Solevy Co. LLC
Street Address:29017 Avenue Penn
Santa Clarita, CA 91355
Contact Person:Joe Mendoza
Quality/Regulatory Manager
Contact Number:Phone: (661) 622-4880
Summary Preparation Date:April 16, 2021
Trade Name:Solevy Co. LLC Water-Based Lubricant
Common Name:Personal Lubricant
Device Classification:Regulation Name:Condom
Regulation Number:21 CFR 884.5300
Product Code:NUC (Lubricant, Personal)
Device Class:Class II
Predicate Device:Product Name:JO H2O Water Based Personal Lubricant
510(k) Number:K150480
Manufacturer:United Consortium, Inc.
Product Code:NUC
Device Class:Class II

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

Device Description

Solevy Co. LLC Water-Based Lubricant is a clear, colorless, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane, and polyisoprene. 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.

4

The device specifications are listed in Table 1 below:

Table 1: Device Specifications

PropertySpecification
AppearanceClear, semi-viscous liquid
ColorColorless
OdorOdorless
Viscosity per USP1,200 - 1,800 cps
pH6.0 - 7.0
Osmolality per USP750 - 950 mOsm/kg
Specific Gravity per USP1.12 - 1.20
Total aerobic microbial count
(TAMC) per USP andand
products. Category 2, bacteria should show not less
than 2.0 log reduction at 14 days and no increase from
14-day count at the 28-day count. Yeast and molds
should show no increase from the initial calculated
count at 14 and 28 days
Presence of Pathogenic
organisms ( Staphylococcus aureus , Pseudomonas aeruginosa , and Candida albicans per USP )Absent

Indications for Use

Solevy Co. LLC Water-Based Lubricant is a water-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, polyurethane, and polyisoprene 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 Water-Based
Lubricant (K203654) | JO H2O Water-Based Personal
Lubricant (K150480) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Solevy Co. LLC Water-Based
Lubricant is a water-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,
polyurethane, and polyisoprene
condoms. | JO H20 Personal Lubricant is a
water-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, polyurethane, and
polyisoprene condoms. |
| Product Code | NUC | NUC |
| Ingredients | Glycerin, Water, Cellulose Gum,
Methylparaben, Propylparaben | Glycerin, Water, Cellulose Gum,
Methylparaben, Propylparaben |
| Appearance | Clear, colorless, semi-viscous
liquid | Clear, colorless, semi-viscous
liquid |
| Water-Based | Yes | Yes |
| Over-the-Counter Use | Yes | Yes |
| Condom
Compatibility | Natural Rubber Latex,
Polyisoprene, Polyurethane | Natural Rubber Latex,
Polyisoprene, Polyurethane |
| Biocompatibility
Tested | Yes | Yes |
| Non-Sterile | Yes | Yes |
| 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.

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Summary of Non-Clinical Performance Data

Biocompatibility

Solevy Co. LLC Water-Based Lubricant has undergone biocompatibility testing 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." Testing included:

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

Shelf-Life

The Solevy Co. LLC Water-Based 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 met all device specifications over the stated shelf-life duration.

Condom Compatibility

The compatibility of the Solevy Co. LLC Water-Based 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 Water-Based Lubricant is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Conclusion

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