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 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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for a personal lubricant. It describes the device, its intended use, comparison to a predicate device, and performance data to support its substantial equivalence.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "Specification" column in Table 1 for device specifications and the successful outcomes of the various performance tests. The reported device performance is indicated by the statement that the device met these specifications and that the tests demonstrated the desired safety and compatibility.

Property	Acceptance Criteria (Specification)	Reported Device Performance
Appearance	Clear, semi-viscous liquid	Clear, colorless, semi-viscous liquid
Color	Colorless	Colorless
Odor	Odorless	Odorless
Viscosity (cps) – USP<912>	750 to 950	Met specification over shelf-life
Total aerobic microbial count (TAMC) – USP<61>/USP<1111>	Less than 100 cfu/g	Met specification over shelf-life
Total yeast and mold count (TYMC) – USP<61>/USP<1111>	Less than 10 cfu/g	Met specification over shelf-life
Presence of Pathogens: Pseudomonas aeruginosa	Absent	Absent (implied, as specifications were met)
Presence of Pathogens: Staphylococcus aureus	Absent	Absent (implied, as specifications were met)
Presence of Pathogens: Candida albicans	Absent	Absent (implied, as specifications were met)
Biocompatibility: Cytotoxicity	Non-cytotoxic	Non-cytotoxic
Biocompatibility: Sensitization	Non-sensitizing	Non-sensitizing
Biocompatibility: Vaginal Irritation	Non-irritating	Non-irritating
Biocompatibility: Acute Systemic Toxicity	Non-systemically toxic	Non-systemically toxic
Shelf-Life	3 years	3 years (based on real-time aging study)
Condom Compatibility: Natural Rubber Latex	Compatible	Compatible
Condom Compatibility: Polyisoprene	Compatible	Compatible
Condom Compatibility: Polyurethane	Not compatible (as per predicate)	Not compatible (consistent with predicate and expectation)

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (e.g., number of units tested for viscosity, number of animals/samples for biocompatibility). The studies are performance tests conducted on the final device, not clinical trials with human subjects.

Data Provenance: The studies were conducted by the manufacturer (Solevy Co. LLC) to support their 510(k) submission. The location or specific laboratory where these tests were performed is not mentioned within the given text. It is implied to be retrospective testing for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since this is a submission for a personal lubricant, not an AI/imaging device, the concept of "experts establishing ground truth for a test set" in the context of diagnostic interpretation is not applicable here. The "ground truth" for this device comes from established laboratory testing standards (e.g., USP, ASTM D7661-10, ISO 10993-1) and their objective measurements.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements based on defined standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This type of study (MRMC) is relevant for diagnostic imaging devices where human readers interpret medical images. This document is for a medical device (personal lubricant) that does not involve image interpretation or human reading of diagnostic outputs.

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

Not applicable. This is not an algorithmic or AI device. The "performance" refers to the physical and biological properties of the lubricant itself.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

Established industry standards and test methods: e.g., USP <912> for viscosity, USP <61>/<1111> for microbial counts, ASTM D7661-10 for condom compatibility, and ISO 10993-1 for biocompatibility.
Defined specifications: The quantitative and qualitative values (e.g., viscosity range, microbial limits, absence of pathogens, non-toxic, non-irritating).
Predicate device characteristics: The subject device is shown to have "the same technological characteristics" and "the same intended use" as the predicate device (JO Premium Personal Lubricant K132954), implying that the predicate's established safety and effectiveness serve as a practical ground truth for equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/ML model for this type of medical device submission. The device is a physical product, and its performance is evaluated through direct testing against predefined standards.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this product.

Summary

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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 (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

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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)

Type of Use (Select one or both, as applicable)
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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 PennSanta Clarita, CA 91355
Contact Person:	Joe MendozaQuality/Regulatory Manager
Contact Number:	Phone: (661) 622-4880
Summary Preparation Date:	April 16, 2021
Trade Name:	Solevy Co. LLC Silicone Based PersonalLubricant
Common Name:	Personal Lubricant
Device Classification:	Regulation Name: CondomRegulation Number: 21 CFR 884.5300Product Code: NUC (Lubricant, Personal)Device Class: Class II
Predicate Device:	Product Name: JO Premium Personal Lubricant510(k) Number: K132954Manufacturer United Consortium, Inc.Product Code: NUCDevice Class: Class II

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

Device Description:

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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) –USP<61>/USP<1111>	Less than 100 cfu/g
Total yeast and mold count (TYMC) –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:

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 BasedPersonal Lubricant (K203644)	JO Premium PersonalLubricant (K132954)
Indications for Use:	Solevy Co. LLC Silicone BasedPersonal Lubricant is a silicone-based personal lubricant, forpenile and/or vaginalapplication, intended tolubricate and moisturize, toenhance the ease and comfortof intimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubberlatex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms.	Jo premium personallubricant is a silicone basedpersonal lubricant for penileand/or vaginal application,intended to lubricate andmoisturize, to enhance theease and comfort of intimatesexual activity andsupplement the body'snatural lubrication. Thisproduct is compatible withnatural rubber latex andpolyisoprene condoms. Thisproduct is not compatiblewith polyurethane condoms.
Product Code	NUC	NUC
Primary Ingredients	DimethiconeCyclopentasiloxaneCyclotetrasiloxaneDimethiconol	DimethiconeCyclopentasiloxaneCyclotetrasiloxaneDimethiconol
Silicone-Based	Yes	Yes
Over-the-Counter	Yes	Yes
CondomCompatibility	Natural Rubber Latex,Polyisoprene	Natural Rubber Latex,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.

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.