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 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.

AI/ML Overview

This document is a 510(k) Premarket Notification for a personal lubricant, not an AI/ML medical device. Therefore, the requested information regarding AI/ML device performance, training data, ground truth establishment, and expert involvement is not applicable.

However, I can extract the acceptance criteria and the studies performed for the Sensuva Premium Silicone Personal Lubricant as described in the document.

Acceptance Criteria and Device Performance for Sensuva Premium Silicone Personal Lubricant

The device is a non-sterile, clear, colorless, thin liquid, silicone-based personal lubricant.

Table of acceptance criteria and the reported device performance:

Property	Acceptance Criteria (Specification)	Reported Device Performance (from studies described)
Appearance	Thin liquid	Maintained its specifications during shelf-life
Color	Clear, colorless	Maintained its specifications during shelf-life
Odor	Characteristic	Maintained its specifications during shelf-life
Viscosity (cps)	300-630 cps	Maintained its specifications during shelf-life
Total aerobic microbial count (TAMC) per USP <61> and <1111>	Less than 100 cfu/g	Maintained its specifications during shelf-life
Total yeast and mold count (TYMC) per USP <61> and <1111>	Less than 10 cfu/g	Maintained its specifications during shelf-life
Presence of Pathogens per USP <62> (Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella/Shigella, Escherichia coli, Candida albicans)	Absent	Maintained its specifications during shelf-life
Biocompatibility	Pass (no adverse biological effects)	Passed
Shelf-Life	8.4 months	Maintained specifications for 8.4 months
Condom Compatibility	Compatible	Compatible with natural rubber latex, polyisoprene, and polyurethane condoms

Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for the individual non-clinical tests (biocompatibility, shelf-life, condom compatibility).
- The data provenance is from non-clinical performance data (laboratory testing) as described. The country of origin of the data is not specified. All studies appear to be prospective in nature (i.e., tests were conducted on the device to assess its performance against defined criteria).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This question is not applicable as this is not an AI/ML device or a diagnostic device requiring expert interpretation for ground truth. The acceptance criteria for the physical, chemical, and biological properties are established by recognized standards (e.g., USP, ISO, ASTM).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML device or a diagnostic device requiring expert adjudication. The results of the non-clinical tests are objectively measured against defined specifications in established standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on established standard specifications and methodologies for physical, chemical, and biological properties relevant to personal lubricants as per recognized guidelines (e.g., USP <61>, <62>, <1111>, ISO 10993 series, ASTM D7661-18). For biocompatibility, the truth is whether the device elicits a toxic or sensitizing response according to the ISO standards. For condom compatibility, it's whether the lubricant degrades the condom material beyond an acceptable threshold per ASTM. For shelf-life, it's whether the product meets its specifications over time under accelerated aging conditions.
The sample size for the training set:
- Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.

Summary

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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 (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)

K212260

Device Name Sensuva Premium Silicone Personal Lubricant

Indications for Use (Describe)

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 – K212260

Sensuva Premium Silicone Personal Lubricant

510(k) Owner/Submitter:	Valencia Naturals, Inc.
Street Address:	9731 Topanga Canyon PlaceChatsworth, CA 91311
Contact Person(s):	Anthony SantoroPresident, Valencia Naturals, Inc.
Contact Number(s):	Phone: (877) 470-7578
Summary Preparation Date:	April 11, 2022
Trade Name:	Sensuva Premium Silicone Personal Lubricant
Common Name:	Personal Lubricant
Device Classification:	Regulation Name: CondomRegulation Number: 21 CFR 884.5300Product Code: NUC (lubricant, personal)Regulatory Class: Class II
Predicate Device:	Product Name: Silicone Personal Lubricant510(k) Number: K180083Manufacturer: United ConsortiumProduct Code: NUC (lubricant, personal)Regulatory Class: Class II

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

Device Description:

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> ( Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella/Shigella, Escherichia coli, Candida albicans )	Absent

Table 1: Device Specifications for Sensuva Premium Silicone Personal Lubricant

Indications for Use:

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 SiliconePersonal LubricantK212260Subject Device	Silicone PersonalLubricantK180083Predicate Device	Comparison
DeviceClassificationName	Lubricant, Personal	Lubricant, Personal	Same
Product Code	NUC	NUC	Same
Indications for Use	Sensuva Premium SiliconePersonal Lubricant is a silicone-based personal lubricant forpenile, anal and/or vaginalapplication, intended tomoisturize and lubricate, toenhance the ease and comfortofintimate sexual activity andsupplement the body's natural	Silicone Personal Lubricantis a silicone-based personallubricant for penile, analand/or vaginal application,intended to lubricate andmoisturize, to enhance theease and comfort ofintimate sexual activity andsupplement thebody's	The subject andpredicate devicehave the sameindications for useand 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
PrimaryIngredients	Dimethicone,Cyclopentasiloxane,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 ofPathogenicOrganisms	Absent	Absent	Same
Over the Counter(OTC) Use	Yes	Yes	Same
Sterile	No	No	Same
CondomCompatibility	Natural Rubber Latex,Polyurethane, Polyisoprene	Natural Rubber Latex,Polyurethane, Polyisoprene	Same
BiocompatibilityTested	Yes	Yes	Same
Shelf-Life	8.4 months	2 years	Different: Thesubject device hasa shorter shelf-lifethan the predicatedevice. Differencesin shelf-lifeduration do raisedifferent questionsof 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.

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.