(267 days)
Not Found
No
The device is a personal lubricant with a simple chemical formulation and no mention of any computational or analytical capabilities.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during intimate sexual activity, which falls under the category of a device for physiological support rather than a therapeutic device.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort and ease during sexual activity. It does not identify or detect diseases or health conditions, which are functions of a diagnostic device.
No
The device description clearly states it is a liquid, silicone-based personal lubricant provided in bottles with pumps, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This is a physical function, not a diagnostic one.
- Device Description: The description details a personal lubricant for topical application, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, shelf-life, and condom compatibility, which are relevant to a personal lubricant, not an IVD.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
NUC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, anal and/or vaginal
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 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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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.
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)
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary – K212260
Sensuva Premium Silicone Personal Lubricant
| 510(k) Owner/Submitter: | Valencia Naturals, Inc. |
|---|---|
| Street Address: | 9731 Topanga Canyon Place |
| Chatsworth, CA 91311 | |
| Contact Person(s): | Anthony Santoro |
| President, 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: Condom |
| Regulation Number: 21 CFR 884.5300 | |
| Product Code: NUC (lubricant, personal) | |
| Regulatory Class: Class II | |
| Predicate Device: | Product Name: Silicone Personal Lubricant |
| 510(k) Number: K180083 | |
| Manufacturer: United Consortium | |
| Product 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 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.
4
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 and | Less than 100 cfu/g |
| Total yeast and mold count (TYMC) per USP and | Less than 10 cfu/g |
| Presence of Pathogens per USP ( Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella/Shigella, Escherichia coli, Candida albicans ) | 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
Personal Lubricant
K212260
Subject Device | Silicone Personal
Lubricant
K180083
Predicate Device | Comparison |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification
Name | Lubricant, Personal | Lubricant, Personal | Same |
| Product Code | NUC | NUC | Same |
| 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
ofintimate sexual activity and
supplement the body's natural | Silicone Personal Lubricant
is a silicone-based personal
lubricant for penile, anal
and/or vaginal application,
intended to lubricate and
moisturize, to enhance the
ease and comfort of
intimate sexual activity and
supplement thebody's | The subject and
predicate device
have the same
indications for use
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
Ingredients | 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 |