← Product Code [NUC](/productcode/NUC) · K211967 # Sensual Massage, Ultra Pure (K211967) _Dreambrands, Inc. · NUC · Nov 9, 2021 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K211967 ## Device Facts - **Applicant:** Dreambrands, Inc. - **Product Code:** [NUC](/productcode/NUC.md) - **Decision Date:** Nov 9, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.5300 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use Sensual Massage/Ultra Pure is a personal lubricant, for penile 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms. ## Device Story Sensual Massage/Ultra Pure is a non-sterile, silicone-based personal lubricant; formulated with dimethiconol, dimethicone, and cyclopentasiloxane. Intended for over-the-counter use to moisturize and lubricate during intimate sexual activity. Device is clear, odorless, and non-greasy. Applied topically by the user. Provides physical lubrication to supplement natural body fluids; enhances comfort during sexual activity. Compatible with natural rubber latex and polyisoprene condoms; incompatible with polyurethane condoms. Does not function as a contraceptive or spermicide. ## Clinical Evidence Bench testing only. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity) confirmed non-cytotoxic, non-irritating, non-sensitizing, and non-toxic. Shelf life validated to 3 years via accelerated (ASTM F1980-16) and real-time aging. Condom compatibility confirmed per ASTM D7661-10 for natural rubber latex and polyisoprene. ## Technological Characteristics Silicone-based lubricant; ingredients: dimethiconol, dimethicone, cyclopentasiloxane. Viscosity: 200–400 cps. Water activity: <0.3 Aw. Non-sterile. Shelf life: 3 years. Testing standards: ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ASTM F1980-16, ASTM D7661-10, USP <61>, USP <62>. ## Regulatory 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 - SILICONE Personal Lubricant ([K191654](/device/K191654.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 9, 2021 Dreambrands, Inc. % Cheryl Wagoner Consultant Wagoner Consulting LLG P.O. Box 15729 Wilmington NC 28408 Re: K211967 > Trade/Device Name: Sensual Massage/Ultra Pure Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 5, 2021 Received: October 7, 2021 Dear Cheryl Wagoner: 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 and Part 809); 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, 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) K211967 Device Name Sensual Massage/Ultra Pure #### Indications for Use (Describe) Sensual Massage/Ultra Pure is a personal lubricant, for penile 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 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) | |------------------------------------------------------------|-----------------------------------------------------------| |------------------------------------------------------------|-----------------------------------------------------------| 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 – K211967 | Submitter | Dreambrands, Inc.
11645 N Cave Creek Rd Ste 5 Phoenix, AZ, 85020-1300 United
States | |----------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Cecile Kehoe
R&D/Regulatory/QA, Dreambrands, Inc.
11645 N. Cave Creek Road
Phoenix, AZ 85020
(602)354-7640
(602)354-7641 fax | | Date Prepared | November 5, 2021 | | Trade Name | Sensual Massage/UltraPure | |-------------------|---------------------------| | Common Name | Personal Lubricant | | Regulation Name | Condom | | Regulation Number | 21 CFR 884.5300 | | Product Code | NUC (Lubricant, Personal) | | Regulatory Class | Class II | ### Predicate Device | SILICONE Personal
Lubricant | Bath Concept Cosmetics
(Dongguan) Co., Ltd | K191654 | |--------------------------------|-----------------------------------------------|---------| |--------------------------------|-----------------------------------------------|---------| The predicate device has not been subject to a design-related recall ### Device Description Sensual Massage/Ultra Pure is a non-sterile, silicone-based personal lubricant comprised on dimethoconol, dimethicone, and cyclopentasiloxane. This over-thecounter product is formulated to be clear, non-greasy, and odorless. The Sensual Massage/Ultra Pure lubricant is neither a contraceptive nor a spermicide. Sensual Massage is available in 2 oz. And 50 ml bottles. The device specifications are listed in the table below. | Parameter | Specification | |---------------------------------------------------|------------------------------------------------------------------| | Appearance | Clear | | Color | Colorless | | Odor | Odorless | | Viscosity | 200 cps – 400 cps | | Water Activity | <0.3 Aw | | Total aerobic microbial count (TAMC) per USP <61> | TAMC <100 cfu/g | | Total yeast and mold count (TYMC) per USP <61> | TYMC <10 cfu/g | | Absence of Pathogenic Organisms per USP <62> | Absence of pathogenic organisms (specifically absence of Candida | {4}------------------------------------------------ | | albicans, Pseudomonas
aeruginosa, Salmonella,
Staphylococcus aureus,
E.Coli, Clostridium
sporogenes, Bile-tolerant
gram-negative bacteria) | |--|-----------------------------------------------------------------------------------------------------------------------------------------------------------| |--|-----------------------------------------------------------------------------------------------------------------------------------------------------------| ## Indications for Use Sensual Massage/Ultra Pure is a personal lubricant, for penile 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms. ## Comparison of the Intended Use and Technological Characteristics of the Subject and Predicate Device The table below details a comparison the intended use and technological characteristics of the subject device and the predicate device. | Device &
Predicate
Device(s): | K211967 | K191654 | Comments | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Device Name | Sensual Massage
/UltraPure | SILICONE Personal
Lubricant | | | Intended Use | Sensual
Massage/UltraPure is an
over-the-counter personal
lubricant. | SILICONE Personal
Lubricant is an over-
the-counter personal
lubricant. | Same | | Indications
for Use | Sensual Massage/Ultra
Pure is a personal
lubricant, for penile 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 | SILICONE Personal
Lubricant is a personal
lubricant, for penile
and/or vaginal
application, intended to
moisturize and
lubricate, to enhance
the ease and comfort
of intimate sexual
activity and
supplement the body's | Same | | | | | | | | natural rubber latex and
polyisoprene condoms.
This product is not
compatible with
polyurethane condoms | natural lubrication. This
product is compatible
with natural rubber
latex and polyisoprene
condoms. This product
is not compatible with
polyurethane condoms. | | | Environment of
Use | OTC | OTC | Same | | Condom
Compatibility | Compatible with natural
rubber latex and
polyisoprene condoms.
Not compatible with
polyurethane condoms. | Compatible with
natural rubber latex
and polyisoprene
condoms. Not
compatible with
polyurethane condoms. | Same | | Base Type | Silicone Based | Silicone Based | Same | | Primary
Ingredients | Dow 1503 Fluid
(Dimethicone/Dimethiconol
blend)
Dow ST-Cyclomethicone
5-NF
Dow Silicone Fluid 1,000
cst (Dimethicone) | Dimethicone
Dimethiconol | Different | | Odor | Odorless | Odorless | Same | | Appearance | Clear | Clear | Same | | Sterility | Non-sterile | Non-sterile | Same | | Viscosity | 200 – 400 cps | 300 - 700 cps | Different | | Water Activity | <0.3 Aw | 30 - 33% | Different | | Microbial
Examination
USP <61> | Total mold/yeast count
<10 cfu/mL | Total mold/yeast count
<10 cfu/mL | Same | | | Total aerobic microbial
count <10 cfu/mL | Total aerobic microbial
count <10 cfu/mL | | | | Absence of pathogens
(Candida albicans,
Pseudomonas aeruginosa,
Salmonella,
Staphylococcus aureus,
E.Coli, Clostridium
sporogenes, Bile-tolerant | Absence of pathogens
(E. Coli,
Pseudomonas
aeruginosa,
Staphylococcus
aureus,
Salmonella Entrica | | | | | | | | | gram-negative bacteria) | subsp,
Candida Albicans,
Clostridium
sporogenes,
Bile-tolerant gram-
negative bacteria) | | | Absence of
Pathogenic
Organisms
USP <62> | Absence Confirmed | Absence Confirmed | Same | | Shelf Life | 3 years | 3 years | Same | {5}------------------------------------------------ {6}------------------------------------------------ The subject and predicate device have similar indications for use statements and have the same intended use (i.e., to provide lubrication during intimate sexual activity). The subject and predicate device have different technological characteristics including different formulations and device specifications. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness. # Summary of Performance Data # Biocompatibility Biocompatibility testing was performed in accordance with ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing" including: - ISO 10993-5:2009 Cytotoxicity (Direct contact) . - ISO 10993-10:2010 Guinea Pig Maximization Sensitization test . - ISO 10993-10:2010 Vaqinal Irritation ● - ISO 10993-11:2017 Acute Systemic Toxicity ● The results of this testing demonstrated that the subject lubricant is non-cytotoxic, nonirritating, non-sensitizing, and not systematically toxic. # Shelf life Sensual Massage/UltraPure has a 3 year (36 months) shelf life based on the results of an accelerated (per ASTM F1980-16) and real-time aging study. The results of the shelf life study demonstrated that the subject device meet all device specifications at baseline and throughout the proposed shelf life. # Condom Compatibility Condom compatibility testing was performed using the methods outlined in ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms". Testing results demonstrate that the subject device is compatible with natural latex and polyisoprene condoms. The subject device is not compatible with polyurethane condoms. {7}------------------------------------------------ ## Conclusion The results of the performance testing described above demonstrate that Sensual Massage/Ultra Pure is as safe and effective as the predicate device and supports a determination of substantial equivalence. --- **Source:** [https://fda.innolitics.com/device/K211967](https://fda.innolitics.com/device/K211967) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com