(138 days)
Not Found
No
The 510(k) summary describes a personal lubricant and does not mention any AI or ML components or functionalities.
Yes
The device is a personal lubricant intended to moisturize and lubricate to enhance comfort during sexual activity, which is a therapeutic purpose.
No
This device is described as a personal lubricant intended to moisturize and lubricate for enhancing intimate sexual activity, which is a therapeutic or supportive function, not a diagnostic one.
No
The device description clearly states it is a silicone-based personal lubricant comprised of chemical components, indicating it is a physical substance, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for personal lubrication during sexual activity, applied to the body (penile and/or vaginal).
- Device Description: It's a silicone-based personal lubricant.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
This device is applied to the body for a physical purpose (lubrication), not used to test samples from the body.
N/A
Intended Use / 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.
Product codes
NUC
Device Description
Sensual Massage/Ultra Pure is a non-sterile, silicone-based personal lubricant comprised on dimethoconol, dimethicone, and cyclopentasiloxane. This over-the-counter 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile 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
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, non-irritating, 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.
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 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
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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) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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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 |
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 | Total mold/yeast count | ||
| 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.