(150 days)
No
The device description and performance studies focus on the chemical composition, packaging, biocompatibility, shelf-life, and condom compatibility of a personal lubricant. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, which falls under general wellness/lifestyle rather than treatment or diagnosis of a disease or condition.
No
The intended use of the device is to moisturize, lubricate, and enhance comfort during sexual activity, not to diagnose any condition.
No
The device description clearly states it is a water-based personal lubricant and describes its physical components (tube material, seal, cap, packaging). There is no mention of software as a component or function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "penile, vaginal and/or anal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This describes a device used on or in the body for physical purposes, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: The description details a personal lubricant with specific ingredients and packaging. This aligns with a topical or internal-use medical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
This product is intended for penile, vaginal and/or anal application 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
KY Banksy Moisture will be marketed as a non-sterile, non-prescription medical device for over-the-counter (OTC) use. This device is a water-based personal lubricant that contains: Water, Glycerin, Propanediol, Xanthan Gum, Benzoic Acid, Sodium Hyaluronate, Potassium Lactate and Lactic Acid. The tube material is composed of High-Density Polyethylene (HDPE) and Low-Density Polyethylene (LDPE), covered with a 50-micron aluminum/inear low-density polyethylene seal and fitted with the Polypropylene (PP) cap. The tube will be packaged in an outer cardboard carton.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, vaginal and/or anal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Non-prescription medical device for over-the-counter (OTC) use.
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
Biocompatibility studies were performed in accordance with the 2016 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" and ISO 10993- 1:2009 as follows:
- ISO10993-5:2009: Cytotoxicity: The subject device test article showed no evidence of causing cell lysis or cytotoxicity to L-929 cells and therefore is not cytotoxic.
- ISO10993-10:2010: Vaginal Irritation: The Irritation Index for the subject device test article was 0. Macroscopically, the vaginal tissue was found to be normal. Therefore, the subject device was considered a nonirritant to vaginal tissue of the rabbit.
- ISO10993-10:2010: Guinea Pig Maximization Sensitization Test: The subject device test article solution showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test.
- ISO10993-11:2006: Acute Systemic Toxicity: There was no mortality or evidence of systemic toxicity of the subject device the subject device met the requirements of ISO10993-11.
Shelf-Life: Accelerated shelf-life testing was conducted on the subject device to support its labeled shelf-life period of 2 years. Results from testing demonstrated that the device can maintain its specifications over the duration of its shelf-life.
Condom Compatibility: KY Banksy Moisture was tested in accordance with ASTM D7661-10 and was determined to be compatible with natural rubber latex and polyisoprene condoms. It was determined not to be compatible with polyurethane condoms.
Key Metrics
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
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May 17, 2019
RB Health (US) LLC Elizabeth Viguerie Senior Regulatory Associate 399 Interpace Parkway Parsippany, NJ 07054
Re: K183505 Trade/Device Name: KY Banksy Moisture Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: April 15, 2019 Received: April 16, 2019
Dear Elizabeth Viguerie:
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. Iisting 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. 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
Sharon Andrews Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183505
Device Name KY Banksy Moisture
Indications for Use (Describe)
This product is intended for penile, vaginal and/or anal application 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 - K183505
1. Submitter Information
| Applicant: | RB Health (US) LLC. |
|---|---|
| Contact: | Elizabeth Viguerie |
| Senior Regulatory Associate | |
| Address: | 399 Interpace Parkway |
| Parsippany NJ 07054-0224, USA | |
| Phone: | (973) 404-2600 |
2. Correspondent Information
| Contact: | Elizabeth Viguerie |
|---|---|
| Address: | 399 Interpace Parkway |
| Parsippany NJ 07054-0224, USA | |
| Phone: | (973) 404-2600 |
| Email: | elizabeth.viguerie@rb.com |
May 17, 2019 3. Date prepared:
4. Device Information
| Device Name: | KY Banksy Moisture |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |
5. Predicate Device Information
| Device Name: | KY Marilyn |
|---|---|
| 510(k) Number: | K151884 |
| Manufacturer: | Reckitt Benckiser LLC |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |
The predicate device has not been subject to a design-related recall.
6. Device Description
KY Banksy Moisture will be marketed as a non-sterile, non-prescription medical device for over-thecounter (OTC) use. This device is a water-based personal lubricant that contains: Water, Glycerin, Propanediol, Xanthan Gum, Benzoic Acid, Sodium Hyaluronate, Potassium Lactate and Lactic Acid. The tube material is composed of High-Density Polyethylene (HDPE) and Low-Density Polyethylene (LDPE), covered with a 50-micron aluminum/inear low-density polyethylene seal and fitted with the Polypropylene (PP) cap. The tube will be packaged in an outer cardboard carton.
Table 1: Device Specifications for KY Banksy Moisture
| Property | Specification |
|---|---|
| Appearance | Clear colorless and homogeneous gel, free from |
| extraneous matter | |
| Odor |
4
| Viscosity | Release: 3,000 – 6,500 cps
Stability: 3,000 - 8,000 cps |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Osmolality | 850 – 1,200 mOsm/kg |
| pH at 25 | 3.5 – 4.5 |
| Benzoic Acid | Release: 0.207 – 0.253 %w/w
Stability: 0.150 - 0.253 %w/w |
| Osmolality | 1050 to 1250 mOsm/kg |
| Total Yeast and Mold Count (TYMC ≤10 cfu/g per EP 8.0 Section: 2.6.12) * | , , and , respectively.
7. Indications for Use
This product is intended for penile, vaginal and/or anal application 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.
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below lists the comparative indications for use and technological characteristics of the subject and predicate device.
Table 2: Comparator Table for Subject Device – KY Banksy Moisture and Predicate Device KY Marilyn
| Feature | KY Banksy Moisture
(K183505) | KY Marilyn (K151884) |
| --------- | --------------------------------- | ---------------------- |
|---|
5
| Indications for Use | ||
|---|---|---|
| This product is intended for | ||
| penile, vaginal and/or anal | ||
| application 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. | This product is intended 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. | ||
| Physical Features | Homogeneous Clear Gel/Odorless | Homogeneous Clear Gel/Odorless |
| Manufacturer | RB Health (US) LLC* | Reckitt Benckiser LLC |
| Base Type | Water | Water |
| Sterile | No | No |
| Primary Ingredients | Xantham Gum, Propanediol, | |
| Glycerin, Benzoic Acid, Purac BF | ||
| P/41, Sodium hyaluronate, Water | Hydroxyethylcellulose, Propylene | |
| Glycol, Glycerol, Multisensate | ||
| Flavor, Sodium Hydroxide, PEG- | ||
| 40 Hydrogenated | ||
| Castor Oil, Benzoic Acid, Water | ||
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Condom Compatibility | Yes | Yes |
| Shelf-life | 2-years | 2-years |
* Please note: Reckitt Benckiser LLC underwent a company name change in 2018 to RB Health (US) LLC.
The subject and predicate device have similar indications for use. The indication for the subject device has been expanded to also include anal use. This change does not represent a new intended use as the intended use of this device is the same as the predicate device, i.e., lubrication of an orifice during intimate sexual activity. The subject and predicate device have similar technological characteristics, including similar formulation. The different technological characteristics of the subject device do not raise of safety and effectiveness questions.
9. Summary of Non-Clinical Performance Testing
Biocompatibility
Biocompatibility studies were performed in accordance with the 2016 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" and ISO 10993- 1:2009 as follows: Based on the results of the below testing, this device was determined to be biocompatible and supports the intended use of the subject lubricant.
- . ISO10993-5:2009: Cytotoxicity: The subject device test article showed no evidence of causing cell lysis or cytotoxicity to L-929 cells and therefore is not cytotoxic.
- . ISO10993-10:2010: Vaginal Irritation: The Irritation Index for the subject device test article was 0. Macroscopically, the vaginal tissue was found to be normal. Therefore, the subject device was considered a nonirritant to vaginal tissue of the rabbit.
- ISO10993-10:2010: Guinea Pig Maximization Sensitization Test: The subject device test article solution showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test.
6
- . ISO10993-11:2006: Acute Systemic Toxicity: There was no mortality or evidence of systemic toxicity of the subject device the subject device met the requirements of ISO10993-11.
Shelf-Life
Accelerated shelf-life testing was conducted on the subject device to support its labeled shelf-life period of 2 years. Results from testing demonstrated that the device can maintain its specifications over the duration of its shelf-life.
Condom Compatibility
KY Banksy Moisture was tested in accordance with ASTM D7661-10 and was determined to be compatible with natural rubber latex and polyisoprene condoms. It was determined not to be compatible with polyurethane condoms.
10. Conclusion
The results of the performance testing described above demonstrate that the KY Banksy Moisture Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.