(140 days)
No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML technologies.
Yes
The intended use of the device is to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication, which is indicative of a therapeutic effect. Additionally, the biocompatibility studies performed align with the requirements for therapeutic devices.
No
Explanation: The device is a personal lubricant for moisturizing and lubrication during sexual activity, not for diagnosing any medical condition.
No
The device description clearly states it is a personal lubricant with a specific chemical formulation and is packaged in physical tubes. It undergoes biocompatibility and shelf-life testing, which are characteristic of 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 "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 topical application for physical lubrication and comfort during sexual activity.
- Device Description: The device is described as a "personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity." This aligns with the intended use of a personal lubricant.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any medical condition. IVDs are specifically designed to perform tests on samples from the human body (like blood, urine, tissue) to provide information for diagnosis or monitoring.
The information provided clearly indicates that this device is a personal lubricant intended for physical application, not for in vitro diagnostic testing.
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
K Y Banksy Aloe is a personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of Water, Propanediol, Xanthan Gum, Benzoic Acid, Aloe Barbadensis Leaf Juice, Potassium Lactate and Lactic Acid. KY Banksy Aloe is packaged in 100 mL tubes composed of High Density Polyethylene (HDPE) and Low-Density Polyethylene (LDPE), covered with a 50 micron aluminium/linear low-density polyethylene seal and fitted with the Polypropylene (PP) cap. The tube is packaged in an outer cardboard carton. KY Banksy Aloe is a personal lubricant for over-the-counter (OTC) use.
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
Over-The-Counter 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
Shelf life: KY Banksy Aloe has a 2-year shelf life in accordance with the results of an accelerated aging stability study. Results from testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of its shelf life.
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:
- Cytotoxicity (ISO 10993-5: 2009): The subject device test article showed no evidence of . causing cell lysis or cytotoxicity to L-929 cells and therefore is not cytotoxic.
- . Vaginal Irritation (ISO 10993-10: 2010): 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 non-irritant to vaginal tissue of the rabbit
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010): 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.
- . Acute Systemic Toxicity (ISO 10993-11: 2006): There was no mortality or evidence of systemic toxicity for the subject device.
Condom Compatibility: KY Banksy Aloe was tested in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" 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
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
April 16, 2019
RB Health (US) LLC Elizabeth Viguerie, MPH Senior Regulatory Associate 399 Interpace Parkway Parsippany, NJ 07054
Re: K183302 Trade/Device Name: KY Banksy Aloe Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 13, 2019 Received: March 15, 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, 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/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 medical devices and radiation-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 Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183302
Device Name KY Banksy Aloe
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)
|X 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 K183302
KY Banksy Aloe
Submitted by: RB Health (US) LLC 399 Interpace Parkway Parsippany NJ 07054-0224 973-404-2715
- Contact Person: Elizabeth Viguerie Senior Regulatory Associate RB Health (US) LLC 973-404-2715
- April 15, 2019 Date Prepared:
- Trade Name: KY Banksy Aloe
- Common Name: Personal Lubricant
- Regulation Number: 21 CFR 884.5300
- Regulation Name: Condom
- Product Code: NUC (Lubricant, Personal)
- Regulatory Class: Class II
- Predicate Device(s): K-Y ® Marilyn Pleasure Gel Reckitt Benckiser LLC 510(k) No.: K151884
The predicate device has not been subject to a design-related recall.
Description of the Device:
K Y Banksy Aloe is a personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of Water, Propanediol, Xanthan Gum, Benzoic Acid, Aloe Barbadensis Leaf Juice, Potassium Lactate and Lactic Acid. KY Banksy Aloe is packaged in 100 mL tubes composed of High Density Polyethylene (HDPE) and Low-Density Polyethylene (LDPE), covered with a 50 micron aluminium/linear low-density polyethylene seal and fitted with the Polypropylene (PP)
4
cap. The tube is packaged in an outer cardboard carton. KY Banksy Aloe is a personal lubricant for over-the-counter (OTC) use.
Device specifications are listed in Table 1 below.
| Property | Specification |
|---|---|
| Appearance | Clear to slightly yellow color and homogenous gel, free from extraneous matter |
| Odor | Odorless |
| Viscosity | 3,000 - 8,000 cps |
| Osmolality | 270 - 670 mOsm/kg |
| pH at 25 °C | 3.5 - 4.5 |
| Total Yeast and Mold Count (TYMC, per EP 8.0 Section: 2.6.12)* | Pseudomonas aeruginosa Absent |
| Staphylococcus aureus Absent | |
| Candida albicans Absent | |
| Preservative Effectiveness Testing (PET, per EP 8.0 Section: 5.1.3)* | Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus NLT 3.0 log reduction from the initial count at 7 days, and no increase from the 7 days' count at 28 days |
| Candida albicans, Aspergillus niger (A. brasiliensis) 2.0 log reduction from the initiation count at 14 days, and no increase from the 14 days' count at 28 days |
Table 1: Subject Device Specifications
- European Pharmacopoeia (EP) standards EP 8.0 Sections 2.6.12, 2.6.13, and 5.1.3 have harmonized with or have comparable specifications to USP standards USP , , and , respectively.
5
Indications of Use Statement: 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.
Summary of Technological Characteristics of New Device in Comparison to Predicate: Comparison of the technological features of the subject and predicate devices is provided in Table 2 below:
| 510(k) | K183302 | K151884 |
|---|---|---|
| Subject Device | Predicate Device | |
| Device Name | KY Banksy Aloe | KY Marilyn Pleasure Gel |
| 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. | KY Marilyn is indicated 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 |
| Base Type | Water | Water |
| Sterile | No | No |
| Primary | ||
| Ingredients | Water, Propanediol, Xanthan Gum, Benzoic | |
| Acid, Aloe Barbadensis Leaf Juice, | ||
| Potassium Lactate, Lactic Acid | Water, Glycerin, Propylene Glycol, | |
| Hydroxyethylcellulose, PEG-40 Hydrogenated | ||
| Castor Oil, Flavor, Benzoic Acid, Sodium | ||
| Hydroxide | ||
| Biocompatibility | ||
| Tested | Yes | Yes |
| Antimicrobial | ||
| Tested | Yes | Yes |
| Condom | ||
| Compatibility | Compatible with natural rubber latex and | |
| polyisoprene condoms. Not compatible with | ||
| polyurethane condoms. | Same | |
| Shelf Life | 2 years | 9 months |
Table 2: Technological Characteristics of Subject Device Compared to Predicate
The subject and predicate devices do not have identical indications for use statements. The indication for the subject devices 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 device and predicate devices also have different technological characteristics, including their formulation and shelf life. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.
6
Summary of Performance Testing:
Shelf life: KY Banksy Aloe has a 2-year shelf life in accordance with the results of an accelerated aging stability study. Results from testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of its shelf life.
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:
- Cytotoxicity (ISO 10993-5: 2009): The subject device test article showed no evidence of . causing cell lysis or cytotoxicity to L-929 cells and therefore is not cytotoxic.
- . Vaginal Irritation (ISO 10993-10: 2010): 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 non-irritant to vaginal tissue of the rabbit
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010): 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.
- . Acute Systemic Toxicity (ISO 10993-11: 2006): There was no mortality or evidence of systemic toxicity for the subject device.
Condom Compatibility: KY Banksy Aloe was tested in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and was determined to be compatible with natural rubber latex and polyisoprene condoms. It was determined not to be compatible with polyurethane condoms.
Conclusion: The results of the performance testing described above demonstrate that the K Y Banksy Aloe is as safe and effective as the predicate device and supports a determination of substantial equivalence