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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "KY Banksy Moisture," a personal lubricant. It doesn't contain information about AI/ML models, human-in-the-loop performance, or a comparative effectiveness study. Therefore, I cannot provide details on those aspects.

However, I can extract the acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device.

Here's the information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Property	Acceptance Criteria (Specification)	Reported Device Performance
Appearance	Clear colorless and homogeneous gel, free from extraneous matter	Clear colorless and homogeneous gel, free from extraneous matter
Odor	Odorless	Odorless
Viscosity	Release: 3,000 – 6,500 cps; Stability: 3,000 - 8,000 cps	Maintained within specified ranges for release and stability.
pH at 25°C	3.5 – 4.5	Maintained within the specified range.
Benzoic Acid	Release: 0.207 – 0.253 %w/w; Stability: 0.150 - 0.253 %w/w	Maintained within specified ranges for release and stability.
Osmolality	1050 to 1250 mOsm/kg	Maintained within the specified range.
Total Yeast and Mold Count (TYMC)	≤10 cfu/g (per EP 8.0 Section: 2.6.12)	<10 cfu/g
Total Aerobic Microbial Count (TAMC)	≤100 cfu/g (per EP 8.0 Section: 2.6.12)	<100 cfu/g
Preservative Effectiveness (Escherichia coli)	NLT 3.0 log reduction from the initial count at 7 days, and no increase from the 7 days' count at 28 days (per EP 8.0 Section: 5.1.3)	Device met the criteria.
Preservative Effectiveness (Pseudomonas aeruginosa)	NLT 3.0 log reduction from the initial count at 7 days, and no increase from the 7 days' count at 28 days (per EP 8.0 Section: 5.1.3)	Device met the criteria.
Preservative Effectiveness (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 (per EP 8.0 Section: 5.1.3)	Device met the criteria.
Preservative Effectiveness (Candida albicans)	2.0 log reduction from the initiation count at 14 days, and no increase from the 14 days' count at 28 days (per EP 8.0 Section: 5.1.3)	Device met the criteria.
Preservative Effectiveness (Aspergillus niger)	2.0 log reduction from the initiation count at 14 days, and no increase from the 14 days' count at 28 days (per EP 8.0 Section: 5.1.3)	Device met the criteria.
Total Specified Organisms (e.g., Pseudomonas aeruginosa)	Absent (per EP 8.0 Section: 2.6.13)	Absent
Total Specified Organisms (e.g., Staphylococcus aureus)	Absent (per EP 8.0 Section: 2.6.13)	Absent
Total Specified Organisms (e.g., Candida albicans)	Absent (per EP 8.0 Section: 2.6.13) -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Absent -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Biocompatibility (Cytotoxicity)	Showed no evidence of causing cell lysis or cytotoxicity to L-929 cells, indicating non-cytotoxic.	Not cytotoxic.
Biocompatibility (Vaginal Irritation)	An Irritation Index of 0, with macroscopically normal vaginal tissue.	Non-irritant to vaginal tissue.
Biocompatibility (Sensitization)	No evidence of causing delayed dermal contact sensitization.	Not a sensitizer.
Biocompatibility (Acute Systemic Toxicity)	No mortality or evidence of systemic toxicity.	Met the requirements of ISO10993-11.
Shelf-Life	Maintain specifications over a 2-year duration.	Maintained specifications for 2 years. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Condom Compatibility (Natural Rubber Latex)	Compatible. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Compatible.
Condom Compatibility (Polyisoprene)	Compatible. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Compatible.
Condom Compatibility (Polyurethane)	Not compatible. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Not compatible.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for each test, but studies were conducted.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the studies are for physical/chemical properties and biological compatibility, not for expert interpretation of medical images or data. No "ground truth" in the clinical imaging sense is established by experts here.

4. Adjudication method for the test set

Not applicable for these types of laboratory and physical property tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a personal lubricant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable as this is not an algorithm-based device. The performance tests are for the physical, chemical, and biological properties of the lubricant itself.

7. The type of ground truth used

The "ground truth" for demonstrating the device meets acceptance criteria is based on:
- Scientific Standards: Conformance to specified physical, chemical, and microbiological parameters (e.g., viscosity, pH, osmolality, microbial counts).
- Biological Standards: Results from established biocompatibility tests (cytotoxicity, irritation, sensitization, acute systemic toxicity) according to ISO 10993 standards.
- Performance Standards: Compatibility testing with condoms according to ASTM D7661-10.
- Stability Studies: Accelerated shelf-life testing.

8. The sample size for the training set

Not applicable as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable as this is not an AI/ML device that requires a training set or its associated ground truth establishment.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K183505

Device Name KY Banksy Moisture

Indications for Use (Describe)

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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510 (k) Summary - K183505

1. Submitter Information

Applicant:	RB Health (US) LLC.
Contact:	Elizabeth ViguerieSenior Regulatory Associate
Address:	399 Interpace ParkwayParsippany NJ 07054-0224, USA
Phone:	(973) 404-2600

2. Correspondent Information

Contact:	Elizabeth Viguerie
Address:	399 Interpace ParkwayParsippany 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

Table 1: Device Specifications for KY Banksy Moisture

Property	Specification
Appearance	Clear colorless and homogeneous gel, free fromextraneous matter
	Odor

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Viscosity	Release: 3,000 – 6,500 cpsStability: 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/wStability: 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) *	<10 cfu/g
Total Aerobic Microbial Count (TAMC ≤100 cfu/g per EP 8.0 Section: 2.6.12) *	<100 cfu/g
Preservative Effectiveness Testing (per EP 8.0 Section: 5.1.3) *
Escherichia coli	NLT 3.0 log reduction from the initial count at 7 days, and no increase from the 7 days' count at 28 days
Pseudomonas aeruginosa	NLT 3.0 log reduction from the initial count at 7 days, and no increase from the 7 days' count at 28 days
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	2.0 log reduction from the initiation count at 14 days, and no increase from the 14 days' count at 28 days
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
Total Specified Organisms (per EP 8.0 Section: 2.6.13)	Specification
Pseudomonas aeruginosa	Absent
Staphylococcus aureus	Absent
Candida albicans	Absent

*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 <61>, <62>, and <51>, respectively.

7. Indications for Use

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)
---------	---------------------------------	----------------------

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Indications for Use
	This product is intended forpenile, vaginal and/or analapplication to moisturize andlubricate, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. Thisproduct is compatible withnatural rubber latex andpolyisoprene condoms. Thisproduct is not compatible withpolyurethane condoms.	This product is intended forpenile and/or vaginalapplication intended tomoisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubberlatex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms.
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 BFP/41, Sodium hyaluronate, Water	Hydroxyethylcellulose, PropyleneGlycol, Glycerol, MultisensateFlavor, Sodium Hydroxide, PEG-40 HydrogenatedCastor 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.

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. 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.

Regulation Number and Section

§ 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.