Belle Sensilube 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. Belle Sensilube is compatible with natural rubber latex and polyisoprene condoms. Belle Sensilube is not compatible with polyurethane condoms.

Device Description

Belle Sensilube is a water-based personal lubricant for over-the-counter use. The subject device is a non-sterile liquid preparation containing water, propylene qlycol, hyroxyethylcellulose, polyacrylamide anionic, lactic acid and potassium lactate, and benzoic acid. The subject device will be packaged in a 40 mL high-density polyethylene bottle fitted with a polypropylene cap. The lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

AI/ML Overview

The provided text describes the submission of a 510(k) premarket notification for a personal lubricant named "Belle Sensilube." This document focuses on demonstrating the substantial equivalence of Belle Sensilube to a legally marketed predicate device (KY Banksy Aloe) rather than outlining a study that proves a device meets specific acceptance criteria for a new medical device.

The information you are requesting, such as ground truth establishment for a test set, sample sizes for training/test sets in the context of an AI/ML-driven device, multireader-multicase studies or the effect size of AI assistance on human readers, and the number of experts for ground truth, is not present in this document. This is because Belle Sensilube is a physical product (personal lubricant), not an AI/ML-driven medical device that would require such studies. The regulatory submission process for this type of device primarily involves demonstrating biocompatibility, shelf-life, and compatibility with other medical devices (like condoms) to establish substantial equivalence to an existing product.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them in the context of an AI/ML device, as the provided document pertains to a personal lubricant.

However, I can extract the "acceptance criteria" (specifications) and performance data for Belle Sensilube as a physical product from the document.

Acceptance Criteria and Reported Device Performance for "Belle Sensilube" (as a physical product):

The table below summarizes the specifications (acceptance criteria) for the Belle Sensilube personal lubricant and the implied performance, as the document states the device met these specifications.

Parameter	Test Method	Specification (Acceptance Criteria)	Reported Device Performance (Implied from the document)
Appearance	Visual	Clear, colorless liquid gel, free from lumps and extraneous matter	Met specification: Clear, colorless liquid gel, free from lumps and extraneous matter.
Odor	Olfactory	No objectionable odor	Met specification: No objectionable odor.
pH	USP <791>	3.5 - 4.5	Met specification: pH was within 3.5 - 4.5.
Viscosity	USP <912>	400 - 1,500 cPs	Met specification: Viscosity was within 400 - 1,500 cPs.
Osmolality	USP <785>	260 - 380 mOsm/kg	Met specification: Osmolality was within 260 - 380 mOsm/kg.
Antimicrobial Effectiveness	EP 5.1.3 / USP <51>	Meets USP <51> acceptance criteria for Category 2 products (e.g., bacteria: ≥ 2.0 log reduction at 14 days, no increase from 14-day to 28-day; yeast/molds: no increase from initial calculated count at 14 and 28 days).	Met specification: Demonstrated antimicrobial effectiveness per USP <51> Category 2 criteria.
Total Microbial Count	EP 2.6.12 / USP <61>	<100 cfu/g	Met specification: Total microbial count was <100 cfu/g.
Fungal/Yeast/Mold Limits	EP 2.6.12 / USP <61>	<10 cfu/g	Met specification: Fungal/Yeast/Mold limits were <10 cfu/g.
Absence of Pathogenic Organisms	EP 2.6.13 / USP <62>	Absent (Staphylococcus Aureus, Pseudomonas Aeruginosa, Candida Albicans)	Met specification: Pathogenic organisms (Staphylococcus Aureus, Pseudomonas Aeruginosa, Candida Albicans) were absent.
Content of benzoic acid	Spectrophotometric	0.13 - 0.22% w/w	Met specification: Content of benzoic acid was within 0.13 - 0.22% w/w.
Biocompatibility	ISO 10993-1, 5, 10, 11, 23 (various parts)	Non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic.	Met specification: Results demonstrate the lubricant is non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic.
Shelf Life	ASTM F1980-16 (accelerated aging for 9 months at 40°C)	Maintain all Table 1 specifications over a 24-month shelf-life.	Met specification: Device specifications from Table 1 were tested across the device shelf-life and the device met the specifications at all time points, supporting a 24-month shelf-life.
Condom Compatibility	ASTM D7661-10	Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms.	Met specification: Belle Sensilube is compatible with natural rubber latex and polyisoprene condoms, and not compatible with polyurethane condoms.

Since the document is for a personal lubricant, the following requested information is not applicable:

Sample size used for the test set and the data provenance: Not an AI/ML context. Testing for physical properties does not typically involve "test sets" in the same way.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for a lubricant's physical or chemical properties is established by laboratory measurements against defined standards, not by expert consensus readings of data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as this is not an AI-driven device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for a lubricant is based on chemical/physical testing standards (e.g., USP, EP, ASTM standards) and biocompatibility testing.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 20, 2023

RB Health (US) LLC Kaitlyn Chan Regulatory Associate 399 Interpace Parkway Parsippany, NJ 07054-0224

Re: K230781 Trade/Device Name: Belle Sensilube Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 15, 2023 Received: March 22, 2023

Dear Kaitlyn Chan:

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.

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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/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,

Reginald K. Avery -S

for

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) K230781

Device Name Belle Sensilube

Indications for Use (Describe)

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)

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510(K) Summary - K230781 Belle Sensilube

l. General Information on Submitter

Applicant:	RB Health (US) LLC
Address:	399 Interpace ParkwayParsippany NJ 07054-0224
Telephone:	862-702-0012
Contact Person:	Kaitlyn Chan
Contact Title:	Regulatory AssociateRB Health (US) LLC
Email:	kaitlyn.chan@reckitt.com
Date Prepared:	June 12, 2023

II. General Information on Device

Proprietary Name:	Belle Sensilube
Common Name:	Personal Lubricant
Regulation Name:	Condom
Regulation Number:	21 CFR 884.5300
Regulatory Class:	II
Product Code:	NUC (Lubricant, Personal)

lll. Predicate Device

Predicate Device	510(k) Number
KY Banksy Aloe	K183302

This predicate device has not been subject to a design-related recall.

IV. Description of Device

The subject device will be packaged in a 40 mL high-density polyethylene bottle fitted with a polypropylene cap. The lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

The specifications for Belle Sensilube are described in Table 1.

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Parameter	Test Method	Specification
Appearance	Visual	Clear, colorless liquid gel, free from lumps and extraneous matter
Odor	Olfactory	No objectionable odor
pH	USP <791>	3.5 - 4.5
Viscosity	USP <912>	400 - 1,500 cPs
Osmolality	USP <785>	260 - 380 mOsm/kg
AntimicrobialEffectiveness	EP 5.1.3 / USP<51>*	Meets USP <51> acceptance criteria for Category 2 products. Category 2, bacteria should show not less than 2.0 log reduction at 14 days and no increase from the 14-day count to the 28-day count. Yeast and molds should show no increase from the initial calculated count at 14 and 28 days
Total Microbial Count	EP 2.6.12 / USP<61>*	<100 cfu/g
Fungal/Yeast/MoldLimits	EP 2.6.12 / USP<61> *	<10 cfu/g
Absence of PathogenicOrganisms( Staphylococcus Aureus,PseudomonasAeruginosa, CandidaAlbicans )	EP 2.6.13 / USP<62>*	Absent
Content of benzoic acid	Spectrophotometric	0.13 - 0.22% w/w

Table 1. 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 <61>, <62>, and <51>, respectively.

V. Indications for Use

VI. Substantial Equivalence Discussion

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Comparison of the technological features of the subject and predicate devices is provided in Table 2 below:

Table 2. Technological Characteristics of Subject Device Compared to Predicate

Characteristic /Feature	Belle Sensilube (subjectdevice)	KY Banksy Aloe(predicate device) –K183302	Comparison
Indication for use	Belle Sensilube is intended forpenile, vaginal and/or analapplication to moisturize andlubricate, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. BelleSensilube is compatible withnatural rubber latex andpolyisoprene condoms. BelleSensilube is not compatiblewith polyurethane condoms.	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.	Same
Water-BasedLubricant	Yes	Yes	Same
Over the Counter	Yes	Yes	Same
Not acontraceptive orSpermicide	Yes	Yes	Same
Non-sterile	Yes	Yes	Same
PrimaryIngredients	Water, propylene glycol,hydroxyethylcellulose,polyacrylamide anionic, lacticacid and potassium lactate,and benzoic acid	Water, propanediol, xanthangum, benzoic acid, aloebarbadensis leaf juice,potassium lactate, and lacticacid	Different: The ingredients of thepredicate device are different;the ingredients do not raisedifferent questions of Safety &Effectiveness (S & E)
Microbial Limits	Total mold/yeast count <10cfu/mLTotal aerobic microbial count<100 cfu/mLAbsence of pathogens(Candida albicans,Pseudomonas aeruginosa,Staphylococcus aureus)	Total mold/yeast count <10cfu/mLTotal aerobic microbial count<100 cfu/mLAbsence of pathogens(Candida albicans,Pseudomonas aeruginosa,Staphylococcus aureus)	Same
Viscosity	400 - 1,500 cPs	3,000 - 8,000 cPs	Different
Osmolality	260 - 380 mOsm/kg	270 - 670 mOsm/kg	Different
pH	3.5 - 4.5	3.5 – 4.5	Same
CondomCompatibility	Compatible with natural rubberlatex and polyisoprenecondoms; not compatible withpolyurethane condoms	Compatible with natural rubberlatex and polyisoprenecondoms; not compatible withpolyurethane condoms	Same

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The subject and predicate devices have identical indications for use and have the same intended use - to provide lubrication during intimate sexual activity. The subject and predicate devices have different technological characteristics, including different formulations and device specifications. The different technological characteristics do not raise different types of safety and effectiveness questions.

VII. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 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/(R)2014) ●
Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010)
Vaginal Irritation (ISO 10993-23: 2021) ●
Acute Systemic Toxicity (ISO 10993-11:2017) .

The results of this testing demonstrate that the subject lubricant is non-cytotoxic, nonirritating, non-sensitizinq, and not systemically toxic.

Shelf Life

The subject device is a non-sterile personal lubricant packaged in a 40 mL bottle with a 24-month shelf-life in accordance with the results of an accelerated aging study. conducted for 9 months at 40°C per ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The device specifications listed in Table 1 were tested across the device shelf-life and the subject device met the specifications at all time points.

Condom Compatibility

The subject device was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane condoms using ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms". The results show that Belle Sensilube is compatible with natural rubber latex and polyisoprene condoms. Belle Sensilube is not compatible with polyurethane condoms.

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VIII. Conclusion

The results of the testing described above demonstrate that the Belle Sensilube 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.