K Number
K230781
Device Name
Belle Sensilube
Manufacturer
Date Cleared
2023-06-20

(90 days)

Product Code
Regulation Number
884.5300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The summary describes a personal lubricant with no mention of AI or ML technology. The performance studies focus on biocompatibility, shelf life, and condom compatibility, which are standard tests for this type of device and do not involve AI/ML.

No
The device is a personal lubricant intended to enhance comfort during sexual activity, not to treat or cure a disease or medical condition, which is the characteristic of a therapeutic device.

No
The intended use of Belle Sensilube is to moisturize and lubricate for sexual activity, not to diagnose a condition or disease.

No

The device description clearly states it is a "non-sterile liquid preparation" and is packaged in a "40 mL high-density polyethylene bottle," indicating it is a physical product, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • 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. These tests are performed outside the body (in vitro).
  • Belle Sensilube's Intended Use: The intended use of Belle Sensilube 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 is a topical application for lubrication and comfort on the body, not a test performed on a sample from the body.
  • Device Description: The device description confirms it's a "water-based personal lubricant for over-the-counter use," a liquid preparation applied externally.

The information provided clearly indicates that Belle Sensilube is a personal lubricant for external use, which falls under a different regulatory category than In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

NUC

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.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K183302

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 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.

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/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

2

Indications for Use

510(k) Number (if known) K230781

Device Name Belle Sensilube

Indications for Use (Describe)

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 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)

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510(K) Summary - K230781 Belle Sensilube

l. General Information on Submitter

Applicant:RB Health (US) LLC
Address:399 Interpace Parkway
Parsippany NJ 07054-0224
Telephone:862-702-0012
Contact Person:Kaitlyn Chan
Contact Title:Regulatory Associate
RB 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 Device510(k) Number
KY Banksy AloeK183302

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

IV. Description of Device

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.

The specifications for Belle Sensilube are described in Table 1.

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ParameterTest MethodSpecification
AppearanceVisualClear, colorless liquid gel, free from lumps and extraneous matter
OdorOlfactoryNo objectionable odor
pHUSP3.5 - 4.5
ViscosityUSP400 - 1,500 cPs
OsmolalityUSP260 - 380 mOsm/kg
Antimicrobial
EffectivenessEP 5.1.3 / USP
  • | Meets USP 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
  • | * | Staphylococcus Aureus,
    Pseudomonas
    Aeruginosa, Candida
    Albicans ) | EP 2.6.13 / USP
  • | 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 , , and , respectively.

V. Indications for Use

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.

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 (subject
device) | KY Banksy Aloe
(predicate device) –
K183302 | Comparison |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | 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. | 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. | Same |
| Water-Based
Lubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Not a
contraceptive or
Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Primary
Ingredients | Water, propylene glycol,
hydroxyethylcellulose,
polyacrylamide anionic, lactic
acid and potassium lactate,
and benzoic acid | Water, propanediol, xanthan
gum, benzoic acid, aloe
barbadensis leaf juice,
potassium lactate, and lactic
acid | Different: The ingredients of the
predicate device are different;
the ingredients do not raise
different questions of Safety &
Effectiveness (S & E) |
| Microbial Limits | Total mold/yeast count