Belle Sensilube

K230781 · Rb Health (Us), LLC · NUC · Jun 20, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K230781
• Device Name: Belle Sensilube
• Applicant: Rb Health (Us), LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jun 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

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 Story

Water-based personal lubricant; non-sterile liquid preparation. Ingredients: water, propylene glycol, hydroxyethylcellulose, polyacrylamide anionic, lactic acid, potassium lactate, benzoic acid. Packaged in 40 mL high-density polyethylene bottle with polypropylene cap. Used by consumers for intimate sexual activity to provide lubrication. Applied topically to penile, vaginal, or anal areas. Enhances comfort by supplementing natural lubrication. Does not function as a contraceptive or spermicide.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity) confirmed non-cytotoxic, non-irritating, non-sensitizing, and non-toxic. Shelf-life validated via accelerated aging (ASTM F1980-16). Condom compatibility tested per ASTM D7661-10.

Technological Characteristics

Water-based lubricant. Materials: water, propylene glycol, hydroxyethylcellulose, polyacrylamide anionic, lactic acid, potassium lactate, benzoic acid. Physical specs: pH 3.5-4.5, viscosity 400-1,500 cPs, osmolality 260-380 mOsm/kg. Packaging: 40 mL HDPE bottle, polypropylene cap. Non-sterile. Testing standards: USP <791>, <912>, <785>, <51>, <61>, <62>; EP 2.6.12, 2.6.13, 5.1.3; ASTM D7661-10; ASTM F1980-16.

Indications for Use

Indicated for penile, vaginal, and/or anal application to moisturize and lubricate to enhance comfort during intimate sexual activity and supplement natural lubrication. Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• KY Banksy Aloe (K183302)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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<br>Parsippany NJ 07054-0224 |
| Telephone: | 862-702-0012 |
| Contact Person: | Kaitlyn Chan |
| Contact Title: | Regulatory Associate<br>RB Health (US) LLC |
| Email: | [e-mail] |
| 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

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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| 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 |
| Antimicrobial<br>Effectiveness | EP 5.1.3 / USP<br><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<br><61>* | <100 cfu/g |
| Fungal/Yeast/Mold<br>Limits | EP 2.6.12 / USP<br><61> * | <10 cfu/g |
| Absence of Pathogenic<br>Organisms<br>( <i>Staphylococcus Aureus,</i><br><i>Pseudomonas</i><br><i>Aeruginosa, Candida</i><br><i>Albicans</i> ) | EP 2.6.13 / USP<br><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

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 /<br>Feature | Belle Sensilube (subject<br>device) | KY Banksy Aloe<br>(predicate device) –<br>K183302 | Comparison |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Belle Sensilube is intended for<br>penile, vaginal and/or anal<br>application to moisturize and<br>lubricate, to enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication. Belle<br>Sensilube is compatible with<br>natural rubber latex and<br>polyisoprene condoms. Belle<br>Sensilube is not compatible<br>with polyurethane condoms. | This product is intended for<br>penile, vaginal and/or anal<br>application to moisturize and<br>lubricate, to enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication. This<br>product is compatible with<br>natural rubber latex and<br>polyisoprene condoms. This<br>product is not compatible with<br>polyurethane condoms. | Same |
| Water-Based<br>Lubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Not a<br>contraceptive or<br>Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Primary<br>Ingredients | Water, propylene glycol,<br>hydroxyethylcellulose,<br>polyacrylamide anionic, lactic<br>acid and potassium lactate,<br>and benzoic acid | Water, propanediol, xanthan<br>gum, benzoic acid, aloe<br>barbadensis leaf juice,<br>potassium lactate, and lactic<br>acid | Different: The ingredients of the<br>predicate device are different;<br>the ingredients do not raise<br>different questions of Safety &<br>Effectiveness (S & E) |
| Microbial Limits | Total mold/yeast count <10<br>cfu/mL<br>Total aerobic microbial count<br><100 cfu/mL<br>Absence of pathogens<br>(Candida albicans,<br>Pseudomonas aeruginosa,<br>Staphylococcus aureus) | Total mold/yeast count <10<br>cfu/mL<br>Total aerobic microbial count<br><100 cfu/mL<br>Absence of pathogens<br>(Candida albicans,<br>Pseudomonas aeruginosa,<br>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 |
| Condom<br>Compatibility | Compatible with natural rubber<br>latex and polyisoprene<br>condoms; not compatible with<br>polyurethane condoms | Compatible with natural rubber<br>latex and polyisoprene<br>condoms; not compatible with<br>polyurethane 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.