TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)

K180764 · Church & Dwight Co., Inc. · NUC · Aug 1, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K180764
• Device Name: TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)
• Applicant: Church & Dwight Co., Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Aug 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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 Story

Trojan™ Azul Personal Lubricant is a hydrous, water-based gel containing aloe, vitamin E, sodium hyaluronate, and hydroxyethylcellulose. Intended for OTC use by individuals to enhance comfort during sexual activity. Applied topically to penile and/or vaginal areas. Lubricant supplements natural moisture; reduces friction. Packaged in PET bottles with flip-top or pump dispensers. Compatible with natural rubber latex and polyisoprene condoms; incompatible with polyurethane condoms. Benefits include improved ease and comfort of intimate activity.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 (Cytotoxicity ISO 10993-5, Rabbit Vaginal Irritation ISO 10993-10, Acute Systemic Toxicity ISO 10993-11, Guinea Pig Maximization Sensitization ISO 10993-10). Condom compatibility tested per modified ASTM D7661. Shelf life validated via accelerated aging stability study evaluating odor, color, viscosity, osmolality, pH, and microbial limits.

Technological Characteristics

Hydrous, water-based gel. Ingredients: Deionized water, glycerin, Symocide pH (preservative), hydroxyethylcellulose, sodium hyaluronate, sodium citrate, sodium chloride, citric acid, sodium hydroxide, vitamin E TPGS, aloe. pH 5.9-6.9. Viscosity 1500-7500 cP. Osmolality 250-550 mOsm/kg. Packaged in PET bottles with polypropylene closures. Non-sterile.

Indications for Use

Indicated for individuals requiring personal lubrication for penile and/or vaginal application to enhance comfort during sexual activity and supplement natural lubrication. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use 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

• TROJAN™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) (K141034)

Submission Summary (Full Text)

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August 1, 2018

Church & Dwight Co., Inc. Joelle Reinson Senior Regulatory Affairs Specialist 500 Charles Ewing Blvd. Ewing, NJ 08628

Re: K180764

Trade/Device Name: Troian™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) Regulation Number: 21 CFR& 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 27, 2018 Received: June 28, 2018

Dear Joelle Reinson:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Sharon M. Andrews -S

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

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TrojanTM Azul Personal Luricant (H2O Sensitive Touch Personal Lubricant)

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

#### K180764

Device Name

Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)

#### Indications for Use (Describe)

Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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)

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March 22, 2018

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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#### 510(k) SUMMARY:

| Submitter Name: | Church & Dwight Co., Inc. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 500 Charles Ewing Boulevard<br>Ewing, NJ 08628<br>Phone: [phone] |
| Contact Person: | Joelle Reinson<br>Senior Regulatory Affairs Specialist<br>Church & Dwight Co., Inc.<br>469 North Harrison Street<br>Princeton, NJ 08543<br>Email: Please add<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | July 31, 2018 |
| Device Trade Name: | Trojan™ Azul Personal Lubricant (H2O Sensitive Touch<br>Personal Lubricant) |
| Device Common Name: | Personal Lubricant |
| Product Code: | NUC (lubricant, personal) |
| Classification: | Class II, Condom (21 CFR § 884.5300) |
| Predicate Device: | K141034: TROJAN™ Azul Personal Lubricant (H2O<br>Sensitive Touch Personal Lubricant) |

## Description of Device:

The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a hydrous, clear water-based personal lubricant with aloe and vitamin E that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is a clear, colorless viscous gel. The lubricant formula is thickened using sodium hyaluronate and hydroxyethylcellulose. It contains a pH buffer system to maintain a slightly acidic pH of 5.9 to 6.9, and is preserved using Symocide pH (Phenoxyethanol, Hydroxyacetophenone, Caprylyl Glycol, and Water).

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The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) may be packaged in two (2) types of polyethylene terephthalate (PET) bottles. One bottle (PET), 5.5 fl. oz. with a screw on, flip-top polypropylene (PP) closure. An induction seal will be placed over the bottle. The second bottle (PET), 4.5 fl. oz., will be the same bottle material with a pump in the bottle. The pump and nozzle will be made of the same material as the flip-top cap (PP). The pump bottle will have a shrink band over the pump.

The following parameters are included as part of the device specifications:

- Appearance ●
- o Color
- Odor ●
- pH
- Viscosity ●
- SymOcide pH Assay
- Osmolality
- Antimicrobial effectiveness ●
- Total Aerobic Microbial Count (TAMC) ●
- Total Yeast and Mold Count (TYMC) ●
- Absence of Pathogenic Organisms (at minimum Pseudomonas ● aeruginosa, Staphylococcus aureus, and Candida albicans)

| Device & Predicate Device(s): | K180764 | K141034 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Trojan Azul personal<br>lubricant (H2O sensitive<br>touch personal lubricant) is<br>a personal lubricant for<br>penile and/or vaginal<br>application, intended to<br>lubricate and moisturize, to<br>enhance to ease and<br>comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication.<br>This product is compatible<br>with natural rubber latex<br>and polyisoprene condoms.<br>This product is not<br>compatible with<br>polyurethane condoms. | Azul personal lubricant is a personal<br>lubricant for penile and/or vaginal<br>application, intended to lubricate and<br>moisturize, to enhance to ease and<br>comfort of intimate sexual activity and<br>supplement the body's natural lubrication.<br>This product is compatible with natural<br>rubber latex and polyisoprene condoms.<br>This product is not compatible with<br>polyurethane condoms. |
| General Device Characteristics | | |
| Sponsor | Church & Dwight Co., Inc. | Church & Dwight Co., Inc. |
| Regulation Number | 884.5300 | 884.5300 |
| Product Code | NUC | NUC |
| Device Class | II | II |
| Condom Compatibility | NRL and polyisoprene | NRL and polyisoprene |

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| Base Type | Water | Water |
|---------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------|
| Primary Ingredients | Deionized Water | Deionized Water |
| | Glycerin, USP | Glycerin, USP |
| | Symocide pH<br>(Phenoxyethanol,<br>Hydroxyacetophenone,<br>Caprylyl Glycol, Water) | Methylparaben, NF |
| | Hydroxyethyl-<br>Cellulose | Hydroxyethyl Cellulose (Natrosol 250<br>HX PHARM) |
| | Sodium Hyaluronate | Sodium Hyaluronate |
| | Sodium Citrate, USP | Sodium Citrate, USP |
| | Sodium Chloride, USP | Sodium Chloride, USP |
| | Citric Acid, USP | Citric Acid, USP |
| | Sodium Hydroxide | Sodium Hydroxide |
| | Vitamin E TPGS<br>(Tocophersolan) | Vitamin E TPGS |
| | Veragel 200 | Aloe |
| | Standardized (Aloe<br>Barbadensis Leaf<br>Extract) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| Appearance | Clear Gel | Clear Gel |
| Color | Clear and colorless | Clear and colorless |
| Odor | Characteristic odor | Characteristic odor |
| pH | 5.9-6.9 | 5.9-6.9 |
| Viscosity | 1500-7500 | 1500-7500 |
| Osmolality | 250 - 550 (S001) | 250 - 550 (S001) |
| Antimicrobial effectiveness | Meets Requirement | Meets Requirement |
| TAMC | < 100 cfu/g | < 100 cfu/g |
| TYMC | <10 cfu/g | <10 cfu/g |
| Absence of pathogenic organisms | Absent | Absent |

The indication for use statement of the subject device is identical to that of the predicate device.

The only difference in the technological characteristics between the subject and predicate device is the inclusion of Symocide instead of Methylparaben. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions as compared to the predicate device. These differences can be address through non-clinical testing.

## Performance Data:

The performance testing results are summarized below.

#### Biocompatibility:

The following biocompatibility testing was performed on the final 510(k)-subject device in accordance with ISO 10993, Biological Evaluation of Medical Devices.

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| Test Performed | Standard |
|---------------------------------------------|--------------|
| Cytotoxicity with Agarose Overlay | ISO 10993-5 |
| Rabbit Vaginal Irritation Study | ISO 10993-10 |
| Acute Systemic Toxicity Study | ISO 10993-11 |
| Guinea Pig Maximization Sensitization Study | ISO 10993-10 |

## Condom Compatibility:

The results for laboratory testing used a modification of the methodology found in ASTM D7661; Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Laboratory test results demonstrated that the proposed device is compatible with leading commercial brands of natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms.

## Shelf Life:

The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) has a validated shelf life based on results of an accelerated aging stability study. Evaluation of Odor, Color, Viscosity. Osmolality, and pH was conducted. Microbial evaluation was conducted via USP testing and results were met for all parameters

## Substantial Equivalence:

Based on the results of performance testing, the Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is substantially equivalent to the predicate device, Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant), K141034.