Trojan Chain Reaction Personal Lubricant

K161544 · Church & Dwight Co., Inc. · NUC · Aug 31, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K161544
• Device Name: Trojan Chain Reaction Personal Lubricant
• Applicant: Church & Dwight Co., Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Aug 31, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

Trojan™ Chain Reaction™ 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. Not compatible with polyurethane or other condoms.

Device Story

Trojan™ Chain Reaction™ Personal Lubricant is a non-sterile, anhydrous, silicone-based (dimethicone/dimethiconol) personal lubricant containing a sensate. It is intended for OTC use to lubricate and moisturize during intimate sexual activity. The device is packaged in a PET bottle with a PP flip-top closure. It is applied topically by the user to the penis and/or vagina. The lubricant supplements natural moisture and enhances comfort. It is compatible with natural rubber latex and polyisoprene condoms but incompatible with polyurethane condoms. The device is not a spermicide or contraceptive.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 (cytotoxicity, systemic toxicity, skin/vaginal/penile irritation, sensitization). Condom compatibility testing performed per ASTM D7761-10 with natural rubber latex and polyisoprene condoms. Accelerated stability study confirmed 2-year shelf life via microbial (USP <61>, <62>, <1111>) and physical property evaluation.

Technological Characteristics

Silicone-based (dimethicone, dimethiconol) lubricant with sensate. Viscosity: 400–800 cps. Non-sterile. Packaged in PET bottle with PP closure. Biocompatible per ISO 10993. Microbial limits: TAMC <100 cfu/g, TYMC <10 cfu/g, absence of pathogens per USP <61>, <62>, <1111>. Compatible with natural rubber latex and polyisoprene condoms per ASTM D7761-10.

Indications for Use

Indicated for individuals requiring lubrication and moisturization during intimate sexual activity; compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane or other 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™ Tingly Warmth Personal Lubricant (K120706)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 31, 2016

Church & Dwight Co., Inc. Lisa Burns Regulatory Affairs Manager 500 Charles Ewing Boulevard Ewing, NJ 08628

Re: K161544

> Trade/Device Name: Trojan™ Chain Reaction™ Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 2, 2016 Received: June 3, 2016

Dear Lisa Burns:

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. 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 (reporting of

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Benjamin R. Fisher -S

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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## Indications for Use

510(k) Number (if known) K161544

Device Name

Trojan™ Chain Reaction™ Personal Lubricant

Indications for Use (Describe)

Trojan™ Chain Reaction™ 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. Not compatible with polyurethane or other condoms.

Type of Use (Select one or both, as applicable)

| <input type="checkbox"/> Residential Use (Part 21 CFR 201.326) - Subject to Discretion | <input checked="checked" type="checkbox"/> Over-The-Counter Use (21 CFR 201.66) - Subject to Discretion |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|

__ 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 - K161544

| Submitter Name: | Church & Dwight Co., Inc. |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 500 Charles Ewing Boulevard<br>Ewing, NJ 08628 |
| Contact Person: | Lisa Burns<br>Manager, Regulatory Affairs<br>Church & Dwight Co., Inc.<br>469 North Harrison Street<br>Princeton, NJ 08543<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | August 30, 2016 |
| Device Trade Name: | Trojan™ Chain Reaction™ Personal Lubricant |
| Device Common Name: | Personal Lubricant |
| Classification Name: | Condom (21 CFR § 884.5300) |
| Product Code: | NUC (lubricant, personal) |
| Classification: | Class II |
| Predicate Device: | Trojan™ Tingly Warmth Personal Lubricant (K120706),<br>Church & Dwight Co., Inc. |
| Indications for Use: | Trojan™ Chain Reaction™ Personal Lubricant is a<br>personal lubricant for penile and/or vaginal application,<br>intended to lubricate and moisturize, to enhance the ease<br>and comfort of intimate sexual activity and supplement the<br>body's natural lubrication. This product is compatible<br>with natural rubber latex and polyisoprene condoms. Not<br>compatible with polyurethane or other condoms. |

Device Description:

The Trojan™ Chain Reaction™ Personal Lubricant is a non-sterile anhydrous, clear silicone-based (Dimethicone, Dimethiconol) personal lubricant with sensate that is compatible with natural rubber latex and

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polyisoprene condoms. This product is not compatible with polyurethane or other condoms. This product is not a spermicide or contraceptive.

The specifications for the subject lubricant include the following:

- . Appearance
- Odor ●
- Viscosity
- Total microbial count (total aerobic microbial count (TAMC) < 100 cfu/g per USP <61> and <1111>)
- Fungal/yeast/mold limits (total combined yeast and mold count (TYMC) < ● 10 cfu/g per USP <61> and <1111>>
- Absence of pathogenic organisms (Pseudomonas aeruginosa, ● Staphylococcus aureus, Candida albicans per USP <62>)

The Chain Reaction™ Personal Lubricant is packaged in a polyethylene terephthalate (PET) bottle with a screw on, flip top polypropylene (PP) closure. An induction seal will be placed over the bottle for tamper resistance. One bottle is packed in a carton.

Intended Use Comparison:

The subject and predicate device have identical indications for use - 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. Therefore, the intended use of the subject and predicate device are the same.

Technological Characteristics Comparison:

The following table compares the key technological characteristics of the subject and predicate device:

| Device & Predicate Device(s): | K161544 | K120706 |
|-------------------------------|------------------------------------------|------------------------------------------|
| Condom Compatibility | Natural rubber latex<br>and polyisoprene | Natural rubber latex<br>and polyisoprene |
| Base Type | Silicone | Silicone |
| Primary Ingredients | Dimethicone | Dimethicone |
| | Dimethiconol | Dimethiconol |
| | Sensate | Sensate |
| Biocompatible | yes | yes |
| Appearance | Clear and colorless | Viscous liquid, clear |
| Odor | Characteristic odor – no<br>malodor | Menthol |
| Viscosity | 400 – 800 cps | 528 – 566 cp |
| Total Microbial Count | <100 cfu/g | <100 cfu/g |

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| Fungal/Yeast/Mold Limits | <10 cfu/g | <10 cfu/g |
|------------------------------------|-------------|-------------|
| Absence of Pathogenic<br>Organisms | absent | absent |
| Sterility | Non-sterile | Non-sterile |
| Shelf-life | 2 years | 2 years |

The subject and predicate device have different technological characteristics, including different formulation and specifications. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions. All personal lubricants must independently demonstrate they are biocompatible, compatible with condoms, and can maintain their specifications for their expected shelf life.

## Biocompatibility:

Biocompatibility testing was performed on the final 510(k)-subject device in accordance with ISO 10993, Biological Evaluation of Medical Devices, 2009. The subject lubricant is biocompatible based on the results of the following biocompatibility studies:

| Test Performed | Standard |
|----------------------------------|-------------------|
| Cytotoxicity | ISO 10993-5:2009 |
| Acute Systemic Toxicity | ISO 10993-11:2006 |
| Primary Rabbit Skin Irritation | ISO 10993-10:2010 |
| Rabbit Vaginal Irritation | ISO 10993-10:2010 |
| Rabbit Penile Irritation | ISO 10993-10:2010 |
| Guinea Pig Maximum Sensitization | ISO 10993-10:2010 |

Condom compatibility:

Condom Compatibility Testing was performed with Chain Reaction™ Personal Lubricant according to ASTM D7761-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" with a modification to include pre-lubricated and un-lubricated dry condoms. Three marketed brands of natural rubber latex condoms and two brands of polyisoprene condoms were tested. Condoms made from polyisoprene were included to represent an alternative to natural rubber latex that may be used with the 510(k)- subject lubricant.

Condom compatibility testing demonstrates that Chain Reaction™ Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms.

## Shelf Life:

Chain Reaction™ Personal Lubricant has a two year (24 month) shelf-life based on the results of an accelerated stability study. Evaluation of viscosity, odor,

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color and appearance was conducted. Microbial evaluation was conducted via USP testing for Total Microbial Count (USP <61> and <1111>, Total Yeast and Mold count (USP <61> and <111>), and Absence of Pathogens (USP <62>). The results were satisfactory for all parameters.

Substantial Equivalence:

The subject device is substantially equivalent to the predicate device. Both the subject and predicate device have identical intended uses and comparable technological characteristics. In addition, non-clinical performance data, biocompatibility testing, and shelf life testing further demonstrate that the subject device is substantially equivalent to the predicate device.