AZUL PERSONAL LUBRICANT

K141034 · Church & Dwight Co., Inc. · NUC · Jul 21, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K141034
• Device Name: AZUL PERSONAL LUBRICANT
• Applicant: Church & Dwight Co., Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The intended use is as a personal lubricant compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane condoms.

Device Story

Azul Personal Lubricant is a hydrous, water-based personal lubricant containing aloe and vitamin E. Formula thickened with sodium hyaluronate and hydroxyethylcellulose; pH-buffered (5.9–6.9); preserved with methylparaben. Packaged in PET bottle with PP flip-top closure and induction seal. Intended for OTC consumer use to enhance comfort during intimate sexual activity. Compatible with natural rubber latex and polyisoprene condoms; incompatible with polyurethane condoms. Device provides lubrication and moisture supplementation.

Clinical Evidence

Bench testing only. Biocompatibility: in vitro cytotoxicity, rabbit vaginal/penile irritation, acute systemic toxicity, guinea pig sensitization, primary rabbit skin irritation. Stability: 2-year shelf life validated via accelerated aging. Condom compatibility: tested per modified ASTM D7661; confirmed compatible with natural rubber latex and polyisoprene, incompatible with polyurethane.

Technological Characteristics

Water-based lubricant; ingredients include aloe, vitamin E, sodium hyaluronate, hydroxyethylcellulose, methylparaben. pH 5.9-6.9. Packaged in PET bottle with PP closure. Compatibility tested per modified ASTM D7661. Non-sterile.

Indications for Use

Indicated for penile and/or vaginal application to lubricate and moisturize, enhance ease and comfort of 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

• Lifestyles Natural (K122054)
• Aloe Cadabra Lubricant (K124044)

Submission Summary (Full Text)

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# JUL 2-1-2014

Pg. I of 3 K 141034 510(k) Premarket Notification Church & Dwight Co., Inc. Azul Personal Lubricant

Confidential July 21, 2014 - Revised Page 2 of 26

## II. 510(k) Summary Azul Personal Lubricant

| Submitter Name: | Church & Dwight Co., Inc. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 500 Charles Ewing Boulevard<br>Ewing, NJ 08628 |
| Contact Person: | Joseph Ciccone<br>Senior Manager, Regulatory Affairs<br>Church & Dwight Co., Inc.<br>500 Charles Ewing Boulevard<br>Ewing, NJ 08628<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | July 21, 2014 |
| Device Trade Name: | Azul Personal Lubricant |
| Device Common Name: | Personal Lubricant |
| Product Code: | NUC - Condom (21 CFR § 884.5300) |
| Classification: | Class II |
| Predicate Devices: | Lifestyles Natural (K122054)<br>Aloe Cadabra Lubricant (K124044) |
| Device Description: | The Azul Personal Lubricant is a hydrous, clear water-based personal<br>lubricant with aloe and vitamin E that is compatible with natural rubber<br>latex and polyisoprene condoms. This product is not compatible with<br>polyurethane condoms. The lubricant formula is thickened using sodium<br>hyaluronate and hydroxyethylcellulose. It contains a pH buffer system to<br>maintain a slightly acidic pH of 5.9 to 6.9, and is preserved using<br>methylparaben. This medical device is designed to meet product<br>specifications which include: |
| | Color/appearance |
| | Odor<br>� |
| | pl-l |
| | Viscosity |
| | Methylparaben assay<br>� |
| | Osmolality |
| | Total aerobic microbial count<br>● |
| | Total yeast and mold count<br>● |
| | Absence of pathogenic organisms |
| | Antimicrobial effectiveness |
| | The Azul Personal Lubricant is packaged in a polyethylene terephthalate<br>(PET) bottle with a screw on, flip top polypropylene (PP) closure. An<br>induction seal will be placed over the bottle for tamper resistance and<br>preservation. |
| Intended Use: | The intended use is as a personal lubricant compatible with natural<br>rubber latex and polyisoprene condoms. Not compatible with<br>polyurethane condoms. |
| Indications for Use: | Azul Personal Lubricant is a personal lubricant for penile and/or vaginal<br>application, intended to lubricate and moisturize, to enhance the ease and<br>comfort of intimate sexual activity and supplement the body's natural<br>lubrication. This product is compatible with natural rubber latex and<br>polyisoprene condoms. This product is not compatible with<br>polyurethane condoms. |
| Technological Characteristics: | Azul Personal Lubricant contains similar ingredients as legally marketed<br>water-based personal lubricants that are compatible with natural rubber<br>latex and polvisoprene condoms. This product is not compatible with<br>polyurethane condoms. |
| Summary of Studies: | |
| | Biocompatibility studies - Performed on the final 510(k)-subject<br>device. These studies include in vitro cytotoxicity study; rabbit<br>vaginal irritation study; rabbit penile irritation study; acute systemic<br>toxicity study; guinea pig maximization sensitization study; primary<br>rabbit skin irritation study. Based on the results of these studies. Azul<br>Personal Lubricant is considered safe for consumer use. |

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Image /page/0/Picture/6 description: The image shows the logo for Trojan brand condoms. The logo features the word "TROJAN" in a bold, sans-serif font, with the tagline "BRAND CONDOMS" underneath in a smaller font. To the right of the wordmark is an image of a Trojan warrior's head, complete with a helmet. The logo is simple, recognizable, and conveys a sense of strength and protection.

Church & Dwight Co.. Inc.

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Pg. 2 of 3 K 141034 510(k) Premarket Notification Church & Dwight Co., Inc. Azul Personal Lubricant

#### Confidential July 21, 2014 - Revised Page 3 of 26

Image /page/1/Picture/3 description: The image shows the logo for Trojan brand condoms. The logo features the word "TROJAN" in bold, sans-serif font, with the tagline "BRAND CONDOMS" in smaller font below. To the right of the wordmark is an image of a Trojan helmet.

CHURCH & DWIGHT CO., INC.

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Pg. 3 of 3 K 141034 510(k) Premarket Notification Church & Dwight Co., Inc. Azul Personal Lubricant

Confidential July 21, 2014 - Revised Page 4 of 26

Shelf life - Stability and shelf life testing was performed on the Azul Personal Lubricant to validate the stability of the device during its intended shelf life of 2 years. Accelerated aging was performed in accordance with accepted standards for medical devices to simulate longterm storage. To evaluate stability, this in vitro study used sealed and unsealed sample bottles to simulate actual device usage.

Condom compatibility - The results for laboratory testing using 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 polyurethanc condoms.

Substantial Equivalence:

The proposed device is substantially equivalent to the predicate devices. Lifestyles Natural and Aloe Cadabra in technology, intended use, safety.

Image /page/2/Picture/6 description: The image shows the word "TROJAN" in bold, sans-serif font. To the right of the word is a stylized image of a Trojan helmet. Below the word "TROJAN" are the words "BRAND CONDOMS" in a smaller font.

### CHURCH & DWIGHT CO., INC.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 21, 2014

Church & Dwight Co., Inc. Joseph Ciccone Senior Manager, Regulatory Affairs 500 Charles Ewing Boulevard Ewing, NJ 08628

- K141034 Re:
Trade/Device Name: Azul Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: April 21, 2014 Received: April 22, 2014

Dear Joseph Ciccone,

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

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Page 2 - Joseph Ciccone

(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.

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" (21CFR 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.

Image /page/4/Picture/8 description: The image shows the name "Benjamin R Fisher -S" in a bold, sans-serif font. The letters "R" and "F" are stylized with a decorative pattern, possibly indicating a logo or design element. The text is horizontally aligned and appears to be part of a title or heading.

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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K 141034 510(k) Premarket Notification Church & Dwight Co., Inc. Azul Personal Lubricant

Confidential July 2, 2014 Page 1 of 26

#### I. Indications for Use

510(k) Number (if known): N/A

・

Device Name: Azul Personal Lubricant

INDICATIONS FOR USE:

Azul 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (21 CFR 801 Subpart D) OR

Over-The-Counter (OTC)_X_ (21 CFR 801 Subpart C)

Beniamin R.F. 2014 1-5:06:53 -04'00'

CHURCH & DWIGHT CO., INC.