Astroglide Diamond Silicone Gel Personal Lubricant

K163395 · Biofilm, Inc. · NUC · Feb 10, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K163395
• Device Name: Astroglide Diamond Silicone Gel Personal Lubricant
• Applicant: Biofilm, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Feb 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Astroglide® Diamond Silicone Gel Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended 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, polyurethane, and polyisoprene condoms.

Device Story

Astroglide® Diamond Silicone Gel Personal Lubricant is a non-sterile, silicone-based personal lubricant. It is applied topically to the penis or vagina to provide moisture and lubrication during sexual activity. The device is intended for over-the-counter use by consumers. It is packaged in a 3-ounce LDPE tube with a polypropylene flip-top cap. The lubricant is formulated to be compatible with natural rubber latex, polyurethane, and polyisoprene condoms. It is not a spermicide or contraceptive. The product benefits the user by reducing friction and enhancing comfort during intimate activity.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1:2009/(R)2013, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), vaginal irritation (ISO 10993-10), and systemic toxicity (ISO 10993-11), all showing non-toxic/non-irritating results. Condom compatibility confirmed per ASTM D7661-10. Shelf-life of 2 years validated via 8-month accelerated aging (ASTM F1980-07) with preservative effectiveness confirmed per USP <51>.

Technological Characteristics

Silicone-based gel; ingredients include Dimethicone, Cyclomethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, and Cocos Nucifera (Coconut) Oil. Viscosity: 12,000-22,000 cP. Packaging: LDPE tube with polypropylene cap. Non-sterile. Tested per ASTM D7661-10 for condom compatibility and ASTM F1980-07 for shelf-life. Microbial limits per USP <61> and <62>.

Indications for Use

Indicated for individuals requiring penile and/or vaginal lubrication to enhance comfort during sexual activity and supplement natural lubrication. Compatible with natural rubber latex, polyurethane, and polyisoprene 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

• ONE® SILICONE Personal Lubricant (K110690)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.

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

February 10, 2017

BioFilm, Inc. Richard Hines Regulatory Affairs Manager 3225 Executive Ridge Vista, CA 92081

Re: K163395

> Trade/Device Name: Astroglide® Diamond Silicone Gel Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 1, 2016 Received: December 5, 2016

Dear Richard Hines:

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.

{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 (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" (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.

Image /page/1/Picture/8 description: The image shows the name "Charles Viviano -S" in a large, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is left-aligned. The overall impression is clean and simple.

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K163395

### Device Name

Astroglide® Diamond Silicone Gel Personal Lubricant

Indications for Use (Describe)

Astroglide® Diamond Silicone Gel Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended 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, polyurethane, and polyisoprene 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary – K163395 Astroglide® Diamond Silicone Gel Personal Lubricant

#### i. General Information on Submitter

| Applicant: | BioFilm, Inc. |
|-----------------------------|---------------------------------------------|
| Address: | 3225 Executive Ridge<br>Vista, CA 92081 USA |
| Telephone: | 760-727-9030 |
| Fax: | 760-727-8080 |
| Contact Person: | Richard Hines |
| Contact Title: | Regulatory Affairs Manager |
| Email: | [e-mail] |
| Date Prepared: | February 9, 2017 |
| Establishment Registration: | 2025771 |

#### ii. General Information on Device

| Proprietary Name: | Astroglide® Diamond Silicone Gel Personal<br>Lubricant |
|----------------------|--------------------------------------------------------|
| Common Name: | Personal Lubricant |
| Classification Name: | Condom (21 CFR 884.5300) |
| Regulatory Class: | II |
| Product Code: | NUC (lubricant, personal) |

#### iii. Predicate Device

| Predicate Device | 510(k) Number |
|--------------------------------------------------------------|---------------|
| ONE® SILICONE Personal Lubricant<br>Original Applicant: ONE® | K110690 |

This predicate device has never been the subject of a device recall.

#### iv. Description of Device

Astroglide® Diamond Silicone Gel Personal Lubricant is non-sterile, clear, odorless, and silicone-based lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

This product primary packaging is a white LDPE 3 ounce tube with a screw on polypropylene flip-top cap. The tube and cap constitute the device final packaging.

The specifications for Astroglide® Diamond Silicone Gel Personal Lubricant are described in the following table.

{4}------------------------------------------------

| Parameter | Specification (Test Method) |
|---------------------------------------------------------------------|-----------------------------|
| Color | Colorless |
| Clarity | Clear |
| Odor | Odorless |
| Absence of particulate matter | Absent |
| Viscosity | 12,000-22,000 cP |
| Total yeast/mold count | <10 cfu/mL (USP <61>) |
| Total aerobic microbial count | <100 cfu/mL (USP <61>) |
| Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans | Absent (USP <62>) |

#### Predicate Device Comparison V.

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

| Characteristic /<br>Feature | Astroglide® Diamond<br>Silicone Gel Personal<br>Lubricant (subject) | One Silicone Personal<br>Lubricant (predicate<br>device) - K110690 | Comparison |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Astroglide® Diamond Silicone<br>Gel Personal Lubricant is a<br>personal lubricant for penile<br>and/or vaginal application,<br>intended 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,<br>polyurethane, and<br>polyisoprene condoms. | ONE® Silicone Personal<br>lubricant is a personal<br>lubricant for penile and/or<br>vaginal application,<br>intended to moisturize and<br>lubricate, to enhance the<br>ease and comfort of<br>intimate sexual activity and<br>supplement the body's<br>natural lubrication. This<br>product is compatible with<br>natural rubber latex,<br>polyisoprene, and<br>polyurethane condoms. | Same: The subject and<br>predicate devices have the<br>same indication for use, and<br>therefore have the same<br>intended use. |
| Silicone-based<br>lubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Non-greasy &<br>odorless | Yes | Yes | Same |
| Not a<br>contraceptive or<br>Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |

{5}------------------------------------------------

| Primary<br>Ingredients | Dimethicone, Cyclomethicone<br>Dimethicone / Vinyl<br>Dimethicone Crosspolymer,<br>Cocos Nucifera (Coconut) Oil | Information is unknown | Different: The ingredients<br>in the predicate device<br>are not known; however,<br>differences in device<br>ingredients do not raise<br>different questions of<br>Safety & Effectiveness (S<br>& E) (e.g.,<br>biocompatibility, condom<br>compatibility) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Microbial Limits | • Total mold/yeast count<br><10 cfu/mL<br>• Total aerobic microbial<br>count <100 cfu/mL<br>• Absence of pathogens<br>(Candida albicans,<br>Pseudomonas aeruginosa,<br>Staphylococcus aureus) | Information is<br>unknown | Different: the<br>microbial limits<br>specifications for the<br>predicate device are<br>not known; however<br>this does not raise<br>different questions of<br>S & E (e.g., microbial<br>specifications within<br>accepted range for<br>these types of<br>devices). |
| Viscosity | 12,000-22,000 cP | Information is<br>unknown | Different: the viscosity<br>of the predicate<br>device is not known;<br>however this does not<br>raise different<br>questions of S & E<br>(e.g., viscosity<br>specification within<br>the accepted range<br>for these types of<br>devices). |

As noted in the table above, the subject and predicate device are similar in that they are both clear, non-sterile, silicone-based lubricants, and are compatible with natural rubber latex, polyisoprene, and polyurethane condoms. However, differences do exist in the formulation and product specification for microbial limits and viscosity. The differences identified do not raise different questions of safety and effectiveness as discussed in the table above.

#### Summary of Non-clinical Performance Testing vi.

## Biocompatibility

Biocompatibility testing was performed in accordance with ISO 10993-1: 2009/(R)2013, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk

{6}------------------------------------------------

## Management Process.

| Biocompatibility Testing | Astroglide® Diamond Silicone Gel Personal<br>Lubricant Results |
|--------------------------------------------------------|----------------------------------------------------------------|
| Cytotoxicity, ISO 10993-5: 2009/(R)2014 | The test article was found to be non-cytotoxic. |
| Guinea Pig Maximization, ISO 10993-10:<br>2010/(R)2014 | The test article was found to be non-sensitizing. |
| Vaginal Irritation, ISO 10993-10: 2010/(R)2014 | The test article was found to be non-irritating. |
| Systemic Toxicity, ISO 10993-11: 2006/(R)2010 | The test article was found to be non-systematically<br>toxic. |

## Condom Compatibility

Astroglide® Diamond Silicone Gel Personal Lubricant 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. Results show that Astroglide® Diamond Silicone Gel Personal Lubricant is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

## Shelf life

Astroglide® Diamond Silicone Gel Personal Lubricant has a shelf-life of 2 years based on 8 months of accelerated aging testing results per ASTM F1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Preservative effectiveness per USP <51> was demonstrated at critical time-points throughout the stability testing including at the time zero (0) and eight-month (8) time points for the accelerated aging study. All specifications for the subject lubricant were met during the shelf-life study.

#### vii. Substantial Equivalence

The results of the testing described above provide reasonable assurance that the Astroglide® Diamond Silicone Gel Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.