Astroglide O Oil Personal Lubricant & Massage Oil

K171985 · Biofilm, Inc. · NUC · Aug 30, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K171985
• Device Name: Astroglide O Oil Personal Lubricant & Massage Oil
• Applicant: Biofilm, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Aug 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Astroglide® O Oil Personal Lubricant & Massage Oil 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 not compatible with condoms.

Device Story

Astroglide® O Oil Personal Lubricant & Massage Oil is a non-sterile, oil-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 formulated with organic oils (sunflower, castor, coconut, sweet almond, jojoba, argan, and ylang-ylang). The product is packaged in a PETE amber bottle with a polypropylene flip-top cap. It is not a spermicide or contraceptive and is explicitly incompatible with condoms. The lubricant enhances comfort by supplementing natural body lubrication.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, vaginal irritation, systemic toxicity) confirmed the device is non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic. Condom compatibility testing per ASTM D7661-10 confirmed incompatibility with natural rubber latex, polyisoprene, and polyurethane condoms. Shelf-life validated to 18 months via accelerated aging per ASTM F1980-07.

Technological Characteristics

Oil-based lubricant; ingredients include organic sunflower, castor, coconut, sweet almond, jojoba, argan, and ylang-ylang oils. Viscosity 60-120 cP. Non-sterile. Primary packaging: PETE amber bottle with polypropylene cap. Microbial limits: total yeast/mold <10 cfu/mL, total aerobic <100 cfu/mL, pathogens absent (USP <61>, <62>).

Indications for Use

Indicated for individuals requiring penile and/or vaginal lubrication to moisturize and enhance comfort during sexual activity. Not compatible with natural rubber latex, polyurethane, or 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

• O Glide Personal Lubricant (K142726)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.

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

August 30, 2017

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

Re: K171985

Trade/Device Name: Astroglide® O Oil Personal Lubricant & Massage Oil Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 30, 2017 Received: July 3, 2017

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.

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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 (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.

# Charles Viviano -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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## Indications for Use

510(k) Number (if known)

K171985

Device Name

Astroglide® O Oil Personal Lubricant & Massage Oil

Indications for Use (Describe)

Astroglide® O Oil Personal Lubricant & Massage Oil 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 not compatible with 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 - K171985 Astroglide® O Oil Personal Lubricant & Massage Oil

#### 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: | August 29, 2017 |
| Establishment Registration: | 2025771 |

#### ii. General Information on Device

| Proprietary Name: | Astroglide® O Oil Personal Lubricant & Massage Oil |
|----------------------|----------------------------------------------------|
| 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 |
|-------------------------------------------------------------------|---------------|
| O Glide Personal Lubricant<br>Original Applicant: Grafenberg Labs | K142726 |

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

#### iv. Description of Device

Astroglide® O Oil Personal Lubricant & Massage Oil is non-sterile, light yellow, lightly coconut and ylang-ylang scented, and oil-based lubricant. All oils used in the subject formulation are certified organic, and the subject lubricant is a USDA certified organic final product. This product is not a spermicide or contraceptive. It is NOT compatible with natural rubber latex, polyurethane, or polyisoprene condoms.

This product primary packaging is a PETE amber bottle with a screw on polypropylene flip-top cap. The bottle and cap constitute the device are labeled front and back and then packaged in a cardboard carton which constitutes the final packaging.

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The specifications for Astroglide® O Oil Personal Lubricant & Massage Oil are described in the following table.

| Parameter | Specification (Test Method) |
|------------------------------------------------------------------------|-----------------------------|
| Color | Light yellow |
| Clarity | Clear |
| Odor | Coconut and ylang-ylang |
| Absence of particulate matter | Absent |
| Viscosity | 60-120 cP |
| Total yeast/mold count | <10 cfu/mL (USP <61>) |
| Total aerobic microbial count | <100 cfu/mL (USP <61>) |
| Staphylococcus aureus, Pseudomonas<br>aeruginosa, and Candida albicans | Absent (USP <62>) |

## v. Indication for Use

Astroglide O Oil Personal Lubricant & Massage Oil 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 not compatible with condoms.

#### Predicate Device Comparison vi.

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

| Characteristic /<br>Feature | ®<br>Astroglide O Oil<br>Personal Lubricant &<br>Massage Oil (subject<br>device) | O Glide Personal<br>Lubricant (predicate<br>device) - K142726 | Comparison |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | ®<br>Astroglide O Oil Personal<br>Lubricant & Massage Oil 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.<br>This product is not compatible<br>with condoms. | O Glide Personal Lubricant<br>is a personal lubricant for<br>penile and/or vaginal<br>application, intended to<br>moisturize and lubricate, to<br>enhance the ease and<br>comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication.<br>This product is not<br>compatible with condoms. | Same: The subject and<br>predicate devices have the<br>same indication for use, and<br>therefore have the same<br>intended use. |
| Oil-Based<br>Lubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Odorless | No | No | Same |
| Not a<br>contraceptive or<br>Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Primary<br>Ingredients | Helianthus Annuus<br>(Sunflower) Seed Oil*, Ricinus<br>Communis (Castor) Seed Oil*,<br>Cocos Nucifera (Coconut)<br>Oil*, Prunus Amygdalus Dulcis<br>(Sweet Almond) Oil*,<br>Simmondsia Chinesis (Jojoba)<br>Seed Oil *, Argania Spinosa<br>Kernel (Argan Tree Nut) Oil*,<br>Tocopherol, Cananga Odorata<br>(Ylang Ylang) Flower Oil*<br>*Indicates Organic | Olus (vegetable) oil,<br>Olea Europeaea (olive)<br>Fruit Oil, Argania<br>Spinosa Kernel Oil,<br>Pichia / Resveratrol<br>Ferment Extract | Different: The ingredients<br>of the predicate device<br>are different; however,<br>differences in device<br>ingredients do not raise<br>different questions of<br>Safety & Effectiveness (S<br>& E) (e.g.,<br>biocompatibility) |
| 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) | • 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) | Same |
| Viscosity | 60-120 cP | Unknown | Different: the viscosity<br>of the predicate<br>device is unknown;<br>however, this does<br>not raise different<br>questions of Safety &<br>Effectiveness (e.g.,<br>viscosity specification<br>within the accepted<br>range for these types<br>of devices). |
| Osmolality | N/A - Oil-based, non-polar<br>formula | N/A - Oil-based, non-polar<br>formula | Same |
| pH | N/A - Oil-based, non-polar<br>formula | N/A - Oil-based, non-polar<br>formula | Same |

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As noted in the table above, the subject and predicate device are similar in that they are both clear, non-sterile, non-aqueous based lubricants. However, differences do exist in the formulation and viscosity. The differences identified do not raise new questions of safety and effectiveness.

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#### vii. Summary of Non-Clinical Performance Testing

## 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 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® O Oil Personal Lubricant & Massage Oil 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® O Oil Personal Lubricant & Massage Oil is NOT compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

## Shelf life

Astroglide® O Oil Personal Lubricant & Massage Oil has a shelf-life of 18 months based on 6 months of accelerated aging testing results per ASTM F1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The accelerated aging study demonstrated that the subject device maintained its specifications over the duration of its shelf life.

#### viii. Substantial Equivalence

The results of the testing described above provide reasonable assurance that the Astroqlide® O Oil Personal Lubricant & Massage Oil is as safe and effective as the predicate device and supports a determination of substantial equivalence.