ASTROGLIDE NATURAL

K141581 · Biofilm, Inc. · NUC · Aug 6, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K141581
• Device Name: ASTROGLIDE NATURAL
• Applicant: Biofilm, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Aug 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Astroglide Natural 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 ONLY compatible with natural rubber latex and polyisoprene condoms.

Device Story

Astroglide Natural is a non-sterile, water-based personal lubricant intended for OTC use to enhance comfort during sexual activity. The device is applied topically to the penis or vagina to supplement natural lubrication. It functions as a physical lubricant; it is not a spermicide or contraceptive. The product is packaged in a PET bottle with a polypropylene flip-top cap. Users apply the lubricant manually as needed. The device benefits patients by reducing friction and increasing comfort during intimate activity. It is compatible with natural rubber latex and polyisoprene condoms, but incompatible with polyurethane condoms.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993, including cytotoxicity, guinea pig maximization, vaginal and penile irritation in rabbits, and systemic toxicity. Condom compatibility testing performed per ASTM D7661-10. Stability testing confirmed a 3-year shelf life.

Technological Characteristics

Water-based personal lubricant. Ingredients: Water, Xylitol, Hydroxyethylcellulose, Phenoxyethanol, Aloe Barbadensis Leaf Juice Extract, Chamomilla Recutita Flower Extract, Pectin, Potassium Ascorbyl Tocopheryl Phosphate, Lactic Acid. pH 4.0-7.0; Osmolarity 769 mOsm/kg; Viscosity 2200-3400 cP. Packaging: PET bottle, polypropylene cap. Compatible with natural rubber latex and polyisoprene condoms per ASTM D7661-10.

Indications for Use

Indicated for penile and/or vaginal application to moisturize and lubricate during intimate sexual activity. 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

• Glycerin and Paraben Free Astroglide (K072647)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure with three faces in profile, representing health and well-being. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.

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

August 6, 2014

BioFilm. Inc. Sherry Castello Regulatory Affairs and Ouality Assurance Associate 3225 Executive Ridge Vista, CA 92081

Re: K141581 Trade/Device Name: Astroglide® Natural Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 10, 2014 Received: June 13, 2014

Dear Sherry Castello,

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Joyce M. Whang -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) K141581

Device Name Astroglide Natural

Indications for Use (Describe)

Astroglide Natural 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 ONLY compatible with natural rubber latex and polyisoprene condoms.

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

- Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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#### 510(k) Summary Astroglide® Natural

#### General Information on Submitter

Applicant: Address:

- Telephone: Fax: Contact Person: Email:
Date Prepared: Establishment Registration:

BioFilm, Inc. 3225 Executive Ridge Vista, CA 92081 USA 760-727-9030 760-727-8080 Sherry Castello Regulatory Affairs Associate [e-mail] Aug 5, 2014 2025771

#### General Information on Device

Proprietary Name: Common Name: Classification Name: Astroqlide® Natural

Personal Lubricant Lubricant, Personal, 21 CFR 884.5300 Condom, Product Code: NUC

#### Predicate Device

| Predicate Device | 510(k) Number | |
|--------------------------------------|---------------|--|
| Glycerin and Paraben Free Astroglide | K072647 | |
| Original Applicant: BioFilm, Inc. | | |

### Description of Device

Astroglide Natural personal lubricant is non-sterile, clear and water based. Astroglide® Natural is a proprietary blend consisting mainly of water soluble ingredients similar to other lubricants currently on the market. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product primary packaging is a clear PET bottle with a screw on flip top cap comprised of polypropylene. Each bottle is packaged into a cardboard carton, which constitutes the device outer packaging.

### Indications for Use

Astroglide® Natural 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 ONLY compatible with natural rubber latex and polyisoprene condoms.

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### Technological Characteristics

There are no fundamental differences in Astroglide® Natural as compared to the predicate device Glycerin and Paraben Free Astroglide. Both lubricants are clear, water based lubricants formulated without glycerin and paraben. Both formulas use Xylitol as a humectant, thickener, and preservative aid.

| Attribute | Astroglide® Natural<br>Lubricant | Predicate: Glycerine and<br>Paraben Free Astroglide |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | To Be Determined | K072647 |
| Indications for use | Astroglide® Natural 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 ONLY<br>compatible with natural rubber<br>latex and polyisoprene<br>condoms. | Glycerin and Paraben<br>Free Astroglide® is a<br>personal lubricant for<br>penile, anal, or vaginal<br>application, intended to<br>moisturize and lubricate,<br>to enhance the ease<br>and comfort of intimate<br>sexual activity and<br>supplement the body's<br>natural lubrication. This<br>product is compatible<br>with latex condoms. |
| Ingredients | Water, Xylitol ,<br>Hydroxyethylcellulose,<br>Phenoxyethanol, Aloe<br>Barbadensis Leaf Juice<br>Extract, Chamomilla Recutita<br>(Matricaria) Flower Extract,<br>Pectin, Potassium Ascorbyl<br>Tocopheryl Phosphate, Lactic<br>Acid | Water, Butylene Glycol, Xylitol,<br>Propylene Glycol,<br>Polyquaternium-15 |
| Storage<br>Instruction | Room Temperature | Room Temperature |
| pH | 4.0 - 7.0 | 3.5 - 6.0 |
| Osmolarity | 769 mOsm/kg | 727 mOsm/kg |
| Viscosity | 2200-3400 cP | 1100 - 1500 cP |
| Condom<br>compatibility | Natural rubber latex and<br>polyisoprene | Latex |

Table 5-1. Technological Characteristics Comparison

#### Biocompatibility

Biocompatibility testing was performed in accordance with ISO 10993, Biological Evaluation of Medical Devices.

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Table 5-2. Biocompatibility of Astroglide® Natural

| Biocompatibility Testing | Astroglide Natural Results |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity | Passed Test - Non-cytotoxic |
| Guinea Pig Maximization, ISO 10993-10 | Passed test - The test article did not<br>elicit any reactions |
| Vaginal Irritation, ISO 10993-10 | The test article was considered non-<br>irritating to the vaginal mucosa in New<br>Zealand White Rabbits as compared to<br>the control article. |
| Penile Irritation, ISO 10993-10 | The test article was considered non-<br>irritating to the penile tissue in New<br>Zealand White Rabbits as compared to<br>the control article. |
| Systemic Toxicity, ISO 10993-11 | All extracts of the test article met the<br>requirements of ISO 10993-11. No test<br>animals exhibited any biological<br>reactivity. |

## Specifications

Astroglide Natural has the following lot release specifications: color, clarity, odor, absence of particulate matter, pH, viscosity, total yeast/mold count, total aerobic microbial count, and absence of pathogens including Staphylococcus aureus, Pseudomonal aeruginosa, and Candida albicans.

### Shelf Life

Astroglide Natural shows a shelf-life of 3 years based on a 3-year real-time stability study and a 1 year accelerated aging study. Preservative effectiveness was demonstrated at critical time-points throughout the stability testing.

# Condom Compatibility

Astroglide® Natural 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® Natural is compatible with latex and polyisoprene condoms but not compatible with polyurethane condoms.

### Substantial Equivalence

Astroglide® Natural personal lubricant has the same intended use and basic technological characteristics as the predicate device. Astroglide® Natural performed well in biocompatibility and performance bench testing proving it is as safe and effective as the predicate device.