Astroglide Sensual Strawberry Personal Lubricant

K213671 · Biofilm, Inc. · NUC · Mar 3, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K213671
• Device Name: Astroglide Sensual Strawberry Personal Lubricant
• Applicant: Biofilm, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Mar 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Astroglide® Sensual Strawberry Personal Lubricant is a personal lubricant for penile, vaginal, and/or anal 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 condoms. This product is not compatible with polyisoprene or polyurethane condoms.

Device Story

Astroglide® Sensual Strawberry Personal Lubricant is a non-sterile, water-based, strawberry-scented/flavored personal lubricant. Intended for OTC use to moisturize and lubricate during intimate sexual activity. Applied topically to penile, vaginal, or anal areas. Compatible with natural rubber latex condoms; incompatible with polyisoprene or polyurethane condoms. Packaged in PETE bottles with polypropylene flip-top caps. Provides physical lubrication to supplement natural body fluids, enhancing comfort. No spermicidal or contraceptive properties.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, irritation, acute systemic toxicity) confirmed the device is non-cytotoxic, non-sensitizing, non-irritating, and not systemically toxic. Condom compatibility tested per ASTM D7661-10. Shelf-life of 8.5 months validated via accelerated aging per ASTM F1980-16.

Technological Characteristics

Water-based lubricant; pH 3.5-5.5; viscosity 200-450 cps; osmolality 200-450 mOsm/kg. Materials: PETE bottle, polypropylene cap. Testing standards: USP <791> (pH), USP <912> (viscosity), USP <785> (osmolality), USP <51> (antimicrobial effectiveness), USP <61>/<62> (microbial limits), ASTM D7661-10 (condom compatibility), ASTM F1980-16 (accelerated aging). Non-sterile.

Indications for Use

Indicated for individuals requiring a personal lubricant for penile, vaginal, and/or anal application to moisturize, lubricate, and enhance comfort during intimate sexual activity. Compatible with natural rubber latex condoms; contraindicated for use with polyisoprene or 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 & Paraben Free Astroglide (K072647)

Submission Summary (Full Text)

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March 3, 2022

BioFilm, Inc. Jennifer Keller R&D Formulation Chemist II 3225 Executive Ridge Vista, CA 92081

Re: K213671

> Trade/Device Name: Astroglide® Sensual Strawberry Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 17, 2021 Received: November 22, 2021

Dear Jennifer Keller:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213671

Device Name Astroglide® Sensual Strawberry Personal Lubricant

Indications for Use (Describe)

Astroglide® Sensual Strawberry Personal Lubricant is a personal lubricant for penile, vaginal, and/or anal 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 condoms. This product is not compatible with polyisoprene or polyurethane 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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#### K213671 Page 1 of 5

#### 510(k) Summary K213671 Astroglide® Sensual Strawberry Personal Lubricant

#### I. Submitter Information

| Applicant: | BioFilm, Inc. |
|-----------------|---------------------------------------------|
| Address: | 3225 Executive Ridge<br>Vista, CA 92081 USA |
| Telephone: | 760-727-9030 |
| Fax: | 760-727-8080 |
| Contact Person: | Jennifer Keller |
| Contact Title: | Research & Development |
| Email: | [e-mail] |
| Date Prepared: | 2/25/2022 |

#### II. General Information on Device

| Proprietary Name: | Astroglide® Sensual Strawberry Personal |
|--------------------|-----------------------------------------|
| | Lubricant |
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (Lubricant, Personal) |
| Regulatory Class: | II |

# III. Predicate Device

| Predicate Device | 510(k) Number |
|----------------------------------------------------------------|---------------|
| Glycerin & Paraben Free Astroglide<br>Applicant: BioFilm, Inc. | K072647 |

The predicate device has not been subject to a design-related recall.

# IV. Description of Device

Astroglide® Sensual Strawberry Personal Lubricant is a non-sterile, clear, strawberry-scented and flavored, water-based personal lubricant intended for penile, anal, or vaginal application. This product is not a spermicide or contraceptive. Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms. It is not compatible with polyisoprene and polyurethane condoms. This product's primary packaging is a PETE clear bottle

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with a screw on polypropylene flip-top cap. The bottle is then packaged in a cardboard carton which constitutes the final packaging.

The specifications for Astroglide® Sensual Strawberry Personal Lubricant are described in the following table.

| Physical Specification Tests | Ranges/Specifications |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Particulate matter | No particles |
| Color | Clear to slight golden |
| Clarity | Clear |
| Odor | Strawberry sent |
| pH (per USP <791>) | 3.5-5.5 |
| Viscosity (per USP <912>) | 200 - 450 cps |
| Osmolality (per USP <785>) | 200 - 450 mOsm/kg, dilution factor of 5 |
| Antimicrobial effectiveness (per<br>USP <51>) | Category 2, bacteria should show not less<br>than 2.0 log reduction at 14 days and no<br>increase from 14-day count at the 28-day<br>count. Yeast and molds should show no<br>increase from the initial calculated count at 14<br>and 28 days |
| Total yeast/mold count (per<br>USP <61> & USP <62>) | < 10 cfu/mL |
| Total aerobic microbial count (per<br>USP <61> & USP <62>) | < 100 cfu/mL |
| Absence of pathogenic organisms<br>( <i>Staphylococcus aureus</i> ,<br><i>Pseudomonas aeruginosa</i> , and<br><i>Candida albicans</i> - per USP <61> &<br>USP <62>) | Absent |

# V. Indications for Use

Astroglide® Sensual Strawberry Personal Lubricant is a personal lubricant for penile, vaginal, and/or anal 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 condoms. This product is not compatible with polyisoprene or polyurethane condoms.

# VI. Predicate Device Comparison

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

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| Product Name | Astroglide® Sensual<br>Strawberry Personal<br>Lubricant<br>K213671<br>Subject Device | Glycerin & Paraben Free<br>Astroglide<br>K072647<br>Predicate Device | Comparison |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Astroglide® Sensual<br>Strawberry Personal Lubricant<br>is a personal lubricant for<br>penile, vaginal, and/or anal<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 compatible<br>with natural rubber latex<br>condoms. This product is not<br>compatible with polyisoprene<br>or polyurethane condoms. | Glycerin & Paraben Free<br>Personal Lubricant<br>Astroglide® is a personal<br>lubricant, for penile, anal, or<br>vaginal application, intended<br>to moisturize and lubricate,<br>to enhance the ease and<br>comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication.<br>This product is compatible<br>with latex condoms. | Same: The<br>indications for use<br>for the subject and<br>predicate device are<br>the same.<br>Therefore, the<br>subject and<br>predicate device<br>have the same<br>intended use. |
| Over-the-<br>Counter Device | Yes | Yes | Same |
| Base Type | Water | Water | Same |
| Ingredients | Purified Water, Glycerin,<br>Propylene Glycol, Methyl<br>Gluceth-20, Natural & Artificial<br>Strawberry Flavor, Clear<br>Xanthan Gum,<br>Hydroxyethylcellulose, Sodium<br>Gluconate, Sodium Saccharin,<br>Sodium Benzoate, Potassium<br>Sorbate, Citric Acid | Purified Water, Butylene<br>Glycol, Propylene Glycol,<br>Xylitol, Polyquaternium-15 | Different: The<br>subject and predicate<br>device have<br>differences in<br>formulation. These<br>differences do not<br>raise different<br>questions of safety<br>and effectiveness<br>(S&E). |
| Condom<br>compatibility | Natural rubber latex<br>condoms. | Natural rubber latex<br>condoms. | Same |
| pH | 3.5-5.5 | 3.5-5.5 | Same |
| Osmolality | 200 - 450 mOsm/kg, 1:5<br>dilution factor | N/A | Different: The<br>subject and<br>predicate device<br>have different<br>osmolality<br>specifications.<br>Differences in<br>osmolality<br>specifications do not<br>raise different<br>questions of S&E. |
| Viscosity | 200 - 450 cps, | 1,100-1,500 cps | Different: The<br>subject and<br>predicate device<br>have different<br>viscosity<br>specifications. |
| Product Name | Astroglide® Sensual<br>Strawberry Personal<br>Lubricant<br>K213671<br>Subject Device | Glycerin & Paraben Free<br>Astroglide<br>K072647<br>Predicate Device | Comparison |
| | | | viscosity<br>specifications do not<br>raise different<br>questions of S&E. |
| 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<br>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<br>aeruginosa,<br>Staphylococcus aureus) | Same |
| Antimicrobial<br>effectiveness<br>(per USP<br><51>) | Category 2, bacteria should<br>show not less than 2.0 log<br>reduction at 14 days and no<br>increase from 14-day count<br>at the 28-day count. Yeast<br>and molds should show no<br>increase from the initial<br>calculated count at 14 and<br>28 days | Category 2, bacteria<br>should show not less than<br>2.0 log reduction at 14<br>days and no increase from<br>14-day count at the 28-<br>day count. Yeast and<br>molds should show no<br>increase from the initial<br>calculated count at 14 and<br>28 days | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Packaging | 2.5 oz PETE bottle<br>polypropylene cap | 2.5 oz PETE bottle with<br>HDPE cap | Different: The<br>subject and<br>predicate device<br>have different<br>packaging.<br>Differences in<br>packaging do not<br>raise different<br>questions of S&E. |
| Shelf-life | 8.5 months | 2 years | Different: The<br>subject and<br>predicate device<br>have different shelf-<br>life durations.<br>Differences in shelf-<br>life durations do not<br>raise different<br>questions of S&E. |

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As noted in the table above, the subject and predicate device have the same indications for use and intended use (i.e., to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication). The subject and predicate device have differences in their technological characteristics.

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However, as stated in the table, the differences in technological characteristics do not raise different questions of safety and effectiveness.

# VII. Summary of Non-Clinical Performance Testing

#### Biocompatibility

Biocompatibility testing on Astroglide® Sensual Strawberry Personal Lubricant was conducted in accordance with the 2020 FDA quidance document "Use of International Standard ISO 10993-1.Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process." Testing included the following assessments:

- . Cytotoxicity per ISO 10993-5:2009
- Sensitization and irritation testing using the human repeat insult patch test, an ● alternative test method to ISO 10993-10:2010
- Acute systemic toxicity testing per ISO 10993-11:2017.

The testing demonstrated that Astroglide® Sensual Strawberry Personal Lubricant is non-cytotoxic, non-sensitizing, non-irritating, and not systemically toxic

#### Condom Compatibility

Astroglide® Sensual Strawberry Personal Lubricant was tested for compatibility with condoms using ASTM D7661-10, "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Results show that Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms and not compatible with polyisoprene or polyurethane condoms.

#### Shelf-Life

Astroglide® Sensual Strawberry Personal Lubricant has a shelf-life of 8.5 months based on accelerated aging testing results per ASTM F1980-16, "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices." All specifications for the subject lubricant, as stated in Section IV of the summary, were met throughout the shelf-life study.

# VIII. Conclusion

The results of the testing described above demonstrate that the Astroglide® Sensual Strawberry Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.