Astroglide X Silicone Personal Lubricant

K210242 · Biofilm, Inc. · NUC · Apr 28, 2021 · Obstetrics/Gynecology

Device Facts

• Record ID: K210242
• Device Name: Astroglide X Silicone Personal Lubricant
• Applicant: Biofilm, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Apr 28, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Astroglide® X Silicone 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 and polyurethane condoms.

Device Story

Astroglide® X Silicone Personal Lubricant is a non-sterile, clear, silicone-based lubricant; intended for OTC use to moisturize and lubricate during intimate sexual activity. Product is applied topically by the user. It supplements natural lubrication and enhances comfort. Device is packaged in a PETE bottle with a polypropylene flip-top cap. It is compatible with natural rubber latex condoms but incompatible with polyisoprene and polyurethane condoms. It is not a spermicide or contraceptive. Safety is established through biocompatibility and condom compatibility testing.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1:2009/(R)2013, including cytotoxicity (ISO 10993-5), sensitization/irritation (HRIPT per ASTM D6355), and acute systemic toxicity (ISO 10993-11). Condom compatibility tested per ASTM D7661-10. Shelf-life of 3 years validated via accelerated aging per ASTM F1980-16.

Technological Characteristics

Silicone-based lubricant (Cyclopentasiloxane, Dimethicone, Cyclohexasiloxane). Viscosity: 225-350 cP. Non-sterile. Primary packaging: PETE bottle with polypropylene cap. Biocompatibility per ISO 10993. Condom compatibility per ASTM D7661-10. Shelf-life testing per ASTM F1980-16.

Indications for Use

Indicated for penile, vaginal, and/or anal application to moisturize and lubricate, enhance comfort during intimate sexual activity, and supplement natural lubrication. Compatible with natural rubber latex condoms; contraindicated for use with polyisoprene and 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

• pjur® Backdoor Anal Glide and pjur® Analyse Me! (K141913)

Submission Summary (Full Text)

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April 28, 2021

BioFilm, Inc. Kevin Jamil Regulatory Affairs 3225 Executive Ridge Vista, CA 92081

Re: K210242

> Trade/Device Name: Astroglide® X Silicone Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 27, 2021 Received: January 29, 2021

Dear Kevin Jamil:

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 and Part 809); 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/cdrl-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,

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) K210242

Device Name Astroglide® X Silicone Personal Lubricant

Indications for Use (Describe)

Astroglide® X Silicone 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 and 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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## 510(k) Summary - K210242 Astroglide® X Silicone 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: | Kevin Jamil |
| Contact Title: | Regulatory Affairs |
| Email: | [e-mail] |
| Date Prepared: | 4/27/2021 |
| Establishment Registration: | 2025771 |

### ii. General Information on Device

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

### iii. Predicate Device

| Predicate Device | 510(k) Number |
|----------------------------------------------------|---------------|
| pjur® Backdoor Anal Glide and pjur®<br>Analyse Me! | K141913 |

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

### iv. Description of Device

Astroglide® X Silicone Personal Lubricant is non-sterile, clear, odorless, and siliconebased lubricant. This product is not a spermicide or contraceptive. Astroglide® X Silicone Personal Lubricant is compatible with natural rubber latex condoms. Astroglide® X Silicone Personal Lubricant is not compatible with polyurethane, or polyisoprene condoms. This product's primary packaging is a PETE clear bottle with a screw on polypropylene flip-top cap. The bottle is packaged in a cardboard carton which constitutes the final packaging.

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

| Parameter | Specification (Test Method) |
|--------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Appearance | Clear |
| Odor | Characteristic |
| Viscosity | 225 to 350 centipoise |
| Total yeast/mold count (USP <61>) | <10 cfu/mL |
| Total aerobic microbial count (USP <61>) | <100 cfu/mL |
| Absence of Pathogenic Organisms,<br>Staphylococcus aureus, Pseudomonas<br>aeruginosa, and Candida albicans<br>(USP <62>) | Absent |
| Water activity (USP<1112>) | 0.3 Aw |

## Table 1. Physical Specifications of Astroglide® X Silicone Personal Lubricant

### V. Indications for Use

Astroglide® X Silicone 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 and polyurethane condoms.

### vi. Substantial Equivalence Discussion

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

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| Characteristic /<br>Feature | Astroglide® X Silicone<br>Personal Lubricant<br>(Subject Device) | pjur® Backdoor Anal<br>Glide and pjur® Analyse<br>Me! (Predicate device) | Comparison |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Astroglide® X Silicone<br>Personal Lubricant is a<br>personal lubricant for penile,<br>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>and polyurethane condoms. | pjur® Backdoor Anal Glide<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<br>the body's natural<br>lubrication. This product is<br>compatible with natural<br>rubber latex, synthetic<br>polyisoprene, and<br>polyurethane condoms. | The subject and predicate<br>devices have the same<br>indications for use except<br>for a difference in condom<br>compatibilities. |
| Condom<br>Compatibility | This product is compatible<br>with natural rubber latex<br>condoms. This product is not<br>compatible with polyisoprene<br>and polyurethane condoms. | This product is<br>compatible with natural<br>rubber latex, synthetic<br>polyurethane, and<br>polyisoprene condoms. | The condom compatibility<br>of the predicate device is<br>different, but it does not<br>raise different questions<br>of safety and<br>effectiveness. |
| Silicone-Based<br>Lubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Appearance | Clear | Clear | Same |
| Not a<br>contraceptive or<br>Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Primary<br>Ingredients | Cyclopentasiloxane<br>Dimethicone<br>Cyclohexasiloxane | cyclopentasiloxane,<br>dimethicone,<br>dimethiconol,<br>Simmondsia Chinensis<br>(Jojoba) Seed Oil | The ingredients of the<br>predicate device are<br>different; however,<br>differences in device<br>ingredients do not raise<br>different questions of<br>safety & effectiveness |
| Characteristic /<br>Feature | Astroglide® X Silicone<br>Personal Lubricant<br>(Subject Device) | pjur® Backdoor Anal<br>Glide and pjur® Analyse<br>Me! (Predicate device) | Comparison |
| 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 | 225 - 350 centipoise | 600 - 1,000 centipoise | The viscosities of the<br>subject and predicate<br>devices are different;<br>however, differences<br>in viscosities do not<br>raise different<br>questions of safety<br>and effectiveness. |
| Water Activity | < 0.3 Aw | < 0.3 Aw | Same |
| Shelf-Life | 3 years | 3 years | Same |

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As noted in the table above, the subject and predicate device have similar indications for use statements nad have the same intended use – to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The subject and predicate device have difference technological characteristics, including different formulations, specifications, and condom compatibilities. The different technological characteristics identified do not raise different questions of safety and.

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

Biocompatibility

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Biocompatibility testing on the subject lubricant 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.

Table 3. Biocompatibility of Astroglide® X Silicone Personal Lubricant

| Test Performed |
|-----------------------------------------------------------------------------------------------------|
| Cytotoxicity per ISO 10993-5: 2009/(R)2014 |
| Human Repeat Insult Patch Testing (HRIPT) per ASTM D6355<br>to address sensitization and irritation |
| Acute Systemic Toxicity per ISO 10993-11: 2017 |

The results of the testing demonstrate that the subject device is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.

# Condom Compatibility

Astroglide® X Silicone Personal Lubricant was tested for compatibility with natural rubber latex condoms using ASTM D7661-10. Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Results show that Astroglide® X Silicone Personal Lubricant is compatible with natural rubber latex condoms only.

# Shelf Life

Astroglide® X Silicone Personal Lubricant has a shelf-life of 3 years based on 12 months of accelerated aging testing results per ASTM F1980-16, Standard Guide for Accelerated Aqing of Sterile Barrier Systems for Medical Devices. All specifications for the subject lubricant listed in Table 1 were met throughout the shelf-life study.

### viiii. Substantial Equivalence

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