Astroglide Ultra Gentle Gel

K220355 · Biofilm, Inc. · NUC · May 26, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K220355
• Device Name: Astroglide Ultra Gentle Gel
• Applicant: Biofilm, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: May 26, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Astroglide Ultra Gentle Gel 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Story

Astroglide Ultra Gentle Gel is a water-based, non-sterile personal lubricant. It is applied topically to penile, vaginal, or anal areas 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. The lubricant supplements natural body lubrication, enhancing comfort. It is not a spermicide or contraceptive. The product is compatible with natural rubber latex and polyisoprene condoms, but incompatible with polyurethane condoms. Healthcare providers do not operate the device; it is for patient self-use.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity per ISO 10993-5, HRIPT per ASTM D6355, systemic toxicity per ISO 10993-11) confirmed the device is non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic. Shelf-life validated via accelerated aging (ASTM F1980-16) for 24 months. Condom compatibility tested per ASTM D7661-18, confirming compatibility with natural rubber latex and polyisoprene, and incompatibility with polyurethane.

Technological Characteristics

Water-based gel. Ingredients: water, propylene glycol, hydroxyethylcellulose, polyquaternium 7, potassium sorbate, sodium benzoate, citric acid. Viscosity: 10,000-25,000 cP; pH: 3.5-5.5; Osmolality: 200-300 mOsm/kg. Packaging: 3 oz LDPE tube. Non-sterile. Testing standards: ISO 10993-1, ISO 10993-5, ISO 10993-11, ASTM D6355, ASTM F1980-16, ASTM D7661-18, USP <51>, <61>, <62>.

Indications for Use

Indicated for penile, vaginal, and/or anal 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 & Paraben Free Astroglide (K072647)

Submission Summary (Full Text)

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May 26, 2022

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

Re: K220355 Trade/Device Name: Astroglide Ultra Gentle Gel Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: April 7, 2022 Received: April 27, 2022

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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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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,

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) K220355

Device Name Astroglide Ultra Gentle Gel

Indications for Use (Describe)

Astroglide Ultra Gentle Gel is a personal lubricant for penile, 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 and polyisoprene condoms. This product is not compatible with 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 – K220355 Astroglide Ultra Gentle Gel

#### l. 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: | May 24, 2022 |

#### II. General Information on Device

| Proprietary Name: | Astroglide Ultra Gentle Gel |
|--------------------|-----------------------------|
| 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 |
|------------------------------------|---------------|
| Glycerin & Paraben Free Astroglide | K072647 |

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

### IV. Description of Device

Astroglide Ultra Gentle Gel is a non-sterile, clear, odorless, and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. The device is composed of water, propylene glycol, hydroxyethylcellulose, polyquaternium 7, potassium sorbate, sodium benzoate and citric acid.

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

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The specifications for Astroglide Ultra Gentle Gel Personal Lubricant are described in Table 1.

| Parameter | Specification (Test Method) |
|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Color | Clear to golden |
| Clarity | Clear |
| Odor | Odorless |
| Absence of particulate matter | No particles |
| Viscosity | 10,000-25,000 cP |
| pH | 3.5-5.5 |
| Osmolality | 200-300 mOsm/kg, 1:5 dilution factor |
| Total yeast/mold count (TYMC) | <10 cfu/mL (USP <61>) |
| Total aerobic microbial count (TAMC) | <100 cfu/mL (USP <61>) |
| Presence of Pathogenic Organisms<br>( <i>Staphylococcus aureus, Pseudomonas<br/>aeruginosa, and Candida albicans</i> ) | Absent (USP <62>) |
| Antimicrobial effectiveness | Meets USP <51> acceptance criteria<br>for Category 2 products. |

# Table 1. Device Specifications

### V. Indications for Use

Astroglide Ultra Gentle Gel 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

### VI. Substantial Equivalence Discussion

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

| Characteristic /<br>Feature | Astroglide Ultra Gentle<br>Gel Personal Lubricant<br>(subject device) | Glycerin & Paraben Free<br>Astroglide (predicate<br>device) - K072647 | Comparison | |
|-----------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indication for use | Astroglide Ultra Gentle Gel 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms. | Glycerin & Paraben Free<br>Astroglide is a personal lubricant for penile, anal 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 latex condoms. | Similar: The subject and predicate devices have similar indications for use, with the exception of the condom compatibility statement, and they have the same intended use. |
| Water-Based<br>Lubricant | | Yes | Yes | Same |
| Over the Counter | | Yes | Yes | Same |
| Not a<br>contraceptive or<br>Spermicide | | Yes | Yes | Same |
| Non-sterile | | Yes | Yes | Same |
| Primary<br>Ingredients | | Water, Propylene glycol,<br>Hydroxyethylcellulose,<br>Polyquaternium 7, Potassium<br>sorbate, Sodium benzoate,<br>Citric Acid | Not publicly available | Different: The ingredients of the predicate device are different; the ingredients do not raise different questions of Safety & Effectiveness (S & E) |
| Microbial Limits | | Total mold/yeast count <10<br>cfu/mL<br>Total aerobic microbial count<br><100 cfu/mL<br>Absence of pathogens<br>(Candida albicans,<br>Pseudomonas aeruginosa,<br>Staphylococcus aureus) | Not publicly available | N/A |
| Viscosity | | 10,000 - 25,000 cP | Not publicly available | N/A |
| Osmolality | | 200-300 mOsm/kg,<br>1:5 dilution factor | Not publicly available | N/A |
| pH | | 3.5-5.5 | Not publicly available | N/A |

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The subject and predicate devices have similar indications for use and have the same intended use – to provide lubrication during intimate sexual activity. The subject and predicate devices have different technological characteristics, including different formulations and device specifications. The different technological characteristics do not raise different types of safety and effectiveness questions.

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

## Biocompatibility

Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:

- Cytotoxicity (per ISO 10993-5:2009/(R)2014) ●
- Human Repeat Insult Patch Testing (HRIPT) per ASTM D6355 to address ● sensitization and irritation
- . Systemic Toxicity (per ISO 10993-11:2017)

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

# Shelf Life

The subject device is a non-sterile personal lubricant packaged in a 3 oz. bottle with a 24-month shelf-life in accordance with the results of an accelerated aging study, conducted for 8 months at 40°C per ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The device specifications listed in Table 1 were tested across the device shelf-life and the subject device met the specifications at all time points.

## Condom Compatibility

Astroglide Ultra Gentle Gel Personal Lubricant was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane condoms using ASTM D7661-18, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results show that Astroglide Ultra Gentle Gel Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. Astroglide Ultra Gentle Gel Personal Lubricant is not compatible with polyurethane condoms.

### VIII. Conclusion

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