Astroglide Warming

K221036 · Biofilm, Inc. · NUC · Jul 1, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K221036
• Device Name: Astroglide Warming
• Applicant: Biofilm, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Astroglide Warming 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 Warming is a non-sterile, water-based personal lubricant. It is applied topically by the user to penile, vaginal, or anal areas to provide moisture and lubrication during intimate sexual activity. The device is intended for over-the-counter use. It functions by physical lubrication to reduce friction and enhance comfort. The product is packaged in a PETE bottle with a polypropylene flip-top cap. It is not a contraceptive or spermicide. The user applies the lubricant manually as needed. The device benefits the patient by supplementing natural lubrication, thereby facilitating sexual activity and reducing discomfort.

Clinical Evidence

No clinical data. 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 non-systemically toxic. Shelf-life validated via accelerated aging (ASTM F1980-16). Condom compatibility tested per ASTM D7661-18, confirming compatibility with natural rubber latex and polyisoprene, but not polyurethane condoms.

Technological Characteristics

Water-based lubricant composed of water, glycerin, propylene glycol, polyquaternium-7, and citric acid. Physical properties: viscosity 175-330 cP, osmolality 2600-2800 mOsm/kg, pH 3.5-5.5. Packaging: PETE bottle with polypropylene cap. Testing standards: ISO 10993-1, ISO 10993-5, ISO 10993-11, ASTM D6355, ASTM F1980-16, ASTM D7661-18. Microbial limits per USP <61> and <62>; antimicrobial effectiveness per USP <51>.

Indications for Use

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

• Astroglide Brand Warming Liquid Personal Lubricant (K041432)

Submission Summary (Full Text)

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July 1, 2022

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

Re: K221036 Trade/Device Name: Astroglide Warming Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 27, 2022 Received: April 7, 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.

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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) K221036

Device Name Astroglide Warming

Indications for Use (Describe)

Astroglide Warming 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.

| 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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K221036 Page 1 of 4

### 510(k) Summary - K221036 Astroglide Warming

#### 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: | June 27, 2022 |

#### II. General Information on Device Proprietary Name: Astroglide Warming Common Name: Personal Lubricant Regulation Name: Condom Regulation Number 21 CFR 884.5300 Regulatory Class: Product Code: NUC (Lubricant, Personal)

#### III. Predicate Device

| Predicate Device | 510(k) Number |
|----------------------------------------------------|---------------|
| Astroglide Brand Warming Liquid Personal Lubricant | K041432 |

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

#### IV. Description of Device

Astroglide Warming is non-sterile, clear and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms only. It is not compatible with polyurethane condoms. The device is composed of water, glycerin, propylene glycol, polyquaternium-7 and citric acid.

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

The specifications for Astroglide Warming Personal Lubricant are described in the Table 1.

| Parameter | Specification (Test Method) |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Absence of particulate matter | No particles |
| Color | Colorless |
| Clarity | Clear |
| Odor | Odorless |
| Viscosity | 175 - 330 cP |
| Osmolality | 2600 – 2800 mOsm/kg, dilution factor of 5 |
| pH | 3.5-5.5 |
| Total yeast/mold count (TYMC) | <10 cfu/mL (USP <61>) |
| Total aerobic microbial count<br>(TAMC) | <100 cfu/mL (USP <61>) |
| Presence of pathogenic organisms<br>(Staphylococcus aureus,<br>Pseudomonas aeruginosa, and<br>Candida albicans) | Absent (USP<62>) |
| Antimicrobial effectiveness | Meets USP<51> acceptance criteria for<br>Category 2 products. |

Table 1. Device Specifications

#### V. Indications for Use

Astroglide Warming 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<br>Warming (subject<br>device) | Astroglide Brand<br>Warming Liquid<br>Personal Lubricant<br>(predicate device) –<br>K041432 | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Astroglide Warming 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 comfort<br>of intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is<br>compatible with natural rubber<br>latex and polyisoprene<br>condoms. This product is not<br>compatible with polyurethane<br>condoms. | Astroglide Brand Warming<br>Liquid is recommended as a<br>personal lubricant to enhance<br>intimate activities. It is<br>designed to help enhance the<br>sexual experience by providing<br>supplemental vaginal<br>lubrication during sexual<br>intercourse. Astroglide Brand<br>Warming Liquid may be used<br>with condoms. | Similar: The subject and<br>predicate devices have<br>similar indications for use,<br>with the exception of<br>condom compatibility<br>statement, and they have<br>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 | Purified Water, Glycerin,<br>Propylene Glycol,<br>Polyquaternium-7, Citric Acid | Not publicly available | N/A |
| 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 | 175 - 330 cP | Not publicly available | N/A |
| Osmolality | 2600-2800 mOsm/kg, 1:5<br>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 2.5 oz. bottle with a 8.5-month shelf-life in accordance with the results of an accelerated aging study, conducted for 3 months at 40°C per ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical 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

Astroqlide Warming 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 Warming is compatible with natural rubber latex and polyisoprene condoms. Astroglide Warming is not compatible with polyurethane condoms.

#### VIII. Conclusion

The results of the testing described above demonstrate that Astroglide Warming is as safe and effective as the predicate device and supports a determination of substantial equivalence.