Astroglide Organix Gel

K200239 · Biofilm, Inc. · NUC · Nov 13, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K200239
• Device Name: Astroglide Organix Gel
• Applicant: Biofilm, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Nov 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Astroglide® Organix® Gel 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 compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms.

Device Story

Astroglide® Organix® Gel is a water-based, non-sterile personal lubricant; applied topically to penile or vaginal tissues to supplement natural lubrication and enhance comfort during sexual activity. Device is for over-the-counter (OTC) use by consumers. Formulation includes water, glycerine, xanthan gum, gellan gum, and various botanical extracts. Packaged in LDPE tubes or foil packs. Product functions by providing physical lubrication; does not involve electronic processing, algorithms, or software. Benefits include reduced friction and increased comfort during intimate activity.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/irritation), and ISO 10993-11 (acute systemic toxicity). Condom compatibility tested per ASTM D7661-10. Shelf-life stability testing confirmed specifications maintained over 6 months (tubes) and 3 months (foil packs).

Technological Characteristics

Water-based lubricant. Ingredients: water, glycerine, xanthan gum, gellan gum, botanical extracts, preservatives. Physical properties: pH 3.5-5.5; viscosity 200,000-300,000 cP; osmolality 500-1000 mOsm/kg. Packaging: LDPE tubes, polypropylene caps, foil packs. Non-sterile. No energy source or software.

Indications for Use

Indicated for individuals requiring personal lubrication for penile and/or vaginal 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 Natural (K141581)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "HUMAN SERVICES-USA" around the edge. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

November 13, 2020

BioFilm Inc. Richard Hines Regulatory Affairs Manager 3225 Executive Ridge Vista, CA 92081

Re: K200239 Trade/Device Name: Astroglide® Organix® Gel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 2, 2020 Received: October 14, 2020

Dear Richard Hines:

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.

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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. 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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) K200239

Device Name Astroglide® Organix® Gel

### Indications for Use (Describe)

Astroglide® Organix® Gel 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 compatible with natural rubber latex and polyisoprene condoms. The 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 - K200239 Astroglide® Organix ® Gel

#### 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: | Richard Hines |
| Contact Title: | Regulatory Affairs Manager |
| Email: | [e-mail] |
| Date Prepared: | November 12, 2020 |

#### Device Information ii.

| Trade Name: | Astroglide® Organix ® Gel | |
|--------------------|---------------------------|--|
| 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 |
|----------------------------------|---------------|
| Astroglide Natural | K141581 |
| Original Applicant: BioFilm Inc. | |

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

#### Description of Device iv.

Astroglide® Organix ® Gel is non-sterile, translucent, colorless to slight yellow, water-based personal lubricant intended for penile and vaginal application 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 and is not compatible with polyurethane condoms. This product is for over-the-counter (OTC) use.

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Astroglide® Organix ® Gel's formulation consists of water, glycerine, xanthan gum, gellan gum, aloe barbabensis powder, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, vaccinium macrocarpon (cranberry) fruit extract, passiflora incarnata flower extract, sodium benzoate, potassium sorbate, and citric acid. It is packaged in white LDPE tube with a screw on flip top cap comprised of polypropylene. This product is also provided in 2.5 ml foil packs.

Device specifications are listed in the table below.

| Parameter | Specification (Test Method) |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Color | Colorless to slight yellow |
| Clarity | Hazy liquid |
| Odor | Odorless |
| Osmolality | 500-1000 mOsm/kg (1:5 dilution) |
| pH | 3.5-5.5 |
| Viscosity | 200,000-300,000 cP |
| Total yeast/mold count | <10 cfu/mL (USP <61>) |
| Total aerobic microbial count | <100 cfu/mL (USP <61>) |
| Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans | Absent (USP <62>) |
| Antimicrobial effectiveness (per USP <51>) | Category 2, bacteria should show not less than 2.0 log reduction at 14 days and no increase from 14-day count at the 28-day count. Yeast and molds should show no increase from the initial calculated count at 14 and 28 days |

#### Indications for Use v.

Astroglide® Organix ® Gel 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

### Summary of Intended Use and Technological Characteristics of the Subject Device vi. in Comparison to the Predicate Device

The following table compares the Indications for Use and technological characteristics of the subject and predicate device:

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| Characteristic /<br>Feature | Astroglide® Organix ®<br>Gel (subject device) | Astroglide ® Natural<br>(predicate device) -<br>K141581 | Comparison |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>use | Astroglide® Organix Gel 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<br>sexual activity and<br>supplement the body's<br>natural lubrication. This<br>product is compatible with<br>natural rubber latex and<br>polyisoprene condoms. This<br>product is not compatible<br>with polyurethane condoms. | Astroglide® Natural is a<br>personal lubricant for penile<br>and/or vaginal application,<br>intended to moisturize and<br>lubricate, to enhance the<br>ease and comfort of<br>intimate sexual activity and<br>supplement the body's<br>natural lubrication.<br>This product is compatible<br>with natural rubber latex<br>and polyisoprene condoms.<br>This product is not<br>compatible with<br>polyurethane condoms. | Same: The subject and<br>predicate devices have the<br>same indication for use with<br>the exception that the it is not<br>compatible with polyurethane<br>condoms. Therefore, the<br>subject and predicate devices<br>have the same intended use<br>(provides lubrication during<br>intimate sexual activity). |
| Water-Based<br>Lubricant | Yes | Yes | Same |
| Over the | Yes | Yes | Same |
| Odorless | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Primary<br>Ingredients | Purified Water, Glycerin*,<br>Xanthan Gum, Gellan Gum,<br>Aloe Barbadensis Powder*,<br>Chamomilla Recutita<br>(Matricaria) Flower Extract*,<br>Calendula Officinalis Flower<br>Extract*, Vaccinium<br>Macrocarpon (Cranberry)<br>Fruit Extract*, Passiflora<br>Incarnata Flower Extract*,<br>Sodium Benzoate, Potassium<br>Sorbate, Citric Acid<br>*Indicates Organic | Water, Xylitol,<br>Hydroxyethylcellulose,<br>Phenoxyethanol, Aloe<br>Barbadensis Leaf Juice Extract,<br>Chamomilla Recutita<br>(Matricaria) Flower Extract,<br>Pectin, Potassium Ascorbyl<br>Tocopheryl Phosphate, Lactic<br>Acid | Different: The ingredients of the<br>predicate device are different;<br>however, differences in device<br>ingredients do not raise different<br>questions of Safety &<br>Effectiveness (S & E). |
| Microbial<br>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, | • 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, | Same |
| Viscosity | 200,000-300,000 centipoise | 2200-3400 centipoise | Different: the viscosity of the<br>subjective device is higher. This<br>difference does not raise<br>different questions of S & E. |
| pH | 3.5-5.5 | 4.0-7.0 | Different: The subject<br>device has a lower pH<br>than the predicate. This<br>difference does not raise<br>different questions of<br>S& E. |
| Osmolality | 500-1000 mOsm/kg (1:5<br>dilution) | 769 mOsm/kg | Different: The<br>osmolality specification<br>for the subject device is<br>different than the<br>predicate device.<br>Difference in osmolality<br>specifications do not<br>raise different questions<br>of S&E. |
| | | | |
| Packaging | LDPE tube and foil | PETE Bottle | Different: The subject<br>device is packaged in a<br>LDPE tube and the<br>predicate is packaged in<br>PETE bottles. The<br>subject device in also<br>packaged a foil pack.<br>These differences do<br>not raise different<br>questions of S &E. |
| Shelf-life | Bottle: 6 months<br>Foil: 3months | Three years | Different: The subject<br>devices have a shorter<br>shelf-life than the<br>predicate device. This<br>difference does not raise<br>different questions of S<br>&E. |

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The subject and predicate device indications for use are not identical, as the predicate device indications for use does not specifically state that it is not compatible with polyurethane condoms. However, the intended use of the subject and predicate devices is the same (i.e., provides lubrication during intimate sexual activity).

In addition, the subject and predicate devices have different technological characteristics as shown in the table above. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

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

## Biocompatibility

Astroglide® Organix® Gel has undergone biocompatibility testing 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." Testing included:

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

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The testing demonstrated that Astroglide® Organix® Gel is non-cytotoxic, nonsensitizing, non-irritating, and not acutely-systemically toxic. Condom Compatibility

Astroglide® Organix® Gel was tested in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Results showed that Astroglide® Organix® Liquid is compatible with natural rubber latex and polyisoprene condoms. Astroglide® Organix® Liquid is not compatible with polyurethane condoms.

## Shelf life

Astroglide® Organix® Gel has a shelf-life of 6 months in 3 oz. LDPE tubes and 3 months in foils packs. Results from testing demonstrated that the device can maintain its specifications (as shown in Section IV) over the duration of its shelf-life in both packaging forms.

#### viii. Conclusion

The results of the testing described above provide reasonable assurance that the Astroglide® Organix Gel Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.