ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT

K141132 · Biofilm, Inc. · PEB · Jan 9, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K141132
• Device Name: ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT
• Applicant: Biofilm, Inc.
• Product Code: PEB · Obstetrics/Gynecology
• Decision Date: Jan 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

Astroglide® TTC 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. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide® TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms.

Device Story

Astroglide TTC is a non-sterile, water-based personal lubricant; applied by hand or via pre-filled tube applicator to penile or vaginal tissues. Formulated with water, propylene glycol, hydroxyethylcellulose, fructose, methylparaben, sodium phosphate, potassium phosphate, propyl paraben, galactose, and sodium hydroxide. Designed with pH and osmolarity compatible with sperm survival and migration. Used by couples trying to conceive in home settings. Lubricant properties do not impede sperm penetration; does not harm sperm motility, DNA integrity, or fertilization capability. Enhances comfort during sexual activity while maintaining compatibility with condoms and reproductive cells.

Clinical Evidence

Bench testing only. Performance data includes: Mouse Embryo Assay (MEA) showing >80% expanded blastocysts; Human Sperm Survival Assay (HSSA) showing ≥80% survival relative to control; Computer Assisted Sperm Analysis (CASA) confirming progressive motility; DNA integrity testing; hamster zona-free ovum penetration assays; and lubricant barrier assays. Biocompatibility testing per ISO 10993-5, -10, and -11 (cytotoxicity, sensitization, vaginal irritation, systemic toxicity) confirmed non-irritating and non-cytotoxic results. Antimicrobial effectiveness and 8-month stability data provided.

Technological Characteristics

Water-based lubricant; ingredients include propylene glycol, hydroxyethylcellulose, fructose, methylparaben, sodium phosphate, potassium phosphate, propyl paraben, galactose, sodium hydroxide. pH 7.2-7.6; osmolarity 220-400 mOsm/kg. Packaged in pre-filled tube applicators. Biocompatibility testing per ISO 10993 standards. Non-sterile.

Indications for Use

Indicated for couples trying to conceive as a personal lubricant for penile and/or vaginal application to moisturize, lubricate, and enhance comfort during intimate sexual activity; compatible with sperm, oocytes, embryos, and natural rubber latex, 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

• Pre-Va Vaginal Lubricant (K072741)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 9, 2015

Biofilm, Inc. Sherry Castello Regulatory Affairs and Quality Assurance Associate 3225 Executive Ridge Vista, CA 92081

K141132 Trade/Device Name: Astroglide TTC Fertility Friendly Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: PEB Dated: November 24, 2014 Received: November 25, 2014

Dear Sherry Castello,

Re:

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. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K141132

Device Name

Astroglide TTC Fertility Friendly Personal Lubricant

Indications for Use (Describe)

Astroglide® TTC 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. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide® TTC is compatible with natural rubber latex, 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Biofilm, Inc. The text "BIOFILM, INC." is in a bold, sans-serif font and is purple. Underneath the text is a curved line, also in purple, that resembles a wave.

## 510(k) Summary Astroglide TTC Fertility Friendly Personal Lubricant

- General Information on Submitter i.

| Applicant: | BioFilm, Inc. |
|-----------------------------|---------------------------------------------|
| Address: | 3225 Executive Ridge<br>Vista, CA 92081 USA |
| Telephone: | 760-727-9030 |
| Fax: | 760-727-8080 |
| Contact Person: | Sherry Castello |
| Email: | [e-mail] |
| Date Prepared: | November 24, 2014 |
| Establishment Registration: | 2025771 |

| ii. | General Information on Device | | |
|-----|-------------------------------|----------------------------------------------------------------------------------------------------------------------|--|
| | Proprietary Name: | Astroglide® TTC Fertility Friendly Personal Lubricant | |
| | 510(k) Number: | K141132 | |
| | Common Name: | Personal Lubricant | |
| | Classification Name: | Lubricant, Personal, Gamete, Fertilization, and Embryo<br>Compatible (21 CFR 884.5300, Condom), product code:<br>PEB | |

#### iii. Predicate Device

Pre-Va Vaginal Lubricant, K072741, manufactured by INGFertility, LLC

#### Description of Device iv.

Astroglide® TTC Fertility Friendly Personal Lubricant is a non-sterile, clear, and water-based personal lubricant for penile and/or vaginal application. Astroglide® TTC has a pH and osmolarity that is compatible with sperm survival and migration. The device is packaged in pre-filled tube applicators which may be used for single use intra-vaginal application or applied directly to penis or vagina.

Astroglide® TTC is formulated using water, propylene glycol, hydroxyethylcellulose, fructose, methylparaben, sodium phosphate, potassium phosphate, propyl paraben, galactose, and sodium hydroxide.

This device is batch lot tested for appearance, color, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay and human sperm survival assay.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Biofilm, Inc. The logo is purple and features the company name in a bold, sans-serif font. Underneath the name is a curved line, also in purple, that adds a visual element to the logo. The registered trademark symbol is present next to the "C" in "INC."

#### Indications for Use V.

Astroglide® TTC 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. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide® TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms.

#### vi. Technological Characteristics of Astroglide® TTC Compared to Predicate

Technological Characteristics of Astroglide TTC and the predicate are very similar. Any minor technological differences noted do not affect the safety or effectiveness of the device.

| Attribute | TTC, Fertility Friendly<br>Personal Lubricant | Predicate: Pre-Va Vaginal<br>Lubricant |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K141132 | K072741 |
| Indications for use | Astroglide® TTC 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.<br>Astroglide TTC is<br>compatible with sperm,<br>oocytes, and embryos and<br>can be used by couples trying<br>to conceive. Astroglide®<br>TTC is compatible with<br>natural rubber latex,<br>polyisoprene and<br>polyurethane condoms. | ● To lubricate vaginal<br>tissues to facilitate entry of<br>diagnostic or therapeutic<br>devices including those<br>used in fertility<br>interventions. Pre-Va may<br>be applied directly to the<br>device or may be<br>deposited intravaginally<br>using the applicator prior<br>to the insertion of<br>diagnostic or therapeutic<br>devices used in fertility<br>interventions.<br>● As a personal lubricant<br>Pre-Va supplements the<br>body's own natural<br>lubrication fluids, to<br>moisturize, relieve friction<br>and to enhance the ease<br>and comfort of intimate<br>sexual activity. Pre-Va is<br>safe for use by couples<br>who are trying to conceive<br>and may be applied to<br>vaginal or penile tissues<br>for lubrication and |

{5}------------------------------------------------

| Attribute | TTC, Fertility Friendly<br>Personal Lubricant | Predicate: Pre-Va Vaginal<br>Lubricant |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ingredients | Water, Propylene Glycol,<br>Hydroxyethylcellulose, Fructose,<br>Methylparaben, Sodium<br>Phosphate, Potassium Phosphate,<br>Propyl Paraben, Galactose,<br>Sodium Hydroxide | Water, Hydroxyethylcellulose,<br>Pluronic 127, Sodium Chloride,<br>Arabinogalactan, Sodium<br>Phosphate, Carbopol 934P,<br>Methyl Paraben, Sodium<br>Hydroxide, Potassium Phosphate |
| Method of<br>Application | Directly by hand or intra-<br>vaginally with pre-filled tube<br>applicator | Directly from tube or with<br>separate disposable applicator |
| Storage Instruction | 36°F to 86°F | 36°F to 86°F |
| pH | 7.2-7.6 | 7.20-7.45 |
| Osmolarity | 220-400 mOsm/kg | 260 to 370 mOsm/kg |
| Endotoxin by LAL<br>methodology | $≤$ 0.7 EU/mL | $≤$ 0.7 EU/mL |
| Mouse Embryo<br>Assay (MEA) | Using 1-cell MEA exposed to<br>10% solution for 30 minutes<br>$>$ 80% expanded blastocysts at 96<br>hrs. | Using 1-cell MEA exposed to 5%<br>solution for 30 minutes, $>$ 80%<br>expanded blastocysts at 96 hrs. |
| Human Sperm<br>Survival Assay<br>(HSSA) | After exposure to 10% TTC for 2<br>hours, $≥$ 80% of the control. | After exposure to 10% Pre-Va for<br>30 min, $≥$ 80% of the control. |
| Condom<br>Compatibility | Compatible with latex,<br>polyurethane, and polyisoprene<br>condoms | Compatible with latex and<br>polyurethane condoms. |

#### Summary of Performance Data vii.

Lubricant barrier assays performed on Astroglide® TTC demonstrated that the properties of the device do not impede sperm penetration into the lubricant. Mouse In vitro fertilization assays in combination with Mouse embryo assays (IVF-MEA) demonstrated normal fertilization and embryo development with no suggestion of toxicity. Mucosal penetration studies using a hyaluronic acid (that mimics cervical mucus) indicate that the "swim-up" ability of sperm exposed to Astroglide TTC is not affected. Computer Assisted Sperm Analysis demonstrates the progressive motility of sperm is not harmed by Astroglide TTC. DNA integrity testing after exposure to Astroglide TTC demonstrated the device does not harm human sperm chromatin (DNA). Sperm penetration assays (hamster zona-free ovum tests) demonstrated that the presence of Astroglide TTC did not affect the penetration of hamster ova by human sperm.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Biofilm, Inc. The logo is purple and features the company name in bold, sans-serif font. A curved line is below the company name. The registered trademark symbol is to the right of the company name.

Condom compatibility studies indicate that TTC is safe to use with natural rubber latex, polyisoprene, and polyurethane condoms.

Biocompatibility tests and results are shown in the table below:

| Biocompatibility Testing | Astroglide TTC Result |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity, Direct Contact, ISO 10993-5,<br>formula | The test article was not considered to have a<br>cytotoxic effect. |
| Guinea Pig Maximization, ISO 10993-10,<br>formula | The test article did not elicit sensitization<br>reactions. |
| Vaginal Irritation, ISO 10993-10, formula | The test article was considered non-irritating<br>to the vaginal mucosa in New Zealand White<br>Rabbits. |
| Systemic Toxicity, ISO 10993-11, formula | Test article met the requirements of ISO<br>10993-11. No test animals exhibited any<br>biological reactivity. |
| Cytotoxicity, MEM Elution, ISO 10993-5,<br>applicator tube | The test article was not considered to have a<br>cytotoxic effect. |
| Guinea Pig Maximization, ISO 10993-10,<br>applicator tube | The test article did not elicit sensitization<br>reactions. |
| Vaginal Irritation, ISO 10993-10, applicator<br>tube | In New Zealand White Rabbits, the test<br>article when extracted in saline was<br>considered minimally irritating. The test<br>article when extracted in cottonseed oil was<br>considered non-irritating. |

On-going stability studies show the device has met acceptance criteria for appearance, color, clarity, odor, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay, and human sperm survival assay for an 8 month shelf-life. Antimicrobial effectiveness testing has been performed and the preservative system is effective.

The performance data concludes that Astroglide® TTC is substantially equivalent to the predicate device Pre-Va Vaginal Lubricant. Astroglide® TTC does not harm sperm, oocytes, or embryos and is safe for use by couples trying to conceive.

#### viii. Conclusion

The proposed and predicate indication statements do not represent a new intended use. Astroglide TTC personal lubricant has the same intended use as PreVa for use in a nonclinical environment. The technological characteristics of Astroglide TTC and the predicate are very similar. Any minor technological differences noted do not affect the safety or efficacy of the device. Performance testing demonstrates that Astroglide TTC does not harm sperm, oocytes, or embryos and is safe to use by couples trying to conceive.