BioGenesis Fertility Lubricant

K190872 · Good Clean Love, Inc. · PEB · Nov 7, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K190872
• Device Name: BioGenesis Fertility Lubricant
• Applicant: Good Clean Love, Inc.
• Product Code: PEB · Obstetrics/Gynecology
• Decision Date: Nov 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

BioGenesis Fertility Lubricant 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. BioGenesis Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. BioGenesis Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.

Device Story

BioGenesis Fertility Lubricant is a water-based personal lubricant provided in a tube. It is intended for use by couples trying to conceive or by clinicians during fertility interventions. The gel is applied to genital tissues or devices to provide moisture and lubrication. It is formulated to be compatible with sperm, oocytes, and embryos, ensuring it does not inhibit sperm motility. The device is used in home or clinical settings. It is compatible with natural rubber latex and polyisoprene condoms but not polyurethane condoms. The lubricant facilitates sexual activity and the use of diagnostic/therapeutic devices in reproductive medicine.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing performed per ISO 10993-5:2009 (cytotoxicity) and ISO 10993-11:2006 (acute systemic toxicity), plus human repeat insult patch testing. Performance testing included Human Sperm Survival Assay (HSSA) showing ≥70% survival at 24 hours, condom compatibility per ASTM D7661-10, and accelerated aging shelf-life testing confirming 12-month stability.

Technological Characteristics

Water-based gel formulation containing lactic acid, hydroxyethylcellulose, sodium chloride, potassium sorbate, sodium benzoate, potassium chloride, magnesium chloride, calcium chloride, and sorbic acid. pH 3.8-4.2; osmolality 300-400 mOsm/kg; viscosity 1,200-10,000 cps. Tested for condom compatibility per ASTM D7661-10. Shelf life 12 months.

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 sexual activity. Compatible with sperm, oocytes, embryos, natural rubber latex, and polyisoprene condoms. Also indicated for lubrication of genital tissues and devices during fertility interventions and reproductive medicine.

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

• BabyDance Fertility Lubricant (K162319)

Submission Summary (Full Text)

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November 7, 2019

Good Clean Love, Inc. Abhishek Gurnani Partner Amin Talati Wasserman, LLP 100 South Wacker Drive, Suite 2000 Chicago, IL 60606

Re: K190872

> Trade/Device Name: BioGenesis Fertility Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated: October 7, 2019 Received: October 8, 2019

Dear Abhishek Gurnani:

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 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. Acting 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) K190872

Device Name BioGenesis Fertility Lubricant

### Indications for Use (Describe)

BioGenesis Fertility Lubricant 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. BioGenesis Fertility Lubricant is compatible with sperm, oocytes, and ean be used by trying to conceive couples. BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

BioGenesis Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|---------------------------------------------------------------------------------|--|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | |

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and

# 510(k) Summary - K190872

This summary uses the format provided in 21 CFR 807.92:

| (1) | Submitter/Owner: | Good Clean Love, Inc.<br>207 West 5th Avenue<br>Eugene, OR 97401<br>Contact: Wendy Strgar<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|-----|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Preparer/Contact: | Abhishek K. Gurnani<br>Amin Talati Wasserman, LLP<br>100 South Wacker Drive, Suite 2000<br>Chicago, IL 60606<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Summary Prepared: | November 7, 2019 |
| (2) | Trade Name: | BioGenesis Fertility Lubricant |
| | Common Name: | Personal Lubricant |
| | Regulation Number: | 21 CFR 884.5300 |
| | Regulation Name: | Condom |
| | Regulatory Class: | Class II |
| | Product Code: | PEB (lubricant, personal, gamete, fertilization,<br>embryo compatible) |

#### (3) Identification of Predicate Device: BabyDance Fertility Lubricant (K162319)

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

(4) Device Description: BioGenesis Fertility Lubricant is water-based formula with ingredients including lactic acid, hydroxyethylcellulose, sodium chloride, potassium sorbate, sodium benzoate, potassium chloride, sorbic acid, magnesium chloride, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications are listed in Table 1 below. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is

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not compatible with polyurethane condoms. It is also compatible with compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples.

| Property | Specification |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Appearance | Gel |
| Color | Clear |
| Odor | Characteristic |
| Viscosity | 1,200-10,000 cps |
| Osmolality | 300–400 mOsm/kg |
| pH at 25 °C | 3.8-4.2 |
| Endotoxin | < 0.5 EU/mL |
| Human Sperm Survival | ≥ 70% after 24 hours |
| Total Aerobic Microbial Count (USP <61>) | <100 cfu/g |
| Total Yeast & Mold Count (USP <61>) | <10 cfu/g |
| Absence of Pathogenic Organisms (USP <62>) | Absent |
| <i>Pseudomonas aeruginosa</i> | Absent |
| <i>Staphylococcus aureus</i> | Absent |
| <i>Candida albicans</i> | Absent |
| <i>Escherichia coli, Salmonella, Clostridium</i><br>Species | Absent |
| Antimicrobial Effectiveness (USP<51>) | |
| <i>Escherichia coli, Pseudomonas aeruginosa,</i><br><i>Staphylococcus aureus</i> | NLT a 2.0 log reduction from initial<br>count at 14 days and no increase<br>from the 14-day count at 28 days |
| <i>Candida albicans, Aspergillus niger</i> | No increase from the initial<br>calculated count at 14 and 28 days |

Table 1: Subject Device Specifications

- (5) Indications for Use Statement: BioGenesis Fertility Lubricant 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. BioGenesis Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
BioGenesis Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.

#### (6) Substantial Equivalence Discussion

The table below compares the intended use and technological characteristics of the subject and predicate devices:

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| | BioGenesis Fertility<br>Lubricant<br>K190872 | BabyDance Fertility<br>Lubricant<br>K162319 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device |
| Sponsor | Good Clean Love Inc. | Fairhaven Health, LLC |
| Indications for Use | BioGenesis Fertility<br>Lubricant is a personal<br>lubricant for penile<br>and/or vaginal<br>application, intended to<br>moisturize and<br>lubricate, to enhance<br>the ease and comfort of<br>intimate sexual activity<br>and supplement the<br>body's natural<br>lubrication. BioGenesis<br>Fertility Lubricant is<br>compatible with sperm,<br>oocytes, and embryos<br>and can be used by<br>trying to conceive<br>couples. BioGenesis<br>Fertility Lubricant is<br>compatible with natural<br>rubber latex and<br>polyisoprene condoms.<br>It is not compatible<br>with polyurethane<br>condoms.<br><br>BioGenesis Fertility<br>Lubricant can be used<br>to lubricate genital<br>tissues and devices to<br>facilitate use of<br>diagnostic and<br>therapeutic devices<br>during fertility<br>interventions and<br>reproductive medicine. | BabyDance Fertility<br>Lubricant is a personal<br>lubricant for penile and/or<br>vaginal application, intended<br>to moisturize and lubricate,<br>to enhance the ease and<br>comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication.<br><br>BabyDance Fertility<br>Lubricant is compatible with<br>sperm, oocytes, and embryos<br>and can be used by trying to<br>conceive couples.<br><br>BabyDance Fertility<br>Lubricant is compatible with<br>natural rubber latex and<br>polyurethane condoms.<br><br>BabyDance Fertility<br>Lubricant can be used to<br>lubricate genital tissues and<br>devices to facilitate use of<br>diagnostic and therapeutic<br>devices during fertility<br>interventions and<br>reproductive medicine. |
| Regulation Number | 884.5300 | 884.5300 |

## Table 2. Technological Characteristics of BioGenesis Fertility Lubricant as Compared to the Predicate Device

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| Product Code | PEB | PEB |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | II | II |
| Base Type | Water | Water |
| Primary Ingredients | Water<br>Hydroxyethylcellulose<br>Sodium Chloride<br>Potassium Chloride<br>Calcium Chloride<br>Magnesium Chloride<br>Potassium Benzoate<br>Sodium Benzoate<br>Sorbic Acid<br>Lactic Acid | Water<br>Cetyl Hydroxyethylcellulose<br>Hypromellose<br>Carbomer Homopolymer<br>Monobasic Sodium<br>Phosphate<br>Dibasic Potassium Phosphate<br>Sodium Chloride<br>D-Xylose<br>Sodium Hydroxide<br>Phenethyl Alcohol<br>Caprylyl Glycol<br>Salvia Sclarea |
| Over the Counter Use | Yes | Yes |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Condom Compatibility | Natural Rubber Latex<br>Polyisoprene | Natural Rubber Latex<br>Polyurethane |
| Shelf-Life | 12 Months | 9 Months |

The subject and predicate devices have the same indications for use statements and have the same intended use. As noted in the table above, the subject and predicate device have different technological characteristics, including a different formulation and a different shelf life. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.

#### (7) Summary of Performance Data:

As part of demonstrating substantial equivalence to the predicate device, the following non-clinical performance tests were conducted.

- . Biocompatibility. BioGenesis Fertility Lubricant has undergone biocompatibility testing including cytotoxicity per ISO 10993-5:2009, human repeat insult patch testing (sensitization and irritation), and acute systemic toxicity testing per ISO 10993-11:2006. The testing found that BioGenesis Fertility Lubricant is biocompatible.
- Non-clinical Performance Testing. Human sperm survival assay (HSSA), and . lubricant barrier assay testing was conducted and indicates that BioGenesis Fertility Lubricant is compatible with sperm and does not inhibit sperm motility.

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- Condom Compatibility. BioGenesis Fertility Lubricant was tested for condom compatibility per ASTM D7661-10: Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. BioGenesis Fertility Lubricant is not compatible with polyurethane condoms.
- Shelf Life. The results of accelerated aging shelf-life testing demonstrated that . BioGenesis Fertility Lubricant maintains its specifications over the duration of its proposed shelf life of twelve months.

#### Conclusion (8)

The results of performance testing described above demonstrate that the BioGenesis Fertility Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.