Pre-Seed™ Fertility Lubricant

K193450 · Church & Dwight Co., Inc. · PEB · Jul 23, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K193450
• Device Name: Pre-Seed™ Fertility Lubricant
• Applicant: Church & Dwight Co., Inc.
• Product Code: PEB · Obstetrics/Gynecology
• Decision Date: Jul 23, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

Pre-Seed™ 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. Pre-Seed™ Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. Pre-Seed™ 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

Pre-Seed™ Fertility Lubricant is a non-sterile, water-based personal lubricant; formulated to supplement natural lubrication; compatible with sperm, oocytes, and embryos. Packaged in High-Density Polyethylene tube with Polypropylene closure; includes single-use Low Density Polyethylene applicators for vaginal delivery. Used by couples trying to conceive or by clinicians during fertility interventions to lubricate tissues and diagnostic/therapeutic devices. Enhances comfort during sexual activity; facilitates device insertion. Benefits include sperm-compatible lubrication that does not inhibit motility. Used in home or clinical settings.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-5, -10, and -11. Human Sperm Survival Assay (HSSA) demonstrated motility ≥ 80% of control at 24 hours. Condom compatibility tested per ASTM D7661-10. Stability testing confirmed specifications maintained over 22-month shelf-life.

Technological Characteristics

Water-based lubricant; ingredients include hydroxyethylcellulose, Pluronic F-127, sodium chloride, and carbopol 934P. Form factor: HDPE tube with LDPE applicators. Compatibility: natural rubber latex and polyisoprene. Testing standards: ISO 10993 (biocompatibility), ASTM D7661-10 (condom compatibility), USP <51>, <61>, <62>, <1111> (microbial/antimicrobial).

Indications for Use

Indicated for couples trying to conceive as a personal lubricant for penile/vaginal application to moisturize, lubricate, and enhance comfort during sexual activity. Also indicated for lubricating genital tissues and devices during fertility interventions and reproductive medicine. Compatible with sperm, oocytes, embryos, 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

• Pre~Va Vaginal Lubricant (K072741)

Submission Summary (Full Text)

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July 23, 2020

Church & Dwight Co., Inc. Joelle Reinson Senior Regulatory Affairs Specialist 500 Charles Ewing Boulevard Ewing, NJ 08628

Re: K193450

> Trade/Device Name: Pre-Seed™ Fertility Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated: June 25, 2020 Received: June 26, 2020

Dear Joelle Reinson:

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,

for

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) K193450

Device Name Pre-Seed™ Fertility Lubricant

#### Indications for Use (Describe)

Pre-Seed™ 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. Pre-Seed™ Fertility Lubricant is compatible with sperm, oocytes, and can be used by trying to conceive couples. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

Pre-Seed™ 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 (*Select one or both, as applicable*)

| <span style="font-family: sans-serif;"> <input disabled="disabled" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: sans-serif;"> <input checked="checked" disabled="disabled" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
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#### 510(k) Summary - K193450

| Submitter Name: | Church & Dwight Co., Inc. |
|---------------------|-------------------------------------------------------------------------|
| Submitter Address: | 500 Charles Ewing Boulevard |
| | Ewing, NJ 08628 |
| Contact Person: | Joelle Reinson |
| | Senior Regulatory Affairs Specialist |
| | Church & Dwight Co., Inc. |
| | 469 North Harrison Street |
| | Princeton, NJ 08543 |
| | Tel: [phone] |
| | Fax: [phone] |
| Date Prepared: | July 23, 2020 |
| Device Trade Name: | Pre-Seed™ Fertility Lubricant |
| Device Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | PEB (lubricant, personal, gamete, fertilization, and embryo compatible) |
| Predicate Device: | K072741: Pre~Va Vaginal Lubricant |

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

#### Description of Device:

Pre-Seed™ Fertility Lubricant is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubrication. The product is also compatible with sperm, oocytes, and embryos, can be used by trying to conceive couples, and can also be used to lubricate diagnostic and therapeutic devices during fertility interventions and reproductive medicine.

Pre-Seed™ Fertility Lubricant is packaged in a High-Density Polyethylene tube with a Polypropylene closure. A foil seal is present over the tube opening under the cap closure. The provided with single-use, piston type, Low Density Polyethylene applicators for delivering the product to the vagina.

| Table 1: Specifications for Pre-Seed™ Fertility Lubricant | | | |
|-----------------------------------------------------------|--|--|--|
|-----------------------------------------------------------|--|--|--|

| Specification | Recommended Acceptance Criteria |
|------------------|-------------------------------------------------------|
| Appearance/Color | Hazy, colorless to slightly yellow, viscous<br>liquid |
| Odor | Characteristic, no off odor<br>(25 °C ± 2) |

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| pH | 7.0-7.4 |
|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Osmolality | 260-370 mOsm/kg |
| Viscosity | 2800-11500 cps |
| Total Aerobic Microbial Count (TAMC)-<br>USP <61> and <1111> | <100 cfu/g |
| Total Yeast & Mold Count (TYMC)-<br>USP<61> and <1111> | <10 cfu/g |
| Absence of Pathogenic organisms (P. aeruginosa, S. aureus, E. coli, Salmonella sp. and C. albicans) - USP <62> | Absent |
| Antimicrobial Effectiveness<br>USP<51> | Bacteria- Not less than 2.0 log reduction from the initial count at 14 days. No increase from 14 days count to 28 days.<br>Yeast & Mold- not increase from the initial calculated count at 14 and 28 days. |
| Endotoxin | <0.7 EU/mL |
| Human Sperm Survival Assay (HSSA) | HSSA: ≥ 80 of control motility at 24 hours after 30 minutes exposure to 10% of subject lubricant. |

#### Indication for Use:

Pre-Seed™ 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. Pre-Seed™ Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

Pre-Seed™ 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.

Table 2. Comparator Table for Subject Device and Predicate Device

| Device & Predicate Device(s): | K193450<br>Subject Device | K072741<br>Predicate Device | Comments |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Sponsor | Church & Dwight | INGfertility, LLC | NA |
| Regulation Number | 884.5300 | 884.5300 | Same |
| Product Code | PEB<br>II | PEB<br>II | |
| Device Class | II | II | |
| Indications for Use | Pre-Seed™ Fertility<br>Lubricant is a personal<br>lubricant for penile and/or<br>vaginal application,<br>intended to moisturize and<br>lubricate, to enhance the<br>ease and comfort of<br>intimate sexual activity and | To lubricate vaginal<br>tissues to facilitate<br>entry of diagnostic or<br>therapeutic devices<br>including those used<br>in fertility<br>interventions. Pre~Va<br>may be applied | Same<br>intended use |
| | supplement the body's<br>natural lubrication. Pre-<br>Seed™ Fertility Lubricant<br>is compatible with sperm,<br>oocytes, and embryos and<br>can be used by trying to<br>conceive couples. It is<br>compatible with natural<br>rubber latex and<br>polyisoprene condoms. It is<br>not compatible with<br>polyurethane condoms.<br><br>Pre-Seed™ 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. | directly to the device<br>or may be deposited<br>intravaginally using<br>the applicator, prior to<br>the insertion of<br>diagnostic or<br>therapeutic devices<br>used in fertility<br>interventions.<br><br>As a personal<br>lubricant Pre~Va<br>supplements the<br>body's own natural<br>lubricating fluids, to<br>moisturize, relieve<br>friction and to<br>enhance the ease and<br>comfort of intimate<br>sexual activity.<br>Pre-Va is safe for use<br>by couples who are<br>trying to conceive and<br>may be appied to<br>vaginal or penile<br>tissues for lubrication<br>and moisturization<br>purposes. It is<br>compatible with latex<br>and polyurethane<br>condom. | |
| Condom Compatibility | Natural rubber latex and<br>polyisoprene | Natural rubber latex<br>and polyurethane | Different |
| Base Type | Water | Water | Same |
| Primary Ingredients | Water<br>Hydroxyethylcellulose<br>SymOcide PH<br>Pluronic F-127<br>Sodium Chloride<br>Dibasic Sodium<br>Phosphate Anhydrous<br>Carbopol 934P<br>Sodium Hydroxide<br>Arabinogalactan<br>Potassium Phosphate<br>Monobasic | Water<br>Hydroxyethylcellulose<br>Pluronic 127<br>Sodium Chloride<br>Arabinogalactan<br>Sodium Phosphate<br>Carbopol 934P<br>Methylparaben<br>Sodium Hydroxide<br>Potassium Phosphate | Different |
| Appearance | Hazy, colorless to slightly<br>yellow viscous liquid | Not provided | Different |
| Odor | Characteristic, no off odor | Not provided | Different |
| Viscosity | 2800-11500 cps | 8500-12000 cps | Different |
| pH | 7.0-7.4 | 7.20-7.45 | Different |
| Osmolality | 260-370 mOsm/kg | 260-360 mOsm/kg | Similar |
| Total Microbial Count | <100 cfu/g | <100 cfu/g | Same |
| Fungal/Yeast/Mold Limits | <10 cfu/g | <10 cfu/g | Same |
| Absence of Pathogenic<br>organism | Absent | Absent | Same |
| Antimicrobial effectiveness<br>per USP <51> and <1112> | Bacteria: Not less than 2.0<br>log reduction from the<br>initial count at 14 days. No<br>increase from 14 days'<br>count 28 days.<br>Yeast & Mold: No increase<br>from the initial calculated<br>count at 14 and 28 days. | Bacteria: Not less than<br>2.0 log reduction from<br>the initial count at 14<br>days. No increase<br>from 14 days' count<br>28 days.<br>Yeast & Mold: No<br>increase from the<br>initial calculated count<br>at 14 and 28 days. | Same |
| Endotoxin | <0.7 EU/mL | <0.5 Eu/ml | Different |
| HSSA | HSSA: motility ≥ 80 of<br>control motility at 24 hours<br>after 30 minutes exposure to<br>10% lubricant | Sperm motility<br>following 30-minutes<br>incubation with 10%<br>diluted lubricant<br>solution equals >80%<br>of sperm motility in<br>control medium | Same |
| Shelf-life | 22 months | 2 years | Different |
| OTC use | Yes | Yes | Same |

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The subject and predicate devices do not have identical indications for use statements; however, these differences do not alter the intended use of the subject device, which is identical to the predicate device.

As noted in the table, the subject and predicate device have different technological characteristics, including different formulations, condom compatibility, specifications (e.g., endotoxin, appearance, odor, pH, viscosity, etc.). The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.

#### Performance Data:

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

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### Biocompatibility:

Pre-Seed™ Fertility Lubricant underwent biocompatibility testing including cytotoxicity per ISO 10993-5:2009, vaginal irritation per ISO 10993-10:2010, guinea pig maximization sensitization per ISO 10993-10:2010 and acute systemic toxicity per ISO 10993-11:2006. The testing demonstrated that the Pre-Seed™ Fertility Lubricant is biocompatible.

### Non-clinical Performance Testing.

Human sperm survival assay (HSSA), and lubricant barrier assay testing was conducted and indicates that Pre-Seed™ Fertility Lubricant is compatible with sperm and does not inhibit sperm motility.

## Condom Compatibility:

Pre-Seed™ 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 Pre-Seed™ Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. Pre-Seed™ Fertility Lubricant is not compatible with polyurethane condoms.

#### Shelf-Life:

Pre-Seed™ Fertility Lubricant has a 22-month shelf-life based on the results from accelerated and real-time stability testing. The results of accelerated aging shelf-life testing demonstrated that Pre-Seed IM Fertility Lubricant maintains its specifications for appearance/color, odor, pH, osmolality, viscosity. TAMC, TYMC, absence of pathogenic organisms, antimicrobial effectiveness, endotoxins, HSSA, and lubricant barrier testing over the duration of its proposed shelf-life of 22 months.

#### Substantial Equivalence:

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