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.

Device Description

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.

AI/ML Overview

The provided document is a 510(k) summary for the Pre-Seed™ Fertility Lubricant. It details the device's characteristics, indications for use, comparison with a predicate device, and the non-clinical performance data used to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Specification	Recommended Acceptance Criteria	Reported Performance (Pre-Seed™ Fertility Lubricant)
Appearance/Color	Hazy, colorless to slightly yellow, viscous liquid	Met acceptance criteria during shelf-life testing
Odor	Characteristic, no off odor (25 °C ± 2)	Met acceptance criteria during shelf-life testing
pH	7.0-7.4	Met acceptance criteria during shelf-life testing
Osmolality	260-370 mOsm/kg	Met acceptance criteria during shelf-life testing
Viscosity	2800-11500 cps	Met acceptance criteria during shelf-life testing
Total Aerobic Microbial Count (TAMC) - USP <61> and <1111>	<100 cfu/g	Met acceptance criteria during shelf-life testing
Total Yeast & Mold Count (TYMC) - USP<61> and <1111>	<10 cfu/g	Met acceptance criteria during shelf-life testing
Absence of Pathogenic organisms (P. aeruginosa, S. aureus, E. coli, Salmonella sp. and C. albicans) - USP <62>	Absent	Met acceptance criteria during shelf-life testing
Antimicrobial Effectiveness - 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. Yeast & Mold: not increase from the initial calculated count at 14 and 28 days.	Met acceptance criteria during shelf-life testing
Endotoxin	<0.7 EU/mL	Met acceptance criteria during shelf-life testing
Human Sperm Survival Assay (HSSA)	HSSA: ≥ 80% of control motility at 24 hours after 30 minutes exposure to 10% of subject lubricant.	Pre-Seed™ Fertility Lubricant is compatible with sperm and does not inhibit sperm motility, meeting the HSSA criteria. Met acceptance criteria during shelf-life testing for maintained HSSA performance.
Biocompatibility (Cytotoxicity, Vaginal Irritation, Sensitization, Acute Systemic Toxicity)	Pass criteria per ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006.	Testing demonstrated that Pre-Seed™ Fertility Lubricant is biocompatible.
Condom Compatibility (Natural Rubber Latex and Polyisoprene Condoms)	Compatible per ASTM D7661-10.	Compatible with natural rubber latex and polyisoprene condoms.
Shelf-Life (for all listed specifications)	Maintained specifications for appearance/color, odor, pH, osmolality, viscosity, TAMC, TYMC, absence of pathogenic organisms, antimicrobial effectiveness, endotoxins, HSSA, and lubricant barrier testing for 22 months.	22-month shelf-life demonstrated through accelerated and real-time stability testing, maintaining all specified parameters.

2. Sample Sizes Used for the Test Set and Data Provenance:

The document describes non-clinical performance testing. It does not refer to a "test set" in the context of clinical trials with human subjects or a defined set of "cases." Instead, the testing involves laboratory-based assessments of the lubricant's physical, chemical, and biological properties.

Sample Size:
- Human Sperm Survival Assay (HSSA): Not explicitly stated, but typically involves multiple replicates and control groups for in vitro testing.
- Biocompatibility: Not explicitly stated, but ISO standards typically define sample sizes for in vitro and in vivo (e.g., animal) tests.
- Condom Compatibility: Not explicitly stated, but ASTM D7661-10 specifies the number of condoms and lubricant applications for testing.
- Shelf-Life, Appearance/Color, Odor, pH, Osmolality, Viscosity, Microbial Count, Endotoxin, Antimicrobial Effectiveness: These are typically performed on multiple batches of the product at various time points during stability studies. The exact number of samples tested is not quantified in the summary.
Data Provenance: The studies are non-clinical, laboratory-based tests. The country of origin of the data is not specified, but the testing was conducted according to international standards (e.g., ISO, USP, ASTM). The data is prospective in the sense that the tests were designed and executed to evaluate the specific product.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This is a non-clinical device, not an AI/diagnostic device that typically requires expert-established ground truth for a test set. The "ground truth" here is objective laboratory measurements against predefined specifications and validated assay methods.

4. Adjudication Method for the Test Set:

Not applicable, as this is non-clinical performance testing against objective criteria, not a diagnostic or AI study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation by human readers. The Pre-Seed™ Fertility Lubricant is a personal lubricant, not a diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Not applicable. This is a physical and chemical product, not an algorithm or AI system. Its performance is inherent in its formulation and physical properties, tested in a standalone manner (the lubricant itself against criteria).

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests is based on:

Objective laboratory measurements: Directly measured physical and chemical properties (pH, osmolality, viscosity, appearance, odor, endotoxin levels, microbial counts).
Validated assay outcomes: Results from standardized biological assays like the Human Sperm Survival Assay (HSSA), which measures sperm motility against a control.
Compliance with international standards: Biocompatibility testing according to ISO 10993 series and condom compatibility testing per ASTM D7661-10. These standards define the procedures and acceptance criteria.
Stability data: Measuring the maintenance of all specifications over time to establish shelf-life.

8. The Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" for this type of non-clinical device performance testing. The lubricant's formulation and manufacturing processes are developed to meet the desired specifications, and then the final product is tested against those specifications.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set mentioned or implied for this non-clinical device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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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: (609) 806.1671
	Fax: (609) 403.7415
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:

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

Specification	Recommended Acceptance Criteria
Appearance/Color	Hazy, colorless to slightly yellow, viscousliquid
Odor	Characteristic, no off odor(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)-USP <61> and <1111>	<100 cfu/g
Total Yeast & Mold Count (TYMC)-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 EffectivenessUSP<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.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):	K193450Subject Device	K072741Predicate Device	Comments
Sponsor	Church & Dwight	INGfertility, LLC	NA
Regulation Number	884.5300	884.5300	Same
Product Code	PEBII	PEBII
Device Class	II	II
Indications for Use	Pre-Seed™ FertilityLubricant is a personallubricant for penile and/orvaginal application,intended to moisturize andlubricate, to enhance theease and comfort ofintimate sexual activity and	To lubricate vaginaltissues to facilitateentry of diagnostic ortherapeutic devicesincluding those usedin fertilityinterventions. Pre~Vamay be applied	Sameintended use
	supplement the body'snatural lubrication. Pre-Seed™ Fertility Lubricantis compatible with sperm,oocytes, and embryos andcan be used by trying toconceive couples. It iscompatible with naturalrubber latex andpolyisoprene condoms. It isnot compatible withpolyurethane condoms.Pre-Seed™ FertilityLubricant can be used tolubricate genital tissues anddevices to facilitate use ofdiagnostic and therapeuticdevices during fertilityinterventions andreproductive medicine.	directly to the deviceor may be depositedintravaginally usingthe applicator, prior tothe insertion ofdiagnostic ortherapeutic devicesused in fertilityinterventions.As a personallubricant Pre~Vasupplements thebody's own naturallubricating fluids, tomoisturize, relievefriction and toenhance the ease andcomfort of intimatesexual activity.Pre-Va is safe for useby couples who aretrying to conceive andmay be appied tovaginal or peniletissues for lubricationand moisturizationpurposes. It iscompatible with latexand polyurethanecondom.
Condom Compatibility	Natural rubber latex andpolyisoprene	Natural rubber latexand polyurethane	Different
Base Type	Water	Water	Same
Primary Ingredients	WaterHydroxyethylcelluloseSymOcide PHPluronic F-127Sodium ChlorideDibasic SodiumPhosphate AnhydrousCarbopol 934PSodium HydroxideArabinogalactanPotassium PhosphateMonobasic	WaterHydroxyethylcellulosePluronic 127Sodium ChlorideArabinogalactanSodium PhosphateCarbopol 934PMethylparabenSodium HydroxidePotassium Phosphate	Different
Appearance	Hazy, colorless to slightlyyellow 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 Pathogenicorganism	Absent	Absent	Same
Antimicrobial effectivenessper USP <51> and <1112>	Bacteria: Not less than 2.0log reduction from theinitial count at 14 days. Noincrease from 14 days'count 28 days.Yeast & Mold: No increasefrom the initial calculatedcount at 14 and 28 days.	Bacteria: Not less than2.0 log reduction fromthe initial count at 14days. No increasefrom 14 days' count28 days.Yeast & Mold: Noincrease from theinitial calculated countat 14 and 28 days.	Same
Endotoxin	<0.7 EU/mL	<0.5 Eu/ml	Different
HSSA	HSSA: motility ≥ 80 ofcontrol motility at 24 hoursafter 30 minutes exposure to10% lubricant	Sperm motilityfollowing 30-minutesincubation with 10%diluted lubricantsolution equals >80%of sperm motility incontrol 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.

Regulation Number and Section

§ 884.5300 Condom.

(a)
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.(b)
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.