BabyDance 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. BabyDance Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BabyDance Fertility Lubricant is compatible with natural rubber latex and polyurethane condoms.

BabyDance 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

This device is a non-sterile, water-based personal lubricant for vaginal and/or penile application. The formulation does not harm sperm function and has a pH and osmolality that are physiologic ("balanced") to that of fertile cervical mucus and semen. The device is compatible with latex and polyurethane condoms.

BabyDance Fertility Lubricant™ is formulated using purified water, cetyl hydroxyethylcellulose, hypromellose, carbomer homopolymer type B, sodium phosphate, potassium phosphate, sodium chloride, xvlose, sodium hydroxide, phenethyl alcohol, caprylyl glycol, and Salvia sclarea. This device is supplied with an applicator.

The device specifications for the BabyDance Fertility Lubricant™ include appearance, odor, pH, viscosity, osmolality, total aerobic microbial count, total yeast and mold count, absence of pathogenic orqanisms (Escherichia coli, Staphylococcus. aureus, Salmonella, Pseudomonas aeruginosa, and Candida albicans), endotoxin, mouse embryo assay (MEA), and human sperm survival assay (HSSA). These specifications were evaluated during the length of the proposed shelf-life and will be tested before lot release.

AI/ML Overview

This document describes the acceptance criteria and supporting studies for the BabyDance Fertility Lubricant™.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a summary of performance testing but does not present a formal table of acceptance criteria with specific numerical thresholds and reported performance values for each criterion. Instead, it describes the types of tests performed to ensure safety and effectiveness.

Here's an inferred table based on the descriptions:

Acceptance Criteria (Inferred from testing)	Reported Device Performance (General statements)
Physical Properties:
Appearance (fresh and aged)	Evaluated using established methods; specifications met.
Odor (fresh and aged)	Evaluated using established methods; specifications met.
pH (fresh and aged)	Evaluated using established methods; specifications met. "Physiologic"
Viscosity (fresh and aged)	Evaluated using established methods; specifications met.
Osmolality (fresh and aged)	Evaluated using established methods; specifications met. "Physiologic"
Microbiological Purity:
Total aerobic microbial count (fresh and aged) per USP <61>	Specifications met.
Total yeast and mold count (fresh and aged) per USP <61>	Specifications met.
Absence of pathogenic organisms (E. coli, S. aureus, Salmonella, P. aeruginosa, C. albicans) per USP <62> (fresh and aged)	Absence confirmed.
Antimicrobial effectiveness per USP <51>	Effective, as per USP <51>.
Endotoxin testing per USP <85>	Specifications met.
Biocompatibility (Lubricant):
Cytotoxicity per ISO 10993-5:2009	Non-cytotoxic.
Guinea Pig Maximization Sensitization per ISO 10993-10:2010	Non-sensitizing.
Skin Irritation per ISO 10993-10:2010	Non-irritating.
Vaginal Irritation per ISO 10993-10:2010	Non-irritating.
Acute Systemic Toxicity per ISO 10993-11:2006	Non-toxic.
Biocompatibility (Applicator):
Cytotoxicity per ISO 10993-5:2009	Non-cytotoxic.
Guinea Pig Maximization Sensitization per ISO 10993-10:2010	Non-sensitizing.
Vaginal Irritation per ISO 10993-10:2010	Non-irritating.
Sperm/Embryo Compatibility:
Mouse Embryo Assay (MEA) (fresh and aged)	Percent developing to expanded blastocyst stage comparable to control. "Does not harm sperm function."
Human Sperm Survival Assay (HSSA) (fresh and aged)	Progressive motility comparable between control and lubricant-exposed treatments. "Does not harm sperm function."
Lubricant Barrier Assay (sperm penetration)	Sperm penetration into lubricant evaluated; results deemed acceptable (details not provided).
Bovine Mucosal Penetration Testing (sperm motility)	Vanguard sperm distance and spermatozoa density comparable to control.
Computer Assisted Sperm Analysis (CASA)	Results comparable between control and lubricant mixture.
Semen Assessment (motility per WHO guidelines)	Motility comparable to control.
Sperm Chromatin Structure Assay (SCSA) (DNA fragmentation)	DNA fragmentation index comparable between control and lubricant mixture.
Mouse In-vitro Fertilization-Embryo Development (mIVF-MEA)	Number of oocytes fertilized and developing to expanded blastocysts comparable between control and lubricant mixture. "Compatible with sperm, oocytes, and embryos."
mIVF-MEA with applicator exposure (fresh and aged applicator)	Impact of lubricant exposed to applicator on fertilization and embryo development comparable to control and lubricant without applicator exposure.
Condom Compatibility:
Compatibility with natural rubber latex and polyurethane condoms per ASTM D7661-10	Compatible.

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

The document does not explicitly state a sample size for a "test set" in the context of clinical trials or performance studies with human subjects for the lubricant's primary function. The studies listed are primarily laboratory-based non-clinical performance and biocompatibility tests.

Animal Models:
- Mouse Embryo Assay (MEA) (one-cell mouse embryos)
- Guinea Pig Maximization Sensitization (Guinea Pigs)
- Skin Irritation (e.g., rabbits or guinea pigs, typical for ISO 10993-10)
- Vaginal Irritation (e.g., rabbits, typical for ISO 10993-10)
- Acute Systemic Toxicity (e.g., mice, typical for ISO 10993-11)
- Bovine Mucosal Penetration Testing (bull sperm, bovine cervical mucus)
Human-derived specimens (in vitro):
- Human Sperm Survival Assay (HSSA) (washed human sperm)
- Lubricant Barrier Assay (neat human semen samples)
- Computer Assisted Sperm Analysis (CASA) (human sperm samples)
- Semen Assessment (neat human semen samples)
- Sperm Chromatin Structure Assay (SCSA) (neat human semen samples)

The data provenance is from various laboratory settings, likely in the US or other countries adhering to ISO/USP standards. The studies appear to be prospective in nature, as they involve testing the manufactured device and its components according to pre-defined protocols.

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

This information is not provided in the document. For the non-clinical performance testing described, "ground truth" is typically established by:

Adherence to validated test methodologies (e.g., USP, ISO, ASTM standards).
Laboratory technicians and scientists performing the tests and interpreting results against pre-defined specifications or controls.
The qualifications of these individuals would typically include degrees in relevant scientific fields (e.g., microbiology, toxicology, reproductive biology) and experience in GLP (Good Laboratory Practice) compliant testing.

4. Adjudication Method for the Test Set:

Not applicable, as this refers to a multi-reader, often clinical, consensus process. The studies performed are laboratory-based with clear predefined endpoints and standardized methods, not subjective clinical evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic imaging devices where multiple readers interpret cases with and without algorithmic assistance. The BabyDance Fertility Lubricant™ is a medical device for use in conception support and general lubrication, not a diagnostic imaging AI tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is not an algorithm or AI system. Its performance is evaluated through direct physical, chemical, and biological testing, sometimes in the presence of biological specimens, but not through an algorithm operating autonomously.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical tests is established by:

Established scientific/medical standards: (e.g., acceptable pH ranges, acceptable osmolality ranges, absence of specific pathogens, non-cytotoxic, non-irritating, non-toxic as defined by ISO/USP standards).
Comparison to controls: Many studies compare the lubricant's effect to a control (e.g., culture medium without lubricant) to determine if there is a statistically significant detrimental effect on sperm function, embryo development, etc.
Conformance to predicate device properties: While not a true "ground truth," the predicate device's known characteristics serve as a benchmark for substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable.

Summary

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

April 28, 2017

Fairhaven Health, LLC Suzanne Munson VP of Product Development/Compliance 1410 11th Street Bellingham, WA 98225

Re: K162319

Trade/Device Name: BabyDance Fertility Lubricant™ Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated: March 30, 2017 Received: March 31, 2017

Dear Suzanne Munson:

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.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely.

Benjamin R. Fisher -S

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

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Indications for Use

510(k) Number (if known) K162319

Device Name BabyDance Fertility Lubricant TM

Indications for Use (Describe)

BabyDance 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. BabyDance Fertility Lubricant is compatible with sperm, oocytes, and ean be used by trying to conceive couples. BabyDance Fertility Lubricant is compatible with natural rubber latex and polyurethane condoms.

BabyDance 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

I. General Information on Submitter

Address:	Fairhaven Health, LLC
	1410 11th Street
	Bellingham, WA 98225

Telephone:	360-543-7888
Email:	suzanne@fairhavenhealth.com
Contact Person:	Suzanne Munson
Date Prepared:	April 27, 2017

II. General Information on Device

Proprietary Name:	BabyDance Fertility Lubricant™
Common Name:	Personal Lubricant
Classification Name:	Condom (21 CFR 884.5300)
Product Code:	PEB (Lubricant, Personal, Gamete, Fertilization, and Embryo
	Compatible)
510(k) Number:	K162319

III. Predicate Device

Pre-Va Vaginal Lubricant (K072741), manufactured by INGFertility, LLC. This predicate device has not been subject to any design related recalls.

IV. Description of Device

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embryo assay (MEA), and human sperm survival assay (HSSA). These specifications were evaluated during the length of the proposed shelf-life and will be tested before lot release.

V. Indications for Use

BabyDance Fertility Lubricant is a personal lubricant for penile and/or vaqinal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. BabyDance Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BabyDance Fertility Lubricant is compatible with natural rubber latex and polyurethane condoms.

BabyDance 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.

Attribute	BabyDance Fertility Lubricant	Pre~Va Vaginal Lubricant
Base of product	Water	Water
CondomCompatibility	Compatible with latex andPolyurethane condoms	Compatible with latex andPolyurethane condoms
Ingredients	Purified water, cetylhydroxyethylcellulose, hypromellose,carbomer homopolymer type B,sodium phosphate, potassiumphosphate, sodium chloride, xylose,sodium hydroxide, phenethyl alcohol,caprylyl glycol, Salvia sclarea	Water, Hydroxyethylcellulose,Pluronic 127, Sodium Chloride,Arabinogalactan, SodiumPhosphate, Carbopol 934P,Methyl Paraben, SodiumHydroxide, Potassium Phosphate

VI. Technological Characteristics of Device Compared to Predicate Device

Both the subject and predicate devices are water-based personal lubricants and have the same condom compatibility. They have different formulations and different values for their specifications; however, these differences do not raise different questions of safety and effectiveness.

VII. Summary of Non-clinical Performance Testing

The following studies have been performed to ensure safety and effectiveness of subject device:

. Physical testing (appearance, pH, viscosity and osmolality) on freshly manufactured and aged BabyDance Fertility Lubricant using established methods

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. Microbiology studies on newly manufactured and aged BabyDance Fertility Lubricant, as follows:
- ★ Total aerobic microbial count testing per USP <61>
- - Total yeast and mold count per USP <61>
- - Absence of pathogenic organisms (Escherichia coli, Staphylococcus. aureus, Salmonella, Pseudomonas aeruginosa, and Candida albicans) testing per USP <62>
- - Antimicrobial effectiveness testing per USP <51>
- - Endotoxin testing per USP <85>
. Biocompatibility studies on newly manufactured BabyDance Fertility Lubricant, as follows:
- ★ Cytotoxicity testing per 10993-5:2009
- ★ Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010
- - Skin Irritation testing per ISO 10993-10:2010
- - Vaginal Irritation testing per ISO 10993-10:2010
- Acute Systemic Toxicity testing per ISO 10993-11:2006 *
. Biocompatibility studies on the applicator, as follows:
- ★ Cytotoxicity testing per 10993-5:2009
- - Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010
- - Vaginal Irritation testing per ISO 10993-10:2010
. Mouse embryo assay (MEA) testing on newly manufactured and aged BabyDance Fertility Lubricant

One-cell mouse embryos were exposed to culture medium with and without added lubricant. Post exposure, mouse embryos were cultured and the percent developing to the expanded blastocyst stage were compared between control and lubricant-exposed treatments.

. Human sperm survival assay (HSSA) testing on freshly manufactured and aged BabyDance Fertility Lubricant
Washed human sperm were resuspended in medium with and without added lubricant and incubated. Following incubation, progressive motility was compared for sperm in both the control and lubricant-exposed treatments.
. Sperm function testing on freshly manufactured BabyDance Fertility Lubricant, as follows:

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- Lubricant barrier assay
  Neat human semen samples were allowed to liquefy. An aliquot of undiluted lubricant was placed on a warmed glass slide. Immediately adjacent to this lubricant, a sample of sperm in semen was placed on the slide. Sperm penetration from semen into the lubricant was evaluated at the sperm-lubricant boundary and at distances into the lubricant samples.
- Bovine mucosal penetration testing
  Capillary tubes were filled with ovulatory phase bovine cervical mucus and sealed at one end. The open end of each tube was placed into a bull sperm sample suspended in either control medium or medium mixed with lubricant. Distance travelled by the vanquard sperm and density of spermatozoa at specified positions in the capillary tube were compared between the two groups.
- Computer assisted sperm analysis (CASA)
  Human sperm samples were incubated with control medium or a medium and lubricant mixture. After incubation and thorough mixing of samples, replicate aliquots were removed from treatments for CASA using a Hamilton Thorne IVOS analyzer. Results were compared between the two groups.
- Semen assessment
  Neat human semen samples were mixed with either control medium or a medium and lubricant mixture and incubated. Followinq incubation, motility of sperm in both treatments was determined according to the World Health Organization (WHO) guidelines for the examination and processing of human semen.
- Sperm Chromatin Structure Assay (SCSA)
  Neat human semen samples were incubated in control medium or in a medium and lubricant mixture. Human sperm chromatin integrity in both treatments was compared (i.e. DNA fragmentation Index), using the Sperm Chromatin Structure Assay (SCSA). The SCSA was performed using acridine orange to stain single and double stranded nucleic acids in sperm with and without lubricant exposure.
- Mouse In-vitro Fertilization-Embryo Development (mIVF-MEA)

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The impact of lubricant on the ability of sperm to penetrate and fertilize oocytes, as well as the ability of resulting zygotes to then develop normally to the blastocyst stage was evaluated using mIVF-MEA. Mouse ova were placed with mouse sperm in a solution containing control medium or a medium and lubricant mixture. After fertilization incubation, presumptive zvgotes were transferred to culture medium for subsequent development to expanded blastocysts. The number of oocytes becoming fertilized and developing into expanded blastocysts was compared between the two groups.

mIVF-MEA testing on BabyDance Lubricant filled in freshly manufactured and . aged applicator
The impact of lubricant exposed to applicators on the ability of sperm to penetrate and fertilize oocytes, as well as the ability of these zygotes to then develop to the blastocyst stage was evaluated using mIVF-MEA. Mouse ova were placed with mouse sperm from three different treatments including: control medium (no lubricant or applicator exposure); medium and lubricant (without applicator exposure); medium and lubricant following exposure to the applicator. After fertilization incubation, the presumptive zygotes were transferred to culture medium for development to expanded blastocysts. The number of oocytes becominq fertilized and developing to expanded blastocysts was compared between the treatments.
. Condom compatibility testing on freshly manufactured BabyDance Fertility Lubricant per ASTM D7661-10

VIII. Conclusion

The subject and predicate devices have the same intended use and the different technological characteristics do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.

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.