(252 days)
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.
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.
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 | Specifications met. |
| Total yeast and mold count (fresh and aged) per USP | Specifications met. |
| Absence of pathogenic organisms (E. coli, S. aureus, Salmonella, P. aeruginosa, C. albicans) per USP (fresh and aged) | Absence confirmed. |
| Antimicrobial effectiveness per USP | Effective, as per USP . |
| Endotoxin testing per USP | 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.
§ 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.