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Sage 2-in-1 Personal Lubricant and Moisturizer is 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. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene or polyurethane condoms

Sage 2-in-1 Personal Lubricant and Moisturizer™ is a non-sterile, water-soluble personal lubricant for over-the-counter (OTC) use. The lubricant will be provided in a 1.6 oz tube and will also be supplied with a low-density polyethylene applicator.

This document is a 510(k) Pre-Market Notification for a medical device called "Sage 2-in-1 Personal Lubricant and Moisturizer™". It asserts substantial equivalence to a predicate device, which inherently means it meets the same safety and effectiveness standards, rather than defining novel acceptance criteria or conducting a comparative effectiveness study.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Sage 2-in-1 Personal Lubricant and Moisturizer™ are primarily based on established standards and physical/chemical properties, as well as biological safety. The "reported device performance" is essentially that the device met these specifications.

2. Sample Size for the Test Set and Data Provenance

This document describes a 510(k) submission, which relies on non-clinical performance testing rather than a clinical "test set" in the sense of patient data for algorithm evaluation.

• Sample Size: Not explicitly stated as a single "test set" in the context of device performance in humans.
  • For biocompatibility tests (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity), these are typically performed on in vitro models or animal models. The exact number of samples or animals is not specified in this summary.
  • For condom compatibility, the standard ASTM D7661-10 would specify the number of condoms and lubricant samples tested. This information is not provided in detail.
  • For shelf-life, samples of the product would be subjected to accelerated aging conditions. The number of samples is not specified.
  • For physical/chemical/microbiological tests, these are typically performed on batches of the manufactured product. The exact number of samples per test is not detailed.
• Data Provenance: The tests are standard laboratory tests (e.g., USP, ISO, ASTM standards). The data would be generated in a laboratory setting, likely in the country where Fairhaven Health, LLC operates (USA), and would be considered prospective data for the purpose of validating the manufacturing and product characteristics. It is not patient data.

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

Not applicable in the context of this 510(k) submission. "Ground truth" established by experts typically refers to clinical diagnosis or evaluation from medical images/records, which is not part of this device's validation. The "ground truth" here is adherence to scientific standards and specifications, which are validated by laboratory personnel qualified in their respective testing domains (e.g., microbiology, chemistry, toxicology).

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human readers or expert consensus on clinical findings. The "adjudication" (or rather, verification) is through the test methods themselves and their interpretation by trained laboratory personnel.

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

No. This document does not describe a MRMC comparative effectiveness study. It is a 510(k) for a personal lubricant, which does not involve human readers evaluating cases or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This device is a personal lubricant, not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:

• Established scientific standards and specifications: (e.g., USP for pH, ISO 10993 for biocompatibility, ASTM D7661-10 for condom compatibility).
• Laboratory measurements and observations: Direct measurements of physical, chemical, and microbiological properties.
• Safety assessment: Demonstrating non-toxicity, non-irritancy, and non-sensitization based on biocompatibility standards.
• The overall "ground truth" for a 510(k) submission is that the device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning model that requires a training set. The "training set" concept does not apply to the validation of a personal lubricant.

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

Not applicable, as there is no training set for this device.

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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:

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.

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