(218 days)
BioGenesis 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. BioGenesis Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
BioGenesis 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.
BioGenesis Fertility Lubricant is water-based formula with ingredients including lactic acid, hydroxyethylcellulose, sodium chloride, potassium sorbate, sodium benzoate, potassium chloride, sorbic acid, magnesium chloride, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications are listed in Table 1 below. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. It is also compatible with compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples.
This document is an FDA 510(k) summary for the BioGenesis Fertility Lubricant (K190872). It describes the acceptance criteria and performance data used to demonstrate its substantial equivalence to a predicate device (BabyDance Fertility Lubricant, K162319).
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and reported device performance:
| Property | Acceptance Criteria (Specification) | Reported Performance |
|---|---|---|
| Appearance | Gel | Gel |
| Color | Clear | Clear |
| Odor | Characteristic | Characteristic |
| Viscosity | 1,200-10,000 cps | 1,200-10,000 cps (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Osmolality | 300–400 mOsm/kg | 300–400 mOsm/kg (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| pH at 25 °C | 3.8-4.2 | 3.8-4.2 (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Endotoxin | ) | ) |
| Pseudomonas aeruginosa | Absent | Absent (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Staphylococcus aureus | Absent | Absent (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Candida albicans | Absent | Absent (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Escherichia coli, Salmonella, Clostridium | Absent | Absent (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Antimicrobial Effectiveness (E. coli, P. aeruginosa, S. aureus) | NLT a 2.0 log reduction from initial count at 14 days and no increase from the 14-day count at 28 days | Meets criteria (Implied, as per "Antimicrobial Effectiveness (USP)" testing and statement the product maintains specifications over shelf life) |
| Antimicrobial Effectiveness (C. albicans, A. niger) | No increase from the initial calculated count at 14 and 28 days | Meets criteria (Implied, as per "Antimicrobial Effectiveness (USP)" testing and statement the product maintains specifications over shelf life) |
| Biocompatibility | Meets ISO 10993-5:2009, human repeat insult patch testing (sensitization and irritation), and ISO 10993-11:2006 | Device is biocompatible (tested per ISO 10993-5:2009, human repeat insult patch testing, and ISO 10993-11:2006) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms | BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms (tested per ASTM D7661-10) |
| Shelf Life | 12 months | BioGenesis Fertility Lubricant maintains its specifications over the duration of its proposed shelf life of twelve months (demonstrated through accelerated aging shelf-life testing) |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes for each non-clinical performance test (e.g., number of replicates for viscosity, number of samples for microbial counts, number of individuals for biocompatibility, etc.). It only mentions that testing was conducted.
- The data provenance is non-clinical laboratory data. There is no indication of country of origin for the data provided, but given the FDA submission, it would adhere to US regulatory standards for testing. The data is retrospective in the sense that the tests were completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this type of device and study. The "ground truth" here is established by validated laboratory test methods and industry standards (e.g., USP, ISO, ASTM). There are no human experts "adjudicating" diagnostic images or clinical outcomes in this context. The experts involved would be those performing the lab tests, who are qualified by their adherence to the specified test methods.
4. Adjudication method for the test set:
- This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly in medical imaging, where multiple human readers assess data and their interpretations need to be reconciled to form a ground truth. For this type of non-clinical device, "adjudication" is replaced by standardized laboratory procedures and validated analytical methods, where a clear pass/fail or specification adherence is determined by the test results themselves.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not performed, nor is it relevant for this non-clinical device. MRMC studies are used to evaluate the impact of a diagnostic aid (like AI) on human reader performance for tasks such as disease detection or diagnosis. This submission focuses on the chemical and physical properties, and biological compatibility of a lubricant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This concept is not applicable to the BioGenesis Fertility Lubricant. This is not an AI/algorithm-based medical device. The "performance" is the inherent chemical, physical, and biological properties of the lubricant itself as measured by laboratory tests.
7. The type of ground truth used:
- The ground truth for this device is based on established scientific and technical standards, laboratory assays, and relevant consensus standards (e.g., ISO, ASTM, USP). It is not clinical "outcomes data" or "expert consensus" in the sense of medical diagnosis. Specifically:
- Chemical and Physical Properties: Defined by specific ranges and characteristics (e.g., viscosity, pH, appearance).
- Microbiological Purity/Effectiveness: Defined by USP standards and specified microbial limits.
- Biocompatibility: Defined by ISO 10993 series of standards.
- Sperm Compatibility: Defined by Human Sperm Survival Assay (HSSA) and lubricant barrier assay, with a specific quantitative acceptance criterion identified (≥ 70% sperm survival).
- Condom Compatibility: Defined by ASTM D7661-10.
- Shelf Life: Defined by accelerated aging studies demonstrating maintenance of all other listed specifications over time.
8. The sample size for the training set:
- This refers to the development of an AI algorithm. Since BioGenesis Fertility Lubricant is a physical product (a lubricant) and not an AI/software device, the concept of a "training set" for an algorithm is not applicable. The product's formulation and manufacturing processes are developed through traditional chemical and pharmaceutical engineering, not machine learning.
9. How the ground truth for the training set was established:
- As stated above, this question is not applicable as there is no AI training set for this device. The "ground truth" for the device's formulation and manufacturing would be established through chemical principles, quality control standards, and iterative product development/testing.
§ 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.