(90 days)
BioNourish 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
BioNourish Lubricant is a personal lubricant that is non-sterile, contains hyaluronic acid, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of water, hydroxyethylcellulose, hyaluronic acid, carrageenan, sodium chloride, xanthan gum, lactic acid, potassium sorbate, sodium benzoate, ceratonia siliqua (carob) gum, and calcium chloride. BioNourish is packaged in 2 fl. oz plastic tubes. The device is packaged with a low-density polyethylene (LDPE) applicator. BioNourish lubricant is a personal lubricant for over-the-counter (OTC) use.
The provided document is a 510(k) Pre-market Notification for a medical device (BioNourish Lubricant). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device's performance is measured against predefined acceptance criteria for clinical efficacy or diagnostic accuracy. Therefore, the information requested in the prompt, which pertains to a clinical or diagnostic study design, such as sample size for test sets and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, is not available in this type of regulatory submission.
However, I can extract the acceptance criteria for the device's physical, chemical, and microbiological properties and the reported performance based on non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Implied by meeting spec) |
|---|---|---|
| Appearance | Clear and transparent | Clear and transparent |
| Odor | Characteristic | Characteristic |
| Viscosity | 5,000 – 28,000 cps | Within 5,000 – 28,000 cps |
| Osmolality | 250 – 400 mOsm/kg | Within 250 – 400 mOsm/kg |
| pH at 25 °C | 3.8-4.2 | Within 3.8-4.2 |
| Total Aerobic Microbial Count (USP) | ) | ) |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility (Sensitization) | Non-sensitizing | Non-sensitizing |
| Biocompatibility (Irritation) | Non-irritating | Non-irritating |
| Biocompatibility (Acute systemic toxicity) | Not acutely-systemically toxic | Not acutely-systemically toxic |
| Condom Compatibility (Natural rubber latex) | Compatible | Compatible |
| Condom Compatibility (Polyisoprene) | Compatible | Compatible |
| Condom Compatibility (Polyurethane) | Not compatible | Not compatible |
| Shelf Life | 1 year (maintaining specifications) | 1 year (specifications maintained) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes pre-market testing to ensure the device meets specified physical, chemical, microbiological, and biocompatibility standards, not a clinical trial with a "test set" in the context of diagnostic performance or clinical efficacy. The data described appears to be from in-vitro and laboratory tests rather than human studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document does not describe a study involving expert-established ground truth for a test set, as it is not a clinical or diagnostic performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is mentioned as this document does not describe a study that would require such a method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a personal lubricant, not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the physical, chemical, and microbiological properties, the "ground truth" or reference standard would be the established scientific and regulatory methods (e.g., USP standards for microbial count, ASTM standards for condom compatibility, ISO standards for biocompatibility). For biocompatibility, the "ground truth" is derived from the results of standardized assays.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an algorithm-based device that requires machine learning training.
9. How the ground truth for the training set was established
Not applicable. This information is not relevant to the nature of the device and the studies presented.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets its acceptance criteria involved a series of non-clinical, laboratory-based tests. These included:
- Biocompatibility Testing: Conducted in accordance with the 2016 FDA guidance document "Use of International Standard ISO 10993-1." Specific tests included:
- Cytotoxicity (per ISO 10993-5: 2009)
- Sensitization and Irritation (using human repeated insult patch testing, an alternative to ISO 10993-10:2010)
- Acute systemic toxicity (per ISO 10993-11:2017)
- Results: The device was determined to be non-cytotoxic, non-sensitizing, non-irritating, and not acutely-systemically toxic.
- Condom Compatibility Testing: Evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms."
- Results: The device was compatible with natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms.
- Shelf Life Testing: An accelerated aging stability study was performed to determine the shelf life.
- Results: The study demonstrated a 1-year shelf life, with the device maintaining all its specified properties (as listed in Table 1) over this duration.
- Device Specifications Testing: Various tests were conducted to confirm the physical (appearance, odor, viscosity), chemical (pH, osmolality), and microbiological (total aerobic microbial count, total yeast & mold count, absence of pathogenic organisms, antimicrobial effectiveness) properties met the defined specifications in "Table 1: Subject Device Specifications."
- Results: All specified properties were met.
The conclusion of these tests was that the BioNourish Lubricant is as safe and effective as the predicate device, supporting its substantial equivalence determination.
§ 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.