(151 days)
OFNat Lubricant (L15) is a personal lubricant for vaginal and penile 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.
OFNat Lubricant (L15) is a non-sterile, water-based personal lubricant for vaginal and penile application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.
Its formulation consists of water (aqua), propanediol, okra extract, hydroxyethylcellulose, sodium lactate, benzoic acid, and flaxseed gum.
OFNat Lubricant (L15) is sold as an over-the-counter (OTC) product and is packaged in 80 ml black HDPE bottle and 5 ml sachet.
This document describes the OFNat Lubricant (L15) device, a personal lubricant. It primarily focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. The information provided is characteristic of a regulatory submission rather than a clinical study report. Therefore, some of the requested data points (like expert qualifications, adjudication methods, MRMC studies, or training set details) are not typically included in such documents and are absent here.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are described as "Specifications" in "Table 1: Device Specifications for OFNat Lubricant (L15)". The reported device performance is indicated by the statement that "the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life" based on accelerated aging results.
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Semi-Viscous liquid | Maintained specification (implied by shelf-life study) |
| Color | Clear | Maintained specification (implied by shelf-life study) |
| Odor | Odorless | Maintained specification (implied by shelf-life study) |
| Viscosity (per USP) | 2,200 – 3,500 cps | Maintained specification (implied by shelf-life study) |
| pH (per USP) | 3.8 – 4.5 | Maintained specification (implied by shelf-life study) |
| Osmolality (per USP) | 3,100 – 4,100 mOsm/kg | Maintained specification (implied by shelf-life study) |
| Total Aerobic Microbial Count (TAMC, per USP ) | ) | ):** |
| Pseudomonas aeruginosa | Absent | Maintained specification (implied by shelf-life study) |
| Staphylococcus aureus | Absent | Maintained specification (implied by shelf-life study) |
| Candida albicans | Absent | Maintained specification (implied by shelf-life study) |
| Escherichia coli | Absent | Maintained specification (implied by shelf-life study) |
| Salmonella spp. | Absent | Maintained specification (implied by shelf-life study) |
| Clostridia spp | Absent | Maintained specification (implied by shelf-life study) |
| Antimicrobial Effectiveness Testing (per USP ): | ||
| Bacteria | Meets USP criteria for category 2. No less than 2.0 log reduction from initial count at 14 days and no increase from the 14-day count at 28 days | Maintained specification (implied by shelf-life study) |
| Yeast and Molds | No increase from the initial calculated count at 14 and 28 days | Maintained specification (implied by shelf-life study) |
| Biocompatibility | Meets ISO 10993 standards (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity) | Supports the biocompatibility of the device materials (conclusion of testing) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms. | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms (conclusion of testing per ASTM D7661-10(R) 2017) |
| Shelf-Life | 17 months, maintaining all specifications in Table 1. | Achieved 17 months, maintaining specifications through accelerated aging. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify exact sample sizes for each test (e.g., how many batches were tested for viscosity, how many animals for biocompatibility). The studies are non-clinical (laboratory and in-vitro, with some in-vivo for biocompatibility) and relate to product quality and safety, not clinical efficacy in humans.
- Test Set Sample Size: Not explicitly stated for individual tests.
- Data Provenance: The testing appears to be conducted by the manufacturer as part of their regulatory submission. The country of origin for the data (where the tests were physically performed) is not specified, but the applicant (Suretex Limited) is in Thailand. The testing is prospective in the sense that it was conducted specifically to support this 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 provided. For non-clinical tests like those described (e.g., viscosity, pH, microbial counts, biocompatibility), the "ground truth" is typically established by validated laboratory methods and adherence to international standards rather than expert consensus on interpretations of complex medical images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. This device is a personal lubricant, and the testing involves laboratory measurements and standard biological assays rather than human interpretation or adjudication of results in the way one might for diagnostic AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. Such studies are typically for diagnostic devices, especially those involving human interpretation of imaging, to assess reader performance with and without an AI aid. This device is not a diagnostic AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This device is a physical product (personal lubricant), not an algorithm or AI. All performance tests are considered "standalone" in the sense that they evaluate the product itself against set specifications.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests is based on:
- Established laboratory measurement standards: e.g., USP for Viscosity, USP for pH, USP for Osmolality, USP for Microbial Counts, USP for Pathogen Presence, USP for Antimicrobial Effectiveness.
- International biocompatibility standards: ISO 10993 series for Cytotoxicity, Sensitization, Vaginal Irritation, and Acute Systemic Toxicity.
- Condom compatibility standard: ASTM D7661-10(R) 2017.
- Manufacturer's defined specifications: for properties like appearance, color, and odor, which are then verified through testing.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this type of device (a physical personal lubricant). The manufacturing process and formulation development might involve iterative testing, but this is not analogous to training an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.