(94 days)
INA Moisturizing Intimate Water-Based 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, polyurethane, and polyisoprene condoms.
INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is a non-sterile, water-based, personal lubricant that is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The device is for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication. INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is sold as an over-the-counter (OTC) product in a 3 fl. oz./ 90 mL Polyethylene vinyl alcohol bottle with Polypropylene flip cap. The Tube will be packaged in an outer box. This product is composed of Deionized Water, Organic Certified Aloe Vera Gel, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Propanediol, Sclerotium Gum, Sodium Hyaluronate, Tremella Fuciformis Sporocarp Extract, Xanthan Gum, Lactic Acid, Red Alga Gel EC, Sodium Benzoate, Potassium Sorbate, Moringa Oleifera Seed Oil, Cariborg Sea Buckthorn Oil Refined.
The provided text is a 510(k) summary for the medical device "INA Moisturizing Intimate Water-Based Personal Lubricant". It details the device's characteristics and its comparison to a predicate device, as well as the performance data used to establish its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Summary of results) |
|---|---|---|
| Appearance | Translucent Viscous Gel | Test results demonstrated compliance with "Translucent Viscous Gel". |
| Color | Straw | Test results demonstrated compliance with "Straw". |
| Odor | None | Test results demonstrated compliance with "None". |
| Viscosity | 8,000 - 10,400 cps | Test results demonstrated compliance within the range of 8,000 - 10,400 cps. |
| pH | 4.3 - 5.3 | Test results demonstrated compliance within the range of 4.3 - 5.3. |
| Osmolality (mOSm/kg) | 1394 - 1428 mOSm/kg | Test results demonstrated compliance within the range of 1394 - 1428 mOSm/kg. |
| Total aerobic microbial count (TAMC) per USP and | and | |
| Presence of Pathogens per USP | Absent ( Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, E. coli, coliforms, Salmonella, and enrichment pathogens) | Test results demonstrated absence of specified pathogenic organisms. |
| Biocompatibility: Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Demonstrated to be non-cytotoxic. |
| Biocompatibility: Sensitization (ISO 10993-10) | Non-sensitizing | Demonstrated to be non-sensitizing. |
| Biocompatibility: Vaginal Irritation (ISO 10993-23) | Non-irritating | Demonstrated to be non-irritating. |
| Biocompatibility: Acute Systemic Toxicity (ISO 10993-11) | Not systemically toxic | Demonstrated to be not systemically toxic. |
| Condom Compatibility | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms (per ASTM-D7661-10) | Determined to be compatible with natural rubber latex, polyisoprene, and polyurethane condoms per ASTM-D7661-10. |
| Shelf Life | 6 months (maintaining all device specifications) | Demonstrated a 6-month shelf life utilizing real-time aging, with device specifications maintained. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each individual test (e.g., number of lubricant batches for viscosity, number of animals for biocompatibility tests, number of condoms for compatibility).
Regarding data provenance, the testing was performed in accordance with international standards, such as ISO and ASTM, and USP pharmacopeia, indicating a standardized and controlled environment for generating technical data. The tests were conducted on the "subject lubricant" (INA Moisturizing Intimate Water-Based Personal Lubricant) and are thus prospective data from laboratory testing specifically for this device. The country of origin of the data is not explicitly stated, but adherence to international standards implies global applicability.
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 testing. The "ground truth" for the performance specifications of a personal lubricant is established by international standards (e.g., ISO, ASTM, USP) and scientific methodologies, not by expert consensus on clinical cases. The interpretation of these test results would be performed by qualified laboratory personnel following the specified test methods.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic evaluations where human readers provide interpretations that need to be resolved. For laboratory-based performance testing of a lubricant, results are objectively measured against predefined specifications.
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
This is not applicable. An MRMC comparative effectiveness study is relevant for AI-powered diagnostic devices or systems where human readers interpret medical images or data. The device in question is a personal lubricant, not a diagnostic or AI-driven system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This question pertains to AI algorithms. The device is a personal lubricant, which does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on objective measurements and interpretations of established international standards and laboratory test methodologies. For example:
- Chemical/Physical properties: Measured values (pH, viscosity, osmolality) compared to defined numerical ranges.
- Microbial limits: Laboratory culture results compared to specified CFU/g limits and absence criteria for pathogens.
- Biocompatibility: In vitro and in vivo test results (e.g., cell viability, skin reactions) interpreted against ISO standard criteria.
- Condom compatibility: Physical properties of condoms after exposure to the lubricant, measured and compared to ASTM standard criteria.
- Shelf life: Real-time stability testing to confirm that all specified properties are maintained over the claimed period.
8. The sample size for the training set
This is not applicable. The device is a physical product (lubricant), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The product formulation is developed through research and development, not by training on data.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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.