(89 days)
Coconu Water Based Personal 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.
Coconu Water Based Personal Lubricant is a non-sterile, water-based personal lubricant that is intended for penile and vaginal application 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. Its formulation consists of water, Coconut) fruit juice, Microcare SB (water, sodium benzoate, potassium sorbate), Keltrol CG (xanthan gum), Purac FCC 50 (water, lactic acid), Geogard 111S (sodium dehydroacetate), CMC 7H3SF PHARM (sodium carboxymethylcellulose). Coconu Water Based Personal Lubricant is packaged in a MDPE (medium density polyethylene) 3 oz tube, packaged in an outer box. Coconu Water Based Personal Lubricant is a personal lubricant for over-the-counter (OTC) use.
The provided text is a 510(k) Summary for the Coconu Water Based Personal Lubricant. It contains information about the device, its intended use, comparison to a predicate device, and a summary of non-clinical performance testing.
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 |
|---|---|---|
| Appearance | Opaque Flowable Gel | Opaque Flowable Gel (implied by meeting specification) |
| Color | Off-White - Light Yellow | Off-White - Light Yellow (implied by meeting specification) |
| Odor | None | None (implied by meeting specification) |
| Viscosity@25°C Spindle #RVS@20rpm | 2,800 cps - 4,500 cps | 2,800 cps - 4,500 cps (implied by meeting specification) |
| Specific Gravity@25°C | 0.90-1.11 | 0.90-1.11 (implied by meeting specification) |
| pH @ 25° | 4.0 to 5.0 | 4.0 to 5.0 (implied by meeting specification) |
| Osmolality (mOSm/kg) (1:10 dilution) per USP | 42.0 mOsm/kg - 46.0 mOsm/kg | 42.0 mOsm/kg - 46.0 mOsm/kg (implied by meeting specification) |
| Total aerobic microbial count (TAMC) per USP and | and | |
| Presence of Pathogens per USP | Absent (Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella/Shigella, Escherichia coli and Candida albicans) | Absent (implied by meeting specification) |
| Biocompatibility: Cytotoxicity | Non-cytotoxic | Non-cytotoxic (from "The results of testing demonstrated the subject device is non-sensitizing, non-irritating, and non-systemically toxic.") |
| Biocompatibility: Dermal Sensitization | Non-sensitizing | Non-sensitizing (from "The results of testing demonstrated the subject device is non-sensitizing, non-irritating, and non-systemically toxic.") |
| Biocompatibility: Vaginal Irritation | Non-irritating | Non-irritating (from "The results of testing demonstrated the subject device is non-sensitizing, non-irritating, and non-systemically toxic.") |
| Biocompatibility: Acute Systemic Toxicity | Non-systemically toxic | Non-systemically toxic (from "The results of testing demonstrated the subject device is non-sensitizing, non-irritating, and non-systemically toxic.") |
| 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. (explicitly stated) |
| Shelf Life | All device specifications listed in Section V (the table above) met at all time points for 8.5 months. | All device specifications listed in Section V met at all time points for 8.5 months (explicitly stated). |
2. Sample size used for the test set and the data provenance
The document does not specify general "test set" sample sizes or data provenance (e.g., country of origin, retrospective/prospective). Instead, it lists various non-clinical performance tests, each likely having its own sample size and methodology defined by the respective ASTM or USP standard. For example:
- Biocompatibility: The specific ISO standards (10993-5, 10993-10, 10993-11) would define the sample sizes for these tests (e.g., number of cells for cytotoxicity, number of guinea pigs for sensitization, number of animals for irritation/systemic toxicity).
- Condom Compatibility: Tested in accordance with ASTM D7661-10. This standard would dictate the number of condoms and lubricant applications required.
- Shelf Life Testing: Per ASTM F1980-16 (accelerated aging). This standard defines the methodology, but specific sample sizes are not provided in this summary.
- Microbial Testing: USP , , , define the methods, which include specific sample weights or volumes for testing.
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 submission. The Coconu Water Based Personal Lubricant is not an AI/ML device, nor is it a diagnostic device that requires expert review or ground truth labeling of medical images or patient data. The "ground truth" for this device's performance is established through adherence to standardized laboratory testing protocols (e.g., ASTM, USP, ISO).
4. Adjudication method for the test set
Not applicable. As noted above, this submission relies on standardized laboratory testing protocols rather than human adjudication of results.
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/ML device, and no MRMC study was conducted or is relevant for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for Coconu Water Based Personal Lubricant is established through:
- Physical and Chemical Property Measurement: Direct measurements of properties like viscosity, pH, specific gravity, osmolality, appearance, color, and odor using calibrated laboratory equipment and standard analytical methods.
- Microbiological Testing: Standardized microbiological culture and identification techniques following USP guidelines.
- Biocompatibility Standards: In vivo and in vitro biological tests conducted in accordance with ISO 10993 series for medical devices.
- Material Compatibility Standards: Testing against a specific ASTM standard (D7661-10) for condom compatibility.
- Accelerated Aging Studies: Conducted per ASTM F1980-16 to determine shelf-life.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. 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.