(60 days)
Astroglide® Glycerin & Paraben Free is a personal lubricant for penile, and/or anal 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.
Astroglide® Glycerin & Paraben Free is a non-sterile, water-based liquid personal lubricant for penile, anal, and/or vaginal application. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. The subject device is sold as an overthe-counter (OTC) product in a 2.5 oz. clear PETE bottle with a screw on polypropylene flip-top cap. The bottle is labeled front and back and then packaged in a cardboard carton which constitutes the final packaging. This device is composed of water, butylene glycol, propylene glycol, xylitol, methyl gluceth-20, polyquarternium-7, hydroxyethyl cellulose, potassium sorbate, sodium benzoate, citric acid.
The provided document is a 510(k) Premarket Notification from the FDA for a personal lubricant called Astroglide® Glycerin & Paraben Free. It primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device, rather than providing details on a study of a device's performance against specific clinical acceptance criteria for diagnostic or AI-driven devices.
Therefore, much of the requested information (sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, training set details) is not applicable to this type of regulatory submission for a personal lubricant.
However, I can extract information related to the acceptance criteria for the product's physical and chemical properties, as well as its biocompatibility and condom compatibility.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Test Method) | Reported Device Performance |
|---|---|---|
| Color | Clear to slight golden | Not explicitly stated as "reported performance," but the device is described as having this specification. |
| Clarity | Clear | Not explicitly stated as "reported performance," but the device is described as having this specification. |
| Odor | Slight sweet odor | Not explicitly stated as "reported performance," but the device is described as having this specification. |
| Absence of particulate matter | Absent | Not explicitly stated as "reported performance," but the device is described as having this specification. |
| Viscosity | 1000-2800 cP | Not explicitly stated as "reported performance," but the device is described as having this specification. |
| pH | 3.5-5.5 | Not explicitly stated as "reported performance," but the device is described as having this specification. |
| Osmolality | 230-300 mOsm/kg, 1:5 dilution factor | Not explicitly stated as "reported performance," but the device is described as having this specification. |
| Total yeast/mold count (TYMC) | ) | Not explicitly stated as "reported performance," but the device is described as having met this specification. |
| Total aerobic microbial count (TAMC) | ) | Not explicitly stated as "reported performance," but the device is described as having met this specification. |
| Presence of Pathogenic Organisms | Absent (USP ) (Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans) | Not explicitly stated as "reported performance," but the device is described as having met this specification. |
| Antimicrobial effectiveness | Meets USP acceptance criteria for Category 2 products. | Not explicitly stated as "reported performance," but the device is described as having met this specification. |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic (per ISO 10993-5:2009/(R)2014) | Demonstrated non-cytotoxic |
| Biocompatibility (Sensitization) | Non-sensitizing (per Human Repeat Insult Patch Testing (HRIPT) per ASTM D6355) | Demonstrated non-sensitizing |
| Biocompatibility (Irritation) | Non-irritating (per Human Repeat Insult Patch Testing (HRIPT) per ASTM D6355) | Demonstrated non-irritating |
| Biocompatibility (Systemic Toxicity) | Not systemically toxic (per ISO 10993-11:2017) | Demonstrated not systemically toxic |
| Shelf Life (Device Specifications) | Met specifications in Table 1 across shelf-life | Met specifications at all time points over 22 months |
| Condom Compatibility (Natural rubber latex) | Compatible (per ASTM D7661-18) | Compatible |
| Condom Compatibility (Polyisoprene) | Compatible (per ASTM D7661-18) | Compatible |
| Condom Compatibility (Polyurethane) | Not Compatible (per ASTM D7661-18) | Not Compatible |
2. Sample size used for the test set and the data provenance
- For physical/chemical specifications: The document refers to standard test methods (e.g., USP , USP ) but does not specify the sample size for these tests. The data provenance is implied to be from BioFilm, Inc.'s internal testing, likely from the U.S.
- For biocompatibility: No specific sample sizes for human subjects or animal models are provided for the HRIPT or systemic toxicity tests. For cytotoxicity, it's generally in vitro testing. Data provenance is implied to be from BioFilm, Inc.'s testing.
- For condom compatibility: No specific sample size (i.e., number of condoms tested) is explicitly mentioned, but the testing was conducted according to ASTM D7661-18. Data provenance is implied to be from BioFilm, Inc.'s testing.
- For shelf life: The study was an accelerated aging study conducted for 8 months at 40°C, per ASTM F1980-16. No sample sizes (number of devices) are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert clinical review or ground truth establishment for diagnostic accuracy. The ground truth for the physical/chemical properties, biocompatibility, and condom compatibility are defined by the standardized test methods themselves.
4. Adjudication method for the test set
Not applicable. There is no subjective assessment requiring adjudication in this type of testing.
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 a personal lubricant device, not an AI-driven diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a personal lubricant device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the various acceptance criteria were established by:
- Standardized laboratory methods/specifications: For color, clarity, odor, particulate matter, viscosity, pH, osmolality, microbial counts (TYMC, TAMC, pathogens), and antimicrobial effectiveness, the ground truth is defined by specified ranges, limits, or absence/presence criteria according to recognized pharmacopeial (USP) or internal standards.
- International Standards (ISO) and ASTM Standards:
- Biocompatibility: ISO 10993-5 (cytotoxicity), ASTM D6355 (sensitization/irritation), ISO 10993-11 (systemic toxicity).
- Shelf Life: ASTM F1980-16 (accelerated aging for medical devices).
- Condom Compatibility: ASTM D7661-18.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-driven device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.