(266 days)
Astroglide® Organix® Liquid 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.
Astroglide® Organix® Liquid is a non-sterile, colorless to slight yellow, water-based personal lubricant 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 and is not compatible with polyurethane condoms. This product is for over-the-counter (OTC) use. Astroglide® Organix® Liquid's formulation consists of water, glycerin, xanthan gum, aloe barbabensis powder, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, vaccinium macrocarpon (cranberry) fruit extract, passiflora incarnata flower extract, sodium benzoate, potassium sorbate, and citric acid. It is packaged in 2.5 oz polyethylene terephthalate bottles with a polypropylene flip-top cap. Bottles are secondarily packaged in cardboard cartons. This product is also provided in 2.5 ml foil packs.
The document describes the Astroglide® Organix® Liquid personal lubricant and its substantial equivalence to a predicate device, Astroglide® Natural. The provided text outlines non-clinical performance testing conducted to support its safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table of device specifications (acceptance criteria) and the reported performance for the Astroglide® Organix® Liquid.
| Parameter | Acceptance Criteria / Specification (Subject Device) | Reported Device Performance (Implied by meeting specifications) |
|---|---|---|
| Appearance | Hazy liquid | Hazy liquid |
| Color | Colorless to slightly yellow | Colorless to slightly yellow |
| Odor | Odorless | Odorless |
| pH (per USP) | 3.5-5.5 | Within 3.5-5.5 |
| Osmolality (per USP) | 500-800 mOsm/kg (1:5 dilution) | Within 500-800 mOsm/kg (1:5 dilution) |
| Viscosity (per USP) | 250-310 cps | Within 250-310 cps |
| Total aerobic microbial count (per USP) | ) | ) |
| Absence of pathogenic organisms ( Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans - per USP) | Absent | Absent |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating, and not acutely-systemically toxic (per ISO 10993-5, 10993-10 alternative, 10993-11) | Demonstrated non-cytotoxic, non-sensitizing, non-irritating, and not acutely-systematically toxic |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms (per ASTM D7661-10) | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms (results showed compatibility with natural rubber latex and polyisoprene condoms) |
| Shelf-life | Maintain device specifications (as shown in Section IV) over 17 months in 2.5 oz bottles and 9 months in foil packs | Devices maintained specifications over 17 months (bottles) and 9 months (foil packs) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes for the individual tests (biocompatibility, condom compatibility, shelf-life, or other device specifications). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective. The testing was conducted in accordance with recognized international standards (ISO, USP, ASTM), which implies a specific methodology, but sample sizes are not reported.
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):
This information is not applicable to this type of device and study. The testing for this personal lubricant involves objective physical, chemical, and biological evaluations according to established standards (e.g., pH, viscosity, microbial counts, biocompatibility assays, condom compatibility tests). Ground truth is established by the results of these standardized tests, not by expert consensus or interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as it pertains to subjective assessments or diagnostic interpretations, which are not relevant for a personal lubricant's performance 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:
This information is not applicable. An MRMC study is relevant for medical imaging or diagnostic AI devices where human readers interpret cases. This document describes the testing of a personal lubricant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. This refers to AI algorithm performance studies, which are not relevant to this product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance criteria is established by objective measurements and standardized test results as defined by the USP, ISO, and ASTM standards. For example:
- pH: Measured directly against the specified range.
- Microbial counts: Counted according to USP and compared to the acceptable limits.
- Biocompatibility: Determined by the specific outcomes of ISO 10993 tests (e.g., cell viability for cytotoxicity, skin reaction for irritation/sensitization).
- Condom Compatibility: Determined by physical tests on condoms as per ASTM D7661-10.
- Shelf-life: Determined by maintaining all device specifications (as defined in Section IV) over the specified time period under controlled conditions.
8. The sample size for the training set:
This information is not applicable. This document describes the performance testing of a physical product (personal lubricant), not the development or validation of an AI algorithm that would require a training set.
9. How the ground truth for the training set was established:
This information 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.