(67 days)
Astroglide® Diamond Silicone Gel 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, polyurethane, and polyisoprene condoms.
Astroglide® Diamond Silicone Gel Personal Lubricant is non-sterile, clear, odorless, and silicone-based lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
This product primary packaging is a white LDPE 3 ounce tube with a screw on polypropylene flip-top cap. The tube and cap constitute the device final packaging.
The provided text is a 510(k) Summary for a medical device (Astroglide® Diamond Silicone Gel Personal Lubricant), seeking to demonstrate substantial equivalence to a predicate device. It primarily focuses on the device's physical properties, biocompatibility, and compatibility with condoms.
This document does not contain information about an AI/Algorithm-based medical device, a multi-reader multi-case (MRMC) study, or any details related to establishing ground truth for a training or test set using experts, as would be expected for an AI/ML device.
Therefore, I cannot extract the information required to answer your questions about acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods for an AI/ML device. The document describes a traditional medical device's non-clinical performance testing.
The information I can provide based on the document is:
- Device Performance Reported: The document describes the performance of the personal lubricant in relation to its physical specifications and safety testing.
- Color: Colorless
- Clarity: Clear
- Odor: Odorless
- Absence of particulate matter: Absent
- Viscosity: 12,000-22,000 cP
- Total yeast/mold count:
§ 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.