(265 days)
Revaree plus vaginal suppositories are a personal lubricant, for 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Farma-Derma's Revaree plus vaginal suppositories is a non-sterile solid preparation personal lubricant containing hyaluronic acid, sweet almond oil, and glycerides. It is presented in the form of vaginal suppositories, 2 g in weight. Each vaginal suppository is individually packed in a polyvinyl chloride (PVC)/polyethylene (PE) blister. The device is available for sale in a pack containing 10 vaginal suppositories (two blisters of 5 vaginal suppositories each) while the sample pack contains 3 vaginal suppositories (one blister).
Due to its shape the device can be easily introduced into the vaginal cavity by finger.
When the vaginal suppository is in contact with the vaginal mucosa, it melts due to body temperature and becomes a viscous mass which remains in contact with the vaginal mucosa, creating a moist environment to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
The provided text describes a medical device called "Revaree plus vaginal suppositories" and its regulatory clearance as substantially equivalent to a predicate device. However, the document does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML powered device.
The document is a 510(k) summary for a physical medical device (vaginal suppositories), not a software or AI/ML device. Therefore, the questions related to AI/ML device performance (e.g., test set, ground truth, expert adjudication, MRMC studies, standalone performance, training set) are not applicable to this submission.
The "Performance Data" section (Page 6) discusses:
- Biocompatibility: Studies performed according to ISO 10993 standards (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity). The results show the lubricant is non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic.
- Shelf Life: 24 months, demonstrated by intermediate and real-time aging studies.
- Condom Compatibility: Not tested, therefore labeled as not compatible with latex, polyisoprene, and polyurethane condoms.
The table on Page 4 lists specifications for the Revaree plus vaginal suppositories, which can be considered acceptance criteria for the physical and chemical properties of the product. The conclusion on Page 7 states that "The results of the testing described above demonstrate that Revaree plus vaginal suppositories are as safe and effective as the predicate device and supports a determination of substantial equivalence." This statement refers to the biocompatibility and shelf-life tests, and likely other manufacturing quality control tests to meet the specifications listed.
Therefore, I cannot provide answers to your specific questions as they pertain to AI/ML device validation, which is not described in the provided text.
§ 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.