(83 days)
The INTROL* Bladder Neck Support Prosthesis with Removal Tool is indicated for the temporary management of genuine stress urinary incontinence.
The INTROL* Bladder Neck Support Prosthesis with Removal Tool is identical in all aspects to INTROL* Bladder Neck Support Prosthesis except for the Removal Tool. The Removal Tool is a rod shaped device, about 7 inches in length with a hook at one end and a handle at the opposite end. The handle is marked with a flat surface about 0.25 inch in width and 4 slightly elevated rings, each about 1 inch apart. The flat handle surface is on the same side of the tool as the open portion of the hook. This configuration indicates the direction of the functioning portion of the hook. The rings are present to enhance the grip of the tool and to enable the user to gauge the depth of the tool once it enters the vagina. The hook is designed to easily engage the front portion of the INTROL * Prosthesis's ring. The Removal Tool surface is smooth. The Removal Tool is composed of high density polypropylene and titanium dioxide pigment. INTROL* Bladder Neck Support Prosthesis is made from a medical grade silicone elastomer. The prosthesis is circular and symmetrically shaped with a central aperture and two ridges.
The provided text does not contain information about acceptance criteria or a study demonstrating the device meets such criteria. The document is a 510(k) summary for the INTROL* Bladder Neck Support Prosthesis with Removal Tool. It primarily focuses on:
- Device Identification: Name, classification, and contact information.
- Substantial Equivalence: States that the device is substantially equivalent to a previously marketed device (INTROL Bladder Neck Support Prosthesis). This is a key regulatory pathway but doesn't typically involve new performance studies against predefined acceptance criteria.
- Indications for Use: Temporary management of genuine stress urinary incontinence.
- Physical Description: Details the added Removal Tool and the existing Prosthesis.
- Biocompatibility: Mentions "Safety tests demonstrate that INTROL* Bladder Neck Support Prosthesis with Removal Tool is non-sensitizing, and non-irritating and suitable for its intended use." However, it does not provide details on the specific acceptance criteria for these tests, the study design, sample size, or the results in a quantifiable manner.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance studies based on the provided text. The document acts as a summary for a regulatory submission based on substantial equivalence, not a detailed report of a performance study.
§ 884.3575 Vaginal pessary.
(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).