(320 days)
Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular tumors, including symptomatic uterine fibroids, and prostatic arteries for symptomatic benign prostatic hyperplasia (BPH).
Embosphere Microspheres are small, compressible, hydrophilic spheres of acrylic polymer and porcine-derived gelatin, provided sterile, non-pyrogenic in 10 saline. They are available in six size ranges (40 um - 1200 um), in svringes (Figure 1) or vials. The syringes contain 1 mL or 2 mL of microspheres in 6 or 7 mL of saline, respectively, in a single unit packaging. Vials contain 1 mL or 2 mL of microspheres in 3 or 4 mL of saline, respectively, in a single unit packaging.
The microspheres are delivered to the target site via catheter under fluoroscopic control. The technological characteristics of the subject devices are identical to the legally marketed Embosphere Microspheres (K991549. K021397).
The provided text does not describe a study involving a device that uses AI or machine learning, nor does it provide acceptance criteria and proof of meeting those criteria in the context of such a device. The device described, Embosphere Microspheres, is a physical medical device used for prostatic artery embolization.
Therefore, I cannot fulfill the request as it asks for information related to AI/ML device performance and studies demonstrating its adherence to acceptance criteria, which is not present in the provided text.
§ 876.5550 Prostatic artery embolization device.
(a)
Identification. A prostatic artery embolization device is an intravascular implant intended to occlude the prostatic arteries to prevent blood flow to the targeted area of the prostate, resulting in a reduction of lower urinary tract symptoms related to benign prostatic hyperplasia. This does not include cyanoacrylates and other embolic agents which act by in situ polymerization or precipitation, or embolization devices used in neurovascular applications (see 21 CFR 882.5950).(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Evaluation of suitability for injection through catheters intended for use in embolization; and
(ii) Evaluation of the size distribution of the device.
(3) Performance data must support the sterility and pyrogenicity of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(5) Clinical data must evaluate post-embolization damage due to non-target embolization under anticipated use conditions.
(6) The labeling must include:
(i) Specific instructions on safe device preparation and use;
(ii) The device shelf life;
(iii) Data regarding urinary retention; and
(iv) Data regarding post-prostatic artery embolization syndrome.