(133 days)
The Modified Novy Cornual Cannulation Set is intended for use through the operating channel of a hysteroscope or other uterine access device, for hysteroscopic selective catheterization and cannulation of the proximal fallopian tube(s), followed by the introduction of chromotubation or contrast medium, in the evaluation of tubal patency.
The Modified Novy Cornual Cannulation Sets consist of an introducing catheter, an obturator, and an inner catheter with wire guide, a blue endoscopic septum cap, and two female Luer lock plugs. With this submission, Cook intends to offer two Novy Sets with curved introducing catheters. Introducing catheters are 5.0 French in size. The curved introducing catheters measuring 35 centimeters or 40 centimeters in length are manufactured with Nylon Torcon with a bonded Nonradiopaque tip. Both Novy Set are supplied sterile and intended for one-time use.
The provided text describes a medical device, the "Modified Novy Cornual Cannulation Set," and its substantial equivalence to a predicate device. However, it does not contain information about an AI/ML powered device, an acceptance criteria table with reported device performance metrics like sensitivity or specificity, or details about studies involving sample size, data provenance, expert ground truth, adjudication, or MRMC comparative effectiveness studies.
The document discusses various performance tests for the device, which are related to its physical and material properties, rather than diagnostic accuracy or AI performance. The provided information solely pertains to the mechanical and biological safety of the device.
Therefore, I cannot provide the requested information about acceptance criteria for an AI-powered device, study details regarding human readers, or AI performance, as these are not present in the given text.
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.