(88 days)
This kits are a convenience assemblage of sterile, disposable medical devices intended for use by trained physicians for various gynocological and obstetrical procedures. See the attached list of "Obstetrical and Gynecological Devices". NHMC does not cause or promote new intended uses for the devices within these kits.
The NHMC custom Ob/Gyn procedure trays or kits are sterile , disposable , medical device convenience kits. NHMC currently markets these kit in Canada as Vaginal Delivery Pack, C Section Pack, and others. These kits are custom to the customer, whose specifies the type and quantity of the materials to be included in the kit.
The provided text is a 510(k) summary for a medical device (National Healthcare Manufacturing Corp. Ob/Gyn Kit or Tray). It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot populate the requested table or answer the specific questions about studies proving the device meets acceptance criteria.
The document focuses on establishing substantial equivalence based on material, packaging, sterilization, and intended use, rather than presenting performance data from studies against specific acceptance criteria.
Based on the provided text, the device is a medical convenience kit, and its approval process relies on demonstrating that its components are already legally marketed and that the assembly itself does not introduce new intended uses or technological characteristics that differ from predicate devices.
This type of device approval (via 510(k) for custom convenience kits) often doesn't involve the rigorous performance studies with acceptance criteria, sample sizes, and expert ground truth establishment that would be seen for a novel diagnostic or therapeutic device. The "proof" is demonstrating that the components are safe and effective, and the assembly maintains those characteristics.
§ 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.