(199 days)
The SINGLE CHANNEL BALLOON CANNULA is to be used with the VALTCHEV UTERINE MOBILIZER, models VUM-4 or VUM-5, for mobilization of the uterus and injection of dye. It is indicated for use during those procedures requiring manipulation of the uterus such as a minilap, laparoscopic tubal occlusion or diagnostic and operative laparoscopy. It is also an efficient intrauterine injector that effectively seals the internal cervical os against the cervical backflow of fluid during its injection through the device's central lumen and as such can be used in laparoscopic tubal patency studies and, in selected patients, for such procedures as hysterosalpingography.
SINGLE CHANNEL BALLOON CANNULA
I apologize, but the provided text does not contain the information requested about acceptance criteria and a study proving a device meets these criteria. The document is a 510(k) clearance letter from the FDA for a "Single Channel Balloon Cannula," indicating that the device is substantially equivalent to legally marketed predicate devices.
The text focuses on regulatory approval, specifically:
- Device Name: Single Channel Balloon Cannula
- Manufacturer: Conkin Surgical Instruments Ltd.
- FDA Decision: Substantial Equivalence (K974801)
- Indications For Use: Mobilization of the uterus and injection of dye during procedures requiring uterine manipulation (e.g., minilap, laparoscopic tubal occlusion, diagnostic and operative laparoscopy), and as an intrauterine injector for laparoscopic tubal patency studies and hysterosalpingography.
There is no mention of specific acceptance criteria, performance metrics, a study design, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. This type of information is typically found in a summary of safety and effectiveness data submitted to the FDA, which is not provided here.
§ 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.