(46 days)
The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems flostat™ Clamp. The device is intended to seize and hold the cervix and to hold and secure the flostat Clamp in place, during audible Doppler procedures.
This Tenaculum is only indicated for use with the flostat Clamp and Transvaginal Doppler Probe for bilateral uterine artery detection and temporary control of bleeding during conservative gynecologic surgery such as laparoscopic myomectomy.
The Burbank Tenaculum is a ring-handled instrument with a tooth at the distal end of one arm and a guiderod attached to the distal end of the other arm. The proximal end of the guiderod is threaded to guide insertion of the Vascular Control Systems flostat Clamp into the vagina and secure the Clamp in place.
A uterine sound, at the distal end of the guiderod, is intended for insertion through the cervical opening into the uterine cavity.
The provided text describes a medical device, the Burbank Tenaculum, and its regulatory clearance process through a 510(k) submission. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the other specific study-related details requested in your prompt.
The document is a "Summary of Safety and Effectiveness" and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results that would typically include acceptance criteria and specific statistical outcomes.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document explicitly states:
- "The Burbank Tenaculum has been designed and tested per design control procedures and was found to meet its product specifications." This is a general statement and does not provide specific acceptance criteria or study details.
- "The Burbank Tenaculum does not raise new issues of safety, effectiveness, or performance of the product." This reinforces the substantial equivalence claim but doesn't offer performance metrics.
To answer your request, I would need a document that specifically details the design verification and validation studies, including the test protocols, acceptance criteria, results, and statistical analyses performed for the device.
§ 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.