(216 days)
To retract and expose the interior of the vagina during general diagnostic and therapeutic gynecological and obstetric procedures.
G-SpecTM Articulated Weighted Vaginal Speculum is supplied with single use disposable blades that attached to a 2 pound stainless steel weighted speculum handle. The disposable blades are supplied in three sizes: 9, 11, and 13 centimeters And can be set to three positions relative to the weighted handle: 90, 80, and 70 degrees The disposable blades snap fit into the reusable weighted speculum handle and are discarded after each use. The reusable weighted speculum handle is reusable and may be cleaned and resterilized.
The provided text is a 510(k) summary for the G-Spec™ Articulated Weighted Vaginal Speculum. It describes the device, its intended use, and its technological characteristics as compared to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, or clinical trial data.
The document states:
"The G-SPEC™ Articulated Weighted Vaginal Speculum has the same intended use and the same basic technology as the predicates identified in the premarket notification submission. The new device contains in some combination similar/same features, materials, and design as the predicates and does not pose any new questions concerning safety and effectiveness."
This indicates that the device's approval was based on demonstrating substantial equivalence to already legally marketed predicate devices, rather than through a new clinical performance study with specific acceptance criteria that would typically be seen for AI/ML devices or novel technologies.
Therefore, I cannot provide the requested information, as it is not present in the provided text. No direct device performance studies were conducted or reported in this 510(k) summary.
§ 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.