(15 days)
To snare, grasp, hold and manipulate cervical and intravaginal tissue.
GYN Disposables Tenaculum 356T is made of glass reinforced polycarbonate. The GYN Disposable Tenaculum is supplied in a Tyvek pouch and has been sterilized by gamma radiation.
The GYN Disposables Tenaculum 356T is a medical device used to snare, grasp, hold, and manipulate cervical and intravaginal tissue. The device is made of glass-reinforced polycarbonate and is supplied sterile by gamma radiation.
Here's an analysis of the acceptance criteria and the studies that demonstrate the device meets them:
Acceptance Criteria and Reported Device Performance
The document describes several tests conducted to ensure the device's safety and performance. The acceptance criteria are generally qualitative (e.g., "met the minimum acceptance criteria," "did not induce cytotoxicity," "passed").
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Strength | The advanced composite design can easily withstand forces during normal use. The instrument met the minimum acceptance criteria for flexibility, arm strength, tip strength, rack strength, force needed to lock, and hinge pin strength. Does not degrade due to gamma sterilization and extended shelf life. | All test reports (flexibility & arm strength, tip strength, rack strength & locking force, hinge pin strength) showed that the instrument met the minimum acceptance criteria. These tests proved that the material does not degrade because of gamma sterilization and extended shelf life. |
| Biocompatibility | Cytotoxicity: No induction of cytotoxicity relative to positive and negative controls. | |
| Pyrogenicity/Sensitization/Irritation: No increase in temperature (in rabbits). | ||
| Hemolysis: No damage to blood cells. | ||
| Dermal Sensitization: Passed (in guinea pig). | ||
| Systemic Toxicity (Acute): Passed (in mouse). | ||
| Intracutaneous Irritation: Passed (in rabbit). | ||
| Vaginal Irritation: Passed (in rabbit). | ||
| All tests meet and exceed criteria established in FDA's 510(k) Memorandum #G95, Table 1 for minimal contact duration ( |
§ 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.