(187 days)
The FemChec™ Pressure Management Device limits the maximum applied pressure while instilling contrast media into the uterus and fallopian tubes. It is to be used in conjunction with an intrauterine catheter for performance of hysterosalpingogram (HSG), such as tubal occlusion confirmation tests in women who have had tubal procedures for permanent female sterilization. The FemChec limits the applied intrauterine pressure to 200 mmHg.
The FemChec is provided with a fluid collector, stopcock, and intrauterine catheter for performing the HSG procedure.
The FemChec Pressure Management Device (FemChec) is a pressure-limiting contrast media syringe that is connected to an intrauterine catheter for low-pressure instillation of contrast media during HSG procedures.
Here's an analysis of the FemChec™ Pressure Management Device's acceptance criteria and the study used to demonstrate its performance, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance for FemChec™ Pressure Management Device
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional/Performance Aspects) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Fluid instilling function of syringe | Confirmed (implied by "fluid instilling function of syringe" test) |
| Attachment functionality | Confirmed (implied by "attachment functionality" test) |
| Single-hand actuation | Confirmed (implied by "single-hand actuation" test) |
| Pressure testing |
§ 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.