(148 days)
Softseal Catheter (a uterine manipulator/injector) is used to access the uterine cavity for the injection and retention of contrast fluid (or gas) into the uterus to enable the visualization of the uterine cavity and fallopian tubes. This device is not for intrafallopian procedure. The following clinical indications are some of the applications:
- Infertility
- Menorrhagia
- Dysmenorrhea Due to Uterine Synechia
- Suspected Endometrial Polyp
- Submucous Fibroid
- Uterine Synechia (Asherman Syndrome)
- Congenital Uterine Abnormality
Softseal HSG Catheter (a uterine manipulator/injector)
I am sorry, but based on the provided text, I cannot provide a description of the acceptance criteria and the study that proves the device meets them. This document is a 510(k) clearance letter from the FDA for a device called "Softseal HSG Catheter." It confirms that the device has been found substantially equivalent to a legally marketed predicate device.
The letter does not include:
- A table of acceptance criteria and reported device performance.
- Details of any specific study conducted to prove the device meets acceptance criteria. This type of information would typically be found in the 510(k) summary or detailed submission, not in the clearance letter itself.
- Sample size, data provenance, number of experts for ground truth, adjudication method, MRMC study results, or standalone algorithm performance. These are all details of a clinical or performance study, which are not present in this document.
- Training set information.
The document only states the device's indications for use and confirms its clearance based on substantial equivalence. It does not provide the underlying data or studies that established this equivalence.
§ 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.