(171 days)
TVUS/HSG-Cath™ is intended for intracervical injection of saline into the uterus for enhanced transvaginal ultrasonography (TVUS), also known as saline infusion sonography (SIS). TVUS/HSG-Cath may also be used for the delivery of contrast media into the female reproductive tract for diagnostic examination of the uterus and fallopian tubes.
TVUS (SIS) with saline infusion:
- persistent abnormal or dysfunctional uterine bleeding .
- suspected myometrial or intraluminal abnormalities (e.g., . fibroids or polyps)
- . thickened or irregular endometrium
- recurrent pregnancy loss t
- pre- and post-operative assessment of uterine pathology . HSG with contrast media:
- unexplained infertility .
- recurrent pregnancy loss
Not Found
The provided document is a 510(k) summary for the TVUS/HSG-Cath™ Saline/Contrast Media Infusion Catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific performance criteria through a standalone study with acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria studies, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or their data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm-only) performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the 510(k) summary (specifically Section 9 from the first page) indicates that the device's substantial equivalence is based on its similarity in intended use, indications for use, and technological characteristics to a predicate device, the "H/S Elliptosphere Catheter, (K013972) ACKRAD Laboratories, Inc."
The document details the intended use and indications for use of the TVUS/HSG-Cath™, which are consistent with the predicate device. For devices seeking 510(k) clearance, the primary "proof" that the device is safe and effective is its substantial equivalence to a legally marketed predicate device, not typically a de novo clinical study against specific performance acceptance criteria like those outlined in the request.
§ 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.