(161 days)
The Intrauterine Venogram Needle Set is intended for hysterography and intrauterine venography for assessment of chronic pelvic pain/congestion.
The Intrauterine Venogram Needle Set contains two components: a catheter sheath and a needle. The single-lumen access catheter has a butb tip, turn connector cap and lock assembly manufactured from nylon. The injection needle is manufactured from stainless steel with a polycarbonate hub. The Information in Venogram Needle set is supplied sterile in lengths from 15 cm to 30 cm and is packaged in a sealed peel-open container.
The provided text is a 510(k) summary for the "Intrauterine Venogram Needle Set" and a letter from the FDA determining substantial equivalence. It describes the device, its intended use, and its similarity to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.
The 510(k) process for this type of medical device (a needle set) typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical performance studies with specific acceptance criteria in the same way that a diagnostic algorithm or a complex interventional device might.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample sized used for the test set and the data provenance: Not applicable/not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
- Adjudication method: Not applicable/not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable/not present.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not present.
- The type of ground truth used: Not applicable/not present.
- The sample size for the training set: Not applicable/not present.
- How the ground truth for the training set was established: Not applicable/not present.
The document states that the device "will be manufactured according to specified process controls and a Quality Assurance Program" and "will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook OB/GYN." This indicates that the regulatory pathway relies more on manufacturing controls and similarity to existing devices than on a specific performance study with defined acceptance criteria as you've described for a diagnostic or AI-based device.
§ 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.