(70 days)
The Transvaginal Ultrasound Probe Holder device is an accessory used in conjunction with a transvaginal ultrasound transducer. The device is intended to seize and hold the cervix and to hold and secure an ultrasound transducer in place, while performing sonographic procedures.
Transvaginal Ultrasound Probe Holder
The provided text is a 510(k) clearance letter from the FDA for a "Cervical Tenaculum/Transvaginal Ultrasound Probe Holder." This document does not describe acceptance criteria or a study proving the device meets those criteria.
510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not typically on a new clinical study with acceptance criteria in the way a PMA device would require. The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
Therefore, I cannot extract the requested information from the provided text because it does not contain:
- A table of acceptance criteria and the reported device performance: This type of information is not part of a 510(k) clearance letter.
- Sample size used for the test set and the data provenance: No new clinical study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a 510(k) based on substantial equivalence.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or required for this type of clearance.
- Standalone performance: No standalone algorithm performance is discussed as this is a physical medical device, not an AI/software device.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (no AI/ML model training).
- How the ground truth for the training set was established: Not applicable.
The document is primarily a regulatory approval letter based on the device's substantial equivalence to existing devices.
§ 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.