(441 days)
The Bellota Sonohysterography Catheter with Cervical Cone (Model: UIC 5FA) is used to access the uterine cavity for saline infusion sonohysterography procedure.
The Bellota Sonohysterography Catheter without Cervical Cone (Model: UIC 5F) is used to access the uterine cavity for saline infusion sonohysterography procedure.
Not Found
The provided OCR text is a 510(k) clearance letter for the Bellota Sonohysterography Catheter. This type of document from the FDA states that a medical device has been found substantially equivalent to a predicate device already on the market.
It is important to understand that 510(k) clearance typically does not involve a clinical study to prove the device meets specific acceptance criteria in terms of performance measures like sensitivity, specificity, or improvement in human reader performance for an AI/software device. Instead, K102898 focuses on demonstrating substantial equivalence in terms of design, materials, indications for use, and safety with a legally marketed predicate device.
Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not typically found or required for a medical device cleared via a 510(k) pathway, especially for a physical device like a catheter. These types of detailed performance studies are more common for novel devices, PMA (Pre-Market Approval) devices, or increasingly for AI/Machine Learning-based medical devices that make diagnostic or prognostic claims.
Based on the provided document, I cannot fulfill the request for information on acceptance criteria and a study proving device performance because the document does not contain this information.
The document primarily focuses on:
- Identifying the device (Bellota Sonohysterography Catheter).
- Stating its intended use (accessing the uterine cavity for saline infusion sonohysterography).
- Declaring that it is substantially equivalent to legally marketed predicate devices.
- Outlining regulatory compliance requirements.
§ 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.