(238 days)
This instrument will be used to cut and clamp the umbilical cord in normal and abnormal deliveries. The instrument will cut and clamp both mother's side and baby's side of the univilical cord, simultaneously.
Not Found
This document is an FDA 510(k) clearance letter for a medical device called "Dr. Jahanger's Cutter (Umbilical Cord Cutter/Clamp)", dated October 29, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.
Based on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria.
Here's why and what information is missing:
- Type of Document: This is an FDA clearance letter, which confirms that a device has been found substantially equivalent to a predicate device. It is not a study report or a summary of device performance testing.
- Purpose of 510(k): The 510(k) pathway for medical device clearance primarily relies on demonstrating substantial equivalence to a device already on the market (the "predicate device"). While some performance data might be submitted, the full details of clinical studies, acceptance criteria, and ground truth establishment are typically not included or summarized in the clearance letter itself.
- Specific Device: The device is a mechanical "Umbilical Cord Cutter/Clamp." For such a device, performance criteria would likely revolve around mechanical integrity, cutting efficiency, clamping effectiveness to prevent blood loss, biocompatibility of materials, and sterilization validation. These are engineering and performance specifications, not often clinical efficacy metrics in the same way an AI diagnostic would have.
Therefore, I cannot provide the requested table and study details because the provided document does not contain that information.
To answer your request, I would need a different type of document, such as:
- A clinical study report for the device.
- A premarket approval (PMA) application summary (which requires more extensive clinical data than a 510(k)).
- A detailed technical file or design history file from the manufacturer.
The provided text only includes the device name, its intended use (to cut and clamp the umbilical cord), and the FDA's determination of substantial equivalence. It does not elaborate on the specific tests, acceptance criteria, or the methodology of any studies conducted to demonstrate its performance.
§ 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.