(28 days)
The intended use is to cut the umbilical cord clamp off a newborn's umbilical cord.
The subject device is a cutter designed to safely cut the umbilical cord clamp. The device is composed I fier book acrise is a outadiene Styrene) Doc 26720NT Natural resin with a stainless steel blade. The device does not make contact with the patient. The device is provided non-sterile and is labeled for single natient use. The subject device is packaged in a 3"x5" Glassine Bag and will be included in the dispenser box with the Busse Posi-Grip Umbilical Cord Clamps.
The Busse Umbilical Cord Clamp Cutter (K021055) is designed to safely cut the umbilical cord clamp. The device is composed of a natural resin with a stainless steel blade. It does not contact the patient, is non-sterile, and is labeled for single patient use.
1. Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the Busse Umbilical Cord Clamp Cutter are based on its functional performance when used with specific umbilical cord clamps.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Proper function when cutting umbilical cord clamps. | Product qualification testing found the umbilical cord clamp cutter to function properly when tested with Busse Posi-Grip Umbilical Cord Clamps. The device successfully cut the umbilical cord clamps without problem. |
2. Sample Size and Data Provenance:
- Test Set Sample Size: The document does not specify an exact numerical sample size for the product qualification testing. It broadly states that the device was "tested with Busse Posi-Grip Umbilical Cord Clamps."
- Data Provenance: The data is from "Product qualification testing" conducted by the submitter (Busse Hospital Disposables Inc. or Azary Technologies LLC on their behalf). No information on the country of origin or if it was retrospective or prospective is provided, but it would typically be considered prospective in-house testing.
3. Number of Experts and Qualifications:
Not applicable. The study described is a functional performance test of a medical device, not a diagnostic or interpretive device requiring expert review for ground truth establishment.
4. Adjudication Method:
Not applicable, as no expert review or adjudication of results is mentioned or relevant for this type of functional performance test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This device is a mechanical cutter, not involved in image interpretation or diagnosis.
6. Standalone Performance:
Yes, a standalone performance assessment was conducted. The product qualification testing focused solely on the "umbilical cord clamp cutter to function properly when tested with Busse Posi-Grip Umbilical Cord Clamps." This test assesses the intrinsic functionality of the device without human interaction beyond its intended operation.
7. Type of Ground Truth Used:
The ground truth for the performance test was operational success – whether the device could physically cut the umbilical cord clamps without problems. This is a functional outcome directly observed during testing.
8. Sample Size for Training Set:
Not applicable. This device is a mechanical cutter and does not involve AI or machine learning that requires a training set.
9. How Ground Truth for Training Set Was Established:
Not applicable, as there is no training set for this mechanical 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.