(81 days)
Sterile, single-use, disposable umbilical cord clamp, used to clamp over the umbilical cord of a newborn at delivery. The device is used to hold the cord securely and prevent blood loss and seepage as the cord dries and shrinks after the birth, prior to and after cutting.
Umbilical cord clamp, injection-molded plastic, blue, singleuse, disposable, packaged, sterile (sterilized by 100% EtO gas).
This document describes a 510(k) premarket notification for an Umbilical Cord Clamp. It does not contain information about acceptance criteria or a study proving device performance in the way a medical AI/ML device submission would. The document focuses on establishing substantial equivalence to predicate devices based on material, configuration, function, manufacturing, packaging, and sterilization.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated:
Information not available in the provided document for this device:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
Extracted Information (where applicable):
1. A table of acceptance criteria and the reported device performance:
Not applicable. This device is a physical umbilical cord clamp, not a diagnostic AI/ML device. The submission establishes substantial equivalence rather than meeting specific performance metrics against acceptance criteria typical for AI/ML.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No "test set" in the context of an AI/ML device study is mentioned. The device was subjected to non-clinical biocompatibility testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device's performance would relate to its structural integrity, sterility, and biocompatibility, which were assessed through non-clinical tests.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
Summary of Nonclinical Tests and Results (as provided in the document):
- Tests: Biocompatibility (cytotoxicity, hemolysis)
- Result: "no problems noted"
- Testing body: An independent lab.
Conclusion: The provided document is for a traditional physical medical device (umbilical cord clamp) and not for an AI/ML device. Therefore, the questions related to AI/ML device evaluation (test sets, training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this submission. The device demonstrates safety and effectiveness through substantial equivalence to predicate devices and results from non-clinical biocompatibility testing.
§ 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.