(90 days)
The Securline Umbilical Cord Clamp is 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 curd dries and shrinks after the birth.
The Securline® Umbilical Cord Clamp is a single use, disposable, molded plastic device, unit packaged, (sterile) or bulk packaged (nonsterile).
The provided text describes a 510(k) summary for the Securline® Umbilical Cord Clamp. This type of device (a medical clamp) typically does not rely on complex algorithms or AI; instead, its performance is assessed through mechanical and biological compatibility tests. Therefore, many of the typical AI/ML study components, such as ground truth establishment with experts, MRMC studies, and standalone algorithm performance, are not applicable here.
Here's an analysis based on the information provided and typical medical device regulatory submissions for non-AI devices:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Favorable results |
| Skin Irritation | Favorable results |
| Mechanical Performance: | |
| Closing forces | Evaluated in comparison to predicate devices |
| Gripping forces | Evaluated in comparison to predicate devices |
| Clinical Equivalence (Implicit): | |
| Function and Use | No different than that of the predicate devices |
| Prevention of blood loss and seepage | Stated intended use, implied as equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the biocompatibility or mechanical performance tests. The testing was conducted by an independent laboratory. The provenance of the data (country of origin, retrospective/prospective) is not specified, but it would typically be prospective testing conducted in a laboratory setting. No human patient data is mentioned for these specific tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable in the context of this device and its testing. For a simple mechanical device like an umbilical cord clamp, "ground truth" is established through standardized laboratory tests (e.g., biocompatibility standards, mechanical testing protocols) rather than expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretation (e.g., image reading by multiple experts). For the physical and biological testing of a cord clamp, objective measurements and predefined pass/fail criteria from test protocols are used, not subjective expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human interpretation, particularly in diagnostic imaging or clinical assessment where the device assists human readers. This device is a physical medical instrument, not an AI or imaging diagnostic aid.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone "algorithm only" performance study was not done. This device does not contain an algorithm or AI component. Its performance is entirely mechanical and biological (biocompatibility).
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is established through:
- Standardized Biocompatibility Tests: Laboratory tests against recognized standards for cytotoxicity and skin irritation.
- Mechanical Measurement Protocols: Objective measurements of closing and gripping forces, compared against predicate devices.
- Predicate Device Equivalence: The primary "ground truth" for regulatory submission is often the performance and safety profile of the legally marketed predicate devices, which the new device aims to be substantially equivalent to.
No pathology or outcomes data is mentioned as being used directly for establishing "ground truth" for the performance tests. Clinical outcomes (like prevention of blood loss) are the intended use facilitated by the device, but the performance criteria are based on laboratory testing and comparison to predicates.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 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.