(313 days)
Regular and Special Umbilical Cord Clamp and Cutter are intended for use in simultaneously clamping and cutting the umbilical cord of the new born baby at delivery
"Regular and Special Umbilical Cord Clamp and Cutter" manufactured by "Ningbo Feite Medical Device Co., Ltd." are a single use, disposable, molded plastic device, unit packaged and sterile, intended to use for the simultaneously cut and clamp umbilical cord of the new born baby at delivery.
"Special Umbilical Cord Clamp and Cutter" are comprised of the exact same part as "Regular Umbilical Cord Clamp and Cutter", with the addition of an electronic clock. The time is automatically recorded when the cutting is performed.
The provided text is a 510(k) summary for the Regular and Special Umbilical Cord Clamp and Cutter. It outlines the device description, intended use, and comparison to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria beyond a general statement.
Here's an analysis based on the information provided and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific performance criteria (e.g., clamping force, cutting efficiency, durability, timekeeping accuracy for "Special" model, sterility assurance level, biocompatibility standards) | "All tests were verified to meet acceptance criteria." (General statement) |
| Biocompatibility | "Biocompatibility testing demonstrated that the devices are biocompatible." |
| Sterility | "Sterilization with EO" (Implies meeting sterility standards, but no specific performance metric given). |
Missing Details: The document states that "Bench testing was performed to ensure that the 'Regular and Special Umbilical Cord Clamp and Cutter' met its specifications. All tests were verified to meet acceptance criteria." However, it does not enumerate these specific acceptance criteria (e.g., what is the required clamping force? What is the maximum number of cuts before failure? What is the acceptable deviation for the electronic clock if applicable?). It also doesn't provide the numerical results for any of these tests, only a blanket statement of compliance.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "Bench testing."
- Data Provenance: Not specified, but given the manufacturer is "Ningbo Feite Medical Device Co., Ltd." in China, it's highly probable the testing was conducted in China. The study is retrospective in the sense that the testing was performed before the 510(k) submission, but it's not a retrospective review of existing patient data. It refers to laboratory/bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a manual instrument, not an AI/software device that requires expert consensus for ground truth establishment. The testing would primarily involve engineers or technicians evaluating physical properties and performance against specifications.
4. Adjudication method for the test set
- Not applicable. This type of physical device testing does not involve adjudication methods like those used for diagnostic AI where multiple experts might review cases.
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
- No. This is not an AI-assisted diagnostic device, so a MRMC comparative effectiveness study is not relevant or included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a manual medical instrument, not an AI algorithm. The "Special Umbilical Cord Clamp and Cutter" has an "electronic clock function," which might involve some internal algorithm for timekeeping, but its performance is evaluated as part of the total device functionality, not as a standalone AI component.
7. The type of ground truth used
- For physical characteristics (e.g., dimension, material, single use): Comparison to the predicate device and engineering specifications.
- For functional performance (e.g., clamping, cutting): Performance against pre-defined functional specifications (though these specific acceptance criteria are not detailed in the summary).
- For biocompatibility: Compliance with established biocompatibility standards (e.g., ISO 10993) via specific tests.
- For sterility: Compliance with sterilization efficacy standards for EO sterilization.
8. The sample size for the training set
- Not applicable. This device does not use an "AI algorithm" in the conventional sense that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no AI-specific training set.
In summary, the document states that bench testing was performed and "All tests were verified to meet acceptance criteria" and "Biocompatibility testing demonstrated that the devices are biocompatible." However, it lacks the specifics commonly requested for AI/diagnostic devices such as detailed acceptance criteria, numerical performance data, and the methodologies for establishing ground truth relevant to such devices. The nature of this device (a manual surgical instrument) means many of the requested points are not applicable.
§ 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.