(336 days)
The Cook® Fetal Membrane Manipulator is indicated as an adjunct to a cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage.
The Cook® Fetal Membrane Manipulator is used to atraumatically push and position emerging fetal membranes back through the cervical canal and into the uterus to facilitate a successful cervical cerclage procedure in order to prolong pregnancy to a successful delivery. The Cook® Fetal Membrane Manipulator is intended to be used as an adjunct to a cervical cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage. The Cook® Fetal Membrane Manipulator is comprised of a November polycarbonate dual lumen catheter with a silicone balloon. The balloon catheter assembly includes a Check-Flo-adapter. The device is provided sterile and intended for one-time use.
The provided text describes a medical device, the Cook® Fetal Membrane Manipulator, and its substantial equivalence to predicate devices. However, it does not include detailed acceptance criteria or the specifics of a study that proves the device meets those criteria.
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 |
|---|---|
| Biocompatibility | Tested in accordance with FDA and recognized international standards. "Well within the acceptance criteria." |
| Sterility | Tested in accordance with FDA and recognized international standards. "Well within the acceptance criteria." |
| Performance | Tested in accordance with FDA and recognized international standards. "Well within the acceptance criteria." |
Missing Information: The specific quantitative or qualitative acceptance criteria for biocompatibility, sterility, and performance are not detailed. For instance, what specific tests were performed for "biocompatibility" (e.g., cytotoxicity, irritation, sensitization), what were their acceptance limits, and what were the exact results? Similarly for sterility (e.g., SAL of 10^-6) and performance (e.g., balloon inflation pressure, catheter maneuverability, membrane repositioning effectiveness).
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified, but given the nature of the device (fetal membrane manipulator), these tests are likely conducted in a lab setting or in animal models, not human clinical trials for this type of 510(k). The document mentions "performance testing" which usually refers to bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable, as this is primarily a device performance and safety evaluation (biocompatibility, sterility, mechanical performance) rather than an interpretative diagnostic device requiring expert ground truth in the traditional sense.
- Qualifications of Experts: Not applicable for the reasons above.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The tests mentioned (biocompatibility, sterility, performance) would typically involve objective measurements against predefined standards rather than consensus-based adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No, this type of study is typically for evaluating the effectiveness of diagnostic devices or AI algorithms where human interpretation is involved. This device is an instrument for a surgical procedure.
- Effect Size of Human Readers Improvement: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study Done: Not applicable. This is a medical instrument, not an algorithm or AI system.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable in the context of expert-derived ground truth. For the reported tests, the "ground truth" would be established scientific standards and methods for assessing biocompatibility (e.g., ISO 10993 series), sterility (e.g., USP or ISO 11137/17665), and engineering performance (e.g., specified mechanical properties, leak tests, etc.).
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the machine learning context. Its development and validation are based on engineering principles, materials science, and established medical device testing protocols.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable.
Summary of what the document does state regarding acceptance criteria and studies:
The 510(k) summary states that "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration established and recognized international standards. Testing results were well within the acceptance criteria. Testing data and information is included in this submission."
This indicates that standard, established protocols were followed for these critical safety and performance aspects. However, the specific details of these protocols, the exact acceptance criteria, and the measured results are not provided in the publicly available summary. Such details would typically be contained within the full 510(k) submission document to the FDA.
§ 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.