(151 days)
The Cook® Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.
The Cook® Cervical Ripening Balloon is a double-balloon catheter designed to mechanically ripen the cervix prior to labor induction at term when the cervix is unfavorable for induction. The tip of the Cook® Cervical Ripening Balloon is placed through the vagina and the cervical canal into the uterus. The distal balloon is positioned against the internal cervical os and inflated with up to 80 mL of saline; the proximal balloon is positioned against the external cervical os and also inflated with up to 80 mL of saline. The Cook Cervical Ripening Balloon provides gradual mechanical cervical dilation by simultaneously providing pressure on the internal and external cervical os.
In addition to the standard version, the Cook® Cervical Ripening Balloon is also available with a removable stylet to add rigidity to the catheter and aid in placement of the balloon through the cervix. The stylet runs the length of the catheter shaft of the Cook® Cervical Ripening Balloon in a separate lumen that is closed at the distal tip. The user removes the stylet from the device once the distal uterine balloon is above the level of the internal cervical os.
The Cook® Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction. This device is regulated under 21 CFR § 884.4260 as a Class II device (Hygroscopic Laminaria cervical dilator).
Acceptance Criteria and Device Performance:
The provided document describes a series of verification tests to demonstrate the reliable design and performance of the Cook® Cervical Ripening Balloon. The acceptance criteria are implicitly defined by the successful completion of these tests.
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Balloon Deflation Reliability | Balloons deflate properly after use. | Demonstrated (explicitly stated: "to demonstrate that the balloons deflate properly after use.") |
| Balloon Burst | Balloons do not burst at the maximum recommended inflation volume under simulated use conditions. | Demonstrated (explicitly stated: "to demonstrate that the balloons do not burst at the maximum recommended inflation volume under simulated use conditions.") |
| Balloon Volume Maintenance | Balloons do not leak. | Demonstrated (explicitly stated: "to demonstrate that the balloons do not leak.") |
| Balloon Integrity | Balloons do not rupture under simulated use conditions. | Demonstrated (explicitly stated: "to demonstrate that the balloons do not rupture under simulated use conditions.") |
| Balloon Response to Pullout | Distal balloon does not pull out from the patient under simulated use conditions. | Demonstrated (explicitly stated: "to demonstrate that the distal balloon does not pull out from the patient under simulated use conditions.") |
| Catheter Tensile | Catheter shaft can sustain the maximum tensile forces anticipated in use. | Demonstrated (explicitly stated: "to demonstrate that the catheter shaft can sustain the maximum tensile forces anticipated in use.") |
| Biocompatibility | Acceptance criteria from ISO 10993-1 are met. | Acceptance criteria from ISO 10993-1 were met (explicitly stated: "The testing shows that the acceptance criteria from ISO 10993-1 were met."). |
| Simulated Use | Non-clinical users can properly follow the use instructions in a simulated environment. | Demonstrated (explicitly stated: "to demonstrate that the non-clinical users can properly follow the use instructions in a simulated environment.") |
Study Details:
The provided text describes a premarket notification for a medical device (510(k)) and outlines the verification testing performed. It does not describe a clinical study in the traditional sense with patient data, statistical analyses, or comparative effectiveness. Instead, it focuses on engineering and biocompatibility testing. Therefore, many of the requested details are not applicable to the information provided.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document describes verification testing rather than testing on a clinical "test set" of patient data. The "samples" would refer to the number of devices tested for each engineering and biocompatibility test (e.g., how many balloons were burst tested, how many catheters were tensile tested). This information (specific sample sizes per test) is not provided in the summary.
- Data provenance for these engineering tests would typically be the manufacturing facility or a contract testing lab. This information is not explicitly stated, nor is it typically included in a high-level 510(k) summary for engineering tests. The tests are "simulated use conditions," implying laboratory or bench testing rather than human subject data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of clinical studies, refers to a definitive diagnosis or outcome. For engineering and biocompatibility tests, "ground truth" is typically defined by scientific principles, standards (like ISO 10993-1), and pre-defined pass/fail criteria. These tests are conducted by engineers and scientists, not typically by medical experts establishing a "ground truth" for patient cases.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human assessment (e.g., image interpretation) where there might be disagreement among reviewers. For physical product verification tests, the results are typically objective measurements against pre-defined specifications.
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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. This device is a physical medical device (balloon catheter), not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic performance, especially of AI/CAD systems.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, for the same reason as above. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the engineering tests, the "ground truth" is defined by the technical specifications, standards (e.g., ISO 10993-1 for biocompatibility), and physical laws that govern the device's performance. The successful demonstration against these criteria means the device performs as intended and meets safety requirements.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of physical medical device verification testing as described. This term applies to machine learning or AI models.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.
§ 884.4260 Hygroscopic Laminaria cervical dilator.
(a)
Identification. A hygroscopicLaminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata orLaminaria japonica). The device is used to induce abortion.(b)
Classification. Class II (performance standards).