(88 days)
Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as Uterine curettage, Labor induction, IUD placement and removal, and Radium placement
This single use device is a hygroscopic laminaria cervical dilator designed to dilate (stretch open) the cervical os by cervical insertion of a cylindrical and expansible material into the cervical canal, made from the root of a seaweed (laminaria digitata). Laminaria expands when it absorbs moisture.
The ability to increase in size slowly (usually 6 to 24 hours) is of advantage in physiologically dilating a closed body orifice such as the cervical canal. When used improperly, it may cause the patient major discomfort or uterine complications
Laminaria is available in 2, 3, 4, 5, 6, 7, 8 and 9 mm diameter sizes with a length varving between 50 and 65 mm. Each laminaria is drilled and attached to a 75-95 mm string to facilitate removal from the cervical canal (the last digit of the product code reflects its size)
Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as uterine or suction curettage, labor induction, IUD placement and removal, and Radium placement
This 510(k) submission describes the Laminaria cervical dilator and claims substantial equivalence to a predicate device, the Staol Laminaria Tents from Norscan Trading Group. The submission focuses on demonstrating that the new device has identical characteristics to the predicate, rather than presenting a study to prove its performance against acceptance criteria in the typical sense of a novel device.
Here's an analysis based on the provided text, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of predefined acceptance criteria and a performance study against them, the submission uses a comparative approach against a predicate device. The "performance" is considered "identical" to the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (vs. Predicate) |
|---|---|
| Indications for use are met | Identical |
| Target population is appropriate | Identical |
| Design is appropriate | Identical |
| Materials are appropriate and safe | Identical |
| Performance characteristics are comparable | Identical |
| Sterility is achieved | Similar (Ethylene Oxide but different parameters) |
| Biocompatibility is maintained | Identical |
| Mechanical safety is ensured | Identical |
| Chemical safety is ensured | Identical |
| Anatomical sites are appropriate | Identical |
| Human factors are acceptable | Identical |
| Energy used and/or delivered is comparable | Identical |
| Compatibility with environment and other devices is ensured | Identical |
| Where used is appropriate | Identical |
| Standards are met | Identical |
| Electrical safety is ensured | Identical (not applicable) |
| Thermal safety is ensured | Identical (not applicable) |
| Radiation safety is ensured | Identical (not applicable) |
2. Sample size used for the test set and the data provenance
The document does not describe a specific "test set" or clinical study with patient data. The argument for the device's safety and effectiveness relies on its technological characteristics being identical or similar to the predicate device, which is already legally marketed. Therefore, there's no data provenance in the context of a new clinical study. This is typical for a 510(k) submission where substantial equivalence is claimed based on similarities to a predicate rather than novel performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no new clinical "test set" was generated, there was no need for experts to establish ground truth for such a set.
4. Adjudication method for the test set
Not applicable. No new clinical "test set" was generated.
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. This is a medical device (cervical dilator), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used
The "ground truth" in this context is the safety and effectiveness profile established for the predicate device. The underlying assumption is that because the Laminaria device is technologically equivalent to the predicate, it shares the same safety and effectiveness profile.
8. The sample size for the training set
Not applicable. There is no machine learning or AI component that would require a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no machine learning or AI component.
§ 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).