(136 days)
Dilapan-S is to be used whenever cervical softening and dilation is desired. Some examples are:
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- Cervical stenosis
- a. related to dysmenorrhea
- b. considered a possible cause of infertility
- c. resulting from cauterization or conization
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- Placement and removal of intrauterine devices
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- Induction of labor
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- Radium placement
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- Drainage of uterine cavity
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- Endometrial biopsy
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- Uterine curettage
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- Suction cannula aspiration
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- Operative hysteroscopy
DILAPAN-S is a hygroscopic cervical dilator that is manufactured from AQUACRYL, a proprietary hydrogel. The dilators are firm hygroscopic rods, similar in shape to natural laminaria tents. DILAPAN-S is capable of increasing in diameter on average from three (3) millimeters to 8.3-10 mm, or four (4) millimeters to 10-12.5 millimeters within 4-6 hours as they absorb moisture from the genital tract.
In clinical trials, DILAPAN-S has been shown to dilate the cervix gradually. It may not be necessary to use general or local anesthetics during the insertion process, thereby eliminating their associated risks to the patient. A Marker String is tied securely to the handle of the DILAPAN - S, and is provided to indicate location.
DILAPAN-S is capable of increasing its volume as it absorbs moisture from the genital tract through hygroscopic action. The volume of DILAPAN-S subsequently exerts radial pressure on the surrounding structures (uterine neck) to dilate progressively. Endocervical pressure on the uterine neck results in mechanical dilation and promotes cervical ripening through reversible cell dehydration and local endogenous prostaglandins release promoting collagen reorganization.
DILAPAN-S is available in boxes of 10 or 25 dilators and in the following dimensions: 4mm x 65mm, 4mm x 55mm, 3mm x 55mm. Each DILAPAN - S is individually wrapped in a single foil pouch and is sterilized by gamma radiation.
Here's a breakdown of the acceptance criteria and study information for the Dilapan-S device, based on the provided FDA 510(k) summary:
Please note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against pre-defined acceptance criteria for a new application. As such, the information provided primarily relates to comparative testing and literature review rather than a single, comprehensive study with explicit acceptance criteria for this specific submission.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria in the typical sense (e.g., "The device must achieve X sensitivity and Y specificity"). Instead, the approach is to demonstrate that Dilapan-S performs "as well as or better than" the predicate device through comparative testing and established clinical use.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (Dilapan-S vs. Laminaria) |
|---|---|
| Biocompatibility: Non-toxic, non-irritating, non-sensitizing, etc. (per ISO 10993) | All required biocompatibility tests (ISO 10993-1) were performed. (Specific results not detailed in summary, but deemed sufficient). |
| Sterilization & Shelf-Life: Effective sterilization and maintenance of sterility over shelf life. | Validation for sterilization including shelf life studies have been performed. (Specifics not detailed). |
| Expansion Characteristics: Similar or improved swelling to cause cervical dilation. | Swells to greater diameters and faster rates than Laminaria. Exerts greater forces during swelling. |
| Clinical Effectiveness & Safety: Safe and effective for cervical softening and dilation across various indications, similar to the predicate device. | "Safe and effective use of DILAPAN-S has been previously shown in numerous clinical studies." "Clinical performance data show that the subject device, with narrowed dry diameter range, is as safe and effective as the laminaria devices." |
| Material Equivalence: Differences in material (synthetic hydrogel vs. seaweed) do not introduce new safety/effectiveness concerns. | Biocompatibility testing addressed safety concerns. Bench and clinical testing addressed effectiveness concerns. |
| Design Equivalence: Differences in design (e.g., handle) do not introduce new safety/effectiveness concerns regarding joint strength. | Sufficient mechanical engineering data provided to demonstrate safe and effective joint strength. |
| Indications for Use Equivalence: Covers similar clinical indications, with any additions not raising new safety/effectiveness questions. | Same general Indications for Use. Additional indication (operative hysteroscopy) supported by clinical literature. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of this 510(k) summary. The document refers to:
- "Comparison testing... with Laminaria" for swell, expansion force, diameter variations, and speed of swelling. The number of samples for these bench tests is not provided.
- "Numerous clinical studies" and "clinical performance data" for safety and effectiveness. The sample sizes for these referenced studies are not detailed in this summary.
- Data Provenance: The document does not specify the country of origin for the referenced clinical studies. It also doesn't explicitly state whether the data was retrospective or prospective. Given the submission date, some referenced clinical studies could be retrospective reviews of existing data or prospectively conducted trials published prior to the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. Given that the submission relies on comparative bench testing and existing clinical literature, there isn't a directly described "ground truth" establishment process for a specific test set within this document, nor is there mention of experts establishing a ground truth for this submission's testing. The "truth" for effectiveness is implied by the scientific literature and comparison to the predicate.
4. Adjudication Method for the Test Set
This information is not provided. As there isn't a defined "test set" in the sense of a clinical trial with specific endpoints requiring adjudication by experts, an adjudication method is not described.
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 device is a physical medical device (cervical dilator), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. As noted above, this is a physical medical device, not an algorithm. Therefore, "standalone algorithm" performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this device's substantial equivalence is established through:
- Bench Testing Data: Direct measurements of physical properties like swelling diameter, swelling rate, and expansion force, comparing Dilapan-S to the predicate device (Laminaria).
- Clinical Literature: Referenced "numerous clinical studies" which demonstrate the safe and effective use of Dilapan-S. These likely use outcomes data (e.g., achieved dilation, complications, patient experience) as their ground truth.
- Biocompatibility Standards: Adherence to established ISO 10993 standards provides ground truth for material safety.
8. The Sample Size for the Training Set
Not Applicable. This device is not an AI/machine learning algorithm, so there is no "training set" in the traditional sense.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set, there is no explanation of how its ground truth would be established.
§ 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).