(73 days)
The Aqueduct 100 Plus Cervical Dilation Balloon Catheter is intended to be used whenever cervical softening and dilation is desired. Some examples are: treatment of cervical stenosis, IUD placement and removal, Radium placement, drainage of uterine cavity, endometrial biopsy, uterine curettage, suction cannula aspiration, operative hysteroscopy.
The Aqueduct 100 Plus Cervical Dilation Balloon Catheter is a balloon cervical dilation catheter which enables the simultaneous dilation of both sides of the cervical canal. The subject device is an updated version of the Aqueduct 100 Cervical Dilation Balloon Catheter cleared under K160664 that merges two separate dilation balloons into one balloon, removes the anchor balloon, replaces the four-way hub with a three-way hub, and removes the stylet from the shaft. The catheter consists of a 2-lumen shaft. One lumen inflates a cylindrical dilation balloon. A second lumen is for infusion of saline solution. In use, the catheter is inserted through the vagina and cervical canal and into the uterus. The catheter is positioned inside the cervix. The user aligns the cylindrical balloon at the internal cervical os and external cervical os. The balloon is inflated with 12.5 ml of saline, providing gradual mechanical dilation of the cervix. After 3 minutes of dilation of the internal and external orifices of the uterus, a controlled injection of 1-2.5 ml of saline may be made through the catheter infusion lumen which exits on the distal end of the catheter. Evidence that cervical dilation is complete can be determined once droplets of the saline injection are observed exiting through the external opening of the cervix. Optimal dilation of 8-9 mm within the cervical canal is typically achieved following 5 minutes of balloon dilation. The entire procedure from catheter insertion to removal is completed in 6-7 minutes. The deflation of the balloon is conducted by attaching a luer lock syringe to the swabable valve and removing saline from the balloon. The subject device is packaged in a mylar/Tyvek pouch and ethylene oxide (EO) sterilized to a SAL 10-6. The packaged device has a shelf-life of 15 months.
The provided document is a 510(k) premarket notification for a medical device called the "Aqueduct 100 Plus Cervical Dilation Balloon Catheter." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness through clinical studies.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a study proving the device meets those criteria, or details about ground truth, expert adjudication, or MRMC studies.
Here's why and what information is available:
- No Acceptance Criteria for Clinical Performance: As this is a 510(k) for substantial equivalence, clinical performance acceptance criteria in the sense of accuracy, sensitivity, specificity, or reader agreement are not typically established or reported here. The "acceptance criteria" discussed implicitly are related to demonstrating that the new device is as safe and effective as the predicate device through non-clinical performance and biocompatibility.
- No Study Proving Device Meets Acceptance Criteria for Clinical Performance: There isn't a clinical study designed to "prove" the device meets specific performance metrics in human use. Instead, the "study" is a collection of engineering, biocompatibility, and sterilization tests.
- No Information on Sample Sizes for Test/Training Sets, Data Provenance, Expert Ground Truth: These details are relevant for AI/ML device studies or clinical trials evaluating diagnostic/prognostic effectiveness, which is not the nature of this submission.
- No MRMC Comparative Effectiveness Study: There is no mention of a human-reader comparative effectiveness study because this device is a physical medical device, not an AI diagnostic tool.
- No Standalone (algorithm only) Performance: This is a physical catheter, not an algorithm.
- No Ground Truth Type: The concept of "ground truth" (e.g., pathology, outcomes data) doesn't apply in the context of this 510(k) submission, as it relates to evaluating the accuracy of a diagnostic or prognostic claim, which is not being made here for the new device itself.
What the document does provide in lieu of your requested information:
The document outlines a series of non-clinical performance tests conducted to demonstrate that the changes in the Aqueduct 100 Plus Cervical Dilation Balloon Catheter (compared to its predicate, the Aqueduct 100) do not raise new questions of safety or effectiveness.
Here's a summary of the non-clinical "acceptance criteria" (or verification activities) and "reported performance" (results) as derived from the document:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Focus)
| Acceptance Criteria Category | Specific Test/Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | Device must be biocompatible according to ISO 10993-1, -5, -10 standards for patient contact. | - Cytotoxicity (ISO 10993-5:2009): Device demonstrated to be noncytotoxic. |
- Sensitization (ISO 10993-10:2010): Device demonstrated to be non-sensitizing.
- Irritation (ISO 10993-10:2010): Device demonstrated to be non-irritating. |
| Sterilization Validation | Device must achieve a Sterility Assurance Level (SAL) of 10-6 via Ethylene Oxide (EO) sterilization, with acceptable EO residuals. | - EO sterilization cycle validated using the overkill method per ANSI/AAMI/ISO 11135:2014. - Ethylene Oxide residuals evaluated according to ISO 10993-7:2008.
- The subject device utilizes the same sterilization process, chamber, and cycle as the predicate device. |
| Bench Performance Testing | Device must meet performance requirements for intravascular catheters (ISO 10555-1, -4) and microbiological methods (ISO 11737-1). Also, performance must be maintained after accelerated aging (15-month shelf life). | - Performance tests performed according to ISO 10555-1:2013 and ISO 10555-4:2013. - Microbiological methods tested according to ISO 11737-1:2018.
- Performance maintained after accelerated aging to simulate a 15-month shelf life for the following:
- Dimensional Verification
- Balloon Burst Pressure (> 8 atm reported in comparison table, and successfully passed after aging)
- Balloon Fatigue
- Balloon Inflation/Deflation Time
- Catheter Bond Strength
- Catheter Pushability
- Conclusion: The submitted performance testing demonstrates that the subject device is as safe and effective as the predicate device. |
2. Sample Sizes, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type (Not applicable for this document)
As explained above, these categories are not relevant to a 510(k) submission for a physical device demonstrating substantial equivalence. The document does not provide such information.
3. Sample Size for Training Set & Ground Truth for Training Set (Not applicable)
Again, these concepts are related to machine learning models or clinical trials, neither of which are described in this 510(k) submission. There is no "training set" for a physical medical device. The "ground truth" for non-clinical tests is established by adhering to recognized international standards and standard laboratory practices.
§ 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).