(416 days)
The Aqueduct 200 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 200 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 and also contains a camera and camera cable. In use, the catheter is inserted through the vagina and cervical canal and into the uterus. Using visual feedback from the forward-looking camera and LED light source the physician advances the catheter through the cervical canal and identifies the end of the canal when entering the internal orifice of the uterus. When the physician identifies the orifice, the catheter is positioned inside the cervix. This aligns the cylindrical dilation 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. The camera cable on the catheter connects to a camera module that provides power to the camera and allows connection to an HDMI port on a monitor to assess proper device placement during a clinical procedure. 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 text describes the Aqueduct 200 Cervical Dilation Balloon Catheter and its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of a clinical or performance study with human subjects, comparing its effectiveness or accuracy against a ground truth for a diagnostic or therapeutic outcome.
Instead, the document details various non-clinical performance data and testing conducted to demonstrate that the device itself is safe and performs as intended, largely in comparison to its predicate device or against engineering/manufacturing standards.
Below is an attempt to structure an answer based on the available information, with significant caveats that many requested sections are not applicable or not present in the document provided.
Acceptance Criteria and Device Performance Study for Aqueduct 200 Cervical Dilation Balloon Catheter
The provided 510(k) summary for the Aqueduct 200 Cervical Dilation Balloon Catheter (K202433) primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and adherence to recognized standards. It does not appear to describe a study that involves clinical outcomes, diagnostic accuracy, or comparative effectiveness with human readers/AI, as would be typical for certain types of medical devices, especially those involving AI or diagnostic interpretation.
The "acceptance criteria" referred to in the document are primarily engineering and safety standards, and device functionality specifications, rather than clinical efficacy targets.
1. Table of Acceptance Criteria and Reported Device Performance
Since the document does not present acceptance criteria as quantitative targets for clinical performance (e.g., sensitivity, specificity for a diagnostic device), this table will list the types of tests performed and the general outcome reported.
| Test Category | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Noncytotoxic, non-irritating, non-sensitizing | Met criteria: noncytotoxic, non-irritating, and non-sensitizing |
| Sterilization Validation | Sterility Assurance Level 10-6 via overkill method | Validated according to ANSI/AAMI/ISO 11135:2014 |
| EO Residuals | Within limits per ISO 10993-7:2008 | Evaluated according to ISO 10993-7:2008 (implied met) |
| Packaging Integrity | Able to withstand shipping, maintain seal strength and dye penetration | Met all predetermined acceptance criteria after accelerated aging |
| Electrical Safety | Adherence to relevant IEC 60601 standards | Tested according to IEC 60601-1:2005, -1-2:2014, -2-18:2009 |
| Electromagnetic Compatibility (EMC) | Adherence to relevant IEC 60601 standards | Tested according to IEC 60601-1-2:2014 |
| Optical Performance (Camera) | Met specified component, photobiological safety, field of view, direction of view, resolution, depth of field, geometric distortion, noise, dynamic range, image intensity uniformity | Met predetermined acceptance criteria for all listed specifications |
| Bench Performance (Mechanical) | Adherence to ISO 10555-1:2013, -4:2013, ISO 11737-1:2018; dimensional verification, camera functionality, balloon burst pressure, balloon fatigue, inflation/deflation time, catheter bond strength, flexibility, pushability, balloon prep/deployment/retraction after accelerated aging. | Met predetermined acceptance criteria for each test (incl. after aging) |
2. Sample Size for Test Set and Data Provenance
This information is not applicable as the document describes non-clinical laboratory and bench testing, not a clinical study with a "test set" of patient data.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable. The "ground truth" for the tests performed was established by validated engineering standards, laboratory test results, and adherence to regulatory guidance, not expert consensus on clinical cases.
4. Adjudication Method
This information is not applicable. There was no clinical study involving interpretation or adjudication of cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or reported in this document. This type of study is typically conducted for diagnostic imaging devices or AI tools that assist human readers in interpreting clinical data. This device is a cervical dilation catheter, primarily a mechanical instrument.
6. Standalone Performance Study (Algorithm Only)
A standalone algorithm performance study was not performed or reported. The device includes a camera, but its primary function is visual feedback for proper placement of the mechanical dilation component. It does not appear to involve an AI algorithm for diagnosis or interpretation.
7. Type of Ground Truth Used
The "ground truth" for the reported performance data was based on:
- Validated laboratory methods and equipment: For biocompatibility (cytotoxicity, sensitization, irritation), sterility, EO residuals, packaging integrity.
- Engineering specifications and standards: For electrical safety, EMC, optical performance (e.g., resolution, field of view), and bench performance (e.g., burst pressure, dimensions, bond strength), referenced against ISO and IEC standards.
- Simulated aging conditions: For shelf-life performance testing.
8. Sample Size for the Training Set
This information is not applicable as there is no mention of a training set for an algorithm in the provided document.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no mention of a training set.
§ 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).