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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.

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.

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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)

• 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.

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The CrossBay™ Cervical Dilator Catheter System is intended to be used whenever cervical softening and dilation is desired. Some examples are:

• Treatment of cervical stenosis
• IUD placement and removal
• Placement of instruments for intrauterine radiotherapy
• Endometrial biopsy
• Global endometrial ablation
• Uterine tissue removal
• Uterine curettage
• Diagnostic hysteroscopy
• Operative hysteroscopy

This device is not intended for use in the induction of labor.

The CrossBay Cervical Dilator Catheter System is a sterile, single use device composed of an inflation device, dilator catheter, everting membrane, and dilator balloon which enable softening and dilation of the cervical canal. The CrossBay Cervical Dilator Catheter System contains an Inflation Device and a Dilator Catheter that accesses the cervix using a hydraulic pressure-filled everting Membrane. The Inflation Device provides the hydraulic energy with saline supplied by the user. Once placed at the exocervix, the Dilator Catheter advances through the cervix by everting the Membrane through the endocervix. A Dilator Balloon is attached to the inner tube of the device that is positioned across the cervix when the everting Membrane is fully everted. The Inflation Device is then used to further pressurize the system to split open the everting Membrane to expose the Dilating Balloon. The Inflation Device is used to pressurize the Dilator Balloon to the prescribed level. Once dilated, the Dilator Catheter is removed from the cervix and the subsequent uterine cavity procedure can commence.

The CrossBay Cervical Dilator Catheter with Dilator Balloon is provided in three sizes of 5mm, 7mm, and 9mm. The three sizes are identical except for the diameter of the Dilator Balloon when pressurized.

I am sorry, but based on the provided text, there is no information about a study proving the device meets acceptance criteria for an AI/ML powered medical device. The document pertains to a 510(k) premarket notification for a mechanical medical device (CrossBay Cervical Dilator Catheter System), not an AI/ML product.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size used for the test set or data provenance for an AI/ML device.
• Number of experts or their qualifications for establishing ground truth for an AI/ML device.
• Adjudication method for an AI/ML device test set.
• MRMC comparative effectiveness study or effect size for AI assistance.
• Standalone (algorithm only) performance for an AI/ML device.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
• Sample size for the training set or how ground truth was established for the training set for an AI/ML device.

The document discusses non-clinical performance data for the mechanical dilator, including bench testing, biocompatibility, sterilization, package integrity, and shelf life. These are standard tests for a physical medical device to demonstrate substantial equivalence to a predicate device, not for an AI/ML model's performance.

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The Aqueduct 100 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 Cervical Dilator is a triple-balloon cervical dilation catheter which enables the simultaneous dilation of both sides of the cervical canal. The catheter consists of a 3-lumen shaft. One lumen inflates an anchoring balloon. A second lumen inflates the 2 cylindrical dilation balloons. The third lumen is for infusion of saline solution and also contains a fixed stiffening stylet to add rigidity to the catheter. The stylet is permanently sealed within the infusion lumen. In use, the catheter is inserted through the vagina and cervical canal and into the uterus where the distal spherical balloon is inflated. The catheter is then withdrawn until the spherical balloon comes into contact with the internal orifice of the uterus, which positions and anchors the catheter within the cervix. This aligns the two cylindrical balloons at the internal cervical os and external cervical os. The balloons are inflated with saline providing gradual mechanical dilation of the cervix.

After 3 minutes of dilation of the internal and external orifices of the uterus, a gentle, controlled injection of 1ml, and up to 2.5ml, of saline can be made through the catheter infusion lumen which exits between the two balloons (and inside the cervical canal). Evidence that cervical dilation is complete can be determined once droplets of the saline injection are observed entering through the external opening of the cervix. Optimal dilation of 8-9mm 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 Aqueduct 100 Cervical Dilator is packaged in a mylar/Tyvek pouch and EO sterilized to SAL 10-6.

The provided document describes the Aqueduct 100 Cervical Dilation Balloon Catheter and its substantial equivalence determination, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the context of an AI/human reader study.

The document indicates "Performance Data" were provided in support of the substantial equivalence determination, but these refer to biocompatibility and in vitro performance tests relevant to the device's physical properties and safety, not a clinical study involving human readers or AI performance.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria for AI/human performance, study design details, expert qualifications, etc.) is not present in the provided text.

The closest information provided is:

1. A table of acceptance criteria and the reported device performance: This information is not provided for an AI or human reader study. The document lists the following in vitro performance tests:

2. Sample size used for the test set and the data provenance: Not applicable, as no such study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on the physical and material equivalence of the Aqueduct 100 Cervical Dilation Balloon Catheter to its predicates based on biocompatibility and in vitro performance testing, not on clinical performance or diagnostic accuracy improved by AI or human readers.

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