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The Signal Gear Urethral Catheter Electrode is intended for mucosal surface stimulation/recording from the external urinary sphincter for use in conjunction with urodynamic evaluation of the patient.

The Signal Gear Urethral Catheter Electrode is a single patient use, disposable sterile device. It consists of an adhesive, highly flexible, polyurethane film substrate that wraps around the urethral (Foley) catheter. The conductive portion of the electrode is printed onto the polyurethane film substrate in a pattern that, when the electrode is wrapped around the catheter, leaves two conductive contact surfaces forming the two electrical contacts of the electrode. The remainder of the conductive pattern is overwrapped by an additional layer of polyurethane film during manufacture in order to insulate the traces. The conductive ink used is silver, with the exception of the two electrical contacts of the electrode, which have an additional printed layer of gold ink.

Lead wires are attached that terminate in a safety connector that cannot be connected to an AC power outlet. The Electrode connects to the user's electrodiagnostic equipment. The electrode is to be used under the supervision of a physician. When the urethral catheter with the applied electrode is inserted in the human urethra, the exposed two electrical contacts of the electrode contact the mucosal lining of the urethra in the location of the external urinary sphincter muscle, and the end of the electrode with leadwire attachments are outside of the urethral meatus.

The provided 510(k) summary for the Neurovision Medical Products Inc. Signal Gear Urethral Catheter Electrode (K113771) describes a non-clinical study to support substantial equivalence. It does not present acceptance criteria or detailed performance data for clinical use, nor does it describe a study involving human subjects or AI.

Here's an analysis based on your request, highlighting what information is not present in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The 510(k) summary focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than defining specific performance metrics or acceptance criteria related to its intended physiological function (mucosal surface stimulation/recording) in a clinical setting.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable, as this was a non-clinical study.
• Data Provenance: Not applicable, as this was a non-clinical study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable, as this was a non-clinical study. The "ground truth" in this context would be engineering specifications and standards for electrical, biocompatibility, and sterilization testing.

4. Adjudication Method for the Test Set

Not applicable, as this was a non-clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done and is not mentioned. This type of study is relevant for diagnostic devices where human readers interpret images or data, often with AI assistance. The Signal Gear Urethral Catheter Electrode is a medical instrument for stimulation/recording, not a diagnostic imaging device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (algorithm only) study was not done and is not mentioned. The device is an electrode for use in conjunction with urodynamic evaluation, implying human operation and interpretation of data. There is no mention of an "algorithm" as a component of this device's performance.

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was based on:

• Engineering specifications and quality standards for manufacturing.
• Established international and industry standards for biocompatibility (ISO 10993-5:2009, ISO 10993-10:2010).
• Standards for accelerated aging (ASTM F1980-07).
• Standards for packaging validation (UNI EN ISO 868-5, 11607-1, DIN 58953-6).
• Standards for bioburden and sterility (UNI EN ISO 11737-1, 11737-2).

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned, the ground truth for it was not established.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Non-Clinical):

The Neurovision Medical Products Inc. Signal Gear Urethral Catheter Electrode underwent several non-clinical tests to demonstrate its safety and performance, and thus its substantial equivalence to the predicate device (Dantec 13L40 St Mark's Pudendal Electrode).

The study involved:

• Inspection for defects: Manufacturing, workmanship, and packaging.
• Electrical continuity testing: To ensure proper electrical function.
• Lead wire pull testing: To assess the mechanical strength of the lead wire attachment.
• Biocompatibility testing:
  • In vitro cytotoxicity: According to ISO 10993-5:2009.
  • Irritation and delayed-type hypersensitivity: According to ISO 10993-10:2010.
• Accelerated aging: Conducted according to ASTM F1980-07 to predict shelf life.
• Packaging validation tests: Conducted according to UNI EN ISO 868-5, 11607-1, and DIN 58953-6 to ensure package integrity and maintain sterility.
• Bioburden and sterility tests: Conducted according to UNI EN ISO 11737-1 and 11737-2 to confirm the device is sterile when packaged.

The document indicates that these non-clinical tests were sufficient to demonstrate that "No new questions of safety or effectiveness are raised," supporting its substantial equivalence to the predicate device. However, specific acceptance criteria for each test (e.g., minimum pull strength, maximum cytotoxicity score) and the quantitative results are not provided in this summary. The FDA's 510(k) clearance implies that the agency found these non-clinical tests adequate for demonstrating substantial equivalence based on the provided data.

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The pressure sensor is for use in the long term weekly monitoring of full serial bladder (vesical) pressure in patients that perform regular clean intermittent catheterizations (CIC). Regular once per week long term monitoring of bladder pressure in patients at risk for developing high bladder pressures and urinary incontinence associated with, urinary tract infections (UTI), vesicoureteral reflux and renal insufficiency. The most significant source of urologic morbidity and mortality in patients with spinal conditions where CIC is used is renal failure secondary to upper tract deterioration from high bladder pressures.

Cystometry (CMG) is an integral part in the urologic evaluation of patients prior to the use of this device. At no time is this device to be used in place of CMGs for diagnostics. Patients with CMG leak point pressures greater than 40 cm H20 are at significant risk for upper tract deterioration. The frequency and timing of CMG urodynamic studies in patients with spinal injuries continues to be controversial, but use of this device may insure that full CMGs or other suitable diagnostics are performed on a timely basis by the patients attending physician.

Single Channel Urological Pressure Gauge

This is a 510(k) clearance letter from the FDA for a Single Channel Urological Pressure Gauge and its Indications For Use. This document does not contain information typically found in a study describing acceptance criteria and device performance.

Therefore, I cannot provide the requested information. This document is a regulatory approval notice, not a study report.

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The Urodynamic Analysis Module is a software program that has been designed to analyze pressure, volume and flow data recorded from the urological tract in pediatric and adult populations. The Urodynamic Analysis Module includes the following analyses: Uroflow analysis. Cystometry analysis, Pressure/flow voiding analysis, Urethral Pressure Profile. The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physiclan. The analyzed data can be viewed on the computer screen or printed out on a separate paper.

The Polygram Software for Windows (KD46322) was designed to record and handle/store physiological parameters. After a recording, the user is able to review the tracings on the computer screen and print the signal tracings or just parts of them. When reviewing the data on the computer screen, the user is able to mark certain segments and calculate certain parameters from the selected signal segments. These parameters include minimum and maximum values. length of selection. By adding the Urodynamic Analysis Module to the Polygram Software for Windows, the user can also have all the pressure, flow and volume data analyzed In terms of physiological properties, comparison with normal values, etc. The analyzed data can thereafter be viewed on screen or printed out on a separate paper. The analysis report includes sections such as patient demographics: interpretation and comment (for user to insert); procedure summary; Urodynamic tracing; analyses (as specified below); and physician signature section.

The provided text describes the Urodynamic Analysis Module, a software program for analyzing urological data. However, it does not contain any specific acceptance criteria or details of a study that proves the device meets such criteria.

The section titled "Performance Testing" indicates that "alpha testing in terms of integration testing has been performed and documented and beta testing in terms of hospital site testing has been done and documented." It further states that "It has been concluded that the alpha and beta testing has meet and passed the specified objectives and should therefore be released to the market."

This statement is a high-level summary and lacks the detailed information required to fill out the requested table and answer the specific questions.

Here's an explanation of why the requested information cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance: This information is entirely absent. There are no measurable criteria (e.g., accuracy percentages, error rates, precision targets) or reported numerical performance data.
2. Sample Size Used for Test Set and Data Provenance: The document mentions "beta testing in terms of hospital site testing," suggesting real-world data was used. However, it does not specify the sample size (number of patients, number of cases), the country of origin, or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications: This information is not provided. We don't know who established the "specified objectives" mentioned or how the ground truth for the testing was determined.
4. Adjudication Method: Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. There is no indication of human reader comparisons, with or without AI assistance, or any effect size.
6. Standalone Performance Study: The document describes the software's analytical capabilities but doesn't detail a standalone performance study with specific metrics, only generalized "alpha and beta testing."
7. Type of Ground Truth Used: The document doesn't specify how ground truth was established for the "specified objectives."
8. Sample Size for Training Set: Not applicable as the text describes a system that analyzes data, not one that uses machine learning models that require a training set in the conventional sense. The "training" here would likely refer to the software's development and internal validation, not a machine learning training phase.
9. How Ground Truth for Training Set was Established: Not applicable for the same reason as point 8.

In summary, the provided 510(k) summary focuses on describing the device's functionality and its equivalence to an older DOS-based version. It only offers a very general statement about performance testing, without the specific details required for a robust analysis of acceptance criteria and proven performance.

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The Rüsch Urodynamic Rectal Balloon 2-way Catheter is intended to provide a fluid conduit for urodynamic studies, where the detrusor pressure is to be calculated from rectal pressure.

The Rusch Urodynamic Rectal Balloon 2-way Catheter consists of a double lumen polyvinyl chloride tube upon which is affixed a latex balloon, with a radiopaque stripe.

To use, the balloon is inflated with sterile water using a luer taper syringe. The catheter is then connected to a transducer, and can be used in conjunction with equipment for calculating the detrusor pressure necessary to open the urinary sphincter).

The provided text describes a 510(k) summary for the Rüsch Urodynamic Rectal Balloon 2-way Catheter. However, it does not contain information about acceptance criteria or specific study results involving a device's performance against such criteria in the manner requested. Instead, it focuses on the device's characteristics, comparison to predicate devices, and a general statement about biocompatibility and bench testing without numerical performance data or detailed study methodology.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The closest information available that might be interpreted in the context of "performance" is the statement:

"The device's performance in these tests [Tensile Testing, Balloon Burst Testing] is comparable with that of the Rüsch Urodynamic Rectal Balloon Catheter (K952573)."

This indicates that some form of performance evaluation was done through bench testing, and the outcome was "comparable" to a predicate device. However, it does not provide the specific numerical acceptance criteria for these tests or the reported numerical performance of the device.

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