Search Results

SpeediCath Flex Coude Pro is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is for male patients only.

The SpeediCath Flex Coude' Pro catheter is a sterile single use hydrophilic coated polyurethane catheter for men. The catheter is to be used for intermittent drainage of the bladder through the urethra by males with missing or reduced bladder control. The catheter has a bended flexible tip that facilitates passage through the urethra to the bladder. The catheter is shielded by a sleeve, which serves as protection form the user's touch during insertion. The SpeediCath Flex Coude' Pro Catheters are offered with a 33cm effective length and range in size from 10Fr to 16Fr. The hydrophilic coating makes this single use catheter ready to use.

This document is an FDA 510(k) summary for the SpeediCath Flex Coudé Pro catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that "proves the device meets acceptance criteria" in the way one might describe a clinical trial for a diagnostic AI.

Here's an analysis based on your requested information, acknowledging that the nature of this submission (a device modification for a urological catheter) means some of your categories might not be directly applicable in the same way they would be for an AI diagnostic device:

Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on the device meeting performance specifications established by voluntary standards and by testing conducted on a predicate device. The "device performance" is reported as "All tests passed the pre-determined acceptance criteria."

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document does not specify exact sample sizes for each test. It refers to "Performance testing." For a physical device like a catheter, this would typically involve testing a statistically significant number of production units according to the applicable standards.
   • "Data provenance" is not explicitly stated in terms of country of origin, but it is implied to be internal testing by the manufacturer, Coloplast Corp, based in Minneapolis, MN, USA. The studies are non-clinical (laboratory/bench testing).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable to this type of device submission. Ground truth, in the context of diagnostic AI, usually refers to definitive diagnoses by experts or pathology. For a physical device, the "ground truth" is typically the physical property being measured (e.g., flow rate, tensile strength) as determined by standardized laboratory methods and equipment, which may be operated by qualified technicians or engineers, but not "experts" in the clinical diagnostic sense.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This concept relates to resolving discrepancies among multiple human readers for diagnostic tasks, which is not relevant to non-clinical bench testing of a physical medical device like a catheter.

4. 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. This is a physical medical device (catheter), not an AI diagnostic system. Therefore, no MRMC study, human readers, or AI assistance is involved.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm or AI system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this device's performance testing is defined by the objective measurements and pass/fail criteria established within the referenced voluntary standards (e.g., ISO, ASTM, EN). For example, a flow rate measurement would be compared against a specified minimum flow rate from the standard.

7. The sample size for the training set:

   • Not applicable. This refers to AI/machine learning models. This submission is for a physical medical device.

8. How the ground truth for the training set was established:

   • Not applicable. This refers to AI/machine learning models. This submission is for a physical medical device.

Summary of Study (Based on Provided Document):

The study described is a series of non-clinical bench and laboratory performance tests conducted to demonstrate the safety and effectiveness of the SpeediCath Flex Coudé Pro catheter and its substantial equivalence to a predicate device (SpeediCath Flex Coude' Pro: K180070). The new device is a modified version, with changes in pouch material/dimensions, sleeve material/dimensions, wetting agent material/volume, and product variants (line extension).

The studies performed include:

• Accelerated Aged Shelf Life Testing: To assess the stability of the coating and tip bend over time, per ISO F1980-16.
• Biocompatibility Testing: According to ISO 10993-1 and FDA Guidance to ensure the materials are safe for patient contact.
• Coefficient of Friction Testing: Per ASTM D1894: 2014, to evaluate the lubricity of the catheter.
• Transportation Testing: Per ASTM D4169, to assess the device and packaging's integrity after simulated shipping conditions.
• Impact Testing (due to modifications): Includes catheter kink testing, catheter tip integrity, coating inspection, proof of packing seal, and peel force test of new material for ease of opening.
• Performance Specifications (based on predicate device testing): Flow rate (EN1616/EN1618 and ASTM F623-99: 2013), tensile strength (EN1616/EN1618), and connector security (EN1616).

The document states that "All tests passed the pre-determined acceptance criteria," implying that the device performs as expected and meets the necessary safety and performance standards for its intended use, demonstrating substantial equivalence to the predicate device despite the minor modifications.

Ask a specific question about this device

The SpeediCath Flex Coudé Pro is indicated for use by patients with urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing the urine to drain. The product is for male patients only.

The SpeediCath Flex Coudé Pro catheter is a sterile single use hydrophilic coated polyurethane catheter for men. The catheter is to be used for intermittent drainage of the bladder through the urethra by males with missing or reduced bladder control. The catheter has a bended flexible tip that facilitates passage through the urethra to the bladder. The catheter is shielded by a sleeve, which serves as protection from the user's touch during insertion.

The provided text is a 510(k) premarket notification for a medical device, the SpeediCath Flex Coudé Pro. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical efficacy studies. Therefore, the document does not contain the information requested about acceptance criteria, clinical study details (like sample size, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/diagnostic device performance).

The "performance testing" mentioned in the document refers to non-clinical bench testing to ensure the physical properties and safety of the modified catheter are comparable to its predicate device. This is typical for a 510(k) submission where the device is a minor modification or a line extension of an already cleared device.

Specifically, the document states:

• "Performance testing for SpeediCath Flex Coude Pro was conducted according to applicable sections of voluntary standards in order to document the following properties of the SpeediCath Flex Coudé Pro catheter." It lists tests such as flow rate, coefficient of friction, tensile strength, connector security, and biocompatibility.
• "The proposed changes do not impact the performance testing." This implies the core performance (mechanical, material, biocompatibility) is expected to be the same as the predicate.
• "The following tests were completed to determine the impact of the modification based on assessment of the device risk documentation: Coating inspection at average and extreme temperatures according to internal test methods. Tip bend inspection at extreme temperature according to internal test methods. Biocompatibility assessment per ISO 10993-1: 2009 Accelerated Aged (per ISO F1980-16) shelf life testing per internal test method assessments for coating and tip bend inspections."
• "All tests passed the pre-determined acceptance criteria."

Since this is a catheter and not a diagnostic device or an AI/ML algorithm-based device, the concepts of human reader improvement with AI, standalone algorithm performance, and expert ground truth establishment for diagnostic accuracy are not applicable to this 510(k) submission.

Therefore, I cannot populate the requested table and information as it pertains to a clinical efficacy study or AI/ML performance evaluation. The document focuses on demonstrating physical and material equivalence through non-clinical testing.

Ask a specific question about this device