Search Results

Latex Foley Catheter is inserted into the bladder through urethra and are indicated for routine urine drainage or for routine post-operative drainage and bladder irrigation.

The Latex Foley Catheter is inserted through the urethra during urinary catheterization and goes into the bladder for urine drainage or irrigation. It consists of a shaft, a drainage funnel, an inflation funnel, an irrigation funnel (if present), a balloon and a valve. The device is made from latex with silicone coating and available in different types (e.g., straight, Tiemann, female etc.) and sizes for adult and pediatric use.

This document is a 510(k) premarket notification for a medical device: the Wellead® Latex Foley Catheter. It is not an AI/ML device, therefore, the information requested in your prompt regarding AI/ML acceptance criteria and studies (e.g., sample sizes for test and training sets, number of experts for ground truth, MRMC studies, standalone performance) is not applicable.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K082815, also a Well Lead Latex Foley Catheter) through nonclinical testing.

Here's an analysis of the provided text in the context of your request, highlighting what is and isn't present:

Not Applicable for this document: The device in question is a physical medical device (Foley catheter), not an AI/ML software or a device that uses AI/ML. Therefore, criteria and studies related to AI/ML device performance (like the number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details, or effect size of AI assistance) are not found in this type of 510(k) submission.

Here's what can be extracted from the document regarding acceptance criteria and performance for this physical device:

1. Acceptance Criteria and Reported Device Performance

The document states that all pre-determined acceptance criteria were met for the nonclinical tests. While specific numerical acceptance criteria (e.g., "flow rate must be >X mL/min") are not explicitly listed in this summary, the types of tests conducted and their successful completion imply meeting such criteria.

Note: The document only states that the acceptance criteria were "met" for all tests. It does not provide the specific numerical results or the exact numerical thresholds for each acceptance criterion. This is typical for a 510(k) summary, as detailed test reports are part of the full submission but not usually included in the public summary.

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

The document describes nonclinical bench testing. It does not specify sample sizes for these tests, nor does it refer to "test sets" in the context of patient data for AI/ML validation.

• Test Set Sample Size: Not specified. (The tests are done on physical catheter samples, not on a dataset of patient images/records.)
• Data Provenance: Not applicable in the context of patient data for AI/ML. The "data" are measurements from bench testing of the physical device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. Ground truth for a physical device's performance (e.g., flow rate, balloon integrity) is established through standardized engineering and laboratory testing protocols, not through expert human review of data.
• Qualifications of Experts: Not applicable. The validation relies on the expertise of engineers and lab technicians performing tests according to recognized standards (ASTM, ISO, BS EN).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human subjective assessment of "truth" that requires adjudication for these nonclinical performance tests.

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

• MRMC Study: No. This is a physical device, not an AI-assisted diagnostic tool for which MRMC studies would be relevant.

6. Standalone Performance

• Standalone Performance: Yes, in a sense. The "standalone" performance here refers to the physical device's performance determined through bench testing (e.g., flow rate, balloon integrity) without human intervention in the device's function or the test outcome. It is not "standalone algorithm performance" as it would be for an AI device.

7. Type of Ground Truth Used

• Ground Truth Type:
  • Engineering/Physical Measurements: The ground truth for the device's performance characteristics (e.g., flow rate, balloon volume, resistance to rupture) is established by using calibrated instruments and standardized methods to measure these physical properties.
  • Compliance with Standards: The "ground truth" for regulatory acceptance is that the device's performance measurements fall within the specified limits defined by international standards (e.g., ASTM F623-19, BS EN 1616:1997) and the manufacturer's own pre-determined acceptance criteria.
  • Biocompatibility: Demonstrated through specific assays and tests as per ISO 10993-1.
  • Sterilization: Validated against a standard (ANSI/AAMI/ISO 11135:2014) to confirm sterility.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

Ask a specific question about this device

The Bardex® I.C. latex Foley catheter is indicated for use in the drainage and/or collection, the The Dardes .. Online. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes calleter through the "drethra" and "into" the "bladen" "Hower, such as nephrostomy tract.

The Bard® Bardex® I.C. latex Foley catheter is a two-way Foley catheter which is placed in the bladder through the urethra. The balloon on the distal end of the catheter is inflated with sterile water after insertion and used to secure the catheter in place and ensure that the opening in the distal tip of the catheter is positioned correctly to allow for urine drainage. The urine drains out through the catheter into a collection device attached to the catheter.

The provided 510(k) summary for the Bardex® I.C. Latex Foley Catheter focuses on substantial equivalence to a predicate device based on its intended use, general design, and fundamental scientific technology. It does not present a study with specific acceptance criteria and detailed device performance metrics in the manner typically associated with studies for a medical imaging AI/ML device.

Instead, the submission states:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document mentions "The Bardex® IC latex Foley catheter was tested in accordance with the relevant standards for function and biocompatibility." but does not elaborate on these standards, acceptance criteria, or specific performance outcomes.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no such test set or study details are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no ground truth establishment for a test set is discussed.

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, as this is a medical device for drainage/collection, not an AI/ML imaging device requiring human reader interaction.

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 concensus, 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.

In summary, this 510(k) pertains to a physical medical device (Foley catheter) and its clearance is based on demonstrating substantial equivalence to a predicate device through adherence to relevant standards for "function and biocompatibility." It does not involve the type of performance study (with acceptance criteria, test sets, ground truth establishment, etc.) that would be conducted for an AI/ML diagnostic or prognostic device.

Ask a specific question about this device

Hydrophilic-Antibacterial Intermittent Catheter is intended for urological use only. The Hydrophilic-Antibacterial Intermittent Catheter is intended for urinary bladder drainage in the management of incontinence, neurogenic bladder dysfunction, and surgical procedures in adult males and females requiring catheterization. Efficacy of the Hydrophilic-Antibacterial Intermittent Catheter in preventing urinary tract infection during intermittent use has not been shown. It is not intended as a treatment for active urinary tract infection.

Intermittent Catheter Closed System Kit is intended for use by patients for the purpose of bladder drainage.

The Hydrophilic-Antibacterial Intermittent Catheter consists of a hydrophilic and antibacterial coated single lumen catheter with either two or four drainage eyes on the proximal tip. It is constructed from medical grade elastomers.

The Intermittent Catheter Closed System Kit consists of a single lumen urethral catheter (Hydrophilic-Antibacterial Intermittent Catheter, Hydrophilic Personal® Catheter K000723, or Antibacterial Personal® Catheter K001143) in a closed system-in-a-bag configuration with an introducer tip and insertion supplies.

Here's an analysis of the provided text to complete the request:

Acceptance Criteria and Study for Rochester Medical Corporation's Urological Catheter and Accessories

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily through showing similar technological and performance characteristics, and biocompatibility testing. It doesn't present specific quantitative acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, accuracy for a diagnostic device) or provide a study demonstrating a direct comparison against such criteria for the Hydrophilic-Antibacterial Intermittent Catheter or the Intermittent Catheter Closed System Kit.

Instead, the "acceptance criteria" can be inferred from the regulatory pathway: proving substantial equivalence through comparison with existing legally marketed devices and demonstrating that the new device does not raise new questions of safety or effectiveness. The "study" in this context refers to the biocompatibility testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility Testing: The document provides details on the methods used for biocompatibility testing but does not specify the sample sizes for each test (e.g., how many cells for cytotoxicity, how many animals for in-vivo tests).
• Data Provenance: The biocompatibility tests are laboratory-based, performed by Rochester Medical Corporation. The document does not indicate country of origin for patients or animals, nor does it classify the data as retrospective or prospective clinical data, as this is pre-market testing.

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

This type of information is not applicable to this 510(k) submission. Biocompatibility testing relies on standardized laboratory protocols (e.g., ISO and USP standards) rather than expert interpretation of clinical ground truth in the way a diagnostic device might require. The "ground truth" for these tests is the outcome of the biological assay itself based on predefined criteria (e.g., cell viability, presence of irritation, mortality).

4. Adjudication Method for the Test Set

This is not applicable. The biocompatibility tests follow standardized, objective laboratory methods. There is no mention of a human adjudication process for interpreting these test outcomes beyond the standard analysis and reporting by the testing personnel.

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

No, an MRMC comparative effectiveness study was not done. This device is a urological catheter, not a diagnostic imaging device typically associated with AI assistance or human reader studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a medical product (catheter), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's safety (biocompatibility) and performance (similarity to predicates) relies on:

• Standardized Laboratory Protocols and Results: For biocompatibility, the truth is established by the factual biological outcomes of in-vitro and in-vivo tests as per ISO and USP standards.
• Engineering and Material Specifications: For technological equivalence, the ground truth is established by comparing the physical, material, and design specifications of the new device against those of legally marketed predicate devices.

8. The Sample Size for the Training Set

There is no mention of a training set in this context. Training sets are relevant for machine learning algorithms or complex diagnostics, not for the submission of a physical medical device like a catheter seeking 510(k) clearance based on substantial equivalence and biocompatibility.

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

This question is not applicable as there is no training set mentioned or implied in the provided document.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The Bardex I. C. Pediatric Foley Catheter is intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

The Bardex I. C. Pediatric Foley Catheter is a two-way latex Foley catheter with silver and hydrogel coatings.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (Bardex I.C. Pediatric Foley Catheter), which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies with acceptance criteria.

The "Performance Data Summary" section explicitly states: "The Bardex I.C. Pediatric Foley Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those Foley catheters currently manufactured. Performance and functional testing standards are based on the FDA draft 'Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters'' dated September 12, 1994."

This indicates that the submission relies on adherence to existing standards and specifications, implying that specific, new performance studies with acceptance criteria were not part of this 510(k) filing for demonstrating equivalence to predicate devices. Therefore, I cannot provide the requested information from the given text.

Ask a specific question about this device

The Bardex® Lubri-Sil™ I.C. Foley Catheter is indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostasis following surgery such as transurethral resection of the prostate.

The Bardex® Lubri-Sil™ I.C. Foley Catheter is a two-way all-silicone Foley catheter with silver and lubricious hydrophilic coatings.

The Bard Lubri-Sil I. C. Foley Catheter is constructed of high grade extruded clear silicone rubber with a molded tip and funnel. It is a twolumen catheter with a drainage lumen and an inflation lumen with two-way valve. A silver coating and then a hydrophilic polymeric coating are applied to the finished catheter. The hydrophilic coating becomes very slippery when wet. The silver coating discourages bacterial adhesion to the catheter surface. The Lubri-Sil I.C. Foley Catheter is available in even shaft sizes 12-24 Fr. with a 5cc balloon and in even shaft sizes 16-24 Fr. with a 30cc balloon.

I am unable to answer your request with the provided information. The text describes a medical device, the Bardex® Lubri-Sil™ I.C. Foley Catheter, its intended use, technological characteristics, and performance data. It also includes an FDA 510(k) clearance letter.

However, the provided text does not contain the specific details required to complete the table and answer all the questions in your prompt, particularly regarding "acceptance criteria" versus "performance requirements," sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established if it were a diagnostic AI device.

The document details performance requirements and states the device "meets" them, but these are not explicitly presented as "acceptance criteria" with numerical targets and reported device performance values in a comparative table as requested. It also describes "performance data" and "testing" but lacks the granular information about study design, sample sizes, and ground truth establishment typically associated with the type of request you've made for an AI/diagnostic device.

The provided document describes a Foley Catheter, which is a physical medical device for drainage, not a diagnostic AI device that would typically have "test sets," "training sets," "ground truth," "experts," or "MRMC studies" in the context you've outlined.

Therefore, to answer your request accurately, I would need a different type of document that describes the acceptance criteria and study detailed for a diagnostic AI device, rather than a physical medical device like a Foley Catheter.

Ask a specific question about this device

The Bardex I. C. 4-Way Foley Catheter is indicated for use in bladder/urinary tract drainage/irrigation and to assist in hemostasis and surgical site drainage following procedures such as transurethral resection of the prostate.

The Bardex I. C. 4-Way Foley Catheter is a new catheter design incorporating the addition of a fourth lumen for prostatic drainage and the addition of several prostatic drainage eyes proximal to the balloon.

The provided text is a 510(k) summary for the Bardex I. C. 4-Way Foley Catheter, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study involving experts, AI, or controlled ground truth assessment.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this specific document. The document highlights the technological characteristics and intended use of the device and compares them to existing predicate devices. It states that performance and functional testing standards are based on a "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters."

Here's an attempt to answer the questions based on the available information, noting where information is not present:

Acceptance Criteria and Device Performance Study Information

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria with corresponding performance metrics in the format of a clinical or performance study. Instead, it focuses on qualitative and structural characteristics compared to predicate devices for substantial equivalence.

Note: The document states "Performance and functional testing standards are based on the 'Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters' dated September 12, 1994." However, the results of these tests, specific acceptance criteria, or a detailed study report are not included in this summary.

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

This document does not describe a clinical or performance test set for evaluating the device against acceptance criteria in the manner typically associated with AI/software device evaluation. It focuses on device characteristics for regulatory submission.

• Sample Size: Not applicable/Not provided in this summary.
• Data Provenance: Not applicable/Not provided in this summary.

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

This document does not describe a process for establishing ground truth using experts, as it's not a study evaluating diagnostic or prognostic performance requiring expert interpretation.

• Number of Experts: Not applicable/Not provided.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

Not applicable, as no expert-adjudicated test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned as this is not an AI/diagnostic imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a physical medical device (catheter), not an algorithm or software.

7. The Type of Ground Truth Used

Not applicable in the context of device performance claims based on this 510(k) summary. The "ground truth" here is the physical and functional specifications of the device itself and its comparison to legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable, as this is a physical medical device and not an AI or machine learning algorithm.

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

Not applicable.

Ask a specific question about this device

The Silicone Antibacterial Foley Catheter is intended for short term use to provide continuous urinary bladder drainage in adult males and females requiring catheterization for surgical procedures, monitoring uring output, management of incontinence, and voiding dysfunction. The catheter has been shown to provide a statistically significant redution in the incidence of catheter acquired bacterial urinary tract infection during the first 5 days of catheterization. This device is not intended to be used as a treatment for active urinary tract infection.

The catherer consists of a standard configuration Foley catheter with a drainage lumen that exits through two drainage eyes on the proximal end. A retention balloon is located near the proximal catheter tip. The retention balloon is filled thru a second lumen with a Luer valve that extends from a side arm on the distal end of the catherer to the balloon. The catherer is coated with nitrofurazone impregnated siliconc on the outside surface and inner lumen. It is available in 12, 18 and 20 Fr sizes. All French sizes are provided in a 16 inch length with a 5 or 10 cc size balloon.

Here's a breakdown of the acceptance criteria and study information for the Rochester Medical Corporation Silicone Antibacterial Foley Catheter, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

• Statistically significant difference in actuarial survival curves for time until CAUTI between the two groups (p = 0.007, Kaplan-Meier survival, Breslow logrank statistic) for the first 5 days of use. |
  | Material Biocompatibility | Passed Cytotoxicity, USP Systemic Toxicity, Subchronic Toxicity, Intracutaneous Injection, Muscle Implant Study, Sensitization Study, Pyrogenicity, and Hemolysis. |
  | Mutagenicity | Some mutagenic changes indicated (Note: This is a reported finding, not explicitly stated as an "acceptance criterion" that was passed, but part of the testing results). |
  | Antibacterial Activity (In-vitro) | Nitrofurazone-impregnated catheter segments showed antibacterial activity against clinical isolates of uro-pathogens including Coagulase-negative staphylococci, S. aureus, Enterococcus spp., C. Minutissimum, E. Coli, Enterobacter spp., and Klebstella spp. |
  | Conformity to Standards | Meets the requirements of ASTM 623-89 Standard Specification for Foley Catheters. |
  | Elution Profile & Bacteriocidal Levels | Elution profile reproducible, and antibacterial agent released at bacteriocidal levels. |
  | Material Degradation with Aging | No evidence of degradation with aging. |

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

• Sample Size: A total of 344 patients were enrolled in the clinical trial.
• Data Provenance: The study was a "single site randomized, double-blind, controlled clinical trial." This indicates it was a prospective study. The country of origin is not explicitly stated, but given the 510(k) submission to the FDA (USA), it is highly probable the study was conducted in the USA.

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

• The document does not explicitly state the number of experts or their qualifications used to establish the ground truth (diagnosis of CAUTI) for the clinical trial. Clinical trials usually rely on defined diagnostic criteria and sometimes independent clinical adjudication committees, but this specific detail is not provided.

4. Adjudication Method for the Test Set

• The document does not explicitly describe an adjudication method for the diagnosis of CAUTI in the clinical trial. It was a "double-blind" study, meaning neither the patients nor the clinicians administering the treatment knew which type of catheter was being used, which helps reduce bias in assessing outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This study was a clinical trial comparing the device to a conventional catheter in human patients, not a study evaluating human readers' diagnostic performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes, a standalone study was done, in the sense that the device itself (the catheter) was tested for its inherent antibacterial properties in an in-vitro capacity and its clinical effectiveness without direct human interaction. The "algorithm" in this context is the inherent antibacterial mechanism of the device.
  • In-vitro studies specifically showed the antibacterial activity of the nitrofurazone-impregnated catheter segments against various uro-pathogens. This is a standalone performance assessment of the device's mechanism.

7. The Type of Ground Truth Used

• For the clinical trial, the ground truth was clinical outcomes data, specifically the "incidence of catheter associated urinary tract infection (CAUTI)." This would have been determined through clinical diagnosis based on established medical criteria (e.g., urine culture results, clinical symptoms).

8. The Sample Size for the Training Set

• This device is a physical medical device (catheter) with an antibacterial coating, not an AI or software-based device that explicitly requires a "training set" in the machine learning sense. Therefore, the concept of a "training set" is not applicable to this submission. The "training" for the device's performance is embedded in its manufacturing process and design, not in a data-driven training regimen.

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

• As explained above, the concept of a "training set" for an AI algorithm is not applicable to this physical medical device.

Ask a specific question about this device