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This device is intended to measure/ display collected urine volume. It detects fill level and temperature.

iBag™ is a urine management system that includes bladder and temperature measurement for catheterized patients who desire to be fully mobile. · iBag™ provides accurate, real-time assistive data. It does this through use of a calibrated drainage bag integrated with a Future Path Medical sensor, a base transmitter unit called Wi-Mitter™ for wireless transmission of urine bag fill and bladder temperature information. Once the Wi-Mitter™ is snapped in place, the container is polled and the measurement of fluid level begins and this data is then transmitted to the patient, the care provider (an aid) a family member, or even to the hospital's base station. Data is transmitted via traditional data networking and may be interpreted and displayed on a user's laptop computer, and other types monitors. Since the data from the Wi-Mitter™ is time and date stamped, time of fill level may be automatically calculated, noted and threshold values used for fill level alarming.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study conducted for the iBag™ Urine Management System:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The predicate device's specifications for volume accuracy and temperature range are used as a proxy for acceptance criteria where the iBag™ device states "SAME" or explicitly meets/exceeds them. For other tests, the text indicates that the testing was "successfully conducted" or that the device meets the respective standard.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: The document does not specify the sample sizes for the "Fill level accuracy" or "Temperature measurement accuracy" tests, nor for the "User Feedback Study" or "Simulated Use Testing."
• Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. It only states that "Bench and test laboratory results indicate that the new device is as safe and effective as the predicate device" and lists the tests conducted.

3. Number and Qualifications of Experts for Ground Truth

The document does not provide any information about the number or qualifications of experts used to establish ground truth for any of the tests.

4. Adjudication Method for the Test Set

The document does not specify any adjudication methods for the test set.

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

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done, or any effect size related to human readers improving with or without AI assistance. This device is not an AI-based system.

6. Standalone Performance (Algorithm Only)

The document primarily focuses on the device's mechanical and electronic performance, not on an algorithm's standalone performance. It states that "iBag™ provides accurate, real-time assistive data" and "Software is designed to be used with little or no training," but does not detail an algorithm's standalone performance separate from the hardware.

7. Type of Ground Truth Used

Based on the provided information, the ground truth for volume and temperature accuracy would likely be established through:

• Reference measurements: Using highly accurate, calibrated instruments to measure actual urine volume and temperature.
• Bench testing: Controlled laboratory conditions for precise measurements.

For other tests like electrical safety, EMC, leak testing, and sterility, the ground truth would be defined by the relevant industry standards (e.g., IEC 60601-1, IEC 60601-1-2) and their specific test protocols.

8. Sample Size for the Training Set

No information is provided about a "training set" as this device is not an AI/ML-based system requiring a training phase in the typical sense. The testing described is for performance validation, not algorithm training.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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The UrAssist system is intended for the non-invasive, non-sterile collection of urine.

UrAssist is a portable urine collection unit which utilizes a battery-operated pump-assisted technology to drain the urine from a collection cup through a plastic tube and into a collection bag that stores a day's amount of urine.

The provided text describes the UrAssist system, a urine collection unit. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way one might expect for a typical medical device with quantitative performance metrics.

Instead, the document is a 510(k) summary for a Class I device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than rigorous performance goal attainment through clinical studies with defined endpoints.

Here's a breakdown of what is and is not in the document, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document as quantitative acceptance criteria with corresponding performance metrics. The document states compliance with general safety and electrical standards and non-clinical testing.

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

• Not specified. The document mentions "in-house testing" and non-clinical studies (biocompatibility, EMC, electrical safety) but does not provide details on sample sizes, methodologies, or data provenance for any specific test set.

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

• Not applicable/Not specified. This document describes a 510(k) submission for a urine collection device, not an imaging or diagnostic AI device where expert ground truth for test sets is typically established. The "testing" referred to is about engineering and material safety, not diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. See point 3.

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

• No. An MRMC study is not mentioned as this device is a physical urine collection unit, not a diagnostic imaging or AI-assisted interpretation tool where reader performance is evaluated.

6. Standalone (Algorithm Only) Performance Study

• No. This is not an algorithm-based device.

7. Type of Ground Truth Used

• Given the nature of the device (a urine collector), the "ground truth" for the tests mentioned (biocompatibility, EMC, electrical safety) would likely be engineering specifications, material standards, and regulatory compliance requirements rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

• Not applicable/Not specified. This is not an AI or machine learning device that requires a training set.

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

• Not applicable. See point 8.

In summary: The provided document is a 510(k) summary for a Class I medical device (urine collector). Its purpose is to demonstrate substantial equivalence to a predicate device, primarily through non-clinical testing for safety, EMC, and biocompatibility, as well as describing its functional characteristics. It does not include the detailed performance study information with explicit acceptance criteria, sample sizes, and expert review often associated with more complex medical devices, especially those incorporating AI or diagnostic functions.

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The Advanced Urological Catheter is used to pass fluids to or from the urinary tract.

Not Found

This document is a 510(k) clearance letter for the "Advanced Urological Catheter" by EntraCare LLC. It details the regulatory approval process but does not contain information regarding
acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific study-related details requested.

Therefore, I cannot provide the requested information from the given text.

The document primarily focuses on:

• The product name and applicant.
• The regulatory classification and product codes.
• Confirmation of substantial equivalence to a legally marketed predicate device.
• General regulatory requirements the manufacturer must adhere to.
• The intended use of the device: "The Advanced Urological Catheter is used to pass fluids to or from the urinary tract."

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The OPTION-vf is intended to provide drainage of the urinary bladder.

The OPTION-yf is indicated for use only for urinary bladder drainage in female patients: 1) who have acute conditions that require short-term (14 days or less) urinary management; 2) who are capable of operating the device in accordance with its instructions for use; and 3) for whom normal bladder cycling is not contraindicated.

The OPTION-yf is an indwelling catheter that provides drainage of the urinary bladder. It is a sterile, single-use, disposable device that is to be prescribed by a physician and inserted and removed by an appropriate health care professional. The device is composed of biocompatible silicone elastomers, and consists of: a flexible shaft with two opposing eyelets in the proximal tip for urine entry, one internal lumen for urine drainage and a second lumen for balloon inflation; a retention balloon; an adjustable retainer ring; a self-sealing balloon inflation microvalve port; and a urine discharge bulb with integral valve. The catheter may be used with the Continuous Drainage Adaptor accessory to provide continuous urinary drainage.

The provided text describes the OPTION-vf™ Urinary Catheter with Adaptor and its 510(k) summary for clearance. However, it does not contain the detailed acceptance criteria, the study design, or the specific performance metrics typically associated with proving a device meets acceptance criteria in the way a diagnostic AI/ML device would.

The document primarily focuses on establishing substantial equivalence to predicate devices based on device description, intended use, and materials. The "Supporting Information" section briefly mentions "verification test results" but does not elaborate on what these tests were, their acceptance criteria, or the results.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be generated. The document does not specify quantitative acceptance criteria or reported performance metrics for the device. It states, "A risk analysis for the OPTION-yf with adaptor and the verification test results reported in this 510(k) application substantiate equivalence to the predicate devices." This is a general statement, not a detailed report of criteria and results.

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 / Not provided. The text does not describe a clinical study in the typical sense with a "test set" of patients or data for performance evaluation. The "verification test results" mentioned are likely engineering or bench tests, not clinical performance studies with patient data.

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 / Not provided. No "test set" and thus no ground truth established by experts is mentioned.

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

• Not applicable / Not provided. No "test set" is described.

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 / Not provided. This device is a urinary catheter, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable / Not provided. This is a physical medical device, not an algorithm.

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

• Not applicable / Not provided. No ground truth for clinical performance is mentioned. The "equivalence" is based on device design, materials, and intended use compared to predicates.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established

• Not applicable / Not provided. As there is no training set, there is no ground truth for it.

Summary based on the provided text:

The document describes the OPTION-vf™ Urinary Catheter with Adaptor and its submission for 510(k) clearance by Opticon Medical. The primary method for proving the device meets regulatory requirements is through substantial equivalence to existing predicate devices (K023090 OPTION-vf™ Urinary Catheter, K760093 Bardex® Silicone Foley Catheter, and BARD® Adaptor and Tubing).

The claim of substantial equivalence is supported by:

• Device Description: The OPTION-vf™ is an indwelling, sterile, single-use, disposable silicone catheter with a flexible shaft, eyelets, lumens, a retention balloon, an adjustable retainer ring, a self-sealing balloon inflation microvalve port, and a urine discharge bulb with an integral valve. The adaptor allows for continuous drainage by holding the valve open.
• Intended Use: Drainage of the urinary bladder in female patients for acute, short-term (≤14 days) conditions, who can operate the device, and for whom normal bladder cycling is not contraindicated.
• Comparison to Predicate Device: The OPTION-vf™ with the adaptor functions similarly to typical continuous drainage Foley catheters (like the Bardex® Silicone Foley Catheter) by providing continuous drainage when the adaptor holds the discharge valve open.
• Supporting Information: A risk analysis and "verification test results" are stated to "substantiate equivalence." However, the details of these tests, their specific acceptance criteria, and the reported results are not provided in this summary.

Conclusion stated: The OPTION-vf™ urinary catheter with adaptor is substantially equivalent to the predicate devices and does not raise any new questions of safety or efficacy.

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The basics of the intended use has not changed. The Maersk Medical 4L drainage bag continue to be intended for collection of fluid which is on its way away from the body. The 4L drainage bag can be used in different treatment procedures within areas as urology and dialysis, but in any case the intended use is the same. The device label will state the following: A: "Peritoned Dialysis Drainage bag" B: "Collection bag fer urine"

The general description, operation, construction and use of the Maersk Medical 4L drainage bag has not changed as a result of the modifications. The 4L drainage bag contains basically the same features as the device described in K843480 and the manufacturing process is identical. However the 4L drainage bags will hold 4000 ml. compared to 2000 ml. for the device described in K843480. On a few points features has been added to the 4L drainage bag, but they are all added to improve patient and healthcare personnel comfort.

The provided text describes a 510(k) premarket notification for a medical device, specifically a 4L drainage bag. The core of this submission is to demonstrate substantial equivalence to an existing legally marketed predicate device (K843480), rather than establishing new performance criteria through a detailed clinical study.

Therefore, the input requests for acceptance criteria, study details, and related metrics often found in a de novo or PMA submission are not directly applicable in the same way for this 510(k). The "performance data" mentioned focuses on demonstrating equivalence to the predicate, not on setting and meeting new, specific performance thresholds against a defined clinical outcome.

Here's an analysis based on the provided text, addressing the requested points where information is available or noting when it's not applicable in the context of a 510(k) for substantial equivalence:

Description of Acceptance Criteria and Study to Prove Device Meets Them

The Maersk Medical 4L drainage bag's acceptance criteria and the "study" to prove it meets them are primarily framed around demonstrating substantial equivalence to a previously cleared predicate device (K843480). This means the acceptance criteria are implicitly that the 4L drainage bag performs at least as safely and effectively as the predicate device for its intended use, despite minor modifications (increased volume and added comfort features). The "study" largely consists of functional and quality testing to support this claim of equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for substantial equivalence, the "acceptance criteria" are not explicitly quantitative performance metrics in the way one might see for a novel device. Instead, they relate to maintaining the functional and quality characteristics of the predicate.

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

The document does not specify a "test set" in the context of a clinical trial or large-scale data analysis. The "performance data" mentioned refers to functional and quality testing, which typically involves a sample of manufactured devices. The specific sample size for these engineering tests is not provided.

• Data Provenance: The testing would have been conducted by Maersk Medical A/S in Denmark (manufacturing facility location). The data is retrospective in the sense that it evaluates the modified device's performance against the established performance of the predicate device, and prospective in that the specific tests were conducted on the newly manufactured 4L bags.

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

Not applicable or not specified in this 510(k) submission. "Ground truth" in the context of expert consensus or clinical diagnosis is not relevant for demonstrating substantial equivalence of a drainage bag. The "ground truth" here is the established safety and effectiveness of the predicate device, as determined by the FDA during its original clearance. The "experts" involved would be the engineers and quality assurance personnel at Maersk Medical conducting the functional and quality tests.

4. Adjudication Method for the Test Set

Not applicable or not specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their discrepancies need to be resolved. This is not the type of study presented for this device.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are used to evaluate diagnostic systems, often AI-assisted, and are not relevant for a drainage bag that collects fluid.

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

Not applicable. This device is a passive medical device (a drainage bag), not an algorithm or an AI-enabled system. There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the established safety and effectiveness profile of the predicate device (K843480). The modifications to the 4L drainage bag are demonstrated to align with this established profile through functional and quality testing. There is no clinical "ground truth" (e.g., pathology, clinical outcomes) generated for this specific submission, as it relies on the predicate's clearance.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning or AI for this device.

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

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To collect urine to provide assistance for male urinary incontinence. This device is intended for non-prescription use and it is re-usable after cleaning and washing. It is intended for non probanpuen ass annected to an indwelling catheter. This device is not designed for pediatric use.

Not Found

The provided document describes a 510(k) submission for a medical device: "Bouser's Urinal". This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It also includes the intended use statement for the device.

Therefore, I cannot provide the requested information based on this document.

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The Conveen® EasiCath Set is indicated for use by patients for intermittent catheterization for the purpose of bladder drainage.

The Conveen® EasiCath Set is a single use, disposable system that consists of a sterile polyvinylchloride intermittent catheter, coated with polyvinvlovrrolidone, and a sterile saline solution ampoule all sealed in a urine collection bag. The user twists open the saline ampoule inside the bag and soaks the catheter for 30 seconds. Once wet, the polyvinylpyrrolidone layer binds water molecules to the surface of the catheter creating a smooth lubricating film. The bag is opened and the catheter is inserted into the patent's urethra. The catheter itself is the same design and materials as our current non-coated Conveen® Intermittent Catheters, K896729.

Here's a breakdown of the acceptance criteria and study information for the Conveen® EasiCath Set, derived from the provided 510(k) summary:

This device appears to be primarily a catheter system and the "acceptance criteria" and "studies" are focused on biocompatibility and safety of its components, rather than a performance study measuring clinical outcomes or diagnostic accuracy which would typically involve human readers or ground truth as seen in AI/imaging devices.

Therefore, many of the requested fields regarding AI/human reader performance, ground truth establishment, and sample sizes for training/test sets are not applicable to this type of device and its submission.

Acceptance Criteria and Reported Device Performance

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The FemAssist™ is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).

The FemAssist™ device is a small (3.5cm in diameter) cylindrical device with a short profile (2.0cm in height) designed and constructed (molded) to fit over the female urethra, between the labia, posterior to the clitoris and anterior to the vagina. The FemAssist™ supports and reinforces the natural action of the muscles that control urine output and prevents accidental urine loss. The female urethra is located between the vagina and the clitoris, in the center of the area about 3cm in diameter. The FemAssist™ product is place by it's own mild vacuum action.

Here's a breakdown of the acceptance criteria and study information for the FemAssist™ Urinary Incontinence Device, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Clinical Efficacy Test Set: Data from 73 women from one clinical site.
   • Clinical Safety Test Set: 222 women initially enrolled. 138 patients were followed for at least 30 days. Data was collected at three (3) US sites.
   • Data Provenance: United States (US sites), prospective clinical study.

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

   • The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study. The effectiveness measure (pad weight test) and adverse event reporting would likely have involved clinical personnel (doctors, nurses) at the study sites, but their specific roles in "ground truth establishment" are not detailed.

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

   • The document does not describe any specific adjudication method for the clinical test set data. Adverse events were "obtained from voiding diaries and physician visits," and pad weight tests are objective measurements.

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:

   • This was not an AI-based device, nor was it a multi-reader, multi-case study. It's a medical device for urinary incontinence.

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

   • This question is not applicable as the device is a physical, external medical device and not an algorithm or AI system. Its performance is tested entirely standalone (device only) as it's designed to be used by the patient without the need for human intervention or interpretation beyond initial fitment and instructions.

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

   • Clinical Effectiveness: Objective measurements - urine leakage measured by the change in pad weight (standardized one-hour pad weight test) and patient self-reported dryness days from voiding diaries.
   • Clinical Safety: Patient self-reported adverse events (from voiding diaries) and physician observations during visits.
   • Biocompatibility/Benchtop: Pass/fail criteria established by recognized standards (NAmSA, USP) for laboratory tests.

7. The sample size for the training set:

   • The concept of a "training set" is not applicable here as this is a physical medical device, not a machine learning model.

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

   • Not applicable (see point 7).

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As a disposable, single use Female External Urinary Collection Pouch, it is intended to collect urine and assist in directing it away from the body.

Mediquest, Inc.'s Female External Urinary Collection Pouch

This set of documents describes an FDA clearance for a "Female External Urinary Collection Pouch" manufactured by Mediquest, Inc. The documents are from 1997. Due to the age of the document and the nature of the device (a simple collection pouch), the level of detail regarding device performance studies is very limited and does not align with the typical requirements for describing AI-powered medical devices as outlined in your prompt.

Based on the provided text, I can extract the following:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific performance metrics. The FDA clearance is based on a determination of "substantial equivalence" to a predicate device. This implies that the device meets the same performance and safety standards as the predicate, but those specific standards are not detailed here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. For a device like a urinary collection pouch from 1997, a formal "test set" in the context of an AI study would not have been conducted. The substantial equivalence determination likely relied on existing data for the predicate device and potentially limited in-house testing by the manufacturer.

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)

This information is not provided. Ground truth establishment for a simple, non-AI device is not relevant in this context.

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

This information is not provided as it's not applicable to this type of device and submission.

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 such study was conducted or mentioned. This device is not AI-powered.

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

This is not applicable, as the device is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This is not applicable. The device is a physical product, and its effectiveness is determined by its ability to collect urine, likely evaluated through basic functional testing or comparison to similar existing products.

8. The sample size for the training set

This information is not provided and is not applicable, as this is not an AI device.

9. How the ground truth for the training set was established

This information is not provided and is not applicable, as this is not an AI device.

In summary: The provided documents pertain to a pre-AI era medical device (a female external urinary collection pouch) that received FDA clearance based on "substantial equivalence" to a predicate device. Therefore, the detailed requirements for AI device studies (acceptance criteria, test sets, ground truth, expert involvement, etc.) are entirely absent from these brief regulatory letters.

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1. For Penile Attachment Only
2. Non-indwelling Urinary Continence Aid
3. Management of Urinary Incontinence
4. Urine Collection Device

The ZIP™ Condom Catheter has four basic elements: 1) the condom/sheath with integral urine collection compartment; 2) the Velcro-like band and support strap; 3) the Application ring; and 4) the specially designed male underpants brief.

The condom/sheath with integral urine collection compartment forms a bulbous tube approximately 10 ½ inches long. The tube is divided into two sections, the condom/sheath and the urine collection compartment. Non-return flow valves separate the condom/sheath portion from the urine collection compartment. The distal end of the urine collection compartment is affixed with a twist-open twistclosed stop-cock drain valve. The urine collection capacity is approximately 450 ml. Typical human urine output thus yields a time related capacity of about 4 to 6 hours.

A series of 4 sizes differing in sheath diameter and length will be offered. Specific name designators for the sizes are vet to be determined.

Design: The ZIP™ Condom Catheter expands upon existing male urine continence devices by first approaching the device as a "total" or "system" concept rather than just a collection of items originally developed for other urine collection purposes.

Only the essential elements of the ideal male urine continence system were considered. First, the system had to be easy to apply and use. Second, it should allow use of traditional male urination methods, i.e., the stand-up urinals found in public restrooms. Third, the system should be small enough to go unnoticed during the typical activities of daily living. Fourth, the system should have adequate capacity so that urine disposal intervals are not unreasonably short. Lastly, the system should be reusable and easily cleaned and sanitized.

This is a natural latex containing product. The ZIP™ Condom Catheter is made from the exact same natural latex formulation as the Everyday - Self-Adhesive Urinary External Catheter made by Hollister. Inc. The use of pure latex to construct the ZIP™ Condom Catheter requires the inclusion of certain FDA required cautionary statements. Latex containing devices must legibly bear an appropriate allergic reaction statement on the device labeling. In conformance with this FDA requirement, Goulter Medical, Inc. attaches a label containing the following cautionary statement to the device. "This product is made from natural rubber latex which may cause allergic reactions in some individuals".

The provided text describes a 510(k) premarket notification for the ZIP™ Condom Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The submission aims to show that the new device is as safe and effective as existing ones by comparing its materials, intended use, design, and method of operation.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. The 510(k) process for this device relies on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantifiable performance acceptance criteria from a clinical trial in the way a novel diagnostic would. The "performance" being evaluated is primarily the functional equivalence to existing devices.

2. Sample sized used for the test set and the data provenance

• Not Applicable. There is no mention of a formal "test set" or clinical study with patient data used to directly evaluate the ZIP™ Condom Catheter's performance. The comparison is against predicate devices based on their established characteristics.

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

• Not Applicable. No experts were used to establish ground truth for a test set as no such study was conducted or detailed in this submission.

4. Adjudication method for the test set

• Not Applicable. No test set or adjudication method is mentioned.

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. This device is a physical medical device (condom catheter), not an AI diagnostic or assistance system. Therefore, no MRMC study or AI-related effectiveness is relevant or mentioned.

6. 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.

7. The type of ground truth used

• Not Applicable / Implied Equivalence. For a 510(k) for this type of device, the "ground truth" is that the predicate devices are considered safe and effective for their intended use. The new device demonstrates substantial equivalence to these established predicate devices.

8. The sample size for the training set

• Not Applicable. There is no mention of a "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not Applicable. There is no training set involved.

Summary of Device Comparison (from Section 10. Feature Comparison Table):

The submission provides a feature comparison table to demonstrate substantial equivalence to predicate devices. This table serves as the primary "proof" for the 510(k) process.

The "Yes" in the "SE?" column (which stands for Substantially Equivalent) indicates that, for that specific feature, the ZIP™ Condom Catheter is considered substantially equivalent to the predicate devices. The two "No" entries highlight differences (Underpant, Additional Items Needed to Use the Device) which the FDA presumably deemed not significant enough to prevent a finding of substantial equivalence overall, especially since the ZIP™ device offers a more integrated solution (integral bag, complete kit) which could be seen as an improvement in convenience rather than a safety/effectiveness concern.

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