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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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The UNI-GARD QUIK CATH™ is indicated for use to drain urine from the bladder and collect the urine from the bladder in a bag. uthe UNI-GARD QUIK CATH™ is a unisex intermittent unitized catheter system.

The UNI-GARD QUIK CATH™ is a sterile, disposable device composed a introducer with lubricant, drainage catheter and urine of collection bag. The introducer containing the lubricant is pressed into the urethral meates until it stops. The catheter is advanced through the introducer and reservoir of lubricant while perforating the introducer tip to enter the urethra. The catheter is advanced until it reaches the bladder and urine begins to flow through the catheter into the urinary collection baq.

This 510(k) notification describes the UNI-GARD QUIK CATH™, an intermittent urinary catheter, and compares it to predicate devices. The submission focuses on technological characteristics and improvements rather than specific performance metrics with acceptance criteria described in the format requested.

Here's the breakdown of the information you requested based on the provided text:

Acceptance Criteria and Device Performance

The provided document (K961906) for the UNI-GARD QUIK CATH™ is a 510(k) premarket notification. In such submissions, the primary "acceptance criterion" is typically substantial equivalence to a legally marketed predicate device. This means demonstrating that the new device is as safe and effective as the predicate. The document highlights various improvements in design and functionality compared to the predicate devices, rather than establishing quantifiable performance thresholds for clinical outcomes.

Therefore, the "acceptance criteria" relate to the design and functional characteristics that are intended to make the device safe and effective and/or demonstrate improvements over the predicate. The "reported device performance" is described through its design features and intended benefits.

Study Information (Based on Provided Text):

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

   • The provided document does not mention any clinical study or test set involving human subjects with a specified sample size. This is a 510(k) submission focused on substantial equivalence through technological characteristics and comparisons to predicate devices. It relies on design features and intended benefits.
   • Data Provenance: Not applicable as no specific clinical test data is presented. The information provided is design, functional, and comparative.

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

   • Not applicable. No clinical test set requiring expert ground truth establishment is described in this document.

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

   • Not applicable. No clinical test set requiring adjudication is described.

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 device is a urinary catheter, not an AI-assisted diagnostic tool.

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

   • Not applicable. This device is a simple medical device, not an algorithm.

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

   • Not applicable. No clinical ground truth is established or referenced for performance testing in this document. The "truth" in a 510(k) for this type of device is often related to the established safety and effectiveness of the predicate device and the demonstration that the new device shares similar technological characteristics or introduces improvements without compromising safety or effectiveness.

7. The sample size for the training set:

   • Not applicable. No machine learning or AI training set is mentioned or relevant for this device.

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

   • Not applicable. As above, no training set or ground truth for such a set is mentioned.

Summary of This 510(k) Notification:

This 510(k) submission for the UNI-GARD QUIK CATH™ primarily focuses on demonstrating substantial equivalence to predicate devices (Bard® Touchless® Plus Unisex Intermittent Catheter and MMG/O'Neil® Sterile Field Urinary Intermittent Catheter System) by detailing its technological characteristics and highlighting improvements in design (simplicity, ergonomics), contamination prevention (sealed introducer), shelf life (new lubricant), and user experience (larger collection bag, longer catheter). It does not present data from specific clinical performance studies with acceptance criteria in the typical statistical sense, but rather relies on functional descriptions and comparisons.

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