(187 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance (as described) |
|---|---|
| Equivalence to Predicate Devices | "The legally marketed devices to which SPECTRUM MedSystems is claiming equivalence...is the Bard® Touchless® Plus Unisex Intermittent Catheter and the MMG/O'Neil® Sterile Field Urinary Intermittent Catheter System." |
| Bladder Drainage Functionality | "Indicated for use to drain urine from the bladder and collect the urine from the bladder in a bag." "The catheter is advanced until it reaches the bladder and urine begins to flow through the catheter into the urinary collection bag." |
| Sterility | "The UNI-GARD QUIK CATH™ is a sterile, disposable device..." |
| Ease of Use/Ergonomics (Improved) | "design improvements over the predicate devices have been aimed at simplifying the designs, ... improvinq the erqonomics of the user when introducing the urine drainage catheter into the urethra..." "Reducing the number of parts making up a medical device improves ergonomics and the ease-of-use. the UNI-GARD QUIK CATH™ accomplishes this objective with the eliminate of the cap and bag retainer ring." |
| Contamination Prevention (Improved) | "The sealed catheter introducer used in the UNI-GARD QUIK CATH™ has been designed to eliminate this possibility of contamination by functioning as a lubricate reservoir, a sterile barrier and a introducer." "The catheter penetrated the distal urethra and bypasses contact with the urethral meatus to reduce the risk of infection." |
| Shelf Life (Extended) | "Extending the shelf life of the pre-lubricated predicate device products will be accomplished by substituting Medical Grade Dow Corning Polydimethylsiloxene lubricant for the traditional KY Jelly." "provide several years of shelf-life in dry storage (Refer to Attachment 2)." |
| Urine Collection Volume (Increased) | "The UNI-GARD QUIK CATH™ will use a 1800 cc collection bag rather than an 1100 cc or 1500 cc bag as used by the predicate devices. This will eliminate the use of a second catheter system to perform the additional drainage of the largest of bladders." |
| Complete Bladder Drainage (Improved Catheter Length) | "The catheter length has also been increased by three inches to a final length of 20 inches to allow complete drainage of the bladder." |
| Lubrication Effectiveness | "The catheter introducer places a thin medical grade lubricant film onto the catheter as it passes through the introducer lubricant reservoir." |
Study Information (Based on Provided Text):
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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.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
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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.
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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.
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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.
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The sample size for the training set:
- Not applicable. No machine learning or AI training set is mentioned or relevant for this device.
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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.
§ 876.5250 Urine collector and accessories.
(a)
Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)
Classification —(1)Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2)
Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.