(29 days)
VaPro Plus Pocket intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.
The VaPro Plus Pocket intermittent catheter is a single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter has the following elements:
- hydrophilic-coated PVC catheter (phthalate free)
- Two smooth catheter eyelets
- protective sleeve
- protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion
- color coded funnel
The packaging contains a sealed water compartment chamber of which the water migrates to the catheter compartment and lubricates the catheter. The outer packaging was designed to be discreet, easy to store, easy to open and facilitate access to the catheter. The catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.
The provided text describes the 510(k) summary for the VaPro Plus Pocket Intermittent Catheter, an amendment to an existing device (VaPro Plus intermittent catheter, K141642). The submission primarily addresses changes to the device's packaging, not the device itself. Therefore, the "study" described focuses on testing relevant to these packaging changes rather than a clinical performance study of the catheter's efficacy for urinary drainage.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since the changes were primarily packaging-related, the acceptance criteria are not clinical performance metrics but rather safety and material integrity aspects.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Satisfactory (referencing K141642 for device, new testing for packaging also satisfactory) |
| Sterility | Satisfactory (using Gamma Irradiation per ANSI/AAMI/ISO 11137-1:2006 & 2:2013) |
| Packaging Integrity | Satisfactory (maintains sterile barrier for at least two years) |
| Transportation Impact | Successful results (no impact to safety or efficacy of catheter performance) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for any of the tests. The document only mentions "Biocompatibility was performed on the new packaging," "Sterility testing was performed," "Packaging integrity testing was performed," and "Transportation testing was performed." The specific number of samples or units tested is not provided.
- Data Provenance: Not explicitly stated, as the tests were performed by the manufacturer (Hollister Incorporated). It is an industrial setting rather than a retrospective or prospective clinical study on human subjects from a specific country.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The tests performed (biocompatibility, sterility, packaging integrity, transportation) are laboratory or engineering tests with objective pass/fail criteria, not subjective assessments requiring expert consensus on a "ground truth" derived from patient data.
4. Adjudication method for the test set:
- Not applicable. As described above, the tests are objective laboratory or engineering evaluations, not studies requiring adjudication of human-read results.
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 an intermittent catheter, which is a physical medical device for urinary drainage. It is not an AI-powered diagnostic or imaging device, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Biocompatibility: Ground truth is established by meeting the requirements of ISO 10993 standards, which involve cytotoxicity, sensitization, irritation, and other systemic effects based on material properties and extracts.
- For Sterility: Ground truth is established by demonstrating a Sterility Assurance Level (SAL) usually of 10^-6, meaning a one-in-a-million chance of a non-sterile unit, as per ISO 11137.
- For Packaging Integrity: Ground truth is established by proving the packaging can maintain a sterile barrier over its shelf life through physical and microbial challenge tests (e.g., burst strength, seal integrity, microbial ingress).
- For Transportation Testing: Ground truth is that the device (catheter) functions as intended and is undamaged after simulated shipping conditions.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.