(261 days)
The PVC Urinary Catheter is launched for clean intermittent catheterization (CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract. It is indicated for use in male, female, and pediatric patients 2-12 years old.
The Silicone Urinary Catheter is intended to be placed in the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.
The Latex Urinary Catheter is intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Neleton catheters are launched for clean internittent catheterization (CIC). Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.
Disposable urinary catheter is a kind of disposable product which is used for draining the bladder, for temporary or short term. Based on the materials, the disposable urinary catheter includes PVC Urinary Catheter, Silicone Urinary Catheter and Latex Urinary Catheter.
PVC Urinary Catheter only has nelaton type structure, which is made of PVC and is intended for draining the bladder for short term. PVC Urinary Catheter consists of drainage funnel, drainage lumen, eyelets and tip. It is supplied in French size ranging from 8 to 20F. The catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.
Silicone Urinary Catheter is made of pure silicone. It is intended to be placed in the bladder, through the urethra, to drain urine into a collection device and has two-way type and three-way type. The two-way type consists of funnel, drainage lumen, drainage eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eyes, balloon, inflating connector and valve. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.
Latex Foley Catheter is made of nature latex, which has nelaton type, two-way type and three-type.
The nelaton Latex Urinary Catheter is intended for draining the bladder for short term and consists of drainage funnel, drainage lumen, eyelets and tip. The nelaton catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2-12 years old.
The two-way type and three-way type are intended to be placed in the bladder, through the urethra, to drain urine into a collection device. The two-way type consists of funnel, drainage lumen, drainage eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eye. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.
This document describes a 510(k) premarket notification for Disposable Urinary Catheters (PVC, Silicone, and Latex). It focuses on demonstrating substantial equivalence to predicate devices, rather than a de novo evaluation of clinical effectiveness with an AI component. Therefore, much of the requested information regarding AI-specific studies (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable or present in this document.
Here's an analysis of the provided information, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting specified performance standards. The reported device performance is that the device "Passed" all tests against these requirements.
| Test Category | Specific Test / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| PVC Urinary Catheter (based on EN 1616:1997(R2007)) | ||
| Surface finish | Meet the requirement of 4.2 of EN 1616:1997(R2007). | Passed |
| Dimensions | Meet the requirement of 4.3 of EN 1616:1997(R2007). | Passed |
| Strength | Meet the requirement of 4.4 of EN 1616:1997(R2007). | Passed |
| Connector security | Meet the requirement of 4.5 of EN 1616:1997(R2007). | Passed |
| Flow rates | Meet the requirement of 4.8 of EN 1616:1997(R2007). | Passed |
| Biocompatibility (based on ISO 10993 series) | ||
| Cytotoxicity | ISO 10093-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Passed |
| Sensitization | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Passed |
| Irritation | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Passed |
| Systemic toxicity | ISO 10993-11 Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity | Passed |
| Sterility | SAL ≤ 10^-6^ | Passed |
| Silicone Urinary Catheter (based on ASTM F623-99(2013)) | ||
| Flow rate through drainage lumen | Meet the requirement of 4.1 of ASTM F623-99(2013). | Passed |
| Balloon Integrity | Meet the requirement of 4.2 of ASTM F623-99(2013). | Passed |
| Inflated Balloon Response to Traction | Meet the requirement of 4.3 of ASTM F623-99(2013). | Passed |
| Balloon Volume Maintenance | Meet the requirement of 4.4 of ASTM F623-99(2013). | Passed |
| Balloon Size and Shaft Size | Meet the requirement of 4.5 of ASTM F623-99(2013). | Passed |
| Deflation Reliability (Failure to Deflate) | Meet the requirement of 4.6 of ASTM F623-99(2013). | Passed |
| Biocompatibility (same ISO standards as PVC) | Cytotoxicity | Passed |
| Sensitization | Passed | |
| Irritation | Passed | |
| Systemic toxicity | Passed | |
| Implantation (Biological Evaluation Of Medical Devices - Part 6: Tests For Local Effects After Implantation) | Passed | |
| Sterility | SAL shall be less than 10^-6^ . | Passed |
| Latex Urinary Catheter (based on EN 1616:1997(R2007) and ASTM F623-99(2013)) | ||
| Surface finish | Meet the requirement of 4.2 of EN 1616:1997(R2007). | Passed |
| Dimensions | Meet the requirement of 4.3 of EN 1616:1997(R2007). | Passed |
| Strength | Meet the requirement of 4.4 of EN 1616:1997(R2007). | Passed |
| Connector security | Meet the requirement of 4.5 of EN 1616:1997(R2007). | Passed |
| Flow rates | Meet the requirement of 4.8 of EN 1616:1997(R2007) and 4.1 of ASTM F623-99(2013). | Passed |
| Balloon Integrity | Meet the requirement of 4.2 of ASTM F623-99(2013). | Passed |
| Inflated Balloon Response to Traction | Meet the requirement of 4.3 of ASTM F623-99(2013). | Passed |
| Balloon Volume Maintenance | Meet the requirement of 4.4 of ASTM F623-99(2013). | Passed |
| Balloon Size and Shaft Size | Meet the requirement of 4.5 of ASTM F623-99(2013). | Passed |
| Deflation Reliability (Failure to Deflate) | Meet the requirement of 4.6 of ASTM F623-99(2013). | Passed |
| Biocompatibility (same ISO standards as above) | Cytotoxicity | Passed |
| Sensitization | Passed | |
| Irritation | Passed | |
| Systemic toxicity | Passed | |
| Implantation | Passed | |
| Sterility | SAL ≤ 10^-6^. | Passed |
2. Sample size used for the test set and the data provenance
This document describes non-clinical "bench testing" and "biocompatibility tests" performed in accordance with standards like EN 1616, ASTM F623, and ISO 10993. These types of tests do not typically involve patient-specific data or test sets in the context of AI. The sample sizes for these bench tests are not specified in this document, nor is the data provenance in terms of country of origin or retrospective/prospective status as it would be for a clinical study. The device manufacturer is Zhanjiang Star Enterprise Co., Ltd based in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical, bench testing submission. No "ground truth" established by experts in a clinical context (e.g., radiologists) is mentioned or required for this type of submission.
4. Adjudication method for the test set
Not applicable. There are no clinical test sets or expert evaluations requiring adjudication in this 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
Not applicable. This device is a urinary catheter, not an AI-powered diagnostic or assistive technology. No MRMC studies were conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (urinary catheter) and does not involve an algorithm or AI.
7. The type of ground truth used
For the performance tests, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced international standards (e.g., EN 1616, ASTM F623). For biocompatibility, the "ground truth" is adherence to the criteria set forth in the ISO 10993 series of standards. This is not clinical "ground truth" such as pathology or outcomes data.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, and therefore, no training set.
9. How the ground truth for the training set was established
Not applicable. No training set exists for this 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.