(352 days)
2 Way Latex Foley Catheters
Indicated where routine drainage of the bladder is required ether postoperatively or for patients with conditions requiring urine drainage.
3 Way Latex Foley Catheter
Indicated where routine drainage of the bladder is required either postoperatively or for patients with conditions requiring urine drainage and for patients requiring bladder irrigation.
The Rüsch Latex Gold Foley Catheter is available as 2 Way catheter, with a proximal funnel, non-return inflation valve and bladder fixation balloon, and 3 Way catheter which includes an additional irrigation channel with proximal funnel. The catheter is manufactured of natural latex, provided sterile, single use, and disposable. The inflation valve is designed for use with Luer lock syringe tips. Balloon inflation volumes in millimeters, as well as shaft size in French gauge (Fr.), Charrière (Ch.), or millimeters (mm), are indicated on the funnel of each individual catheters are siliconized, or surface finished with Polytetrafluoroethylene (PTFE). The Gold Foley Catheter maximum use/indwelling period is less than 30 days. The device has different models of catheters namely PURE GOLD, Gold Pediatric, Gold, and the Gold Haematuria.
The provided text is an FDA 510(k) Premarket Notification for a medical device: the Rüsch Latex Gold Foley Catheter. This document largely focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not describe acceptance criteria for an AI/software as a medical device (SaMD) or a study proving its performance against such criteria. The document explicitly lists nonclinical testing conducted for the physical Foley catheter, such as biocompatibility, sterilization validation, accelerated aging, and performance/functional testing per ASTM standards for a physical medical device.
Therefore, I cannot extract the requested information regarding acceptance criteria for an AI/software device, its performance, sample sizes for test/training sets, expert qualifications, or details about MRMC studies, as these types of studies were not conducted or described in this document for the Rüsch Latex Gold Foley Catheter.
The document pertains to a physical medical device. The "acceptance criteria" discussed implicitly are related to the successful completion of the listed nonclinical tests and demonstrating substantial equivalence to the predicate device, YiKang Latex Foley Catheter (K173340), for FDA clearance. The "study that proves the device meets the acceptance criteria" refers to the nonclinical testing detailed in section 7 of the document.
Here's how I can answer based on the provided text, interpreting "acceptance criteria" and "study" in the context of a physical medical device:
Acceptance Criteria for the Rüsch Latex Gold Foley Catheter (Based on Nonclinical Testing):
| Acceptance Criteria | Reported Device Performance (Summary from Document) |
|---|---|
| Biocompatibility | Device is biocompatible. |
| - Cytotoxicity per ISO 10993-5:2009 | Met acceptance criteria (implied by overall biocompatibility statement). |
| - Sensitization per ISO 10993-10:2021 | Met acceptance criteria (implied by overall biocompatibility statement). |
| - Irritation per ISO 10993-23:2021 | Met acceptance criteria (implied by overall biocompatibility statement). |
| - Acute Systemic Toxicity per ISO 10993-11:2017 | Met acceptance criteria (implied by overall biocompatibility statement). |
| - Subacute Systemic Toxicity per ISO 10993-11:2017 | Met acceptance criteria (implied by overall biocompatibility statement). |
| - Material Mediated Pyrogenicity per ISO 10993-11:2017 | Met acceptance criteria (implied by overall biocompatibility statement). |
| - Implantation per ISO 10993-6:2016 | Met acceptance criteria (implied by overall biocompatibility statement). |
| Sterilization Validation | All standards met for ethylene oxide sterilization. |
| - ISO 11137-1:2006 (R)2015 | Met acceptance criteria (implied by overall sterilization validation statement). |
| - ISO 11137-1:2013 | Met acceptance criteria (implied by overall sterilization validation statement). |
| Accelerated Aging | Device maintains functional performance and packaging sterility over shelf life. |
| - Conformance with ASTM F1980-16 | Met acceptance criteria. |
| Performance/Functional Testing | Device met performance criteria outlined in the standard. |
| - Per ASTM 623-19 Standard Performance Specification for Foley Catheter | Met acceptance criteria. |
Study Information (for a Physical Medical Device):
- Sample sizes used for the test set and the data provenance: Not explicitly stated as numerical sample sizes. The document refers to "testing" and "assessment" for each standard. The data provenance is internal testing conducted by the manufacturer (Teleflex Medical, Inc.) to comply with FDA recognized standards. The data is retrospective in the sense that the tests were performed on manufactured devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are laboratory-based, objective performance tests on the physical device, not subjective expert reviews of data like in AI/SaMD studies. The "ground truth" is defined by the standards (e.g., successful sterilization, acceptable biocompatibility levels, functional performance specifications).
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Testing is objective and based on meeting specified numerical or qualitative limits defined by the standards.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical device, not an AI/SaMD.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a physical device, not an AI/SaMD.
- The type of ground truth used:
- Biocompatibility: In vitro and in vivo biological responses as defined by ISO 10993 series of standards (e.g., cell viability, skin irritation, systemic toxicity, tissue reaction on implantation).
- Sterilization: Sterility assurance level (SAL) achieved through validated processes per ISO 11137.
- Accelerated Aging: Functional performance of the device and integrity of the sterile barrier system after simulated aging.
- Performance/Functional Testing: Physical and mechanical properties (e.g., balloon inflation, flow rate, material integrity) as specified by ASTM 623-19.
- The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML model.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) for a traditional medical device (Foley catheter) and does not contain the information requested for AI/SaMD performance studies.
§ 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.