(27 days)
The AMSelf TM Closed Catheterization System is intended for use in the drainage of urine from the bladder.
The AMSelf TM Closed Catheterization System is a single-use patient device, compromising a PVC urological catheter and a drainage bag assembled in a closed-system configuration.
This 510(k) submission (K082831) for the AMSelf™ Closed Catheterization System is a premarket notification for a Class II medical device. The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, the AMSure™ Urethral Catheterization Tray (K030712), rather than presenting a study to prove performance against specific acceptance criteria for a novel device.
The provided information indicates that "Performance and biocompatibility testing has demonstrated that the AMSelf™ Closed Catheterization System is safe and effective for its intended use." However, it does not explicitly detail the acceptance criteria, the specific results of these tests, or how these results "prove" the device meets the criteria. The submission is a standard FDA 510(k) filing, which aims to demonstrate that a new device is as safe and effective as an already legally marketed device (the predicate device). Therefore, the "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with specific performance endpoints is not present in this document.
Given the nature of the document, most of the requested information regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth data for training sets is not applicable or explicitly stated.
Here's an attempt to address your prompts based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. The "performance" assessment is covered by the statement: "Performance and biocompatibility testing has demonstrated that the AMSelf™ Closed Catheterization System is safe and effective for its intended use." This implies that the device successfully met internal or regulatory performance standards for a catheterization system. The implicit acceptance criterion is that the device performs equivalently to the predicate device, K030712, in terms of safety and effectiveness for urine drainage.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety and effectiveness for intended use (drainage of urine from the bladder), equivalent to predicate device K030712. | "Performance and biocompatibility testing has demonstrated that the AMSelf™ Closed Catheterization System is safe and effective for its intended use." The FDA's substantial equivalence determination (K082831) confirms that the device is considered as safe and effective as a legally marketed predicate device (K030712) for the stated indications for use. This implies the device passed necessary tests (e.g., sterility, material compatibility, functional integrity for fluid drainage, leak testing, ease of use for catheter insertion and removal, packaging integrity) to be deemed safe and effective for its purpose, aligning with the performance of the predicate. Specific quantitative results are not provided in this summary. |
| Biocompatibility with human tissues (for a device in contact with mucous membranes and internal body fluids). | "Biocompatibility testing has demonstrated that the AMSelf™ Closed Catheterization System is safe and effective for its intended use." This indicates the materials used in the system are suitable for human contact without adverse reactions, typically confirmed through ISO 10993 series testing (though specific tests aren't listed). |
| Maintains sterile barrier and integrity of the closed system for urine drainage. | Implied through "performance and biocompatibility testing." A closed catheterization system specifically aims to reduce infection risk, so maintaining sterility and integrity during use would be a key performance aspect. |
| Functional performance in draining urine from the bladder, including flow rate and prevention of reflux/leakage (standard for such devices). | Implied through "performance testing." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size used for performance or biocompatibility testing, nor does it specify the provenance of any data (e.g., country of origin, retrospective or prospective). Such details are typically found in the full 510(k) submission, which this summary does not include.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The submission is for a physical medical device, not an interpretative AI/image analysis product where "ground truth" is established by experts. Performance and biocompatibility testing for such devices are typically conducted in laboratories following established standards and protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed for this physical device.
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
This information is not applicable and not provided. MRMC studies are generally performed for diagnostic imaging devices or AI-assisted diagnostic tools, not for a physical device like a catheterization system. There is no AI component mentioned in this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a physical catheterization system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided in the context of "ground truth" as typically discussed for diagnostic or AI-driven systems. For a physical device, testing involves objective measures of criteria like sterility, material strength, flow rates, biocompatibility, and leak integrity. The "ground truth" or reference standards are typically established through recognized laboratory testing standards and methods (e.g., ISO standards, ASTM standards, USP monographs), with results empirically measured against these standards, rather than expert consensus on a diagnosis.
8. The sample size for the training set
This information is not applicable and not provided. Since this is a physical medical device and not an AI or machine learning algorithm, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no "training set" for this physical medical 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.