(57 days)
Pre-filled Syringe for Balloon Inflation with Sterile Water is intended to be used in inflating foley catheter balloon.
The AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water is a 3cc, 5cc, 10cc and 30cc syringe pre-filled with USP purified water and gamma irradiated. The syringe is produced using polypropylene for the device barrel and plunger and pharmaceutical grade latex free rubber for both the plunger gasket and syringe tip cover. The shelf life of AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water is 3 years.
The provided document describes the AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water, which is a pre-filled syringe intended for inflating foley catheter balloons. The document is a 510(k) Premarket Notification, which aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute safety and effectiveness through extensive clinical trials.
Therefore, the information regarding acceptance criteria and study details is presented in the context of demonstrating substantial equivalence rather than a detailed clinical effectiveness study of a novel AI device.
Here's the information as requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that the AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water underwent performance testing to establish substantial equivalence. It does not provide specific quantitative acceptance criteria or detailed performance metrics in the way a clinical study report for an AI device might. Instead, it refers to conformity with established standards.
| Acceptance Criteria (General Description from Text) | Reported Device Performance (General Description from Text) |
|---|---|
| Functional Criteria | Meets acceptance criterion for all functional criteria. |
| Sterility Criteria | Meets acceptance criterion for all sterility criteria. |
| Biocompatibility Criteria | Meets acceptance criterion for all biocompatibility criteria. |
| Other Performance Criteria | Meets acceptance criterion for all other performance criteria. |
| Conformity with ISO7886-1, ISO 80369-7, USP 40 | Conforms with these standards. |
| Conformity with ISO 10993-5, ISO 10993-10 requirements | Conforms with these standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the performance tests, nor does it provide details on the data provenance (country of origin, retrospective/prospective). The tests mentioned are laboratory/bench tests, not typically clinical studies involving patient data.
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 type of information is not applicable to this 510(k) submission. The "ground truth" for this device's evaluation is based on established engineering specifications, material science, and regulatory standards for medical devices, not expert human interpretation of medical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The evaluation relies on standardized test methods and conformity to norms, not on expert adjudication of medical findings.
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 pre-filled syringe, not an AI or diagnostic imaging device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for evaluating this device's performance is based on established engineering specifications, material standards, and regulatory requirements (e.g., ISO, USP standards) for syringe functionality, sterility, and biocompatibility.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm.
§ 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.