(116 days)
The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short-term use (less than 30 days).
The Accuryn Monitoring System consists of the three components, the Accuryn Sensing Urinary Catheter, Accuryn Urine Collection Set, and the Accuryn Monitor.
The Accuryn Sensing Urinary Catheter is a single use, sterile, MR conditional, disposable 16 French, twoway silicone urinary bladder catheter with two opposing drainage eyes and 4 lumens.
The first lumen of the Urinary Catheter is for urine drainage and is packaged pre-connected to the Accuryn Urine Collection Set. The Accuryn Urine Collection Set function with the Accuryn Monitor to measure and display urine output and is considered a 510(k) exempt device per 21 CFR 876.1800 (urine flow or volume measuring system, product code EXY).
The second lumen is for the 5cc retention balloon, which serves to keep the catheter in place. Inflation of the retention balloon is provided by connecting a barrel tip syringe filled with sterile water to the catheter by means of a two-way valve. Sterile water is conveyed through the retention balloon lumen to inflate the retention balloon; water is contained within the balloon to maintain retention; the water is removed by reopening the valve to deflate the balloon prior to removing the catheter from the bladder.
The third lumen contains a thermistor wire for monitoring a patient's core body temperature in degrees Fahrenheit and degrees Celsius when connected to the Accuryn Monitor.
The fourth lumen consists of a closed air column that connects to a pressure transducer inside the Accuryn Monitor. Intra-abdominal pressure is measured via this lumen and displayed on the Monitor screen.
This 510(k) summary provides information on the Accuryn Monitoring System. However, it does not contain the details required to fully address all the requested points, especially concerning a traditional "study" in the sense of clinical trials or multi-reader, multi-case evaluations for AI. This is because the device appears to be a physical monitoring system, not an AI or imaging diagnostic tool.
Therefore, many of the requested fields cannot be directly answered from the provided text. I will address what can be inferred and explicitly state where information is missing.
Acceptance Criteria and Device Performance (Inferred from general claims and predicate device equivalence)
The document states that "Results from the bench tests for design verification and validation have proven acceptable performance on all tests to indicate that the device is suitable for its intended use and is as safe and effective as the predicate devices to support a determination of substantial equivalence."
While specific numerical acceptance criteria and performance data are not provided in this summary, the FDA's clearance implies that the device met internal criteria based on the testing performed. The "reported device performance" is implicitly that it functions as intended for urine drainage/collection, urine output monitoring, core body temperature monitoring, and intra-abdominal pressure monitoring, with accuracy considered comparable to predicate devices.
| Acceptance Criteria (Inferred from Indications for Use and Testing) | Reported Device Performance (Inferred from Substantial Equivalence and Bench Testing Conclusion) |
|---|---|
| Urine Drainage & Collection: Effective and safe urinary catheter function. | Functions as a urinary catheter for drainage and collection. |
| Urine Output Monitoring: Accurate measurement and display of urine output. | Measures and displays urine output effectively. |
| Core Body Temperature Monitoring: Accurate measurement and display of core body temperature. | Measures and displays core body temperature (inferred to be accurate and reliable). |
| Intra-abdominal Pressure Monitoring: Accurate measurement and display of intra-abdominal pressure. | Measures and displays intra-abdominal pressure (inferred to be accurate and reliable). |
| Biocompatibility: Meets ISO 10993-1 standards for biological safety. | Meets ISO 10993-1 and FDA Draft Guidance (2013) for biological evaluation. |
| Catheter Performance: Conforms to ASTM F623-99 (2006) for Foley catheters. | Conforms to ASTM F623-99 (2006) and coefficient of friction testing. |
| MR Compatibility: Meets ASTM standards for safety in an MR environment. | Meets ASTM F2052-14, F2213-06 (R2011), F2182-11a, and F2119-07 (R2013) standards for MR compatibility. |
| Software Safety: Complies with FDA Guidance for Software Contained in Medical Devices (2005). | Complies with FDA Guidance for Moderate Level of Concern device software. |
| Electrical Safety & EMC: Meets IEC 60601-1 3rd Ed. and IEC 60601-1-2 (2007) standards. | Meets IEC 60601-1 3rd Ed. and IEC 60601-1-2 (2007) for basic safety and essential performance. |
| Sterility: Provided sterile. | Provided sterile. |
| Single Use: Designed for single use. | Designed for single use. |
| Short-term Use: Intended for less than 30 days. | Intended for less than 30 days. |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The performance evaluation primarily involved bench testing (e.g., biocompatibility, catheter performance, MR compatibility, electrical safety) rather than human clinical trials.
- Data Provenance: Not specified, but given it's bench testing, the "data provenance" would relate to laboratory conditions and test setups, not patient data from specific countries. It is implicitly retrospective as the testing was completed prior to submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) summary. This device is a physical monitoring system and does not involve interpretation of images or data by human experts for ground truth establishment in the way AI/imaging devices might. Ground truth for its measurements would be established by reference standards in a lab setting.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this summary describes bench testing of a physical device, not a human reader study or AI algorithm evaluation requiring adjudication of expert opinions.
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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:
- No. This is a physical monitoring system, not an AI or imaging device that would typically undergo an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "software-related documentation" was provided for a "Moderate Level of Concern device" (per FDA Guidance 2005). However, this refers to the embedded software in the monitor, not a standalone AI algorithm for diagnostic interpretation in the sense typically asked for in these questions. The performance evaluation was of the system (catheter + monitor) as a whole for its intended physiological measurements.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Testing Standards: For the physical characteristics and measurement capabilities, ground truth was implicitly established against established scientific and engineering standards (e.g., ASTM, IEC, ISO) and reference methods/equipment used in the bench tests. For example, temperature measurements would be validated against calibrated thermometers, and pressure measurements against calibrated pressure transducers.
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The sample size for the training set:
- Not applicable. This device is not an AI algorithm that undergoes "training" on a dataset in the conventional sense. Its design and validation rely on engineering principles, material science, and performance testing against established standards.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 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.