(282 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 with the Accuryn Sensing Urinary Catheter (SmartFoley®) - IAP UO Temp 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 three components, the Accuryn Sensing Urinary Catheter, Accuryn Urine Collection Set or Accuryn SmartFoley Adapter, and the Accuryn Monitor.
The Accuryn Sensing Urinary Catheter is a single use, sterile, MR conditional, disposable (12F, 14F, and 16 F), two-way silicone urinary bladder catheter with two opposing drainage eyes and four lumens. The first lumen is for urine drainage, the second lumen for the retention balloon, the third lumen embedded with a thermistor, and the fourth lumen to measure intra-abdominal pressure (IAP).
The Accuryn SmartFoley® comes in three configurations:
- IAP, U/O, Temp (intra-abdominal pressure, urine output, and core temperature)
- U/O. Temp (urine output and core temperature) ●
- Adapter (that is compatible with commercially available Foley catheters between 6-24Fr)
The Accuryn Urine Collection Set is provided permanently pre-connected to the Accuryn Sensing Urinary Catheter's drainage lumen conveys urine to a urine measurement cassette. which connects to the Accuryn Monitor. The cassette feeds the urine collection bag. Potrero Medical also provides a configuration of the Accuryn Urine Collection Set that is not provided pre-connected to the catheter/foley. It is known as Accuryn SmartFoley Adapter and enables the user to connect a Foley catheter of their choice to the Accuryn Urine Collection Set. The Accuryn Urine Collection Set and Accuryn SmartFoley Adapter function in conjunction with the Accuryn Monitor to measure and display urine output is considered a 510(k) exempt device per 21 CFR 876.1800 (urine flow or volume measuring system, product code EXY).
The Accuryn Monitor is a portable electronic device which maintains urine flow from the foley through the Accuryn Urine Collection Set or Accuryn SmartFoley Adapter, measures the urine output volume in the measurement cassette, and displays the urine output. The Accuryn Monitor also measures and displays the temperature from the thermistor and intra-abdominal pressure (IAP) from the pressure lumen. The monitor contains software.
The provided text is a 510(k) summary for the Accuryn Monitoring System. This document focuses on demonstrating substantial equivalence to a predicate device rather than outright proving device performance against pre-defined acceptance criteria in the manner of a novel device. Therefore, the information typically found in a study proving acceptance criteria for a new AI/ML medical device (like MRMC studies, detailed ground truth establishment, training set provenance, etc.) is largely not present in this type of submission.
The "acceptance criteria" here are essentially that the new device configurations (smaller catheter sizes) perform comparably to the predicate device and don't introduce new safety or effectiveness concerns. The "study" proving this is a series of non-clinical performance tests designed to validate and verify the device's adherence to relevant standards and its functional characteristics.
Here's an attempt to answer your questions based on the provided text, highlighting where information is absent due to the nature of a 510(k) submission for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria with corresponding performance values in the way one might expect for a novel AI/ML device. Instead, it summarily states that the device "met all acceptance criteria" and "Performance testing data has demonstrated that the Accuryn Monitoring System is safe and effective for its intended use."
The closest a comparison table comes to "acceptance criteria" is the "Comments" column in the Comparison of Technological Characteristics and Device Use with Predicate Device section, where "Same" indicates meeting the implicit criterion of being equivalent to the predicate.
| Comparison Feature | Subject Device | Predicate Device | Comments (Implicit Acceptance Criteria for Substantial Equivalence) |
|---|---|---|---|
| Product Class | II | II | Same |
| Product Code | EZL, PHU, EXY | EZL, PHU, EXY | Same |
| Indications for Use | As described | As described | Subject device specifies the Accuryn Sensing Urinary Catheter (SmartFoley®) – IAP UO Temp is the catheter with intra-abdominal pressure measurement ability. The Accuryn SmartFoley UO Temp is an alternative option for users who do not need the IAP functionality. This is a clarification, not a difference in fundamental intended use. |
| Use environment | Hospital | Hospital | Same |
| Users | Medical Staff | Medical Staff | Same |
| IAP UO Temp Catheter Size | 12Fr, 14Fr, 16Fr | 16Fr | Two smaller French sizes are being introduced. Performance of these new sizes against relevant standards would be the implicit acceptance criteria. |
| Lumens | 4 | 4 | Same |
| Performance Standard | ASTM F623 | ASTM F623 | Same |
| Use Duration | Foley: |
§ 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.