(245 days)
TraumaGuard Intra-abdominal Pressure Sensing System is intended for use in the drainage of urine for continuous measuring of intraabdominal pressure (IAP) and core body temperature (CBT). The measured IAP can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS).
The TraumaGuard Intra-abdominal Pressure Sensing System is comprised of a catheter and cable used to connect to standard biometric monitors. The catheter is a Foley catheter that provides continuous biometric monitoring of intra-abdominal pressure and core body temperature.
TraumaGuard (TG) is a silicone catheter with two polyurethane pressure sensing balloons used to detect changes in intra-abdominal pressure (IAP), the outer distal balloon and the inner sensing balloon. The outer balloon is filled with 2.0 - 2.5cc of sterile water to ensure contact with the bladder wall. The inner sensing balloon has a column of air that runs the entire length of the catheter from the middle of the outer sensing balloon to a connector on the hub.
Temperature can be displayed in Celsius or Fahrenheit and is accurate within ±1°C over a range of 25°C to 40°C (77°F to 104°F). Pressure displayed is between 0mmHg and 40mmHg.
The inflation, drainage and sensing ports of the catheter are color-coded and can be operated with a Luer Lock syringe tip.
Each TG is sterile and individually pouched. The TG Cables are reusable. TG is a single use catheter intended for short-term use (no more than 30 days).
This document describes a medical device, the TraumaGuard Intra-abdominal Pressure Sensing System, which is a Foley catheter with additional capabilities for continuously measuring intra-abdominal pressure (IAP) and core body temperature (CBT). The document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a quantitative table with corresponding numerical performance results. Instead, it lists functional and safety tests and states that "Representative samples of the TraumaGuard device were tested in accordance with the company's design control procedures to ensure that the functional and performance requirements of the device were met." It further notes that "Finished, sterile devices underwent performance bench testing in simulated conditions."
Implied Acceptance Criteria and Performance (Based on Device Description and Testing):
| Acceptance Criteria Category | Specific Test/Performance Requirement (Implied) | Reported Device Performance (as stated or implied) |
|---|---|---|
| Temperature Measurement | Accuracy of core body temperature measurement. | Accurate within ±1°C over a range of 25°C to 40°C (77°F to 104°F). |
| Pressure Measurement | Range of intra-abdominal pressure measurement. | Pressure displayed is between 0mmHg and 40mmHg. |
| Pressure Sensing Function | Continuous pressure monitoring (dynamic, static, recharge). | Confirmed through Static Pressure, Dynamic Pressure, and Recharge Pressure tests. |
| Drainage Function | Drainage flow rate. | Testing performed (Drainage Flow Rate). |
| Catheter Integrity | Balloon integrity (resistance to rupture). | Tested (Balloon Integrity (Resistance to Rupture)). |
| Balloon Performance | Inflated balloon response to pullout. | Tested (Inflated Balloon Response to Pullout). |
| Balloon Volume | Balloon volume maintenance. | Tested (Balloon Volume Maintenance). |
| Dimensional Accuracy | Balloon size and shaft size (catheter dimensional verification). | Tested (Balloon Size and Shaft Size). |
| Deflation Reliability | Reliability of deflation. | Tested (Deflation Reliability (Failure to Deflate)). |
| Sterilization | Sterility Assurance Level (SAL). | Minimum SAL of 1 x 10^-6 achieved (E-beam Radiation method). |
| Biocompatibility | Biological safety. | Evaluated using ISO 10993-1:2018. |
| Electrical Safety | Electrical safety requirements. | Conforms to IEC 60601-1. |
| MR Compatibility | MRI compatibility. | Yes. |
| Wear Duration | Maximum wear duration of the catheter. | 30 days. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Representative samples of the TraumaGuard device were tested in accordance with the company's design control procedures... Finished, sterile devices underwent performance bench testing in simulated conditions."
- Sample Size: The exact sample size used for the test set is not specified. The term "Representative samples" is qualitative.
- Data Provenance: The testing was "performance bench testing in simulated conditions." This indicates laboratory or bench testing, not human clinical data. The country of origin of the data is not explicitly stated, but given the FDA submission, it's presumed to be from the manufacturer's testing facilities, likely within the US or a country with equivalent regulatory standards. The testing is prospective in nature, as it involves newly manufactured devices undergoing specific performance tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for this device's performance is established through direct physical measurements (e.g., temperature readings, pressure readings, flow rates, dimensional measurements) on the device itself during bench testing, not through expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set
Not applicable. As the ground truth is established by direct measurement on the device during bench testing, there is no need for expert adjudication of data.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This document describes a 510(k) submission for a physical medical device (a catheter) with integrated sensing capabilities. It is not an AI/imaging diagnostic device that would typically involve a multi-reader, multi-case study to assess human reader improvement with or without AI assistance. The focus is on the substantial equivalence of the device's functional performance to a predicate.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in essence. The performance testing described (Static Pressure, Dynamic Pressure, Recharge Pressure, Temperature Measurement, etc.) evaluates the device's sensing capabilities stand-alone, without direct human intervention in the primary sensing and measurement process. The device's internal mechanisms (e.g., dual balloon pressure sensing system) and temperature sensor are evaluated for their inherent accuracy and functionality.
7. The Type of Ground Truth Used
The ground truth used for the performance evaluation of the TraumaGuard system is physical measurement against calibrated standards/references during bench testing. For example:
- Temperature: Comparison against a known temperature source.
- Pressure: Comparison against known pressure values or calibrated pressure gauges.
- Flow Rate: Measurement of fluid volume over time.
- Dimensional: Measurement with calibrated instruments (e.g., calipers).
8. The Sample Size for the Training Set
Not applicable. This device is a hardware product for measurement, not an AI algorithm that requires a training set of data. Its performance is based on its physical design and manufacturing, tested against physical criteria.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI algorithm being trained, there is no "training set" or ground truth associated with it in this context.
N/A