(100 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. TG Cables are reusable. TG is a single use catheter intended for short-term use (no more than 30 days).
This document is a 510(k) Premarket Notification from the FDA regarding the "TraumaGuard Intra-abdominal Pressure Sensing System." It describes the device, its intended use, and its substantial equivalence to a previously cleared predicate device.
Based on the provided text, the acceptance criteria and study proving the device meets those criteria are primarily focused on bench testing and laboratory studies demonstrating functional and safety performance, particularly regarding MR compatibility, rather than a clinical study evaluating AI assistance or human reader improvement. The submission is for a new version of an existing device (K210570) with the primary modification being the addition of MR conditional labeling.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a neat table of acceptance criteria with corresponding performance values for all aspects. However, it lists the standards followed and the outcome of the testing. The core "acceptance criteria" here relate to demonstrating that the new device (with MR conditional labeling) performs equivalently to the predicate device for its original functions, and meets MR safety standards.
| Acceptance Criterion (Inferred from Standards & Testing) | Reported Device Performance (Summary) |
|---|---|
| Functional and Performance Requirements | Representative samples were tested in accordance with the company's design control procedures to ensure functional and performance requirements were met. (General statement, no specific metrics provided for IAP/CBT accuracy beyond the general statement for the original device: "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.") |
| MRI Safety (Magnetically Induced Displacement Force) | A study was performed in accordance with ASTM F2503-20 and ASTM F2052-21. The study established MRI safety conditions. (No specific force values are provided, but the outcome is "MR Conditional.") |
| MRI Safety (Magnetically Induced Torque) | A study was performed in accordance with ASTM F2503-20 and ASTM F2213-17. The study established MRI safety conditions. (No specific torque values are provided, but the outcome is "MR Conditional.") |
| MRI Safety (Image Artifact) | A study was performed in accordance with ASTM F2503-20. The study established MRI safety conditions. (No specific artifact measurements are provided, but the outcome is "MR Conditional.") |
| MRI Safety (RF-induced Heating) | A study was performed in accordance with ASTM F2503-20 and ASTM F2182-19e2. An additional Computational Modeling and Simulation (CM&S) study was performed to estimate in-vivo temperature rise. The study established MRI safety conditions. (No specific temperature rise values are provided, but the outcome is "MR Conditional.") |
| Biocompatibility (Non-Pyrogenicity) | Additional testing was performed to support and demonstrate non-pyrogenicity, focusing on ISO 10993-1:2018. ISO Materials Mediated Rabbit Pyrogen (GLP) Report # 385393 was conducted. (Outcome implies non-pyrogenicity was demonstrated). |
| Sterility Assurance Level (SAL) | Minimum SAL of 1 x 10-6 achieved via E-beam Radiation. (This is a standard requirement for sterile devices). |
| Foley Catheter Performance | ASTM F623-19 Standard Performance Specification for Foley Catheters was used in testing. (Implies compliance with general Foley catheter performance). |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "Representative samples of the TraumaGuard device were tested." It does not specify the exact sample size for the functional, performance, or MRI safety testing.
- Data Provenance: The studies were laboratory and bench tests ("laboratory tests," "bench testing") rather than clinical studies with patient data. The origin would be the testing facility, likely in the US, as Sentinel Medical Technologies is based in Jacksonville, FL. The studies appear to be prospective as they were conducted to gather data for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of information is not applicable to the evidence provided in this 510(k) summary. The submission relies on physical and engineering bench testing, as well as computational modeling, against established international and ASTM standards for medical device performance and safety (e.g., MRI safety, biocompatibility, sterilization). There is no mention of "experts" establishing ground truth in the context of clinical interpretation or diagnosis, as there would be for an AI-based diagnostic device.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving human interpretation of medical images or data, to resolve discrepancies or determine a definitive ground truth. As this submission focuses on bench testing and device performance against physical standards, there is no human interpretation or adjudication process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission is for a device that directly measures physical parameters (IAP and CBT) and is a catheter, not an AI or imaging diagnostic software that assists human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm-only performance study was not done in the context of AI. The device itself is the "algorithm" in a sense, as it provides direct measurements. The performance testing focuses on the accuracy and safety of these direct measurements and the device's physical properties. There is no AI component described in the device functionality.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Physical measurement standards: Ensured by calibrated equipment and methods defined in the listed ASTM and ISO standards for properties like temperature accuracy, pressure range, and MRI safety parameters (displacement, torque, heating, artifact).
- Biocompatibility standards: ISO 10993 series and associated GLP reports for non-pyrogenicity.
- Sterilization standards: Achieving a specified SAL.
Essentially, the "ground truth" is adherence to pre-defined, measurable engineering, physical, chemical, and biological safety standards for medical devices, rather than a clinical ground truth like pathology, expert consensus on images, or outcomes data.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device that measures IAP and CBT; it does not involve machine learning or AI models that require training sets. The "training" for this device would be its manufacturing process and design, not data-driven algorithm training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
§ 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.