TraumaGuard Intra-abdominal Pressure Sensing System
Device Facts
| Record ID | K240057 |
|---|---|
| Device Name | TraumaGuard Intra-abdominal Pressure Sensing System |
| Applicant | Sentinel Medical Technologies, LLC |
| Product Code | EZL · Gastroenterology, Urology |
| Decision Date | Apr 17, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5130 |
| Device Class | Class 2 |
Indications for Use
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).
Device Story
Silicone Foley catheter with two polyurethane balloons; outer distal balloon filled with sterile water for bladder wall contact; inner sensing balloon contains air column. Intra-abdominal pressure (IAP) increases constrict outer balloon, displacing air in inner balloon proximally; tension increases on connector in catheter hub; pressure sensor in reusable cable detects tension. Temperature and pressure data transmitted to standard hospital bedside monitors. Used in clinical settings by healthcare providers. Provides continuous IAP and CBT monitoring to aid diagnosis of IAH and ACS. Benefits include real-time physiological monitoring to prevent or manage abdominal compartment syndrome.
Clinical Evidence
Bench testing only. No clinical data. Testing included MRI safety evaluations (ASTM F2052-21, F2213-17, F2182-19e2, F2503-20) and computational modeling for RF-induced heating. Biocompatibility and non-pyrogenicity assessed per ISO 10993-1:2018 and ISO 10993-12:2021.
Technological Characteristics
Silicone catheter; polyurethane sensing balloons; reusable custom cables. Dimensions: 18 French. Sterilization: E-beam radiation (SAL 1x10^-6). Connectivity: Connects to standard hospital bedside monitors. Standards: ASTM F623-19 (Foley catheters), ASTM F2503-20 (MRI safety), ISO 10993-1 (Biocompatibility).
Indications for Use
Indicated for patients requiring urinary drainage, continuous intra-abdominal pressure (IAP) monitoring, and core body temperature (CBT) monitoring. Used as an aid in diagnosing intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS).
Regulatory Classification
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).
Predicate Devices
- TraumaGuard Intra-abdominal Pressure Sensing System (K210570)
Submission Summary (Full Text)
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April 17, 2024
Sentinel Medical Technologies, LLC Jackelyn Rodriguez Ouality Assurance/ Regulatory Affairs Director 50 N Laura Street. Suite 2500 Jacksonville, FL 32202
Re: K240057
Trade/Device Name: TraumaGuard Intra-abdominal Pressure Sensing System Regulation Number: 21 CF§R 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL, PHU Dated: February 28, 2024 Received: February 29, 2024
Dear Jackelyn Rodriguez:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Sharon M. Andrews -S
for Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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## Indications for Use
Submission Number (if known)
K240057
Device Name
TraumaGuard Intra-abdominal Pressure Sensing System
Indications for Use (Describe)
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).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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## 510(k) Summary
#### Table 1: 510(k) Summary
| Submitter: | Sentinel Medical Technologies, LLC<br>50 N Laura St, Ste 2500<br>Jacksonville, FL 32202<br>1-800-579-4910 |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jackelyn Rodriguez<br>Quality Assurance/<br>Regulatory Affairs<br>Phone: 6097554559<br>E-mail: jrodriguez@sentinelmedtech.com |
| Date Prepared: | December 29, 2023 |
| Trade Name: | TraumaGuard Intra-abdominal Pressure Sensing System |
| Common Name: | Intra-Abdominal Pressure Monitoring Device |
| Classification: | Class II |
| Establishment<br>Registration Number | 3021468326 |
| Product Code: | EZL, PHU |
| Regulation | 21 CFR 876.5130 |
| Predicate Device(s): | The subject device is equivalent to the following device:<br>TraumaGuard Intra-abdominal Pressure Sensing System (K210570)<br>This predicate has not been subject to a design-related recall. |
| Device Description: | The TraumaGuard Intra-abdominal Pressure Sensing System is<br>comprised of a catheter and cable used to connect to standard<br>biometric monitors. The catheter is a Foley catheter that provides<br>continuous biometric monitoring of intra-abdominal pressure and<br>core body temperature.<br><br>TraumaGuard (TG) is a silicone catheter with two polyurethane<br>pressure sensing balloons used to detect changes in intra-abdominal<br>pressure (IAP), the outer distal balloon and the inner sensing<br>balloon. The outer balloon is filled with 2.0 - 2.5cc of sterile water<br>to ensure contact with the bladder wall. The inner sensing balloon<br>has a column of air that runs the entire length of the catheter from<br>the middle of the outer sensing balloon to a connector on the hub.<br><br>Temperature can be displayed in Celsius or Fahrenheit and is<br>accurate within ±1°C over a range of 25°C to 40°C (77°F to 104°F).<br>Pressure displayed is between 0mmHg and 40mmHg. |
| | The inflation, drainage and sensing ports of the catheter are color-<br>coded and can be operated with a Luer Lock syringe tip. |
| | Each TG is sterile and individually pouched. TG Cables are<br>reusable. TG is a single use catheter intended for short-term use (no<br>more than 30 days). |
| Indication for Use: | TraumaGuard Intra-abdominal Pressure Sensing System is intended<br>for use in the drainage of urine for continuous measuring of<br>intraabdominal pressure (IAP) and core body temperature (CBT). The<br>measured IAP can be used as an aid in the diagnosis of intra-<br>abdominal hypertension (IAH) and abdominal compartment<br>syndrome (ACS). |
| | The Indications for Use statement for the TraumaGuard Intra-<br>abdominal Pressure Sensing System is identical to the predicate<br>device. Both the subject and predicate devices have the same<br>intended use for the drainage of urine for continuous measuring of<br>IAP and CBT. |
| Legally Marketed<br>Devices To Which<br>Substantial Equivalence<br>Is Claimed: | The TraumaGuard Intra-abdominal Pressure Sensing System is<br>identical to the existing sizes of TraumaGuard Intra-abdominal<br>Pressure Sensing System in intended use, materials, physical<br>characteristics, and performance characteristics. The modifications<br>attributed to the predicate device are the addition of MR conditional<br>to the labeling. |
| Performance Data: | Performance data for the TraumaGuard Intra-abdominal Pressure<br>Sensing System is compared to that of the predicate device<br>(K210570) identified in these 510(K) summaries. Results of<br>laboratory tests demonstrate the TraumaGuard Intra-abdominal<br>Pressure Sensing System is substantially equivalent to the legally<br>marketed device. |
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## Table 2: 510(k) Device Comparison
| | TraumaGuard Intra-abdominal<br>Pressure Catheter (Subject<br>Device) | TraumaGuard Intra-abdominal<br>Pressure Catheter (Predicate<br>Device) | Comment |
|-----------------|----------------------------------------------------------------------|------------------------------------------------------------------------|---------|
| Device Overview | | | |
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| 510(k) Number | K230902 | K210570 | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Decision Date | To be determined | October 29, 2021 | |
| Manufacturer | Sentinel Medical Technology | Sentinel Medical Technology | Same |
| Classification | Class II | Class II | Same |
| Product Code | EZL, PHU | PHU | Same |
| Regulation | 21 CFR 876.5130 | Unclassified | Same |
| Medical<br>Specialty | General and Plastic Surgery<br>Gastroenterology/Urology | General and Plastic Surgery | Same |
| Indications for<br>Use | The TraumaGuard Intra-abdominal Pressure Sensing<br>Catheter is intended for the<br>drainage of urine from the<br>bladder, monitoring of urine<br>output (when used with a standard<br>collection bag), monitoring of<br>core body temperature and<br>continuous measuring of intra-<br>abdominal pressure. The<br>measured pressures can be used<br>as an aid in the diagnosis of intra-<br>abdominal hypertension, and the<br>associated clinical syndrome of<br>abdominal compartment<br>syndrome. The TraumaGuard<br>intra-abdominal pressure sensing<br>catheter displays core body<br>temperature in the healthcare<br>setting in degrees Fahrenheit and<br>degrees Celsius.<br>TraumaGuard is a single use<br>device intended for short-term use<br>(less than 30 days). | The TraumaGuard Intra-abdominal Pressure Sensing<br>Catheter is intended for the<br>drainage of urine from the<br>bladder, monitoring of urine<br>output (when used with a<br>standard collection bag),<br>monitoring of core body<br>temperature and continuous<br>measuring of intra-abdominal<br>pressure. The measured pressures<br>can be used as an aid in the<br>diagnosis of intra-abdominal<br>hypertension, and the associated<br>clinical syndrome of abdominal<br>compartment syndrome. The<br>TraumaGuard intra-abdominal<br>pressure sensing catheter displays<br>core body temperature in the<br>healthcare setting in degrees<br>Fahrenheit and degrees Celsius.<br>TraumaGuard is a single use<br>device intended for short-term use<br>(less than 30 days). | Same |
| Intended Use | To serve as a Foley catheter and<br>monitor of core body temperature<br>and intra-abdominal pressure. | To serve as a Foley catheter and<br>monitor of core body temperature<br>and intra-abdominal pressure. | Same |
| Principle of<br>operation | Outer distal balloon constricts<br>onto inner sensing balloon when<br>intra- abdominal pressure<br>increases. This displaces the air in<br>the inner pressure sensing balloon<br>proximally which increases the<br>tension of the connector located<br>in the catheter hub onto the<br>pressure sensor located in the<br>cable. | Outer distal balloon constricts<br>onto inner sensing balloon when<br>intra- abdominal pressure<br>increases. This displaces the air<br>in the inner pressure sensing<br>balloon proximally which<br>increases the tension of the<br>connector located in the catheter<br>hub onto the pressure sensor<br>located in the cable. | Same |
| Technical<br>Comparison | Dual pressure sensing balloon<br>system allows for continuous<br>monitoring of IAP. Collection of<br>urine via standard urine collection<br>tubing and bag. TraumaGuard<br>cable connects to standard<br>hospital bedside monitors already<br>located in clinical setting. | Dual pressure sensing balloon<br>system allows for continuous<br>monitoring of IAP. Collection of<br>urine via standard urine<br>collection tubing and bag.<br>TraumaGuard cable connects to<br>standard hospital bedside<br>monitors already located in<br>clinical setting. | Same |
| Components | Silicone catheter with silicone<br>retention balloon and<br>polyurethane balloons. Pressure<br>and temperature transmitting<br>custom cables | Silicone catheter with silicone<br>retention balloon and<br>polyurethane balloons. Pressure<br>and temperature transmitting<br>custom cables | Same |
| Placement | In the bladder | In the bladder | Same |
| Balloons | 3 | 3 | Same |
| Catheter<br>French Size | 18 | 18 | Same |
| Not made with<br>natural rubber<br>latex | Yes | Yes | Same |
| Biomonitoring | Intra-abdominal pressure and core<br>body temperature | Intra-abdominal pressure and<br>core body temperature | Same |
| Catheter | Single Use Disposable | Single Use Disposable | Same |
| Mode of<br>Pressure Sensing | Sensor located in cable<br>connected to catheter hub | Sensor located in cable connected<br>to catheter hub | Same |
| Custom<br>Console<br>Required | No | No | Same |
| Wear Duration | 30 days | 30 days | Same |
| Monitoring<br>Duration | Continuous | Continuous | Same |
| Sterilization<br>Method | E-beam Radiation | E-beam Radiation | Same |
| Minimum SAL | 1 x 10-6 | 1 x 10-6 | Same |
| MR<br>Compatible | Conditional | MR Unsafe | See Below |
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| Functional and Safety | Representative samples of the TraumaGuard device were tested in |
|-----------------------|-----------------------------------------------------------------------------|
| Testing: | accordance with the company's design control procedures to ensure the |
| | functional and performance requirements of the device were met. Finished, |
| | sterile devices underwent MRI safety testing in simulated conditions. |
| | A study was performed to evaluate magnetically induced displacement force, |
| | magnetically induced torque, image artifact, RF-induced heating and RF |
| | exposure in the magnetic resonance imaging (MRI) environment for the |
| | Trauma Guard Catheter. |
| | This study established MRI safety conditions in accordance with ASTM |
| | F2503-20. The Standard used lists the MRI safety evaluations and the |
| | associated ASTM standard test methods. |
| | |
| | An additional Computational Modeling and Simulation (CM&S) study was |
| | performed to estimate in-vivo temperature rise due to RF-induced heating of |
| | the Sentinel Medical Technologies TraumaGuard catheter. |
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| | The following standards were used in testing: |
|---|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ● | ASTM F2503-20 Standard Practice For Marking Medical<br>Devices And Other Items For Safety In The Magnetic<br>Resonance Environment. |
| ● | ASTM F623-19 Standard Performance Specification for Foley<br>Catheters. |
| ● | ASTM F2052-21 Standard Test Method For Measurement Of<br>Magnetically Induced Displacement Force On Medical<br>Devices In The Magnetic Resonance Environment. |
| ● | ASTM F2213-17 Standard Test Method For Measurement Of<br>Magnetically Induced Torque On Medical Devices In The<br>Magnetic Resonance Environment. |
| ● | ASTM F2182-19e2 Standard Test Method For Measurement<br>Of Radio Frequency Induced Heating On Or Near Passive<br>Implants During Magnetic Resonance Imaging. |
| ● | ISO 10993-1, Biological evaluation of medical devices - Part<br>1: Evaluation and testing within a risk management process. |
| ● | ISO 10993-12:2021 Biological Evaluation of Medical<br>Devices, Part 12: Sample Preparation and Reference<br>Materials. |
| | Additional testing was performed to support and demonstrate the non-<br>pyrogenicity of the Sentinel TraumaGuard Intra-abdominal Pressure Sensing<br>Catheter. This assessment focuses on the requirements of ISO 10993-1:2018.<br>ISO Materials Mediated Rabbit Pyrogen (GLP) Report # 385393 |
| | The following guidance documents were used:<br>Testing and Labeling Medical Devices for Safety in the<br>Magnetic Resonance (MR) Environment. Guidance for<br>Industry and Food and Drug Administration Staff. Document<br>issued on October 10, 2023.<br>Use of International Standard ISO 10993-1, "Biological<br>evaluation of medical devices - Part 1: Evaluation and testing<br>within a risk management process" Guidance for Industry and<br>Food and Drug Administration Staff Document issued on<br>September 8, 2023 |
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| Conclusion: | The TraumaGuard Intra-abdominal Pressure Sensing System intended use, materials, and fundamental scientific technology is identical to the predicate device (K210570). Performance bench and laboratory testing demonstrate the labeling differences between the subject device and the predicate device do not raise new questions of safety and effectiveness. |
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