(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.
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October 29, 2021
Sentinel Medical Technologies, LLC % Darci Diage Owner TPL Consulting 1056 Eugenia Pl, Suite B Carpinteria, California 93013
Re: K210570
Trade/Device Name: TraumaGuard Intra-abdominal Pressure Sensing System Regulatory Class: Unclassified Product Code: PHU Dated: September 17, 2021 Received: September 23, 2021
Dear Darci Diage:
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 (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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Anjana Jain -S
for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210570
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary – K210570
Table 1: 510(k) Summary
| Submitter: | Sentinel Medical Technologies, LLC50 N Laura Street, Suite 2500Jacksonville, FL 32202Phone number: (904) 704-9787 |
|---|---|
| Contact Person: | Darci DiageRegulatory AffairsPhone: 707.953.2615E-mail: darci@tplconsulting.net |
| Date Prepared: | September 20, 2021 |
| Trade Name: | TraumaGuard Intra-abdominal Pressure Sensing System |
| Common Name: | Intra-Abdominal Pressure Monitoring Device |
| Classification: | Unclassified, pre-amendment device |
| Product Code: | PHU |
| Regulation | Unclassified |
| Predicate Device(s): | The subject device is equivalent to the following device:• Accuryn Monitoring System (K153655)This predicate has not been subject to a design-related recall. |
| Device Description: | 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). |
| Indication for Use: | TraumaGuard Intra-abdominal Pressure Sensing System is intendedfor use in the drainage of urine for continuous measuring ofintraabdominal pressure (IAP) and core body temperature (CBT). Themeasured IAP can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and abdominal compartmentsyndrome (ACS). |
| The Indications for Use statement for the ThermaGuard Intra-abdominal Pressure Sensing System is not identical to the predicatedevice; however, the differences do not alter the intended therapeuticuse of the device, nor do they affect the safety and effectiveness ofthe device relative to the predicate. Both the subject and predicatedevices have the same intended use for the drainage of urine forcontinuous measuring of IAP and CBT. The predicate device has acontainer mounted on the monitor that is used to measure the amountof urine collected; the subject device does not include a urinemeasurement container. |
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| TraumaGuard Intra-abdominal Pressure Catheter(Subject Device) | Accuryn Monitoring System(Predicate Device) | Comment | |
|---|---|---|---|
| Device Overview | |||
| 510(k) NumberDecision Date | K210570To be determined | K153655April 5, 2016 | |
| Manufacturer | Sentinel Medical Technology | Potrero Medical, Inc | |
| Classification | Unclassified | Class II | |
| Indications forUse | TraumaGuard Intra-abdominalPressure Sensing System isintended for use in thedrainage of urine forcontinuous measuring ofintraabdominal pressure (IAP)and core body temperature(CBT). The measured IAP canbe used as an aid in thediagnosis of intra-abdominalhypertension (IAH) andabdominal compartmentsyndrome (ACS). | The Accuryn MonitoringSystem is intended for use inthe drainage and/or collectionof urine, and in the monitoringof urine output and core bodytemperature, in degreesFahrenheit and degreesCelsius. The AccurynMonitoring System is alsointended for use in themonitoring of intra-abdominalpressure. The measuredpressures can be used as an aidin the diagnosis of intra-abdominal hypertension (IAH)and the associated clinicalsyndrome of abdominalcompartment syndrome(ACS). The Accuryn SensingUrinary Catheter is a singleuse device intended for short-term use (less than 30 days). | Subject device isnot indicated forthe monitoring ofurine output. |
| Intended Use | To serve as a Foley catheterand monitor of core bodytemperature and intra-abdominal pressure | To serve as a Foley catheterand monitor of core bodytemperature and intra-abdominal pressure. | Same |
| Principle ofoperation | Outer distal balloon constrictsonto inner sensing balloonwhen intra-abdominal pressureincreases. This displaces the airin the inner pressure sensingballoon proximally whichincreases the tension of theconnector located in thecatheter hub onto the pressuresensor located in the cable. | The bladder is filled withsaline and used as medium totransmit pressure form bladderwall to pressure sensingballoon. This constricts thesensing balloon transmitting apressure response through thepressure lumen connected tothe monitor. The pressuresensor located on the console isreading the pressure within thesystem. | Subject device hasa dual balloonpressure sensingmechanism thatcan measure IAPin an emptybladder. |
| TechnicalComparison | Dual pressure sensing balloonsystem allows for continuousmonitoring of IAP. Collectionof urine via standard urinecollection tubing and bag.TraumaGuard cable connectsto standard hospital bedside | Single pressure sensing balloonlumen that transmits pressurechanges in a full bladderbecause of increased IAP.System is provided with themonitor and custom drainagetubing that connects to a urine | Core bodytemperaturemonitoring is thesame. |
| TraumaGuard Intra-abdominal Pressure Catheter(Subject Device) | Accuryn Monitoring System(Predicate Device) | Comment | |
| monitors already located inclinical setting. | collection vessel located on themonitor. | ||
| Components | Silicone catheter with siliconeretention balloon andpolyurethane balloons.Pressure and temperaturetransmitting custom cables. | Silicone catheter with siliconeretention balloon andpolyurethane balloon.Collection and sensing Tubing.Custom monitor withcollection vessel. | Subject devicedoes not includecollection andsensing tubing orcustom monitorwith collectionvessel. |
| Placement | In the bladder | In the bladder | Same |
| Balloons | 3 | 2 | Additional innerballoon is part ofthe dual balloonpressure sensingsystem. |
| Catheter FrenchSize | 18 | 16 | Pressure sensingballoon systemincreases Frenchsize. |
| Latex Free | Yes | Yes | Same |
| Biomonitoring | Intra-abdominal pressure andcore body temperature | Intra-abdominal pressure andcore body temperature | Same |
| Catheter | Single Use Disposable | Single Use Disposable | Same |
| Mode ofPressureSensing | Sensor located in cableconnected to catheter hub | Sensor located in the monitorconnected to catheter viatubing | Predicate has apressuretransducerinside the tubingconnecting tothe monitor. |
| Custom ConsoleRequired | No | Yes | Subject deviceplugs into astandard bedsidemonitor. |
| Wear Duration | 30 days | 30 days | Same |
| MonitoringDuration | Continuous | Non-continuous | Dual pressuresensing balloonsystem allows formeasuringpressure in anempty bladderinstead ofrequiring salineintroduction tobladder. |
| SterilizationMethod | E-beam Radiation | Ethylene Oxide | Split dosevalidatedminimizes risk offurther cross-link |
| TraumaGuard Intra-abdominal Pressure Catheter(Subject Device) | Accuryn Monitoring System(Predicate Device) | Comment | |
| polymers;performancetesting notimpacted. | |||
| Minimum SAL | $1 x 10^{-6}$ | $1 x 10^{-6}$ | Same |
| MR Compatible | Yes | Yes | Same |
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| Functional and SafetyTesting: | Representative samples of the TraumaGuard device were tested inaccordance with the company's design control procedures to ensure that thefunctional and performance requirements of the device were met. Finished,sterile devices underwent performance bench testing in simulated conditions. Aa result of verification and validation activities and risk assessment, testingensures the device design meets its functional and performance requirements.Testing includes the following:• Drainage Flow Rate• Balloon Integrity (Resistance to Rupture)• Inflated Balloon Response to Pullout• Balloon Volume Maintenance• Balloon Size and Shaft Size (Catheter Dimensional Verification)• Deflation Reliability (Failure to Deflate)• Temperature MeasurementAdditional testing was performed for the pressure sensing function of theTraumaGuard device. To verify the functional requirement for continuouspressure monitoring the following tests were performed:• Static Pressure• Dynamic Pressure• Recharge PressureThe following standards were used in testing:• ISO 11137-1:2006/AMD 2:2018 Sterilization of healthcareproducts – Radiation – Part 1: Requirements fordevelopment, validation and routine control of a sterilizationprocess for medical devices• ISO 10993-1:2018, Biological evaluation of medical devices• ASTM F623-19 Standard Performance Specification for FoleyCatheters.• IEC 60601-1 Medical Electrical Equipment – Part 1: GeneralRequirements for Safety |
|---|---|
| ----------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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| Conclusion: | The TraumaGuard Intra-abdominal Pressure Sensing System intended use, indicationfor use, materials, and fundamental scientific technology is similar to the predicate device. Performance bench testing demonstrate that the differences between the subject device and the predicate device do not raise new risks of safety and effectiveness. |
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N/A