TraumaGuard Intra-abdominal Pressure Sensing System

K210570 · Sentinel Medical Technologies, LLC · PHU · Oct 29, 2021 · SU

Device Facts

• Record ID: K210570
• Device Name: TraumaGuard Intra-abdominal Pressure Sensing System
• Applicant: Sentinel Medical Technologies, LLC
• Product Code: PHU · SU
• Decision Date: Oct 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

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

TraumaGuard is a silicone Foley catheter with two polyurethane pressure-sensing balloons; outer distal balloon and inner sensing balloon. Outer balloon filled with 2.0-2.5cc sterile water for bladder wall contact; inner balloon contains air column connected to hub. As IAP increases, outer balloon constricts, displacing air in inner balloon proximally, increasing tension on cable-integrated pressure sensor. Device connects to standard bedside biometric monitors. Used in clinical settings by healthcare providers for continuous IAP and CBT monitoring. Output displayed on bedside monitor; assists clinicians in diagnosing IAH and ACS. Benefits include continuous monitoring without requiring saline bladder instillation or custom consoles.

Clinical Evidence

Bench testing only. Performance verified via drainage flow rate, balloon integrity, pullout response, volume maintenance, dimensional verification, deflation reliability, and temperature accuracy. Pressure sensing function validated through static, dynamic, and recharge pressure testing.

Technological Characteristics

Silicone catheter with polyurethane balloons; 18 French size. Dual-balloon pressure sensing mechanism. E-beam radiation sterilization (SAL 10^-6). Connectivity via cable to standard bedside monitors. Standards: ISO 11137-1, ISO 10993-1, ASTM F623-19, IEC 60601-1.

Indications for Use

Indicated for patients requiring urinary drainage and continuous monitoring of intra-abdominal pressure (IAP) and core body temperature (CBT) to aid in the diagnosis of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS).

Regulatory Classification

Identification

Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.

Predicate Devices

• Accuryn Monitoring System (K153655)

Submission Summary (Full Text)

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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 [phone] 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, LLC<br>50 N Laura Street, Suite 2500<br>Jacksonville, FL 32202<br>Phone number: [phone] |
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| Contact Person: | Darci Diage<br>Regulatory Affairs<br>Phone: [phone]<br>E-mail: [e-mail] |
| 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:<br>• Accuryn Monitoring System (K153655)<br>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.<br><br>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.<br><br>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.<br><br>The inflation, drainage and sensing ports of the catheter are color-coded and can be operated with a Luer Lock syringe tip.<br>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 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 ThermaGuard Intra-<br>abdominal Pressure Sensing System is not identical to the predicate<br>device; however, the differences do not alter the intended therapeutic<br>use of the device, nor do they affect the safety and effectiveness of<br>the device relative to the predicate. Both the subject and predicate<br>devices have the same intended use for the drainage of urine for<br>continuous measuring of IAP and CBT. The predicate device has a<br>container mounted on the monitor that is used to measure the amount<br>of urine collected; the subject device does not include a urine<br>measurement container. |

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| | TraumaGuard Intra-<br>abdominal Pressure Catheter<br>(Subject Device) | Accuryn Monitoring System<br>(Predicate Device) | Comment |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Overview | | | |
| 510(k) Number<br>Decision Date | K210570<br>To be determined | K153655<br>April 5, 2016 | |
| Manufacturer | Sentinel Medical Technology | Potrero Medical, Inc | |
| Classification | Unclassified | Class II | |
| Indications for<br>Use | TraumaGuard Intra-abdominal<br>Pressure Sensing System is<br>intended for use in the<br>drainage of urine for<br>continuous measuring of<br>intraabdominal pressure (IAP)<br>and core body temperature<br>(CBT). The measured IAP can<br>be used as an aid in the<br>diagnosis of intra-abdominal<br>hypertension (IAH) and<br>abdominal compartment<br>syndrome (ACS). | The Accuryn Monitoring<br>System is intended for use in<br>the drainage and/or collection<br>of urine, and in the monitoring<br>of urine output and core body<br>temperature, in degrees<br>Fahrenheit and degrees<br>Celsius. The Accuryn<br>Monitoring System is also<br>intended for use in the<br>monitoring of intra-abdominal<br>pressure. The measured<br>pressures can be used as an aid<br>in the diagnosis of intra-<br>abdominal hypertension (IAH)<br>and the associated clinical<br>syndrome of abdominal<br>compartment syndrome<br>(ACS). The Accuryn Sensing<br>Urinary Catheter is a single<br>use device intended for short-<br>term use (less than 30 days). | Subject device is<br>not indicated for<br>the monitoring of<br>urine output. |
| Intended Use | To serve as a Foley catheter<br>and monitor of core body<br>temperature and intra-<br>abdominal pressure | To serve as a Foley catheter<br>and monitor of core body<br>temperature and intra-<br>abdominal pressure. | Same |
| Principle of<br>operation | Outer distal balloon constricts<br>onto inner sensing balloon<br>when 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<br>catheter hub onto the pressure<br>sensor located in the cable. | The bladder is filled with<br>saline and used as medium to<br>transmit pressure form bladder<br>wall to pressure sensing<br>balloon. This constricts the<br>sensing balloon transmitting a<br>pressure response through the<br>pressure lumen connected to<br>the monitor. The pressure<br>sensor located on the console is<br>reading the pressure within the<br>system. | Subject device has<br>a dual balloon<br>pressure sensing<br>mechanism that<br>can measure IAP<br>in an empty<br>bladder. |
| Technical<br>Comparison | Dual pressure sensing balloon<br>system allows for continuous<br>monitoring of IAP. Collection<br>of urine via standard urine<br>collection tubing and bag.<br>TraumaGuard cable connects<br>to standard hospital bedside | Single pressure sensing balloon<br>lumen that transmits pressure<br>changes in a full bladder<br>because of increased IAP.<br>System is provided with the<br>monitor and custom drainage<br>tubing that connects to a urine | Core body<br>temperature<br>monitoring is the<br>same. |
| | TraumaGuard Intra-<br>abdominal Pressure Catheter<br>(Subject Device) | Accuryn Monitoring System<br>(Predicate Device) | Comment |
| | monitors already located in<br>clinical setting. | collection vessel located on the<br>monitor. | |
| Components | Silicone catheter with silicone<br>retention balloon and<br>polyurethane balloons.<br>Pressure and temperature<br>transmitting custom cables. | Silicone catheter with silicone<br>retention balloon and<br>polyurethane balloon.<br>Collection and sensing Tubing.<br>Custom monitor with<br>collection vessel. | Subject device<br>does not include<br>collection and<br>sensing tubing or<br>custom monitor<br>with collection<br>vessel. |
| Placement | In the bladder | In the bladder | Same |
| Balloons | 3 | 2 | Additional inner<br>balloon is part of<br>the dual balloon<br>pressure sensing<br>system. |
| Catheter French<br>Size | 18 | 16 | Pressure sensing<br>balloon system<br>increases French<br>size. |
| Latex Free | Yes | Yes | Same |
| Biomonitoring | Intra-abdominal pressure and<br>core body temperature | Intra-abdominal pressure and<br>core body temperature | Same |
| Catheter | Single Use Disposable | Single Use Disposable | Same |
| Mode of<br>Pressure<br>Sensing | Sensor located in cable<br>connected to catheter hub | Sensor located in the monitor<br>connected to catheter via<br>tubing | Predicate has a<br>pressure<br>transducer<br>inside the tubing<br>connecting to<br>the monitor. |
| Custom Console<br>Required | No | Yes | Subject device<br>plugs into a<br>standard bedside<br>monitor. |
| Wear Duration | 30 days | 30 days | Same |
| Monitoring<br>Duration | Continuous | Non-continuous | Dual pressure<br>sensing balloon<br>system allows for<br>measuring<br>pressure in an<br>empty bladder<br>instead of<br>requiring saline<br>introduction to<br>bladder. |
| Sterilization<br>Method | E-beam Radiation | Ethylene Oxide | Split dose<br>validated<br>minimizes risk of<br>further cross-link |
| | TraumaGuard Intra-<br>abdominal Pressure Catheter<br>(Subject Device) | Accuryn Monitoring System<br>(Predicate Device) | Comment |
| | | | polymers;<br>performance<br>testing not<br>impacted. |
| Minimum SAL | $1 x 10^{-6}$ | $1 x 10^{-6}$ | Same |
| MR Compatible | Yes | Yes | Same |

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| Functional and Safety<br>Testing: | Representative samples of the TraumaGuard device were tested in<br>accordance with the company's design control procedures to ensure that the<br>functional and performance requirements of the device were met. Finished,<br>sterile devices underwent performance bench testing in simulated conditions. A<br>a result of verification and validation activities and risk assessment, testing<br>ensures the device design meets its functional and performance requirements.<br>Testing includes the following:<br>• Drainage Flow Rate<br>• Balloon Integrity (Resistance to Rupture)<br>• Inflated Balloon Response to Pullout<br>• Balloon Volume Maintenance<br>• Balloon Size and Shaft Size (Catheter Dimensional Verification)<br>• Deflation Reliability (Failure to Deflate)<br>• Temperature Measurement<br><br>Additional testing was performed for the pressure sensing function of the<br>TraumaGuard device. To verify the functional requirement for continuous<br>pressure monitoring the following tests were performed:<br>• Static Pressure<br>• Dynamic Pressure<br>• Recharge Pressure<br><br>The following standards were used in testing:<br>• ISO 11137-1:2006/AMD 2:2018 Sterilization of healthcare<br>products – Radiation – Part 1: Requirements for<br>development, validation and routine control of a sterilization<br>process for medical devices<br>• ISO 10993-1:2018, Biological evaluation of medical devices<br>• ASTM F623-19 Standard Performance Specification for Foley<br>Catheters.<br>• IEC 60601-1 Medical Electrical Equipment – Part 1: General<br>Requirements 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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