Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical components and basic biometric measurements (pressure and temperature) without mentioning any computational analysis or algorithms that would suggest AI/ML. The performance studies compare the device to a predicate and focus on physical and safety characteristics.

Therapeutic

No
The device is intended for diagnostic purposes (measuring IAP to aid in the diagnosis of IAH and ACS) and monitors core body temperature, rather than directly treating a disease or condition.

Diagnostic

Yes

The device aids in the diagnosis of Intra-abdominal Hypertension (IAH) and Abdominal Compartment Syndrome (ACS) by measuring intra-abdominal pressure (IAP).

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of a catheter and cable, which are hardware components. The performance studies also detail testing on the physical catheter.

IVD (In Vitro Diagnostic)

Based on the provided information, the TraumaGuard Intra-abdominal Pressure Sensing System is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The TraumaGuard system directly measures intra-abdominal pressure and core body temperature within the patient's body using a catheter inserted into the bladder. It does not analyze samples like blood, urine, or tissue outside the body.
The intended use describes direct physiological measurement. The system is used for "continuous measuring of intraabdominal pressure (IAP) and core body temperature (CBT)" and aids in diagnosis based on these direct measurements.

Therefore, the TraumaGuard Intra-abdominal Pressure Sensing System is a medical device used for physiological monitoring and measurement, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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).

Product codes

EZL, PHU

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. TG Cables are reusable. TG is a single use catheter intended for short-term use (no more than 30 days).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bladder

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare setting

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Functional and Safety Testing: Representative samples of the TraumaGuard device were tested in 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Temperature 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.

Predicate Device(s)

K210570

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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).

1

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
50 N Laura St, Ste 2500
Jacksonville, FL 32202
1-800-579-4910 |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jackelyn Rodriguez
Quality Assurance/
Regulatory Affairs
Phone: 6097554559
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
Registration Number | 3021468326 |
| Product Code: | EZL, PHU |
| Regulation | 21 CFR 876.5130 |
| Predicate Device(s): | The subject device is equivalent to the following device:
TraumaGuard Intra-abdominal Pressure Sensing System (K210570)
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. 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
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 Indications for Use statement for the TraumaGuard Intra-
abdominal Pressure Sensing System is identical to the predicate
device. Both the subject and predicate devices have the same
intended use for the drainage of urine for continuous measuring of
IAP and CBT. |
| Legally Marketed
Devices To Which
Substantial Equivalence
Is Claimed: | The TraumaGuard Intra-abdominal Pressure Sensing System is
identical to the existing sizes of TraumaGuard Intra-abdominal
Pressure Sensing System in intended use, materials, physical
characteristics, and performance characteristics. The modifications
attributed to the predicate device are the addition of MR conditional
to the labeling. |
| Performance Data: | Performance data for the TraumaGuard Intra-abdominal Pressure
Sensing System is compared to that of the predicate device
(K210570) identified in these 510(K) summaries. Results of
laboratory tests demonstrate the TraumaGuard Intra-abdominal
Pressure Sensing System is substantially equivalent to the legally
marketed device. |

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Table 2: 510(k) Device Comparison

| | TraumaGuard Intra-abdominal
Pressure Catheter (Subject
Device) | TraumaGuard Intra-abdominal
Pressure Catheter (Predicate
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
Specialty	General and Plastic Surgery
Gastroenterology/Urology	General and Plastic Surgery	Same
Indications for
Use	The TraumaGuard Intra-abdominal Pressure Sensing
Catheter is intended for the
drainage of urine from the
bladder, monitoring of urine
output (when used with a standard
collection bag), monitoring of
core body temperature and
continuous measuring of intra-
abdominal pressure. The
measured pressures can be used
as an aid in the diagnosis of intra-
abdominal hypertension, and the
associated clinical syndrome of
abdominal compartment
syndrome. The TraumaGuard
intra-abdominal pressure sensing
catheter displays core body
temperature in the healthcare
setting in degrees Fahrenheit and
degrees Celsius.
TraumaGuard is a single use
device intended for short-term use
(less than 30 days).	The TraumaGuard Intra-abdominal Pressure Sensing
Catheter is intended for the
drainage of urine from the
bladder, monitoring of urine
output (when used with a
standard collection bag),
monitoring of core body
temperature and continuous
measuring of intra-abdominal
pressure. The measured pressures
can be used as an aid in the
diagnosis of intra-abdominal
hypertension, and the associated
clinical syndrome of abdominal
compartment syndrome. The
TraumaGuard intra-abdominal
pressure sensing catheter displays
core body temperature in the
healthcare setting in degrees
Fahrenheit and degrees Celsius.
TraumaGuard is a single use
device intended for short-term use
(less than 30 days).	Same
Intended Use	To serve as a Foley catheter and
monitor of core body temperature
and intra-abdominal pressure.	To serve as a Foley catheter and
monitor of core body temperature
and intra-abdominal pressure.	Same
Principle of
operation	Outer distal balloon constricts
onto inner sensing balloon when
intra- abdominal pressure
increases. This displaces the air in
the inner pressure sensing balloon
proximally which increases the
tension of the connector located
in the catheter hub onto the
pressure sensor located in the
cable.	Outer distal balloon constricts
onto inner sensing balloon when
intra- abdominal pressure
increases. This displaces the air
in the inner pressure sensing
balloon proximally which
increases the tension of the
connector located in the catheter
hub onto the pressure sensor
located in the cable.	Same
Technical
Comparison	Dual pressure sensing balloon
system allows for continuous
monitoring of IAP. Collection of
urine via standard urine collection
tubing and bag. TraumaGuard
cable connects to standard
hospital bedside monitors already
located in clinical setting.	Dual pressure sensing balloon
system allows for continuous
monitoring of IAP. Collection of
urine via standard urine
collection tubing and bag.
TraumaGuard cable connects to
standard hospital bedside
monitors already located in
clinical setting.	Same
Components	Silicone catheter with silicone
retention balloon and
polyurethane balloons. Pressure
and temperature transmitting
custom cables	Silicone catheter with silicone
retention balloon and
polyurethane balloons. Pressure
and temperature transmitting
custom cables	Same
Placement	In the bladder	In the bladder	Same
Balloons	3	3	Same
Catheter
French Size	18	18	Same
Not made with
natural rubber
latex	Yes	Yes	Same
Biomonitoring	Intra-abdominal pressure and core
body temperature	Intra-abdominal pressure and
core body temperature	Same
Catheter	Single Use Disposable	Single Use Disposable	Same
Mode of
Pressure Sensing	Sensor located in cable
connected to catheter hub	Sensor located in cable connected
to catheter hub	Same
Custom
Console
Required	No	No	Same
Wear Duration	30 days	30 days	Same
Monitoring
Duration	Continuous	Continuous	Same
Sterilization
Method	E-beam Radiation	E-beam Radiation	Same
Minimum SAL	1 x 10-6	1 x 10-6	Same
MR
Compatible	Conditional	MR Unsafe	See Below

6

7

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.

8

	The following standards were used in testing:
●	ASTM F2503-20 Standard Practice For Marking Medical
Devices And Other Items For Safety In The Magnetic
Resonance Environment.
●	ASTM F623-19 Standard Performance Specification for Foley
Catheters.
●	ASTM F2052-21 Standard Test Method For Measurement Of
Magnetically Induced Displacement Force On Medical
Devices In The Magnetic Resonance Environment.
●	ASTM F2213-17 Standard Test Method For Measurement Of
Magnetically Induced Torque On Medical Devices In The
Magnetic Resonance Environment.
●	ASTM F2182-19e2 Standard Test Method For Measurement
Of Radio Frequency Induced Heating On Or Near Passive
Implants During Magnetic Resonance Imaging.
●	ISO 10993-1, Biological evaluation of medical devices - Part
1: Evaluation and testing within a risk management process.
●	ISO 10993-12:2021 Biological Evaluation of Medical
Devices, Part 12: Sample Preparation and Reference
Materials.
	Additional testing was performed to support and demonstrate the non-
pyrogenicity of the Sentinel TraumaGuard Intra-abdominal Pressure Sensing
Catheter. This assessment focuses on the requirements of ISO 10993-1:2018.
ISO Materials Mediated Rabbit Pyrogen (GLP) Report # 385393
	The following guidance documents were used:
Testing and Labeling Medical Devices for Safety in the
Magnetic Resonance (MR) Environment. Guidance for
Industry and Food and Drug Administration Staff. Document
issued on October 10, 2023.
Use of International Standard ISO 10993-1, "Biological
evaluation of medical devices - Part 1: Evaluation and testing
within a risk management process" Guidance for Industry and
Food and Drug Administration Staff Document issued on
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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