(245 days)
Not Found
No
The summary describes a physical device (catheter and cable) that measures pressure and temperature. There is no mention of algorithms, data analysis beyond simple measurement display, or any terms related to AI/ML. The performance studies focus on physical properties and measurement accuracy, not algorithmic performance.
No.
The device is for sensing and measuring intra-abdominal pressure and core body temperature as an aid in diagnosis, not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "The measured IAP can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS)." This directly indicates its role in diagnosis.
No
The device description explicitly states it is comprised of a catheter and cable, which are hardware components. The performance studies also detail testing of physical attributes like drainage flow rate, balloon integrity, and temperature measurement, further indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- TraumaGuard Function: The TraumaGuard system is a catheter-based device that is inserted into the bladder. It directly measures intra-abdominal pressure and core body temperature in situ (within the body). It also facilitates the drainage of urine.
- Lack of Specimen Analysis: The device does not collect a specimen and then analyze it outside the body. It is a direct measurement tool.
While the measured IAP is used as an aid in the diagnosis of IAH and ACS, the device itself is not performing an in vitro diagnostic test on a bodily fluid or tissue sample. It's a physiological monitoring device.
N/A
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 (comma separated list FDA assigned to the subject device)
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. The 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
In the bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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. Finished, sterile devices underwent performance bench testing in simulated conditions. A result of verification and validation activities and risk assessment, testing ensures 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 Measurement
Additional testing was performed for the pressure sensing function of the TraumaGuard device. To verify the functional requirement for continuous pressure monitoring the following tests were performed:
• Static Pressure
• Dynamic Pressure
• Recharge Pressure
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
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
1
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
2
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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3
510(k) Summary – K210570
Table 1: 510(k) Summary
| Submitter: | Sentinel Medical Technologies, LLC
50 N Laura Street, Suite 2500
Jacksonville, FL 32202
Phone number: (904) 704-9787 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Darci Diage
Regulatory Affairs
Phone: 707.953.2615
E-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 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 ThermaGuard Intra-
abdominal Pressure Sensing System is not identical to the predicate
device; however, the differences do not alter the intended therapeutic
use of the device, nor do they affect the safety and effectiveness of
the device relative to the predicate. Both the subject and predicate
devices have the same intended use for the drainage of urine for
continuous measuring of IAP and CBT. The predicate device has a
container mounted on the monitor that is used to measure the amount
of urine collected; the subject device does not include a urine
measurement container. |
4
5
| | TraumaGuard Intra-
abdominal Pressure Catheter
(Subject Device) | Accuryn Monitoring System
(Predicate Device) | Comment |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Overview | | | |
| 510(k) Number
Decision Date | K210570
To be determined | K153655
April 5, 2016 | |
| Manufacturer | Sentinel Medical Technology | Potrero Medical, Inc | |
| Classification | Unclassified | Class II | |
| 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). | The Accuryn Monitoring
System is intended for use in
the drainage and/or collection
of urine, and in the monitoring
of urine output and core body
temperature, in degrees
Fahrenheit and degrees
Celsius. The Accuryn
Monitoring System is also
intended for use in the
monitoring of intra-abdominal
pressure. The measured
pressures can be used as an aid
in the diagnosis of intra-
abdominal hypertension (IAH)
and the associated clinical
syndrome of abdominal
compartment syndrome
(ACS). The Accuryn Sensing
Urinary Catheter is a single
use device intended for short-
term use (less than 30 days). | Subject device is
not indicated for
the monitoring of
urine output. |
| 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. | The bladder is filled with
saline and used as medium to
transmit pressure form bladder
wall to pressure sensing
balloon. This constricts the
sensing balloon transmitting a
pressure response through the
pressure lumen connected to
the monitor. The pressure
sensor located on the console is
reading the pressure within the
system. | Subject device has
a dual balloon
pressure sensing
mechanism that
can measure IAP
in an empty
bladder. |
| 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 | Single pressure sensing balloon
lumen that transmits pressure
changes in a full bladder
because of increased IAP.
System is provided with the
monitor and custom drainage
tubing that connects to a urine | Core body
temperature
monitoring is the
same. |
| | TraumaGuard Intra-
abdominal Pressure Catheter
(Subject Device) | Accuryn Monitoring System
(Predicate Device) | Comment |
| | monitors already located in
clinical setting. | collection vessel located on the
monitor. | |
| Components | Silicone catheter with silicone
retention balloon and
polyurethane balloons.
Pressure and temperature
transmitting custom cables. | Silicone catheter with silicone
retention balloon and
polyurethane balloon.
Collection and sensing Tubing.
Custom monitor with
collection vessel. | Subject device
does not include
collection and
sensing tubing or
custom monitor
with collection
vessel. |
| Placement | In the bladder | In the bladder | Same |
| Balloons | 3 | 2 | Additional inner
balloon is part of
the dual balloon
pressure sensing
system. |
| Catheter French
Size | 18 | 16 | Pressure sensing
balloon system
increases French
size. |
| Latex Free | 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 the monitor
connected to catheter via
tubing | Predicate has a
pressure
transducer
inside the tubing
connecting to
the monitor. |
| Custom Console
Required | No | Yes | Subject device
plugs into a
standard bedside
monitor. |
| Wear Duration | 30 days | 30 days | Same |
| Monitoring
Duration | Continuous | Non-continuous | Dual pressure
sensing balloon
system allows for
measuring
pressure in an
empty bladder
instead of
requiring saline
introduction to
bladder. |
| Sterilization
Method | E-beam Radiation | Ethylene Oxide | Split dose
validated
minimizes risk of
further cross-link |
| | TraumaGuard Intra-
abdominal Pressure Catheter
(Subject Device) | Accuryn Monitoring System
(Predicate Device) | Comment |
| | | | polymers;
performance
testing not
impacted. |
| Minimum SAL | $1 x 10^{-6}$ | $1 x 10^{-6}$ | Same |
| MR Compatible | Yes | Yes | Same |
6
7
| Functional and Safety
Testing: | 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. Finished,
sterile devices underwent performance bench testing in simulated conditions. A
a result of verification and validation activities and risk assessment, testing
ensures 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 Measurement
Additional testing was performed for the pressure sensing function of the
TraumaGuard device. To verify the functional requirement for continuous
pressure monitoring the following tests were performed:
• Static Pressure
• Dynamic Pressure
• Recharge Pressure
The following standards were used in testing:
• ISO 11137-1:2006/AMD 2:2018 Sterilization of healthcare
products – Radiation – Part 1: Requirements for
development, validation and routine control of a sterilization
process for medical devices
• ISO 10993-1:2018, Biological evaluation of medical devices
• ASTM F623-19 Standard Performance Specification for Foley
Catheters.
• IEC 60601-1 Medical Electrical Equipment – Part 1: General
Requirements for Safety |
| ----------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
8
| 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. |
|---|---|
| ------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |