TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)

{0}  September 4, 2026 Sentinel Medical Technologies Jackelyn Rodriguez Quality Assurance Regulatory Affairs Director 50 N Laura St. Suite 2500 Jacksonville, Florida 32202 Re: K260756 Trade/Device Name: TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and accessories Regulatory Class: II Product Code: EZL, PHU Dated: August 2, 2026 Received: August 3, 2026 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: The Center for Devices and Radiological Health (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, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260756 - Jackelyn Rodriguez Page 2 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). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 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); medical device reporting (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-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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 {2} K260756 - Jackelyn Rodriguez Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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, # ANDREW M. FALES -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 Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K260756 Device Name TraumaGuard Intra-abdominal Pressure Sensing System (000-0221) Indications for Use (Describe) The TraumaGuard Intra-abdominal Pressure-Sensing System is intended to provide continuous intra-abdominal pressure (IAP) and core body temperature (CBT) measurements while allowing the drainage of urine. 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) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4} K260756 Page 1 of 12 ## **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:** | September 2, 2026 | | **Trade Name:** | TraumaGuard Intra-abdominal Pressure Sensing System (000-0221) | | **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 (K240057) This predicate has not been subject to a design-related recall. | | **Device Description:** | The TraumaGuard Intra-abdominal Pressure Sensing System (referred to as TraumaGuard v2) measures Intra-abdominal pressure (IAP) in patients to provide continuous monitoring and early warning of increased abdominal pressure. TraumaGuard (TG) v2 is comprised of a urinary catheter that functions as a traditional Foley catheter to remove urine from the bladder, while also providing continuous measurement of IAP and core body temperature (CBT). A cable with separate controller and adapter components are used to connect to standard biometric monitors. The TG v2 catheter is similar to a traditional silicone Foley catheter used to drain urine from the bladder. Like other Foley catheters on the market, the TG v2 catheter is comprised of an extruded silicone shaft, over molded silicone hub, and a silicone retention balloon approximately 5cm from the tip of the catheter. The catheter contains a drainage lumen, balloon inflation channels, two opposite drainage eyes, and an atraumatic tip. The color-coded inflation and drainage ports are located on the catheter hub and can be operated | Premarket Notification for the TraumaGuard Intra-Abdominal Pressure Sensing System – Rev 2 Sentinel Medical Technology {5} K260756 Page 2 of 12 using a Luer syringe. The catheter connects to the cable using a keyed connector. The TG v2 catheter design also includes a polyurethane sensing balloon used to detect changes in IAP. The sensing balloon is filled with 3cc of air and acts to average the pressure within the bladder environment as a proxy for true IAP. The pressure is passed through a hole in the catheter body to a digital pressure sensor housed in the catheter tip. Pressure is passed as an electrical signal from the catheter to the controller cable through a standard off-the-shelf-connector. Core body temperature is measured by a thermistor located adjacent to the digital pressure sensor, with the signal routed via wires through the TG v2 catheter shaft. The temperature read by the thermistor is directly passed through the catheter to the controller and adapter cables to be read by the patient monitor with no interference or alteration by the TraumaGuard system. The TG v2 cable consists of a patient monitor adapter component and a controller component. When connected, the cable provides power to the TraumaGuard catheter and transmits pressure and temperature data to the patient monitor. Additionally, the controller contains a display, buttons, and LED indicators. Each TG v2 catheter is sterile, individually pouched, and for single use. The TG v2 controller and adapter cable components may be cleaned by standard wipe down and are reusable. Each TG v2 is sterile and individually pouched. TG v2 cables are reusable. TG v2 is a single use catheter intended for short-term use (no more than 30 days). Premarket Notification for the TraumaGuard Intra-Abdominal Pressure Sensing System – Rev 2 Sentinel Medical Technology {6} K260756 Page 3 of 12 | **Indication for Use:** | The TraumaGuard Intra-abdominal Pressure-Sensing System is intended to provide continuous intra-abdominal pressure (IAP) and core body temperature (CBT) measurements while allowing the drainage of urine. 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. | | **Performance Data:** | Performance data for the TraumaGuard Intra-abdominal Pressure Sensing System is compared to that of the predicate device (K240057) 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. | **Table 2: 510(k) Device Comparison** Premarket Notification for the TraumaGuard Intra-Abdominal Pressure Sensing System – Rev 2 Sentinel Medical Technology {7} K260756 Page 4 of 12 | Item | TraumaGuard Intra-abdominal Pressure Sensing System (Subject Device) | TraumaGuard Intra-abdominal Pressure Sensing System (Predicate Device) | Comment | | --- | --- | --- | --- | | 510(k) Number Decision Date | K260756 | K240057 April 17, 2024 | | | Manufacturer | Sentinel Medical Technologies | Sentinel Medical Technologies | Same | | Classification | Class II | Class II | Same | | Product Code | EZL, PHU | EZL, PHU | Same | | Regulation | 21 CFR 876.5130 | 21 CFR 876.5130 | Same | | Medical Specialty | Gastroenterology/Urology | Gastroenterology/Urology | Same | | Indications for Use | The TraumaGuard Intra-abdominal Pressure-Sensing System is intended to provide continuous intra-abdominal pressure (IAP) and core body temperature (CBT) measurements while allowing the drainage of urine. 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 intended to provide continuous intra-abdominal pressure (IAP) and core body temperature (CBT) measurements while allowing the drainage of urine. The measured IAP can be used as an aid in the diagnosis of intra-abdominal hypertension (“IAH”) and abdominal compartment syndrome (“ACS”). | Same | | Intended Use | To serve as a Foley catheter and monitor core body temperature and Intra-abdominal pressure | To serve as a Foley catheter and monitor core body temperature and Intra-abdominal pressure | Same | | Principle of Operation | Balloon at the distal end of the device reacts to a change in | Balloon at the distal end of the device reacts to a change in | Same | Premarket Notification for the TraumaGuard Intra-Abdominal Pressure Sensing System Sentinel Medical Technology {8} K260756 Page 5 of 12 | | pressure. Sensors for temperature and pressure in the device transmit this data through the cables to the patient monitor. | pressure. Sensors for temperature and pressure in the device transmit this data through the cables to the patient monitor. | | | --- | --- | --- | --- | | Technical Comparison | Catheter pressure sensing balloon with digital pressure sensor allows for continuous monitoring of IAP. Collection of urine via standard urine collection tubing and bag. connect to standard hospital bedside monitors already located in the clinical setting. | Catheter 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 the clinical setting. | Performance bench testing | | Patient Contacting Components | Silicone catheter with a silicone retention balloon and polyurethane balloon (outer pressure sensing). | Silicone catheter with a silicone retention balloon and polyurethane balloons. | Same | | Placement | In the Bladder | In the Bladder | Same | | Balloons | 2 | 3 | Different | | Catheter French Size | 18 | 18 | Same | | Latex Free? | Yes | Yes | Same | | Biomonitoring | Intra-abdominal pressure and core body temperature | Intra-abdominal pressure and core body temperature | Same | | Pressure Measurement Accuracy | ±3mmHg | ±3mmHg | Performance bench testing | | Temperature Measurement Accuracy | ±1°C | ±1°C | Performance bench testing | | Catheter | Single Use Disposable | Single Use Disposable | Same | | Wear Duration | 30 Days (catheter) | 30 Days (catheter) | 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 | Yes | Yes | Same | Premarket Notification for the TraumaGuard Intra-Abdominal Pressure Sensing System Sentinel Medical Technology {9} K260756 Page 6 of 12 # 1.1. Device Comparison Discussion The TraumaGuard v2 Intra-abdominal Pressure Sensing System is an updated design of the predicate TraumaGuard Intra-abdominal Pressure Sensing System. The updated design simplifies catheter-to-cable connection, reduces the number of components in the catheter, reduces Cost of Goods Sold (COGS), while retaining equivalent fundamental technology, intended use, and principle of operation. Both devices are comprised of a Foley catheter that measures intra-abdominal pressure and core body temperature, and a cable used to connect to standard biometric patient monitors. The underlying scientific principle of using bladder pressure as a surrogate for intra-abdominal pressure remains the same. The design of the TraumaGuard v2 catheter is functionally equivalent to the predicate device. Both devices operate as Foley catheters intended for bladder drainage, intra-abdominal pressure measurement, and core body temperature monitoring. Both devices are silicone, retention-type Foley catheters incorporating inflation channels, drainage holes, a drainage lumen, a retention balloon, and an outer pressure-sensing balloon. The working length, French size, and body-contacting materials are also identical between the two catheters. Additionally, both devices measure core body temperature via a thermistor routed through the catheter shaft. The difference between the TraumaGuard v2 catheter and predicate catheter is the design of the pressure measurement system. The digital pressure sensor has been moved from within the cable (TraumaGuard) to inside of the catheter itself (TraumaGuard v2). In the predicate TraumaGuard catheter, the pressure-sensing mechanism utilized a balloon at the catheter tip connected to an air column. When Intra-abdominal pressure increased, the outer balloon compressed the inner balloon, displacing air through the air column and generating tension at the connector in the catheter hub, which was transmitted to a pressure sensor in the cable. In the TraumaGuard v2 catheter, the pressure sensor has been moved to replace the inner balloon and air column within the catheter shaft. As the outer balloon constricts in response to pressure changes, the sensor directly measures the pressure and transmits the resulting electrical signal through the cable to the patient monitor. Along with the catheter, the design of the TraumaGuard v2 cable is functionally equivalent to that of the predicate TraumaGuard cable in supplying power to the catheter and transmitting pressure and temperature measurement signals to the patient monitor. However, the TraumaGuard v2 cable consists of separate controller and adapter components rather than the single integrated cable. In addition, the updated pressure sensing system allows for the use of standard off-the-shelf connectors to connect the device components, as opposed to the custom connectors required for the predicate device. Premarket Notification for the TraumaGuard Intra-Abdominal Pressure Sensing System Sentinel Medical Technology {10} K260756 Page 7 of 12 | 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. Catheter Pressure Measurement Performance Testing: Per Design Verification Report DVR0003 (Dynamic & Static Pressure Test, Rev A), a sample of 12 TraumaGuard v2 catheter units was tested on a qualified dynamic test stand to verify requirement DREQ-6 (Catheter Enables Pressure Measurement) across the clinically relevant IAP range of 5-25 mmHg. Catheters were submerged in a temperature-controlled water column at 37 ± 1°C and evaluated under dynamic step-pressure testing and a continuous 24-hour static hold at 15 mmHg, with a repeat dynamic run performed after the static hold. All 12 units met the acceptance criteria at both timepoints: measurement accuracy within ±3 mmHg of the reference gauge, response time to | | --- | --- | Premarket Notification for the TraumaGuard Intra-Abdominal Pressure Sensing System Sentinel Medical Technology {11} K260756 Page 8 of 12 | | detect and report a pressure change within 120 seconds, and static stability within ±3 mmHg over 24 hours. This testing was conducted under protocol DVP0003 and statistically evaluated per SOP-013, within the company's ISO 13485:2016 quality system and ISO 14971:2019 risk management framework. DVR0002 Drainage Lumen Flow Rate summarizes the results of testing as part of design verification for TraumaGuard device requirement specifying that the TraumaGuard v2 catheter must allow for a minimum flow rate of 100 mL/min through the drainage holes when both the retention and pressure sensing balloons are inflated. This specification is based on the performance requirements given by ISO 20696 Sterile Urethral Catheters for Single Use and ASTM F623 Standard Performance Specification for Foley Catheter. The results of testing and statistical analysis demonstrate that the minimum expected flow rate for the TraumaGuard v2 catheter is 400 mL/min. These results meet the minimum specification of 100 mL/min. Therefore, it is concluded that the TraumaGuard v2 catheter satisfies the flow rate device requirement given by DREQ-2 Flow Rate, and the catheter is thereby compliant with ISO 20696 and ASTM F623. DVR0006 TraumaGuard Temperature Measurement Test summarizes the results of testing as part of design verification for TraumaGuard device requirements ensuring that the TraumaGuard v2 catheter accurately measures core body temperature within a range of 34°C to 42°C with an accuracy of ±1°C, equivalent to the predicate device. The catheter must detect a 2°C change within 2 minutes (120 seconds). The results of testing demonstrate that the accuracy and response time of the TraumaGuard v2 catheter meet the respective specifications of ±1°C and 120 seconds. Therefore, it is concluded that the TraumaGuard v2 catheter satisfies the temperature measurement requirements given by Design | | --- | --- | Premarket Notification for the TraumaGuard Intra-Abdominal Pressure Sensing System Sentinel Medical Technology {12} K260756 Page 9 of 12 | | requirement # DREQ-4 Catheter Enables Temperature Measurements. **Electrical Safety and Electromagnetic Compatibility (EMC) Testing:** Per Design Verification Report DVR0011 (IEC 60601 Compliance Report, Rev 1), the TraumaGuard v2 catheter, controller cable, and adapter cable were tested by F2 Labs, an accredited third-party laboratory, under Test Report No. F2X35630B-01S. Overall result: "Does meet all requirements," with no items of concern or failures observed against IEC 60601-1:2005+AMD1:2012+AMD2:2020/EN 60601-1:2006, covering power inputs, humidity, accessible parts, marking legibility/durability, working voltage, leakages, dielectrics, ball pressure, temperatures, ingress protection, cleaning, limited energy, and mechanical stress (push, impact, drop, mould stress) clauses. Ingress protection was separately verified to an IP21 rating (protection against access to hazardous parts and against dripping water) per IEC/EN 60529. As part of this assessment, F2 Labs also audited the TraumaGuard v2 risk management file against ISO 14971:2019 and reviewed labeling and Instructions for Use against IEC 60601-1 documentation requirements, with all reviewed items found compliant. EMC testing was performed under DVR0011, Attachment 2 (F2 Labs Report No. F2X35630B-01E) per IEC 60601-1-2:2014+A1:2020/EN 60601-1-2:2015, with an overall result of "PASS," meeting ASCA program specifications. Testing addressed radiated and conducted emissions (CISPR 11:2015+A1:2016+A2:2019) and immunity to electrostatic discharge, radiated RF fields, close-proximity RF fields (e.g., RFID), electrical fast transient/burst, surge, conducted RF, power-frequency magnetic fields, and voltage dips/interruptions (IEC 61000-4-2, -3, -4, -5, -6, -8, -11, and -39), with all results within acceptance limits. | | --- | --- | Premarket Notification for the TraumaGuard Intra-Abdominal Pressure Sensing System Sentinel Medical Technology {13} K260756 Page 10 of 12 | | The following standards were used in testing: **LABELING, SYMBOLS & USABILITY** - EN ISO 15223-1:2021 + Amd 1:2025 – Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements (Fourth edition, 2021-07); Amendment 1:2025 – Addition of defined term for authorized representative and modified EC REP symbol to not be country- or region-specific - ISO 20417:2026 – Medical devices — Information to be supplied by the manufacturer (Second edition; supersedes ISO 20417:2021) - IEC 62366-1:2015 + AMD1:2020 CSV – Medical devices — Part 1: Application of usability engineering to medical devices **ELECTRICAL SAFETY & EMC** - IEC 60601-1:2005 + AMD1:2012 + AMD2:2020 (Edition 3.2, Consolidated Version) – Medical electrical equipment — Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2:2014 + AMD1:2020 (Edition 4.1, Consolidated Version) – Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests - IEC 60529:1989 + AMD1:1999 + AMD2:2013 CSV – Degrees of protection provided by enclosures (IP Code) **BIOLOGICAL EVALUATION** - ISO 10993-1:2025 – Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (Sixth edition; supersedes EN ISO 10993-1:2009) - ISO 10993-3:2014 – Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity - ISO 10993-5:2009 – Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity - ISO 10993-10:2021 – Biological evaluation of medical devices — Part 10: Tests for skin sensitization - ANSI/AAMI/ISO 10993-11:2017 (Reaffirmed 2023) – Biological evaluation of medical devices — Part 11: Tests for systemic toxicity - ISO 10993-12:2021 – Biological evaluation of medical devices — Part 12: Sample preparation and reference materials - ISO 10993-17:2023 – Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents - ISO 10993-18:2020 – Biological evaluation of medical | | --- | --- | Premarket Notification for the TraumaGuard Intra-Abdominal Pressure Sensing System Sentinel Medical Technology {14} K260756 Page 11 of 12 | | devices — Part 18: Chemical characterization of medical device materials within a risk management process - ISO 10993-23:2021 – Biological evaluation of medical devices — Part 23: Tests for irritation**STERILIZATION** - ANSI/AAMI/ISO 11737-1:2018 + Amd 1:2021 – Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products - ISO 11737-2:2019 – Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process - EN ISO 11137-1:2015 + A1:2013 + A2:2018/2020 – Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - EN ISO 11137-2:2015 + A1:2023 – Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose**PACKAGING** - ISO 11607-1:2019 + Amd 1:2023 – Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (supersedes EN ISO 11607-1:2009) - ISO 11607-2:2019 – Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (supersedes EN ISO 11607-2:2006) - ASTM F88/F88M-23 – Standard Test Method for Seal Strength of Flexible Barrier Materials (supersedes F88/F88M-21) - ASTM F1886-16 – Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection - ASTM F2096-11 (2019) – Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) - ASTM D4332-22 – Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing - ASTM D4169-23e1 – Standard Practice for Performance Testing of Shipping Containers and Systems**DEVICE PERFORMANCE** - ASTM F623-25 – Standard Performance Specification for Foley Catheter (supersedes F623-19) - ISO 20696:2018, Sterile urethral catheters for single use Published (Edition 1, 2018)**MRI SAFETY / COMPATIBILITY** | | --- | --- | Premarket Notification for the TraumaGuard Intra-Abdominal Pressure Sensing System Sentinel Medical Technology {15} K260756 Page 12 of 12 | | - ASTM F2052-21 – Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment - ASTM F2213-25 – Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment (supersedes F2213-17) - ASTM F2119-24 – Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants (supersedes F2119-07(2013)) - ASTM F2182-19e2 – Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging 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 | | --- | --- | # **Conclusion:** The TraumaGuard Intra-abdominal Pressure Sensing System intended use, materials, and fundamental scientific technology is substantially equivalent to the predicate device (K240057). Performance bench and laboratory testing demonstrate the subject device is as safe and effective as the predicate device. Premarket Notification for the TraumaGuard Intra-Abdominal Pressure Sensing System Sentinel Medical Technology