(100 days)
TraumaGuard Intra-abdominal Pressure Sensing System is intended for use in the drainage of urine for continuous measuring of intraabdominal pressure (IAP) and core body temperature (CBT). The measured IAP can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS).
The TraumaGuard Intra-abdominal Pressure Sensing System is comprised of a catheter and cable used to connect to standard biometric monitors. The catheter is a Foley catheter that provides continuous biometric monitoring of intra-abdominal pressure and core body temperature.
TraumaGuard (TG) is a silicone catheter with two polyurethane pressure sensing balloons used to detect changes in intra-abdominal pressure (IAP), the outer distal balloon and the inner sensing balloon. The outer balloon is filled with 2.0 - 2.5cc of sterile water to ensure contact with the bladder wall. The inner sensing balloon has a column of air that runs the entire length of the catheter from the middle of the outer sensing balloon to a connector on the hub.
Temperature can be displayed in Celsius or Fahrenheit and is accurate within ±1°C over a range of 25°C to 40°C (77°F to 104°F). Pressure displayed is between 0mmHg and 40mmHg.
The inflation, drainage and sensing ports of the catheter are color-coded and can be operated with a Luer Lock syringe tip.
Each TG is sterile and individually pouched. TG Cables are reusable. TG is a single use catheter intended for short-term use (no more than 30 days).
This document is a 510(k) Premarket Notification from the FDA regarding the "TraumaGuard Intra-abdominal Pressure Sensing System." It describes the device, its intended use, and its substantial equivalence to a previously cleared predicate device.
Based on the provided text, the acceptance criteria and study proving the device meets those criteria are primarily focused on bench testing and laboratory studies demonstrating functional and safety performance, particularly regarding MR compatibility, rather than a clinical study evaluating AI assistance or human reader improvement. The submission is for a new version of an existing device (K210570) with the primary modification being the addition of MR conditional labeling.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a neat table of acceptance criteria with corresponding performance values for all aspects. However, it lists the standards followed and the outcome of the testing. The core "acceptance criteria" here relate to demonstrating that the new device (with MR conditional labeling) performs equivalently to the predicate device for its original functions, and meets MR safety standards.
| Acceptance Criterion (Inferred from Standards & Testing) | Reported Device Performance (Summary) |
|---|---|
| Functional and Performance Requirements | Representative samples were tested in accordance with the company's design control procedures to ensure functional and performance requirements were met. (General statement, no specific metrics provided for IAP/CBT accuracy beyond the general statement for the original device: "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.") |
| MRI Safety (Magnetically Induced Displacement Force) | A study was performed in accordance with ASTM F2503-20 and ASTM F2052-21. The study established MRI safety conditions. (No specific force values are provided, but the outcome is "MR Conditional.") |
| MRI Safety (Magnetically Induced Torque) | A study was performed in accordance with ASTM F2503-20 and ASTM F2213-17. The study established MRI safety conditions. (No specific torque values are provided, but the outcome is "MR Conditional.") |
| MRI Safety (Image Artifact) | A study was performed in accordance with ASTM F2503-20. The study established MRI safety conditions. (No specific artifact measurements are provided, but the outcome is "MR Conditional.") |
| MRI Safety (RF-induced Heating) | A study was performed in accordance with ASTM F2503-20 and ASTM F2182-19e2. An additional Computational Modeling and Simulation (CM&S) study was performed to estimate in-vivo temperature rise. The study established MRI safety conditions. (No specific temperature rise values are provided, but the outcome is "MR Conditional.") |
| Biocompatibility (Non-Pyrogenicity) | Additional testing was performed to support and demonstrate non-pyrogenicity, focusing on ISO 10993-1:2018. ISO Materials Mediated Rabbit Pyrogen (GLP) Report # 385393 was conducted. (Outcome implies non-pyrogenicity was demonstrated). |
| Sterility Assurance Level (SAL) | Minimum SAL of 1 x 10-6 achieved via E-beam Radiation. (This is a standard requirement for sterile devices). |
| Foley Catheter Performance | ASTM F623-19 Standard Performance Specification for Foley Catheters was used in testing. (Implies compliance with general Foley catheter performance). |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "Representative samples of the TraumaGuard device were tested." It does not specify the exact sample size for the functional, performance, or MRI safety testing.
- Data Provenance: The studies were laboratory and bench tests ("laboratory tests," "bench testing") rather than clinical studies with patient data. The origin would be the testing facility, likely in the US, as Sentinel Medical Technologies is based in Jacksonville, FL. The studies appear to be prospective as they were conducted to gather data for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of information is not applicable to the evidence provided in this 510(k) summary. The submission relies on physical and engineering bench testing, as well as computational modeling, against established international and ASTM standards for medical device performance and safety (e.g., MRI safety, biocompatibility, sterilization). There is no mention of "experts" establishing ground truth in the context of clinical interpretation or diagnosis, as there would be for an AI-based diagnostic device.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving human interpretation of medical images or data, to resolve discrepancies or determine a definitive ground truth. As this submission focuses on bench testing and device performance against physical standards, there is no human interpretation or adjudication process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission is for a device that directly measures physical parameters (IAP and CBT) and is a catheter, not an AI or imaging diagnostic software that assists human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm-only performance study was not done in the context of AI. The device itself is the "algorithm" in a sense, as it provides direct measurements. The performance testing focuses on the accuracy and safety of these direct measurements and the device's physical properties. There is no AI component described in the device functionality.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Physical measurement standards: Ensured by calibrated equipment and methods defined in the listed ASTM and ISO standards for properties like temperature accuracy, pressure range, and MRI safety parameters (displacement, torque, heating, artifact).
- Biocompatibility standards: ISO 10993 series and associated GLP reports for non-pyrogenicity.
- Sterilization standards: Achieving a specified SAL.
Essentially, the "ground truth" is adherence to pre-defined, measurable engineering, physical, chemical, and biological safety standards for medical devices, rather than a clinical ground truth like pathology, expert consensus on images, or outcomes data.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device that measures IAP and CBT; it does not involve machine learning or AI models that require training sets. The "training" for this device would be its manufacturing process and design, not data-driven algorithm training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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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).
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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)
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, LLC50 N Laura St, Ste 2500Jacksonville, FL 322021-800-579-4910 |
|---|---|
| Contact Person: | Jackelyn RodriguezQuality Assurance/Regulatory AffairsPhone: 6097554559E-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 |
| EstablishmentRegistration 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 iscomprised of a catheter and cable used to connect to standardbiometric monitors. The catheter is a Foley catheter that providescontinuous biometric monitoring of intra-abdominal pressure andcore body temperature.TraumaGuard (TG) is a silicone catheter with two polyurethanepressure sensing balloons used to detect changes in intra-abdominalpressure (IAP), the outer distal balloon and the inner sensingballoon. The outer balloon is filled with 2.0 - 2.5cc of sterile waterto ensure contact with the bladder wall. The inner sensing balloonhas a column of air that runs the entire length of the catheter fromthe middle of the outer sensing balloon to a connector on the hub.Temperature can be displayed in Celsius or Fahrenheit and isaccurate 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 arereusable. TG is a single use catheter intended for short-term use (nomore than 30 days). | |
| Indication for Use: | TraumaGuard Intra-abdominal Pressure Sensing System is intendedfor use in the drainage of urine for continuous measuring ofintraabdominal pressure (IAP) and core body temperature (CBT). Themeasured IAP can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and abdominal compartmentsyndrome (ACS). |
| The Indications for Use statement for the TraumaGuard Intra-abdominal Pressure Sensing System is identical to the predicatedevice. Both the subject and predicate devices have the sameintended use for the drainage of urine for continuous measuring ofIAP and CBT. | |
| Legally MarketedDevices To WhichSubstantial EquivalenceIs Claimed: | The TraumaGuard Intra-abdominal Pressure Sensing System isidentical to the existing sizes of TraumaGuard Intra-abdominalPressure Sensing System in intended use, materials, physicalcharacteristics, and performance characteristics. The modificationsattributed to the predicate device are the addition of MR conditionalto the labeling. |
| Performance Data: | Performance data for the TraumaGuard Intra-abdominal PressureSensing System is compared to that of the predicate device(K210570) identified in these 510(K) summaries. Results oflaboratory tests demonstrate the TraumaGuard Intra-abdominalPressure Sensing System is substantially equivalent to the legallymarketed device. |
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Table 2: 510(k) Device Comparison
| TraumaGuard Intra-abdominalPressure Catheter (SubjectDevice) | TraumaGuard Intra-abdominalPressure Catheter (PredicateDevice) | 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 |
| MedicalSpecialty | General and Plastic SurgeryGastroenterology/Urology | General and Plastic Surgery | Same |
| Indications forUse | The TraumaGuard Intra-abdominal Pressure SensingCatheter is intended for thedrainage of urine from thebladder, monitoring of urineoutput (when used with a standardcollection bag), monitoring ofcore body temperature andcontinuous measuring of intra-abdominal pressure. Themeasured pressures can be usedas an aid in the diagnosis of intra-abdominal hypertension, and theassociated clinical syndrome ofabdominal compartmentsyndrome. The TraumaGuardintra-abdominal pressure sensingcatheter displays core bodytemperature in the healthcaresetting in degrees Fahrenheit anddegrees Celsius.TraumaGuard is a single usedevice intended for short-term use(less than 30 days). | The TraumaGuard Intra-abdominal Pressure SensingCatheter is intended for thedrainage of urine from thebladder, monitoring of urineoutput (when used with astandard collection bag),monitoring of core bodytemperature and continuousmeasuring of intra-abdominalpressure. The measured pressurescan be used as an aid in thediagnosis of intra-abdominalhypertension, and the associatedclinical syndrome of abdominalcompartment syndrome. TheTraumaGuard intra-abdominalpressure sensing catheter displayscore body temperature in thehealthcare setting in degreesFahrenheit and degrees Celsius.TraumaGuard is a single usedevice intended for short-term use(less than 30 days). | Same |
| Intended Use | To serve as a Foley catheter andmonitor of core body temperatureand intra-abdominal pressure. | To serve as a Foley catheter andmonitor of core body temperatureand intra-abdominal pressure. | Same |
| Principle ofoperation | Outer distal balloon constrictsonto inner sensing balloon whenintra- abdominal pressureincreases. This displaces the air inthe inner pressure sensing balloonproximally which increases thetension of the connector locatedin the catheter hub onto thepressure sensor located in thecable. | Outer distal balloon constrictsonto inner sensing balloon whenintra- abdominal pressureincreases. This displaces the airin the inner pressure sensingballoon proximally whichincreases the tension of theconnector located in the catheterhub onto the pressure sensorlocated in the cable. | Same |
| TechnicalComparison | Dual pressure sensing balloonsystem allows for continuousmonitoring of IAP. Collection ofurine via standard urine collectiontubing and bag. TraumaGuardcable connects to standardhospital bedside monitors alreadylocated in clinical setting. | Dual pressure sensing balloonsystem allows for continuousmonitoring of IAP. Collection ofurine via standard urinecollection tubing and bag.TraumaGuard cable connects tostandard hospital bedsidemonitors already located inclinical setting. | Same |
| Components | Silicone catheter with siliconeretention balloon andpolyurethane balloons. Pressureand temperature transmittingcustom cables | Silicone catheter with siliconeretention balloon andpolyurethane balloons. Pressureand temperature transmittingcustom cables | Same |
| Placement | In the bladder | In the bladder | Same |
| Balloons | 3 | 3 | Same |
| CatheterFrench Size | 18 | 18 | Same |
| Not made withnatural rubberlatex | Yes | Yes | Same |
| Biomonitoring | Intra-abdominal pressure and corebody temperature | Intra-abdominal pressure andcore body temperature | Same |
| Catheter | Single Use Disposable | Single Use Disposable | Same |
| Mode ofPressure Sensing | Sensor located in cableconnected to catheter hub | Sensor located in cable connectedto catheter hub | Same |
| CustomConsoleRequired | No | No | Same |
| Wear Duration | 30 days | 30 days | Same |
| MonitoringDuration | Continuous | Continuous | Same |
| SterilizationMethod | E-beam Radiation | E-beam Radiation | Same |
| Minimum SAL | 1 x 10-6 | 1 x 10-6 | Same |
| MRCompatible | Conditional | MR Unsafe | See Below |
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| 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. |
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| The following standards were used in testing: | |
|---|---|
| ● | ASTM F2503-20 Standard Practice For Marking MedicalDevices And Other Items For Safety In The MagneticResonance Environment. |
| ● | ASTM F623-19 Standard Performance Specification for FoleyCatheters. |
| ● | ASTM F2052-21 Standard Test Method For Measurement OfMagnetically Induced Displacement Force On MedicalDevices In The Magnetic Resonance Environment. |
| ● | ASTM F2213-17 Standard Test Method For Measurement OfMagnetically Induced Torque On Medical Devices In TheMagnetic Resonance Environment. |
| ● | ASTM F2182-19e2 Standard Test Method For MeasurementOf Radio Frequency Induced Heating On Or Near PassiveImplants During Magnetic Resonance Imaging. |
| ● | ISO 10993-1, Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process. |
| ● | ISO 10993-12:2021 Biological Evaluation of MedicalDevices, Part 12: Sample Preparation and ReferenceMaterials. |
| Additional testing was performed to support and demonstrate the non-pyrogenicity of the Sentinel TraumaGuard Intra-abdominal Pressure SensingCatheter. 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 theMagnetic Resonance (MR) Environment. Guidance forIndustry and Food and Drug Administration Staff. Documentissued on October 10, 2023.Use of International Standard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1: Evaluation and testingwithin a risk management process" Guidance for Industry andFood and Drug Administration Staff Document issued onSeptember 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. |
|---|---|
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
§ 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.