(150 days)
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
The TruWave Disposable Pressure Transducer is a sterile, single-use device that is used to monitor intravascular, intracranial, and intrauterine pressures. The pressure transducer has a straight, flow-through design across the pressure sensor, and is available with or without the integral flush device. The pressure sensor is a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A transparent fluid path with an integral stopcock at one end and an integral flush device (either 3mL or 30mL) at the other end encloses the sensor. The enclosure of the TruWave Disposable Pressure Transducer has a pathway for air to enter the housing and acts as a vent. A disposable cable (available in 10-inch/25 cm and 48-inch/120 cm lengths) attached to the pressure transducer housing interfaces with an Edwards Lifesciences reusable cable that is specifically wired for the monitor being used. The TruWave Disposable Pressure Transducer can be mounted on the patient's arm using an arm strap or it may be mounted on an IV pole in a holder. The TruWave Disposable Pressure Transducer may be a component in various pressure monitoring kits or systems.
The provided text describes a 510(k) premarket notification for a medical device, the TruWave Disposable Pressure Transducer. The information primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests.
However, the question asks for details related to acceptance criteria, device performance, and study information that would typically be found in a clinical study report or a more detailed performance study. The provided document does not contain a table of acceptance criteria with reported device performance metrics in a quantitative sense, nor does it detail a clinical study with human patients, ground truth establishment by experts, or MRMC studies.
Instead, the document states: "All device acceptance criteria were met. Results of non-clinical testing show that the subject device TruWave Disposable Pressure Transducer meets its intended use and demonstrate that the device is as safe, as effective, and performs as well as the predicate device." It then lists types of non-clinical testing performed.
Therefore,Based on the provided text, the following information can be extracted regarding acceptance criteria and the study:
1. A table of acceptance criteria and the reported device performance:
The document states "All device acceptance criteria were met" and that the non-clinical testing demonstrated the device "meets its intended use and demonstrate that the device is as safe, as effective, and performs as well as the predicate device." However, a specific table outlining quantitative acceptance criteria and their corresponding reported device performance values is not provided in the excerpt. The text mentions several types of testing performed to demonstrate equivalence and safety/effectiveness.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1:2018) | Compliance demonstrated. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1, IEC 60601-2-37, and IEC 60601-1-2 standards. |
| Electromagnetic Immunity (EMI) | Complies with IEC 60601-1, IEC 60601-2-37, and IEC 60601-1-2 standards. |
| Electrical Safety (ANSI/AAMI BP22:1994, IEC 60601-2-34:2011) | Defibrillator challenge, dielectric strength, liquid ingress, and leakage current tests performed and met. |
| Device Performance (ANSI/AAMI BP22:1994, IEC 60601-2-34:2011) | Accuracy, excitation/signal impedance, light sensitivity, symmetry, and overpressure tests conducted and met. |
| Magnetic Resonance (MR) Safety (ASTM F2503-20) | Performed and met standards. |
| Mechanical Testing (ANSI/AAMI BP22:1994, Edwards' design requirements) | Performed and met requirements. |
| Usability/Human Factors | Evaluated by healthcare provider users. Output implied to be satisfactory as acceptance criteria were met. |
2. Sample size(s) used for the test set and the data provenance:
The document refers to "non-clinical testing" and does not specify sample sizes in terms of number of devices or data points for each test category. No information on data provenance (e.g., country of origin, retrospective or prospective) is provided, as these are non-clinical (laboratory/bench) tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The testing described is non-clinical performance and safety testing against established standards, not a clinical study requiring expert consensus for ground truth. The "usability/human factors" evaluation was performed by "healthcare provider users," but without details on the number or specific qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided, as it pertains to clinical studies with expert reviewers and not the non-clinical testing described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and not provided. The device is a physical pressure transducer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided, as the device is a physical pressure transducer, not an algorithm.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" relates to compliance with established international and national standards (e.g., ISO 10993-1, IEC 60601 series, ANSI/AAMI BP22, ASTM F2503) and the manufacturer's internal design requirements. This is based on standardized measurement and testing protocols, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set:
This information is not applicable and not provided. The described tests are for device verification and validation, not for training a model or algorithm.
9. How the ground truth for the training set was established:
This information is not applicable and not provided, as there is no "training set" in the context of the reported non-clinical device testing.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 22, 2022
Edwards Lifesciences LLC Carmen Chen Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K222216
Trade/Device Name: TruWave Disposable Pressure Transducer Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO Dated: November 22, 2022 Received: November 22, 2022
Dear Carmen Chen:
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.
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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 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 (OS) 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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name TruWave Disposable Pressure Transducer
Indications for Use (Describe)
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
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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SECTION 5. 510(K) SUMMARY
| 510(k) Submitter | Edwards Lifesciences, LLCOne Edwards WayIrvine, CA, USA 92614 | ||
|---|---|---|---|
| Contact Person | Primary ContactCarmen G ChenManager, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Telephone: (949) 250 - 5469Fax: (949) 809 - 2954Email:Carmen.Chen@edwards.com | Secondary ContactKaren O'LearySr. Director, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Telephone: (949) 610-9179Fax: (949) 809 - 2954Email:Karen.OLeary@edwards.com | |
| Date Prepared | December 21, 2022 | ||
| Trade Name | TruWave™ | ||
| Common Name | Disposable Pressure Transducer | ||
| RegulationNumber/RegulationName | 21 CFR 870.2870 / Transducer, Pressure, Catheter Tip | ||
| Product Code | DXO | ||
| Regulation Class | Class II | ||
| Predicate Device | K183413- TruWave Disposable Pressure Transducer (cleared 01 May 2019) | ||
| DeviceDescription | The TruWave Disposable Pressure Transducer is a sterile, single-usedevice that is used to monitor intravascular, intracranial, and intrauterinepressures. The pressure transducer has a straight, flow-through designacross the pressure sensor, and is available with or without the integralflush device. The pressure sensor is a pressure sensitive silicon chip withtwo electrodes for excitation voltage and two electrodes for signal output.A transparent fluid path with an integral stopcock at one end and anintegral flush device (either 3mL or 30mL) at the other end encloses thesensor. The enclosure of the TruWave Disposable Pressure Transducer hasa pathway for air to enter the housing and acts as a vent. A disposablecable (available in 10-inch/25 cm and 48-inch/120 cm lengths) attached tothe pressure transducer housing interfaces with an Edwards Lifesciencesreusable cable that is specifically wired for the monitor being used. TheTruWave Disposable Pressure Transducer can be mounted on the patient's | ||
| arm using an arm strap or it may be mounted on an IV pole in a holder. | |||
| The TruWave Disposable Pressure Transducer may be a component in various pressure monitoring kits or systems. | |||
| Indications forUse/IntendedUse | The Pressure Monitoring Kit with TruWave Disposable PressureTransducer is for use on patients requiring intravascular, intracranial, orintrauterine pressure monitoring. | ||
| Comparison toPredicate Device | The subject TruWave Disposable Pressure Transducer device of thisTraditional 510(k) is identical to the predicate device cleared in K183413in terms of indications for use/intended use except for the proposed design,material, and labeling changes to the device. See table below. Differencesin technological characteristics do not raise any new concerns of safety andeffectiveness. Verification and validation testing for the subject devicedemonstrate safety and effectiveness. The TruWave Disposable PressureTransducer has shown to be substantially equivalent to the predicate devicefor its intended use in a hospital setting or other appropriate clinicalenvironment. | ||
| Device Testing | Biocompatibility testing was performed in accordance with ISO 10993-1:2018 – Biological evaluation of medical devices – Part 1: Evaluation andtesting within a risk management process, and FDA guidance document,Use of International Standard ISO 10993-1, “Biological evaluation ofmedical devices – Part 1: Evaluation and testing within a risk managementprocess”, issued on September 4, 2020. | ||
| Electromagnetic compatibility (EMC) and Electromagnetic Immunity(EMI) testing were conducted and comply with the IEC 60601-1, IEC60601-2-37 standards for safety and the IEC 60601-1-2 standard for EMC. | |||
| Electrical safety testing (including defibrillator challenge, dielectricstrength, liquid ingress, and leakage current) was performed in accordancewith ANSI/AAMI BP22:1994/(R)2016 and IEC 60601-2-34: 2011 | |||
| Testing (including accuracy, excitation/signal impedance, light sensitivity,symmetry, and overpressure) was conducted per ANSI/AAMIBP22:1994/(R)2016 and IEC 60601-2-34: 2011. | |||
| Magnetic resonance safety testing was performed based on ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items forSafety in the Magnetic Resonance Environment. | |||
| Mechanical testing was performed in accordance with ANSI/AAMIBP22:1994/(R) 2016 and Edwards' design requirements. | |||
| The usability/human factors of the TruWave Disposable PressureTransducer were evaluated by healthcare provider users. | |||
| All device acceptance criteria were met. Results of non-clinical testing | |||
| Conclusion | show that the subject device TruWave Disposable Pressure Transducer | ||
| meets its intended use and demonstrate that the device is as safe, as | |||
| effective, and performs as well as the predicate device. The differences | |||
| between the subject device and predicate device do not raise new issues of | |||
| safety and/or effectiveness. Therefore, the subject device TruWave | |||
| Disposable Pressure Transducer is substantially equivalent to the predicate | |||
| device TruWave Disposable Pressure Transducer (K183413). | |||
| Function/Parameter | Subject Device(K222216) | Predicate Device(K183413) | Comparison |
| Device Name | TruWave™ DisposablePressure Transducer | TruWave™ DisposablePressure Transducer | Same |
| 510(k) Number | K222216 | K183413(cleared on 01 April 2019) | Not Applicable |
| Manufacturer | Edwards Lifesciences, LLC | Edwards Lifesciences, LLC | Same |
| Device Classification | Class II | Class II | Same |
| Regulation Number | 21 CFR §870.2870- Cathetertip pressure transducer | 21 CFR §870.2870- Cathetertip pressure transducer | Same |
| Product Code | DXO | DXO | Same |
| Intended Use | The Pressure Monitoring Kitwith TruWave DPT is usedon patients requiringintravascular, intracranial, orintrauterine pressuremonitoring. | The Pressure Monitoring Kitwith TruWave DPT is usedon patients requiringintravascular, intracranial, orintrauterine pressuremonitoring. | Same |
| Indications for Use | The Pressure Monitoring Kitwith TruWave DPT is foruse on patients requiringintravascular, intracranial, orintrauterine pressuremonitoring. | The Pressure Monitoring Kitwith TruWave DPT is foruse on patients requiringintravascular, intracranial, orintrauterine pressuremonitoring. | Same |
| Operating Principle | The TruWave DPT sensorconsists of a silicon chipwhich when fluid flowsthrough the fluid path allowsa piezo-electric diaphragm ofthe chip to be deflected,which changes resistance ofthe circuit, whichcorrespondingly causes achange in voltage. Thisvoltage change is transmittedthrough the cable to a patientmonitor. | The TruWave DPT sensorconsists of a silicon chipwhich when fluid flowsthrough the fluid path allowsa piezo-electric diaphragm ofthe chip to be deflected,which changes resistance ofthe circuit, whichcorrespondingly causes achange in voltage. Thisvoltage change is transmittedthrough the cable to a patientmonitor. | Same |
| Design | Straight, flow-through designacross the pressure sensorHousing with curved sidegrips and arm mount strapslots | Straight, flow-through designacross the pressure sensorHousing with straight sidegrips and arm mount strapslots | SameDifferent because the subjectdevice has curved side grips.No new issues of safety andeffectiveness. |
| No test port | Has test port | Different because the subjectdevice does not contain a testport.No new issues of safety andeffectiveness. | |
| Function/Parameter | Subject Device(K222216) | Predicate Device(K183413) | Comparison |
| Has small profile analog pressure sensor with 4 contact pads | Has large profile analog pressure sensor with 5 contact pads | Different because the subject device contains a new, smaller analog pressure sensor. The following tests were conducted:• Biocompatibility• EMC/EMI and Electrical Safety and Performance• MR Safety• MechanicalNo new issues of safety and effectiveness. | |
| Integrated flush device;Molded-in fluid channel as the restrictor to regulate flow | Integrated flush device;Bonded-in PVC capillary tubing component as the restrictor to regulate flow | Different because the subject device does not contain a PVC capillary tubing (i.e., flow restrictor) component. The following tests were conducted:• Biocompatibility• MechanicalNo new issues of safety and effectiveness. | |
| Integrated stopcock;3-way stopcock body molded into flowpath and stopcock handle mechanically assembled | Integrated stopcock;3-way stopcock bonded onto housing using UV cure adhesive | Different. The following tests were conducted:• Biocompatibility• MechanicalNo new issues of safety and effectiveness. | |
| Flush pull-tab is angled at 45° from the Housing | Flush pull-tab is angled at 90° from the Housing | Different because the flush pull-tab (i.e., Snap-tab) of the subject device is angled at 45° instead of 90° from the Housing. The following tests were conducted:• Biocompatibility• Mechanical• Design ValidationNo new issues of safety and effectiveness. | |
| Function/Parameter | Subject Device(K222216) | Predicate Device(K183413) | Comparison |
| Disposable cable is 10 inchesin length and has four copperwires | Disposable cable is 12 inchesin length and has five copperwires | Different because thedisposable cable of thesubject device is shorter, hasone less conductive wire, andhas a smaller cross-sectionthan the predicate device.The following tests wereconducted:• EMC/EMI andElectrical Safetyand Performance• MR Safety• MechanicalNo new issues of safety andeffectiveness. | |
| Materials | Sensor Gel:SiliconeSensor Gel Cup:Polybutylene terephthalate(PBT) | Sensor Gel:SiliconeSensor Gel Cup:Polycarbonate | Same |
| Different. The followingtests were conducted:• Biocompatibility• EMC/EMI andElectrical Safetyand Performance• MechanicalNo new issues of safety andeffectiveness. | |||
| Resistors:Laser-trimmed integratedcircuit | Resistors:Laser-trimmed screenedероху | Different. The followingtests were conducted:• EMC/EMI andElectrical Safetyand Performance• MR SafetyNo new issues of safety andeffectiveness. | |
| Spring terminals:Beryllium copper | Pads and metallization:Palladium silver | Different. The followingtests were conducted:• EMC/EMI andElectrical Safetyand Performance• MR Safety• MechanicalNo new issues of safety andeffectiveness. | |
| Sensor Seal:Silicone gasket | Sensor Seal:Ultraviolet cure (acrylic)adhesive | Different. The followingtests were conducted:• Biocompatibility• EMC/EMI andElectrical Safetyand Performance• MechanicalNo new issues of safety andeffectiveness. | |
| Function/Parameter | Subject Device(K222216) | Predicate Device(K183413) | Comparison |
| Flush pull-tab:Silicone | Flush pull-tab:Silicone | Different; slight changes inchemical composition. Thefollowing tests wereconducted:• Biocompatibility• MechanicalNo new issues of safety andeffectiveness. | |
| Stopcock body:Polycarbonate | Stopcock body:Polycarbonate | Same | |
| Housing:Polycarbonate | Housing:Polycarbonate | Same | |
| Disposable cable jacket:PVC with plasticizer | Disposable cable jacket:PVC with plasticizer | Different. The following testwas conducted:• MechanicalNo new issues of safety andeffectiveness. | |
| Molded-in Fluid ChannelRestrictor:Polycarbonate | Capillary Tubing Restrictor:PVC with DINCH plasticizer | Different; eliminating PVCand integrating the flowrestrictor into the flowpath.The following tests wereconducted:• Biocompatibility• MechanicalNo new issues of safety andeffectiveness. | |
| Accessories | Pressure Tubing | Pressure Tubing | Same |
| Stopcocks | Stopcocks | Same | |
| Flush device(3mL/hr or 30 mL/hr) | Flush device(3mL/hr or 30 mL/hr) | Same | |
| IV Set | IV Set | Same | |
| VAMP (Venous ArterialBlood ManagementProtection System) | VAMP (Venous ArterialBlood ManagementProtection System) | Same | |
| Disposable holder/TruClipholder | Disposable holder/TruClipholder | Same | |
| IV Pole Clamp, IV PoleMount Plate | IV Pole Clamp, IV PoleMount Plate | Same | |
| Arm Mount Plate/Strap | Arm Mount Plate/Strap | Same | |
| Compatible monitor cable | Compatible monitor cable | Same | |
| Sterilization | 100% Ethylene OxideE-beam radiation | 100% Ethylene OxideE-beam radiation | Same |
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§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).