TruWave Disposable Pressure Transducer

K222216 · Edwards Lifesciences, LLC · DXO · Dec 22, 2022 · Cardiovascular

Device Facts

• Record ID: K222216
• Device Name: TruWave Disposable Pressure Transducer
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXO · Cardiovascular
• Decision Date: Dec 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2870
• Device Class: Class 2

Intended Use

The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

Device Story

TruWave Disposable Pressure Transducer is a sterile, single-use device for monitoring intravascular, intracranial, and intrauterine pressures. It features a straight, flow-through design with an integrated pressure-sensitive silicon chip. Fluid flow deflects a piezo-electric diaphragm on the chip, changing circuit resistance and generating a voltage signal proportional to pressure. This signal is transmitted via a disposable cable to a reusable cable connected to a patient monitor. The device includes an integrated stopcock and flush device (3mL or 30mL) and can be mounted on an IV pole or patient arm. Healthcare providers (physicians, nurses) use the monitor output to assess patient hemodynamic status and guide clinical decision-making. The device benefits patients by providing continuous, real-time pressure data for critical care management.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1), EMC/EMI (IEC 60601-1-2), electrical safety (ANSI/AAMI BP22, IEC 60601-2-34), MR safety (ASTM F2503), and mechanical performance. Usability/human factors were evaluated by healthcare providers. All acceptance criteria were met.

Technological Characteristics

Materials: Silicone (gel, seal, pull-tab), PBT (gel cup), Polycarbonate (stopcock, housing, fluid channel). Sensing: Piezo-electric silicon chip. Connectivity: Wired interface to patient monitor via disposable/reusable cable. Sterilization: Ethylene Oxide or E-beam radiation. Standards: ANSI/AAMI BP22, IEC 60601-1, IEC 60601-2-34, IEC 60601-2-37, ISO 10993-1, ASTM F2503.

Indications for Use

Indicated for patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

Regulatory Classification

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.

Predicate Devices

• TruWave Disposable Pressure Transducer (K183413)

Submission Summary (Full Text)

{0}------------------------------------------------

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.

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known)

K222216

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)

#### 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."

{3}------------------------------------------------

## SECTION 5. 510(K) SUMMARY

| 510(k) Submitter | Edwards Lifesciences, LLC<br>One Edwards Way<br>Irvine, CA, USA 92614 | | |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | <b>Primary Contact</b><br>Carmen G Chen<br>Manager, Regulatory Affairs<br>Edwards Lifesciences<br>One Edwards Way<br>Irvine, CA 92614<br>Telephone: (949) 250 - 5469<br>Fax: (949) 809 - 2954<br>Email:<br>[e-mail] | <b>Secondary Contact</b><br>Karen O'Leary<br>Sr. Director, Regulatory Affairs<br>Edwards Lifesciences<br>One Edwards Way<br>Irvine, CA 92614<br>Telephone: [phone]<br>Fax: (949) 809 - 2954<br>Email:<br>[e-mail] | |
| | Date Prepared | December 21, 2022 | |
| Trade Name | TruWave™ | | |
| Common Name | Disposable Pressure Transducer | | |
| Regulation<br>Number/<br>Regulation<br>Name | 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) | | |
| Device<br>Description | The TruWave Disposable Pressure Transducer is a sterile, single-use<br>device that is used to monitor intravascular, intracranial, and intrauterine<br>pressures. The pressure transducer has a straight, flow-through design<br>across the pressure sensor, and is available with or without the integral<br>flush device. The pressure sensor is a pressure sensitive silicon chip with<br>two electrodes for excitation voltage and two electrodes for signal output.<br>A transparent fluid path with an integral stopcock at one end and an<br>integral flush device (either 3mL or 30mL) at the other end encloses the<br>sensor. The enclosure of the TruWave Disposable Pressure Transducer has<br>a pathway for air to enter the housing and acts as a vent. A disposable<br>cable (available in 10-inch/25 cm and 48-inch/120 cm lengths) attached to<br>the pressure transducer housing interfaces with an Edwards Lifesciences<br>reusable cable that is specifically wired for the monitor being used. The<br>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. | | |
| Indications for<br>Use/Intended<br>Use | The Pressure Monitoring Kit with TruWave Disposable Pressure<br>Transducer is for use on patients requiring intravascular, intracranial, or<br>intrauterine pressure monitoring. | | |
| Comparison to<br>Predicate Device | The subject TruWave Disposable Pressure Transducer device of this<br>Traditional 510(k) is identical to the predicate device cleared in K183413<br>in terms of indications for use/intended use except for the proposed design,<br>material, and labeling changes to the device. See table below. Differences<br>in technological characteristics do not raise any new concerns of safety and<br>effectiveness. Verification and validation testing for the subject device<br>demonstrate safety and effectiveness. The TruWave Disposable Pressure<br>Transducer has shown to be substantially equivalent to the predicate device<br>for its intended use in a hospital setting or other appropriate clinical<br>environment. | | |
| Device Testing | Biocompatibility testing was performed in accordance with ISO 10993-1:<br>2018 – Biological evaluation of medical devices – Part 1: Evaluation and<br>testing within a risk management process, and FDA guidance document,<br>Use of International Standard ISO 10993-1, “Biological evaluation of<br>medical devices – Part 1: Evaluation and testing within a risk management<br>process”, issued on September 4, 2020. | | |
| | Electromagnetic compatibility (EMC) and Electromagnetic Immunity<br>(EMI) testing were conducted and comply with the IEC 60601-1, IEC<br>60601-2-37 standards for safety and the IEC 60601-1-2 standard for EMC. | | |
| | Electrical safety testing (including defibrillator challenge, dielectric<br>strength, liquid ingress, and leakage current) was performed in accordance<br>with ANSI/AAMI BP22:1994/(R)2016 and IEC 60601-2-34: 2011 | | |
| | Testing (including accuracy, excitation/signal impedance, light sensitivity,<br>symmetry, and overpressure) was conducted per ANSI/AAMI<br>BP22:1994/(R)2016 and IEC 60601-2-34: 2011. | | |
| | Magnetic resonance safety testing was performed based on ASTM F2503-<br>20 Standard Practice for Marking Medical Devices and Other Items for<br>Safety in the Magnetic Resonance Environment. | | |
| | Mechanical testing was performed in accordance with ANSI/AAMI<br>BP22:1994/(R) 2016 and Edwards' design requirements. | | |
| | The usability/human factors of the TruWave Disposable Pressure<br>Transducer 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<br>(K222216) | Predicate Device<br>(K183413) | Comparison |
| Device Name | TruWave™ Disposable<br>Pressure Transducer | TruWave™ Disposable<br>Pressure Transducer | Same |
| 510(k) Number | K222216 | K183413<br>(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- Catheter<br>tip pressure transducer | 21 CFR §870.2870- Catheter<br>tip pressure transducer | Same |
| Product Code | DXO | DXO | Same |
| Intended Use | The Pressure Monitoring Kit<br>with TruWave DPT is used<br>on patients requiring<br>intravascular, intracranial, or<br>intrauterine pressure<br>monitoring. | The Pressure Monitoring Kit<br>with TruWave DPT is used<br>on patients requiring<br>intravascular, intracranial, or<br>intrauterine pressure<br>monitoring. | Same |
| Indications for Use | The Pressure Monitoring Kit<br>with TruWave DPT is for<br>use on patients requiring<br>intravascular, intracranial, or<br>intrauterine pressure<br>monitoring. | The Pressure Monitoring Kit<br>with TruWave DPT is for<br>use on patients requiring<br>intravascular, intracranial, or<br>intrauterine pressure<br>monitoring. | Same |
| Operating Principle | The TruWave DPT sensor<br>consists of a silicon chip<br>which when fluid flows<br>through the fluid path allows<br>a piezo-electric diaphragm of<br>the chip to be deflected,<br>which changes resistance of<br>the circuit, which<br>correspondingly causes a<br>change in voltage. This<br>voltage change is transmitted<br>through the cable to a patient<br>monitor. | The TruWave DPT sensor<br>consists of a silicon chip<br>which when fluid flows<br>through the fluid path allows<br>a piezo-electric diaphragm of<br>the chip to be deflected,<br>which changes resistance of<br>the circuit, which<br>correspondingly causes a<br>change in voltage. This<br>voltage change is transmitted<br>through the cable to a patient<br>monitor. | Same |
| Design | Straight, flow-through design<br>across the pressure sensor<br>Housing with curved side<br>grips and arm mount strap<br>slots…