TruWave Disposable Pressure Transducer

K183413 · Edwards Lifeciences, LLC · DXO · May 1, 2019 · Cardiovascular

Device Facts

• Record ID: K183413
• Device Name: TruWave Disposable Pressure Transducer
• Applicant: Edwards Lifeciences, LLC
• Product Code: DXO · Cardiovascular
• Decision Date: May 1, 2019
• 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 kit for monitoring intravascular, intracranial, or intrauterine pressure. Device features straight, flow-through design where fluid passes across pressure sensor; available with or without integral flush device. Kit includes sterile cable (12-inch or 48-inch) interfacing with Edwards Lifesciences cables wired for specific patient monitors. Used in hospitals and clinical environments; operated by healthcare professionals. Device converts physiological pressure into electrical signals displayed on patient monitors to assist clinical decision-making and patient management.

Clinical Evidence

No clinical data. Substantial equivalence supported by biocompatibility and functional bench testing.

Technological Characteristics

Sterile, single-use pressure transducer with straight, flow-through design. Includes integral flush device option and sterile interface cables (30 cm or 120 cm). Operates via pressure sensing of fluid column. Biocompatibility and functional testing performed.

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 (K171996)
• TruWave Disposable Pressure Transducer (K142749)

Submission Summary (Full Text)

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May 1, 2019

Edwards Lifeciences, LLC Ye Seul Kim Senior Specialist, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K183413

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: March 29, 2019 Received: April 1, 2019

Dear Ye Seul Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Matthew Hillebrenner Director (Acting) DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K183413

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, LLC | |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Primary Contact | Secondary Contact |
| | Ye Seul Kim<br>Senior Specialist, Regulatory Affairs<br>Edwards Lifesciences<br>One Edwards Way<br>Irvine, CA 92614<br>Tel: (949) 250 - 2445<br>Fax: (949) 809 - 5425<br>Email: [e-mail] | Renate MacLaren<br>Senior Manager, Regulatory Affairs<br>Edwards Lifesciences<br>One Edwards Way<br>Irvine, CA 92614<br>Tel: (949) 250 - 5783<br>Fax: (949) 809 – 2941<br>Email: [e-mail] |
| Date Prepared | December 7, 2018 | |
| Trade Name | TruWave™ | |
| Common Name | Disposable Pressure Transducer | |
| Classification<br>Name | Transducer, pressure, catheter tip (21 CFR 870.2870) | |
| Regulation<br>Class/Product<br>Code | Class II<br>DXO | |
| Primary<br>Predicate Device | K171996, TruWave Disposable Pressure Transducer (cleared 10/23/2017) | |
| Secondary<br>Predicate Device | K142749, TruWave Disposable Pressure Transducer (cleared 01/18/2015) | |
| Device<br>Description | The Edwards Lifesciences Pressure Monitoring kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data.<br><br>The TruWave disposable pressure transducer has a straight, flow through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device. | |
| Indications for<br>Use/Intended Use | The Pressure Monitoring kit with TruWave disposable pressure transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring. | |
| Comparative<br>Analysis | The subject device is identical to the predicate devices in terms of intended use/ indications for use, and technology. The proposed change to the device is a material change to a component of an existing legally | |
| | marketed device. Testing was conducted to ensure that the change in<br>material did not alter the performance of the TruWave disposable<br>pressure transducer. | |
| | The subject TruWave disposable pressure transducer has been shown<br>to be substantially equivalent to the predicate devices for its intended<br>use in hospitals and other appropriate clinical environments. | |
| Functional/<br>Safety Testing | The TruWave disposable pressure transducer kits successfully passed<br>biocompatibility and functional testing. | |
| Conclusion | The subject TruWave disposable pressure transducer kits are<br>substantially equivalent to the predicate TruWave disposable pressure<br>transducer kits (K171996 and K142749). | |

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