TruWave Disposable Pressure Transducer

K171996 · Edwards Lifesciences, LLC · DXO · Oct 23, 2017 · Cardiovascular

Device Facts

• Record ID: K171996
• Device Name: TruWave Disposable Pressure Transducer
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXO · Cardiovascular
• Decision Date: Oct 23, 2017
• 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

Sterile, single-use pressure monitoring kit; monitors intravascular, intracranial, or intrauterine pressure. Device features straight, flow-through design where fluid passes across pressure sensor; includes optional integral flush device. Interfaces with patient monitor via specific cable (12-inch or 48-inch lengths). Used in hospitals and clinical environments by healthcare professionals. Provides real-time pressure data to clinicians for patient monitoring and clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility, functional, electrical performance, safety, and usability testing.

Technological Characteristics

Disposable pressure transducer with straight, flow-through design. Materials include non-phthalate plasticizers (TOTM, DINCH). Electrical performance complies with AAMI/ANSI BP22:1994/(R)2016. Sterilization method: E-beam radiation.

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

• Pressure Monitoring Kit with TruWave Disposable Pressure Transducers (K141495)
• TruWave Disposable Pressure Transducer (K142749)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

October 23, 2017

Edwards Lifesciences, LLC Renate MacLaren Senior Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K171996

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: September 21, 2017 Received: September 22, 2017

Dear Renate Maclaren:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Wilhelm

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K171996

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

# K171996

| Sponsor: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration Number: | 2015691 |
| Contact Person: | Renate A. MacLaren, Ph.D.<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 |
| Date: | June 30, 2017 |
| Trade Name: | TruWave™ Disposable Pressure Transducer |
| Common Name: | Disposable Pressure Transducer |
| Classification Name: | Transducer, pressure, catheter tip<br>21 CFR 870.2870 |
| Product Code: | DXO, Class II |
| Primary Predicate<br>Device: | K141495, Pressure Monitoring Kit with TruWave Disposable<br>Pressure Transducers (cleared 09/03/2014) |
| Secondary Predicate<br>Device: | K142749, TruWave Disposable Pressure Transducer (cleared<br>01/18/2015) |
| Device Description: | The Edwards Lifesciences Pressure Monitoring Kit with TruWave<br>disposable pressure transducer is a sterile, single-use kit that<br>monitors intravascular blood pressure, intracranial pressure, and<br>intrauterine pressure. The disposable sterile cable (available in 12-<br>inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with<br>an Edwards Lifesciences cable that is specifically wired for the<br>patient monitor used to display the pressure data.<br>The TruWave Disposable Pressure Transducer has a straight, flow<br>through design, where the fluid is passed across the pressure<br>sensor. The DPT is available either with or without an integral flush<br>device. |
| Indications for Use/<br>Intended Use: | The Pressure Monitoring Kit with TruWave Disposable Pressure<br>Transducer is for use on patients requiring intravascular,<br>intracranial, or intrauterine pressure monitoring. |
| Comparison to<br>Predicate Device: | The subject device of this Traditional 510(k) is identical to its<br>predicate device in terms of intended use/ indications for use, and<br>technology. The proposed changes to the device include a change<br>of sterilization method (100% Ethylene Oxide to E-beam radiation),<br>change in the PVC plasticizer from DEHP to the following non-<br>phthalate plasticizers: Tris-(2-Ethylhexyl) Trimellitate (TOTM) for<br>the drip chamber housing in the IV sets and Cyclohexane-1, 2-<br>dicarboxylic acid diisononyl ester (DINCH®) for tubing. Update to<br>product labeling to reflect changes in sterilization method (from EO<br>to E-beam radiation) and removal of phthalate symbol on all levels<br>of packaging. Clarifying the design verification (electrical) test<br>results in the Instructions for Use 'Performance Specifications'<br>section to comply with AAMI/ ANSI BP22: 1994/(R) 2016. Testing<br>was conducted to ensure that the change in sterilization method<br>and change in materials did not alter the performance of the<br>TruWave DPT kits. The TruWave disposable pressure transducer<br>kits have been shown to be substantially equivalent to the predicate<br>device for its intended use in hospitals and other appropriate clinical<br>environments. |
| Functional/Safety<br>Testing: | The TruWave disposable pressure transducer kits successfully<br>passed biocompatibility, functional testing, electrical performance<br>and safety testing, and usability testing. The products also passed<br>all biocompatibility testing. |
| Conclusion: | The subject TruWave Disposable Pressure Transducer kits are<br>substantially equivalent to the predicate TruWave Disposable<br>Pressure Transducer Kits (K141495 and K142749) |

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