TruWave Disposable Pressure Transducer

K142749 · Edwards Lifesciences, LLC · DXO · Jan 18, 2015 · Cardiovascular

Device Facts

• Record ID: K142749
• Device Name: TruWave Disposable Pressure Transducer
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXO · Cardiovascular
• Decision Date: Jan 18, 2015
• 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; utilizes TruWave disposable pressure transducer with straight, flow-through design; fluid passes across pressure sensor. Interfaces with patient monitor via dedicated cable. Used in hospital/clinical environments by healthcare professionals. Monitors intravascular, intracranial, or intrauterine pressure; provides real-time pressure data to clinicians for patient management. Benefits include accurate, continuous pressure monitoring for critical care patients. Device includes optional integral flush device (3 mL/hr or 30 mL/hr).

Clinical Evidence

Bench testing only. Performance testing compared subject device to predicate, confirming unchanged technology and materials. Functional performance testing post-MRI exposure verified pressure accuracy (nonlinearity and hysteresis).

Technological Characteristics

Single-use, sterile (EtO). Materials: Polycarbonate, PVC, Soda-Lime Glass. Standards: ISO 10993-4:2002, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006. Operating range: -50 to +300 mmHg. Nonlinearity/Hysteresis: ±1.5% of reading or ±1 mmHg. Straight flow-through sensor design.

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 (K141495)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 16, 2015

Edwards Lifesciences, LLC. Mr. Andrew S. Mazurkiewicz, Jr., MBA/MKT Senior Associate, Regulatory Affairs Critical Care One Edwards Way, CA 92614

Re: K142749

> Trade/Device Names: TruWave™ Disposable Pressure Transducers Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II (two) Product Code: DXO Dated: December 2, 2014 Received: December 4, 2014

Dear Mr. Mazurkiewicz:

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, 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

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Page 2 - Mr. Andrew S. Mazurkiewicz, Jr.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

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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### SECTION 4 - INDICATIONS FOR USE STATEMENT

### Indications for Use

510(k) Number (if known): K142749

Device Name: TruWave™ Disposable Pressure Transducer

#### Indications For Use:

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

Prescription Use _ X__

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# K142749

# SECTION 5 – 510(k) SUMMARY

| TruWave™ Disposable Pressure Transducer 510(k) | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | Edwards Lifesciences, LLC |
| Contact Person | Andrew S. Mazurkiewicz, Jr.,<br>MBA/MKT Edwards Lifesciences<br>One Edwards Way<br>Irvine, CA 92614<br>Tel: [phone] |
| Date Prepared | September 23, 2014 |
| Trade Name | TruWave™ |
| Common Name | Disposable Pressure Transducer |
| Classification<br>Name | Transducer, pressure, catheter tip |
| Regulation<br>Class/Product<br>Code | 21 CFR 870.2870<br>Class II<br>DXO |
| Predicate Device(s) | K141495 - TruWave Disposable Pressure Transducer (Cleared<br>9/3/2014) |
| 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 an<br>Edwards Lifesciences cable that is specifically wired for the patient<br>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 |
| | device. |
| Device<br>Characteristics | Single Use Sterile (EtO)<br>Prevalent Patient Contact Materials: Polycarbonate, PVC, Soda-Lime<br>Glass |
| Environment of<br>Use | Healthcare facility/hospital |
| Materials of Use | Polycarbonate, PVC, Soda-Lime Glass<br>Consensus standards: ISO 10993-4:2002, ISO 10993-5:2009, ISO<br>10993-10:2010, ISO 10993-11:2006 |
| Key Performance<br>Specifications | Integral flush device: 3 mL/hr or 30 mL/hr<br>Operating Pressure Range: -50 to + 300 mmHg<br>Nonlinearity and Hysteresis: ±1.5% of reading or ± 1 mmHg, whichever<br>is greater |
| Indications for<br>Use/Intended Use | The Pressure Monitoring Kit with TruWave Disposable Pressure<br>Transducer is for use on patients requiring intravascular, intracranial, or<br>intrauterine pressure monitoring. |
| Comparative<br>Analysis | Performance testing was conducted to compare the proposed device to<br>the predicate device. The results of the performance testing indicate that<br>the scientific technology and materials of the proposed device is<br>unchanged from the legally marketed device (predicate).<br>The proposed change to the TruWave disposable pressure transducer<br>has been shown to be safe, effective, and substantially equivalent to the<br>predicate device (TruWave disposable pressure transducer) for its<br>intended use in hospitals and other appropriate clinical environments. |
| Functional/ Safety<br>Testing | The TruWave disposable pressure transducer has successfully passed<br>functional- performance post MRI exposure, the testing included<br>pressure accuracy (nonlinearity and hysteresis). |
| Conclusion | The TruWave disposable pressure transducers has been shown to be<br>safe, effective, and substantially equivalent to the predicate device<br>(TruWave disposable pressure transducer) for its intended use in<br>hospitals and other appropriate clinical environments. |

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