WIRELESS PHYSIOLOGIC MONITORING SYSTEM

K053016 · Edwards Lifesciences, LLC · DXO · Dec 30, 2005 · Cardiovascular

Device Facts

• Record ID: K053016
• Device Name: WIRELESS PHYSIOLOGIC MONITORING SYSTEM
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXO · Cardiovascular
• Decision Date: Dec 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2870
• Device Class: Class 2

Intended Use

The Wireless Physiologic Monitoring System is indicated for use on patients requiring pressure monitoring. The Wireless Physiologic Monitoring System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers.

Device Story

Wireless Physiologic Monitoring System replaces physical cabling between disposable blood pressure transducers and bedside patient monitors in hospital settings. System utilizes RFID for initial setup and Wireless Medical Telemetry Service (WMTS) band for continuous transmission of pressure data from transducers to monitors. Designed to support existing transducer performance requirements; retains wired connectors as backup. Operates in clinical environments; used by healthcare providers to facilitate remote monitoring of patient pressure data. Wireless transmission eliminates cable clutter; maintains clinical decision-making capabilities equivalent to direct-wired connections.

Clinical Evidence

No clinical data. Substantial equivalence supported by functional testing and electrical safety testing.

Technological Characteristics

Wireless transmission system using RFID for setup and WMTS band for data transmission. Replaces physical cables between disposable pressure transducers and bedside monitors. Includes wired connector backups. Class II device (21 CFR 870.2870).

Indications for Use

Indicated for patients requiring 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

• Phoenix Disposable Pressure Transducer
• #73-600 SurgiChip Tag Surgical Marker
• M3290A IntelliVue Information Center Software Rel. F.0
• M4840A Telemetry System II with M4841A TelePac+
• MPT 24
• VitalView 24

Submission Summary (Full Text)

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K05-30/6

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DEC 3 0 2005

## 510(k) Summary

5

| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614-5686 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Diane Peterson<br>Project Manager, Regulatory Affairs |
| Date Prepared: | October 24, 2005 |
| Trade name: | Wireless Physiologic Monitoring System |
| Classification<br>Name: | Transducer, Pressure, Catheter tip<br>(21 CFR 870.2870) Transmitters and receivers, physiological<br>signal, radiofrequency (21 CFR 870.2910) |
| Predicate Devices: | Phoenix Disposable Pressure Transducer<br>#73-600 SurgiChip Tag Surgical Marker M3290A IntelliVue Information Center<br>Software Rel. F.0 and M4840A Telemetry<br>System II with M4841A TelePac+ MPT 24 and VitalView 24 |
| Device<br>Description: | The Edwards Lifesciences' Wireless Physiologic<br>Monitoring System replaces the existing cabling<br>between disposable blood pressure transducers and<br>bedside monitors in hospital settings. The wireless<br>link allows the system to support all transducer<br>performance requirements and specifications<br>currently supported with a direct cable connection.<br>Existing system cabling connectors are retained in<br>the event that all available channels are filled, or in<br>the unlikely event that issues are found in particular<br>situations that preclude the use of the wireless<br>connection.<br><br>The Wireless Physiologic Monitoring System utilizes<br>two types of wireless technology to provide a |

October 24, 2005 510(k) Notification for the Wireless Physiologic Monitoring System Page 11

convenient solution for replacing cabling between the

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## Edwards

disposable pressure transducer and the patient monitor. Radio Frequency Identification (RFID) is utilized as a convenient method to initially setup the system, and the Wireless Medical Telemetry Service band (WMTS) is used for the continuous transmission of data from the transducers to the monitor during normal operation. The Wireless Physiologic Monitoring System is Intended Use: indicated for use on patients requiring pressure monitoring. The Wireless Physiologic Monitoring System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers. The Wireless Physiologic Monitoring System has Comparative been demonstrated to be as safe and effective as Analysis: the predicate devices for its intended use. The Wireless Physiologic Monitoring System has Functional/Safety successfully undergone functional testing as well as Testing: electrical safety testing. This product has been

The Wireless Physiologic Monitoring System is Conclusion: substantially equivalent to the predicate devices.

shown to be equivalent to the predicate devices.

October 24, 2005 510(k) Notification for the Wireless Physiologic Monitoring System Page 12

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 2005

Edwards Lifesciences LLC c/o Ms. Diane Peterson Project Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614

Re: K053016

Trade Name: Wireless Physiologic Monitoring System Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II (two) Product Code: DXO Dated: October 24, 2005 Received: October 26, 2005

Dear Ms. Peterson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms. Diane Peterson

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Blumminion 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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## Indications for Use Statement 4

510(k) Number (if known):

Device Name: Wireless Physiologic Monitoring System

Indications for Use:

The Wireless Physiologic Monitoring System is indicated for use on patients requiring pressure monitoring. The Wireless Physiologic Monitoring System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers.

Prescription Use __X__________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use __ (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bihmmuma

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