AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER

K111854 · St. Jude Medical Systems AB · DRG · Oct 21, 2011 · Cardiovascular

Device Facts

• Record ID: K111854
• Device Name: AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER
• Applicant: St. Jude Medical Systems AB
• Product Code: DRG · Cardiovascular
• Decision Date: Oct 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Indications for Use

PressureWire Net is intended to condition physiological signals from measuring devices (PressureWire and an external pressure transducer), transmit and receive via radiofrequency, and reconditions the signals to its original format so that those can be displayed on and/or recorded in a receiving device (RadiAnalyzer Xpress or other Monitor systems). The physiological signals can also be distributed via cable.

Device Story

PressureWire Net functions as a radiofrequency (RF) physiological signal transmitter and receiver. It accepts input signals from a PressureWire and an external pressure transducer; it conditions these signals for RF transmission to a host system (e.g., RadiAnalyzer Xpress or other monitors) or distribution via cable. The device reconditions received signals to their original format for display or recording. It expands connectivity options by including a USB connector. Used in clinical settings, it facilitates the monitoring of cardiovascular physiological signals. By enabling wireless or wired signal transmission, it allows healthcare providers to integrate pressure measurements into host monitoring systems, supporting clinical decision-making regarding cardiovascular status.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance testing and literature review.

Technological Characteristics

RF physiological signal transmitter/receiver. Connectivity includes RF transmission, cable distribution, and USB interface. Complies with IEC 60601-1 (2005), IEC 60601-1-2 (2007), IEC 60601-1-4 (2000), IEC 60601-2-34 (2000), and CAN/CSA C22.2 No.601.1-M90. Not supplied sterile; no direct patient contact.

Indications for Use

Indicated for conditioning physiological signals from the cardiovascular system, transmitting/receiving via radiofrequency, and reconditioning signals for display or distribution via cable.

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Predicate Devices

• RadiAnalyzer Xpress (K092105)
• PressureWire (K080813)

Submission Summary (Full Text)

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OCT 2 1 2011

#### 510(k) SUMMARY as required per 807.92(c)

## Submitter:

# Name, Title, and Telephone Number of Contact:

| | Mats Granlund, Ph.D.<br>Director Quality & Regulatory Affairs<br>St. Jude Medical Systems AB<br>Uppsala, Sweden<br>Phone: [phone]<br>FAX: [phone]<br>email: |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Submission: | August 3, 2011 |
| Product Code: | DRG |
| Classification Name: | Radio Frequency Physiological Signal Transmitter and Receiver |
| Class: | II |
| Establishment Registration: 8030904 | |

Legally Marketed Device Identification: PressureWire Net

## Proposed Device Description:

PressureWire Net is a radiofrequency physiological signal transmitter and receiver that is used for conditioning a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a host system.

PressureWire Net receives signals from the manufacturer's PressureWire and from a standard external pressure transducer, and then transmits those signals to a host system for further calculation and presentation. The subject device expands the contact range to also include a standard USB connector.

## Proposed Intended Use:

PressureWire Net is intended to condition physiological signals from measuring devices (PressureWire and an external pressure transducer), transmit and receive via radiofrequency, and

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reconditions the signals to its original format so that those can be displayed on and/or recorded in reconditions the signals to its original format 30 that these satems). The physiological signals can also be distributed via cable.

Indication for Use:

Indication for USE:
PressureWire Net is indicated to condition a physiological signal from the cardiovascular system, Pressurewite Net is indicated to condition a proving career.
transmit and receive via radiofrequency, and recondition the signal to its original format so that it ti allsint and receive via radion ical also be distributed via cable.

#### Predicate Devices:

- K092105 510(k): t Trade Name: RadiAnalyzer Xpress 01/19/2005 SE Date: Manufacturer: Radi Medical Systems AB, Inc.
- K080813 510(k) : . Trade Name: PressureWire 7/01/2008 SE Date: Manufacturer: Radi Medical Systems AB, Inc.

#### Substantial Equivalence:

Assessment of non clinical performance data for equivalence:

Assessment of non onlines tested in accordance with applicable standards and internal design The Fressure who recedures and was determined to be as safe and effective for its intended use as the predicate device(s).

Assessment of clinical performance data for equivalence:

Assoconient or virined evaluation based on literature review and product performance of the Onlined porcernited on the predicate device indicates that the PressureWire Net is substantially equivalent to the predicate devices.

#### Sterilization:

Not Applicable. The system is not supplied sterile.

#### Biocompatibility:

Not Applicable. The device does not directly contact the user or patient.

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K111854 pg 3 of 3

# Standards and Guidance Documents for Reference:

| Standards No | Standards Organization | Standard Title | Version |
|--------------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 60601-1 | IEC | Medical Electrical equipment - Part 1: General requirements for safety and essential performance | 2005-12 |
| 60601-1-2 | IEC | Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance –Collateral standard: Electromagnetic compatibility – Requirements and Tests | 2007-03 |
| 60601-1-4 | IEC | Medical electrical equipment – Part 1-4: General requirements for safety – Collateral Standard: Programmable electrical medical systems | 2000-04 |
| 60601-2-34 | IEC | Medical electrical equipment – Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment | 2000-10 |
| C22.2 No.601.1-M90 | CAN/CSA | Medical Electrical Equipment - Part 1: General Requirements for Safety | |

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird symbol, with three curved lines representing the wings and a wavy line representing the body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 21 2011

St. Jude Medical Systems AB c/o Mr. Mats Granlund Palmbladsgatan 10 Uppsala Sweden SE-751 35

Re: K111854

Trade/Device Name: PressureWire Net (AO USB Receiver, WI-Box, WI-Box PSU kit, WI-Box Xpress cable, PW USB Receiver) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG Dated: August 3, 2011 Received: August 8, 2011

Dear Mr. Granlund:

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 contractly and warranties. We remind you, however, that device labeling must be truthful and not micheading.

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 devire (1 n. 1) found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FTDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Mats Granlund

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 (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/CentersQffices/CDRHOffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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# Indications for Use

510(k) K111854

Number (if known)

Device Name PressureWire Net

PressureWire Net is intended to condition physiological signals from measuring Intended Use devices (PressureWire and an external pressure transducer), transmit and receive via radiofrequency, and reconditions the signals to its original format so that those can be displayed on and/or recorded in a receiving device (RadiAnalyzer Xpress or other Monitor systems). The physiological signals can also be distributed via cable.

Indication for Use:

PressureWire Net is indicated to condition a physiological signal from the cardiovascular system, transmit and receive via radiofrequency, and recondition the signal to its original format so that it can be displayed. The physiological signal can also be distributed via cable.

Prescription Use

AND/OR

Over - The- Counter Use_

(Part 21 CFR 801 Subpart D)

(Part 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) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K111854 |