XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION

K063840 · Witt Biomedical Corp · MWI · Feb 6, 2007 · Cardiovascular

Device Facts

• Record ID: K063840
• Device Name: XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION
• Applicant: Witt Biomedical Corp
• Product Code: MWI · Cardiovascular
• Decision Date: Feb 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station is intended for complete physiologic/hemodynamic monitoring, clinical data acquisition, medical image/data processing, and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. Xper Information Management/Physiomonitoring 5 and/or 5 system, Patient Care Console and Central Station provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device. Use of Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The Xper Information Management Central Station and Patient Care Consoles are intended for complete physiologic monitoring, clinical data acquisition, medical image processing and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses. Use of Xper Information Management Central Station and Patient Care Console is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The Xper Information Management ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. The Xper ECG Management system does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. The Xper ECG Management system provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

Device Story

System for physiologic/hemodynamic monitoring, clinical data acquisition, and medical image/data processing; used in cardiac catheterization, invasive radiology, and electrophysiology labs. Inputs include physiologic signals and ECG data (resting, stress, holter) from source devices. System stores, transmits, and displays data for review and report generation; provides visual/audible alarms for anomalous occurrences. Operated by professional healthcare providers in clinical facilities; functions as stand-alone or networked via intranet/internet. Does not perform arrhythmia detection or automated ECG interpretation; stores interpretive statements from source devices. Facilitates clinical assessment and timely response to patient status; supports distributed data viewing.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and hazard analysis.

Technological Characteristics

Physiologic/hemodynamic monitoring system; includes patient care consoles, central stations, and ECG management software. Hardware/software upgrades for integration of current technology. Connectivity via intranet/internet or stand-alone. User-adjustable visual/audible alarms. Class II device (21 CFR 870.2300).

Indications for Use

Indicated for professional healthcare providers requiring physiologic/hemodynamic monitoring, clinical data acquisition, and medical image/data processing in cardiac catheterization, invasive radiology, electrophysiology labs, or general healthcare environments. Includes ECG data storage for resting, stress, and holter studies. Contraindicated for unattended patient monitoring or situations requiring arrhythmia detection.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• CALYSTO Series IV, Patient Care Monitor and Central Station, and ECG Management System (K033030)

Submission Summary (Full Text)

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K063840
P1/2

Section 5 - 510(K) SUMMARY Submitted by: Witt Biomedical Corporation (a wholly owned subsidiary of Philips Holding USA, Inc.) 305 North Drive, Melbourne Florida 32934 Contact Person: James Luker FEB 6 20G7 Phone: [phone] Fax: [phone] Date Prepared: December 22, 2006 Proprietary Name: Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station, and ECG Management system Common Name: Physio-monitoring System Classification Name: 21 CFR § 870.2300 74 MWI Monitor, Physiological, Patient (without Arrhythmia detection or alarms) Class II CALYSTO Series IV, Patient Care Monitor and Central Station, and ECG Predicate Device: Management System K033030 Device Description: The Xper Information Management device is intended to be used for complete physiologic/hemodynamic monitoring and information gathering as well as medical image review through links to cleared devices. It facilitates clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Intended Use: Patient Care Console and Central Station is intended for complete physiologic/hemodynamic monitoring, clinical data acquisition, medical image/data processing, and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device. Use of Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The Xper Information Management Central Station and Patient Care Consoles are intended for complete physiologic monitoring, clinical data acquisition, medical image processing and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses. Use of Xper Information Management Central Station and Patient Care Console is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

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KC63840
P2/2

The Xper ECG Management System is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. Xper ECG Management System does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. Xper ECG Management system provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

The modified device has the same technological characteristics as the legally marketed predicate device (K033030). The modifications consist of these primary changes:

- Introduction of trade name A
- > GUI updates.
- > Upgrades in hardware and software (custom and off the shelf) to facilitate integration of the latest technology.

Verification. Validation, and Testing:

Technological

Characteristics:

The Performance Testing as well as the Hazard analysis for the Xper Information Management system provides objective evidence that it is substantially equivalent the predicate CALYSTO Series IV system

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

. . .

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, represented by simple lines, standing close together.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 6 2007

Witt Biomedical Corp. c/o James Luker 305 North Drive Melbourne, FL 32934

Re: K063840

Trade Name: Physio-monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MHX Dated: December 22, 2006 Received: December 26, 2006

Dear Mr. Luker:

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.

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

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### Page 2 - Mr. Luker

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 on the regulation on the "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.bhml

Sincerely yours,

Bhimman 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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## 510(k) Number:

Device Name: Xper Information Management/Physiomonitoring 5 system and/or Vascular 5, Patient Care Console and Central Station and ECG Management system

Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station is intended for complete physiologic/hemodynamic monitoring, clinical data acquisition, medical image/data processing, and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. Xper Information Management/Physiomonitoring 5 and/or 5 system, Patient Care Console and Central Station provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

Use of Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

The Xper Information Management Central Station and Patient Care Consoles are intended for complete physiologic monitoring, clinical data acquisition, medical image processing and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses.

Use of Xper Information Management Central Station and Patient Care Console is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

B/mmmma
Sign-Off

Vision of Cardiovascular Devices
510(k) Number K613840

Page 1 of 2

Philips Xper Traditional 510(k)

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# 510(k) Number:

Device Name: Xper Information Management/Physiomonitoring 5 and/or Vascular 5, Patient Care Console and Central Station and ECG management system

The Xper Information Management ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. The Xper ECG Management system does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. The Xper ECG Management system provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Page 1 of 1

Bhumma
on Sign-Off

of Cardiovascular Devices
) Number K063840

Philips Xper Traditional 510(k)