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 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.

AI/ML Overview

The provided text focuses on the 510(k) summary for the Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station, and ECG Management system. It describes the device, its intended use, and states its substantial equivalence to a predicate device based on "Performance Testing as well as the Hazard analysis." However, it does not provide specific acceptance criteria, detailed results from performance tests, or information about specific studies that demonstrate the device meets acceptance criteria.

The document states that the modifications to the device primarily involve:

Introduction of a new trade name.
GUI updates.
Upgrades in hardware and software to facilitate integration of the latest technology.

It explicitly mentions that the modified device has the "same technological characteristics as the legally marketed predicate device (K033030)." This strongly suggests that the focus of the 510(k) submission was on demonstrating that these changes did not adversely affect the device's fundamental safety and effectiveness, rather than performing entirely new clinical or detailed performance studies against novel acceptance criteria.

Therefore, for most of the requested information, the answer will be that the details are not available in the provided text.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Device Performance Reporting
Not explicitly stated in the document. The document implies that the acceptance criterion was "substantial equivalence" to the predicate device K033030.	"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." No specific performance metrics or thresholds are reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in the document. The text refers to "Performance Testing" and "Hazard analysis" but does not detail the nature of these tests, the data sources, or sample sizes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided in the document. This type of information would typically be detailed in a more comprehensive clinical study report, which is not part of this 510(k) summary. Given the nature of the device (physiomonitoring and information management, not diagnostic interpretation), "ground truth" in the diagnostic sense might not be applicable in the same way as for an AI-powered diagnostic tool. The document states "Its users, responsible to interpret the data made available, will be professional health care providers."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not done. This device is described as a physiomonitoring and information management system, not an AI-assisted diagnostic tool that aids human readers in interpretation. The document explicitly states for the ECG Management System that it "does not provide interpretive functions."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable in the context of this device as described. The device "facilitates clinical data acquisition and analytical assessment" and its "users, responsible to interpret the data made available, will be professional health care providers." The ECG Management System "does not provide interpretive functions."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated. Given that the device handles "physiologic/hemodynamic monitoring" and "clinical data acquisition," the "ground truth" for its performance would likely relate to the accuracy of physiological measurements, data integrity, system functionality, and adherence to safety standards. However, the document does not specify how this "ground truth" was established for testing purposes.

8. The sample size for the training set

Not applicable/Not provided. This device is not described as an AI/ML device that requires a training set in the conventional sense for learning patterns or making predictions. It's a system for managing and displaying physiological data.

9. How the ground truth for the training set was established

Not applicable/Not provided. As above, this is not an AI/ML device requiring a training set with established ground truth for learning.

Summary

{0}------------------------------------------------

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: (321) 253-5693 Fax: (321) 253-0372 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.

{1}------------------------------------------------

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

{2}------------------------------------------------

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

{3}------------------------------------------------

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 (240) 276-0120. 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 (800) 633-2041 or (240) 276-3150 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

{4}------------------------------------------------

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

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)

{5}------------------------------------------------

510(k) Number:

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

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)

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
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.(b)
Classification. Class II (performance standards).