M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0

K102495 · Philips Medical Systems · MHX · Sep 30, 2010 · Cardiovascular

Device Facts

• Record ID: K102495
• Device Name: M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
• Applicant: Philips Medical Systems
• Product Code: MHX · Cardiovascular
• Decision Date: Sep 30, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

Indicated for central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Device Story

IntelliVue Information Center (IIC) is central station software running on off-the-shelf workstations/servers; connects to patient-connected monitors and telemetry devices. Inputs: physiologic waveforms and parameters from multiple patients. Processing: centralizes data display, generates alarm signals, provides retrospective review, and manages data import/export. Output: visual display of physiologic waves/parameters in summary or detailed format; alarm notifications. Used in clinical settings by healthcare providers to monitor patient status, assess treatment adequacy, and exclude symptom causes. Benefits: enables centralized oversight of multiple patients to facilitate timely clinical decision-making.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, performance tests, and safety testing based on hazard analysis. Pass/Fail criteria were derived from predicate device specifications; results demonstrated substantial equivalence.

Technological Characteristics

Central station software for patient monitoring; runs on off-the-shelf workstations and servers. Features include physiologic waveform/parameter display, arrhythmia detection, ST segment monitoring, alarm generation, and retrospective data review. Networked connectivity to patient monitors and telemetry devices.

Indications for Use

Indicated for central monitoring of adult, pediatric, and neonatal patients; includes cardiac arrhythmia monitoring for all populations and ST segment monitoring for adult patients.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• M3290A IntelliVue Information Center Software, Release L.0 (K081983, K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, K964832)

Submission Summary (Full Text)

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

K102495 Pl

## Philips Medical Systems

Patient Monitoring Quality & Regulatory Group 3000 Minuteman Road Mailstop 0480 Andover, MA 01810 Tel: [phone] Fax: [phone]

SEP 3 0 2010

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.

The submitter of this premarket notification is:

Theresa Poole Regulatory Affairs Specialist Patient Monitoring Philips Medical Systems 3000 Minuteman Road, MS0480 Andover, MA 01810-1099

Tel: [phone] Fax: [phone] Email: [e-mail]

This summary was prepared on 30 August 2010.

The name of this device is the IntelliVue Information Center Classification names are as follows:

| Classification | ProCode | Description |
|----------------|---------|--------------------------------------------------------------|
| None | 74 MHX | Physiological Monitor, Patient Monitor |
| 870.1025, II | 74 DSI | Arrhythmia Detector and Alarm |
| 870.1025, II | 74 MLD | Monitor, ST Alarm |
| 870.2800, II | 74 DSH | Recorder, Magnetic Tape, Medical |
| 870.2300, II | 74 MSX | System, Network and Communication,<br>Physiological Monitors |

The M3290B IntelliVue Information Center (IIC) is substantially equivalent to the previously cleared M3290A IntelliVue Information Center Software, Release L.0 provieted pursuant to K081983, K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, and K964832.

The IntelliVue Information Center Software is central station software that runs on off-the-shelf Wir interest and servers which can connect to recorders for waveform printing. It displays physiologic waves and parameters from multiple patient connected monitors and telemetry

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

K102495 P2/2

devices in summary or detailed format, and generates alarm signals. It provides retrospective review applications and a variety of data import and export functions.

The device has the same Indications for Use and Intended Use Statement as the legally marketed predicate devices.

The device has the same technological characteristics as the legally marketed predicate devices.

Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The M3290B IntelliVue Information Center Software meets all defined reliability requirements and performance claims.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

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

Ms. Theresa Poole Regulatory Affairs Specialist Philips Medical Systems 3000 Minuteman Road, MS 0480 Andover, Massachusetts 01810-1099

SEP 30 2010

Re: K102495

Device Name: M3290B IntelliVue Information Center Software release A.0 Regulation Number: 21 CFR 870.1025 Regulation Name: Patient physiological monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (Two) Product Codes: MHX, DSI, MLD, DSH, MSX Dated: August 30, 2010 Received: August 31, 2010

Dear Ms. Poole:

..

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.

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

Page 2 - Ms. Theresa Poole

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 nf 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/CentersOffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

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

Enclosure

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

## ODE Indications Statement 3.1

Indications for Use

510(k) Number (if known): KIO2495

Device Name: M3290B IntelliVue Information Center Software Release A.0

Indications for Use:

Indicated for central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Prescription Use Yes (Part 21 CFR 801 Subpart D)

AND/OR

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Over-The-Counter Use No (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE).

W.M.S.

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** K102475

Confidential

Page 9

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Image /page/4/Picture/16 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K102495' and appear to be written with a dark ink on a white background. The characters are slightly uneven, suggesting they were written by hand rather than printed.

SEP 3 0 2010