INTELLIBRIDGE SYSTEM

K093177 · Philips Medical Systems · MWI · Dec 18, 2009 · Cardiovascular

Device Facts

• Record ID: K093177
• Device Name: INTELLIBRIDGE SYSTEM
• Applicant: Philips Medical Systems
• Product Code: MWI · Cardiovascular
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The IntelliBridge System is indicated for use in the data collection and clinical information management either directly or through networks with independent bedside devices. The IntelliBridge System is not intended for monitoring purposes nor is the device intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

Device Story

IntelliBridge System functions as a data management system for clinical information; collects data from independent bedside devices via network or direct connection. System components include EC40/EC80 multi-port modules and SC50 management console. Device does not perform patient monitoring or control connected bedside equipment; serves as a conduit for data aggregation and management. Used in clinical environments; operated by healthcare professionals. Output allows clinicians to view aggregated data from various bedside devices to support clinical information management workflows.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, performance tests, and hazard analysis. Pass/Fail criteria based on predicate device specifications; results confirmed performance and reliability requirements were met.

Technological Characteristics

Data management system comprising EC40/EC80 multi-port modules and SC50 management console. Connectivity via network or direct interface to bedside devices. Software-based transmission and storage of patient data. No patient monitoring or alarm functionality.

Indications for Use

Indicated for data collection and clinical information management from independent bedside devices. Not intended for patient monitoring or control of connected clinical devices.

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

• Philips DeviceLink System

Submission Summary (Full Text)

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K093177 pg 1 of 1

## 510K Summary

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(c).

- The submitter of this pre-market notification is: 1. Claire Arakaki Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 United States Tel: [phone] Fax: [phone] Email: [e-mail]
DEC 1 8 2009

This summary was prepared on September 25, 2009.

- The name of the subject device is the Philips IntelliBridge System. 2.
- 3. The trade name of the device is the Philips IntelliBridge System.
- The common usual name is data management system. 4.
- The Classification names are as follows: న్.

| Device Panel | Classification | ProCode | Description |
|------------------|----------------|---------|-----------------------------------------------------------------------------|
| General Hospital | Not classified | NSX | Software, transmission and storage, patient<br>data |
| Cardiovascular | 870.2300, II | MWI | Monitor, Physiological, Patient (without<br>arrhythmia detection or alarms) |
| Cardiovascular | 870.1025, II | MHX | Monitor, Physiological, Patient (with<br>arrhythmia detection or alarms) |

- The modified device is substantially equivalent to the previously cleared Philips DeviceLink System. ર.
- The major modifications are as follows: 7.
- Introduction of a new multi-port module (EC40/EC80) ♥
- Introduction of a management console (SC50) .
- The subject device has the same intended use as the legally marketed predicate device: 8. The IntelliBridge System is indicated for use in the data collection and clinical information management either directly or through networks with independent bedside devices. The IntelliBridge System is not intended for monitoring purposes nor is the device intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.
- The subject device has the same fundamental technological characteristics as the legally marketed 9. predicate devices.
- 10. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject devices with respect to the predicates. 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, the specifications of the subject device and test results showed substantial equivalence. The results demonstrate that the Philips IntelliBridge System meets all reliability requirements and performance claims and supports a determination of substantial equivalence.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Philips Medical Systems c/o Claire Arakaki, Regulatory Affairs Specialist 3000 Minuteman Road Andover, MA 01810

DEC 1 8 2009

Re: K093177

Trade/Device Name: IntelliBridge System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI Dated: November 25, 2009 Received: November 27, 2009

Dear Ms. Arakaki:

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 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 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

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Page 2 - Ms. Claire Arakaki

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/CDRH/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

Sincerely yours

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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pg loti

Indications for Use

510 (k) Number (if known): K093177

Device Name: IntelliBridge System

The IntelliBridge System is indicated for use in the data collection and clinical information management. The IntelliBridge System is not intended for monitoring purposes nor is the device intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

YES AND/OR over-the-counter Use: NO Prescription Use: (Part 21 CFFR 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)

(Division Sign-Off) Division of Cardiovascular Devices 5) 01ki Numb