INTELLIBRIDGE SYSTEM by PHILIPS MEDICAL SYSTEMS

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.

Device Description

The name of the subject device is the Philips IntelliBridge System. The trade name of the device is the Philips IntelliBridge System. The common usual name is data management system.

AI/ML Overview

The Philips IntelliBridge System is a data management system that collects and manages clinical information from independent bedside devices. The provided 510(k) summary (K093177) does not contain detailed information about specific acceptance criteria and a study demonstrating the device's performance against these criteria in a quantitative manner that would be expected for an AI/ML medical device.

The document indicates that the device has the same intended use and fundamental technological characteristics as its predicate device (Philips DeviceLink System). The testing involved "system level tests, performance tests, and safety testing from hazard analysis." The pass/fail criteria were "based on the specifications cleared for the predicate device, the specifications of the subject device." The conclusion was that the device "meets all reliability requirements and performance claims and supports a determination of substantial equivalence."

Given the information provided, it is not possible to fill out the table with specific quantitative acceptance criteria or detailed study parameters typical for AI/ML device evaluations. The device appears to be a data integration and management system, not one that uses AI/ML for diagnostic or prognostic purposes, and thus the evaluation methods would be different.

Therefore, the following information is based only on the details explicitly stated in the provided text, and many sections will indicate "Not specified" or "Not applicable" due to the nature of the device and the content of the 510(k) summary.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
System Functionality	Meets "all reliability requirements"	"meets all reliability requirements"
Performance Claims	Meets "performance claims"	"meets... performance claims"
Safety	Passes "safety testing from hazard analysis"	Test results "showed substantial equivalence" and "meets all reliability requirements and performance claims"
Substantial Equivalence	Based on specifications of predicate device and subject device	"supports a determination of substantial equivalence"

2. Sample size used for the test set and the data provenance

Sample size for test set: Not specified. The document globally refers to "system level tests, performance tests, and safety testing."
Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not applicable/Not specified. The device is a data management system; it does not generate diagnostic or prognostic outputs that would typically require expert-established ground truth in the way an AI/ML diagnostic tool would.
Qualifications of experts: Not applicable/Not specified.

4. Adjudication method for the test set

Adjudication method: Not applicable/Not specified. The testing described appears to be functional, system-level, and safety testing, not clinical performance testing requiring adjudication of interpretations.

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

MRMC study done: No. This type of study is typically for AI/ML-driven diagnostic devices. The Philips IntelliBridge System is a data management system and does not involve human readers interpreting data enhanced by AI.
Effect size of improvement: Not applicable.

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

Standalone study done: Not applicable/Not specified in the context of an AI algorithm. The device, being a data management system, likely underwent extensive standalone functional and integration testing to ensure it correctly collects, transmits, and manages data, but this is not an "algorithm only" performance evaluation in the AI sense.

7. The type of ground truth used

Type of ground truth: Not applicable. For a data management system, "ground truth" would relate to the accurate and timely transfer and storage of data according to specified protocols and system requirements, rather than a clinical outcome or expert judgment on an image/signal. The pass/fail criteria were "based on the specifications cleared for the predicate device, the specifications of the subject device."

8. The sample size for the training set

Sample size for training set: Not applicable. This device is not an AI/ML product developed using a training set.

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

How ground truth was established: Not applicable. This device is not an AI/ML product developed using a training set.

Summary

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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: 978-659-4348 Fax: 978-685-5624 Email: Claire.arakaki@philips.com
DEC 1 8 2009

This summary was prepared on September 25, 2009.

The name of the subject device is the Philips IntelliBridge System. 2.
1. 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, patientdata
Cardiovascular	870.2300, II	MWI	Monitor, Physiological, Patient (withoutarrhythmia detection or alarms)
Cardiovascular	870.1025, II	MHX	Monitor, Physiological, Patient (witharrhythmia 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.
1. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

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

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).