(71 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data collection and management, not intelligent analysis or prediction.
No
The device is described as a "data management system" that collects and manages clinical information. Its intended use explicitly states it is "not intended for monitoring purposes nor is the device intended to control any of the clinical devices," which means it does not directly treat, diagnose, or mitigate a disease or condition, which are characteristics of a therapeutic device.
No
The device is described as a "data management system" intended for "data collection and clinical information management." It explicitly states, "The IntelliBridge System is not intended for monitoring purposes nor is the device intended to control any of the clinical devices...it is connected to." This indicates it's for data handling, not for making a diagnosis or providing diagnostic information based on analysis of clinical data.
Unknown
The summary describes a "data management system" that collects and manages clinical information from independent bedside devices/information systems. While this function is typically software-based, the summary does not explicitly state that the device is only software. It refers to "system level tests" and "safety testing from hazard analysis," which could potentially involve hardware components or interactions beyond just software. Without a clear statement confirming it's solely software, it's not possible to definitively classify it as a software-only medical device based on this summary alone.
Based on the provided information, the Philips IntelliBridge System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "data collection and clinical information management." This is focused on managing data from other devices, not on performing tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The common name is "data management system." This aligns with its function of handling data, not performing diagnostic tests.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing diagnostic or monitoring information based on sample analysis
The IntelliBridge System acts as a data hub, collecting information from other clinical devices. It does not perform the diagnostic testing itself.
N/A
Intended Use / Indications for Use
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.
Product codes
NSX, MWI, MHX
Device Description
The subject device is the Philips IntelliBridge System. Major modifications include the introduction of a new multi-port module (EC40/EC80) and a management console (SC50).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Philips DeviceLink System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
-
- 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 |
| data | |||
| Cardiovascular | 870.2300, II | MWI | Monitor, Physiological, Patient (without |
| arrhythmia detection or alarms) | |||
| Cardiovascular | 870.1025, II | MHX | Monitor, Physiological, Patient (with |
| 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.
-
- 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.
1
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
2
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
Sincerely yours
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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