(30 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard monitoring and data display functions.
No
The device is described as central station software for monitoring, not a device that directly administers treatment or performs therapy. It provides information for treatment decisions but does not perform the treatment itself.
Yes
The device is indicated to "gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms," which are indicative of a diagnostic purpose. It displays physiologic waves and parameters and generates alarm signals based on monitored cardiac arrhythmia and ST segment, providing data for clinical assessment.
Yes
The device is described as "central station software" that runs on off-the-shelf hardware and connects to other medical devices. The description focuses solely on the software's functions and capabilities, without mentioning any proprietary hardware components included with the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the IntelliVue Information Center Software "displays physiologic waves and parameters from multiple patient connected monitors and telemetry devices." This means it is processing data from devices connected to the patient, not analyzing samples taken from the patient.
- Intended Use: The intended use focuses on central monitoring of patients and analyzing cardiac and ST segment data, which are physiological signals, not results from in vitro tests.
The device is a patient monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
MHX, DSI, MLD, DSH, MSX
Device Description
The M3290B IntelliVue Information Center (IIC) 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 devices in summary or detailed format, and generates alarm signals. It provides retrospective review applications and a variety of data import and export functions.
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
adult, pediatric, and neonatal patients
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, 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.
Key Metrics
Not Found
Predicate Device(s)
K081983, K062271, K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K000854, K993907, K993171, K964832
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.
0
K102495 Pl
Philips Medical Systems
Patient Monitoring Quality & Regulatory Group 3000 Minuteman Road Mailstop 0480 Andover, MA 01810 Tel: (978) 659-3000 Fax: (978) 685-5624
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: 978 659 7621 Fax: 978 685 5624 Email: theresa.poole@philips.com
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, |
| 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 (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.
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
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SEP 3 0 2010