(14 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on software for central monitoring and data integration.
No
The device is indicated for monitoring patients to gain information for treatment, monitor adequacy of treatment, or exclude causes of symptoms. It does not directly treat or cure a disease or condition.
Yes
The device is indicated for monitoring cardiac arrhythmia and ST segment, which involves analyzing physiological data to gain information for treatment, monitor adequacy of treatment, or exclude causes of symptoms, aligning with diagnostic purposes.
Yes
The device description explicitly states "M3290A IntelliVue Information Center Software Release G.00". While it's a central monitoring system, the submission focuses on the software component and its integration with a database server. The testing described also focuses on system-level and software-related aspects.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes monitoring physiological parameters (cardiac arrhythmia, ST segment) of patients. This is a direct monitoring function, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is described as "IntelliVue Information Center Software," which is consistent with a patient monitoring system, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on the analysis of samples.
- Reagents or kits used for testing.
Therefore, the information provided strongly indicates that this device is a patient monitoring system and 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 (comma separated list FDA assigned to the subject device)
MHX, DSI, MLD, DSH, MSX
Device Description
The modification is a change that provides different alert data export via the hospital LAN.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental 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 results demonstrate that web software interface functionality meets all reliability requirements and performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
summary of 510(k) safety and effectiveness information This i s submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.
- The submitter of this premarket notification is:
Philips Medical Systems
This summary was prepared on 21 March, 2005.
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- The name of this device is the M3290A IntelliVue Information Center Software Release G.00 (for DataBase Server with Alert Data Integration). 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 |
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- The modification is a change that provides different alert data export via the hospital LAN.
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- The new device has the same Indications for Use as the legally marketed predicate device. 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 .
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- The new device has the same technological characteristics as the legally marketed predicate device.
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental 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 results demonstrate that web software interface functionality meets all reliability requirements and performance claims.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 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 a stylized image of an eagle with three lines representing its wings.
APR - 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Phillips Medical Systems c/o Mr. Dave Osborn Quality Program Manager Cardiac & Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099
Re: K050742
R050142
Trade Name: M3290A Intellivue Information Center Software Release G.00 (for Database Server with Alert Data Integration) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: II (two) Product Code: MHX Dated: March 21, 2005 Received: March 22, 2005
Dear Mr. Osborn:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn 910(s) perceise is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally the enactment date of the Medical Device Amendments, or to commerce price to May 20, 1978, in excordance with the provisions of the Federal Food, DNAA de vices that have been require approval of a premarket approval application (PMA). alle Cosmetic Act (Tec) that to not require to the general controls provisions of the Act. The I ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of the rece 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 if your device is classified (see above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FIA thay be subject to sueri additional controller , Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oous overnming your device in the Federal Register.
2
Page 2 - Mr. Dave Osborn
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
B Zimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K050742 510(k) Number (if known):
M3290A IntelliVue Information Center Software Release G.00 Device Name: (for DataBase Server with Alert Data Integration)
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.
Over-The-Counter Use No Prescription Use yes AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B/Hummerter
scular Devices
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