(115 days)
No
The summary does not mention AI, ML, or related concepts, and the description focuses on supporting existing monitoring devices.
Yes
The device is used to monitor cardiac arrhythmia and ST segments to gain information for treatment or to monitor the adequacy of treatment, indicating its role in managing patient conditions.
Yes
The device is indicated for monitoring cardiac arrhythmia and ST segments to gain information for treatment, monitor adequacy of treatment, or exclude causes of symptoms, which are all diagnostic purposes.
No
The device description explicitly states it provides support for the "MRx Monitor/Defibrillator" and the "M3177 Trend Display," which are hardware devices. The performance studies also mention system-level tests, integration tests, environmental tests, and safety testing, indicating interaction with hardware components.
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 measurement of the patient's body, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Device Description: The description focuses on supporting patient monitors and displays, which are devices used for direct patient monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to monitor the patient directly.
N/A
Intended Use / Indications for Use
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
74 MHX, 74 DSI, 74 MLD, 74 DSH, 74 MSX
Device Description
Not Found
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
clinician
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
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.
Summary of Performance Studies
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
Not Found
Predicate Device(s)
K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K993907, K993171, K964832
Reference Device(s)
K053522, K051106, K041235, K032858
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
8.0 510 (k) Summary
NOV 3 V 2006
510(k) safety and effectiveness information is This summary of 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
- The submitter of this premarket notification is:
This summary was prepared on 3 August, 2006.
-
- The name of this device is the M3290A IntelliVue Information Center Software Release J.00 (for M3140, M3145, M3151, M3154, M3155, M3169, M3170, and M3177). 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 new device is substantially equivalent to the previously cleared IntelliVue Information Center Software cleared under K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K993907, K993171, & K964832 and the IntelliVue Patient Monitor under K053522, K051106, K041235, & K032858.
-
- The modification is a change that provides support for the MRx Monitor/Defibrillator and the M3177 Trend Display.
-
- The new device has the same Indications for Use as the leqally 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 .
-
- 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.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 U 2006
Phillips Medical Systems c/o Mr. Dave Osborn Quality Program Manager Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099
Re: K062271
Trade Name: M3290A IntelliVue Information Center Software, Release J.00 (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170, and M3177) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: MHX Dated: November 17, 2006 Received: November 20, 2006
Dear Mr. Osborn:
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 such 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.
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B/fimmman 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
510(k) Number (if known): K062271
M3290A IntelliVue Information Center Software Release J.00 Device Name: (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170, and M3177)
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 nond/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use No____________________________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blumunma
Division Slan-Off Division of Cardioy 510(k) Number
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