(29 days)
Not Found
No
The summary describes a software update to allow operation on a VLAN network and does not mention AI or ML capabilities.
No.
This device is a central monitoring system that provides information for treatment and to monitor the adequacy of treatment, but it does not directly perform or facilitate a therapeutic action itself.
Yes
The device is indicated for monitoring cardiac arrhythmia and ST segment to gain information for treatment, monitor adequacy of treatment, or exclude causes of symptoms, which aligns with the definition of a diagnostic device.
No
The device description explicitly mentions "IntelliVue Clinical Network on VLAN," which implies a network infrastructure component beyond just software. While the modification is software-related, the overall system includes hardware elements (the network infrastructure) that are part of the device's operation.
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 in vivo monitoring, meaning it's done on a living organism. IVDs, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body).
- Device Description: The device is software and a network for central monitoring. This aligns with patient monitoring systems, not laboratory diagnostic devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are hallmarks of IVDs.
Therefore, the device described 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 (comma separated list FDA assigned to the subject device)
74 MHX, 74 DSI, 74 MLD, 74 DSH, 74 MSX
Device Description
The modification is a change that permits operation of the IntelliVue Clinical Network on customer provided IEEE 802.1q compatible VLAN network infrastructure.
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 / central monitoring
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 IntelliVue Clinical Network on VLAN infrastructure 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.
K993171, K993907, K001057, K001664, K011093, K021422, K023698, K030038, K031403, K040357
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
MAY 1 2 2004
8.0 510 (k) Summary
summary of 510(k) safety and effectiveness information រ ន This 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 12 April, 2004.
-
- The name of this device is the M3290A IntelliVue Information Center Software Release E.01 and IntelliVue Clinical Network on VLAN. 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 modification is a change that permits operation of the IntelliVue Clinical Network on customer provided IEEE 802.1q compatible VLAN network infrastructure.
-
- 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 seqment 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 IntelliVue Clinical Network on VLAN infrastructure meets all reliability requirements and performance claims.
1
Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 2004
Philips Medical Systems c/o Mr. Dave Osborn Quality Program Manager 3000 Minuteman Road Andover, MA 01810
Rc: K040955
KU40933
Trade Name: M3290A Intellivue Information Center Software, Release E.01, and Intellivue Clinical Network on VLAN Regulation Number: 21 CFR 870. 1025 Regulation Name: Patient Physiological Monitor (With Arrhythmia Detection or Alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: April 12, 2004 Received: April 13, 2004
Dear Mr. Osborn:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boctor > I pc device 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) is regars actment date of the Medical Device Amendments, or to continered prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, de vices mat nave been rechasined in avere approval of a premarket approval application (PMA). and Cosmetor rear (11ct) the device, subject to the general controls provisions of the Act. The I ou may, mereleve, maniel 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 may be subject to such additions, 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 Please be advised that I DA s issuation of a backed complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must or any Federal statutes and regulations daminding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, with 801); good manufacturing practice requirements as set CFK Fatt 607), labeling (21 OFR Part 820); and if applicable, the clectronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product launtion control pro herems (2) ====================================================================================================================================== Fins icher while anow you to begin maining of substantial equivalence of your device to a legally premaired notification. THPT BAT maining of casification 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 If you desire specific at nee 101 ) 594-4646. Also, please note the regulation entitled, Comact the Office of Comment of Comment of notification" (21CFR Part 807.97) you may obtain. I whisoralium by reference to premiesponsibilities under the Act may be obtained from the Oinci general information on your respectional 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,
Dna Heiseku for
Bram D. Zuckerman, M 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): _ K040 455
M3290A IntelliVue Information Center Software, Device Name: M3290A Incellivae IntelliVue Clinical Network on VLAN
Indications for Use:
mandate is our Indicated for central monitoring on and clinician decides to monitor and neonatur pacients) and neonatal patients cardiae arriferma of adult patients to gain information for and/OL ST Segment of adaily 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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dna Xuelu
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