(15 days)
No
The summary describes a software update for a central monitoring system focused on improved database access and web interface functionality. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is described as software for central monitoring of patients and is intended to gain information for treatment, monitor adequacy of treatment, or exclude causes of symptoms, but it does not directly provide therapeutic intervention itself.
Yes
The device is used to monitor cardiac arrhythmias and ST segments to gain information for treatment, monitor adequacy of treatment, or exclude causes of symptoms, which are all diagnostic functions.
Yes
The device is described as "software-based change" and "software interface functionality," and the predicate device is also described as "Web software." There is no mention of hardware components being part of the device itself, only the system it integrates with (hospital intra/internet system).
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 a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device is software for a central monitoring system. This aligns with patient monitoring, not laboratory testing of samples.
- 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.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for real-time monitoring of patients 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
The modification is a software-based change that provides improved database server access via the hospital intra/internet system.
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 / Hospital
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
Testing involved system level tests, integration predicate. tests, environmental tests, and safety testing from hazard Pass/Fail criteria were based on the analysis. specifications cleared for the predicate device and test results showed substantial equivalence.
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. 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)
Reference Device(s)
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
NOV 1 9 2002
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 C.F.R. §807.92.
- The submitter of this premarket notification is:
Philips Medical Systems
This summary was prepared on 1 November, 2002.
-
- The name of this device is the M3290A IntelliVue Information Center Software Release E.0 (for DataBase Server with Web Server including Near-Realtime Export). Classification names are as follows:
| Classification | ProCode | Description |
|---|---|---|
| None | 74 MHX | Physiological Monitor, Patient |
| Monitor | ||
| 870.1025, III | 74 DSI | Arrhythmia Detector and Alarm |
| 870.1025, III | 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 VIC Web software cleared under K993907.
-
- The modification is a software-based change that provides improved database server access via the hospital intra/internet system.
-
- 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
1
Testing involved system level tests, integration predicate. tests, environmental tests, and safety testing from hazard Pass/Fail criteria were based on the analysis. 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philins Medical Systems c/o Mr. David Osborn Ouality Program Manager 3000 Minuteman Road Andover, MA 01810
Re: K023698
Trade Name: M3290A IntelliVue DataBase Server Software for M3154 with Web Server including Near-Realtime export, Release E.0
Regulation Number: 21 CFR 870.1025
Regulation Name: Patient Physiological Monitor (with arrhythmia detection and alarms) Regulatory Class: Class III (three)
Product Code: MHX
Dated: November 1, 2002
Received: November 4, 2002
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.
3
Page 2 - Mr. David 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 (OS) 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Dma Sluschu for
Brand P. Zuckerman, M.D.
Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page : of
510(k) Number (if known):
Device Name: M3290A IntelliVue DataBase Server Software for M3154 with Web Server including Near-Realtime export, Release E.0
For central monitoring of multiple Indications for Use: . 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)
f Cardiovascular & Respiratory Devices
Number K023698
Date 11/18