(12 days)
Not Found
No
The document describes software for central monitoring and arrhythmia/ST segment analysis, but there is no mention of AI, ML, or related concepts like training/test sets, image processing, or specific performance metrics typically associated with AI/ML algorithms.
No.
The device is for monitoring cardiac arrhythmia and ST segments to provide information for treatment decisions, not to directly treat patients.
Yes
The "Intended Use / Indications for Use" section states that the device is used to "gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms," which are all functions of a diagnostic device.
Yes
The device description lists only software components and the performance studies focus on software verification, validation, and testing, indicating it is a software-only medical device.
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 signals (cardiac arrhythmia and ST segment) from patients. This is a clinical monitoring function, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is described as software components for central monitoring. This aligns with a system that processes and displays real-time patient data.
- 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 intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to monitor the patient directly, not to analyze samples from the patient.
N/A
Intended Use / Indications for Use
For central monitoring of 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
- PIC Software, Release D.02 .
- Application Server Software, Release A.0 .
- UDP Server Software, Release A.0 .
- TCP/IP PC Client Software, Release A.0
- UDP PC Client Software, Release A.0. .
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
Used at a centralized location.
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 established the performance, functionality, and reliability characteristics of the new device with respect to the predicates. Testing involved system level tests, integration tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the software functionality meets all reliability requirements and performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K964832, K993171, K993907, K001057, K011093
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
MAY 1 5 2002
9.0 510(k) Summary
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: Dave Osborn Quality Program Manager Cardiac and Monitoring Systems Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1085
978 659 3178 Tel: 978 685 5624 Fax: Email: d.g.osborn@ieee.org
This summary was prepared on May 1, 2002.
The name of this device is the PIC Software Release D.02.
- PIC Software, Release D.02 .
- Application Server Software, Release A.0 .
- UDP Server Software, Release A.0 .
- TCP/IP PC Client Software, Release A.0 ●
- UDP PC Client Software, Release A.0. .
- Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Panel 74 | |||
| Cardiovascular | 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 |
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- The modification is a software-based change that adds tabular trends to the trend review capability and permits ICA compatible applications to be served to both PIC Software and other clients.
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- The new device has the same intended use as the legally marketed They are used to display physiologic waves, predicate devices. parameters and, trends, to format data for compliant strip chart recorders, to format data for printed reports, and the secondary annunciation of alarms for up to 16 patients from other networked medical devices at a centralized location. To provide retrospective review of alarms, physiologic waves and parameters. And to provide
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primary annunciation of alarms, and configuration and control access for networked telemetry monitors at a centralized location.
021422
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- The new device has the same technological characteristics as the legally marketed predicate devices.
-
- Verification, validation, and testing activities established the performance, functionality, and reliability characteristics of the new device with respect to the predicates. Testing involved system level tests, integration tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the software functionality meets all reliability requirements and performance claims.
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2002
Ms. Dave Osborn Quality Program Manager Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099
Re: K021422
Trade Name: Philips M3290A Information Center Software, Revision D.02 Philips M2387A Application Server Software for M2385A, Release A.0 Philips M2389A UDP Server Software, Release A.0 Philips M2390A TCP/IP PC Client, Release A.0 Philips M2391A UDP PC Client, Release A.0 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: May 2, 2002 Received: May 3, 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.
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Page 2 - Ms. Dave Osborn
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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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,
Sincerely yours,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Philips M3290A Information Center Software, Release D.02 Philips M2387A Application Server Software for M2385A, Release A.0 Philips M2389A UDP Server Software, Release A.0 Philips M2390A TCP/IP PC Client, Release A.0 Philips M2391A UDP PC Client, Release A.0
Indications for Use: For central monitoring of 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 | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021422