(177 days)
No
The document describes a simple paging system for event annunciation and does not mention any AI/ML capabilities or related concepts like training/test sets for algorithmic performance.
No
The device is described as an "annunciation of events" system meant to alert individuals to a patient's condition, not to directly treat or diagnose. It is explicitly stated that "Primary care ... remains unchanged by the addition of the IMPACT pager."
No
The device is described as a pager system for event annunciation, alerting identified individuals to patient conditions. It explicitly states that "Primary care via the central station, patient bedside monitor, or telemetry system remains unchanged" and "this information is secondary to the primary care provided." This indicates it is a communication and alerting tool, not a device used to obtain diagnostic insights or information about the patient's medical condition. It facilitates communication of information generated by primary diagnostic or monitoring systems.
Unknown
The summary describes a "Pager System" and mentions "functional performance testing of the CardioPager system" and "information at the pager was checked for correctness". While it focuses on the software's function (annunciation of events), the description of a "pager" and checking "information at the pager" strongly suggests a hardware component is involved in receiving and displaying the information. The summary does not explicitly state it is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "annunciation of events within a zone coverage area" and alerting individuals to "a defined patient condition." This describes a communication and notification system, not a device used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description reinforces the idea of a system for "annunciation of events" and providing "zone information" and "alerts." It doesn't mention any interaction with biological samples or diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Performing chemical, biological, or immunological tests
- Providing diagnostic information based on laboratory results
The device's function is clearly focused on communication and alerting within a healthcare setting, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The IMPACT Pager System is intended to be used for the annunciation of events within a zone coverage area that is secondary to the primary care that is provided. Primary care via the central station, patient bedside monitor, or telemetry system remains unchanged.
This device is intended to be used within the hospital/facility environment.
Product codes
74 MSX
Device Description
The IMPACT pager is intended for the annunciation of events to provide zone information that is secondary to the primary care provided. It provides specific information within a zone and alerts or draws an identified individual's attention to a defined patient condition in a timely manner. Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of the IMPACT pager.
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
Not Found
Intended User / Care Setting
hospital/facility environment.
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
Functional performance testing of the CardioPager system was accomplished and provided in the submission. This test plan fully exercised the administrator application running on the server as well as the operation of the Unity™ alarm monitoring services of the CardioPager server. Additionally, the information at the pager was checked for correctness, as mentioned above.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation test results indicated that the IMPACT Pager System met the requirements of its intended use. Again, this information is secondary to the primary care provided. Primary care remains unchanged by the addition of the IMPACT pager.
Marquette Medical Systems has demonstrated that use of the IMPACT Pager System is as safe and effective, and performs substantially equivalent to use of the ADU/ Pager-LAN System.
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
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
14718608
NOV 1 3 1997
510(k) Summary of Safety and Effectiveness
1. Submitter
Marquette Medical Systems 8200 West Tower Avenue Milwaukee, WI 53223 USA
Establishment Registration Number 2124823
Contact Name / Telephone Number Dianne Schmitz Corporate Regulatory Affairs Marquette Medical Systems
Phone: (414) 362-3230
Date: 8 May 97
General Information 2.
Trade/Proprietary Name
Marquette's name for this device is IMPACT (Informing Mobile Personnel and Care Tracking) Pager System.
Common/Usual Name
This device is commonly known as a pager.
Device Classification
This device is unclassified according to a review performed of the CDRH Manual -FDA 91-4246 Classification Names for Medical Devices and In Vitro Diagnostic Products, as well as the Diogenes - The 510(k) Register and database.
Performance Standards
Performance standards (Section 514 of the Act) have not yet been established for the device that is the subject of this premarket notification submission.
Legally Marketed Predicate Device(s) 3.
The legally marketed predicate product is the ADU/ Pager-LAN System, K962827 .
র্বা Device Description and Intended Use
The IMPACT pager is intended for the annunciation of events to provide zone information that is secondary to the primary care provided. It provides specific information within a zone and alerts or draws an identified individual's aftention to a defined patient condition in a timely manner. Primary care via the central station, telemetry system, or patient bedside monitor remains unchanged by the addition of the IMPACT pager.
1
Test Summary & Conclusion 6.
The CardioPager Server, Micro Serial Server, and the Pager Transmitter are not used in the patient environment. These devices are purchased from the manufacturer with appropriate U.L. listing or classification on the device and/or the external power modules. The devices' U.L. Listing or Classification was reviewed by Marquette's Technical Coordinator and found to be appropriate. Marquette's reliability group also performed additional electrical and mechanical performance and safety tests which were specified and included in the submission.
While the CardioPager system functions as a secondary enunciator of alams, the bedside monitor and central station make up the patient monitoring system. Patient waveform acquisition, determination of alarm conditions, and alam notifications are primary functions of the patient monitoring system, which has been previously verified for accuracy. Because the CardioPager replicates arthythmia type, heart rate, and waveform information obtained from the monitoring system via Ethemet, this Information was compared for correctness during the functional performance testing.
Functional performance testing of the CardioPager system was accomplished and provided in the submission. This test plan fully exercised the administrator application running on the server as well as the operation of the Unity™ alarm monitoring services of the CardioPager server. Additionally, the information at the pager was checked for correctness, as mentioned above.
Validation test results indicated that the IMPACT Pager System met the requirements of its intended use. Again, this information is secondary to the primary care provided. Primary care remains unchanged by the addition of the IMPACT pager.
Marquette Medical Systems has demonstrated that use of the IMPACT Pager System is as safe and effective, and performs substantially equivalent to use of the ADU/ Pager-LAN System.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 3 1997
Ms. Dianne Schmitz Marquette Medical Systems 8200 West Tower Avenue Milwaukee, Wisconsin 53223
Re : K971868 IMPACT (Informing Mobile Personnel and Care Tracking) Pager System Regulatory Class: III (three) Product Code: 74 MSX Dated: September 5, 1997 Received: September 8, 1997
Dear Ms. Schmitz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Dianne Schmitz
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Unknown; 510(k) filed on May 16, 1997
Stop(s) Number (if known)
IMPACT (Informing Mobile Personnel and Care Tracking) Device Name: Pager System
Indications For Use:
The IMRACT Pager System is intended to be used for the annunciation of events within a zone coverage area that is secondary to the primary care that is provided. Primary care via the central station, patient bedside monitor, or telemetry system remains unchanged.
This device is intended to be used within the hospital/facility environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chaison Formen for Arc
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Prescription Use
(Per 21 CFR 801.109)
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