(194 days)
Not Found
No
The description details a system for transmitting patient monitoring data and alarms via a standard paging protocol. There is no mention of algorithms that learn from data or perform tasks typically associated with AI/ML, such as pattern recognition, prediction, or decision support beyond simple alarm forwarding.
No
The device is described as a paging system that interfaces with primary patient monitoring systems to provide secondary alarm notification, informing healthcare providers of patient alarm information. It does not provide any form of therapy or treatment to the patient.
No
Explanation: The device is described as a "paging system" that provides "a secondary means of annunciating and displaying patient alarm information." Its purpose is to transmit existing alarm and monitoring data to mobile healthcare providers, not to generate or interpret diagnostic information itself. It serves as a "parallel, redundant mechanism to inform the clinical staff of patient events," explicitly stating that it "is not intended to be a primary alarm enunciator."
No
The device description explicitly states that the system includes hardware components: a standard IBM-compatible PC (Critical-Server), a paging transmitter, a standard serial-to-Ethernet converter, and Cardio-Pager™ receiver units.
Based on the provided information, the Cardio-Pager™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Cardio-Pager™ Function: The Cardio-Pager™ System's intended use and device description clearly state that it is a paging system that interfaces with patient monitoring systems to relay real-time patient alarm information and status updates to healthcare providers. It does not analyze any biological specimens.
- Focus on Patient Monitoring Data: The system's input is data from patient monitoring devices (like heart rate and waveform data), not biological samples.
Therefore, the Cardio-Pager™ System falls under the category of a patient monitoring accessory or a communication system for patient monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The Cardio-Pager™ System described in this submission is a paging system that interfaces with primary patient monitoring systems in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers. The Cardio-Pager™ System has been validated for use with the Marquette Unity Network and the Hewlett-Packard System CareNet. This pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events.
This device is indicated for use in real-time monitoring of routine patient status and alarm events. The Cardio-Pager™ is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use only in a hospital environment.
Product codes (comma separated list FDA assigned to the subject device)
74DRG, 74 MSX
Device Description
The Cardio-Pager™ System (also referred to as StatView) is a secondary alarm notification system that transmits text and waveform data from patient monitoring devices to a graphical pager worn by a trained professional in a hospital environment. The system monitors the patient monitoring devices for alarm conditions, and responds by transmitting a page that includes text and waveform information from the patient. This system is not intended to be a primary alarm enunciator. The Cardio-Pager™ System alerts and informs the clinician about critical patient alarms without requiring them to be at or near the bedside or central monitors. The system can also provide periodic updates of heart rate and waveform data at intervals established by the caregivers.
The primary components in the Cardio-Pager™ System are the Critical-Server (also referred to as the WT Server) and the Transmission Subsystem. The server is a standard IBM-compatible PC that connects directly to the patient-monitoring network. The Transmission Subsystem consists of the paging transmitter, a standard serial-to-Ethernet converter, and the Cardio-Pager™ receiver units.
Software modules in the Critical-Server acquire patient information from the patient monitoring network, manage the initiation of paging messages, convert the data to proper format for transmission to the paging transmitter, and send the message to the paging transmitter via a LAN. The paging transmitter then sends the page, using standard POCSAG paging protocol. One or more of the Cardio-Pager™ receiver units may receive the page.
Addition of the Cardio-Pager™ System to the patient monitoring computer network does not in any way affect, modify, or interrupt the normal operation of the hospital patient monitoring 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
Not Found
Intended User / Care Setting
qualified medical professionals who have been trained on the use of the device. It is intended for use only in a hospital environment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Following software validation and verification activities, two types of performance testing were conducted for the Cardio-Pager™ System. First, the software was tested using a Data Acquisition (DA) module simulator to test the software in simulated conditions using no specific manufacturer's patient monitoring equipment (PME). The second type of testing consisted of finished device or "systems level" testing. Systems level testing was performed for two specific Cardio-Pager™ configurations: One with the DA module customized to facilitate interface with the Marquette Unity Network and the other with the DA module customized to facilitate interface with the Hewlett-Packard CareNet System. Both performance tests challenged all functional requirements for the Cardio-Pager™ System including: the receipt and transmission of patient alarms, the request, receipt and transmission of scheduled updates, the transmission of text messages, and the Cardio-Pager™ receipt of transmitted alarms, scheduled updates, and text messages. In addition, all communication requirements between the Cardio-Pager System™ and Marquette or Hewlett-Packard patient monitoring equipment (PME) were challenged by testing with a variety of Marquette and Hewlett-Packard patient monitoring devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software validation and verification activities followed by:
- Software testing with a Data Acquisition (DA) module simulator in simulated conditions without specific manufacturer's patient monitoring equipment (PME).
- "Systems level" testing of finished devices:
- Configuration with DA module customized for Marquette Unity Network.
- Configuration with DA module customized for Hewlett-Packard CareNet System.
Both tests challenged all functional requirements including receipt and transmission of patient alarms, request/receipt/transmission of scheduled updates, transmission of text messages, and Cardio-Pager™ receipt of transmitted alarms, scheduled updates, and text messages. Communication requirements between the Cardio-Pager System™ and Marquette or Hewlett-Packard PME were also challenged by testing with a variety of devices.
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.
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
§ 870.2300 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
Image /page/0/Picture/1 description: The image shows the logo for Data Critical Corp. The logo features a stylized graphic above the company name. The graphic consists of several horizontal lines with a circle in the middle, creating a three-dimensional effect. The text "Data Critical Corp." is written in a serif font.
System 510(k) -- K973527 lemental Information tial- Data Critical Corp. Redmond, WA
MAR 3 1 1998
Summary of Safety and Effectiveness
This summary of safety and effectiveness is submitted for public release in accordance with the requirements of SMDA 1990 and 21 CFR 820.92.
Submitter's Name:
Data Critical Corp. 2733 152nd Ave. NE Redmond, WA 98052 (425) 885-3500
Contact Person Drew D. Weaver, Director, Regulatory Affairs Data Critical Corp. (206) 885-3500
Date of Summary:
Cardio-Pager™ System Device Name:
(74DRG) 21 CFR 870.2910 Classification Name: Radiofrequency physiological signal transmitter and receiver
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
February 3, 1998
- MMS Pager-LAN Paging System 1) Marquette Medical Systems Milwaukee, WI K962827
-
- Palmvue Hewlett Packard K945277
Marquette Impact.wf 3) Marquette Medical Systems Milwaukee, WI K971868
1
Image /page/1/Picture/0 description: The image shows the logo for Data Critical Corp. The logo consists of a black abstract shape above the company name. The company name is written in a serif font. The abstract shape appears to be a stylized representation of a sun or a burst of energy.
Device Description:
The Cardio-Pager™ System (also referred to as StatView) is a secondary alarm notification system that transmits text and waveform data from patient monitoring devices to a graphical pager worn by a trained professional in a hospital environment. The system monitors the patient monitoring devices for alarm conditions, and responds by transmitting a page that includes text and waveform information from the patient. This system is not intended to be a primary alarm enunciator. The Cardio-Pager™ System alerts and informs the clinician about critical patient alarms without requiring them to be at or near the bedside or central monitors. The system can also provide periodic updates of heart rate and waveform data at intervals established by the caregivers.
The primary components in the Cardio-Pager™ System are the Critical-Server (also referred to as the WT Server) and the Transmission Subsystem. The server is a standard IBM-compatible PC that connects directly to the patient-monitoring network. The Transmission Subsystem consists of the paging transmitter, a standard serial-to-Ethernet converter, and the Cardio-Pager™ receiver units.
Software modules in the Critical-Server acquire patient information from the patient monitoring network, manage the initiation of paging messages, convert the data to proper format for transmission to the paging transmitter, and send the message to the paging transmitter via a LAN. The paging transmitter then sends the page, using standard POCSAG paging protocol. One or more of the Cardio-Pager™ receiver units may receive the page.
Addition of the Cardio-Pager™ System to the patient monitoring computer network does not in any way affect, modify, or interrupt the normal operation of the hospital patient monitoring system.
Intended Use:
The Cardio-Pager™ System described in this submission is a paging system that interfaces with Primary Patient Monitoring Systems in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers. This pager is intended to serves as a parallel, redundant mechanism to inform the clinical staff of patient events.
This device is indicated for use in real-time monitoring of routine patient status and alarm events. The Cardio-Pager™ is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use only in a hospital
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Data Critical Corp.
environment. The device has been validated for use with the Marquette Unity Network and the Hewlett-Packard Systems CareNet System.
Descriptive Summary of Technological Characteristics and Those of Predicate
The Cardio-Pager™ System has the same basic intended use as the predicate devices, namely to extend access to information from patient monitoring systems to mobile caregivers. Cardio-Pager™ is the same device as the Marquette Impact.wf. The Cardio-Pager™ System has identifical technological characteristics and is intended for use in the same application as the Marquette Impact.wf device. Both the Marquette Impact.wf and the Cardio-Pager serve as a secondary means of annunciating patient events and relaying information from the primary monitoring station through the use of a graphical interface paging system. The Cardio-Pager™ combines the alarm annunciation features of Marquette's Pager-LAN with the waveform paging capabilities of the Hewlett-Packard Palm Vue. The underlying wireless communication technology, standard alpha-numeric paging based on the POCSAG protocol. is identical in all three devices. The information provided to the caregiver in Cardio-Pager™ is a combination of the textual alarm information provided by Pager-LAN and the waveform information provided by Palm Vue. Essentially, the Cardio-Pager™ System enhances the functionality of the Pager-LAN by adding the important patient waveform to the information set available to the mobile caregiver.
Performance Data
Following software validation and verification activities, two types of performance testing were conducted for the Cardio-Pager™ System. First, the software was tested using a Data Acquisition (DA) module simulator to test the software in simulated conditions using no specific manufacturer's patient monitoring equipment (PME). The second type of testing consisted of finished device or "systems level" testing. Systems level testing was performed for two specific Cardio-Pager™ configurations: One with the DA module customized to facilitate interface with the Marquette Unity Network and the other with the DA module customized to facilitate interface with the Hewlett-Packard CareNet System. Both performance tests challenged all functional requirements for the Cardio-Pager™ System including: the receipt and transmission of patient alarms, the request, receipt and transmission of scheduled updates, the transmission of text messages, and the Cardio-Pager™ receipt of transmitted alarms, scheduled updates, and text messages. In addition, all communication requirements between the Cardio-Pager System™ and Marquette or Hewlett-Packard patient monitoring equipment (PME) were challenged by testing with a variety of Marquette and Hewlett-Packard patient monitoring devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 1998
Mr. Drew D. Weaver Data Critical Corporation 2733 152nd Avenue, NE Redmond, WA 98052
Re: K973527 Cardio-Pager™ System Regulatory Class: III (three) Product Code: 74 MSX Dated: February 18, 1998 February 19, 1998 Received:
Dear Mr. Weaver:
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, Druq, 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 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 (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 requlatory 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.
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Page 2 - Mr. Drew D. Weaver
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 regulation 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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Cardio-Pager™ System 510(k)
Supplemental Information
Confidential-Data Critical Corp.
Redmond, WA
510(k) Number (if known): K973527
Device Name:
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Cardio-Pager™ System
Indications for Use:
The Cardio-Pager™ System described in this submission is a paging system that interfaces with primary patient monitoring systems in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers. The Cardio-Pager™ System has been validated for use with the Marquette Unity Network and the Hewlett-Packard System CareNet. This pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events.
This device is indicated for use in real-time monitoring of routine patient status and alarm events. The Cardio-Pager™ is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use only in a hospital environment.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-The-Counter Use Per 21 CFR 801.109 Jur Division Sign-Off)
Division of Cardiovascular, Respiratory,
Division of Cardiovascular, Devices 1157 Division of Cardion.
Division of Cardional Devices and Neurological Devices - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -