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 environment. The device has been validated for use with the Marquette Unity Network and the Hewlett-Packard Systems CareNet System.

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.

AI/ML Overview

The provided text describes the Cardio-Pager™ System, a secondary alarm notification system that transmits text and waveform data from patient monitoring devices to a graphical pager. The document details the device's description, intended use, and performance data from testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., "accuracy must be >95%"). Instead, it describes functional validation tests. The reported device performance is that it met all challenged functional requirements.

Acceptance Criteria (Implicit)	Reported Device Performance
Functional Requirements (Overall System)	All functional requirements were challenged and met in testing.
Receipt & Transmission of Patient Alarms	Tested and validated.
Request, Receipt & Transmission of Scheduled Updates	Tested and validated.
Transmission of Text Messages	Tested and validated.
Cardio-Pager™ Receipt of Transmitted Alarms	Tested and validated.
Cardio-Pager™ Receipt of Scheduled Updates	Tested and validated.
Cardio-Pager™ Receipt of Text Messages	Tested and validated.
Compatibility with Marquette Unity Network	Validation for use with Marquette Unity Network confirmed through system-level testing.
Compatibility with Hewlett-Packard CareNet System	Validation for use with Hewlett-Packard CareNet System confirmed through system-level testing.
Communication between Cardio-Pager System™ and PME (various)	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, indicating successful communication across different devices.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a numerical sample size (e.g., number of alarms, updates, or messages) for the functional tests. It mentions "a variety of Marquette and Hewlett-Packard patient monitoring devices" were used for system-level testing.
Data Provenance: The testing was conducted internally by Data Critical Corp. (manufacturer). No information is provided about the country of origin of the data, patient data, or whether it was retrospective or prospective, as the testing was focused on device functionality rather than clinical outcomes with actual patient data. It appears to be prospective functional testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The concept of "ground truth" as typically applied to AI/diagnostic devices (e.g., expert consensus on medical images) does not directly apply to this functional validation. The ground truth here is the expected behavior of the system based on its design specifications. The testing was against these predefined functional requirements, not against expert medical diagnoses. Therefore, no medical experts were used to establish "ground truth" for the test set in the traditional sense. The "experts" would be the engineers and QA personnel who designed and verified the system's intended functionality.

4. Adjudication Method for the Test Set

Not applicable in the AI/diagnostic sense. The testing involved verifying if the device performed as designed against its functional specifications. There was no "adjudication" between multiple interpretations of medical data. The outcomes of the tests were pass/fail based on meeting the functional requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. The Cardio-Pager™ System is a paging and notification system, not an AI diagnostic tool that assists human readers in interpreting medical cases. Its purpose is to deliver information, not to interpret it or improve diagnostic accuracy with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance testing described is essentially standalone. The system autonomously performs its functions (acquiring, managing, converting, transmitting data, and displaying on the pager). While it interfaces with patient monitoring devices, the testing focuses on the Cardio-Pager™ System's ability to execute its programmed functions without continuous human intervention during the data transmission process. The "human-in-the-loop" aspect comes from the clinician receiving the page and acting on the information, but the system's performance in delivering that information was tested independently.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used was the functional design specifications of the Cardio-Pager™ System. The device was tested to ensure it accurately received, transmitted, and displayed the expected text and waveform data according to its predefined operational logic. This is not medical ground truth (like a pathology report for diagnosing a disease), but rather engineering ground truth (does the system do what it's designed to do?).

8. The Sample Size for the Training Set

Not applicable. The Cardio-Pager™ System is not an AI/machine learning device that requires a training set. It is a predefined software and hardware system operating based on fixed algorithms and protocols.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

K973527

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
1. 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:

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:

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image is a black and white drawing of a dark object with a light circle in the middle. The dark object is rectangular in shape and has a rough texture. The light circle is located in the center of the dark object and is surrounded by a dark halo. The image is simple and abstract.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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.

{4}------------------------------------------------

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

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Data Critical Corp. The logo features a black graphic element above the company name. The graphic element appears to be a stylized representation of a data storage device or a critical component. The text "Data Critical Corp." is written in a serif font.

Cardio-Pager™ System 510(k)
Supplemental Information
Confidential-Data Critical Corp.
Redmond, WA

510(k) Number (if known): K973527

Device Name:

ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

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.

(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 Jur Division Sign-Off)
Division of Cardiovascular, Respiratory,
Division of Cardiovascular, Devices 1157 Division of Cardion.
Division of Cardional Devices and Neurological Devices - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Regulation Number and Section

§ 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).