The AlarmView™ Wireless Data Network System is for use in real-time monitoring of routine patient status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. The AlarmView™ System provides a secondary means of annunciating and displaying patient alarm information to mobile healthcare professionals.

The AlarmView™ System is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital type environments and is not for home use.

The AlarmView™ System is to supplement and not replace any part of the current device monitoring procedure.

The AlarmView™ System is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.

Device Description

The modified AlarmView™ Wireless Data Network System is a low powered local area wireless paging system that provides secondary annunciation of primary medical device alarms via wireless communication devices carried by healthcare professionals.

AI/ML Overview

The provided text (K013156) is a 510(k) summary for a device modification, and it describes a device that provides secondary annunciation of primary medical device alarms via wireless communication devices. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies to establish specific acceptance criteria for diagnostic accuracy or clinical outcomes.

Therefore, the provided document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor does it describe specific studies with sample sizes, expert ground truth establishment, or comparative effectiveness studies (MRMC or standalone) in the context of diagnostic or clinical outcome performance.

The document states:

"The safety and effectiveness of the modified AlarmView™ Wireless Data Network System described in this submission has been demonstrated through risk analysis and verification and validation testing."
"Test results demonstrated that the modified AlarmView™ Wireless Data Network System, functionality and safety characteristics are substantially equivalent to the predicate device."

This indicates that the "study" for this submission was primarily focused on engineering verification and validation testing to ensure the modified device functions as intended and maintains the safety and effectiveness profile of its predicate. It's not a study designed to evaluate, for example, the diagnostic accuracy of an AI algorithm or the improvement in human clinical decision-making.

Given this, I cannot extract the information required for the requested table and study details from the provided text because it doesn't exist within the scope of this 510(k) summary.

Summary

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K013156

OCT 1 9 2001

CONFIDENTIAL Data Critical Corporation AlarmView™ Wireless Network System Special 510(k): Device Modification

510(k) SUMMARY

This 510(k) summary is submitted in accordance with 21 CFR 807.92.

Submitter's Name:	Data Critical Corporation
Submitter's Address:	19820 North Creek ParkwayBothell, WA 98011
Telephone:	425-482-7000
Fax:	425-482-7010
Contact Person:	Teresa M. Davidson
Date Prepared:	September 20, 2001
Device Trade Name:	AlarmView™ Wireless Data Network System
Device Classification Name:	System, Network and Communication, Physiological Monitors
Device Classification:	Class II
Predicate Device(s):	AlarmView™ Wireless Data Network SystemK012005

Device Description

Intended Use

The AlarmView™ Wireless Data Network System is for use in real-time monitoring of routine patient 사 status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. The AlarmView™ System provides a secondary means of annunciating and displaying patient alarm information to mobile healthcare professionals.
The AlarmView™ System is limited to use by qualified medical professionals who have been trained . on the use of the device. It is for use in hospital type environments and is not for home use.
The AlarmView™ System is to supplement and not replace any part of the current device monitoring l procedure.
. The AlarmView™ System is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.

Performance Data

The safety and effectiveness of the modified AlarmView™ Wireless Data Network System described in this submission has been demonstrated through risk analysis and verification and validation testing. Test results demonstrated that the modified AlarmView™ Wireless Data Network System, functionality and safety characteristics are substantially equivalent to the predicate device.

Conclusions

Based on the information provided in this submission, the modified AlarmView™ Wireless Data Network System is substantially equivalent to the predicate device and does not raise new issues of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2001

Ms. Teresa M. Davidson Director of Regulatory Affairs and Quality Assurance Data Critical Corporation 19820 North Creek Parkway Bothell. WA 98011

Re: K013156

Trade Name: AlarmView™ Wireless Data Network System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor Regulatory Class: Class II (two) Product Code: MSX Dated: September 20, 2001 Received: September 21, 2001

Dear Ms. Davidson:

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 11 Jour device 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.

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Page 2 - Ms. Teresa M. Davidson

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,

James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: AlarmView™ Wireless Data Network System

Indications For Use:

The AlarmView™ System is to supplement and not replace any part of the current device monitoring procedure.

The AlarmView™ System is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013156

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

000133

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).