MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM

K013156 · Data Critical Corp. · MSX · Oct 19, 2001 · Cardiovascular

Device Facts

• Record ID: K013156
• Device Name: MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
• Applicant: Data Critical Corp.
• Product Code: MSX · Cardiovascular
• Decision Date: Oct 19, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

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 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 Story

AlarmView™ Wireless Data Network System is a low-powered local area wireless paging system; provides secondary annunciation of primary medical device alarms. Inputs: alarm signals from primary medical monitoring devices. Transformation: wireless transmission of alarm data to mobile receivers carried by clinical staff. Output: visual/audible alarm notification on mobile devices. Context: hospital environment; operated by trained medical professionals. Benefit: provides redundant notification to clinical staff, ensuring timely awareness of patient events; supplements existing monitoring procedures without replacing primary diagnostic equipment or physician care.

Clinical Evidence

Bench testing only. Safety and effectiveness demonstrated through risk analysis and verification and validation testing.

Technological Characteristics

Low-powered local area wireless paging system. Operates as a secondary annunciation network for physiological monitors. Connectivity: wireless network. Class II device (21 CFR 870.2300).

Indications for Use

Indicated for real-time monitoring of patient status and alarm events from primary medical devices in hospital environments. Intended for use by trained, qualified medical professionals. Not for home use. Not a diagnostic device; intended as a secondary, redundant annunciation system.

Regulatory Classification

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.

Predicate Devices

• AlarmView™ Wireless Data Network System (K012005)

Submission Summary (Full Text)

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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 Parkway<br>Bothell, 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 System<br>K012005 |

## 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.

### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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™ 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.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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