MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM

{0}------------------------------------------------ **JUL 24 2001** ## 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: | June 26, 2001 | | Device Trade Name: | AlarmView™ Wireless Data Network System | | Device Classification Name: | System, Network and Communication, Physiological Monitor | | Device Classification: | Class II | | Predicate Device(s): | AlarmView™ Wireless Data Network System<br>K010912 | #### 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. #### 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™ Wireless Data Network 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™ Wireless Data Network System is to supplement and not replace any part of the current device monitoring procedure. The AlarmView™ Wireless Data Network 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 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 of safety and effectiveness. 000729 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUL 2 4 2001 Ms. Teresa M. Davidson Ms. Teresa Nr. Davidson Director of Regulatory Affairs and Quality Assurance Data Critical Corporation 19820 North Creek Parkway Bothell, WA 98011 Re: K012005 Trade Name: AlarmView™ Wireless Data Network System Regulation Number: 21 CFR 870.2300 Regulatory Class: II (two) Product Code: 74 MSX Dated: June 26, 2001 Received: June 27, 2001 Dear Ms. Davidson: We have reviewed your Section 510(k) notification of intent to market the device referenced above We have reviewed your Section 310(K) nothoution of the indications for use stated in and we have determined the device is substantially equivalent semmerse wrige to and we have determined the devices is sucstantly equartered in interstate commerce prior to the enclosure) to legally marketed predical Device Amendments, or to devices that have been May 28, 1976, the ellactificate of the medical Food, Drug, and Cosmetic Act (Act). reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act feciassified in accordance with the provisions of the general control provisions of the Act. The You may, therefore, market the device, subject to the gatination, listing of devices, general control provisions of the rise mendorotibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarke If your device is classified (SCC above) into entrols. Existing major regulations affecting your Approval), It may be subject to such additions, Title 21, Parts 800 to 895. A substantially device can be found in the Code of I casial Regulture Current Good Manufacturing Practices General equirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requirements, as set form in the Quality bystelli respections, the Food and Drug regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug regulation (21 CFR 1 at 820) and that, and assumptions. Failure to comply with the GMP regulation Administration (1 DA) will verty such assumptions and our communicements concerning may result in regulatory action: "In addition, a be this response to your premarket notification your device in the rederal Register. Thease noter and responses of through 542 of the {2}------------------------------------------------ Page 2 - Ms. Teresa M. Davidson Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. 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) 594-4645. 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 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/dsma/dsmamain.html". Sincerely yours, Nola Tillh nes E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## 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™ Wireless Data Network 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™ Wireless Data Network System is to supplement and not replace any part of the current device monitoring procedure. The AlarmView™ Wireless Data Network 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) Dale Tull Division of Cardiovascular & Respiratory Devices 510(k) Number K012605 OR Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ 000127