(28 days)
Not Found
No
The summary describes a wireless paging system for relaying existing medical device alarms and does not mention any AI/ML capabilities or related concepts like image processing, training data, or performance metrics typically associated with AI/ML.
No
The device is described as a system for monitoring and annunciating alarms from other medical devices, serving as a secondary means to inform clinical staff. It does not directly treat or diagnose a disease or condition.
No
The device is specifically stated as "not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care." It serves as a secondary alarm annunciation system.
No
The device description explicitly states it 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." This indicates the system includes hardware components for wireless communication and paging, not just software.
Based on the provided information, the AlarmView™ Wireless Data Network System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AlarmView™ Function: The AlarmView™ system's intended use and description clearly state its purpose is to monitor and annunciate alarms from medical devices in real-time. It's a communication and notification system for existing patient monitoring equipment.
- No Specimen Analysis: There is no mention of the AlarmView™ system analyzing any biological specimens from the patient.
- Focus on Device Alarms: The entire description revolves around the system's interaction with other medical devices and the communication of their alarm events.
Therefore, the AlarmView™ system falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MSX
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.
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; hospital type environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
AlarmView™ Wireless Data Network System K012005
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
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 |
| 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 |
| 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.
1
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™ 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.
(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)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
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