(87 days)
Not Found
Not Found
No
The description focuses on data transmission and formatting for paging, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device is a monitoring system that provides supplemental alarm information and does not directly treat or diagnose a medical condition.
No
The device description explicitly states, "AlarmView does not diagnose alarms" and "AlamView is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care." Its purpose is for real-time monitoring and alarming, not for diagnosis.
No
The device description explicitly states that AlarmView consists of the AV Transmitter, AV Pager, and the AC PDA, indicating hardware components are part of the system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states that AlarmView is a paging system that interfaces with existing medical devices to relay alarm information. It reads data from the output port of these devices and formats it for transmission to a pager.
- No Sample Analysis: The device does not interact with or analyze any samples taken from the patient's body. Its function is purely data relay and communication.
- Intended Use: The intended use is for "real-time monitoring of routine patient status and alarm events on medical devices" and serving as a "secondary means of annunciating and displaying patient alarm information." This is a monitoring and communication function, not a diagnostic one based on sample analysis.
- Explicit Statement: The text explicitly states, "AlamView is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care." While this refers to its diagnostic capability in general, it further reinforces that its primary function is not in vitro diagnosis.
Therefore, AlarmView falls under the category of a medical device for monitoring and communication, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended 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. It is intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers.
AlarmView 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 and hospital type environments and is not for home use.
AlarmView is intended to supplement and not to replace any part of the current device monitoring procedures.
AlarmView is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.
AlarmView is currently validated for use with the N-x9y and N-3x00 data protocols.
Product codes (comma separated list FDA assigned to the subject device)
MSX
Device Description
AlarmView is a paging system that interfaces with a primary patient clinical device in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers.
AlarmView reads the patient information from the output data port and does not change the primary monitor in any way. It formats the patient information into a message that can be transmitted to a pager carried by mobile health caregivers. AlarmView does not diagnose alarms.
AlarmView consists of the AV Transmitter, AV Pager, and the AC PDA (Personal Digital Assistant) used for administration.
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 and 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)
Not Found
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.
StatView™ System by Data Critical Corporation 1), TS2000 by Trincore Systems 2), Pager-LAN by GE Marquette Medical Systems 3), "Paging" by Vitalcom 4)
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
Summary of Safety and Effectiveness: Data Critical Corporation 510(k) Notification: AlarmView™ - Physiological Monitor System, Network and Communication August 23, 1999
510(k) SUMMARY:
SAFETY AND EFFECTIVENESS SUMMARY
This information of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter's Name/Address:
Drew D. Weaver Director of Regulatory Affairs Data Critical Corporation 19820 North Creek Parkway, #100 Bothell, WA 98011
(425) 482-7000 (425) 482-7010 facsimile
Contact Person:
Same as above
Date Summary Prepared:
August 23, 1999
Device Name:
| Common Name: | Physiological Monitor System, Network and
Communication (Patient information Paging System) |
|----------------------------|------------------------------------------------------------------------------------------------|
| Trade Name: | AlarmView™ System |
| Classification (if known): | Physiological Monitor System, Network and
Communication (21 CFR 870.2910) |
| | 74 MSX
Class II |
1
Summary of Safety and Effectiveness: Data Critical Corporation 510(k) Notification: AlarmView™ - Physiological Monitor System, Network and Communication August 23, 1999
Predicate Devices:
AlarmView™ System is substantially equivalent to the following predicate devices:
- StatView™ System by Data Critical Corporation 1)
- TS2000 by Trincore Systems 2)
- Pager-LAN by GE Marquette Medical Systems 3)
-
- "Paging" by Vitalcom.
Applicant Device Description:
AlarmView™ is a paging system that interfaces with a primary patient clinical device in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers.
AlarmView reads the patient information from the output data port and does not change the primary monitor in any way. It formats the patient information into a message that can be transmitted to a pager carried by mobile health careqivers. AlarmView does not diagnose alarms.
AlarmView consists of the AV Transmitter, AV Pager, and the AC PDA (Personal Digital Assistant) used for administration.
Applicant Device Intended Use:
This device is intended 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. It is intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers.
AlarmView 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 and hospital type environments and is not for home use.
AlarmView is intended to supplement and not to replace any part of the current device monitoring procedures.
AlarmView is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.
2
Summary of Safety and Effectiveness: Data Critical Corporation 510(k) Notification: AlarmView™ - Physiological Monitor System, Network and Communication August 23, 1999
Technological Characteristics:
AlarmView is the same in technological characteristics as the cited predicate devices. Most of the predicate devices consist of a paging system. In all cases, the predicates are connected to a medical device that is used to transmit patient data to an appropriate health care provider.
AlarmView has the same safety and efficacy characteristics as the predicate 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Public Health Service
NOV 1 9 1999
Mr. Drew D. Weaver Director of Regulatory Affairs Data Critical Corporation 19820 North Creek Parkway, #100 Bothell, WA 98011
Re : K992848 Alarmview System II (Two) Regulatory Class: Product Code: MSX Dated: August 23, 1999 Received: August 24, 1999
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 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 In addition, with the GMP requlation may result in requlatory action. 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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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 leqally 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 requlation 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
KeKe Hill
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
Indications For Use:
This device is intended 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. It is intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers.
AlarmView 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 and hospital type environments and is not for home use.
AlarmView is intended to supplement and not to replace any part of the current device monitoring procedures.
AlamView is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.
AlarmView is currently validated for use with the N-x9y and N-3x00 data protocols.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K992848
Prescription Use OR Over-The-Counter
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use -------
(Optional Format 1-2-96)