(224 days)
M1490A
Not Found
No
The description focuses on a paging system that transmits pre-determined alarm information from primary monitoring systems without any indication of learning, adaptation, or complex data analysis beyond formatting and transmission. The "semi-automatic mode" refers to human filtering, not algorithmic decision-making.
No
The device is a paging system for alarm notification, not a treatment or diagnostic device.
No
The device is described as a paging system that transmits alarm information from primary monitoring systems. It explicitly states, "StatView does not diagnose alarms but transmits what the PPMS determines to be an alarm," indicating it does not perform diagnostic functions itself.
No
The device description explicitly states that the StatView system consists of a StatView Server (WT Server), StatView Transmitter, and StatView Receiver, indicating the presence of hardware components beyond just software.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- StatView's Function: StatView is a paging system that interfaces with patient monitoring systems. Its purpose is to transmit alarm information generated by those monitoring systems to mobile healthcare providers. It does not analyze biological samples or perform any diagnostic tests on the patient's body or samples from it.
- Intended Use: The intended use clearly states it's for "real-time monitoring of routine patient status and alarm events" and serves as a "parallel, redundant mechanism to inform the clinical staff of patient events." This is about communication and information relay, not diagnostic testing.
- Device Description: The description reinforces that StatView "reads the same alarm information that the PPMS uses" and "does not diagnose alarms but transmits what the PPMS determines to be an alarm."
Therefore, StatView falls under the category of a patient monitoring accessory or communication system, 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. StatView is limited to use by qualified medical professionals who have been trained on the use of the device. StatView is not intended for home use.
StatView™ is a paging system that interfaces with primary patient monitoring systems (PPMS) to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. It intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers.
Product codes (comma separated list FDA assigned to the subject device)
MSX
Device Description
StatView™ System is a paging system that interfaces with primary patient monitoring systems (PPMS) in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers.
StatView interfaces with the PPMS and reads the same alarm information that the PPMS uses, then formats that information into a message that can be transmitted to the receivers carried by mobile health caregivers. Although StatView reads the same alarm information that the PPMS LAN sends, it does not change it or modify it in any way. StatView does not diagnose alarms but transmits what the PPMS determines to be an alarm.
StatView consists of the StatView Server (WT Server), StatView Transmitter, and StatView Receiver.
In addition to the capabilities of the previous version of StatView (predicate device), users of the StatView system can send pre-programmed text messages that can be easily selected when initiating a text page as well as scheduling text messages. Semi-automatic mode is used for facilities that with their monitoring technicians to continue to filter the alarm traffic sent to the mobile caregivers.
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 / Not Found
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, Pager-LAN, Palm Vue (M1490A), Paging
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
SEP 2 0 1999
510(k) SUMMARY:
Image /page/0/Picture/3 description: The image shows the words "Data Critical" with a line going through the words. The line resembles an EKG reading. The line goes through the middle of the words, and it has a small peak between the words "Data" and "Critical."
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 2733 152nd Avenue NE Redmond, WA 98052
(425) 885-3500 (425) 885-3377 facsimile
Contact Person:
Same as above
Date Summary Prepared:
February 5, 1999
Device Name:
| Common Name: | Physiological Monitor System, Network and
Communication (Alarm Paging System) |
|----------------------------|----------------------------------------------------------------------------------|
| Trade Name: | StatViewTM System |
| Classification (if known): | Physiological Monitor System, Network and
Communication (21 CFR 870.2910) |
| | 74 MSX
Class III |
1
Predicate Devices:
StatView™ System is substantially equivalent to the following predicate devices: StatView™ System (previously cleared) by Data Critical Corporation, Pager-LAN by GE Marquette Medical Systems, and Palm Vue (M1490A) by Hewlett Packard, and "Paging" by Vitalcom.
Applicant Device Description:
StatView™ System is a paging system that interfaces with primary patient monitoring systems (PPMS) in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers.
StatView interfaces with the PPMS and reads the same alarm information that the PPMS uses, then formats that information into a message that can be transmitted to the receivers carried by mobile health caregivers. Although StatView reads the same alarm information that the PPMS LAN sends, it does not change it or modify it in any way. StatView does not diagnose alarms but transmits what the PPMS determines to be an alarm.
StatView consists of the StatView Server (WT Server), StatView Transmitter, and StatView Receiver.
In addition to the capabilities of the previous version of StatView (predicate device), users of the StatView system can send pre-programmed text messages that can be easily selected when initiating a text page as well as scheduling text messages. Semi-automatic mode is used for facilities that with their monitoring technicians to continue to filter the alarm traffic sent to the mobile caregivers.
Applicant Device Intended Use:
This device is intended for use in real-time monitoring of routine patient status and alarm events. StatView is limited to use by qualified medical professionals who have been trained on the use of the device. StatView is not intended for home use.
StatView™ is a paging system that interfaces with primary patient monitoring systems (PPMS) to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. It intended to be a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers.
2
Technological Characteristics:
StatView is the same in technological characteristics as the cited predicate devices. All the predicate devices consist of a paging system connected to primary patient monitoring equipment that is used to transmit patient data to an appropriate health care provider.
StatView has the same safety and efficacy characteristics as the predicate devices.
3
Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line and are easily readable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 20 1999
Mr. Drew Weaver Director of Regulatory Affairs Data Critical Corporation 19820 North Creek Parkway, Suite 100 Bothell, WA 98011
K990378 Re: StatView™ System Regulatory Class: III (three) Product Code: MSX Dated: July 16, 1999 Received: July 19, 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 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 (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 A substantially equivalent determination assumes compliance to 895. with 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 with the GMP regulation may result in requlatory action. In addition, 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.
4
Page 2 - Mr. Drew 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 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) 594-4648. 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 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,
Thomas J. Callahon
Thomas J. CallaMan, 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 indicated for use in real-time monitoring of routine patient status and alarm events. StatView is limited to use by qualified medical professionals who have been trained on the use of the device. StatView is not intended for home use.
StatView™ is a paging system that interfaces with primary patient monitoring systems (PPMS) to serve 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.
StatView™ has been validated for use with the following networks: Héwlett-Packard CareNet, GE Marquette Medical Unity, and Siemens Medical Systems Infinity.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
and the same of the same of the same of the same of
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
| 510(k) Number | K990378 |
|---|---|
| --------------- | --------- |
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)