STATVIEW SYSTEM by DATA CRITICAL CORP.

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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the StatView™ System, a physiological monitor system, network, and communication device (alarm paging system). This type of document is focused on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing specific performance studies against defined acceptance criteria in the manner of a clinical trial for a new drug or a novel medical device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The document explicitly states: "StatView has the same safety and efficacy characteristics as the predicate devices." This highlights that the approval is based on equivalence, not a standalone performance study with novel criteria.

Specifically, the following information is NOT available in the provided text:

A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance criteria for the StatView™ System. It focuses on functional descriptions and equivalence to predicate devices.
Sample size used for the test set and the data provenance: No details on a test set, its size, or origin are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information about ground truth establishment or experts is present.
Adjudication method for the test set: Not applicable as no test set or ground truth process is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a paging system for alarm annunciation to human healthcare providers, implying human-in-the-loop by design. No "algorithm only" performance is discussed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth process is described.
The sample size for the training set: Not applicable; the document refers to the system's function rather than a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable.

What the document does provide:

Intended Use: "This device is intended for use in real-time monitoring of routine patient status and alarm events... 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."
Technological Characteristics: States that "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."
Equivalence Claim: The core of the submission is the claim that "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."

In essence, for this type of medical device submission in 1999, the "study" demonstrating that the device met "acceptance criteria" was the argument for substantial equivalence to legally marketed predicate devices, based on similar intended use and technological characteristics, rather than a novel performance study against predefined quantitative metrics.

Summary

{0}------------------------------------------------

SEP 2 0 1999

K990378

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 andCommunication (Alarm Paging System)
Trade Name:	StatViewTM System
Classification (if known):	Physiological Monitor System, Network andCommunication (21 CFR 870.2910)
	74 MSXClass 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 consists of the StatView Server (WT Server), StatView Transmitter, and StatView Receiver.

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:

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)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).