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.

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.

AI/ML Overview

The provided text for the AlarmView™ Wireless Data Network System's 510(k) summary (JUL 24 2001) does not contain detailed acceptance criteria or a specific study demonstrating device performance against such criteria in the way a diagnostic AI device submission would. This 510(k) is for a "Wireless Data Network System" that provides secondary annunciation of medical device alarms, not an AI/ML-driven diagnostic tool.

The submission focuses on establishing substantial equivalence to an existing predicate device (AlarmView™ Wireless Data Network System, K010912), rather than proving diagnostic performance against quantitative metrics like sensitivity or specificity.

Therefore, many of the requested fields cannot be answered based on the provided document.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined in the document as quantitative performance metrics for a diagnostic device. The submission focuses on substantial equivalence to a predicate, implying it meets the same implicit safety and effectiveness standards.	"Test results demonstrated that the modified AlarmView™ Wireless Data Network System, functionality and safety characteristics are substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable/Not provided. The document doesn't describe a "test set" in the context of diagnostic performance evaluation with patient data. The "validation testing" likely refers to engineering verification and validation of system functionality and performance characteristics rather than clinical data evaluation.
Data Provenance: Not applicable/Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable/Not provided. Ground truth establishment is not relevant for this type of device submission.
Qualifications of Experts: Not applicable/Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This is not an AI-driven diagnostic device; it's a wireless alarm notification system.
Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance Study: No. This is not an algorithm, but a hardware/software system designed to relay information to humans. Its function is inherently "human-in-the-loop."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable/Not provided.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/Not provided. This is not an AI/ML device that requires a "training set."

9. How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable/Not provided.

Summary of Study (Based on provided text):

The submission describes a "validation testing" and "risk analysis" as the basis for demonstrating safety and effectiveness. The "study" (or rather, the basis for approval) is centered around showing substantial equivalence to an already legally marketed predicate device (K010912). The key finding is: "Test results demonstrated that the modified AlarmView™ Wireless Data Network System, functionality and safety characteristics are substantially equivalent to the predicate device."

This indicates that the validation focused on ensuring the modified device performs its intended functions (receiving and annunciating alarms wirelessly) safely and effectively, similar to the predicate, and does not introduce new questions of safety or effectiveness. It's a regulatory "comparison" rather than a clinical trial or AI performance study.

Summary

{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 ParkwayBothell, 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 SystemK010912

Device Description

Indications For 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 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

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

000127

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).