The TeleVital VitalWare VMS is a vital sign monitoring and patient information software product intended to be used in conjunction with independent monitoring devices, and ancillary systems for the real-time collection, storage, and transmission to remote viewing sites.

The system is intended to be used in a hospital or clinic environment. Clinical judgment and experience are required to check and interpret the information delivered. VitalWare VMS is not intended to, and is not capable of controlling any of the medical devices it interfaces with.

Device Description

The TeleVital VitalWare VMS is a software system utilized for the real-time collection, storage, transmission, surveillance and management of vital sign data. The system can be used with any supported monitoring device or ancillary system connected directly to a PC computer or a network. The vital sign data is made available on any workstation on the network and/or Internet allowing health care professionals at the point of care to receive assistance from a supplementary care location. A typical deployment is composed of more than one PC workstation connected to one or more servers, receiving data from one or more medical devices over a network.

AI/ML Overview

The provided 510(k) summary for the TeleVital VitalWare VMS device describes a software system for managing vital sign data. However, it does not include granular details about specific acceptance criteria, study methodologies, or performance metrics typically associated with AI/ML-based device evaluations.

Based on the provided text, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or specific quantitative performance metrics for the VitalWare VMS. Instead, it refers to overall performance and reliability characteristics.

Acceptance Criteria	Reported Device Performance
Not Specified	Not Specified
(e.g., Data collection accuracy, Data transmission reliability, System uptime, User interface responsiveness)	(Evaluated against product specifications, risk analysis, and usability in hospital/clinic settings)

2. Sample Size for the Test Set and Data Provenance:

Sample Size for Test Set: Not specified. The document states "usability tests within an Inpatient Intensive Care Unit and an Outpatient Clinic environment" and "validation studies conducted in two states," but without specifying the number of patients, data points, or cases used in these tests.
Data Provenance: The validation studies were "conducted in two states," implying clinical environments within the United States. It's not explicitly stated whether the data was retrospective or prospective, though "real-time collection" suggests some prospective element to its intended use and testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not specified. The document mentions that "Clinical judgment and experience are required to check and interpret the information delivered," but does not detail how ground truth was established by experts during testing or validation.

4. Adjudication Method for the Test Set:

Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not explicitly described. The device is a "Physiological Transmitter and Receiver" and a "software system utilized for the real-time collection, storage, transmission, surveillance and management of vital sign data," not an AI/ML-driven diagnostic tool that would typically involve human readers interpreting results. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply here.

6. Standalone (Algorithm Only) Performance Study:

No, an explicit standalone performance study of an algorithm was not described. The VitalWare VMS is presented as a software system that interfaces with independent monitoring devices. Its performance is tied to the overall system's ability to collect, store, transmit, and display data reliably. The testing involved "verification and validation activities...to establish the performance and reliability characteristics...based on product specifications, safety testing based on risk analysis, and usability tests."

7. Type of Ground Truth Used:

Not specified directly in a way applicable to diagnostic accuracy (e.g., pathology, outcomes data). For a vital sign management system, ground truth would likely refer to the actual vital signs recorded by the independent monitoring devices and the accurate representation and transmission of that data by the VitalWare VMS. Usability testing would also involve ground truth regarding user workflows and satisfaction.

8. Sample Size for the Training Set:

Not applicable. The VitalWare VMS is described as a software system for data management, not an AI/ML device that undergoes a training phase with a specific dataset.

9. How Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a training set for an AI/ML model.

Summary of what is available vs. missing:

The 510(k) summary focuses on the device's intended use, technological characteristics, and comparison to predicate devices, emphasizing that the system's "performance and reliability characteristics" were established through "tests based on product specifications, safety testing...and usability tests." It concludes that these tests provide "a very high confidence level that the device is safe and effective when used as intended."

However, for the specific details requested regarding AI/ML device evaluation (such as defined acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, and explicit ground truth establishment for diagnostic performance), the document does not provide this level of detail. This is consistent with a 2005 submission for a vital sign data management system, which predates the widespread FDA guidance and requirements for AI/ML-based medical devices.

Summary

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MAY 1 3 2005

E 510 (K) Summary

Submitter's Name:	TeleVital Inc.
Submitter's Address:	1326 Piper Drive, Milpitas CA
Submitter's Telephone:	408-262-2665
Contact Name:	Kishore Kumar
Date Summary was Prepared:	January 10, 2005
Trade or Proprietary Name:	VitalWare VMS
Common or Usual Name:	Physiological Transmitter and Receiver
Classification Name:	Radiofrequency physiological signal transmitter and receiver
Predicate Devices:	Device Name	510(k) Number
	Argus System - Continuous Expert Care Network(modification of K001972 -10/27/00)	K012171
	MPT 24 and Vital View 24	K000276

Description:

VitalCom Network Monitoring System

Intended Use:

The system intended to be used in a hospital or clinic environment. Clinical judgment

TeleVital Inc

K041741

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and experience are required to check and interpret the information delivered. VitalWare VMS is not intended to, and is not capable of controlling any of the medical devices it interfaces with.

Substantial Equivalence Summary:

VitalWare VMS software is similar to the predicates in that it has the same intended use, modes of operation, features and specifications. All devices are intended for the realtime capture, management and display of vital sign and patient medical information over a networked healthcare environment.

Testing & Performance Data:

Verification and validation activities were conducted to establish the performance and reliability characteristics of the VitalWare VMS device. Testing involved tests based on product specifications, safety testing based on risk analysis, and usability tests within an Inpatient Intensive Care Unit and an Outpatient Clinic environment.

Conclusion:

The results of comparing the intended use, function, technological characteristics, mode of operation and specifications, of the VitalWare product with those of the predicate demonstrates that VitalWare VMS is substantially equivalent to existing products on the market today. Results of defined and controlled testing against its stated specifications and results gathered from hospital and clinic validation studies conducted in two states provides a very high confidence level that the device is safe and effective when used as intended.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of several curved lines.

MAY 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Televital, Inc. c/o Grace Bartoo, Ph.D., RAC Decus Biomedical, LLC 409 Walnut Street San Carlos, CA 94070

Re: K050128

Trade Name: VitalWare VMS Regulation Number: 21 CFR 870.2910 Regulation Number: 21 CFN 870.2716
Regulation Name: Radiofrequency Physiological Signal Transmitter and Receivers Regulatory Class: II (two) Product Code: DRG Dated: April 15, 2005 Received: April 18, 2005

Dear Dr.. Bartoo:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(s) premaint is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivale with referenced above and nave delemined the arrate to redicate devices marketed in interstate for use stated in the enclosure) to regally marked people and Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drue, commerce prior to May 28, 1976, the elaculience with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance who raspected application (PMA).
and Cosmetic Act (Act) that do not require approval approval applisions of the Act. The and Cosmetic Act (Act) that do not require approval or a pravisions of the Act. The Act. The
You may, therefore, market the device, subject to the general contration of th You may, therefore, market the device, subject or the gentral vannual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act merade requirements
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 If your device is classified (see above) nito cities in tepenlations affecting your device can
may be subject to such additional controls. Existing major regulations affecti may be subject to such additional controlis: Existing mays of a 998. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 899 ster be found in the Code of Federal Regatations, Frid 24, 2017 and 2017 and Register.

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Page 2 - Grace Bartoo, Ph.D., RAC

Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised that FDA $ issualice of a succession with other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decertimation that your are roo be other Federal agencies. You must as and ligit or any Federal statures and regulations daministered or registration and listing (21 l comply with all the Act s requirements, morading practice requirements as set a CFR Part 807); labeling (21 CFR Part 601); good and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and if applicable, the elect forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000product radiation control provisions (Sections of Persons of Personal in your Section 510(k)
This letter will allow you to begin marketing your device as described in your de I his letter will allow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalenced thus, premarket notification. The PDA miding of basianal equaline 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), please if you desire specific advice for your ac 1240) 276-0120. Also, please note the regulation entitled, contact the Office of Comphance at (216) ++6 Part 807.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Part 807.97) viously wather " Misoranding by reference to promations in the Act may be obtained from the Other general information on your responsional 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,

Bhimmarfor

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ | 050128

Device Name: Vital Ware VMS

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummen
Division Sign. Div.

(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number

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Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).