CIMVA Universal is indicated for analyzing patterns of variation of physiological parameters (heart rate and respiratory rate) derived from the output of third party monitoring systems. CIMVA Universal is not designed for vital signs monitoring or self-monitoring of patients.

Device Description

The CIMVA Universal software is resident in a hospital server or other computer that is periodically connected to a repository of recorded data from third party physiological monitors. The current version of the software has four functions:

Allows the user to import a specified amount of recorded monitor data (e.g. up to 96 hours) stored in external repositories.
Allows the physician to choose the type of multi-organ variability analysis that he/she desires.
Calculates the selected measures of Variability.
Provides a physician-configurable report of the calculations
CIMVA Universal also allows the clinician to measure the degree to which multi-organ variability measures are altered in response to clinical events that are input by the user.
The calculations performed by CIMVA Universal are algorithms available in the public domain (as described in journal articles, etc.). None of the variability measures are proprietary to TMS. The results of these analyses could help physicians conduct research on the potential clinical utility of one or more of these variability measurements.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "CIMVA Universal" device. It is a software that analyzes patterns of variation of physiological parameters (heart rate and respiratory rate) from third-party monitoring systems.

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

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the format of a table. Instead, it makes a general statement about compliance.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices	"Software validation has demonstrated that the CIMVA Universal is in compliance with the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Compliance with applicable sections of the Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm	"...and the applicable sections of the Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm."
Operation in accordance with its labeling claims	"Testing has demonstrated that the software device operates in accordance with its labeling claims."
Substantial equivalence to the predicate Philips IntelliVue	"The company concludes that the Philips IntelliVue with the CIMVA Universal is substantially equivalent to the predicate Philips IntelliVue."

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

The document does not specify the sample size used for the test set or the provenance of the data (e.g., country of origin, retrospective or prospective). It states that the software "allows the user to import a specified amount of recorded monitor data (e.g. up to 96 hours) stored in external repositories" and that "all analyses are retrospective."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish ground truth for a test set. The device performs calculations based on public domain algorithms and does not involve clinical interpretation or diagnostic capabilities that would require expert-established ground truth in the traditional sense for performance evaluation against human experts.

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

The document does not specify any adjudication method, as it doesn't describe a study comparing the device's output against expert ground truth.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The device is not intended to assist human readers in interpretation or diagnosis; rather, it provides variability calculations that "could help physicians conduct research on the potential clinical utility of one or more of these variability measurements."

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

The document implies a standalone evaluation in terms of software validation. It states, "Software validation has demonstrated that the CIMVA Universal is in compliance with the FDA's Guidance..." and "Testing has demonstrated that the software device operates in accordance with its labeling claims." However, this evaluation is not in the context of clinical performance (e.g., diagnostic accuracy vs. ground truth) but rather in terms of software functionality and regulatory compliance. The device itself is stated to be "not a stand-alone analysis device, rather it is intended to be an adjunct to third party physiological monitors."

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

The concept of "ground truth" as typically used in diagnostic performance studies (e.g., expert consensus, pathology) is not applicable or explicitly mentioned in the context of the device's validation. The device calculates "measures of variability" using "algorithms available in the public domain." The ground truth for such an evaluation would likely be the mathematical correctness of these calculations, which would be verified through software testing rather than clinical expert review.

8. The sample size for the training set

The document does not mention a training set or its sample size. The calculations performed by CIMVA Universal are based on "algorithms available in the public domain (as described in journal articles, etc.)" and are not described as being derived from or trained on a specific dataset within the context of this submission.

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

Since no training set is mentioned in the context of machine learning model development, the establishment of ground truth for a training set is not applicable to the information provided.

Summary

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・

CIMVA Universal Traditional Premarket Notification: K123472

K123472 p1/3

Section 5: 510(k) Summary

Category	Comments
Sponsor:	Therapeutic Monitoring Systems (TMS), Inc.1900 Merivale Road, Suite 210,Ottawa, ONK2G 4N4 CanadaTel +1 613.368.4311 x403Fax +1 613.368.4313Company Contact:Simon P. Goulet, Chief Operating Officersgoulet@therapeuticmonitoring.com
Correspondent ContactInformation:	Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 510-337-0140Fax: 510-337-0416
Device Common Name:	Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Device ClassificationRegulation & Name:	21CFR870.1025monitor, physiological, patient (with arrhythmiadetection or alarms)
Device Classification &Product Code:	Class 2,MHX
Device Proprietary Name:	CIMVA Universal
Category	Cardiovascular

Predicate Device Information:

Predicate Device:	IntelliVue
Predicate Device Manufacturer:	Philips
Predicate Device Common Name:	Arrhythmia detector and alarm (includingST-segment measurement and alarm).
Predicate Device Premarket Notification #	K103646
Predicate Device Classification:	21CFR870.1025
Predicate Device Classification &Product Code:	Class 2,MHX

・

. . . .

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K123472 p2/3

b. Date Summary Prepared 1 March 2013

c. Description of Device

Allows the user to import a specified amount of recorded monitor data (e.g. up to 96 hours) stored in external repositories.
Allows the physician to choose the type of multi-organ variability analysis that he/she desires.
Calculates the selected measures of Variability.
Provides a physician-configurable report of the calculations

CIMVA Universal also allows the clinician to measure the degree to which multi-organ variability measures are altered in response to clinical events that are input by the user.

The calculations performed by CIMVA Universal are algorithms available in the public domain (as described in journal articles, etc.). None of the variability measures are proprietary to TMS. The results of these analyses could help physicians conduct research on the potential clinical utility of one or more of these variability measurements.

d. Indications for Use

e. Comparison to Predicate Device

The CIMVA Universal is not a stand-alone analysis device, rather it is intended to be an adjunct to third party physiological monitors. As a result, substantial equivalence is justified by comparing a third party physiological monitor (in this case the Philips IntelliVue; K 103646) versus the same IntelliVue device with the CIMVA Universal attached.

The use of the CIMVA Universal does not change the intended use of the predicate device. The CIMVA Universal does not raise new or additional questions of safety or effectiveness because all analyses are retrospective and none of them constitute a vital sign. The CIMVA Universal has no alarms associated with its analysis.

Section 5, Page 2

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Therapeutic
Monitoring
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CIMVA Universal Traditional Premarket Notification: K123472

K123472 p3/3

The testing described below establishes that CIMVA Universal is in compliance with the Special Controls for Physiological Monitors with the product code MHX.

The company concludes that the Philips IntelliVue with the CIMVA Universal is substantially equivalent to the predicate Philips IntelliVue.

f. Summary of Supporting Data

Software validation has demonstrated that the CIMVA Universal is in compliance with the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, and the applicable sections of the Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm.

Testing has demonstrated that the software device operates in accordance with its labeling claims.

Section 5, Page 3

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 5, 2013

Therapeutic Monitoring Systems, Inc. c/o Mr. Craig J. Coombs President Coombs Medical Device Consulting, Inc. 1193 Sherman Street Alameda, CA 94501

Re: K123472

Trade/Device Name: CIMVA Universal Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MHX Dated: January 15, 2013 Received: January 16, 2013

Dear Mr. Coombs:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Mr. Craig J. Coombs

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

for

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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Therapeutic
Monitoring
Systems

K123472

Section 4: Indications for Use Statement

510(k) Number (if known): K123472

Device Name: CIMVA Universal

Indications For Use:

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Section 4, Page 1

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.