CIMVA UNIVERSAL

K123472 · Therapeutic Monitoring Systems (Tms), Inc. · MHX · Mar 5, 2013 · Cardiovascular

Device Facts

• Record ID: K123472
• Device Name: CIMVA UNIVERSAL
• Applicant: Therapeutic Monitoring Systems (Tms), Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Mar 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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 Story

CIMVA Universal is a software-based analysis tool residing on hospital servers or computers; it imports retrospective physiological data (heart rate, respiratory rate) from third-party monitoring systems. The software allows clinicians to select and apply public-domain multi-organ variability analysis algorithms to the imported data (up to 96 hours). It generates configurable reports for research purposes, enabling clinicians to assess how variability measures change in response to user-inputted clinical events. The device is intended for use by clinicians in a hospital setting as an adjunct to existing monitoring systems. It does not perform real-time monitoring, provides no alarms, and does not replace vital signs monitoring. By quantifying physiological variability, it assists physicians in conducting research on the clinical utility of these measurements.

Clinical Evidence

No clinical data. Software validation was performed to demonstrate compliance with FDA guidance for software in medical devices and Class II Special Controls for Arrhythmia Detectors and Alarms. Testing confirmed the software operates according to its labeling claims.

Technological Characteristics

Software-only device; operates on hospital servers or computers. Implements public-domain algorithms for multi-organ variability analysis. Connectivity via periodic import of recorded data from third-party physiological monitors. No hardware components, sensors, or energy sources integral to the device.

Indications for Use

Indicated for analyzing patterns of variation in heart rate and respiratory rate derived from third-party monitoring systems. Not for vital signs monitoring or patient self-monitoring.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• IntelliVue (K103646)

Submission Summary (Full Text)

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CIMVA Universal Traditional Premarket Notification: K123472

# K123472 p1/3

# Section 5: 510(k) Summary

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| Category | Comments |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Therapeutic Monitoring Systems (TMS), Inc.<br>1900 Merivale Road, Suite 210,<br>Ottawa, ON<br>K2G 4N4 Canada<br>Tel [phone] x403<br>Fax [phone]<br>Company Contact:<br>Simon P. Goulet, Chief Operating Officer<br>[e-mail] |
| Correspondent Contact<br>Information: | Craig Coombs<br>Coombs Medical Device Consulting<br>1193 Sherman Street<br>Alameda, CA 94501<br>Tel: [phone]<br>Fax: [phone] |
| Device Common Name: | Arrhythmia detector and alarm (including ST-<br>segment measurement and alarm). |
| Device Classification<br>Regulation & Name: | 21CFR870.1025<br>monitor, physiological, patient (with arrhythmia<br>detection or alarms) |
| Device Classification &<br>Product Code: | Class 2,<br>MHX |
| Device Proprietary Name: | CIMVA Universal |
| Category | Cardiovascular |

# Predicate Device Information:

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

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#### K123472 p2/3

#### b. Date Summary Prepared 1 March 2013

#### c. Description of Device

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:

1. Allows the user to import a specified amount of recorded monitor data (e.g. up to 96 hours) stored in external repositories.

2. Allows the physician to choose the type of multi-organ variability analysis that he/she desires.

3. Calculates the selected measures of Variability.

4. 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

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.

#### 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
Systems

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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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 [phone] or [phone] 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:

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.

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)

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Section 4, Page 1