MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION

K991786 · General Electric Medical Systems Information Techn · DPS · Nov 18, 1999 · Cardiovascular

Device Facts

• Record ID: K991786
• Device Name: MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION
• Applicant: General Electric Medical Systems Information Techn
• Product Code: DPS · Cardiovascular
• Decision Date: Nov 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The MARS Unity Workstation is intended to acquire, analyze, edit, review, report and store ambulatory and monitoring network ECG and multiparameter data. The MARS Unity Workstation is intended to be used by trained operators under the direct supervision of a licensed health care practitioner in a hospital or clinic environment. Patient population includes both adult and pediatric. The Heart Rate Variability (HRV) Option is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability heart rate data. Heart Rate Variability (HRV) Option is intended to provide only HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis. The HRV measurements produced by Heart Rate Variability (HRV) Option are intended to be used by qualified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgement. The HRV feature of this device has not been shown to be safe and effective for a specific clinical diagnosis.

Device Story

MARS Unity Workstation is an off-the-shelf computer platform for Holter analysis and clinical review of ECG and multiparameter data; inputs include data from solid-state electronic ECG recorders, tape recorders, and real-time monitoring networks. The system performs acquisition, analysis, editing, review, reporting, and storage. The HRV software option calculates RR interval variability using Time Domain (simple statistics) or Spectral mode (power spectrum). Used in hospitals or clinics by trained operators under physician supervision. Output consists of ECG waveforms and HRV measurements; clinicians use these to support clinical judgment alongside patient history and other tests. The device does not provide automated diagnosis or interpretation of HRV data.

Clinical Evidence

No clinical data. Bench testing only, including risk analysis, requirements specification reviews, code inspections, software and hardware testing, safety testing, environmental testing, and final validation.

Technological Characteristics

Off-the-shelf computer hardware platform. Software-based analysis of ECG and multiparameter data. HRV analysis via Time Domain (statistical) or Spectral (power spectrum) modes. Connectivity via monitoring network. No specific materials or sterilization methods described as the device is a workstation.

Indications for Use

Indicated for adult and pediatric patients requiring acquisition, analysis, and review of ambulatory and network ECG and multiparameter data. HRV option provides RR interval variability measurements for use by qualified personnel as an adjunct to clinical evaluation; not indicated for automated diagnosis.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• CENTRA II Analysis System (K922171)
• Spacelabs Heart Rate Variability Software Option (K950779)

Submission Summary (Full Text)

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## Section 2 Summary and Certification

## 2.1 510(k) Summary of Safety and Effectiveness

| Date: | May 24, 1999 | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Marquette Medical Systems<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA | |
| Contact Person: | Laura L McComis<br>Corporate Regulatory Affairs<br>GE Marquette Medical Systems<br>Phone: [phone]<br>Fax: [phone] | |
| Device: | Trade Name: | MARS Unity Workstation with Heart Rate Variability (HRV) Option |
| Common/Usual Name: | | Holter Analysis System |
| Classification Names: | | Classification Name: Computer, Diagnostic, Programmable<br>Classification Number: 74DQK |
| Predicate Devices: | | K922171 CENTRA II Analysis System<br>K950779 Spacelabs Heart Rate Variability Software Option |
| Device Description: | | The Multi-Parameter Analysis and Review System (MARS) unity<br>workstation is an off-the-shelf computer hardware platform that<br>supports a number of software applications including Holter<br>analysis and editing system software and full disclosure clinical<br>review software.<br><br>1) The Holter analysis software performs acquisition, analysis,<br>editing, review, reporting and storage of ambulatory ECG<br>and multiparameter data acquired from solid-state electronic<br>ECG recorders, tape recorders and the monitoring real-time<br>network.<br><br>2) The clinical review software (CRS) is a full disclosure system<br>that acquires ECG and mixed parameter waveform data<br>from Marquette's Unity monitoring network for display and<br>reporting.<br><br>Heart Rate Variability (HRV) Option is a software option for<br>Marquette Holter analysis systems which measures the variation<br>from one cardiac cycle to the next, utilizing specific morphology.<br>Heart rate variability can be analyzed using either the Time<br>Domain mode, which quantifies variations using simple statistics,<br>or the Spectral mode, which characterizes interval variations as<br>a power spectrum. |
| Intended Use: | The MARS Unity Workstation is intended to acquire, analyze, edit,<br>review, report and store ambulatory and monitoring network<br>ECG and multiparameter data. The MARS Unity Workstation is<br>intended to be used by trained operators under the direct<br>supervision of a licensed health care practitioner in a hospital or<br>clinic environment. Patient population includes both adult and<br>pediatric.<br><br>The Heart Rate Variability (HRV) Option is intended to be used for<br>the analysis of the variability in RR intervals (heart rate) and to<br>report measurements of the variability heart rate data.<br><br>Heart Rate Variability (HRV) Option is intended to provide only<br>HRV measurements and is not intended to produce any<br>interpretation of those measurements or any kind of diagnosis.<br><br>The HRV measurements produced by Heart Rate Variability (HRV)<br>Option are intended to be used by qualified personnel in<br>evaluating the patient in conjunction with patient's clinical<br>history, symptoms, other diagnostic tests, as well as the<br>professional's clinical judgement.<br><br>The HRV feature of this device has not been shown to be safe<br>and effective for a specific clinical diagnosis. | |
| Technology: | MARS Unity Workstation with Heart Rate Variability (HRV) Option<br>employs the same technology as the predicate devices. | |
| Test Summary: | The MARS Unity Workstation with Heart Rate Variability (HRV)<br>Option complies with voluntary standards as detailed in Section 9<br>Specific Standards and Guidances of this submission. The<br>following quality assurance measures were applied to the<br>development of MARS Unity Workstation with Heart Rate<br>Variability (HRV) Option:<br>Risk analysis Requirements specification reviews Code inspections Software and Hardware Testing Safety testing Environmental testing Final validation | |
| Conclusion: | The results of these measures demonstrate MARS Unity<br>Workstation with Heart Rate Variability (HRV) Option is as safe, as<br>effective, and performs as well as the predicate devices, CENTRA<br>IL Analysis System and Spacelabs Heart Rate Variability Software | |

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Option.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 1 8 1999

Ms. Laura L. McCornis Regulatory Affairs Specialist GE Marquette Medical Systems 8200 W. Tower Avenue Milwaukee, WI 53223

K991786 Re: MARS Unity Workstation with Heart Rate Variability II (two) Requlatory Class: Product Code: DPS Dated: September 17, 1999 Received: September 20, 1999

Dear Ms. McCornis:

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 leqally 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 Requlation (QS) for Medical Devices: General requlation (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 requlation may result in regulatory 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.

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Page 2 - Ms. Laura L. McCornis

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Nancy C. Brogdon for
Celia M. Witten, Ph.D., M.I

Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 11 Indications for Use Statement

510(k) Number (if known):

Unknown - 510(k) filed: May 24, 1999

Device Name: Option

MARS Unity Workstation with Heart Rate Variability (HRV)

Indications For Use:

The MARS Unity Workstation is intended to acquire, analyze, edit, review, report and store ambulatory and monitoring network ECG and multiparameter data. The MARS Unity Workstation is intended to be used by trained operators under the direct supervision of a licensed health care practitioner in a hospital or clinic environment. Patient population includes both adult and pediatric.

The Heart Rate Variability (HRV) Option is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability heart rate data.

Heart Rate Variability (HRV) Option is intended to provide only HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.

The HRV measurements produced by Heart Rate Variability (HRV) Option are intended to be used by qualified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgement.

The HRV feature of this device has not been shown to be safe and effective for a specific clinical diagnosis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/4/Picture/13 description: The image shows the words "Prescription Use" followed by "(Per 21 CFR 801.109)". There is a check mark above the line under the word "Use". The text is in a simple, sans-serif font.

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Nancy C. Boydon

ascular, Resmiratory,