(177 days)
Not Found
No
The document describes standard ECG and multiparameter data analysis techniques (Time Domain and Spectral mode for HRV) and does not mention AI, ML, or related terms. The focus is on data acquisition, analysis, editing, review, reporting, and storage using established methods.
No
The device is described as a workstation and software for acquiring, analyzing, editing, reviewing, reporting, and storing ECG and multiparameter data, including heart rate variability (HRV) measurements. Its intended use is for analysis and reporting, not for providing therapy or treatment. The HRV option explicitly states it is not intended to produce any interpretation or diagnosis, and its measurements are to be used in conjunction with other diagnostic tests and clinical judgment.
Yes
The device acquires, analyzes, reviews, and reports ECG and multiparameter data, and specifically, the HRV option analyzes variability in RR intervals (heart rate) and provides measurements. While it explicitly states it does not produce interpretation or diagnosis, the function of providing measurements for evaluation by qualified personnel in conjunction with other clinical information aligns with a diagnostic purpose.
No
The device description explicitly states that the MARS Unity Workstation is an "off-the-shelf computer hardware platform that supports a number of software applications." This indicates the device includes hardware components in addition to the software.
Based on the provided information, the MARS Unity Workstation with the Heart Rate Variability (HRV) Option is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- MARS Unity Workstation Function: The MARS Unity Workstation acquires, analyzes, edits, reviews, reports, and stores ambulatory and monitoring network ECG and multiparameter data. This data is acquired directly from the patient (ECG signals, etc.), not from a specimen taken from the body.
- HRV Option Function: The HRV Option analyzes variability in RR intervals (heart rate), which is derived from the ECG data. It does not analyze a specimen.
- Intended Use: The intended use describes the device as being used to process data acquired from the patient, not from a specimen.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens.
Therefore, the MARS Unity Workstation with the HRV Option falls under the category of a medical device that processes physiological data acquired directly from the patient, rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
74DQK
Device Description
The Multi-Parameter Analysis and Review System (MARS) unity workstation is an off-the-shelf computer hardware platform that supports a number of software applications including Holter analysis and editing system software and full disclosure clinical review software.
-
The Holter analysis software performs acquisition, analysis, editing, review, reporting and storage of ambulatory ECG and multiparameter data acquired from solid-state electronic ECG recorders, tape recorders and the monitoring real-time network.
-
The clinical review software (CRS) is a full disclosure system that acquires ECG and mixed parameter waveform data from Marquette's Unity monitoring network for display and reporting.
Heart Rate Variability (HRV) Option is a software option for Marquette Holter analysis systems which measures the variation from one cardiac cycle to the next, utilizing specific morphology. Heart rate variability can be analyzed using either the Time Domain mode, which quantifies variations using simple statistics, or the Spectral mode, which characterizes interval variations as a power spectrum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Patient population includes both adult and pediatric.
Intended User / Care Setting
intended to be used by trained operators under the direct supervision of a licensed health care practitioner in a hospital or clinic environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The MARS Unity Workstation with Heart Rate Variability (HRV) Option complies with voluntary standards as detailed in Section 9 Specific Standards and Guidances of this submission. The following quality assurance measures were applied to the development of MARS Unity Workstation with Heart Rate Variability (HRV) Option: Risk analysis Requirements specification reviews Code inspections Software and Hardware Testing Safety testing Environmental testing Final validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
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.(b)
Classification. Class II (performance standards).
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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 | |
| 8200 West Tower Avenue | ||
| Milwaukee, WI 53223 USA | ||
| Contact Person: | Laura L McComis | |
| Corporate Regulatory Affairs | ||
| GE Marquette Medical Systems | ||
| Phone: (414) 362-2688 | ||
| Fax: (414) 355-3790 | ||
| 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 | |
| Classification Number: 74DQK | ||
| Predicate Devices: | K922171 CENTRA II Analysis System | |
| K950779 Spacelabs Heart Rate Variability Software Option | ||
| Device Description: | The Multi-Parameter Analysis and Review System (MARS) unity | |
| workstation is an off-the-shelf computer hardware platform that | ||
| supports a number of software applications including Holter | ||
| analysis and editing system software and full disclosure clinical | ||
| review software. |
-
The Holter analysis software performs acquisition, analysis,
editing, review, reporting and storage of ambulatory ECG
and multiparameter data acquired from solid-state electronic
ECG recorders, tape recorders and the monitoring real-time
network. -
The clinical review software (CRS) is a full disclosure system
that acquires ECG and mixed parameter waveform data
from Marquette's Unity monitoring network for display and
reporting.
Heart Rate Variability (HRV) Option is a software option for
Marquette Holter analysis systems which measures the variation
from one cardiac cycle to the next, utilizing specific morphology.
Heart rate variability can be analyzed using either the Time
Domain mode, which quantifies variations using simple statistics,
or the Spectral mode, which characterizes interval variations as
a power spectrum. |
| 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. | |
| Technology: | MARS Unity Workstation with Heart Rate Variability (HRV) Option
employs the same technology as the predicate devices. | |
| Test Summary: | The MARS Unity Workstation with Heart Rate Variability (HRV)
Option complies with voluntary standards as detailed in Section 9
Specific Standards and Guidances of this submission. The
following quality assurance measures were applied to the
development of MARS Unity Workstation with Heart Rate
Variability (HRV) Option:
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
Workstation with Heart Rate Variability (HRV) Option is as safe, as
effective, and performs as well as the predicate devices, CENTRA
IL Analysis System and Spacelabs Heart Rate Variability Software | |
1
Option.
.
2
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.
3
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 (301) 594-4648. 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,
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
4
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,