CARDIOMAGIC 2000 SOFTWARE

K964036 · Instromedix, Inc. · DXH · Jul 18, 1997 · Cardiovascular

Device Facts

• Record ID: K964036
• Device Name: CARDIOMAGIC 2000 SOFTWARE
• Applicant: Instromedix, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Jul 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Transtelephonic monitoring of arrhythmia and/or pacemaker implant patients that do not require emergency medical intervention. In-office acquisition and display of single and/or multi-lead ECG. Collection, storing, reporting, transfer, and management of patient(s) health information.

Device Story

CardioMagic 2000 is a database software system for cardiac patient follow-up. It operates on IBM-compatible PCs, potentially networked. It interfaces with an Instromedix LifeSigns Receiving Center (LRC) to acquire transmitted ECG waveforms and data from transtelephonic monitors and ECG event recorders. The software provides remote control of the LRC, displays waveforms/data on-screen, and supports data organization, editing, and reporting. It does not perform automated waveform analysis; clinical interpretation by a physician is required. The system stores patient demographics, device parameters, and telemetry data. It is used in clinical/office environments to assist in evaluating pacemaker performance and patient ECG rhythms. It provides no real-time alarms.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Software application for IBM-compatible PCs; Windows 95 operating system. Relational database architecture. Interfaces: serial port for digitized ECG signals, printer interface, and remote receiver control. Connectivity: standalone or networked. Security: security key and network security features. No automated waveform analysis algorithms.

Indications for Use

Indicated for arrhythmia and pacemaker implant patients requiring non-emergency monitoring. Suitable for use in clinical settings by physicians, clinics, and hospitals for patient follow-up and data management.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

• CardioMagic (previous versions)
• PaceArt CPTS
• PaceBase

Submission Summary (Full Text)

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JUL 18 1997

SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS
CARDIOMAGIC® 2000 SOFTWARE
INSTROMEDIX, INC.
510(k) NUMBER K964036

CardioMagic® 2000 Cardiac Monitoring System Software (CMS) is a productivity enhancing, office automation product. The intended users of CMS are physicians, clinics, and hospitals with cardiac patient follow-up and monitoring practices. CMS is a database software product, intended to involve competent intervention before any impact on health occurs. The software does not analyze the information. Clinical judgment and experience are required to check and interpret the printed reports, as part of the process of evaluating pacemaker performance, or patient ECG rhythms. There are no known contraindications for use of this device.

CardioMagic software is installed on an IBM compatible personal computer, which may also be networked to other PC's. An Instromedix LifeSigns Receiving Center™ (LRC) may be attached to the PC, to acquire transmitted data and waveforms from transtelephonic pacemaker monitors and ECG event recorders.

CardioMagic provides remote control of the LRC, presents the received waveforms and data on the computer screen, assists in editing, viewing, and organizing the received data, and provides database support for patient and device information, and provide reports.

The CardioMagic® 2000 CMS is substantially equivalent to previous CardioMagic products, PaceArt CPTS, and PaceBase.

One Technology Center
7431 N.E. Evergreen Parkway
Hillsboro, Oregon 97124-5898 USA
Phone: [phone]
[phone]
FAX: [phone]

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Instromedox

Tools for medicine to help humankind

# SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS

# CARDIOMAGIC® 2000 SOFTWARE

Page 2 of 3

| COMPARISON | CARDIOMAGIC® 2000 | | | CARDIOMAGIC® SAW | | PACEART® | PACEBASE® |
| --- | --- | --- | --- | --- | --- | --- | --- |
| FEATURES SPEC | MINUET™ | CONCERTO™ | SYMPHONY™ | AM | ENHANCED | | |
| EMPHASIS | ARRHYTHMIA | PACER FOLLOWUP | BOTH | ARRHYTHMIA | BOTH | BOTH | BOTH |
| COMPATIBILITY | | | | | | | |
| SINGLE USER | YES | YES | YES | YES | YES | YES | YES |
| NETWORK COMPATIBLE | NO | NO | YES | YES | YES | YES | YES |
| IBM COMPATIBLE COMPUTERS | YES | YES | YES | YES | YES | YES | YES |
| OPERATING SYSTEM | WIN 95 | WIN 95 | WIN 95 | DOS, WIN, WIN 95 | DOS, WIN, WIN 95 | DOS, WIN, WIN 95 | DOS |
| TRANSTELEPHONIC RECEPTION | YES | YES | YES | YES | YES | YES | YES |
| IN-OFFICE ECG RECEPTION | YES | YES | YES | YES | YES | YES | YES |
| SCREEN TOOLS | | | | | | | |
| ECG STRIPS VIEWING | YES | YES | YES | YES | YES | YES | YES |
| SCREEN CALIPERS | YES | YES | YES | YES | YES | YES | NO |
| EDIT TRANSMISSIONS | YES | YES | YES | YES | YES | YES | YES |
| CONTEXT SENSITIVE HELP SUPPORT | YES | YES | YES | NO | NO | UNK | NO |
| RECEIVER CONTROL | YES | YES | YES | YES | YES | YES | YES |
| SOFTWARE ECG FILTERS | YES | YES | YES | NO | NO | YES | NO |
| PACER FAI | | | | | | | |
| DISPLAY/RECORD ECG AND PACEMAKER PULSE EVENTS | NA | NO | YES | NA | YES | YES | YES |
| MAGNET MODE MARKERS | NA | YES | YES | NA | YES | YES | NO |
| NON-MAGNET AND MAGNET MODE ECG COLLECTION | NA | YES | YES | NA | YES | YES | NO |
| MANUAL ENTRY OF MAGNET RATE | NA | YES | YES | NA | YES | YES | YES |
| AUTOMATICALLY MEASURES PACER PULSEWIDTH | NA | NO | NO | NA | NO | YES | YES |
| MANUAL PACER PULSE DATA ENTRY | NA | YES | YES | NA | YES | YES | YES |
| RECORDS PACER PULSE DATA FROM TRANSMITTER | NA | YES | YES | NA | YES | YES | YES |
| MEASURES PACER PULSE WIDTH | NA | NO | YES | NA | YES | YES | YES |
| ECG FAI | | | | | | | |
| SUPPORT OF IMX 3X FORMATE | YES | YES | YES | YES | YES | NO | NO |
| SUPPORT OF M, IMX 1X FORMATE | YES | YES | YES | YES | YES | YES | YES |
| AUTOMATICALLY DETERMINES HEART RATE | YES | YES | YES | NO | NO | YES | NO |
| ON-SCREEN EDITING OF ECG | YES | YES | YES | YES | YES | YES | NO |
| INTERFACES | | | | | | | |
| INTERFACES TO EXTERNAL ECG TRANSTELEPHONIC RECEIVER | YES | YES | YES | YES | YES | YES | YES |
| RECEIVES DIGITIZED ECG SIGNALS VIA SERIAL PORT | YES | YES | YES | YES | YES | YES | YES |
| IMPLANT INTERROGATOR CONNECTION INTERFACE | NO | NO | YES | NO | NO | YES | YES |
| PRINTER INTERFACE | YES | YES | YES | YES | YES | YES | YES |
| REMOTE USER SUPPORT | YES | YES | YES | NO | YES | YES | NO |
| AUTOGAILER | NO | NO | YES | NO | NO | YES | NO |
| OUTPUTS | | | | | | | |
| HARDCOPY REPORT GENERATION | YES | YES | YES | YES | YES | YES | YES |
| FILE TRANSFER | YES | YES | YES | YES | YES | YES | YES |
| FAX REPORTS | YES | YES | YES | NO | YES | YES | NO |
| MAILING LIST/DATA MERGE | YES | YES | YES | YES | YES | YES | NO |
| ELECTRONIC DATA TRANSFER/MERGE | YES | YES | YES | NO | YES | YES | NO |
| DATABASE | | | | | | | |
| DATA BASE STORAGE AND RETRIEVAL | YES | YES | YES | YES | YES | YES | YES |
| DATABASE SEARCH & FILTERS | YES | YES | YES | YES | YES | YES | YES |
| RELATIONAL DATA BASE OF PATIENT DEMOGRAPHIC INFORMATION, LEAD AND ELECTRODE INFORMATION, INSURANCE INFORMATION, REFERRING PHYSICIAN INFORMATION | YES | YES | YES | YES | YES | YES | YES |
| RELATIONAL DATA BASE OF IMPLANT INFORMATION, PROGRAMMING PARAMETERS, THRESHOLDS, | NO | YES | YES | YES | YES | YES | YES |
| DEVICE DICTIONARY | NO | YES | YES | NO | YES | YES | YES |
| SCHEDULER | | | | | | | |
| TELEPHONE CALLING SCHEDULE | NO | YES | YES | YES | YES | YES | YES |
| OFFICE CALL SCHEDULING | NO | YES | YES | YES | YES | YES | YES |
| SECURITY | | | | | | | |
| SECURITY KEY | YES | YES | YES | YES | YES | UNK | UNK |
| SECURITY CODE | NO | NO | YES | YES | YES | UNK | YES |
| NET SECURITY (VIA NETWORK) | YES | YES | YES | YES | YES | UNK | UNK |

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X

Instromedix

Tools for medicine to help humankind

# SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS

## CARDIOMAGIC® 2000 SOFTWARE

Page 3 of 3

The primary purpose of CardioMagic, PaceArt and PaceBase software products is to provide to cardiac clinicians and automated computer system for tracking cardiac patients. These systems utilize a commercial relational database system. The database provides fields for storing device information such as: threshold, elective replacement intervals, device parameters and measurements, and telemetry data; and patient information inch includes contacts and scheduled appointments. These systems store ECG signals and related data. The CardioMagic, PaceArt and PaceBase systems are application programs which operate on IBM compatible personal computers. Unlike the PaceArt CPTS product, CMS does not perform any waveform analysis on a patient’s ECG. Thus, CardioMagic 2000 is substantially equivalent to previous CardioMagic products, PaceArt CPTS, and PaceBase.

© Copyright 1997, Instromedix, Inc. All rights reserved.

The device does not sound any real-time alarm. Chas C. July 18, 97

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Herbert H. Semler, M.D.
Instromedix, Inc.
One Technology Center
7431 N.E. Evergreen Parkway
Hillsboro, Oregon 97124-5898

JUL 18 1997

Re: K964036
CardioMagic® 2000 Software
Regulatory Class: II (two)
Product Code: 74 DXH
Dated: April 15, 1997
Received: April 21, 1997

Dear Dr. Semler:

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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation 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 - Herbert H. Semler, M.D.

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 regulation (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" (21 CFR 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/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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07/17/97 THU 10:12 FAX [phone]
INSTRUMEDIX
003

Page 1 of 1

510(k) Number (if known): K964036

Device Name: CardioMagic® 2000 Software

Indications For Use:

Transtelephonic monitoring of arrhythmia and/or pacemaker implant patients that do not require emergency medical intervention.
In-office acquisition and display of single and/or multi-lead ECG.
Collection, storing, reporting, transfer, and management of patient(s) health information.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑
(Per 21 CFR 801.109)


(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number