(283 days)
Not Found
No
The device description explicitly states that "The software does not analyze the information. Clinical judgment and experience are required to check and interpret the printed reports." This indicates a lack of automated analysis, which is a core function of AI/ML in this context. Additionally, there are no mentions of AI, DNN, or ML in the provided text.
No
The device is a software product intended for monitoring and managing patient data, not for delivering a therapeutic treatment.
Yes
The device aids in transtelephonic monitoring of arrhythmia and/or pacemaker implant patients, and performs in-office acquisition and display of single and/or multi-lead ECG. This involves gathering and presenting physiological data for interpretation, which are key characteristics of a diagnostic device. While it states that the software itself does not analyze the information and "Clinical judgment and experience are required to check and interpret the printed reports," the device facilitates the collection and display of data necessary for a diagnosis.
No
The device description explicitly states that an Instromedix LifeSigns Receiving Center™ (LRC) "may be attached to the PC, to acquire transmitted data and waveforms." This indicates a hardware component is involved in the data acquisition process, even if the primary function is software-based data management and display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CardioMagic® 2000 Cardiac Monitoring System Software is described as a system for:
- Transtelephonic monitoring of arrhythmia and pacemaker patients.
- In-office acquisition and display of ECG.
- Collection, storing, reporting, transfer, and management of patient health information.
- Receiving transmitted data and waveforms from transtelephonic pacemaker monitors and ECG event recorders.
- Lack of Sample Analysis: The description explicitly states, "The software does not analyze the information." It focuses on the acquisition, display, organization, and management of data and waveforms, not on analyzing biological samples.
The device is clearly focused on monitoring and managing cardiac data acquired through non-invasive means (ECG and transtelephonic transmission), not on analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
Transtelephonic monitoring of arthythmia 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.
Product codes (comma separated list FDA assigned to the subject device)
74 DXH
Device Description
CardioMagic 2000 Cardiac Monitoring System Software (CMS) is a productivity enhancing, office automation product. 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 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. The device does not sound any real-time (alarm).
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
Not Found
Intended User / Care Setting
physicians, clinics, and hospitals with cardiac patient follow-up and monitoring practices.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K964036 (CardioMagic products, PaceArt CPTS, and PaceBase)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
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.(b)
Classification. Class II (performance standards).
0
JUL 18 1997
Image /page/0/Picture/1 description: The image shows the logo for "Instromedix". The logo features a stylized "X" symbol to the left of the company name, which is written in a bold, sans-serif font. Below the company name is the tagline "Tools for medicine to help humankind".
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 Ν.Ε. Evergreen Parkway
Hillsboro, Oregon 97124-5898 USA
Phone: (503) 681-9000
(800) 633-3361
FAX: (503) 681-8230
1
Tools for medicine to help humankind
SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS CARDIOMAGIC® 2000 SOFTWARE Page 2 of 3
| COMPARISON
| FEATURE/SPEC | CARDIOMAGIC® 2000 | CARDIOMAGIC® S/W | PACEART® | PACEBASE® | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EMPHASIS | MINUETT™ | ||||||||||||||
| ARRHYTHMIA | CONCERTO™ | ||||||||||||||
| PACER FOLLOWUP | SYMPHONY™ | ||||||||||||||
| BOTH | AM | ||||||||||||||
| ARRHYTHMIA | ENHANCED | ||||||||||||||
| 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 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 F/U | |||||||||||||||
| 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 F/U | |||||||||||||||
| SUPPORT OF IMX 3X FORMATS | YES | YES | YES | YES | YES | NO | NO | ||||||||
| SUPPORT OF M, IMX 1X FORMATS | 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 | ||||||||
| AUTODIALER | 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 |
2
ls 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
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, possibly representing a family, with their arms raised in a gesture of support or unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 1997
Herbert H. Semler, M.D. Instromedix, Inc. One. Technology Center 7431 N.E. Evergreen Parkway Hillsboro, Oregon 97124-5898
Re: K964036 CardioMagic® 2000 Software Requlatory 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, Druq, 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 Regulation (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 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 requlations.
4
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 (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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INSTROMED I X
@003
Page 1 of 1
510(k) Number (if known): K964036
Device Name: _CardioMagic® 2000 Software
Indications For Use:
ﺰ
Transtelephonic monitoring of arthythmia 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)
D.J. Don A. Carloco
(Division Sign-Off) (Division Sign-Oit)
Division of Cardiovascular, Respiratory, Division ological Devices
510(k) Number J
Prescription Use_ X (Per 21 CFR 801.109)