(89 days)
No
The description explicitly states "There are no diagnostic algorithms built into M1765A ECG Manager applications." and focuses on data management and viewing, not analysis or interpretation using AI/ML.
No
The device is described as a computer software program for viewing, editing, printing, and archiving electrocardiograph records, and it explicitly states that there are no diagnostic algorithms built into it. It manages data from an ECG machine, but does not itself provide therapy.
No
The device is described as a data management system for viewing, editing, printing, and archiving ECG records. It explicitly states, "There are no diagnostic algorithms built into M1765A ECG Manager applications. All clinical rules and decision logic is embedded in the software of the electrocardiographs." This indicates it does not perform diagnostic functions itself.
Yes
The device is described as a "computer software program" and a "software application" that is installed on a user-provided computer. It manages data from separate hardware devices (electrocardiographs) but does not include any hardware components itself.
Based on the provided information, the M1765A ECG Manager is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The M1765A ECG Manager deals with digitized electrocardiograph records, which are electrical signals from the heart, not biological specimens.
- The intended use and device description clearly state its function is for viewing, managing, editing, printing, and archiving ECG data. It's a data management system for ECG records.
- The description explicitly states "There are no diagnostic algorithms built into M1765A ECG Manager applications. All clinical rules and decision logic is embedded in the software of the electrocardiographs." This further reinforces that the device itself does not perform diagnostic testing on biological samples.
Therefore, the M1765A ECG Manager falls under the category of a medical device, but specifically one that manages and processes data from another diagnostic device (the electrocardiograph), rather than being an IVD itself.
N/A
Intended Use / Indications for Use
The M1765A ECG Manager is a computer software program which allows viewing, manual editing, printing and archiving of digitized electrocardiograph records from Hewlett-Packard Company electrocardiograph machines.
Product codes
74 DPS
Device Description
The M1765A ECG Manager is a data management system which allows users to receive, store, view, manually edit, copy, print, and delete 12 lead ECG information which originated on HP PageWriter cardiographs. The M1765A ECG Manager employs the Microsoft Windows 95 or NT operating system, and Microsoft's Access relational database. Ease of use is assured by use of timetested, industry standard graphical user interfaces. The system consists of a software application which is installed by the user on a user-provided IBMcompatible personal computer running the Microsoft Windows 95 or NT operating The product is designed to be installed and operated by users with system. minimal computer skills. Voluminous, context-sensitive online HELP facilities are provided as part of the product. There are no diagnostic algorithms built into M1765A ECG Manager applications. All clinical rules and decision logic is embedded in the software of the electrocardiographs.
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
users with minimal computer skills.
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
Non-clinical tests were conducted to demonstrate that the ECG Manager software meets all product requirements. The testing of the ECG Manager demonstrates that the performance is substantially equivalent to predicate devices cited above.
Key Metrics
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).
0
510(k) Summary for MAR 18 1998 M1765A ECG Manager
DATE SUMMARY PREPARED 1.
December 16, 1997
2. SUBMITTER'S NAME AND ADDRESS
Hewlett-Packard Company 3000 Minuteman Road Andover, MA 01810-1099
3. CONTACT PERSON
Mr. George Diller
(978) 659-4971 Telephone: (978) 659-3168 Facsimile:
DEVICE NAME 4.
Proprietary Name: M1765A ECG Manager Common Name: ECG Management System Classification Name: unknown
ડ. PREDICATE DEVICES
The legally marketed device to which equivalence is being claimed is the Muse 5000 System manufactured by Marquette Electronics, Inc. (K840932). The design of ECG Manager is substantially equivalent in safety and performance to a subset of the Muse 5000 features, with the important exception that ECG Manager does not perform any computerized interpretation of the ECG waveform.
1
DEVICE DESCRIPTION 6.
The M1765A ECG Manager is a data management system which allows users to receive, store, view, manually edit, copy, print, and delete 12 lead ECG information which originated on HP PageWriter cardiographs. The M1765A ECG Manager employs the Microsoft Windows 95 or NT operating system, and Microsoft's Access relational database. Ease of use is assured by use of timetested, industry standard graphical user interfaces. The system consists of a software application which is installed by the user on a user-provided IBMcompatible personal computer running the Microsoft Windows 95 or NT operating The product is designed to be installed and operated by users with system. minimal computer skills. Voluminous, context-sensitive online HELP facilities are provided as part of the product. There are no diagnostic algorithms built into M1765A ECG Manager applications. All clinical rules and decision logic is embedded in the software of the electrocardiographs.
INTENDED USE 7.
The M1765A ECG Manager is a computer software program which allows viewing, manual editing, printing and archiving of digitized electrocardiograph records from Hewlett-Packard Company electrocardiograph machines.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 8.
The ECG Manager and the Muse 5000 both are PC based systems utilizing commercial operating systems.
Both offer viewing and editing on a video screen, hard copy printouts, and connection to the electrocardiograph via direct connect, removable diskette, or modem. An important difference is that ECG Manager does not perform any computerized interpretation of the ECG waveform.
9. NONCLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The design of the ECG Manager has been thoroughly validated at the unit and system level. Non-clinical tests were conducted to demonstrate that the ECG Manager software meets all product requirements.
2
CONCLUSIONS FROM NONCLINICAL TESTING 10.
The testing of the ECG Manager demonstrates that the performance is substantially equivalent to predicate devices cited above.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR | 8 1998
Mr. George Diller Project Manager, R&D Hewlett-Packard Company Cardiology Products Division 3000 Minuteman Road Andover, MA 01810
Re: K974746 M1765A ECG Manager Regulatory Class: II (two) Product Code: 74 DPS Dated: December 16, 1997 Received: December 19, 1997
Dear Mr. Diller:
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.
4
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 Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: M1765A ECG Manager
Indications For Use:
The M1765A ECG Manager is a computer software program which allows viewing, manual editing, printing and archiving of digitized electrocardiograph records from Hewlett-Packard Company electrocardiograph machines.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V. Donkin Tilli
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
12/16/97