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.

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 system. The product is designed to be installed and operated by users with 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.

AI/ML Overview

This 510(k) summary (K974746) for the M1765A ECG Manager describes a data management system for ECG information. It explicitly states that the device does not perform any computerized interpretation of the ECG waveform and There are no diagnostic algorithms built into M1765A ECG Manager applications. Given this, the concept of "acceptance criteria" for diagnostic performance, as well as a "study that proves the device meets the acceptance criteria" in terms of clinical accuracy, sensitivity, or specificity, is not applicable in the traditional sense for AI/ML devices.

Instead, the "acceptance criteria" for this device would relate to its functionality as a data management system (e.g., ability to receive, store, view, edit, copy, print, delete ECG data, and ease of use, stability, and absence of critical software bugs). The "study" proving it meets these criteria would be software validation testing.

Here's an attempt to answer using the provided information, noting the significant limitations due to the nature of this device as a non-diagnostic software:

Description of Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria

The M1765A ECG Manager is a software application designed for the management of digitized electrocardiograph records. It explicitly states that it does not perform any computerized interpretation of the ECG waveform and There are no diagnostic algorithms built into M1765A ECG Manager applications. Therefore, the acceptance criteria and study described here are for the device's functional performance as a data management system, not for diagnostic accuracy or clinical effectiveness in interpreting ECGs.

The "acceptance criteria" implicitly revolve around the system's ability to reliably perform its stated functions: receiving, storing, viewing, manually editing, copying, printing, and deleting 12-lead ECG information. The "study" demonstrating this involves non-clinical software validation testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device, explicit quantitative "acceptance criteria" and "reported device performance" in terms of clinical metrics (like sensitivity, specificity) are not provided in the document. Instead, the criteria are functional, and the performance is reported as successful validation.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Requirements:
- Ability to receive 12-lead ECG information	Met through thorough validation at unit and system level.
- Ability to store 12-lead ECG information	Met through thorough validation at unit and system level.
- Ability to view 12-lead ECG information	Met through thorough validation at unit and system level.
- Ability to manually edit 12-lead ECG information	Met through thorough validation at unit and system level.
- Ability to copy 12-lead ECG information	Met through thorough validation at unit and system level.
- Ability to print 12-lead ECG information	Met through thorough validation at unit and system level.
- Ability to delete 12-lead ECG information	Met through thorough validation at unit and system level.
- Integration with HP PageWriter cardiographs	Met, as the system manages records from these machines.
- Runs on Microsoft Windows 95 or NT operating systems	Met, as the product is designed for these specified operating systems.
- Utilizes Microsoft Access relational database	Met, as specified in the device description.
- Ease of use (graphical user interfaces, online HELP)	Met, "assured by use of timetested, industry standard graphical user interfaces."
- No diagnostic algorithms / computerized interpretation	Met, explicitly stated: "ECG Manager does not perform any computerized interpretation of the ECG waveform."
Non-Functional Requirements:
- System stability and reliability	Met, as indicated by successful "thoroughly validated at the unit and system level" testing.
- Compliance with all product requirements	Met, as "non-clinical tests were conducted to demonstrate that the ECG Manager software meets all product requirements."
- Substantial equivalence to predicate device (functional)	Met, as concluded from non-clinical testing.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable in the context of clinical data for diagnostic performance. The testing was non-clinical software validation. The document does not specify a "test set" sample size in terms of clinical ECG cases, nor does it refer to data provenance (country of origin, retrospective/prospective). The "data" being tested would be the functionality of the software itself rather than its performance on a specific dataset of ECGs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As this device does not perform diagnostic functions, there is no "ground truth" related to ECG interpretation that needs to be established by experts. Ground truth in this context would be whether the software performs its stated data management functions correctly, which is verified through software testing procedures, not expert adjudication of clinical cases.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical "test set" requiring adjudication for diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device does not involve AI for interpretation or diagnosis, and therefore, does not aim to improve human reader performance in interpreting ECGs.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense, the primary "performance" assessed was the standalone functionality of the software as a data management system. The "algorithm" here refers to the software's functional logic for managing data, not a diagnostic algorithm. The document states: "Non-clinical tests were conducted to demonstrate that the ECG Manager software meets all product requirements." This indicates a standalone assessment of the software's capabilities.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the non-clinical tests would be the predefined functional and non-functional software requirements and specifications. The software is tested against these specifications to ensure it performs as intended (e.g., an ECG stored is retrievable, an ECG printed matches the displayed version, etc.). There is no medical "ground truth" (e.g., pathology, outcomes data, or expert consensus on disease presence) required.

8. The Sample Size for the Training Set

Not applicable. The M1765A ECG Manager does not employ AI/ML algorithms that require training data. It is a traditional software application performing data management functions.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary

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K974746

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.

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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.

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.

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CONCLUSIONS FROM NONCLINICAL TESTING 10.

The testing of the ECG Manager demonstrates that the performance is substantially equivalent to predicate devices cited above.

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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.

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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

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: M1765A ECG Manager

Indications For Use:

(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)

Over-The-Counter Use _

(Optional Format 1-2-96)

12/16/97

Regulation Number and Section

§ 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).