M1765A ECG MANAGER

K974746 · Hewlett-Packard Co. · DPS · Mar 18, 1998 · Cardiovascular

Device Facts

• Record ID: K974746
• Device Name: M1765A ECG MANAGER
• Applicant: Hewlett-Packard Co.
• Product Code: DPS · Cardiovascular
• Decision Date: Mar 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

M1765A ECG Manager is a software-based data management system for 12-lead ECG records. Input data originates from HP PageWriter cardiographs via direct connection, removable diskette, or modem. System functions include receiving, storing, viewing, manually editing, printing, and deleting ECG records. Operated by clinical staff on user-provided IBM-compatible PCs running Windows 95 or NT. No diagnostic algorithms or computerized waveform interpretation are performed; all clinical decision logic remains embedded in the source cardiograph. Output is displayed on a video screen or provided as hard-copy printouts. System facilitates record archiving and clinical review workflows.

Clinical Evidence

Bench testing only. The device underwent unit and system-level validation to demonstrate that the software meets all product requirements.

Technological Characteristics

PC-based software application; runs on IBM-compatible hardware using Microsoft Windows 95 or NT operating systems; utilizes Microsoft Access relational database; connectivity via direct connect, removable diskette, or modem; no diagnostic algorithms; graphical user interface.

Indications for Use

Indicated for the management of digitized 12-lead ECG records originating from Hewlett-Packard electrocardiograph machines, allowing clinicians to view, manually edit, print, and archive patient data.

Regulatory Classification

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.

Predicate Devices

• Muse 5000 System (K840932)

Submission Summary (Full Text)

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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

[phone] Telephone: [phone] 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.

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.

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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 [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

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:

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