HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES

K973437 · Hewlett-Packard GmbH · DPS · Dec 3, 1997 · Cardiovascular

Device Facts

• Record ID: K973437
• Device Name: HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES
• Applicant: Hewlett-Packard GmbH
• Product Code: DPS · Cardiovascular
• Decision Date: Dec 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The HP M1001B/M1002B ECG Plug-in Modules together with the Patient Monitor M1175A/M1176A are indicated for use in health care facilities by health care professionals when the patient's clinician deems it appropriate to use a device that: - Can measure and display multiple physiological parameters and waves' a) of one patient, and can generate alarms and printouts based on those measurements. - Can be used on adult, pediatric, and neonatal patients as specified in b) the Technical Data Sheets. - 1. List of supported measurements - ECG (a) - Respiration (b)

Device Story

M1001B ECG and M1002B ECG/Respiration modules function as plug-in components for Hewlett-Packard Component Monitoring System (CMS) M1175A/M1176A. Devices acquire ECG and respiration signals from patients; process data to display physiological waveforms and parameters; generate clinical alarms; provide printouts. Used in health care facilities by health care professionals. Modifications to existing hardware/software were validated via regression testing to ensure substantial equivalence to original CMS modules. Output assists clinicians in patient monitoring and decision-making.

Clinical Evidence

Bench testing only. Validation included regression testing of modified hardware and software components to confirm performance equivalence to the predicate device.

Technological Characteristics

Plug-in modules for CMS M1175A/M1176A patient monitors. Measures ECG and respiration. Includes hardware and software for signal acquisition, processing, and alarm generation. Designed for adult, pediatric, and neonatal use.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in health care facilities for monitoring, recording, and alarming of ECG and respiration parameters.

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

• CMS (K882609)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the text 'K973431' in a handwritten style. Below this text, the words 'Page 141' are printed in a smaller font size. The text appears to be part of a document or record, possibly indicating a page number or identification code.

## P -- [510(k)] Summary of Safety and Effectiveness

DEC - 3 1997

The M1001B ECG and M1002B ECG/Respiration Modules are intended for monitoring, recording, and alarming of ECG and respiration for adult, pediatric, and neonatal patients. Existing hardware and software of the M1001B ECG and M1002B ECG/Respiration plug-in modules (which were originally cleared together with CMS under K882609) were modified. The CMS hardware and CMS software modules are unchanged. The modified M1001B ECG and M1002B ECG/Respiration plug-in modules were fully validated (including regression testing).

The comparison of intended use and technological characteristics of this device to other legally marketed devices taken together with the validation results and other information in this submission indicate that this device is substantially equivalent to legally marketed predicate devices in safety, effectiveness and intended use.

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized design of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 1997

Mr. Egon Pfeil Medical Products Group-Europe Hewlett-Packard GmbH Schickardstrasse 4 D-71034 Boeblingen Germany

Re: K973437 Models M1001B ECG and M1002B ECG/Respiration Plug-in Modules of Component Monitoring System (CMS) M1175A/76A Regulatory Class: II (two) Product Code: 74 DPS September 8, 1997 Dated: Received: September 10, 1997

Dear Mr. Pfeil:

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 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 requlatory 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.

{2}------------------------------------------------

Page 2 - Mr. Egon Pfeil

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 Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the Hewlett-Packard (HP) logo. The logo consists of the letters 'hp' in a circle on the left, and the words 'HEWLETT' and 'PACKARD' stacked on top of each other on the right. The logo is black and white.

## INDICATIONS FOR USE

510(k) Number (if known):

## Device Name: M1001B ECG and M1002B ECG/Respiration Plug-in Modules

Indications For Use:

The HP M1001B/M1002B ECG Plug-in Modules together with the Patient Monitor M1175A/M1176A are indicated for use in health care facilities by health care professionals when the patient's clinician deems it appropriate to use a device that:

- Can measure and display multiple physiological parameters and waves' a) of one patient, and can generate alarms and printouts based on those measurements.
- Can be used on adult, pediatric, and neonatal patients as specified in b) the Technical Data Sheets.
- 1. List of supported measurements
- ECG (a)
- Respiration (b)

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

Concurrence of CDRH, Office of Device Evaluation

Woy Sezmdin M.D.

(Division Sign-Om)
Division of Cardiovascular, Respiratory,
and Neurological Devices K973437
510(k) Number.

Prescription Use: ves (Per 21 CFR 801.109) OR

Over-The-Counter Use: no

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(Optional Format 1-2-96)