MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A

K981576 · Hewlett-Packard GmbH · MHX · Jul 17, 1998 · Cardiovascular

Device Facts

• Record ID: K981576
• Device Name: MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A
• Applicant: Hewlett-Packard GmbH
• Product Code: MHX · Cardiovascular
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The HP M3000A/M3046A Compact Portable Patient Monitor is 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 a) waves' 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 (a) ECG (b) Respiration Invasive blood pressure (c) Non-invasive blood pressure (d) SpO2 and Pleth (e) Temperature (f)

Device Story

Compact portable patient monitor for healthcare facilities; operated by healthcare professionals. Inputs: ECG, respiration, invasive/non-invasive blood pressure, SpO2, plethysmography, and temperature sensors. Device processes physiological signals to display real-time waveforms and numerical data; generates alarms and printouts. Modification adds neonatal non-invasive blood pressure monitoring capability. Output used by clinicians for patient assessment and clinical decision-making regarding vital signs and physiological status.

Clinical Evidence

Bench testing only; device was fully validated.

Technological Characteristics

Compact portable patient monitor; includes software for signal processing and alarming. Supports ECG, respiration, invasive/non-invasive blood pressure, SpO2, pleth, and temperature measurements.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in healthcare facilities for monitoring and alarming of ECG, respiration, oxygen saturation, invasive and non-invasive blood pressure, and temperature.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Submission Summary (Full Text)

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

The M3000A/M3046A Compact Portable Patient Monitor is intended for monitoring, and alarming of ECG, respiration, oxygen saturation, invasive and non-invasive pressure, and temperature.

This [510(k)] modification adds a new feature (patient population) to the M3000A/M3046A Compact Portable Patient Monitor: the capability of monitoring neonatal patients is added to the noninvasive blood pressure measurement.

The M3000A/M3046A Compact Portable Patient Monitor contains software.

The HP M3000A/M3046A Compact Portable Patient Monitor was fully validated.

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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 1998

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

K981576 Re: Hewlett-Packard Models M3000A/M3046A Patient Monitor Requlatory Class: III (three) Product Code: MHX Dated: April 30, 1998 Received: May 4, 1998

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 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 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 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.qov/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

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## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: M3000A/M3046A Compact Portable Patient Monitor

Indications For Use:

The HP M3000A/M3046A Compact Portable Patient Monitor is 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 a) waves' 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
- (a) ECG
- (b) Respiration
- Invasive blood pressure (c)
- Non-invasive blood pressure (d)
- SpO2 and Pleth (e)
- Temperature (f)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Device

Prescription Use: yes (Per 21 CFR 801.109) OR

Over-The-Counter Use: no

(Optional Format 1-2-96)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number