MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)

K971910 · Hewlett-Packard GmbH · DSI · Mar 23, 1998 · Cardiovascular

Device Facts

• Record ID: K971910
• Device Name: MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)
• Applicant: Hewlett-Packard GmbH
• Product Code: DSI · Cardiovascular
• Decision Date: Mar 23, 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 waves' of a) one patient, and can generate alarms and printouts based on those measurements. - Can be used on adult, pediatric, and neonatal patients as specified in the b) Technical Data Sheets. The non-intrasive pressure can be used for adult and pediatric patients. 1. List of supported measurements - ECG (a) - Respiration (b) - Invasive blood pressure (c) - Non-invasive blood pressure (d) - SpO2 and Pleth (e) - Temperature (f)

Device Story

Compact portable patient monitor for health care facilities; operated by clinicians. Inputs: physiological signals via ECG, respiration, invasive/non-invasive blood pressure, SpO2, Pleth, and temperature sensors. Device processes signals to display real-time waveforms and numerical data; generates alarms and printouts for clinical review. Supports monitoring of single patient across adult, pediatric, and neonatal populations. Output assists clinicians in patient assessment and clinical decision-making; facilitates continuous monitoring to improve patient safety.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-parameter patient monitor; supports ECG, respiration, invasive/non-invasive blood pressure, SpO2, Pleth, and temperature. Form factor: compact portable unit. Connectivity: supports printouts and alarm generation. Sterilization: not applicable (non-sterile).

Indications for Use

Indicated for adult, pediatric, and neonatal patients in health care facilities for monitoring physiological parameters including ECG, respiration, invasive/non-invasive blood pressure, SpO2, Pleth, and temperature. Non-invasive blood pressure is restricted to adult and pediatric patients.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1998

Mr. Egon Pfeil Hewlett-Packard GmbH Schickardstrasse 4 D-71034 Boeblingen Germany

Re: K971910 Hewlett-Packard Models M3000A Multi-Measurement Server and M3046A Compact Portable Patient Monitor Requlatory Class: III (three) Product Code: 74 DSI December 5, 1997 Dated: Received: December 12, 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, Druq, 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, labelinq, 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 requlations.

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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

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## 510(k) Number (if known): K971910

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

Prescription Use: yes (Per 21 CFR 801,109)

OR

Over-The-Counter Use: no

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(Optional Format 1-2-96)

. Praz

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

510(k) Number _