PM-8000 PATIENT MONITOR, MODEL 8000

K032733 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · DRT · Mar 3, 2004 · Cardiovascular

Device Facts

• Record ID: K032733
• Device Name: PM-8000 PATIENT MONITOR, MODEL 8000
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: DRT · Cardiovascular
• Decision Date: Mar 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The PM-8000 Patient Monitor is a vital signs monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PM-8000 Patient Monitor has many features and functions, yet is easy to use through an integrated keypad, knob and an intuitive menu system. The patient parameters that can be monitored by PM-8000 Patient Monitor are: ECG (3-lead or 5-lead selectable). Heart Rate derived from selected source (SP02, ECG), Respiration Rate (derived from ECG), Non-invasive blood pressure (NBP), Oxygen Saturation of the blood (SpO2), Temperature (TEMP) and invasive pressure (IBP). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs. The PM-8000 Patient Monitor is intended for us in health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment. The PM-8000 Patient Monitor is not recommended for use in a patient's home or residence, during the patient transport, or when it has not been ordered by a physician.

Device Story

Battery or line-powered patient monitor; acquires physiological signals (ECG, RESP, NIBP, SpO2, TEMP, IBP) via patient interface; converts signals to digital data; processes data for alarm conditions; displays waveforms and numeric values on color TFT screen; optional built-in recorder for hard copies. Used in healthcare facilities by qualified medical personnel. Operator adjusts alarm settings via keypad/knob; audible/visual alarms notify staff of excursions. Provides real-time monitoring to assist clinical decision-making; benefits patient through continuous vital sign surveillance.

Clinical Evidence

Bench testing only. Verified compliance with ANSI/AAMI EC13-2002 (cardiac monitors), SP10 (NIBP), and various IEC/EN safety standards (IEC 601-1, 601-1-1, 601-1-2, 601-1-4, 601-2-27, 601-2-30, EN865, EN1441). Hazard analysis and system validation conducted.

Technological Characteristics

Battery or line-powered; color TFT display; integral keypad/knob interface. Parameters: ECG (3/5-lead), NIBP, SpO2 (Masimo technology), TEMP, IBP. Standards: ANSI/AAMI EC13-2002, SP10, IEC 601-1 series, EN865, EN1441. Software-controlled alarm generation and signal processing.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in healthcare facilities for monitoring ECG, heart rate, respiration rate, NIBP, SpO2, temperature, and invasive pressure. Not for home use, patient transport, or use without physician order.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• Datascope Passport 2TM Vital Signs Monitor (K993531)

Submission Summary (Full Text)

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#### 510(K) SUMMARY Exhibit #1

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

The assigned 510(k) number is: 0332333

## Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tcl: [phone]

Fax: [phone]

#### Contact Person: ●

Li Dongling Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

#### Date Prepared: ●

July 28, 2003

#### Name of the device:

- Trade/Proprietary Name: PM-8000 Patient Monitor ●
- . Common Name: Patient Monitor
- . Classification

| 21 CFR 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm) | Class II |
|-----------------|---------------------------------------------------------------------|----------|
| 21 CFR 870.1130 | Non-Invasive blood pressure measurement System | Class II |
| 21 CFR 870.1110 | Blood pressure computer | Class II |
| 21 CFR 880.2910 | Clinical Electronic Thermometer -<br>Temperature Monitor with Probe | Class II |

Page 1 of 4 0056 PM-8000 Patient Monitor

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21 CFR 870.2700 Oximeter, Pulse

K032733

Class II

## Legally Marketed Predicate Device:

Datascope Passport 2TM Vital Signs Monitor K993531

#### Description:

The PM-8000 Patient Monitor is a battery or linc-powered patient monitor. The PM-8000 Patient Monitor acquires the physiological signals such as ECG, respiration (RESP), non-invasive blood pressure (NIBP), Saturation of Pulse Oxygen (SpO2), temperature (TEMP) and invasive pressure (IBP). These physiological signals are converted into digital data and processed. The PM-8000 Patient Monitor examines the data for alarm conditions and presents them on the color TFT display.

The optional built-in recorder provides hard copies of all digital data and waveforms as well as Tabular and Graphic Trend Information.

## Statement of intended Use:

The PM-8000 Patient Monitor is a vital signs monitor used on a human patient. The target populations are adult, pediatric and neonatal patients. The PM-8000 Patient Monitor has many features and functions, yet is easy to use through an integral keypad, knob and an intuitive menu system.

The patient parameters that can be monitored by PM-8000 are: ECG (3-lead or 5-lead sclectable), Heart Rate derived from selected source (SpO2, ECG), Respiration Rate (derived from ECG), Non-invasive blood pressure (NIBP), Saturation of Pulse Oxygen (SpO2), Temperature (TEMP) and Invasive pressure (IBP). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.

The PM-8000 Patient Monitor is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.

The PM-8000 Patient Monitor is not recommended for use in a patient's home or residence, during the patient transport, or when it has not been ordered by a physician.

## Comparison of Technological Characteristics:

The PM-8000 patient monitor is substantially equivalent to a combination of systems currently marketed by Datascope Corporation. The design, components, storage

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technology and energy source of the PM-8000 patient monitor are similar to those of its predicate device. All these systems provide a means for interfacing with a patient, collecting parameter specific physiological data, and processing the data for alarm generation and display of numeric values and waveforms on a bedside or central monitoring system.

There is only one notable difference between the technical specifications of the PM-8000 portable patient monitor and Datascope Passport 2TM Vital Signs Monitor. This difference relates to the PM-8000 patient monitor's measurement range for Systolic and Diastolic Pressure in the Adult/Podiatric/Nconatal Mode. In this instance, however, the specifications of the PM-8000 patient monitor are met the SP-10 standard.

The pulse oximetry design is licensed from Masimo and is similar to the Masimo design used in the predicate device.

These technological differences do not affect the safety or efficacy of the device. Any safety issues that may be raised by a software controlled medical device are the same issues already addressed by the predicate device and are addressed in the systems hazard analysis and in the system validation.

### Testing:

Laboratory testing was conducted to validate and verify that the PM-8000 patient monitor met all design specifications and was substantially equivalent to the Datascope Passport 21" Vital Signs Monitor. This testing consisted of all environmental testing idcntified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. Additional testing was performed to demonstrate compliance with the ANSI/AAMI standards EC13-2002, "Cardiac monitors, heart rate meters, and alarms". Finally, a hazard analysis of the system and its software was performed and testing was conducted to validate the systems overall opcration. Some safety testing has been performed by third party agencies to ensure the device complicable industry and safety standards. The PM-8000 portable patient monitor has also been tested to assure compliance to the requirements of various published standards, including EN865-1997, IEC 601-1:1988+A1: 1991+A2: 1995 +corrigendum June, 1995, IEC 601-1-1:2000, IEC 601-1-2:2001, IEC 601-1-4:1996, IEC 601-2-27:1994, IEC 601-2-30:1995, and EN1441 (1997).

Testing of the non-invasive blood pressure portion of the system was conducted according to the requirements outlined in the ANSI/AAMI Standards SP10 "Electronic automated sphygmomanometers."

MINDRAY PROPRIETARY

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Testing of the pulse oximetry portion of the system was conducted according to Masimo's testing protocol.

Although the device is neither life supporting nor life sustaining, diagnostic information derived from the use of the device and alarms generated by the device may be critical to the proper management of the patient. So, the arcas of risk for this device are the same as other devices in this class, and the following:

- Electrical shock ●
Excessive electrical chassis leakage current can disturb the normal electrophysiology of the heart.

- Misdi:agnosis .
- Inadequate design of the signal processing and measurement circuitry or । program can lead generation of inaccurate diagnostic data. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily.
- Inadequate design of the device's software, used to make various measurements, can lead to generation of inaccurate diagnostic data. If inaccurate diagnostic data are used in managing the patient, the physician may prescribe a course of treatment that places the patient at risk unnecessarily.
- Inadequate design of the systems ability to alert the users through audible and -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------visual indicators, can lead to user mistrust and/or inadequate response to the patient's condition. If an inadequate response to the patient's condition should occur the patient may unnecessarily be placed at risk.

### Conclusion:

The conclusions drawn from clinical and laboratory testing of the PM-8000 patient monitor demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the Datascope Passport 2TM Vital Signs Monitor, K#993531

MINDRAY PROPRIETARY

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

mar - 3 2004

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. c/o Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K032733

Trade Name: PM-8000 Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer & rate alarm) Regulatory Class: Class II (two) Product Code: DRT Dated: December 18, 2003 Received: December 19, 2003

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section > I (x) prematic is substantially equivalent (for the indications
referenced above and have determined the devices devices devices marketed in i referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the encrosule) to regally market of the Medical Device American of the Federal Food. Drug commerce prior to May 28, 1970, the chacanence with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, therefore, market the Act include requirements for annual registration, listing of
general controls provisions of the Act include required michranding and general controls provisions of the Frectines required in the mobibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) miss exisi on a crise to any of cegulation, FDA may may be subject to such additional controlis. Little 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In be found in the Code of Peacharter, concerning your device in the Federal Register.

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Page 2 - Ms. Susan D. Goldstein-Falk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit B

Page 1 of of 1

# 510(k) Number (if known): _ Ko32733

#### Device Name: PM-8000 Patient Monitor

#### Indications For Use:

The PM-8000 Patient Monitor is a vital signs monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PM-8000 Patient Monitor has many features and functions, yet is easy to use through an integrated keypad, knob and an intuitive menu system.

The patient parameters that can be monitored by PM-8000 Patient Monitor are: ECG (3-lead or 5-lead selectable). Heart Rate derived from selected source (SP02, ECG), Respiration Rate (derived from ECG), Non-invasive blood pressure (NBP), Oxygen Saturation of the blood (SpO2), Temperature (TEMP) and invasive pressure (IBP). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.

The PM-8000 Patient Monitor is intended for us in health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.

The PM-8000 Patient Monitor is not recommended for use in a patient's home or residence, during the patient transport, or when it has not been ordered by a physician.

Prescription Use X (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use (21 CFT 807 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division/Sign-Off) Division of Cardiovascular Devices | |
| 510(k) Number | C032733 |