(184 days)
Not Found
No
The document describes a standard vital signs monitor that processes physiological signals and checks for alarm conditions. There is no mention of AI, ML, or any advanced analytical techniques beyond basic signal processing and threshold-based alarming.
No.
The device is a vital signs monitor that acquires and displays physiological signals and alarms, but it does not provide any treatment or therapeutic intervention.
No.
The device is a vital signs patient monitor that acquires and presents physiological signals; it does not diagnose medical conditions.
No
The device description explicitly states it is a "battery or line-powered patient monitor" that "acquires the physiological signals" and "presents them on the color TFT display," indicating it includes hardware components beyond just software.
Based on the provided text, the PM-8000 Express Patient Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- PM-8000 Function: The PM-8000 Express Patient Monitor directly measures physiological signals from the patient's body (ECG, respiration, blood pressure, SpO2, temperature, invasive pressure, carbon dioxide). It does not analyze samples taken from the body.
The device is a vital signs monitor used for direct patient monitoring, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The PM-8000 Express Patient Monitor is a vital signs monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PM-8000 Express 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 Express Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO2), Temperature (TEMP), Invasive Blood Pressure(IBP) and Carbon Dioxide (CO2). 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 Express 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 Express Patient Monitor is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.
Product codes
MWI
Device Description
The PM-8000 Express Patient Monitor is a battery or line-powered patient monitor. The Patient Monitor acquires the physiological signals such as ECG(3-lead or 5-lead selectable), respiration (RESP), non-invasive blood pressure (NIBP), saturation of pulse oxygen (SpO2>, temperature (TEMP), invasive pressure (IBP) and carbon dioxide(CO2). These physiological signals are converted into digital data and processed. The PM-8000 Express Patient Monitor examines the data for alarm conditions and presents them on the color TFT display. The Patient Monitor also provides advantageous operating control for the user.
The optional built-in recorder, the optional CF memory card provides hard copies of all digital data and waveforms as well as Tabular and Graphic Trend Information, and storage the previous monitoring data information when power off accidentally.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
adult, pediatric and neonatal patients.
Intended User / Care Setting
It is intended for use by qualified medical personnel trained in the use of the equipment.
The PM-8000 Express Patient Monitor is intended for use in health care facility setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing was conducted to validate and verify that the PM-8000 Express Patient Monitor met all design specifications and was substantially equivalent to the predicate devices. This testing consisted of all environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Drafi Guidance Document. Additional testing was performed to demonstrate compliance with the ANSI/AAMI standards EC13. "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 operation. Some safety testing has been performed by third party agencies to ensure the device complies with applicable industry and safety standards. The PM-8000 Express Patient Monitor has also been tested to assure compliance with the requirements of various published standards, including EN865, IEC60601-1-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4, IEC60601-2-27, IEC60601-2-30, and ISO14971.
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."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
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.(b)
Classification. Class II (performance standards).
0
Exhibit #1 510(K) SUMMARY
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: K053193
Submitter:
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Tel: +86 755 2658 2888 Fax: +86 755 2658 2680
- 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:
Oct. 25, 2005
Name of the device:
● Trade/Proprietary Name: PM-8000 Express 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 Thermometers - | |
| Temperature Monitor with Probe | Class II | |
| 21 CFR 870.2700 | Oximeter, Pulse | Class II |
| 21 CFR 870.2710 | Ear Oximeter, Pulse | Class II |
| 21 CFR 868.1400 | Carbon Dioxide Gas Analyzer | Class II |
Page 1 of 4 PM-8000 Express Patient Monitor
1
Legally Marketed Predicate Device:
| K043348 | PM-8000 Patient Monitor (by Mindray Co., Ltd.) |
|---|---|
| K041790 | S/5 Compact Anesthesia Monitor (by Datex-Ohmeda Co., Ltd.) |
Description:
The PM-8000 Express Patient Monitor is a battery or line-powered patient monitor. The Patient Monitor acquires the physiological signals such as ECG(3-lead or 5-lead selectable), respiration (RESP), non-invasive blood pressure (NIBP), saturation of pulse oxygen (SpO2>, temperature (TEMP), invasive pressure (IBP) and carbon dioxide(CO2). These physiological signals are converted into digital data and processed. The PM-8000 Express Patient Monitor examines the data for alarm conditions and presents them on the color TFT display. The Patient Monitor also provides advantageous operating control for the user.
The optional built-in recorder, the optional CF memory card provides hard copies of all digital data and waveforms as well as Tabular and Graphic Trend Information, and storage the previous monitoring data information when power off accidentally.
Statement of intended Use:
The PM-8000 Express Patient Monitor is a vital signs monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PM-8000 Express 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 Express Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Saturation of Pulse Oxygen(SpO2), Temperature (TEMP), Invasive Blood Pressure(IBP) and Carbon Dioxide (CO2). 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 Express Patient Monitor is intended for use in health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.
The PM-8000 Express Patient Monitor is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.
Comparison of Technological Characteristics:
The PM-8000 Express Patient Monitor is substantially equivalent to systems currently
2
marketed predicate devices. The design, components, storage technology and energy source of the PM-8000 Express Patient Monitor are similar to the predicate device named PM-8000 Patient Monitor (K#043348). Both PM-8000 Express and PM-8000 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. The parameters' specification of the PM-8000 Express Patient Monitor, including ECG, RESP, HR, PR, RESP. NIBP, SpO2, TEMP, IBP, is similar to the predicate PM-8000 Patient Monitor. The PM-8000 Express's specification of CO2 is similar to S/5(K# 041790).
The notable difference between the technical specifications of the PM-8000 Express and PM-8000 is shown as following:
The PM-8000 Express Patient Monitor provides optional CF memory card, which can be used as a mass storage for patient information.
For the monitoring parameters. while the specification of some parameters is different, but all these parameters of the pending device and the predicate device comply with some ANSI/AAMI standards, IEC standards, EN standards and ISO standards.
The PM-8000 Express Patient Monitor provides two kinds of Temperature accessories applicable, YSI series and MR series. Both of them have same measurement range and accuracy, and both comply with EN12470-4.For CO2, both the pending device and the predicate device compy with EN864, ISO9918.
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 Express Patient Monitor met all design specifications and was substantially equivalent to the predicate devices. This testing consisted of all environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Drafi Guidance Document. Additional testing was performed to demonstrate compliance with the ANSI/AAMI standards EC13. "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 operation. Some safety testing has been performed by third party agencies to ensure the device complies with applicable industry and safety standards. The PM-8000 Express Patient
3
Monitor has also been tested to assure compliance with the requirements of various published standards, including EN865, IEC60601-1-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4, IEC60601-2-27, IEC60601-2-30, and ISO14971.
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."
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 areas 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. -
. Misdiagnosis
- 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 svstems 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-9000 Express 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 PM-8000 Patient Monitor numbered K#043348(by Mindray Co., Ltd) and the S/5 Compact Anesthesia Monitor numbered K#041790(by Datex-Ohmeda Co., Ltd.).
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it is often used to represent healthcare organizations.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 18 2006
Shenzhen Mindray Bio-Medical Electronics Co., Ltd c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K053193
Trade Name: PM-8000 Express Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MWI Dated: May 10, 2006 Received: May 11, 2005
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
5
Page 2 -Ms. Susan D. Goldstein-Falk
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 (301) 594-4646. 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 may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dona P. bochner
Image /page/5/Picture/5 description: The image contains a single letter 'W' in a bold, sans-serif font. The letter is black and appears to be isolated against a white background. The letter is slightly distorted.
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 #F
Page _ of 1 1
510(k) Number (if known): Kn 53193
Device Name: PM-8000 Express Patient Monitor
Indications For Use:
The PM-8000 Express Patient Monitor is a vital signs monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PM-8000 Express 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 Express Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO2), Temperature (TEMP), Invasive Blood Pressure(IBP) and Carbon Dioxide (CO2). 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 Express 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 Express Patient Monitor is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.
Prescription Use X (Per 21 CFR 801 Subpart D)
Over-The Counter Use OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Varhmer
Tivision of Cardiovascular Devices
310(k) Number K053193