(90 days)
No
The summary describes a standard patient monitor with basic physiological parameter monitoring, alarming, and data storage functions. There is no mention of AI, ML, or any advanced analytical capabilities that would suggest the use of these technologies.
No
The device is a patient monitor, designed to monitor and display physiological parameters, not to provide therapy.
No
The device description indicates it is a patient monitor used for "monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters." It does not mention using these parameters to diagnose a condition.
No
The device description explicitly states it is a "Patient Monitor" and mentions being "driven by AC or DC power supply," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The M Series Patient Monitor directly monitors physiological parameters within the patient's body (ECG, SpO2, NIBP, etc.). It is a patient monitoring device, not a device that analyzes samples taken from the patient.
- Intended Use: The intended use clearly states monitoring of physiological parameters of patients, not the analysis of biological specimens.
Therefore, the M Series Patient Monitor falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
M Series Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.
The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.
Product codes
MHX, DRT, DXN, DSK, DQA, BZQ, CCK, FLL
Device Description
The proposed device, M Series Patient Monitor (M66, M69, M8000 and M9000) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.
It has the alarming function with audio and visual alarming, which may raise the user attention of system error and exceeding the pre-set limit of physiological parameter, and data storage function, which can replay the data and alarming event.
The device is driven by AC or DC power supply.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonatal patient.
Intended User / Care Setting
healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
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
Not Found
Summary of Performance Studies
Laboratory testing was conducted to validate and verify that M Series Patient Monitor met all design specifications, including electrical safety, EMC, biocompatibility, specification. Results of these tests demonstrate compliance to the requirements of all consensus standards
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.
0
APR - 8 2010
Chapter III 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:
K 100046
| Sponsor | Guangdong Biolight Meditech Co., Ltd |
|---|---|
| Manufacturer | Innovation First Road, Technology Innovation Coast |
| Zhuhai, Guangdong, 519085, China | |
| Contact Person: Mr. Tianbao Li, Chief Engineer | |
| Tel: +86-756-3399963 | |
| Fax: +86-756-3399989 | |
| E-mail: li_tb@blt.com.cn | |
| Submission | |
| Correspondent | Ms. Diana Hong / Mr. Lee Fu |
| Shanghai Mid-Link Business Consulting Co., Ltd | |
| Suite 5D, No.19, Lane 999, Zhongshan Road (S-2) | |
| Shanghai, 200030, China | |
| Proposed Device | |
| Trade Name | M Seires Patient Monitor |
| Model | M66 M69 M7000 M8000 M9000 |
| Classification Name | Monitor, Physiological, Patient |
| Product Code | MHX |
| Regulation Number | 21 CFR 870.1025 |
| Panel | Cardiovascular |
| Subsequent Product Code | DRT, DXN, DSK, DQA, BZQ, CCK, FLL |
| Device Description | The proposed device, M Series Patient Monitor (M66, M69, M8000 and |
| M9000) is intended to be used for monitoring, displaying, reviewing, | |
| storing and alarming of multiple physiological parameters including | |
| ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen | |
| Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure | |
| (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and | |
| Temperature (TEMP) of adult, pediatric and neonatal patient. |
It has the alarming function with audio and visual alarming, which may raise the user attention of system error and exceeding the pre-set limit of
1
physiological parameter, and data storage function, which can replay the data and alarming event.
The device is driven by AC or DC power supply.
Intended Use
Testing Summary
Predicate Device
SE Determination
M Series Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.
The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.
Laboratory testing was conducted to validate and verify that M Series Patient Monitor met all design specifications, including electrical safety, EMC, biocompatibility, specification. Results of these tests demonstrate compliance to the requirements of all consensus standards
PM-7000 Patient Monitor (K072346)
The proposed device, M Series Patient Monitor, is Substantially Equivalent (SE) to the predicate device, PM-7000 Patient Monitor (K072346).
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a bird or eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR - 8 2010
Guangdong Biolight Meditech Co., Ltd. c/o Diana Hong Suite 5D, NO.19, Lane 999 Zhongshan Road (S-2) Shanghai, China, 200030
Re: K100046
Trade/Device Name: M Series Patient Monitor (M66, M69, M7000, M8000 and M9000 models).
Regulation Number: 21 CFR 870.1025
Regulation Name: Physiological Patient Monitor Regulatory Class: Class II (two) Product Code: MHX, DRT, DXN, DSK, DQA, BZQ, CCK, FFL Dated: March 19, 2010 Received: March 22, 2010
Dear Ms Hong:
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 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
3
Page 2 - Ms. Diana Hong -
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Submission for M Series Patient Monitor – Indication for Use Form Guangdong Biolight Meditech Co., Ltd
Exhibit #A Indication for Use Form
K100046 510(k) Number:
Device Name: M Series Patient Monitor
Indications for Use:
M Series Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of adult, pediation and neonatal patient as listed below:
| Parameters | M66 | M69 | M7000 | M8000 | M9000 |
|---|---|---|---|---|---|
| ECG | X | X | X | X | X |
| Heart Rate | X | X | X | X | X |
| Respiration Rate (RESP) | X | X | X | X | X |
| Pulse Oxygen Saturation (SpO2) | X | X | X | X | X |
| Non-Invasive Blood Pressure (NIBP) | X | X | X | X | X |
| Invasive Blood Pressure (IBP) | X | X | -- | X | X |
| Carbon Dioxide (CO2) | X | X | -- | X | X |
| Temperature (TEMP) | X | X | X | X | X |
The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
It is not intended for helicopter transport or hospital ambulance
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
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| Division of Cardiovascular Devices | |
| 510(k) Number |