(90 days)
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.
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.
The provided text describes a 510(k) submission for the M Series Patient Monitor. It focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or an AI/algorithm component.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI component, as this information is not present in the given document.
The document only states that:
- "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."
Without further details on these "design specifications" or "consensus standards" and the specific results of "laboratory testing," I cannot create the table or answer the other detailed questions you've posed. The document is a regulatory submission for a patient monitor and not a clinical study report for an AI device.
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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 CoastZhuhai, Guangdong, 519085, ChinaContact Person: Mr. Tianbao Li, Chief EngineerTel: +86-756-3399963Fax: +86-756-3399989E-mail: li_tb@blt.com.cn |
| SubmissionCorrespondent | Ms. Diana Hong / Mr. Lee FuShanghai Mid-Link Business Consulting Co., LtdSuite 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 andM9000) is intended to be used for monitoring, displaying, reviewing,storing and alarming of multiple physiological parameters includingECG, Heart Rate (HR), Respiration Rate (RESP), Pulse OxygenSaturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure(NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), andTemperature (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
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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
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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
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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) | |
|---|---|
| Page 1 of 1 | |
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number |
§ 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.