(27 days)
Not Found
No
The description focuses on standard physiological monitoring and alarming functions, with no mention of AI, ML, or related concepts.
No
The description states the device is for 'monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters', not for treating or providing therapy.
No
The device is described as a "Patient Monitor" and its intended use is for "monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters." It provides real-time data but does not state that it is used to specifically identify or determine the nature of a disease or condition, which is characteristic of a diagnostic device.
No
The device description explicitly mentions monitoring multiple physiological parameters (ECG, SpO2, NIBP, etc.) and being driven by AC or DC power supply, indicating the presence of hardware components for data acquisition and power.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that this device is a patient monitor that measures physiological parameters directly from the patient (ECG, HR, RESP, SpO2, PR, NIBP, CO2, TEMP). It does not analyze samples taken from the patient.
Therefore, the function of this device falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Patient Monitors, M8500, are 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), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. They are not intended for helicopter transport or hospital ambulance.
Product codes
MHX
Device Description
The proposed devices are 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), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. They have 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. They are not intended for helicopter transport or hospital ambulance.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Per the risk management during the design change control, the verification tests performed demonstrated that risks of each hazard are reduced to acceptable region.
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
§ 870.1025 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
K112803
P1/2
OCT 2 4 2011
Premarket Notification
Special Section 510(k) Submission
Project No.: M0312011Bd
Section IX 510(k) Summary
Image /page/0/Picture/5 description: The image shows a logo with the letters "BLT" in bold, followed by the word "BIOLIGHT" in smaller, but still bold letters. Above the letters "BLT" is a graphic of a plant with a circle above it. To the right of the letters "BLT" is a series of Chinese characters.
Section IX 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: _______________________________________________________________________________________________________________________________________________
| Date of Preparation | September 23, 2011 |
|---|---|
| Sponsor | Guangdong Biolight Meditech Co., Ltd [Reg #:3007305624] |
| 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 | Ms. Diana Hong / Mr. Lee Fu |
| Correspondent | Mid-Link Consulting Co., Ltd |
| P.O. BOX 237-023, Shanghai, 200237, China | |
| Proposed Device | Patient Monitor, M8500 |
| Modification to: M9000 Patient Monitor as cleared in K100046 | |
| 21 CFR 870.1025 MHX Class II | |
| Intended Use | Patient Monitors, M8500, are 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), carbon dioxide (CO2), and | |
| Temperature (TEMP) of adult, pediatric and neonatal patient. The monitors are to | |
| be used in healthcare facilities by clinical physicians or appropriate medical staff | |
| under the direction of physicians. They are not intended for helicopter transport or | |
| hospital ambulance. | |
| Device Description | The proposed devices are 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), carbon dioxide (CO2), and | |
| Temperature (TEMP) of adult, pediatric and neonatal patient. | |
| They have the alarming function with audio and visual alarming which may raise |
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1
K112803
p2/2
Premarket Notification Project No.: M0312011Bd Special Section 510(k) Submission
Section IX 510(k) Summary
Image /page/1/Picture/3 description: The image shows a logo with the letters "BLT" in bold, followed by the word "BIOLIGHT". To the left of the letters is a symbol that looks like a plant with a circle above it. To the right of the letters are three Chinese characters. The logo is in black and white.
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.
Test Summary
Conclusion
Per the risk management during the design change control, the verification tests performed demonstrated that risks of each hazard are reduced to acceptable region.
The proposed devices are Substantially Equiavlent (SE) to the predicate device, M9000 Patient Monitor as cleared in K100046, with respect of effectiveness and safety.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 4 2011
Guangdong Biolight Meditech Co., Ltd. c/o Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 237-023 Shanghai 200237 CHINA
Re: K112803
Trade/Device Name: Patient Monitor, Model M8500 Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MHX Dated: September 15, 2011 Received: September 17, 2011
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 10 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.
3
Page 2 - Ms. Diana Hong
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); 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/dcfault.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/ResourcesforYou/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
Premarket Notification Special Section 510(k) Submission
Project No .: M0312011Bd
Section III Indication for Use Form
Image /page/4/Picture/4 description: The image shows a logo with the text "BLT. BIOLIGHT" in bold, black letters. Above the text is a graphic of three leaves surrounding a circle. To the right of the text is a set of three Chinese characters, also in bold, black letters. The logo appears to be for a company or organization related to biology or light.
6
Section III Indication for Use Form
510(k) NUMBER (if known):
DEVICE NAME: Patient Monitor
INDICATION FOR USE:
Patient Monitors; M8500, are 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), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. They are not intended for helicopter transport or hospital ambulance.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K112803 |
|---|---|
| --------------- | --------- |