(67 days)
Not Found
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 such technologies.
No
The device is a patient monitor, which is used for monitoring and displaying physiological parameters, not for treating conditions.
No
Explanation: The device is described as a patient monitor intended for "monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters." It does not mention analyzing data to diagnose a condition, but rather continuously monitors parameters and alerts users to changes.
No
The device description explicitly mentions monitoring multiple physiological parameters, which requires hardware sensors and components to acquire the data. It also mentions being driven by AC or DC power supply, further indicating a hardware component.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use and device description clearly state that this device monitors physiological parameters directly from the patient (ECG, SpO2, NIBP, etc.). It does not involve the analysis of blood, urine, tissue, or other samples taken outside the body.
- The device description focuses on monitoring and displaying real-time physiological data. This is characteristic of patient monitoring devices, not IVDs.
Therefore, this device falls under the category of a patient monitoring system, which is a different type of medical device than an IVD.
N/A
Intended Use / Indications for Use
Patient Monitors, M9500 / AnyView A8 / AnyView A6, 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), Invasive Blood Pressure (IBP), 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, DRT, DXN
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), Invasive Blood Pressure (IBP), 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
The monitors are to be used in 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The verification tests include: IEC 60601-1:1988+A1:1991+A2:1995; IEC 60601-1-2:2001+A1:2004.
The information in this 510(k) Summary demonstrates that the proposed devices are Substantially Equiavlent (SE) to the predicate device, M9000 Patient Monitor as cleared in K100046, with respect of effectiveness and safety.
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
Premarket Notification Special Section 510(k) Submission Additional Information I-K 102040
y T
Report SN: JN00620100712FDA Submission Date: 11 JUN 2010
Exhibit #3 510(k) Summary
17
Exhibit #3 510(k) Summary
SEP 2 4 2010
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: K102040
| Date of Preparation | 11 JUN 2010 |
|---|---|
| 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: Ii tb@blt.com.cn |
| Submission | Ms. Diana Hong / Mr. Lee Fu |
| Correspondent | Shanghai Mid-Link Business Consulting Co., Ltd |
| | Suite 5D, No.19, Lane 999, Zhongshan Road (S-2), Shanghai, 200030, China |
| | T: +86-21-64264467 F: 240-238-7587 E: info@mid-link.net |
| Proposed Device | Patient Monitor, M9500, AnyView A8 and AnyView A6 |
| | Modification to: M9500 Patient Monitor as cleared in K10046 |
| | 21 CFR 870.1025 MHX Class II |
| Intended Use | Patient Monitors, M9500 / Any View A8 / Any View A6, 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),
Invasive Blood Pressure (IBP), 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), Invasive Blood Pressure
(IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and
neonatal patient. |
1
Premarket Notification Special Section 510(k) Submission Additional Information I-K 102040
40
く
Report SN: JN00620100712FDA Submission Date: 11 JUN 2010
Exhibit #3 510(k) Summary
Image /page/1/Picture/3 description: The image shows a logo with the text "BLT. BIOLIGHT" in bold, black letters. Above the text is a symbol that looks like a plant with three leaves. To the right of the text is a series of Chinese characters. The logo appears to be for a company or product related to biology or light.
42
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.
Test Summary 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 verification tests include: IEC 60601-1:1988+A1:1991+A2:1995; IEC 60601-1-2:2001+A1:2004.
Conclusion The information in this 510(k) Summary demonstrates that 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Guangdong Biolight Meditech Co., Ltd. c/o Ms. Diana Hong Shanghai Midlink Business Consulting Co., Ltd. 5D, No. 19, Lane 999, Zhongshan Rd. (S-2) Shanghai 200030 China
SEP 2 4 2010
Re: K102040
Trade/Device Name: Patient Monitor Models M9500, AnyView A8 and AnyView A6 Regulatory Number: 21 CFR 870.1025
Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm)
Regulatory Class: Class II (Two)
Product Code: MHX, DRT, DXN
Dated: August 23, 2010
Received: August 25, 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.
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/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,
O Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
4
1/1
2010
Premarket Notification Special Section 510(k) Submission Report SN: JN00620100712FDA Submission Date: 12 JUL 2010
Section III Indication for Use Form
BLT. BIOLIGHT
Section III Indication for Use Form -
K102040 510(k) NUMBER (if known):
DEVICE NAME: Patient Monitor, M9500 / Any View A8 / Any View A6
INDICATION FOR USE:
Patient Monitors, M9500 / AnyView A8 / AnyView A6, 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), Invasive Blood Pressure (IBP), 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)
AND/OR
Over-The-Counter Use (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)
ZJMS
iovascular Devices
510(k) Nu
б