(67 days)
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.
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.
The provided text describes a 510(k) summary for a patient monitor and focuses on regulatory compliance rather than detailed device performance studies or specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, and ground truth establishment is not explicitly available in the provided document.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria or specific numerical performance metrics for the patient monitor's physiological parameter measurements (e.g., accuracy ranges for SpO2, NIBP, etc.).
The "Test Summary" section states: "Per the risk management during the design change control, the verification tests performed demonstrated that risks of each hazard are reduced to acceptable region." This is a general statement about meeting risk management objectives but does not quantify performance.
It also notes the device was tested against:
- IEC 60601-1:1988+A1:1991+A2:1995 (Medical electrical equipment - Part 1: General requirements for safety)
- IEC 60601-1-2:2001+A1:2004 (Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests)
These are safety and electromagnetic compatibility standards, not performance standards for the physiological parameters themselves.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text does not describe a clinical study with a specific test set of patients or data provenance details.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. As no clinical performance study details are given, there's no mention of experts establishing ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards, rather than comparative clinical performance with human readers.
6. Standalone Performance Study
The document does not describe a standalone (algorithm only without human-in-the-loop performance) study for physiological measurement accuracy. The "verification tests" mentioned are related to safety and EMC standards.
7. Type of Ground Truth Used
Given the absence of a detailed clinical performance study, the type of ground truth used for specific physiological measurements is not described. The focus is on compliance with general safety and EMC standards, and substantial equivalence to a predicate device.
8. Sample Size for the Training Set
This information is not applicable. The device described is a patient monitor, not an AI/ML algorithm that typically requires a training set of data for development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set for an AI/ML algorithm.
Summary of what is present:
- Device: Patient Monitors, M9500, AnyView A8 and AnyView A6.
- Intended Use: Monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters (ECG, HR, RESP, SpO2, PR, NIBP, IBP, CO2, TEMP) for adult, pediatric, and neonatal patients in healthcare facilities.
- Studies Mentioned: Verification tests against IEC 60601-1 and IEC 60601-1-2 for risk management, safety, and electromagnetic compatibility.
- Conclusion: The devices are Substantially Equivalent (SE) to the predicate device, M9000 Patient Monitor (cleared in K100046), with respect to effectiveness and safety. This "substantial equivalence" is the primary justification for market clearance, implying that the new device meets similar performance and safety levels as the predicate device. However, the exact performance metrics compared are not detailed in this summary.
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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 CoastZhuhai, Guangdong, 519085, ChinaContact Person: Mr. Tianbao Li, Chief EngineerTel: +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 formonitoring, displaying, reviewing, storing and alarming of multiple physiologicalparameters including ECG, Heart Rate (HR), Respiration Rate (RESP), PulseOxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP),Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) ofadult, pediatric and neonatal patient. The monitors are to be used in healthcarefacilities by clinical physicians or appropriate medical staff under the direction ofphysicians. 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 includingECG 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 andneonatal patient. |
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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.
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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.
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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
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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
§ 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.