(92 days)
No
The description focuses on data collection, display, storage, and alarming based on set thresholds, with no mention of AI/ML terms or capabilities.
No.
The device is a monitoring system that collects, displays, and alarms vital sign information; it does not provide any treatment or intervention.
No
The device collects, stores, displays, and alarms vital sign information from bedside monitors. It monitors parameters but does not provide a diagnosis.
Yes
The device is described as "Central Monitoring System Software" and its function is to collect, store, display, and alarm vital sign information from compatible bedside monitors. The description explicitly states it is "software" and its connection to bedside units is via a network, implying it is a software application running on a separate computing platform, not a hardware device itself. The performance studies focus on software verification and validation and compatibility with bedside monitors, further supporting its software-only nature.
Based on the provided information, 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 the Central Monitoring System Software collects, stores, displays, and alarms based on vital sign information from compatible bedside monitors. These vital signs (ECG, HR, SpO2, NIBP, etc.) are measured directly from the patient's body using sensors and transducers, not from samples taken from the body.
- Lack of Sample Analysis: There is no mention of analyzing biological samples or performing tests on them.
The device is a patient monitoring system that aggregates and displays real-time physiological data. This falls under the category of patient monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Central Monitoring System Software is intended to conduct centralized monitoring of adult, pediatrics and neonatal patient's vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitoring parameters include Electrocardiogram(ECG), Heart Rate(HR), Respiration(RESP), Pulse Oxygen Saturation(SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Impedance Cardiograph(ICG), TEMP(Temperature), Carbon dioxide (CO2), Anesthetic Gas (AG), Fetal Heart Rate (FHR), Uterine contraction (TOCO) and Fetal Movement (FM) etc. It is intended to be used in the hospital or medical institutions, and it is not intended for home use.
Product codes
MHX
Device Description
M6000C central monitoring system software, the risk management object, can central monitor significant vital sign parameters of multi-patients, including ECG/HR, RESP, SpO2, PULSE, NIBP, IBP, ICG, TEMP, CO2, AG, FHR, TOCO and FM. It is connected by network with bedside units and receives data from bedside units. Then, the data are displayed on the screen or recorded or printed as per needs. When the monitored data exceed a set value, the central monitoring system software will start alarm system and gives out alarm to remind doctors and nurses for attention.
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, pediatrics and neonatal
Intended User / Care Setting
hospital or medical institutions
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The Central Monitoring System also complies with voluntary standards for medical devices. The test results demonstrated that the proposed device complies with the following standards: EN ISO 14971: 2012 Medical Device Risk Management A, IEC 62366: 2007 Medical Devices - Application of Usability Engineering to Medical Devices.
The following data were provided to support the substantial equivalence determination:
- Performance testing was conducted to verify that the Central Monitoring System Software is compatible with various bedside monitors.
- Performance testing was conducted to verify that the data latency rates were acceptable for the clinical environment.
- Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 24, 2017
Guangdong Biolight Meditech Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN
Re: K170514
Trade/Device Name: M6000C Central Monitoring System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX Dated: February 14, 2017 Received: February 21, 2017
Dear Diana 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
M.A. Hillemann
for
for 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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Indications for Use
510(k) Number (if known) K170514
Device Name M6000C Central Monitoring System
Indications for Use (Describe)
Central Monitoring System Software is intended to conduct centralized monitoring of adult, pediatrics and neonatal patient's vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitoring parameters include Electrocardiogram(ECG), Heart Rate(HR), Respiration(RESP), Pulse Oxygen Saturation(SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Impedance Cardiograph(ICG), TEMP(Temperature), Carbon dioxide (CO2), Anesthetic Gas (AG), Fetal Heart Rate (FHR), Uterine contraction (TOCO) and Fetal Movement (FM) etc. It is intended to be used in the hospital or medical institutions, and it is not intended for home use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Tab #6 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K170514
-
- Date of Preparation: 05/04/2017
-
- Sponsor Identification Guangdong Biolight Meditech Co., Ltd. No.2 Innovation First Road, Technology Innovation Coast, Hi-Tech Zone, Zhuhai, Guangdong, 519085, P.R. China
Establishment Registration Number: 3007305624 Contact Person: Jin Liang Position: R&D Director Tel: +86-756-3399967 Fax: +86-756-3399989 Email: liang_j@blt.com.cn
-
- Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Cindy Wang (Alternative Contact Person) Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
- Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Cindy Wang (Alternative Contact Person) Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
-
- Identification of Proposed Device Trade Name: Central Monitoring System Common Name: Central Monitoring System Model(s): M6000C Regulatory Information Classification Name: Perinatal monitoring system and accessories Classification: II; Product Code: MHX; Regulation Number: 21 CFR 870.1025; Review Panel: Cardiovascular;
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Intended Use Statement:
Central Monitoring System Software is intended to conduct centralized monitoring of adult, pediatrics and neonatal patient's vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitor. Rate(HR), The monitoring parameters include Electrocardiogram(ECG), Heart Respiration(RESP), Pulse Oxygen Saturation(SpO2), Pulse Rate(PR), Non-invasive Blood (NIBP), Pressure Invasive -Blood Pressure(IBP), Impedance Cardiograph(ICG), TEMP(Temperature), Carbon dioxide (CO2), Anesthetic Gas (AG), Fetal Heart Rate (FHR), Uterine contraction (TOCO) and Fetal Movement (FM) etc. It is intended to be used in the hospital or medical institutions, and it is not intended for home use.
Device Description:
M6000C central monitoring system software, the risk management object, can central monitor significant vital sign parameters of multi-patients, including ECG/HR, RESP, SpO2, PULSE, NIBP, IBP, ICG, TEMP, CO2, AG, FHR, TOCO and FM. It is connected by network with bedside units and receives data from bedside units. Then, the data are displayed on the screen or recorded or printed as per needs. When the monitored data exceed a set value, the central monitoring system software will start alarm system and gives out alarm to remind doctors and nurses for attention.
- ર. Identification of Predicate Device and Reference Device
Predicate Device 510(k) Number: K120727 Product Name: Central monitoring system Model Name: MFM-CMS
Reference Device 510(k) Number: K153580 Product Name: Central monitoring system Model Name: M6000C
6. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The Central Monitoring System also complies with voluntary standards for medical devices.
The test results demonstrated that the proposed device complies with the following standards:
5
- EN ISO 14971: 2012 Medical Device Risk Management A
- A IEC 62366: 2007 Medical Devices - Application of Usability Engineering to Medical Devices
The following data were provided to support the substantial equivalence determination:
- ≫ Performance testing was conducted to verify that the Central Monitoring System Software is compatible with various bedside monitors.
-
Performance testing was conducted to verify that the data latency rates were acceptable for the clinical environment.
- ≫ Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005)
Please note that the subject is a software only product, EMC and Electrical Safety Evaluation are not required.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
| ITEM | Proposed Device
Central Monitoring System
Truscope CNS | Predicate Device |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Code | MHX | MHX |
| Regulation
No. | 870.1025 | 870.1025 |
| Class | II | II |
| Intended
Use | Central Monitoring System
Software is intended to conduct
centralized monitoring of adult,
pediatrics and neonatal patient's
vital sign information from
compatible bedside monitors. The
software collects, stores, displays
and alarms the information
provided on the bedside monitor.
The monitoring parameters include
Electrocardiogram(ECG), Heart
Rate(HR), Respiration(RESP), | MFM-CMS provided centralized
monitoring and critical care
management for patients
monitored by EDAN bedside
monitors, From MFM-CMS,
clinicians can gain access to
patient information from patients
on the Network. MFM-CMS
display waveforms , parameters
and alarm status of EDAN bedside
monitors for up to 32 patients on a
single screen or up to 64 patients |
| | | |
| | Pulse Oxygen Saturation(SpO2),
Pulse Rate(PR), Non-invasive
Blood Pressure (NIBP), Invasive
Blood Pressure(IBP), Impedance
Cardiograph(ICG),
TEMP(Temperature), Carbon
dioxide (CO2), Anesthetic Gas
(AG), Fetal Heart Rate (FHR),
Uterine contraction (TOCO) and
Fetal Movement (FM) etc. It is
intended to be used in the hospital
or medical institutions, and it is not
intended for home use. | using two screens |
| Network | Wired and Wireless | Wired and wireless |
| Display | Patient demography data, and
notes.
Providing the means to display
multiple beds simultaneously. | Waveforms and notes
Providing the means to display
multiple beds simultaneously |
| Print | Print Patient's monitoring records | Print Patient's monitoring records |
| Archive | Providing the ability to archive
files to a secondary or tertiary
storage medium (i.e. optical disk).
Providing automatic archiving of
the data. | Providing the ability to archive
files to a secondary or tertiary
storage medium (i.e. optical disk).
Providing automatic archiving of
the data. |
| Alarm | Visual alerts of out-of-limit data | Visual alerts of out-of-limit data |
| Electronic
patient
record | Easy interfacing with any IT
patient record system for data
acquisition, viewing and storage of
electronic patient record. | Easy interfacing with any IT
patient record system for data
acquisition, viewing and storage of
electronic patient record. |
| Notes | Providing the user the ability to
enter comments and specific data. | Providing the user the ability to
enter comments and specific data. |
| Complied
Standard | IEC 62304 | IEC 62304 |
Substantially Equivalent (SE) Comparison 8.
Table 1 Comparison of Technology Characteristics
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9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.