(267 days)
Not Found
No
The description focuses on data collection, storage, display, and basic alarming based on set values, with no mention of AI/ML terms or capabilities like learning, prediction, or complex pattern recognition.
No
The device is a monitoring system that collects and displays vital sign information, and provides alarms, but it does not directly treat or diagnose a medical condition.
No
The device collects, stores, displays, and alarms vital sign information, but it does not claim to interpret or diagnose medical conditions based on that data. It serves as a monitoring and information management tool for medical personnel.
Yes
The device description explicitly states "The Central Monitoring System Software-only device". While it interacts with bedside monitors (hardware), the device itself, as described, is solely the software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Central Monitoring System Software described here collects, stores, displays, and alarms on physiological vital signs directly from compatible bedside monitors. These vital signs (ECG, HR, SpO2, NIBP, FHR, TOCO, etc.) are measured in vivo (within the living body) by the bedside monitors, not from specimens in vitro (outside the living body).
- Lack of Specimen Analysis: There is no mention of the software analyzing any biological specimens. Its function is to centralize and manage data already acquired by other devices.
Therefore, the device falls under the category of patient monitoring systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Central Monitoring System Software is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women'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), 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). It is intended to be used in the hospital or medical institutions, and it is not intended for home use.
Product codes
HGM
Device Description
The Central Monitoring System Software-only device that is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women's vital sign information from compatible bedside monitors connected by a wired or wireless network. The Central Monitoring System consists of two models: M6000C and Truscope CNS. Both models provide functions including collecting, storing, displaying, and alarming (e.g. when the monitored data exceeds a set value, the device will alarm to alert medical personnel) the information which is received from the bedside monitor(s). Multiple patients can be monitored simultaneously. Parameters monitored include ECG/HR, RESP, SpO2, PULSE, NIBP, IBP, ICG, TEMP, CO2, AG, FHR, TOCO and FM.
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
Not Found
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.
- A Performance testing was conducted to verify that the Central Monitoring System Software is compatible with various bedside monitors.
- A Performance testing was conducted to verify that the data latency rates were acceptable for the clinical environment.
- A 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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three faces in profile, representing health and well-being. The figure is positioned within a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling the top portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 7, 2016
Guangdong Biolight Meditech Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai 200237 CHINA
Re: K153580
Trade/Device Name: Central Monitoring System Software Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: Class II Product Code: HGM Dated: August 5, 2016 Received: August 8, 2016
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.
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
1
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 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 yours.
Douglas Silverstein -S For Division 2016.09.07 15:26:22 -04'00' Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153580
Device Name Central Monitoring System Software
Indications for Use (Describe)
Central Monitoring System Software is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women'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(ECCG), 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). 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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510(k) Summary
K153580
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
-
- Date of Preparation: 09/06/2016
-
- 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 3. Ms. Diana Hong (Primary 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
-
- Identification of Proposed Device Trade Name: Central Monitoring System Software Common Name: Central Monitoring System Software Model(s): Truscope CNS/ M6000C
Regulatory Information
Classification Name: Perinatal monitoring system and accessories Classification: Class II Product Code: HGM, system, monitoring, perinatal Regulation Number: 21 CFR 884.2740 Review Panel: Obstetrics/Gynecology
-
- Identification of Predicate Device(s)
510(k) Number: K103172 Product Name: Obstetrical Data Management and Monitoring Software Application Model Name: CIV-OB (PLUS)
- Identification of Predicate Device(s)
-
Device Description 6.
The Central Monitoring System Software-only device that is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women's vital sign information from compatible bedside monitors connected by a wired or wireless network. The Central Monitoring System consists of
4
two models: M6000C and Truscope CNS. Both models provide functions including collecting, storing, displaying, and alarming (e.g. when the monitored data exceeds a set value, the device will alarm to alert medical personnel) the information which is received from the bedside monitor(s). Multiple patients can be monitored simultaneously. Parameters monitored include ECG/HR, RESP, SpO2, PULSE, NIBP, IBP, ICG, TEMP, CO2, AG, FHR, TOCO and FM.
-
- Indications for Use
Central Monitoring System Software is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women'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), 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). It is intended to be used in the hospital or medical institutions, and it is not intended for home use.
- Indications for Use
| 8. | Predicate Comparison |
|---|---|
| ---- | ---------------------- |
| Item | Proposed Device(s) | Predicate Device(s) |
|---|---|---|
| Product Code | HGM | HGM |
| Regulation Number | 21 CFR 884.2740 | 21 CFR 884.2740 |
| Intended Use | Central Monitoring System Software is | |
| intended to conduct centralized | ||
| antepartum and intrapartum | ||
| monitoring of pregnant women'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), | ||
| 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). It | ||
| is intended to be used in the hospital or | ||
| medical institutions, and it is not | ||
| intended for home use. | The CIVNET CIV-obTM (plus) is | |
| a clinical data managing software | ||
| application and is indicated for | ||
| antepartumn and intrapartumn | ||
| monitoring of pregnant women in a | ||
| healthcare setting. | ||
| The CIVNET CIV-obT* (plus) is | ||
| indented to manage perinatal | ||
| monitoring data acquired from | ||
| bedside monitors or manual inputs | ||
| for viewing at the central nursing | ||
| station. The system also produces | ||
| an electronic medical record. | ||
| The CIYNET CIV-ob1~" (plus) | ||
| has display fields for the following | ||
| obstetric data: | ||
| Monitoring site details Patient demographics, Provider notes, fetal heart rate (FHR), uterine activity(via | ||
| tocodynamometry or IUP) Head Decent Cervix Dilation | ||
| Sterile | Not applicable | Not applicable |
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| Single Use | Not applicable | Not applicable |
|---|---|---|
| Biocompatibility | Not applicable | Not applicable |
| Network | ||
| connecting to | ||
| bedside monitor | Wired and Wireless | Wired |
| Display | Fetal heart rate, TOCO, maternal vital | |
| signs, patient demographic data, and | ||
| notes. | ||
| Providing the means to display | ||
| multiple beds simultaneously. | Fetal heart rate, TOCO, maternal | |
| vital signs, patient demographic | ||
| data, and notes. | ||
| Providing the means to display | ||
| multiple beds simultaneously. | ||
| Print (locally or remotely) CTG, | ||
| patient record | Print (locally or remotely) CTG, | |
| patient records s, and CIV-ob TM | ||
| (plus) data base definition (e.g. | ||
| item names). | ||
| Archive | CTG and maternal vital signs. | |
| Providing the ability to archive files | ||
| to a secondary or tertiary storage | ||
| medium (i.e. optical disk). | ||
| Providing automatic archiving of the | ||
| data. | CTG and maternal vital signs. | |
| Providing the ability to archive | ||
| files to a secondary or tertiary | ||
| storage medium (i.e. optical disk). | ||
| Saving data automatically. | ||
| Alarm | Visual alerts of fetal/maternal monitor | |
| such as out-of-limit heart rate or poor | ||
| signal quality. | Visual alerts of fetal/maternal | |
| monitor such as out-of-limit heart | ||
| rate or poor signal quality. | ||
| 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. | ||
| Remote Access | Review fetal/maternal monitor data | Review fetal/maternal monitor data |
Central Monitoring System Software and the predicate device do not have identical indication for use statements; however, they have the same intended use (centralized antepartum and intrapartum monitoring of pregnant women's vital sign information).
In addition, there are differences in the device technological characteristics. The predicate device uses a wired network to connect to the bedside units, while the subject device gives the option of a wired or wireless network. Wireless networks are widely used for various applications. There are also differences in the parameters that the subject device and predicate collect, store, display and alarm. These differences do not raise different questions of safety as compared to the predicate device.
-
- Non-Clinical Testing
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.
- Non-Clinical Testing
The test results demonstrated that the proposed device complies with the following standards:
- IEC 62366: 2007 Medical Devices Application of Usability Engineering to Medical Devices A
- IEC 62304: 2006 Medical Device Software Software Life Cycle Process >
6
The following data were provided to support the substantial equivalence determination:
- A Performance testing was conducted to verify that the Central Monitoring System Software is compatible with various bedside monitors.
- A Performance testing was conducted to verify that the data latency rates were acceptable for the clinical environment.
- A 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)
-
- Substantially Equivalent (SE) Conclusion
Based on the comparison and performance data described above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.