(261 days)
No
The summary describes a standard vital signs monitor and does not mention any AI or ML capabilities. The performance studies focus on compliance with established standards and substantial equivalence to a predicate device, without any mention of training or test data sets typically associated with AI/ML development.
No
The device is described as a "patient monitor" which is used for "monitoring, displaying, storing and alarming of multiple physiological parameters." It does not provide any treatment or therapy.
No
The device is described as a "Patient Monitor" and its intended use is for "monitoring, displaying, storing and alarming of multiple physiological parameters." It provides real-time data on vital signs but does not make a diagnosis or aid in the diagnostic process.
No
The device description explicitly states it is a portable device consisting of a main unit and accessories, including physical sensors (NIBP cuff, Temperature sensor, CO2 sensor, and SpO2 sensor). This indicates it includes hardware components beyond just software.
Based on the provided information, the V9 Patient Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- V9 Patient Monitor Function: The V9 Patient Monitor directly measures physiological parameters from the patient's body using sensors (SpO2 sensor, NIBP cuff, Temperature sensor, CO2 sensor). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "monitoring, displaying, storing and alarming of multiple physiological parameters of patients." This is direct patient monitoring, not laboratory testing of samples.
Therefore, the V9 Patient Monitor falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
V9 Patient Monitor is intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters of patients, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).
V9 Patient Monitor is used to monitor vital signals for patients and is intended to be used in controlled, hospital environments. It is applicable for adult, pediatric and neonatal patiented for helicopter transport, hospital ambulance or home use.
Product codes (comma separated list FDA assigned to the subject device)
MWI
Device Description
The V9 Patient Monitor can provide the monitoring of physiological parameters such as the Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp). The V9 Patient Monitor is a portable device, consists of main unit and accessories, including NIBP cuff, Temperature sensor, CO2 sensor and SpO2 sensor.
It consists of main unit and accessories, including NIBP cuff, Temperature sensor, CO2 sensor and SpO2 sensor.
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 patients.
Intended User / Care Setting
controlled, hospital environments.
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 as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-8: 2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 80601-2-30:2013 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- IEC 80601-2-61:2011 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 80601-2-55:2011 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- A ISO 80601-2-56: 2009 Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
- ANSI C63.27-2017 American National Standard For Evaluation Of Wireless Coexistence
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device predicate.
No clinical study is included in this submission, because all modules have been previously cleared by FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 5, 2019
Guangdong Biolight Meditech Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 Cn
Re: K181919
Trade/Device Name: Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: February 19, 2019 Received: February 26, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181919
Device Name Patient Monitor Model: V9
Indications for Use (Describe)
V9 Patient Monitor is intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters of patients, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).
V9 Patient Monitor is used to monitor vital signals for patients and is intended to be used in controlled, hospital environments. It is applicable for adult, pediatric and neonatal patiented for helicopter transport, hospital ambulance or 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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3
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: K181919
-
- Date of Preparation: 4/5/2019
-
- Sponsor Identification
Guangdong Biolight Meditech Co., Ltd.
No.2 Innovation First Road, Technical Innovation Coast Hi-Tech Zone, Zhuhai, 519085, Guangdong, China.
Establishment Registration Number: 3007305624
Contact Person: Dan Hou Position: Manager Tel: +86-0756-3399971 Fax: +86-0756-3399989 Email: hou d@blt.com.cn
3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850 Fax: 001-3609253199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Patient Monitor Model: V9 Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Classification: II Product Code: MWI Regulation Number: 21 CFR 870.2300 Review Panel: Cardiovascular
Indications for Use:
V9 Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of patients, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).
V9 Patient Monitor is used to monitor vital signals for patients and is intended to be used in controlled, hospital environments. It is applicable for adult, pediatric and neonatal patients. It is not intended for helicopter transport, hospital ambulance or home use.
Device Description
The V9 Patient Monitor can provide the monitoring of physiological parameters such as the Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp). The V9 Patient Monitor is a portable device, consists of main unit and accessories, including NIBP cuff, Temperature sensor, CO2 sensor and SpO2 sensor.
It consists of main unit and accessories, including NIBP cuff, Temperature sensor, CO2 sensor and SpO2 sensor.
All modules, boards and accessories used in V9 Patient Monitor has already been cleared by FDA, referring to Table 1. In which, two NIBP and three SpO2 modules are optional for proposed device.
| Module | 510(k) Number | |
|---|---|---|
| NIBP | BLT NIBP Module | K153135 |
| Suntech NIBP Module | K152552 | |
| SpO2 | Nellcor SpO2 Module | K052186 |
| MASIMO SpO2 Module | K101896 | |
| BLT SpO2 Module | K153135 | |
| Temperature | Temperature Module | K153135 |
| CO2 | CO2 Module | K153135 |
| Table 1. List of 510(k) of Modules | ||
|---|---|---|
| ------------------------------------ | -- | -- |
5
5. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
-
IEC 60601-1-8: 2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
-
IEC 80601-2-30:2013 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
-
IEC 80601-2-61:2011 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 80601-2-55:2011 Medical electrical equipment Part 2-55: Particular requirements for the > basic safety and essential performance of respiratory gas monitors
- A ISO 80601-2-56: 2009 Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
-
ANSI C63.27-2017 American National Standard For Evaluation Of Wireless Coexistence
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device predicate.
-
- Clinical Test Conclusion
No clinical study is included in this submission, because all modules have been previously cleared by FDA. The K Number of each module is listed in Table 1 of this document.
- Clinical Test Conclusion
-
- Identification of Predicate Device
Predicate Device 510(k) Number: K153135 Product Name: V6 Vital Signs Monitor
- Identification of Predicate Device
6
8. Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device
Vital Signs Monitor V6, K153135 |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | MWI | MWI |
| Regulation Number | 21 CFR 870.2300 | 21 CFR 870.2300 |
| Class | II | II |
| Indications for Use | V9 Patient Monitor is intended to be
used for monitoring, displaying,
reviewing, storing and alarming of
multiple physiological parameters of
patients, including Pulse Oxygen
Saturation (SpO2), Pulse Rate (PR),
Non-invasive Blood Pressure (NIBP),
Carbon dioxide (CO2) and Temperature
(Temp).
V9 Patient Monitor is used to monitor
vital signals for patients and is intended
to be used in controlled, hospital
environments. It is applicable for adult,
pediatric and neonatal patients. It is not
intended for helicopter transport,
hospital ambulance or home use. | The vital signs monitor is intended to be
used for monitoring, displaying, reviewing,
storing and alarming of multiple
physiological parameters of patients,
including Pulse Oxygen Saturation (SpO2),
Pulse Rate (PR), Non-invasive Blood
Pressure (NIBP), Carbon dioxide (CO2)
and Temperature (Temp).
This vital signs monitor is used to monitor
vital signals for patients and is suitable for
use in hospital environments including
out-patient department, wards and NICU. It
is not intended for helicopter transport,
hospital ambulance or home use. And it is
applicable for adult, pediatric and neonatal
patients. |
| Intended Population | The monitors are intended for adult,
pediatric and neonatal. | The monitors are intended for adult,
pediatric and neonatal. |
| Intended
Environment | The V9 Patient Monitor is used to be
used in hospital environments including
out-patient outpatient departments,
wards and NICU. It is not intended for
helicopter transport, hospital ambulance
or home use. | The vital signs monitor is used to be used
in hospital environments including
out-patient outpatient departments, wards
and NICU. It is not intended for helicopter
transport, hospital ambulance or home use. |
| Power Supply | The monitors can be supplied by AC
power. | The monitors can be supplied by AC
power. |
| Number of Patient
be monitored each
time | Single patient each time | Single patient each time |
| Sterile | No | No |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Alarm Function | Comply with IEC60601-1-8 | Comply with IEC60601-1-8 |
| SpO2 Module | BLT, Nellcor and Masimo
Comply with IEC 80601-2-61 | BLT and Nellcor
Comply with IEC 80601-2-61 |
| | NIBP Module | BLT and Suntech
Comply with IEC 80601-2-30 |
| CO2 Module | Comply with ISO 80601-2-55 | Comply with ISO 80601-2-55 |
| Temp Module | Comply with ISO 80601-2-56 | Comply with ISO 80601-2-56 |
| Patient Contact
Accessories | SpO2 Sensor, NIBP cuff, CO2 Sensor
and Temp Sensor | SpO2 Sensor, NIBP cuff, CO2 Sensor and
Temp Sensor |
| | Biocompatibility | All the patient contact accessories were
previously cleared by FDA |
Table 2 Substantially Equivalent Comparison
7
The SpO2 and NIBP module of proposed device and predicate device is different. Masimo SpO2 and Suntech NIBP are not included in predicate device, however, the Masimo SpO2 and Suntech NIBP have been cleared by FDA under K131898 and K152552. Therefore, this difference is considered not to affect the substantially equivalency (SE) between the proposed and predicate device.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.