(238 days)
Not Found
No
The document describes a standard patient monitoring system and does not mention any AI or ML capabilities. The performance studies focus on compliance with established medical device standards.
No
Patient monitors are diagnostic devices that monitor and display physiological parameters, they do not administer therapy.
Yes
This device is intended for "monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters" which directly supports diagnosis by providing data for clinical assessment. It also performs "arrhythmia detection" and "ST segment analysis," both of which are diagnostic functions.
No
The device description explicitly states that the patient monitors consist of "host units and function modules" and describes various hardware components that collect and process physiological data. This indicates it is a hardware-based medical device with potentially integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters". These parameters are measured directly from the patient's body (ECG, respiration, temperature, SpO2, NIBP, etc.).
- 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. This device does not perform such tests on samples.
- Device Description: The device description details how the device collects physiological data directly from the patient via function modules and displays it. It does not mention any analysis of biological samples.
Therefore, this patient monitor falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Patient monitors are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Cerebral State Index (CSI), Bispectral Index (BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin (SpCO), and Methemoglobin(SpMet).
The arrhythmia detection, ST segment analysis only applied to a single adult patient.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician.
It is not intended for helicopter transport, hospital ambulance, or home use.
Product codes
MWI, DSI, MLD, DRT, DXN, DSK, FLL, DQA, CCK, CBQ, CBS, CBR, CCL, GWQ, DSB
Device Description
The Patient Monitors consist of two parts, which are host units and function modules.
The host units of Any View A Series Patient Monitors are available in four modules, which are Any View A3, AnyView A5, Any View A6 and AnyView A8, The units, themselves, did NOT collect any physiological data from the patient, which are collected by function modules and transmitted to the host unit. They shall be worked with the basic function module, EMS or MPS.
The host units of Q Series Patient Monitors are available in six modules, which are Q2, Q3, Q6 and Q7. These host units could complete the measurement of ECG, RESP, TEMP, SpO2, NIBP and IBP.
In addition, there are several extended function modules, which could be connected with the host units to complete the measurement functions, including TEMP, CO2 Mainstream, CO2 Sidestream, SpO2 Nellcor, SpO2 Masimo, AG Mainstream, AG Sidestream, ICG and CSM (CSI).
Mentions image processing
No
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patient (for arrhythmia detection, ST segment analysis)
Intended User / Care Setting
Healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician. Not intended for helicopter transport, hospital ambulance, or home use.
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, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; a) Amendment 1, 1991-11, Amendment 2, 1995.
- IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2: General Requirements for Safety b) Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
- AAMI EC13:2002, Cardiac monitors, heart rate meters, and alarms;
- AAMI SP10:2002/ A1:2003 (R) 2008, Manual, electronic or automated sphygmomanometers;
- ISO 9919:2005, Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use;
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
§ 870.2300 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
FEB 1 8 2014
K131898; Page 1 of 5
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: _ K131898
- l. Date of Submission: 12/30/2013
-
- Sponsor Identification
Guangdong Biolight Meditech Co., Ltd Innovation First Road, Technology Innovation Coast Zhuhai, Guangdong, 519085, China
Establishment Registration Number: 3007305624
Contact Person: Ms. Liang, Jing Position: R&D Director Tel: +86-756-3399967 Fax: +86-756-3399989 Email: liang_j@blt.com.cn
-
- Submission Correspondent
Ms. Diana Hong& Mr. Lee Fu 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
- Submission Correspondent
1
1
K 131898; page 2 of 5
4. Proposed Device Identification
Proposed Device Name: Patient Monitors
Proposed Device Common Name: AnyView A8, AnyView A6, AnyView A5, AnyView A3, Q2, Q3, Q4, Q5, Q6 and Q7
Classification:
| Regulation No. | Classification Name | Product Code | Device Class |
|---|---|---|---|
| Main Code | |||
| 21 CFR 870.2300 | Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) | MWI | Class II |
| Subsequent Product Codes | |||
| 21 CFR 870.1025 | Detector and Alarm, Arrhythmia | DSI | Class II |
| 21 CFR 870.1025 | Monitor, ST Segment with Alarm | MLD | Class II |
| 21 CFR 870.2300 | Cardiac monitor (including cardiotachometer and alarm) | DRT | Class II |
| 21 CFR 870.1130 | Non-invasive blood pressure measurement system | DXN | Class II |
| 21 CFR 870.1113 | Blood pressure computer | DSK | Class II |
| 21 CFR 880.2910 | Clinical Electronic Thermometers - Temperature Monitor with Probe | FLL | Class II |
| 21 CFR 870.2700 | Oximeter, Pulse | DQA | Class II |
| 21 CFR 868.1400 | Carbon Dioxide Gas Analyzer | CCK | Class II |
| 21 CFR 868.1500 | Enflurane gas analyzer | CBQ | Class II |
| 21 CFR 868.1620 | Halothane gas analyzer | CBS | Class II |
| 21 CFR 868.1700 | Nitrous Oxide gas analyzer | CBR | Class II |
| 21 CFR 868.1720 | Oxygen gas analyszer | CCL | Class II |
| 21 CFR 882.1400 | Electroencephalograph | GWQ | Class II |
| 21 CFR 870.2770 | Impedance plethysmograph | DSB | Class II |
Intended Use Statement:
Patient monitors are intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters including ECG (3-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (RESP), Temperature (TESP), Temperature (TEMP), Pulse Oxygen Saturation (SpOz), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood
2
K131898; page 3 of 5
Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Cerebral State Index (CSI), Bispectral Index (BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin (SpCO) and Methemoglobin(SpMet).
The arrhythmia detection, ST segment analysis only applied to a single adult patient.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician. It is not intended for helicopter transport, hospital ambulance, or home use.
-
- Predicate Device Identification
Predicate Device 1 510(k) Number: K120193 Product Name: Any View Patient Monitors Manufacturer: Guangdong Biolight Meditech Co., Ltd
- Predicate Device Identification
Predicate Device 2 510(k) Number: K072286 Product Name: Aspect Medical Systems BIS EEG VISTA Monitor System Manufacturer: Aspect Medical Systems, Inc.
-
- Device Description
The Patient Monitors consist of two parts, which are host units and function modules.
- Device Description
The host units of Any View A Series Patient Monitors are available in four modules, which are Any View A3, AnyView A5, Any View A6 and AnyView A8, The units, themselves, did NOT collect any physiological data from the patient, which are collected by function modules and transmitted to the host unit. They shall be worked with the basic function module, EMS or MPS.
The host units of Q Series Patient Monitors are available in six modules, which are Q2, Q3, Q6 and Q7. These host units could complete the measurement of ECG, RESP, TEMP, SpO2, NIBP and IBP.
In addition, there are several extended function modules, which could be connected with the host units to complete the measurement functions, including TEMP, CO2 Mainstream, CO2 Sidestream, SpO2 Nellcor, SpO2 Masimo, AG Mainstream, AG Sidestream, ICG and CSM (CSI).
3
K131898; page 4 of 5
7. 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, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; a) Amendment 1, 1991-11, Amendment 2, 1995.
- IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2: General Requirements for Safety b) Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
- c) AAMI EC13:2002, Cardiac monitors, heart rate meters, and alarms;
- AAMI SP10:2002/ A1:2003 (R) 2008, Manual, electronic or automated sphygmomanometers; d)
- ISO 9919:2005, Medical electrical equipment Particular requirements for the basic safety and e) essential performance of pulse oximeter equipment for medical use;
- Substantially Equivalent (SE) Conclusion 8.
The following table compares the A Series / Q Series Patient Monitors to the predicate devices with respect to intended use, technological characteristics and principles of operation, etc.
| Item | Proposed Device(s) | Predicate Device(s) |
|---|---|---|
| Product Code | MWI | MWI |
| Regulation Number | 870.2300 | 870.2300 |
| Subsequent Product Code | DSI / MLD / DRT / DXN / DSK / FLL / DQA / CCK / CBQ / CBS / CBR / CCL / GWQ / DSB | DSI / MLD / DRT / DXN / DSK / FLL / DQA / CCK / CBQ / CBS / CBR / CCL/ GWQ / DSB |
| Intended Use | Patient monitors are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation(SpO2), Pulse Rate (PR), Non-invasive Blood Pressure | The AnyView series patient monitors including models AnyView A8, AnyView A6, AnyView A5 and AnyView A3 are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR) |
Table 3-1 Comparison of Technology Characteristics
4
4
| (NIBP), Invasive Blood Pressure (IBP),
Carbon dioxide (CO2), Anesthetic Gas
(AG), Impedance Cardiograph (ICG),
Cerebral State Index (CSI), Bispectral
Index (BIS), Total Hemoglobin(SpHb),
Carboxyhemoglobin (SpCO), and
Methemoglobin(SpMet), The arrhythmia
detection, ST segment analysis is only
applied to a single adult patient.
The monitors are to be used in healthcare
facilities by clinical physicians or
appropriate medical staff under the
direction of physician. It is not intended
for helicopter transport, hospital
ambulance, or home use. | Respiration Rate (RESP), Temperature
(TEMP), Pulse Oxygen
Saturation(SpO2), Pulse Rate (PR),
Non-invasive Blood Pressure (NIBP),
Invasive Blood Pressure (IBP), Carbon
dioxide (CO2), Anesthetic Gas (AG),
Impedance Cardiograph (ICG) and
Cerebral State Index (CSI).
The arrhythmia detection, ST segment
analysis is only applied to a single adult
patient.
The monitors are to be used in
healthcare facilities by clinical
physicians or appropriate medical staff
under the direction of physician. It is
not intended for helicopter transport,
hospital ambulance, or home use. | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Sterile | No | No |
| Single Use | No | No |
| Energy Source | AC Power / DC Power | AC Power / DC Power |
| Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Performance | Comply with AAMI EC13
Comply with AAMI SP10
Comply with ISO 9919
Comply with IEC 60601-1-8 | Comply with AAMI EC13
Comply with AAMI SP10
Comply with ISO 9919
Comply with IEC 60601-1-8 |
The proposed devices, A Series / Q Series Patient Monitors, AnyView A8, AnyView A6, AnyView A5, AnyView A3, Q2, Q3, Q4, Q5, Q6 and Q7, are determined to be Substantially Equivalent (SE) to the predicate devices, as identified above.
·
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 18, 2014
Guangdong Biolight Meditech Co., Ltd. C/O Ms. Diana Hong General Manager P.O. Box 120-119 Shanghai, 200120 CH
Re: K131898
Trade/Device Name: A series and O Series Patient Monitors Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (Without Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MWI Dated: January 3, 2014 Received: January 8, 2014
Dear Ms. 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.
6
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) (2) CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Owen P. Earis -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K131898 Page 1 of 1
Indications for Use
510(k) Number (if known):
Patient Monitors Device Name:
.. . . . . ....
Indications for Use: Patient monitors are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Cerebral State Index (CSI), Bispectral Index (BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin (SpCO), and Methemoglobin(SpMet).
The arrhythmia detection, ST segment analysis only applied to a single adult patient.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician.
It is not intended for helicopter transport, hospital ambulance, or home use,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
x Prescription Use: ____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use: (21 CFR 807 Subpart C)
Cwer Z.
Digitally signed by Owen P. e: 2014.02.18 13:29:35