(115 days)
Not Found
No
The summary describes a standard vital signs monitor and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a monitor used for measuring and displaying vital signs, which aids in diagnosis and monitoring, but it does not treat or prevent a disease or condition.
No
Explanation: The device is described as a vital signs monitor used for measuring and displaying physiological parameters (SpO2, pulse rate, NIBP). While these measurements provide information about a patient's health status, the description does not state that the device is intended for diagnosing a specific disease or condition, but rather for monitoring.
No
The device description explicitly states it is a "portable device" and a "vital signs monitor," which are terms typically associated with hardware devices that perform physical measurements. The description of measuring SpO2, PR, and NIBP further implies the use of sensors and other hardware components.
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 non-invasively measuring vital signs (SpO2, pulse rate, NIBP) from the patient's body.
- Device Description: The description reinforces that it measures these parameters directly from the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the human body. This vital signs monitor is a patient-contacting device that measures physiological parameters directly.
N/A
Intended Use / Indications for Use
The vital signs monitor is a portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial haemoglobin (SpO2), pulse rate(PR), Non-invasive measurement of blood pressure(NIBP) of adult and pediatric patients in hospitals, medical facilities, and sub-acute environments. The vital signs monitor is intended for spot-checking and/or continuous monitoring of patients.
Product codes
MWI, DQA, DXN
Device Description
The proposed device, MD2000B Vital Signs Monitor, is a portable device, which is intended for measuring and/or cont pulse oxygen saturation (SpO2), pulse rate (PR), systolic pressure (SYS), diastolic pressure (DIA) and mean arterial pressure (MAP) on adult and pediatric.
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 and pediatric
Intended User / Care Setting
hospitals, medical facilities, and sub-acute 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)
Performance testing including clinical and laboratory Testing was conducted to validate and verify that the proposed device, MD2000B Vital Signs Monitor met all design specifications and was substantially equivalent to the predicate device.
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
Section 4 510(k) Summary
JUL - 9 2010
12
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
| Sponsor: | Beijing Choice Electronic Technology Co., Ltd
Bailangyuan Bldg B 1127-1128, Fuxing road, A36
Beijing, 100039, China
Establishment Registration Number: 3005569927 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Mr. Chen Lei |
| Correspondent: | Ms. Diana Hong
Mr. Tarzan. Wang
Shanghai Mid-Link Business Consulting Co., Ltd
Suite 5D, No. 19, Lane 999, Zhongshan No.2
Road(S)
Shanghai, 200030, China
Tel: +86-21-64264467
Fax: (240)238-7587
Email: Diana.hong@mid-link.net |
| Proposed Device Information | |
| Trade Name | Vital Signs Monitor; |
| Model: | MD2000B; |
| Classification Name: | monitor, physiological, patient; |
| Product Code: | MWI; |
| Subsequent Product Codes: | DQA,DXN |
| Regulation Number: | 870.2300; |
| Device Class: | II |
| Intended Use: | The vital signs monitor is a portable device indicated
for use in non-invasively measuring and displaying
functional oxygen saturation of arterial haemoglobin
(SpO2), pulse rate(PR), Non-invasive measurement
of blood pressure(NIBP) of adult and pediatric |
patients in hospitals, medical facilities, and sub-acute environments. The vital signs monitor is intended for spot-checking and/or continuous monitoring
of
1
Report SN: SHA00920090508FDA patients. Predicate Device: VS-800 Vital Signs Monitor K Number: K063055 The proposed device, MD2000B Vital Signs Monitor, Device Description: is a portable device, which is intended for measuring and/or cont pulse oxygen saturation (SpO2), pulse rate (PR), systolic pressure (SYS), diastolic pressure (DIA) and mean arterial pressure (MAP) on adult and pediatric. Performance testing including clinical and laboratory Testing Conclusion: testing was conducted to validate and verify that the proposed device, MD2000B Vital Signs Monitor met all design specifications and was substantially equivalent to the predicate device. The proposed device, MD2000B Vital Signs Monitor SE Conclusion:
is substantially equivalent (SE) to the predicate device, VS-800 Vital Signs Monitor.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services, with three wave-like lines emanating from a central point.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL - 9 2010
Beijing Choice Electronic Technology Co., Ltd. c/o Ms. Diana Hong General Manager Shanghai Mid-Link Business Consulting Co., Ltd. Suite 8D, No. 19, Lane 999, Zhongshan No. 2 Road(S) CHINA 200030
Re: K100740
Trade/Device Name: MD 2000B Vital Signs Monitor 1 Regulatory Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MWI Dated: June 2, 2010 Received: June 3, 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, Or ve 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.
3
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication For Use
510(k) Number (if known): Pending
Device Name: MD 2000B Vital Sign Monitor
Indications for Use:
The vital signs monitor is a portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial haemoglobin (SpO2), pulse rate(PR), Non-invasive measurement of blood pressure(NIBP) of adult and pediatric patients in hospitals, medical facilities, and sub-acute environments. The vital signs monitor is intended for spot-checking and/or continuous monitoring of patients.
Prescription Use √ (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)
W.W.
(Division Sign-Off)
Division of Cardiovascular Devices
Page 1 of
510(k) Number