MD2000B VITAL SIGN MONITOR, MODEL MD2000B

K100740 · Beijing Choice Electronic Technololgy Co., Ltd. · MWI · Jul 9, 2010 · Cardiovascular

Device Facts

• Record ID: K100740
• Device Name: MD2000B VITAL SIGN MONITOR, MODEL MD2000B
• Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
• Product Code: MWI · Cardiovascular
• Decision Date: Jul 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

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 patients.

Device Story

MD2000B Vital Signs Monitor is a portable device for non-invasive measurement of SpO2, pulse rate, and NIBP (systolic, diastolic, MAP). Used in hospitals, medical facilities, and sub-acute environments for spot-checking or continuous patient monitoring. Operated by healthcare professionals. Device processes physiological signals to display real-time vital sign data, assisting clinicians in patient assessment and monitoring. Benefits include portable, efficient vital sign tracking for adult and pediatric populations.

Clinical Evidence

Performance testing included both clinical and laboratory testing to validate and verify that the MD2000B met all design specifications. No specific sensitivity, specificity, or AUC metrics were provided in the summary.

Technological Characteristics

Portable physiological patient monitor. Measures SpO2 via pulse oximetry and NIBP via oscillometric method. Intended for adult and pediatric use. Class II device. No specific materials, connectivity, or software architecture details provided.

Indications for Use

Indicated for non-invasive measurement and display of SpO2, pulse rate, and NIBP (systolic, diastolic, mean arterial pressure) in adult and pediatric patients within hospitals, medical facilities, and sub-acute environments.

Regulatory Classification

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.

Predicate Devices

• VS-800 Vital Signs Monitor (K063055)

Submission Summary (Full Text)

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# 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<br>Bailangyuan Bldg B 1127-1128, Fuxing road, A36<br>Beijing, 100039, China<br>Establishment Registration Number: 3005569927 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Mr. Chen Lei |
| Correspondent: | Ms. Diana Hong<br>Mr. Tarzan. Wang<br>Shanghai Mid-Link Business Consulting Co., Ltd<br>Suite 5D, No. 19, Lane 999, Zhongshan No.2<br>Road(S)<br>Shanghai, 200030, China<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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<br>for use in non-invasively measuring and displaying<br>functional oxygen saturation of arterial haemoglobin<br>(SpO2), pulse rate(PR), Non-invasive measurement<br>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

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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.

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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.

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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 [phone] or [phone] 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

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### 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

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510(k) Number