PATIENT MONITOR, MODEL PM50

K101127 · Contec Medical System Co., Ltd. · MWI · Jun 11, 2010 · Cardiovascular

Device Facts

• Record ID: K101127
• Device Name: PATIENT MONITOR, MODEL PM50
• Applicant: Contec Medical System Co., Ltd.
• Product Code: MWI · Cardiovascular
• Decision Date: Jun 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The Patient 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 patients in hospitals, medical facilities, and sub-acute environments. The patient monitor is intended for spot-checking and/or continuous monitoring of patients.

Device Story

PM50 Patient Monitor is a portable device for non-invasive measurement of SpO2, pulse rate, and NIBP (systolic, diastolic, mean arterial pressure). Used in hospitals, medical facilities, and sub-acute environments for spot-checking or continuous monitoring of adult patients. Device processes physiological signals to display real-time vital signs. Healthcare providers use output for patient assessment and clinical decision-making. Benefits include portable, continuous monitoring capability for improved patient oversight.

Clinical Evidence

Clinical testing conducted at Qinhuangdao Maternal and Child Health Hospital. SpO2 accuracy evaluated per ISO 9919:2005; NIBP accuracy evaluated per ANSI/AAMI SP10:2002+A1:2003+A2:2006. Results demonstrated that the device met all accuracy requirements with no adverse effects or complications reported.

Technological Characteristics

Portable patient monitor; measures SpO2 (pulse oximetry) and NIBP (oscillometric method). Designed for adult patients. Complies with ISO 9919:2005 and ANSI/AAMI SP10:2002 standards for measurement accuracy.

Indications for Use

Indicated for non-invasive measurement and display of SpO2, pulse rate, and NIBP in adult patients in hospitals, medical facilities, and sub-acute environments for spot-checking or continuous monitoring.

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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# 510(k) Summary

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: | k101127 |
|--------------------------------|---------|
|--------------------------------|---------|

| Sponsor: | Contec Medical Systems Co., Ltd |
|-----------------------------|-------------------------------------------------------------------------------------------------------|
| | No. 24, West Huanghe Road |
| | Qinhuangdao, Hebei, 066000, China |
| | Establishment Registration Number: 3006979678 |
| | Contact Person: Mr. Li Xueyong, Quality Manager |
| | Tel:[phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| 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: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Proposed Device Information | |
| Trade Name | Patient Monitor; |
| Model: | PM50; |
| Classification Name: | monitor, physiological, patient; |
| Product Code: | MWI; |
| Subsequent Product Codes: | DQA,DXN |
| Regulation Number: | 870.2300; |
| Device Class: | II |
| Intended Use: | The patient monitor is a portable device indicated for use in non-invasively measuring and displaying |

functional

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oxygen

of

arterial

saturation

haemoglobin (SpO2), pulse rate(PR), Non-invasive measurement of blood pressure(NIBP) of adult

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| Predicate Device: | VS-800 Vital Signs Monitor<br>K Number: K063055 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The proposed device, PM50 Patient Monitor, is a<br>portable device, which is intended for measuring<br>and/or cont pulse oxygen saturation (SpO2), pulse<br>rate (PR), systolic pressure (SYS), diastolic<br>pressure (DIA) and mean arterial pressure (MAP)<br>on adult and pediatric. |
| Testing Conclusion: | Performance testing including clinical and<br>laboratory testing was conducted to validate and<br>verify that the proposed device, PM50 Patient<br>Monitor met all design specifications and was<br>substantially equivalent to the predicate device. |
| Clinical Test Discussion | The proposed device. PM50 Patient Monitor was<br>tested in accordance Annex EE of ISO 9919 to<br>evaluate SpO2 measurement accuracy. The test was<br>sponsored by Contec Medical Systems Co., Ltd.<br>and investigated in Qinhuangdao Maternal and<br>Child Health Hospital.<br><br>The proposed device. PM50 Patient Monitor was<br>tested in accordance AAMI Sp10 to evaluate NIBP<br>measurement accuracy. The test was sponsored by<br>Contec Medical Systems Co., Ltd. and investigated<br>in Qinhuangdao Maternal and Child Health<br>Hospital.<br><br>There are no any adverse effects and complications<br>during test, the data obtained in the test meet the<br>accuracy requirements of ISO 9919:2005 and<br>ANSI/AAMI SP10:2002+A1: 2003+A2:2006. |
| SE Conclusion: | The proposed device, PM50 Patient Monitor is |

.

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substantially equivalent (SE) to the predicate device, VS-800 Vital Signs Monitor.

and the comments of the comments of the comments of

1

Comments of the country

.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUN 1 1 2010

Contec Medical Systems Co., Ltd. c/o Ms. Diana Hong Shanghai Mid-Link Business Consulting Co., Ltd Suite 5D. No. 19, Lane 999, Zhongshan No. 2 Road (S) Shanghai, 200030 CHINA

K101127 Re:

> Trade/Device Name: Patient Monitor, PM50 Regulatory Number: 21 CFR 870.2300 Regulation Name: Patient Physiological Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: MWI Dated: April 15, 2010 Received: April 22, 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, 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.

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.

ﺍﻟﻘﺎﺩﺭ

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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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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): =

Device Name: __ Patient Monitor, PM50

Indications for Use:

The Patient 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 patients in hospitals, medical facilities, and sub-acute environments. The patient monitor is intended for spot-checking and/or continuous monitoring of patients.

Prescription Use _ _ _ J (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. West.

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(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number.