PATIENT MONITOR

K101692 · Contec Medical System Co., Ltd. · MHX · Jun 28, 2011 · Cardiovascular

Device Facts

• Record ID: K101692
• Device Name: PATIENT MONITOR
• Applicant: Contec Medical System Co., Ltd.
• Product Code: MHX · Cardiovascular
• Decision Date: Jun 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CMS8000 Patient Monitor is intended to be used for monitoring, reviewing, storing and alaming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), cation dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The Pulse Oxygen Saturation (SpO2) and Pulse Rate (PR) are intended use for adult and pediatric patient. The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.

Device Story

CMS8000 Patient Monitor collects physiological signals including ECG, HR, RESP, NIBP, IBP, CO2, TEMP, SpO2, and PR; processes data for display, storage, and alarm generation; provides audio and visual alerts to clinicians. Used in healthcare facilities by physicians or medical staff; AC/DC powered. Output enables real-time patient status assessment and clinical decision-making; facilitates continuous monitoring to improve patient safety.

Clinical Evidence

Clinical testing conducted to verify SpO2 and NIBP measurement performance per ISO 9919 and AAMI SP10 standards. Bench testing performed to verify compliance with IEC 60601-1, IEC 60601-1-2, AAMI/ANSI EC13, IEC 60601-2-34, and ISO 21647. No specific clinical trial results or statistical metrics (e.g., sensitivity/specificity) provided in the summary.

Technological Characteristics

Multi-parameter patient monitor; AC/DC power; supports ECG, HR, RESP, NIBP, IBP, CO2, TEMP, SpO2, PR. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), AAMI/ANSI EC13 (cardiac monitors), ISO 9919 (pulse oximetry), AAMI SP10 (sphygmomanometers), IEC 60601-2-34 (IBP), and ISO 21647 (respiratory gas).

Indications for Use

Indicated for monitoring physiological parameters (ECG, HR, RESP, NIBP, IBP, CO2, TEMP) in adult, pediatric, and neonatal patients; SpO2 and PR monitoring indicated for adult and pediatric patients. Used in healthcare facilities by clinical staff. Contraindicated for helicopter or ambulance transport.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• PM-7000 Patient Monitor (K072346)

Submission Summary (Full Text)

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# JUN 28 2011

Premarket Notification
Section 510(k) Submission
Section III 510(k) Submission
Section III 510(k) Summary

### Section III 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Date of Submission | Jun 8th, 2010 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | Establishment Registration No.: 3006979678 |
| | Contec Medical Systems Co., Ltd, No. 24, West Huanghe Road,Qinhuangdao, Hebei, 066000, China |
| | Contact Person: XueYong Li, Quality Manager |
| Correspondent | Ms. Diana Hong / Mr. Tarzan. Wang |
| | Shanghai Mid-Link Business Consulting Co., Ltd |
| | Suite 5D, No.19, Lane 999, Zhongshan Road (S-2), Shanghai, 200030, China |
| | T: [phone]; |
| | F: 240-238-7587 |
| | [e-mail] |
| Proposed Device | Patient Monitors, CMS8000 |
| Common Name | Patient Monitor |
| Classification | Monitor, Physiological, Patient , MHX , 21 CFR 870.1025 |
| Panel | Cardiovascular |
| Subsequent Code | DSI, MLD, DRT, DXN, DSK, DQA, BZQ, CCK, FLL |
| Device Description | The proposed device, CMS8000 Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters. It has the physical and technical alarming function with audio and visual alarming, The device can driven by AC or DC power supply. |
| Technological<br>Characteristics | The proposed device, CMS8000 Patient Monitor has no any new technological characteristics, all function and technological characteristic are same or similar as the predicate device. |
| Intended Use | The CMS8000 Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The Pulse Oxygen Saturation (SpO2) and Pulse Rate (PR) are intended use for adult and pediatric |

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Premarket Notification
Section 510(k) Submission
Section III 510(k) Submission
III 510(k) Summary

| | patient. |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff<br>under the direction of physicians. It is not intended for helicopter transport or hospital ambulance. |
| Testing | Performance testing including clinical and bench testing was conducted to validate and verify that<br>the proposed device, the Patient Monitors met all design specifications. |
| Clinical Discussion | The proposed device, General Patient Monitors, has conducted clinical test into performance<br>verification of SpO2 and NIBP measure function according with the standard of ISO 9919 and<br>AAMI SP10. |
| Non Clinical Discussion | The proposed device, General Patient Monitors, has conducted the test according with the<br>following standard to demonstrate the effectiveness and safety performance of device. |
| | IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; |
| | Amendment 1, 1991-11, Amendment 2, 1995. |
| | IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety -<br>Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. |
| | AAMI / ANSI EC13:2002/(R) 2007, Cardiac monitors, heart rate meters, and alarms. |
| | ISO 9919:2005: Medical electrical equipment - Particular requirements for the basic safety and<br>essential performance of pulse oximeter equipment for medical use. |
| | AAMI SP10:2002, Manual, electronic or automated sphygmomanometers. |
| | IEC 60601-2-34:2000, Medical electrical equipment - Part 2-34: Particular requirements for the<br>safety, including essential performance, of invasive blood pressure monitoring equipment. |
| | ISO 21647:2004, Medical electrical equipment - Particular requirements for the basic safety and<br>essential performance of respiratory gas monitors. |
| SE Conclusion | The proposed device, General Patient Monitors, is Substantially Equivalent (SE) to the Predicate<br>Device, PM-7000 Patient Monitor, K072346 |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Contect Medical System Co., Ltd. c/o Diana Hong Suite 8D , Zhongxin Zhongshan Mansion, NO. 19, Lane 999, Zhong Shan, Shanghai China 200030

JUN 2 8 2011

Re: K101692

Trade/Device Name: CMS8000 Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection and alarms) Regulatory Class: Class II (two) Product Code: MHX, DSI, MLD, DRT, DXN, DSK, DQA, BZQ, CCK, FLL Dated: June 14, 2011 Received: June 15, 2011

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.

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### Page 2 - Ms. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. 601 Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Section 510(k) Submission Section II Indication for Use Statement

### Section II Indication for Use Statement

510(k) Number: Device Name: Patient Monitor Model: CMS8000

Indications for Use:

The CMS8000 Patient Monitor is intended to be used for monitoring, reviewing, storing and alaming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), cation dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.

The Pulse Oxygen Saturation (SpO2) and Pulse Rate (PR) are intended use for adult and pediatric patient. The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.

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 NEBDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| | Page _1_ of |
| (Division Sign-Off)<br>Division of Cardiovascular Devices | |
| 510(k) Number | k10106 |

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