ENDEAVOUR MONITORING SYSTEM

K102004 · Mindray DS USA, Inc. · MHX · Sep 10, 2010 · Cardiovascular

Device Facts

• Record ID: K102004
• Device Name: ENDEAVOUR MONITORING SYSTEM
• Applicant: Mindray DS USA, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Sep 10, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Endeavour Monitoring System is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters: - ECG waveform derived from 3, 5, 6 and 12 lead measurements - Heart Rate - Pulse Oximetry (SpO2) - ST Segment Analysis - Arrhythmia Detection - Non Invasive Blood Pressure (NIBP) - Invasive Blood Pressure (IBP) - Cardiac Output (CO) - Respiratory Gasses - Respiration Rate - Temperature The Endeavour Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.

Device Story

Modular multi-parameter patient monitor; inputs include ECG (3/5/6/12-lead), SpO2, NIBP, IBP, CO, respiratory gases, respiration rate, temperature. Transforms physiological signals into real-time waveforms, numeric values, and alarms; performs IV drug and hemodynamic calculations. Used in hospital settings under direct supervision of licensed healthcare practitioners. Output displayed on monitor for clinician review; supports clinical decision-making regarding patient status and treatment. Benefits include continuous patient surveillance and automated diagnostic support.

Clinical Evidence

Non-significant risk clinical study compared NIBP module performance between Endeavour and Accutorr Plus (K983575). Results showed no statistically significant difference in mean systolic or diastolic blood pressure readings. No adverse events reported.

Technological Characteristics

Modular multi-parameter monitor. Materials: handle, outer housing, front bezel. Standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-34, IEC 60601-1-8, IEC 60601-2-27, IEC 60601-2-25, IEC 60601-2-30, ISO 10993-1, ISO 15223, ISO 14971, ISO 9919, ANSI/AAMI SP10, ASTM E1112, EC13, EC11, EC57, EN ISO 21647. Connectivity: network interface. Software: programmable electrical medical system.

Indications for Use

Indicated for intra-hospital monitoring of adult, pediatric, and neonate patients. Arrhythmia/ST segment analysis limited to adult/pediatric. IV drug calculations limited to adult. Cardiac output limited to adult/pediatric.

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

• Spectrum Monitor (K062098)
• Accutorr Plus Monitor (K983575)

Submission Summary (Full Text)

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K102004

## 510(k) Summary Endeavour Monitoring System

This 510(k) Summary is provided in accordance with the requirements of 21 CFR 807.92.

. .

| Date: | July 13, 2010 |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Mindray DS USA, Inc.<br>800 MacArthur Blvd.<br>Mahwah, NJ 07430<br>Contact: Russell Olsen<br>Director, Quality Assurance and Regulatory Affairs<br>Telephone: [phone]<br>Facsimile: 201-995-8605<br>SEP 10 2010 |
| Device Trade Name: | Endeavour Monitoring System |
| Common Name: | Multi-parameter patient monitor (with arrhythmia detection or alarms) |
| Device Classification: | §870.1025- MHX - Physiological, Patient Monitor, with<br>arrhythmia detector or alarms<br>§870.1025- DSI - Arrhythmia detector and alarm<br>§870.1025- MLD - ST Segment with alarm monitor<br>§870.1110- DSK- Blood Pressure computer<br>§870.1130- DXN - Non-invasive blood pressure measurement system<br>§868.1400- CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase<br>§870.1425- DQK - Programmable diagnostic computer<br>§870.2300- DRT - Cardiac Monitor (Incl. Cardiotachometer and rate<br>alarm)<br>§870.2700- DQA- Oximeter<br>§880.2910- FLL - Clinical electronic thermometer<br>§870.1435- DXG - Single-function, pre-programmed diagnostic<br>computer |
| Predicate Devices: | Spectrum Monitor - K062098<br>Accutorr Plus Monitor - K983575 |
| Device description: | The Endeavour Monitoring System is a multi physiological<br>parameter patient monitor. It is a modular system that allows users<br>to customize monitored parameters based on a patients monitoring<br>need or acuity level. |
| Indications for Use: | The Endeavour Monitoring System is intended for intra hospital use<br>under the direct supervision of a licensed healthcare practitioner. The |
| Mindray DS USA, Inc.<br>Endeavour Monitoring System<br>510(k) Summary | |

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Indications for Use for the Endeavour include the monitoring of the following human physiological parameters:

-ECG waveform derived from 3, 5, 6 and 12 lead measurements -Heart Rate

-Pulse Oximetry (SpO2)

-ST Segment Analysis -Arrhythmia Detection

-Non Invasive Blood Pressure (NIBP)

-Invasive Blood Pressure (IBP)

- -Cardiac Output (CO)
- -Respiratory Gasses
- -Respiration Rate
- -Temperature

The Endeavour Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.

The target populations are adult, pediatric and neonate with the exception of.

-Arrhythmia detection and ST Segment Analysis, for which the target populations are adult and pediatric only,

-IV Drug Calculations for which the target population is adult only, and

-Cardiac Output for which the target population is adult and pediatric onlv.

Technological Comparison to Predicate Device:

The Endeavour is equivalent to predicated devices respecting indications for use, basic operation, performance specifications and energy supply. The Endeavour incorporates the use of new materials for the handle, outer housing and front bezel. Additionally, the Endeavour supports a modular parameter design where as the predicate devices are internally configured.

Mindray DS USA, Inc. Endeavour Monitoring System 510(k) Summary

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## Summary of Performance Testing:

The Endeavour Monitoring System has been tested and found to be in compliance with the following recognized safety, performance and electromagnetic compatibility standards.

| IEC 60601-1:1988 +A1:1991 +A2:1995 | Medical electrical Equipment - General Requirements for Safety |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests |
| IEC 60601-1-4:1996 + A1:1999 | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems |
| IEC 60601-2-34:2000 | Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment |
| IEC 60601-1-8:2003 +A1:2006 | Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| IEC 60601-2-27:2005 | Medical electrical equipment, Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment |
| IEC 60601-2-25:1993 + A1:1999 | Medical electrical equipment, Part 2: Particular requirements for the safety of electrocardigraphs |
| IEC 60601-2-30:1999 | Medical electrical equipment, Part 2: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment. |
| ISO 10993-1:2003 | Biological evaluation of medical devices - Part 1: Evaluation and testing. |
| AAMI / ANSI HE74:2001 | Human Factors Design Process for Medical Devices |
| ISO 15223: 2000 | Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied |
| ISO 14971:2007 | Medical devices -- Application of risk management to medical devices |
| ISO 9919:2005 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
| ANSI/AAMI SP10:2002 + A1:2003 + A2:2006 | Manual, electronic or automated sphygmomanometers |
| ASTM E1112-00 (2006) | Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature |
| EC13: 2002/(R)2007 | Cardiac monitors, heart rate meters, and alarms |
| EC11:1991/(R)2007 | Diagnostic electrocardiographic devices |
| EC57:1998/( R )2003 | Testing and Reporting Performance Results of Cardiac<br>Rhythm and ST-Segment Measurement Algorithms |
| EN ISO 21647:2004 + Cor 2006 | Medical electrical equipment - Particular requirements<br>for the basic safety and essential performance of<br>respiratory gas monitors |

Mindray DS USA, Inc. Endeavour Monitoring System 510(k) Summary

Page 3 of 4

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| | Additionally, a risk analysis has been developed to identify potential<br>hazards and document the mitigation of the hazards. The device's<br>software has been verified and validated in accordance with the<br>appropriate test requirements. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Testing Summary: | A non-significant risk study was conducted on the Endeavour Monitor to<br>verify the clinical performance of the non-invasive blood pressure<br>(NIBP) module to the predicate device, the Accutorr Plus Monitor<br>(K983575). This clinical study was designed to compare the<br>performance of the NIBP module in the Endeavour to that on the<br>Accutorr Plus. |
| | The analysis demonstrated that there was no statistically significant<br>difference in the mean readings obtained with the Endeavour and the<br>Accutorr Plus for both systolic and diastolic blood pressure. No adverse<br>events were reported. |
| Conclusion: | Based on the technological comparison of the subject and predicate<br>devices, the results of clinical performance testing and compliance with<br>applicable performance, safety and electromagnetic compatibility<br>standards, the Endeavour Monitoring System shall be considered as safe,<br>as effective and substantially equivalent to the legally marketed predicate<br>devices. |

Mindray DS USA, Inc.
Endeavour Monitoring System 510(k) Summary

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Mindray DS USA, Inc. c/o Mr. Russell Olsen Director, Quality Assurance and Regulatory 800 MacArthur Blvd. Mahwah, NJ 0743

SEP 1 0 2010

Re: K102004

> Trade/Device Name: Endeavour Monitoring System Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MHX Dated: July 14, 2010 Received: July 15, 2010

Dear Mr. Olsen:

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.

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

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Page 2 – Mr. Russell Olsen

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/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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## Indications for Use

510(k) Number (if known):

KID2004

Device Name: ____ Endeavour Monitoring System SEP 1 0 2010

Indications for Use:

The Endeavour Monitoring System is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters:

- ECG waveform derived from 3, 5, 6 and 12 lead measurements .
- Heart Rate .
- Pulse Oximetry (SpO2) .
- ST Segment Analysis �
- Arrhythmia Detection .
- Non Invasive Blood Pressure (NIBP) ●
- Invasive Blood Pressure (IBP) .
- Cardiac Output (CO) .
- Respiratory Gasses .
- Respiration Rate .
- Temperature �

The Endeavour Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.

The target populations are adult, pediatric and neonate with the exception of:

- Arrhythmia detection and ST Segment Analysis, for which the target populations are adult 트 and pediatric only,
- IV Drug Calculations for which the target population is adult only, and 트
- Cardiac Output for which the target population is adult and pediatric only. 합

Over-The-Counter Use AND/OR Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division/Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | C162004 |

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