(57 days)
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 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 only.
The Endeavour Monitoring System is a multi physiological parameter patient monitor. It is a modular system that allows users to customize monitored parameters based on a patients monitoring need or acuity level.
Here's an analysis of the provided text regarding the Endeavour Monitoring System's acceptance criteria and study information:
Acceptance Criteria and Device Performance for Endeavour Monitoring System
This summary is based on the provided 510(k) submission for the Endeavour Monitoring System (K102004).
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on compliance with established medical device standards and a clinical study comparing Non-Invasive Blood Pressure (NIBP) measurement. Specific quantitative acceptance criteria for each physiological parameter were not explicitly detailed in the provided text, but compliance with relevant IEC, ISO, AAMI, and ASTM standards serves as the implicit acceptance criteria for most parameters.
For the NIBP module, the acceptance criterion was implicitly defined by demonstrating no statistically significant difference in mean readings compared to the predicate device.
| Parameter/Test | Acceptance Criteria (Implicit from Standards/Study Design) | Reported Device Performance |
|---|---|---|
| General Safety and Performance | Compliance with numerous recognized safety, performance, and electromagnetic compatibility standards (listed in the document). | "The Endeavour Monitoring System has been tested and found to be in compliance with the following recognized safety, performance and electromagnetic compatibility standards." (A list of 18 standards follows). |
| Non-Invasive Blood Pressure (NIBP) Module Clinical Performance | No statistically significant difference in mean readings for systolic and diastolic blood pressure compared to the predicate device (Accutorr Plus Monitor - K983575). | "The analysis demonstrated that there was no statistically significant difference in the mean readings obtained with the Endeavour and the Accutorr Plus for both systolic and diastolic blood pressure. No adverse events were reported." |
| Risk Analysis | Identification and documented mitigation of potential hazards. | "Additionally, a risk analysis has been developed to identify potential hazards and document the mitigation of the hazards." |
| Software Verification and Validation | Verification and validation in accordance with appropriate test requirements. | "The device's software has been verified and validated in accordance with the appropriate test requirements." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for NIBP Clinical Study: The specific number of subjects in the clinical study for NIBP is not mentioned in the provided text. It is only referred to as a "non-significant risk study."
- Data Provenance: The document does not specify the country of origin of the data. The study was a "non-significant risk study," which implies it was a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For the NIBP clinical study, the ground truth was established by comparison to the predicate device, the Accutorr Plus Monitor (K983575). The text does not mention the use of experts to establish a separate ground truth or their qualifications. The predicate device itself acts as the reference for comparison.
4. Adjudication Method for the Test Set
Since the NIBP study compared the device to a predicate device, there's no mention of an adjudication method in the traditional sense (e.g., 2+1 or 3+1 expert consensus) as would be seen in image interpretation or diagnostic studies. The comparison was likely a direct measurement comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. This device is a physiological monitoring system and not an AI-based diagnostic tool that would typically involve human readers interpreting output. The study focused on the performance of the NIBP module against a predicate device, not on how human readers' performance improved with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The NIBP clinical study appears to evaluate the device's NIBP algorithm in a standalone manner, comparing its measurements directly to a predicate device. While a human uses the device, the study's focus was on the machine's measurement accuracy versus another machine, not on human interpretation of the machine's output. Therefore, for the NIBP component, this was essentially a standalone performance evaluation of the measurement capability. For other parameters, compliance with standards (e.g., for heart rate, SpO2, etc.) also implies standalone verification of their algorithms/measurement capabilities.
7. The Type of Ground Truth Used
For the NIBP clinical study, the ground truth was the measurements obtained from the legally marketed predicate device, the Accutorr Plus Monitor (K983575). This is a form of comparative ground truth against an established and accepted reference.
8. The Sample Size for the Training Set
The document does not provide information regarding a "training set" or its sample size. This is a physiological monitoring device, and the submission primarily focuses on compliance with established performance standards and validation against a predicate device, rather than the development and training of a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for an AI/machine learning algorithm, this information is not applicable and not provided in the document. The device's performance is established through adherence to recognized standards and clinical comparison to a predicate.
{0}------------------------------------------------
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.800 MacArthur Blvd.Mahwah, NJ 07430Contact: Russell OlsenDirector, Quality Assurance and Regulatory AffairsTelephone: 201-995-8391Facsimile: 201-995-8605SEP 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, witharrhythmia detector or alarms§870.1025- DSI - Arrhythmia detector and alarm§870.1025- MLD - ST Segment with alarm monitor§870.1110- DSK- Blood Pressure computer§870.1130- DXN - Non-invasive blood pressure measurement system§868.1400- CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase§870.1425- DQK - Programmable diagnostic computer§870.2300- DRT - Cardiac Monitor (Incl. Cardiotachometer and ratealarm)§870.2700- DQA- Oximeter§880.2910- FLL - Clinical electronic thermometer§870.1435- DXG - Single-function, pre-programmed diagnosticcomputer |
| Predicate Devices: | Spectrum Monitor - K062098Accutorr Plus Monitor - K983575 |
| Device description: | The Endeavour Monitoring System is a multi physiologicalparameter patient monitor. It is a modular system that allows usersto customize monitored parameters based on a patients monitoringneed or acuity level. |
| Indications for Use: | The Endeavour Monitoring System is intended for intra hospital useunder the direct supervision of a licensed healthcare practitioner. The |
| Mindray DS USA, Inc.Endeavour Monitoring System510(k) Summary |
Page 1 OF 4
{1}------------------------------------------------
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
Page 2 OF 4
{2}------------------------------------------------
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 CardiacRhythm and ST-Segment Measurement Algorithms |
| EN ISO 21647:2004 + Cor 2006 | Medical electrical equipment - Particular requirementsfor the basic safety and essential performance ofrespiratory gas monitors |
Mindray DS USA, Inc. Endeavour Monitoring System 510(k) Summary
Page 3 of 4
{3}------------------------------------------------
| Additionally, a risk analysis has been developed to identify potentialhazards and document the mitigation of the hazards. The device'ssoftware has been verified and validated in accordance with theappropriate test requirements. | |
|---|---|
| Clinical Testing Summary: | A non-significant risk study was conducted on the Endeavour Monitor toverify the clinical performance of the non-invasive blood pressure(NIBP) module to the predicate device, the Accutorr Plus Monitor(K983575). This clinical study was designed to compare theperformance of the NIBP module in the Endeavour to that on theAccutorr Plus. |
| The analysis demonstrated that there was no statistically significantdifference in the mean readings obtained with the Endeavour and theAccutorr Plus for both systolic and diastolic blood pressure. No adverseevents were reported. | |
| Conclusion: | Based on the technological comparison of the subject and predicatedevices, the results of clinical performance testing and compliance withapplicable performance, safety and electromagnetic compatibilitystandards, the Endeavour Monitoring System shall be considered as safe,as effective and substantially equivalent to the legally marketed predicatedevices. |
Mindray DS USA, Inc.
Endeavour Monitoring System 510(k) Summary
PAGE 4 OF 4
{4}------------------------------------------------
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
{5}------------------------------------------------
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 (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
{6}------------------------------------------------
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 |
Page 1 of 1
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.