MODIFICATION TO ENVOY PATIENT MONITOR
Device Facts
| Record ID | K011784 |
|---|---|
| Device Name | MODIFICATION TO ENVOY PATIENT MONITOR |
| Applicant | Mennen Medical , Ltd. |
| Product Code | DSI · Cardiovascular |
| Decision Date | Aug 16, 2001 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
ENVOY is intended for use as a multiparameter physiological patient monitoring system. The ENVOY can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the ENVOY to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include display of multiparameter waveforms, vital signs, alarm & status messages. The Mennen Medical ENVOY is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring. The following are examples of intended clinical applications: Critical Care Patients; Cardiac Step-down/Telemetry Units; Emergency Departments; Intra-operative (Anesthesia) Monitoring; Post Anesthesia Care.
Device Story
Envoy is a multiparameter physiological patient monitor for hospital use. It consists of a main processing unit, color display, and module rack for plug-in vital signs modules. The 12-lead ECG/respiration module acquires cardiac electrical activity via multi-lead cables and electrodes. Signals are amplified, digitized, and processed using proprietary algorithms to generate waveforms and numeric values. The system displays up to 8 traces simultaneously. Clinicians interact via front panel controls and a quick-knob menu. Output includes real-time waveforms, vital signs, and alarm status. The device assists clinicians in assessing patient physiological conditions in critical care, telemetry, emergency, and anesthesia environments. It is not life-supporting or life-sustaining.
Clinical Evidence
Bench testing included safety and EMC testing per IEC 60601-1 and related standards. Clinical evaluation was performed in a local hospital setting to verify performance.
Technological Characteristics
Multiparameter monitor with plug-in modules. ECG sensing via multi-lead cables (3, 5, 6, or 10 lead sets). Electrical safety per IEC 60601-1, IEC 60601-2-27, and AAMI/ANSI EC13. Connectivity via module rack. Software-driven processing with proprietary algorithms for ECG, respiration, and invasive blood pressure. Type CF patient isolation.
Indications for Use
Indicated for adult, pediatric, and neonatal patients in hospital settings requiring physiological monitoring of ECG/heart rate, invasive/non-invasive blood pressure, temperature, pulse oximetry, respiration, and EtCO2. No specific contraindications listed.
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
- MENNEN MEDICAL ENVOY PATIENT MONITOR (K001120)
Related Devices
- K974510 — ENVOY PATIENT MONITOR · Mennen Medical, Inc. · Apr 14, 1998
- K964750 — EAGLE 4000 PATIENT MONITOR · Marquette Electronics, Inc. · Feb 21, 1997
- K102004 — ENDEAVOUR MONITORING SYSTEM · Mindray DS USA, Inc. · Sep 10, 2010
- K101449 — INTELLIVUE PATIENT MONITOR · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Jun 18, 2010
- K131414 — CARESCAPE MONITOR B850 · GE Healthcare Finland Oy · Aug 28, 2013
Submission Summary (Full Text)
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Food and Drug Administration
K011784
17 July, 2001
Food and Eagle
ENVOY Patient Monitor - Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module
AUG 1 6 2001
# MENNEN MEDICAL LTD.
Kiryat Weizmann Science Park P.O.B. 102 Rehovot 76100 Israel Tel: 972-8-9383030 Fax: 972-8-9406519
Date prepared: 17th July, 2001
# Topic: 510(k) Safety and Effectiveness Summary as per 21 CFR Section 807.92 Special 510k Device Modification (K011784): Envoy Patient Monitor - 12Lead ECG/Resp. Module
# Establishment Name, Registration Number and Address
| Name: | Mennen Medical Ltd. |
|----------------------|------------------------------|
| Registration Number: | 9611022 |
| Operator Number: | 9011766 |
| Address: | Kiryat Weizmann Science Park |
| | Rehovot 76100 Israel |
| | Tel: 972-8-938-3030 |
| | Fax: 972-8-940-6519 |
Contact person:
Asher Kassel, Director of Regulatory Affairs
Food and Drug Administration To: Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville MD, 20850
Document Control Clerk Attn.: Asher Kassel, Director of Regulatory Affairs From:
### Product Name
ENVOY Proprietary: Physiological Patient Monitor Common: 550-010-000 (full system) Mennen Medical Part Number: 554-000-010 (CPU only)
## FDA Classification
| Classification Name: | Arrhtymia Detector and Alarm |
|------------------------|------------------------------|
| Classification Number: | 21 CFR 870.1025 |
| Classification: | Class III |
| Product Code: | 74 DSI |
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# KO11784
#### Food and Drug Administration
17 July, 2001
ENVOY Patient Monitor - Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module
## Performance Standards
None promulgated
## Voluntary Standards
UL 2601-1, IEC 60601-1 for electrical safety for medical equipment AAMI/ EC 11 - Diagnostic electrocardiograph devices (1991) AAMI/ EC 13 - Cardiac monitors, heart-rate meters, alarms (1992) AAMI/ ES 1 - Safe current limits for electromedical apparatus (1993) IEC 60601-1: General Requirement for Safety for Medical Electrical Systems - part 1, (1988); Amendment 1 - 1991-11 Amendment 2 - 1995-03 IEC 60602-2-27: Medical electrical equipment, Part 2, (1994) Requirements for safety of electrocardiograph monitoring equipment.
## Predicate Device
MENNEN MEDICAL ENVOY PATIENT MONITOR (K001120).
## Device Description: Envoy Patient Monitor
The Envoy is a multiparameter physiological patient monitor, capable of monitoring:
- · ECG/Heart Rate
- · invasive blood pressure
- · non-invasive blood pressure
- · respiration
- · pulse oximetry
- · two temperature channels
- · cardiac output
- · eTCO2
The Envoy bedside patient monitor consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules. The modules monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays.
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ENVOY Patient Monitor - Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module
ENVOY vital signs modules acquire vital signs data from the patient, and display their waveforms and alarms indications on the ENVOY display unit. Vital signs and waveform information are displayed simultaneously on the ENVOY Display Unit. Up to 8 traces can be displayed at any one time.
The vital signs modules interface with readily available physiologic transducers through electrically isolated patient input connections. After amplification, the signals are digitized, analyzed and displayed. All processing and alarm determination for ECG, Respiration and Invasive Blood Pressure is made using proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions. The SpO2, Non-Invasive Blood Pressure and EtCO2 Modules incorporate software and/or hardware technology developed by vendors whose products are marketed in the USA.
Information from each vital sign is presented in a separate portion of the display. Each vital sign is labeled for identification and numeric value. Displayed Vital sign information can include: Primary Vital Sign Name, Waveform, Vital Sign Numeric Value, Alarm Status Message.
Operation of the ENVOY is accomplished by interaction with front panel controls on the main processor unit. A quick-knob control allows direct interaction with displayed menus for direct parameter selection and setup. Where manual entry of alphanumeric information is required, a menu keyboard menu is display.
ENVOY is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, nor life sustaining device; nor is it implantable and therefore sterility is not a consideration.
ENVOY complies with IEC 601-1 Medical Electrical Equipment, IEC 601-2-27 Safety of Electrocardiographic monitoring, IEC 601-2-30 Requirements for Automatic Cycling Indirect Blood Pressure monitoring, AAMI/ANSI SP-10/A1 Electronic or Automated Sphygmomanometers, IEC 601-2-34 Requirements for Invasive Blood Pressure monitoring, AAMI/ANSI ES1 Safe Current Limits for Electromedical Apparatus, and AAMVANSI EC13, Cardiac Monitors, Heart Rate Meters and Alarms. ENVOY is not a kit, does not contain any drug or biological products and is not for prescription use.
## Functional Description of the Envoy 12Lead ECG/Resp. module
The ECG/Resp. module is the source of all ECG data in the Envoy bedside monitor. ECG is measured using a multi-lead cable via electrodes attached to the patient's chest.
Monitoring the ECG produces a continuous waveform of cardiac electrical activity to enable an accurate assessment of a patient's current physiological condition. With the ECG module, you can use a 3, 5 6 or 10 lead electrode ECG cable set to display up to 12 selectable ECG leads in up to three channels.
The 12 Lead ECG/Resp. module is housed in the Envoy module rack, where it occupies a single slot. It includes ECG and respiration monitoring.
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ENVOY Patient Monitor - Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module
## ENVOY Intended Use:
ENVOY is intended for use as a multiparameter physiological patient monitoring system.
The ENVOY can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the ENVOY to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.
Functions include display of multiparameter waveforms, vital signs, alarm & status messages.
The Mennen Medical ENVOY is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring.
The following are examples of intended clinical applications:
- · Critical Care Patients
- · Cardiac Step-down/Telemetry Units
- · Emergency Departments
- · Intra-operative (Anesthesia) Monitoring
- Post Anesthesia Care
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ENVOY Patient Monitor -- Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module
## Substantial Equivalency Information:
The following tables summarize and compare data on the Mennen Medical ENVOY 3/5/6 Lead ECG/Resp. module (predicate device - K001120) to the subject of this Special 510(k) submittal, the ENVOY 12 Lead ECG/Resp. module (modified device). We submit that the ENVOY 12 Lead ECG/Resp. module (modified device) is substantially equivalent to the Mennen Medical ENVOY 3/5/6 Lead ECG/Resp. module (predicate device - K001120), available in the U.S. market.
SE Comparison: 12 Lead ECG/Resp. module vs 3/5/6 Lead ECG/Resp. module
The following tables summarize and compare data on the Mennen Medical ENVOY 3/5/6 Lead ECG/Resp. module (predicate device - K001120) to the subject of this Special 510(k) submittal, the ENVOY 12 Lead ECG/Resp. module (modified device).
| Monitored<br>Parameters<br>ECG/HEART RATE | ENVOY<br>3/5/6 Lead ECG/Resp. module | ENVOY<br>12 Lead ECG/Resp. module |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Part/Option Number | 551-104-000 | C51-112-000 |
| Monitored Leads | Multi-lead ECG Module<br>(3 /5/6-leads) | Multi-lead ECG Module<br>(3/5/6/12 leads) -<br>No Substantial Difference |
| Sampling Rate and<br>Resolution | 641 Hz sampling rate<br>22 bit resolution | the same |
| Frequency Response -<br>analog output | Diagnostic: 0.05 to 150 Hz<br>Monitor: 0.5 to 40 Hz<br>Exercise: 1.0 to 25 Hz<br>According to ANSI/AAMI EC11(10)<br>para.3.2.7.2 | the same |
| Input Impedance | 20M ohm: typical<br>5M ohm: differential, dc to 10Hz<br>2.5M ohm: differential 10 to 100 Hz<br>as per ANSI/AAMI EC13(9)<br>para.3.2.9.2 | the same |
| Common Mode<br>Rejection (CMR) | 120 dB, minimum<br>Lead Fault Detection based on<br>impedance | the same |
| Baseline Recovery | within 3 sec,<br>1 sec after lead switch | the same |
| Monitored<br>Parameters<br>ECG/HEART RATE | ENVOY<br>3/5/6 Lead ECG/Resp. module | ENVOY<br>12 Lead ECG/Resp. module |
| Gain Levels | 250 - 8000 | the same |
| Pacemaker Detection<br>and Rejection | Amplitude: 2 mV to 700 mV<br>Width: 0.1 ms to 2.0 ms as per<br>ANSI/AAMI EC13(9) para.3.1.4<br>Pacemaker flag inserted into<br>displayed waveform | the same |
| Patient Isolation | Meets ANSI/AAMI ESI-1985<br>standard for Safe Current Limits for<br>Electromedical Apparatus<br>(5kV dc, 2.5kV AC | the same |
| Heart Rate (HR)<br>Counting | 20 to 300 BPM | the same |
| HR Accuracy | $\pm$ 2 BPM. Values below 20 are<br>recorded as zero | the same |
| QRS Detection Range | 0.25 to 5.0 millivolt height<br>70 to 120 milliseconds width | the same |
| Leads analyzed for: | Heart Rate and Arrhythmia<br>Configuration<br>Top two displayed | the same |
| HR Alarm Settings | 20 (low) to 250 (high),<br>non-overlapping | the same |
| Lead Fault Sense | when ECG electrode is interrupted<br>or becomes marginal | the same |
| Defib. Pulse Protection | 5KV as per ANSI/AAMI EC13 (9),<br>clause 3.2.2.2 and per IEC 601-2-27<br>(12), clause 17,101 and 102 | the same |
| Degree of protection<br>against electrical shock | Type CF | the same |
| Monitored<br>Parameters<br>ECG/HEART RATE | ENVOY<br>3/5/6 Lead ECG/Resp. module | ENVOY<br>12 Lead ECG/Resp. module |
| Electrosurgical<br>Interference<br>Suppression Provided | Yes | the same |
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K011784
Food and Drug Administration
ENVOY ENVOY Monitored 12 Lead ECG/Resp. module 3/5/6 Lead ECG/Resp. module Parameters ECG/HEART RATE the same differential voltage of up to ± 5mv at Dynamic Range a rate up to ±320 mV/sec as per ANSI/AAMI EC13(9), para. 3.2.9.1 <30 microVp-p ANSI/AAMI EC13(9) the same Noise para.3.2.9.3
ENVOY Patient Monitor - Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module
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Food and Drug Administration
ENVOY Patient Monitor – Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module
| Monitored<br>Parameters<br>RESPIRATION | ENVOY<br>3/5/6 Lead ECG/Resp. module | ENVOY<br>12 Lead ECG/Resp. module |
|----------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Part/Option Number | 551-104-000 | C51-112-000 |
| Lead Selection | RA-LA (transthorac) or RA-LL<br>(transabdominal) | the same |
| Frequency Response | 0.13 to 2.5 Hz (-3 dB) | the same |
| Impedance Range | 100 to 3000 ohm @ 100 kHz | 100 to 1500 ohm @ 65 kHz -<br>No Substantial Difference |
| Respiration Sensitivity<br>Range | 0.2 ohm to 5.0 ohm | the same |
| Respiration Rate<br>Counting Range | 8 to 150 BPM | 8 to 120 BPM -<br>No Substantial Difference |
| Overload Recovery<br>Time | typically 1 sec,<br>max 10 sec | the same |
| Lead Fault Sense | >3K ohm | the same |
| Manual threshold mode | 0.2 ohm/1000 ohm (0.02%) to 5<br>ohm/1000 ohm (0.5%) at 20 BPM | 0.2 ohm/1500 ohm (0.013%) to 5<br>ohm/1000 ohm (0.33%) at 20 BPM |
| Automatic Threshold | 0.35 ohm/1000 ohm (0.035%) to 5<br>ohm/1000 ohm (0.5%) at 20 BPM | the same |
| Alarm Settings | Low rate: 0 - 150 BPM<br>High: rate: 8 - 150 BPM | Low rate: 0 - 120 BPM<br>High: rate: 8 - 120 BPM -<br>No Substantial Difference |
| Apnea Alarm Delay | 10 - 90 sec, selectable<br>(default 10 sec.) | 10 - 90 sec, selectable<br>(default 10 sec.) -<br>the same |
| Apnea Alarm Reset | Automatic as defined by System<br>administrator (default 3 breaths) | the same |
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Food and Drug Administration
ENVOY Patient Monitor – Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module
| Displayed<br>Parameters | ENVOY<br>3/5/6 Lead ECG/Resp. module | ENVOY<br>12 Lead ECG/Resp. module |
|-------------------------|--------------------------------------|-----------------------------------|
| ECG | Yes | Yes |
| Heart Rate | Yes | Yes |
| Respiration | Yes | Yes |
| Alarm Indications: | ENVOY<br>3/5/6 Lead ECG/Resp. module | ENVOY<br>12 Lead ECG/Resp. module |
|--------------------|--------------------------------------|-----------------------------------|
| ECG | Visual & Sound | Visual & Sound |
| Heart Rate | Visual & Sound | Visual & Sound |
| Respiration | Visual & Sound | Visual & Sound |
| Display<br>Functions | ENVOY<br>3/5/6 Lead ECG/Resp. module | ENVOY<br>12 Lead ECG/Resp. module |
|--------------------------------------|--------------------------------------|-----------------------------------|
| Change ECG Lead<br>Selection | YES | YES |
| Display of Arrhythmia<br>Information | YES | YES |
| Data Review: Trends | YES | YES |
| Data Review: Tabular | YES | YES |
| User defined<br>Configuration Setup | YES | YES |
| User defined Default<br>Settings | YES | YES |
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K011784
Food and Drug Administration
17 July, 2001
ENVOY Patient Monitor -- Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module
## Conclusion of comparison of Technological characteristics:
We consider the 12 Lead ECG/Resp. module to be substantially equivalent to the 3/5/6 Lead ECG/Resp. module and we submit that any differences between the two modules:
*fall within the scope of a Special 510(k) Device Modification *do not raise any new issues of safety and effectiveness
## Testing
The 12 Lead ECG/Resp. module of the Envoy patient monitor has been subject to extensive safety and performance testing. Final testing for the system included various performance tests designed to ensure that the device meets all functional requirements and performance specifications. Safety testing and EMC testing were performed by an independent testing laboratory to ensure that the device complies to applicable industry and safety standards. The 12 Lead ECG/Resp. module of the Envoy patient monitor has also been clinically tested and evaluated in a local hospital.
Signature:
A. Kassel
Asher Kassel Director of Regulatory Affairs MENNEN MEDICAL LTD.
972-8-9383011 Tel: 972-8-9406519, or Fax: E-mail: asher@mmi.co.il
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Image /page/9/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2001
Mr. Asher Kassel Mennen Medical Ltd. Kiryat Weizmann Science Park P.O.B. 102 Rehovot 76100 ISRAEL
Re: K011784
Trade Name: Envoy Patient Monitor, 12 Lead ECG/Resp. Module Regulatory Number: 21 CFR 870.1025 Regulatory Class: III (three) Product Code: 74 DSI Dated: July 17, 2001 Received: July 19, 2001
#### Dear Mr. Kassel:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave 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 stated in the onerosare, to regarry ent date of the Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (100). Tot may) attresses, sontols provisions of the Act include requirements for annual provisions of the Frea - 11tes, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket rippt of ally wills) will be code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspottonist the GMP regulation may result in regulatory action. In addition, FDA may publish
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## Page 2 - Mr. Asher Kassel
further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Food and Drug Administration
K011784
7 June, 2001
ENVOY Patient Monitor – Device Modification: Special 510 (k) for 12 Lead ECG/Resp. module
## INDICATIONS FOR USE
ENVOY is intended for use as a multiparameter physiological patient monitoring system.
The ENVOY can monitor ECG/heart rate, two invasive blood pressure channels, two The ENVOT our monitor oximetry, respiration, non-invasive blood pressure and temporature offectively allows the ENVOY to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.
Functions include display of multiparameter waveforms, vital signs, alarm & status messages.
The Mennen Medical ENVOY is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring.
The following are examples of intended clinical applications:
- · Critical Care Patients
- · Cardiac Step-down/Telemetry Units
- Emergency Departments
- · Intra-operative (Anesthesia) Monitoring
- · Post Anesthesia Care
Dale Till
Division of Cardiovascular & Respiratory Devices
510(k) Number K011784
Prescription Use - \$\checkmark\$
