MODIFICATION TO ENVOY PATIENT MONITOR

{0}------------------------------------------------ DEC 0 3 2002 Image /page/0/Picture/1 description: The image shows the text "Food and Drug Administration". The text is in a simple, sans-serif font and is left-aligned. The text is likely a heading or title, possibly indicating the source or subject of a document or website. ENVOY Patient Monitor – Device Modification: Special 510(k) for new 12L ECG/Telemetry module Image /page/0/Picture/3 description: The image shows the logo for "mennenmedical". The logo consists of a lowercase "m" inside of a black circle on the top left. The word "mennen" is in bold font, and the word "medical" is in a regular font. Mennen Medical Ltd., 4 Hayarden Street, Yavne PO Box 102, Rehovot 76100 Israel Page 1 of Tel.: +972-8-9323333 Fax: +972-8-9328510 Date: 2002 # Topic: 510(k) Safety and Effectiveness Summary as per 21 CFR Section 807.92(c) Envoy Patient Monitor - Device Modification: Special 510k for new ECG/Telemetry module ## Establishment Name, Registration Number and Address: | Name: | Mennen Medical Ltd. | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Registration Number | 9611022 | | Operator Number: | 9011766 | | Address: | 4 Hayarden Street, Yavne, 81228, Israel | | Postal Address: | PO Box 102,<br>Rehovot, 76100, Israel | | Tel: | +972-8-9323333 | | Fax: | +972-8-9328510 | | Contact person: | Asher Kassel, Director of Regulatory Affairs | | To: | Food and Drug Administration<br>Center for Devices and Radiological Health<br>Document Mail Center (HFZ-401)<br>9200 Corporate Boulevard<br>Rockville MD, 20850 | | Attn.: | Document Control Clerk | | From: | Asher Kassel, Director of Regulatory Affairs | | Product Name: | | | Proprietary: | ENVOY | | Common: | Physiological Patient Monitor | | Mennen Medical Part Number: | 550-010-000 (full system)<br>554-000-010 (CPU only) | | 12L ECG/Telemetry module (receiver): | P/N: 551-119-000 | | 12L ECG/Telemetry module (transmitter): | P/N: 551-119-100 | {1}------------------------------------------------ ## FDA Classification of Envoy Patient Monitor: | Classification Name: | Arrhythmia Detector and Alarm | |------------------------|-------------------------------| | Classification Number: | 21 CFR 870.1025 | | Classification: | Class III | | Product Code: | 74 DSI | ## FDA Classification of ECG/Telemetry Module: | Classification Name: | Arrhythmia detector and alarm | |------------------------|-------------------------------| | Classification Number: | 21 CFR 870.1025 | | Classification: | Class III | | Product Code: | DSI | # Performance Standards: None promulgated # Voluntary Standards: - . - IEC 60601-1: Medical Electrical Equipment General Requirements for Safety - IEC 60601-1-2: General Requirements for Safety. Collateral Standard: Electromagnetic . compatibility - Requirements and tests - IEC 60601-2-27: Safety of Electrocardiographic monitoring . - AAMI/ANSI ES1: Safe Current Limits for Electromedical Apparatus, and ● - AAMI/ANSI EC13: Cardiac Monitors, Heart Rate Meters and Alarms. . #### Predicate Device: MENNEN MEDICAL ENVOY PATIENT MONITOR (K011784). #### 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 {2}------------------------------------------------ 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. The 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 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. The Envoy is not a kit, does not contain any drug or biological products and is not for prescription use. The sale of and use of the Envoy is restricted to qualified medical personnel only. ### Functional Description and intended use of of the ECG/Telemetry module: The 12L ECG telemetry module can be used instead of the regular ECG module to monitor the ECG of patients whose condition enables them to be mobile. ECG is monitored by attaching electrodes to the patient's chest and by connecting the electrodes via a cable to the ECG module in the patient monitor. A 10-wire cable enables ECG monitoring via 12 ECG leads, while a 5-wire cable enables the display of 7 ECG leads. The ECG signal is used to detect the QRS complex, and for the detection and alarm of Heart Rate, Arrhythmia and ST changes. The ECG telemetry does away with the need to connect the patient cable to the bedside monitor: instead, the patient cable is connected to a lightweight transmitter (240 gram) carried by the patient. This enables the patient to move around freely while being monitored by the Envoy patient monitor. The telemetry operating range is 15 meters (with no barrier) from the receiver. For a longer operating distance, you need to add an optional Antenna network. The Telemetry system can use up to 256 channels working in parallel. Each telemetry transmitter is coupled to one telemetry receiver. The telemetry receiver is located in a ECG Telemetry module connected to the Envoy module rack. The single width ECG Telemetry module is intended to be used to monitor 12 lead ECG for patients monitored by the bedside Envoy monitor. Telemetry monitoring is used when the condition of the patient enables him/her to move around. {3}------------------------------------------------ This application is typical to Cardiology Step Down units and to post Open Heart Surgery units, where the patient is connected to a multi parameter monitor at the first stage of hospitalization, and as his condition improves, he is encouraged to be ambulatory with only ECG monitoring by telemetry # ENVOY Intended Use: Food and Drug Administration The 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 ● {4}------------------------------------------------ # Summary of the technological characteristics of the new ECG/Telemetry module (OEM Mortara technology): The following tables summarize data on the Mennen Medical Envoy 12L ECG/Telemetry module (modified device): | Envoy<br>12 L ECG/Telemetry module | | |------------------------------------|---------------------------------------------------------------------------------------------| | Part Number: | 551-119-000 (module with receiver)<br>551-119-100 (transmitter) | | Monitored<br>Parameters: | • ECG<br>• Heart Rte | | Module size: | Single slot<br>Height: 10.0cm (4.0 in)<br>Width: 4.0 cm (1.6 in)<br>Depth: 14.0 cm (5.5 in) | | Features | Envoy 12L ECG/Telemetry module | |---------------------------------------|-------------------------------------------------------------------------------| | Monitored Leads | Single block 10 lead (12L) | | Sampling Rate and Resolution | 500 Hz sampling rate<br>20 bit resolution | | 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 | | Input Impedance | 47 megohoms | | Baseline Recovery | within 3 sec, 1 sec after lead switch | | Input Dynamic Range | 700 mv. | | Electrode offset tolerance | Electrode offset tolerance | | Pacemaker Detection and<br>Rejection | 10,000 s/sec/channel used for pacemaker artifact detection | | Patient Isolation | Transmitter is battery operated (internally powered) and<br>fully isolated | | Heart Rate (HR) Counting | 20 to 300 BPM | | HR Accuracy | ± 2 BPM. Values below 20 are recorded as zero | | QRS Detection Range | 0.25 to 5.0 millivolt height<br>70 to 120 milliseconds width | {5}------------------------------------------------ | Features | Envoy 12L ECG/Telemetry module | |--------------------------------------------------|---------------------------------------------------------------| | Leads analyzed for | Heart Rate and Arrhythmia Configuration;<br>Top two displayed | | HR Alarm Settings | 20 (Low) to 350 (High), non-overlapping | | Lead Fault Sense | When ECG electrode is interrupted or becomes marginal | | Defib. Pulse Protection | Defibrillator protected when used with OEM patient cable | | Degree of protection against<br>electrical shock | Transmitter is Type CF | | Alarm Indications: | Envoy 12L ECG/Telemetry module | |-----------------------------------|--------------------------------| | ECG | Visual & Sound | | Heart Rate | Visual & Sound | | Display Functions | Envoy 12L ECG/Telemetry module | | Change ECG Lead Selection | Yes | | Display of Arrhythmia Information | Yes | | Data Review: Trends | Yes | | Data Review: Tabular | Yes | | User defined Configuration Setup | Yes | | User defined Default Settings | Yes | # Conclusion of comparison of technological characteristics: We consider the Envoy ECG/Telemetry module to be substantially equivalent to the Envoy 12 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 and - . do not raise any new issues of safety and effectiveness {6}------------------------------------------------ ## Testing The Envoy 12L ECG/Telemetry module 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. {7}------------------------------------------------ NEWEND OF HARFER & HUMAN SERVICES Image /page/7/Picture/1 description: The image contains blurry text that is difficult to read. The text appears to be in a sans-serif font. Due to the poor image quality, it is not possible to provide a more detailed description. Food and Drug Administra 9200 Corporate Boulevare Rockville MD 20850 Mennen Medical Ltd. c/o Mr. Asher Kassel Regulatory Affairs P.O. Box 102 Rehovot 76100 ISRAEL Re: K023798 Trade Name: The Envoy Regulation Name: Arrhythmia Detector & Alarm Regulation Number: 21 CFR 870.1025 Regulatory Class: Class III (three) Product Code: DSI Dated: November 12, 2002 Received: November 14, 2002 Dear Mr. Kassel: 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 vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {8}------------------------------------------------ Page 2 -- Mr. Asher Kassel 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer 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 vours. Kaitlin Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ### INDICATIONS FOR USE The Envoy is intended for use as a multiparameter 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 remote monitoring and recording patient information or any in-hospital application requiring remote 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 Division of Cardiovascular & Respiratory Devices 510(k) Number K023798 Prescription Use (Per 21 CFR 801.109)