LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P

{0}------------------------------------------------ JUN 1 4 2005 Image /page/0/Picture/1 description: The image shows the text "K05 0919" on the top line and "P. 1/7" on the bottom line. The text is written in a handwritten style. The numbers are clearly visible and the letters are also easily readable. # ### 510(k) Summary For Analogic Corporation ## LIFEGARD II Family #### Date this Summary was Prepared: 1. April 8, 2005 : #### 2. Submitter's Name and Address: | Submitter's Name: | Analogic Corporation | |-----------------------|----------------------| | Address: | 8 Centennial Drive | | City, State, and Zip: | Peabody, MA 01960 | | Registration Number: | 1219601 | #### 3. Contact Person: | Name: | Janet R. Kwiatkowski | |------------|---------------------------| | Title: | Regulatory Affairs | | Telephone: | (978) 326-4186 | | Facsimile: | (978) 977-6808 | | E-mail: | Jkwiatkowski@analogic.com | #### 4. Device Name: | Proprietary or Trade Name: | LIFEGARD II Family | |------------------------------|-----------------------------------------------------------------------------------| | Common Name: | Arrhythmia detector and alarm (including ST-segment<br>measurement and alarm) | | Classification Name: | Monitor, Physiological, Patient (with Arrhythmia Detection<br>or Alarms) | | Classification Panel: | Cardiovascular Devices | | Product Codes: | MHX, DSI, DSJ, DXN, MLC, DQA, DSB, DSA, FLL | | Code of Federal Regulations: | 870.1025, 870.1100, 870.1130, 870.2340, 870.2700,<br>870.2770, 870.2900, 880.2910 | {1}------------------------------------------------ | Device Panel | CFR<br>Section | Product<br>Code | Device<br>Class | Description | |--------------------------------------|----------------|-----------------|-----------------|----------------------------------------------------------------------------| | Cardiovascular<br>Devices | 870.1025 | MHX | II | Monitor, physiological,<br>patient(with arrhythmia<br>detection or alarms) | | | 870.1025 | DSI | II | Detector and alarm, arrhythmia | | | 870.2770 | DSB | II | Plethysmograph, impedance | | | 870.1100 | DSJ | II | Alarm, blood-pressure | | | 870.1130 | DXN | II | System, measurement, blood-<br>pressure, non-invasive | | | 870.2340 | MLC | II | Monitor, ST segment | | | 870.2700 | DQA | II | Oximeter | | | 870.2900 | DSA | II | Cable, transducer and<br>electrode, patient, (including<br>connector) | | General Hospital<br>and Personal Use | 880.2910 | FLL | II | Thermometer, electronic,<br>clinical | ### Regulatory Classification of LIFEGARD II Family #### న. Predicate Devices: The legally marketed devices to which equivalence is being claimed are: The C3 Patient Monitors cleared under Premarket Notification K030931 and K041434. - . The Impedance Cardiography (ICG) parameter incorporated in the LIFEGARD II Family is identical in all aspects to the parent C3 Family. - . The electrocardiograph (ECG) parameter incorporated in the LIFEGARD II Family is identical to the parent C3 Family. - The end-tidal carbon dioxide (EtCO2) method of measurement is identical to the . parent C3 Family. - The temperature probes are pre-amendment devices. The method of temperature . measurement is identical to the parent C3 Family. - . The non-invasive blood pressure (NIBP) measurement method is identical to parent C3 Family. {2}------------------------------------------------ The M3046A (M2/M3/M4) Compact Portable Patient Monitor device cleared under K023871. This predicate device was chosen specifically for the arrhythmia with ST segment indication. The continuous non-invasive blood pressure Multi-parameter patient monitoring system cleared under K011152. The LIFEGARD II contains the identical technology of the predicate device. The Pulse Oximeter, Sensors and Cables with accessories and Physiological Signal Amplifier cleared under K012891and K040113, respectively. The technology as cleared in K012891 and K040113 is identical to the technology incorporated in the LIFEGARD II Family of devices. #### 6. Description of LIFEGARD II Family The LIFEGARD II Family is a compact, lightweight device for measuring, processing, printing, and displaying information derived from nine physiological measurements: - . Electrocardiogram (ECG). A three lead or five lead ECG is acquired and a waveform can be displayed real-time on the LCD screen or permanently recorded on the optional printer. The design of the ECG function is derived directly from the predicate devices, the parent C3 Family of patient monitors. - . Respiration. Waveform and numeric respiration rate value from ECG. Airway respiration rate from EtCO2 if available. The design of the respiration parameter is derived directly from the predicate devices, the parent C3 Family of patient monitors. - Arrhythmia with ST segment analysis software performs five distinct operations: beat . detection, lead selection, beat classification, ventricular tachyarrhythmia detection, and ST segment measurement. The design of arrhythmia with ST segment function provides VF and ST segment deviation functionality similar to the predicate device, M3046A (M2/M3/M4) Compact Portable Patient Monitor - . Pulse Oximetry (SpO2). Functional Oxygen Saturation is calculated from the ratio of light transmissivity through the capillary bed at two wavelengths. The SpO2 subsystem uses software and firmware that is used in the OxiMAX Pulse Oximetry System and Sandman SD20 Amplifier patient monitor and system. - . The temperature is measured using thermistor probes for continuous temperature measurements. These are pre-amendment devices. - . Blood pressure is measured non-invasively (NIBP) by the oscillometric method. This is the same as in the predicate devices, parent C3 Family of patient monitors. {3}------------------------------------------------ - Continuous non-invasive blood pressure (CNIBP) is a non-invasive blood pressure . monitor which uses a pressure sensor placed on the wrist over the radial artery. This is the same technology as in the predicate device, Vasotrac APM205A. - . End-tidal CO2 (EtCO2) This method pulls a constant sample flow of exhaled breath from the patient, and analyzes it with a remote CO2 sensor built into the measurement system. This is the same as in the predicate devices, parent C3 Family of patient monitors. - Impedance Cardiograph (ICG). This mode uses Thoracic Electrical Bioimpedance (TEB). . This is identical in all aspects to the predicate device, the C3 ICG. - An internal thermal printer records waveforms, hemodynamic parameters and tabular . trends on a 50-mm wide strip chart. - . External USB printing identical to the parent C3 Family. The LIFEGARD II Family is powered by internal sealed lead-acid batteries or from the mains supply via a battery eliminator. A fully charged battery will power the monitor for three hours. {4}------------------------------------------------ #### 7. Intended Use: The device is for use on individual adult and pediatric patients in hospital areas and hospitaltype facilities, such as clinical users may use the monitor during hospital transport. These indications were previously cleared under K030931 and K041434. The purpose and function of the LIFEGARD II Family is to monitor: - . ECG - . Heart rate - . Non-invasive blood pressure (NIBP) - Functional arterial oxygen saturation (SpO2) . - Respiration rate - . Temperature and - . End-tidal carbon dioxide (EtCO2) - Impedance Cardiography (ICG) . - . Arrhythmia with ST segment detection - Continuous non-invasive blood pressure (CNIBP) . The Impedance Cardiography (ICG) is intended for use on individual adult patients that meet the limits specified below: - . Height: 4 ft - 7 ft - 6 in (122 - 229 cm) - Weight: 67 350 lbs (30 159 Kg) . The CNIBP is a non-invasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery. This device is intended to be used on patients by trained medical personnel to continuously monitor systolic, diastolic and mean blood pressure and pulse rate. This pressure information is intended to guide clinicians in the therapeutic management of their patients by providing accurate and frequent updated blood pressure information in a safe, non-invasive, easily obtained and comfortable manner. #### 8. Comparison of Technological Characteristics: The technological characteristics of the LIFEGARD II Family are the same as the legally marketed predicate devices. {5}------------------------------------------------ #### Non-clinical Tests to Be Used In Determination of Substantial Equivalence: 9. Prior to marketing the LIFEGARD II Family, verification testing activities will be conducted to establish the compliance, performance and reliability characteristics of the LIFEGARD II Family. This is to include the following non-clinical tests: IEC 60601-1 (including Amendments 1 & 2), Medical Electrical Equipment - General Requirements for Safety IEC 60601-1-2: 2001 Medical electrical equipment - Electromagnetic compatibility emission limits meet Group 1 Class B IEC 60601-2-27 Medical electrical equipment - Particular requirements for the safety of electrocardiographic monitoring equipment IEC 60601-2-30 Medical electrical equipment - Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment IEC 60601-2-49 Medical electrical equipment - Particular requirements for the safety of multifunction patient monitoring equipment ANSI/AAMI EC 13 Cardiac monitors, heart rate meters, and alarms ANSI/AAMI EC 57 Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms ANSI/AAMI SP10 Manual, Electronic, or Automated Sphygmomanometers EN 864 Capnometers for use with humans EN 865 Pulse Oximeters Mechanical shock and vibration tests will be performed in accordance with IEC 60068 series of standards to ensure transport does not damage the device Shipping container transportation tests will be performed in accordance with IEC 60068-2-27 to ensure packaging of equipment is not adversely affected during shipping Altitude tests will be performed to ensure that operation at higher altitudes does not adversely affect electrical safety or performance Tests will be performed to verify enclosure material robustness and resistance to cleaning materials commonly used in hospitals {6}------------------------------------------------ 2050219 p.717 #### 10. Conclusions from Non-clinical Testing: The test schedule of the LIFEGARD II Family combined with the AAMI EC 57 tests already performed including the current test data from Nellcor showing equivalent performance of the SpO2 module incorporated into the LIFEGARD II Family demonstrates that the performance of the LIFEGARD II Family patient monitors is substantially equivalent to the parent C3 Family of patient monitors and the non-Analogic predicate devices cited in Section 5 of this summary. The device will present no new concerns regarding safety and effectiveness. APPENDIX D {7}------------------------------------------------ Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized representation of a human figure, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 4 2005 Ms. Janet R. Kwiatkowski Regulatory Affairs Specialist Analogic Corporation 8 Centennial Drive Peabody, MA 01960 Re: K050919 Trade Name: LIFEGARD II Family Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with Arrhythmia Detection or Alarms) Regulatory Class: Class II (two) Product Code: DSI Dated: April 8, 2005 Received: April 12, 2005 Dear Ms. Kwiatkowski: We have reviewed your Section 510(k) premarket notification of intent to market the device wo nevers for over for a seeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorobate) to regars and ment date of the Medical Device Amendments, or to conninered proc to 1125 20, 2017, 11:28 provisions of the Federal Food, Drug, de nees may been receases of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, are every, mains 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 If your device 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 -- Ms. Janet R. Kwiatkowski Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso be actived a determination that your device complies with other requirements of the Act that I Dri has Intact and regulations administered by other Federal agencies. You must of any I catal statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set of it in the quality systems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and quality by oversions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control proved in arketing your device as described in your Section 510(k) I mis letter will and my of substantial equivalence of your device of your device to a legally premated predicated 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), please If you desire specific aarroliance at (240) 276-0295. Also, please note the regulation entitled, connact the Office of Complains and (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and oddess http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, B/Simmons for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "ANALOGIC" in a bold, sans-serif font. The letters are all capitalized and black. There is a registered trademark symbol to the right of the letter "C" and a black square to the right of the trademark symbol. Device Name: LIFEGARD II Family ### Indications for Use Statement The device is for use on individual adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport. These indications were previously cleared under K030931 and K041434. The purpose and function of the LIFEGARD II Family is to monitor: - ECG . - . Heart rate - Non-invasive blood pressure (NIBP) . - Functional arterial oxygen saturation (SpO2) . - . Respiration rate - Temperature and . - End-tidal carbon dioxide (EtCO2) . - Impedance Cardiography (ICG) . - Arrhythmia with ST segment detection . - Continuous non-invasive blood pressure (CNIBP) . X The Impedance Cardiography (ICG) is intended for use on individual adult patients that meet the limits specified below: - Height: 4 ft 7 ft 6 in (122 229 cm) . - Weight: 67 350 lbs (30 159 Kg) . The CNIBP is a non-invasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery. This device is intended to be used on patients by trained medical personnel to continuously monitor systolic, diastolic and mean blood pressure and pulse rate. This pressure information is intended to guide clinicians in the therapeutic management of their patients by providing accurate and frequent updated blood pressure information in a safe, non-invasive, easily obtained and comfortable manner. Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE) Blummo Division Sign Off