Diagnostic Station DS20

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 6, 2016 Schiller Ag % Jim Chickering Regulatory Affairs Manager Zoe Medical, Inc. 460 Boston Street Topsfield, Massachusetts 01983 Re: K152043 Trade/Device Name: Diagnostic Station Ds20 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DXN, BZG, DQA, MWI, BZQ, FLL, JKS Dated: March 21, 2016 Received: March 29, 2016 Dear Jim Chickering: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. # Sincerely yours, Shawn W. Forrest -S 2016.05.06 09:06:22 -04'00' for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K152043 Device Name Diagnostic Station DS20 #### Indications for Use (Describe) The Diagnostic Station DS20 is a 12-lead EGG device used for the recording, analysis and evaluation of ECG waveforms. Recordings made with the DS20 can be used as a diagnostic aid for heart function and heart conditions. The DS20 also measures the following patient vital information to further assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO2), carboxyhemoglobin saturation (SpCO), respiration, temperature, and weight. The DS20 is intended for data collection only. It is not intended for continuous momitoring use and does not provide an alarm function. The DS20 is indicated for use in hospital and clinic settings, on adult and pediatric patients. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial;"> <svg height="15" width="15"> <rect height="15" style="fill:lightgray;stroke-width:1;stroke:rgb(0,0,0)" width="15" x="0" y="0"></rect> <path d="M2 2 L13 13 M13 2 L2 13" stroke="black" stroke-width="2"></path> </svg> Prescription Use (Part 21 CER 801 Subpart D)</span> | <span style="font-family: Arial;"> <svg height="15" width="15"> <rect height="15" style="fill:lightgray;stroke-width:1;stroke:rgb(0,0,0)" width="15" x="0" y="0"></rect> </svg> Over The Counter Use (21 CER 801 Subpart C)</span> | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summarv #### I. SUBMITTER SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland Phone: +41 41 766 42 52 FAX: +41 41 761 08 80 Contact Person: Zhenrong Yu MD, PhD Date Prepared: June 30, 2015 #### II. DEVICE Name of Device: Diagnostic Station DS20 Common Name: Electrocardiograph, Diagnostic Spirometer, Vital Signs Device Classification Product Code: DPS - Electrocardiograph (21 CFR 870.2340) Secondary Product Codes: DXN - NIBP Measurement System (21 CFR 870.1130) BZG - Diagnostic Spirometer (21 CFR 870.1840) DQA - Oximeter (21 CFR 870.2700) MWI - Physiological Patient Monitor (21 CFR 870.2300) BZQ - Breathing Frequency Monitor (21 CFR 868.2375) FLL - Clinical Electronic Thermometer (21 CFR 880.2910) JKS - Carbon Monoxide Test System (21 CFR 862.3220) Regulatory Class: II {4}------------------------------------------------ ## III. PREDICATE DEVICE The primary predicate device is the SCHILLER Cardiovit AT-10 Plus. Secondary predicate devices are cited for their use of the same physiological parameter OEM module as the subject device. No reference devices were used in this submission. | Predicate Scope | Predicate Device | 510(k) | Classification | |---------------------------------------------------------------------------------|----------------------------------------------|---------|----------------| | Primary Predicate<br>(12-lead ECG Electrocardiograph<br>with Spirometry option) | SCHILLER Cardiovit AT-10 Plus | K050686 | DPS | | OEM Module<br>Non-invasive Blood Pressure (NIBP) | SCHILLER BP-200 Plus | K063814 | DXN | | OEM Module<br>Pulse Oximetry (SpO2) | Covidien Respiratory Patient<br>Monitor | K130320 | DQA | | OEM Module<br>Pulse Oximetry (SpO2, SpCO) | Masimo Radical 7 | K110028 | DQA, JKS | | OEM Module<br>5-lead ECG and Respiration | Zoe Medical Nightingale<br>Monitoring System | K130740 | MWI | | OEM Module<br>Temperature | Exergen<br>Temporal Scanner Thermometer | K011291 | FLL | #### IV. DEVICE DESCRIPTION The Diagnostic Station DS20 is a 12-lead EGG (Electrocardiograph) device used for the recording, analysis and evaluation of ECG waveforms. It also measures the following patient vital information to further aid in patient assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO>), carboxyhemoglobin saturation (SpCO), respiration, temperature and weight. It also supports a 5-lead ECG measurement of heart rate when 12-lead ECG analysis is not needed. The DS20 does not provide a patient monitoring capability with alarm annunciation. The DS20 has a color display. It accepts user input via a touch panel, barcode scanner or keyboard. It can generate a variety of reports that can be viewed on the display or printed on a strip chart recorder or laser printer. The DS20 is mains- or battery-powered and uses sensors that come in contact with the patient. The DS20 is intended to function in the patient vicinity alongside other medical devices. It can operate as a stand-alone device or can be connected to the SCHILLER SEMA3 Data Management System via Ethernet (land-line or WiFi) in order to store reports and retrieve work orders for a given patient. {5}------------------------------------------------ ### V. INDICATIONS FOR USE The Diagnostic Station DS20 is a 12-lead EGG device used for the recording, analysis and evaluation of ECG waveforms. Recordings made with the DS20 can be used as a diagnostic aid for heart function and heart conditions. The DS20 also measures the following patient vital information to further aid in patient assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO-), carboxyhemoglobin saturation (SpCO), respiration, temperature, and weight. The DS20 is intended for data collection only. It is not intended for continuous monitoring use and does not provide an alarm function. The DS20 is indicated for use in hospital and clinic settings, on adult and pediatric patients. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE The subject device has the same technological characteristics and intended use as the primary predicate. Differences between the subject device and primary predicate include the use of: - . a larger display - a touch panel instead of fixed keys for user input ● - an external laser printer instead of an integrated thermal printer for reports ● - . newer battery technology - . more readily available electrical components (e.g., microcontrollers, memory chips) Additional physiological parameters have been added to the subject device, which are provided by OEM modules. These OEM modules are used in the cited secondary predicates. These differences do not raise different questions of safety and effectiveness. {6}------------------------------------------------ ## VII. PERFORMANCE DATA #### Electrical safety, essential performance and electromagnetic compatibility (EMC) testing The Diagnostic Station DS20 was successfully tested to the following regulatory standards: | Standard | Standard Title | |--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1:2005 +<br>CORR 1 (2006) +<br>CORR 2 (2007) | 3rd Edition, Medical Electrical Equipment, Part 1: General requirements for basic safety and essential performance | | AAMI ES 60601-1:2005 | 3rd Edition, Medical Electrical Equipment, Part 1: General requirements for basic safety and essential performance | | ANSI/AAMI SP10:2002,<br>Am1:2003 | Manual, electronic and automated sphygmomanometers | | IEC 60601-1-2:2007 | Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility | | IEC 60601-1-4:2000 | Medical Electrical Equipment, Part 1-4: General Requirements for basic safety and essential performance - Collateral Standard: Programmable electrical medical systems | | IEC 60601-1-6:2010 | Medical Electrical Equipment, Part 1-6: General Requirements for basic safety and essential performance - Collateral Standard: Usability | | IEC 60601-2-25:2011 | Medical Electrical Equipment, Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs | | IEC 60601-2-27:2011 | Medical Electrical Equipment, Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment | | IEC 80601-2-30:2009 | Medical Electrical Equipment, Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers | | ISO 80601-2-49:2011 | Medical Electrical Equipment, Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment | | ISO 80601-2-56:2009 | Medical Electrical Equipment, Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement | | ISO 80601-2-61:2011 | Medical Electrical Equipment, Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | | IEC 62366:2007 +<br>A1:2014 | Medical Devices - Application of usability engineering to medical devices | | IEC 62304:2006 | Medical Device Software - Software life cycle processes | #### Software Verification and Validation Testing Software verification and validation testing was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered as a "moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient through incorrect or delayed information or through the action of a care provider. {7}------------------------------------------------ ## VIII. CONCLUSIONS Based upon a comparison of devices and performance testing results, the SCHILLER Diagnostic Station DS20 is substantially equivalent to the predicate devices.