CNAP Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 11, 2019 CNSystems Medizintechnik GmbH Bernd Wellisch Head of Regulatory Reininghausstrasse 13 Graz, 8020 At Re: K183521 Trade/Device Name: CNAP Monitor 500 HD Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DXG Dated: December 14, 2018 Received: December 19, 2018 Dear Bernd Wellisch: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183521 Device Name CNAP Monitor 500 HD ### Indications for Use (Describe) The CNAP® Monitor 500 HD is intended for the non-invasive continuous monitoring of blood pressure, and the determination of associated derived hemodynamic parameters including cardiac output within hospitals. The device displays the blood pressure waveform, trends, and numeric for blood pressure, pulse rate, and associated derived hemodynamic parameters. Alarms are generated for blood pressure parameters and pulse rate. The CNAP® Monitor 500 HD is to be used for adults and is to be operated by healthcare professionals. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------|---------------------------------------------| | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ### 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) Summary - CNAP® Monitor 500 HD 5 This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. | Submission date | 08/06/2019 | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) submitter | CNSystems Medizintechnik GmbH<br>Reininghausstrasse 13<br>8020 Graz, Austria<br>Tel: 0043-316-7234560<br>E-Mail: regulatory@cnsystems.com | | Primary contact person | Bernd Wellisch / Head of Regulatory Affairs<br>Tel: 0043-316-723456-702<br>E-Mail: bernd.wellisch@cnsystems.com | | Device name | Non-invasive continuous blood pressure and<br>hemodynamic monitoring system | | Trade name | CNAP® Monitor 500 HD | | Review panel | Cardiovascular devices | | Classification regulation | 870.1130, 870.1435 | | Product code | DXN, DXG | | Device class | Class II (two) | #### Submitter´s information 5.1 {4}------------------------------------------------ #### Device information 5.2 # 5.2.1 Primary Predicate Device - CNAP® Monitor 500i, 500at | Clearance number: | K082599 | |------------------------------------------------------------------------|----------------------------------------------------------------------------| | Manufacturer: | CNSystems Medizintechnik AG<br>Reininghausstrasse 13, A-8020 Graz, Austria | | This predicate device has not been subject to a design-related recall. | | ### 5.2.2 Secondary Predicate Device - EV1000 Clinical Platform Non-Invasive (NI) and ClearSight Finger Cuffs or ClearSight System, EV1000 Clinical Platform | Clearance number: | K160552 | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------| | Manufacturer: | Edwards Lifesciences, LLC<br>One Edwards Way, Irvine, California 92614 | | This predicate device has been subject to a design-related recall class 1, event ID 82456. The CNAP® Monitor 500 HD was assessed regarding the assessed cause and hazard and found to be not affected. See Section 10 and 11 for Details. | | ### 5.2.3 Third Predicate Device - PulsioFlex Monitoring System | Clearance number: | K172259 | |------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | Manufacturer: | PULSION Medical Systems SE;<br>Maquet Cardiovascular<br>45 Barbour Pond Drive Wayne, New Jersey 07470 | | This predicate device has not been subject to a design-related recall. | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for CN Systems. The logo consists of the letters 'cn' in red, followed by 'systems' in gray. To the right of the text is a red silhouette of a woman's figure. #### Device Description 5.3 Image /page/5/Picture/3 description: The image shows a CNAP Monitor 500 HD and its accessories. The accessories include an NBP cuff, NBP extension hose, CNAP cable, CNAP controller, and CNAP double finger cuff. The monitor has a screen displaying various readings, including 103/71, 4.9, and 72. Figure 1 CNAP® Monitor 500 HD with external components The CNAP® Monitor 500 HD is a stand-alone device for continuous non-invasive blood pressure and hemodynamic monitoring with alarming functionality. The continuous non-invasive blood pressure is measured on the patient's finger using a double finger cuff, the oscillometric blood pressure measurement function (Advantage 2.0 OEM module by SunTech Inc.) is used for intermittent calibration of the continuous blood pressure curve. Medium priority alarming can be set for blood pressure beat values and pulse rate. #### Indications for use / Intended use 5.4 The CNAP® Monitor 500 HD is intended for the non-invasive continuous monitoring of blood pressure, pulse rate, and the determination of associated derived hemodynamic parameters including cardiac output within hospitals. The device displays the blood pressure waveform, trends, and numeric for blood pressure, pulse rate, and associated derived hemodynamic parameters, Alarms are generated for blood pressure parameters and pulse rate. The CNAP® Monitor 500 HD is to be used for adults and is to be operated by healthcare professionals. #### Comparison of technological characteristics with the predicate device 5.5 The hardware of the CNAP® Monitor 500 HD is very similar to the primary predicate CNAP® Monitor 500i, 500at, with following modifications: ## Changes to hardware: - Exchange of the display and adaption of related components (e.g. ferrite) ● - Exchange of components and pressure sensors in the CNAP® Controller ● and related redesign of the printed circuit board (PCB). - Additional symbol stickers on the housing of the CNAP® Monitor 500 HD ● ## Functional improvements and additional parameters: - New variability parameter derived from blood pressure curve: PPV. ● {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for CN Systems. The text "cn systems" is written in a sans-serif font, with "cn" in red and "systems" in gray. To the right of the text is a red silhouette of a person. - New hemodynamic parameters derived from blood pressure curve: CO, ● SV, SVR, CI, SI, SVRI, and subsequently modified screen layout. - Improved controllers for the continuous blood pressure measurement . function and startup sequence for the continuous blood pressure measurement function. #### Performance data 5.6 The Design verification and validation has demonstrated that the CNAP® Monitor 500 HD performs within its specifications and within the limits of the applied performance standards. The design verification and validation activities for the CNAP® Monitor 500 HD consists of: - . Requirement verification - Code reviews ● - Static code analysis ● - Regression testing - Verification of applicable product standards and Product Requirements ● - (Clinical) Performance Validation and (Summative) Usability Validation ● #### Biocompatibility testinq 5.6.1 All surface materials have a biocompatibility approval. The materials are not modified during assembling and therefore all certificates remain valid, a new assessment for biocompatibility is not necessary. The biocompatibility evaluation for CNAP® Monitor 500 HD device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA. Cytotoxicity, Sensitization, Irritation tests were performed. #### 5.6.2 Electrical safety and electromagnetic compatibility (EMC), Mechanical and acoustical testing The Electromagnetic Compatibility and Electrical Safety, according to applicable product standards: - IEC 60601-1:2005+A1:2012 ● - IEC 60601-1-2:2014 ● - IEC 60601-1-8:2006+A1:2012 ● - IEC 80601-2-30:2009 . confirmed by the accredited laboratories OVE AUSTRIAN are ELECTOTECHNICAL ASSOCIATION, TÜV Testing Laboratory Vienna, Intertek Testing Services NA and Seibersdorf laboratories. ### Section 5 510(k) Summary DocName: 005 510(k) Summary.pdf {7}------------------------------------------------ Image /page/7/Picture/1 description: The image contains the logo for "cnsystems". The "cn" portion of the logo is in red, while the "systems" portion is in gray. To the right of the text is a red silhouette of a woman's figure. ## 5.6.3 Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided 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 was considered as a "major" level of concern, since the CNAP® Monitor 500 HD is a stand-alone non-invasive blood pressure monitoring device with an alarming system. ### 5.6.4 Animal Testing Not applicable. ### 5.6.5 Clinical Testing For clinical testing and evaluation measurement data from different sources was used to demonstrate that the device is substantially equivalent to the predicate devices. ### 5.6.6 Performance Data - Conclusion The clinical performance data demonstrates that the CNAP® Monitor 500 HD performs comparable to the predicate devices for the assessed parameters. #### Conclusion for Substantial Equivalence 5.7 - CNSystems has concluded that the technological characteristics of the CNAP® Monitor 500 HD are substantial equivalent to the primary predicate device, as it relies on the same hardware platform and measurement principle. In addition, the technological characteristics regarding the calculation the hemodynamic and variability parameters from the continuous waveform are substantially equivalent in performance to the secondary predicate device. CNSystems has conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design output of the new device meets the design input requirements. The CNAP® Monitor 500 HD has been shown to be safe and effective. It is substantial equivalent to the predicate devices for their respective intended uses. Section 5 510(k) Summary DocName: 005 510(k) Summary.pdf