Compass Cast and MAP

{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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other to form a single, abstract shape. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 November 22, 2016 Silver Spring, MD 20993-0002 Centurion Medical Products Corporation Matthew Price Director, Regulatory Affairs & Quality Assurance 100 Centurion Way Williamston, Michigan 48895 Re: K161408 Trade/Device Name: Compass Cast and MAP System Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II Product Code: DRS, DXG Dated: September 20, 2016 Received: September 22, 2016 Dear Matthew Price: 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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 vours. Mude Jellman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | |-----------------------------------------| | Food and Drug Administration | # Indications for Use 510(k) Number (if known) K161408 Device Name Compass Cast and MAP Indications for Use (Describe) The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents. Type of Use (Select one or both, as applicable) > 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." FORM FDA 3881 (8/14) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ | | 510(k) Summary | |--|----------------| |--|----------------| Centurion Medical Products Corporation 100 Centurion Way Williamston, MI 48895 Matthew K. Price Director of Regulatory Affairs and Quality Assurance Phone: (517) 546-5400 (517) 546-3356 Facsimile: November 14, 2016 Traditional Compass Cast and MAP System Disposable Pressure Transducer Extravascular Blood Pressure Transducer Single-Function, Preprogrammed Diagnostic Computer ll 870.2850 870.1435 DRS / DXG Cardiovascular - (1) Slight modification to the predicate Compass CT Port circuit board to accommodate an added secondary Bluetooth radio board that allows for wireless communication with the new Compass MAP. All modifications are internal to the Compass Cast, so that the external plastic housing and all other physical components of the device remain identical to the predicate Compass CT Port. - (2) Development of new Compass Monitor Accessory Plug (MAP), which is a reusable, non-sterile component that can be plugged into a compatible monitor and paired to the Compass Cast to then allow for complementary display of all pressure information on a separate monitor. ### Predicate SE Device(s): Manufacturer: Date Summary Prepared: Common Name of Device: Trade Name (Proprietary Name): Device Description Submission Type: Classification Name: Device Classification: Classification Panel: Reason for 510(k): Regulation: Product Code: Contact: The Compass CT and Compass CT Port are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The devices have a distal male luer fitting to connect to a needle or catheter, and a proximal female luer fitting that can be connected to accessory devices (e.g. syringes, caps, or infusion tubing). The devices measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD. The Compass CT Port has an additional, sealed proximal port through which commercially available guidewires can be inserted during pressure measurement. {4}------------------------------------------------ ## Description: The Compass CT Port device is being modified to add wireless Bluetooth capability to the point-of-use Compass Cast device, in order to allow for optional display of acquired pressure data and information to a separate display monitor. The modified product will consist of two components that are packaged separately, the compass Cast (Subject Device) and MAP (Monitor Accessory Plug - Accessory). The Compass Cast (Subject Device) is a single-use, sterile pressure transducer that is physically identical to the predicate device Compass CT Port (510(k) K133624) with the exception of a slight modification to the main CT Port circuit board to accommodate the secondary Bluetooth radio board. All components and functionality of the main circuit board remain identical. The MAP (Accessory) is a non-sterile, reusable monitor accessory plug that receives a digital pressure signal from the Compass Cast and converts the digital pressure signal to an analog output that is identical to the analog output of a traditional wired pressure transducer. There are two versions of the MAP device: - 1) Wireless Pressure Receiver - GE Monitor (CWMG001-5) - 2) Wireless Pressure Receiver Philips Monitor (CWMP001-5) The MAP Accessory has not received prior 510(k) clearance. ### Indications for Use: The Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents. ### Summary of Technological Characteristics between Subject and Predicate Device: The Compass Cast and MAP system retain the same fundamental scientific technology as the predicate device. The intended use is identical as well as the operating principles at the point of use with the compass Cast – direct measurement of physiological pressure, including during the infusion of fluids and therapeutic and diagnostic agents. ldentical to the predicate Compass CT Port, the Compass Cast remains a single-use, sterile pressure transducer that is physically identical to the Compass CT Port from 510(k) K133624 except for: (1) a secondary, internal circuit board that gives the modified device wireless (low energy Bluetooth) capability, and (2) a slightly thicker battery to provide increased capacity due to the added wireless transmission functionality. The Compass Cast device thus incorporates the exact physical elements (including a coin cell battery) contained in the predicate Compass CT Port except for some slight modifications to the main predicate Compass CT Port circuit board changes were necessary to accommodate the added secondary Bluetooth radio board, but all components and functionality of the main circuit board remain identical. The Compass Cast and MAP do not transmit any patient identifying data; they simply transmit pressure data that has no patient identifiers. The Bluetooth capability allows the pressure data to be freely viewable on the monitors in the patient room without the use of a wire connection. Lastly, while the Compass Cast uses a thicker coin cell battery compared to the predicate Compass CT Port (specifically, it uses a CR1632 instead of a CR1616) to account for the added wireless transmission functionality drawing more power from the battery, the nominal voltage of the two batteries remains identical (3V). Following is a side by side comparison of the features of the subject and predicate device. {5}------------------------------------------------ | Design / Technological<br>Characteristic | Predicate Compass CT Port | Subject Compass Cast<br>(and MAP only as applicable) | |----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Compass CT Port disposable<br>pressure transducer with integrated<br>digital display is intended for direct<br>measurement and monitoring of<br>physiological pressure, including<br>during the infusion of fluids and<br>therapeutic and diagnostic agents. | The Compass Cast and MAP disposable<br>pressure transducer system with<br>integrated digital display and wireless<br>transmission capability is intended for<br>direct measurement and monitoring of<br>physiologic pressure, including during the<br>infusion of fluids and therapeutic and<br>diagnostic agents. | | Regulatory History | K133624 | K161408 | | Classification Panel | Cardiovascular | Identical | | Classification Name | Extravascular Pressure Transducer<br>and Single-Function, Preprogrammed<br>Diagnostic Computer | Identical | | Device Class | Class II (21 CFR 870.2850 and<br>870.1435) | Identical | | Device Code | DRS and DXG | Identical | | General Technological<br>Design | Designed as a pressure transducer<br>with an integrated digital display to<br>allow for "point of use"<br>measurement and monitoring of<br>physiological pressures. | Identical<br>(but also incorporates wireless Bluetooth<br>capability for display to compatible<br>monitor via new Compass MAP<br>component) | | Wireless Low Energy<br>Bluetooth Capability via<br>Compass MAP | No | Yes | | Luer Connections | Proximal male and distal female luer<br>tested per ISO 594-1 ISO 594-2 | Identical | | Pressure Sensing Element | Piezoresistive bridge transducer<br>tested per ANSI/AAMI<br>BP22:1994(R)2006 | Identical | | Pressure Accuracy and<br>Functional Performance | Meet or exceed ANSI/AAMI<br>BP22:1994(R)2006 | Identical | | Power Source | 3 V DC from internal lithium battery | Identical | | External Cable | None | Identical | | Fluid Path Materials | USP Class VI polycarbonate | Identical | | Display | Integrated LCD | Identical | | Display Range – Max | 1,198 mm Hg (-199 to +999 mm Hg) | Identical | | Accuracy | -199 to -51 mm Hg: ±3% of reading<br>-50 to +50 mm Hg: ±2 mm Hg<br>51 to 999 mm Hg: ±3% of reading | Identical | | Guidewire Port | Yes | Identical | | Zero Drift | ±1 mm Hg per 4 hours | Identical | | Light Sensitivity | < 1 mm Hg | Identical | ## Table 1: Summary of Design and Technological Characteristics for the Predicate Compass Device (K133624) and the Subject Compass Cast and MAP (Modified) Biocompatible Single-use only Sterilization Yes Yes Ethylene Oxide Identical Identical Identical {6}------------------------------------------------ ## Performance Data: The results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the Compass Cast and MAP System are sufficient for its intended use and support a determination of substantial equivalence. #### Summary of Testing: Sterilization The Compass Cast will be available only in sterile product will be sterilized using ethylene oxide. The sterilization method was validated and performed in accordance with ANSI/AAMI/ISO 11135-1:2014, Sterilization of health care products – Ethylene oxide - Requirement, validation and routine control of a sterilization process for medical devices. A sterility assurance level of 1 x 10 ° has been validated for this product. The Compass MAP will be sold non-sterile, reusable, as an accessory to the Compass Cast. ## EO Residuals Ethylene Oxide Residual testing was performed in accordance with ANSI/AAMI/ISO 10993-7:2008. Testing was performed (Centurion Protocol# 17205-16) on product code CLCK001 (Compass Vascular Access Lock) as this model was selected as a "worst case" representative for the Compass family of products. The Compass Vascular Access Lock is identical in physical construction to the Compass Cast with the exception of the electronics. A second circuit board is attached perpendicular to the main PCB in the Compass Cast to allow for wireless transmission capability. However, this additional component is contained within the device's housing and has no impact on sterility. Three samples were processed through two routine (Cycle 20) sterilization cycles for a total of eight (8) hours exposure and subjected to 24 hours of forced heated aeration. The duration of contact for the Compass product is <8 hours. As a result, a simulated use extraction was performed at body temperature (37°C) for a duration of 8 hours. The proposed limits as defined in in ANSI/AAMI/ISO 10993-7:2008 are 4 mg/device for EO and 9 mg/device for EC. ### BET Testing The Kinetic Chromogenic Test Method has been validated as the test method for determining the presence of bacterial endotoxins on the Compass family of devices. The Endotoxin limit applied to the Compass Products is 2.15 EU/Device (0.06 EU/ml). The selected endotoxin limit is based on the potential contact with Cerebrospinal Fluid in accordance with AAMI ANSI ST72:2011. ### Electromagnetic Compatibility/Electrical Safety EMC and Wireless Communication Testing were performed on the Compass Cast and MAP system due to the modification to incorporate a low energy Bluetooth communication. A slight modification was made to the Compass CT Port circuit board to accommodate a secondary Bluetooth radio board that enables wireless communication. A thicker coin cell battery was also added to provide increased capacity. The Compass monitor accessory plug (MAP) was developed as a reusable, non-sterile component that can be plugged into a monitor and paired to the Compass Cast device to allow the pressure information to be viewed on a separate monitor. The Compass Cast and MAP were evaluated for electromagnetic compatibility and safety in accordance with IEC 60601-1-2:2007 and confirmed to be compliant. The results demonstrate that the Compass Cast and MAP, when transported, stored, installed, operated in normal use, and maintained according to the instructions of the manufacturer, cause no safety hazard which could reasonably be foreseen and which is not connected with its intended application, in normal condition and in single fault condition. Refer to Table 2 for applicable test references. {7}------------------------------------------------ | | | TABLE 2: Test References | |--|--|--------------------------| |--|--|--------------------------| | Standard | Results | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | IEC 60601-1-2:2007 Third Edition, Medical electrical equipment –<br>Part 1-2: General requirements for basic safety and essential<br>performance - collateral standard: Electromagnetic compatibility –<br>Requirements and tests | In Compliance | | Safety Code 6; HC Pub: 091029; KDB447498 | In Compliance | | Federal Register CFR 47, Part 15, subpart B:2007 Radiated<br>Emissions, Part 15.109(b), Class A | In Compliance | | RSS-247 - Digital Transmission systems (DTSs), Frequency Hopping<br>Systems (FHSs) and Licence-Exempt Local Area Network (LE-LAN)<br>Devices; RSS-Gen, General Requirement and Information for the<br>Certification of Radio Apparatus | In Compliance | | ANSI/AAMI/ISO 11135: 2014 Sterilization of health-care products –<br>Ethylene oxide-Requirements for the development, validation and<br>routine control of a sterilization process for medical devices | In Compliance | | ANSI/AAMI/ISO 10993-7:2008(R)2012, Biological Evaluation of<br>Medical Devices - Part 7, Ethylene Oxide Residuals | In Compliance | | General Principles of Software Validation; Final guidance for<br>Industry and FDA Staff (January 2002) | In Compliance | | AAMI ANSI BP22:1994 (R) 2011 Blood Pressure Transducers | In Compliance | | AAMI ANSI ST72:2011 Bacterial endotoxins – Test methods, routine<br>monitoring, and alternatives to batch testing | In Compliance | Standards Data Reports for 510(k) (FORM 3654) are attached for the applicable standards referenced above.