Opto Wire and OptoMonitor System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 12, 2015 Opsens. Inc. % Pamela Papineau President Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, Massachusetts 01432 Re: K142598 Trade/Device Name: OptoWire and OptoMonitor System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DXO Dated: May 13, 2015 Received: May 14, 2015 Dear Pamela Papineau: 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. Isting 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 {1}------------------------------------------------ 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 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. 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. A. Mitchell Stein forBram 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) K142598 #### Device Name OptoWire and OptoMonitor System #### Indications for Use (Describe) To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or other any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span style="font-size: 20px;">☑</span> </div> | |----------------------------------------------|------------------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span style="font-size: 20px;">☐</span> </div> | #### 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}------------------------------------------------ # Section 5 – 510(k) Summary ### General Information | Owner's Name: | Opsens, Inc. | |-------------------------|---------------------------------------------------------------------------------------------| | Address: | 2014 rue Cyrille Duquet, #125<br>Quebec, QC G1N 4N6 Canada | | Telephone: | 418-682-9996 | | Fax Number: | 418-682-9939 | | Contact Person: | Pamela Papineau, RAC (US, EU, CAN)<br>Delphi Medical Device Consulting, Inc. | | Address: | 5 Whitcomb Avenue<br>Ayer, MA 01432 | | Telephone Number: | (978) 772-3552 | | Fax Number: | (978) 796-5460 | | Subject Device: | | | Trade Name: | OptoWire and OptoMonitor System | | Common Name: | Intravascular Pressure Monitoring System | | Product Code: | DXQ / DXO | | FDA Regulation: | 21 CFR 870.1330 - Catheter Guide Wire<br>21 CFR 870.2870 – Catheter Tip Pressure Transducer | | Device Classification: | Class II | | Predicate Devices: | | | Product Name: | PrimeWire Prestige Plus Pressure Guide Wire (Volcano Corp.) | | Common Name: | Pressure Guide Wire | | Product Code: | DQX | | FDA Regulation: | 21 CFR 870.1330 – Catheter Guide Wire | | Device Classification: | Class II | | Premarket Notification: | K111395 | | Product Name: | ComboMap Pressure and Flow System (Volcano Corp.) | ComboMap Pressure and Flow System (Volcano Corp.) Intravascular Pressure Monitoring System OBJ 21 CFR 870.1200 – Diagnostic Intravascular Catheter Class II K041134 ## Indications for Use: Premarket Notification: Common Name: FDA Regulation: Device Classification: Product Code: To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or other any interventional procedures. Blood pressure {4}------------------------------------------------ measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease. ## Device Description: The OptoWire and OptoMonitor System includes a pressure sensing guidewire (OptoWire), electronic signal processing and display units (OptoMonitor) that process signals received from the OptoWire to display intravascular blood pressure and fractional flow reserve (FFR) values, and various connection cables. The OptoWire and OptoWire cable are sterile, single-use devices; the remaining system components are reusable. ## Substantial Equivalence: The OptoWire and OptoMonitor System is substantially equivalent to the Volcano Corp. PrimeWire Prestige Plus Pressure Sensing Guidewire (K111395) and the Volcano Corp. ComboMap Pressure and Flow System (K041134). Substantial equivalence is based on indications for use, technological characteristics, device materials, performance characteristics; physical and functional test results, and conformity with standards. A substantial equivalence summary table is provided at the end of this 510(k) Summary. ## Biocompatibility Testing: Testing has been performed on the OptoWire device in accordance with the ISO 10993 family of standards to confirm that all patient-contacting materials are biocompatible. This testing included cytotoxicity, intracutaneous toxicity, acute systemic toxicity, sensitization, hemocompatibility and pyrogenicity. #### Sterilization, Packaging and Shelf Llife: The OptoWire is sterilized to a 106 SAL using an ethylene oxide process that has been validated in accordance with ISO 11135-1. The remaining system components are non-sterile. Testing has been performed to confirm that all packaging (sterile barrier and outer packaging) meets predetermined acceptance criteria with respect to sterile package seal strength and seal integrity, and that the packaging adequately protects all system components throughout transportation and storage. The sterile product shelf life has been validated through package and product testing of unaged devices as well as devices that have been held at an elevated temperature to simulate the labelled shelf life. Samples will also be tested after real time aging. #### Software: The OptoMonitor contains software that has been developed, documented and validated in accordance with industry standards (IEC 62304 - Medical device software - Software life cycle processes) and FDA guidance (General Principles of Software Validation; Final Guidance for FDA and Industry). Complete software design, risk and validation documents have been provided in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Software validation has demonstrated that the system software operates in accordance with design specifications and the system operates as intended when used for its intended use. {5}------------------------------------------------ # Electrical Safety and EMC Testing: The OptoMonitor has been tested in accordance with IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) to demonstrate electrical safety; testing in accordance with IEC 60601-1-2 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests) has confirmed electromagnetic compatibility. # Performance Testing - Bench: Bench testing has been performed to confirm that the OptoWire and OptoMonitor System meets predetermined acceptance criteria and is substantially equivalent to the predicate devices. The following is a summary of the performance (bench) testing presented in this 510(k): | Component | Testing | Purpose | Met Acceptance<br>Criteria? | | |------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | | OptoWire | | | | | Mechanical /<br>Functional<br>Verification | • Tip Testing<br>• Wire<br>Flexibility/Support<br>• Tensile Test<br>• Torque Tests<br>• Turn to Failure<br>• Fatigue Test<br>• Coating Testing<br>• Compatibility Test<br>• Surface Inspection<br>• Corrosion Test<br>• Dimensional testing | • Sensor Sensitivity to<br>Bending<br>• Pressure and Sensor<br>Testing<br>• Optical Contrast<br>• Optical Sensor Testing<br>• Ambient Pressure<br>Range<br>• Signal Loss<br>• Connection/<br>Disconnection Testing<br>• Age testing | • Functionality<br>and<br>Performance<br>• Safety<br>• Usability | Yes. All internal<br>design criteria were<br>successfully met.<br>Subject device<br>compared favorably<br>to predicate devices<br>tested. | | OptoMonitor | | | | | | • SCU<br>Hardware<br>• DU<br>Hardware<br>• HCU<br>Hardware<br>• System | • visual & design<br>• specs & environment<br>• single fault conditions<br>• electrical performance | • Age Testing<br>• Transportation Testing<br>• Cleaning | • Functionality<br>and<br>Performance<br>• Reliability<br>• Safety<br>• Usability<br>• Environmental | Yes. All internal<br>design criteria were<br>successfully met. | ## Performance Testing - Animal: Animal studies have been performed to characterize the in-vivo performance of the OptoWire and OptoMonitor System, as compared to the predicate device and other currently marketed devices with the same indications for use. Animal testing included assessment of the system handling characteristics, compatibility with other devices, and pressure measurement capabilities. ## Conclusion: The OptoWire and OptoMonitor System has been demonstrated to be substantially equivalent to the predicate devices. {6}------------------------------------------------ | | OptoWire and OptoMonitor System<br>(current submission; Opsens, Inc.) | PrimeWire Prestige Plus<br>Pressure Guide Wire<br>(K111395; Volcano Corp.) | ComboMap Pressure and Flow System<br>(K041134; Volcano Corp.) | |------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Common/Usual Name | Intravascular Pressure Guide Wire<br>and Monitoring System | Intravascular Pressure Guide Wire | Intravascular Pressure Monitoring System | | Device Class | Class II | Class II | Class II | | Product Code / Regulation | DQX / 21 CFR 870.1330<br>DXO / 21 CFR 870.2870 | DQX / 21 CFR 870.1330 | OBJ / 21 CFR 870.2870 | | Regulation Name | Pressure Guide Wire<br>Diagnostic Intravascular Monitor | Pressure Guide Wire | Diagnostic Intravascular Monitor | | Indications for Use | To measure pressure in blood vessels,<br>including both coronary and peripheral<br>vessels, during diagnostic angiography<br>and/or any interventional procedures.<br>Blood pressure measurements provide<br>hemodynamic information, such as<br>fractional flow reserve, for the diagnosis<br>and treatment of blood vessel disease. | To measure pressure in blood vessels,<br>including both coronary and peripheral<br>vessels, during diagnostic angiography<br>and/or any interventional procedures.<br>Blood pressure measurements provide<br>hemodynamic information for the diagnosis<br>and treatment of blood vessel disease.<br>Intended for use with signal processing<br>system such as Volcano ComboMap. | A multi-mode system intended for use in<br>all blood vessels, including coronary and<br>peripheral arteries, to measure<br>intravascular blood pressure and/or blood<br>flow velocities during diagnostic<br>angiography and/or interventional<br>procedures.<br>Intended for use with pressure sensing<br>guidewire such as Volcano PrimeWire. | | System Components | Sterile, disposable guidewire<br>Reusable signal processor / monitor<br>Embedded software<br>Connecting cables | Sterile, disposable guidewire | Reusable signal processor / monitor<br>Embedded software<br>Connecting cables | | System Capabilities | Measurement of intravascular blood<br>pressure including FFR. | Measurement of intravascular blood<br>pressure and flow including FFR<br>(when used with pressure/flow system) | Measurement of intravascular blood<br>pressure and flow including FFR<br>(when used with pressure wire) | | Prescription Use | Rx Only | Rx Only | Rx Only | | Pressure Sensing & Signal<br>Transmission Technology | Fiberoptic sensor & fiber bundle embedded<br>in guidewire | Hard wired strain gauge embedded in<br>guidewire | Hard wired strain gauge embedded in<br>compatible guidewire | | | OptoWire and OptoMonitor System<br>(current submission; Opsens, Inc.) | PrimeWire Prestige Plus<br>Pressure Guide Wire<br>(K111395; Volcano Corp.) | ComboMap Pressure and Flow System<br>(K041134; Volcano Corp.) | | Sterile, Single Use Patient<br>Contact Component? | Yes – OptoWire | Yes – PrimeWire Prestige Plus | No – computer-controlled pressure and<br>flow monitoring instrument intended for<br>use with compatible pressure guidewire | | FFR Capability? | Yes | Yes | Yes | | FFR Viewing? | Yes | N/A | Yes | | Basis for FFR Determination | Simultaneous acquisition of 2 pressure<br>values: distal pressure from sensor<br>embedded in OptoWire; aortic pressure<br>from external pressure transducer | Simultaneous acquisition of 2 pressure<br>values: distal pressure from sensor<br>embedded in PrimeWire; aortic pressure<br>from external pressure transducer | Simultaneous acquisition of 2 pressure<br>values: distal pressure from sensor<br>embedded in compatible guidewire; aortic<br>pressure from external pressure transducer | | Operating Temperature<br>(Monitor) | 15°C to 30°C | N/A | 16°C to 32°C | | Transport Temperature<br>(Monitor) | -25°C to 60°C | N/A | -20°C to 60°C | | Operating Relative Humidity<br>(Monitor) | 10% to 85% non-condensing | N/A | 30% to 75% | | Storage Temperature<br>(Monitor) | Room Temperature | N/A | -20°C to 60°C | | Operating Pressure | 70 to 106 kPa | N/A | 50 to 106 kPa | | Pressure Range | -30 to 300 mmHg | -30 to 300 mmHg | -30 to 300 mmHg | | Pressure Accuracy | +/- 1 mmHg plus +/- 1% of reading<br>(pressure range -30 to 50 mmHg) or +/- 3%<br>of reading (pressure range 50 to 300<br>mmHg) | Unknown | +/- 1 mmHg plus +/- 1% of reading<br>(pressure range -30 to 50 mmHg) or +/-<br>3% of reading (pressure range 50 to 300<br>mmHg) | | Thermal Zero Shift | <0.3 mmHg/deg C | <0.3 mmHg/deg C | N/A | | Zero Drift | <1 mmHg/h | Unknown | N/A | | Electrical Isolation | Class 2 (double isolation) | N/A | Class 1 | | User Interface | Touchscreen | N/A | Touchscreen, Remote Control | | Auto-zeroing | Yes | N/A | Yes | | | OptoWire and OptoMonitor System<br>(current submission; Opsens, Inc.) | PrimeWire Prestige Plus<br>Pressure Guide Wire<br>(K111395; Volcano Corp.) | ComboMap Pressure and Flow System<br>(K041134; Volcano Corp.) | | Real Time Curves | Aortic instantaneous pressure, aortic mean pressure, distal instantaneous pressure,<br>distal mean pressure | N/A | Aortic instantaneous pressure, aortic mean pressure, distal instantaneous pressure,<br>distal mean pressure, Pa/Pd trend curve | | Real Time Numerical Values | Mean aortic pressure, mean distal pressure,<br>mean Pd/mean Pa | N/A | Mean aortic pressure, mean distal pressure,<br>mean Pd/mean Pa, heartbeat | | Minimum Pd/Pa Cursor<br>(Detection of FFR Locus) | Yes | N/A | Yes | | Recording Values | Instantaneous Pa, Pd and Pd/Pa; mean Pa;<br>mean Pd; mean Pd/mean Pa | N/A | Instantaneous Pa, Pd and Pd/Pa; mean Pa;<br>mean Pd; mean Pd/mean Pa | | Display Monitor | LCD | N/A | LCD | | Aortic Input | High Level (100 mmHg/V) | N/A | High Level (100 mmHg/V)<br>Low Level (5uV/V/mmHg) | | Aortic Output | No | N/A | Low Level (5uV/V/mmHg) | | Distal Input | OptoWire (optical) | N/A | Compatible pressure wire (PrimeWire)<br>(electrical) | | Distal Output | Low Level (5uV/V/mmHg) | N/A | Low Level (5uV/V/mmHg) | | Guidewire OD | 0.014" | 0.014" | N/A | | Guidewire Length | 175 cm | 185 cm, 300 cm | N/A | | Guidewire Shaft Material | Stainless Steel; Nitinol | Stainless Steel; SS | N/A | | Guidewire Coating | Teflon; Silicone | Teflon; GlyDx Hydrophilic coating | N/A | | Guidewire Tip Configuration | Straight | Straight, pre-shaped "J" | N/A | | Guidewire Tip Length | 3.5 cm | 3.0 cm | N/A | | Radiopaque Tip? | Yes | Yes | N/A | | Pressure Sensor Location | 3.5 cm from distal tip | 3.0 cm from distal tip | N/A | # Substantial Equivalence Comparison {7}------------------------------------------------ {8}------------------------------------------------