OptoMonitor 3

{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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 18, 2020 Opsens Inc. Marc Chaunet Director, Regulatory Affairs and Quality System 750 boulevard Du Parc Technologique Quebec, G1P 4S3 Ca Re: K193620 Trade/Device Name: OptoMonitor 3 Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO Dated: May 18, 2020 Received: May 18, 2020 Dear Marc Chaunet: 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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, LT 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) K193620 Device Name OptoMonitor 3 Indications for Use (Describe) To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel desease. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | 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}------------------------------------------------ ### ഗ 510(k) Summary OptoMonitor 3 #### SUBMITTER 1. Address: Opsens, Inc. 750, Boulevard du Parc Technologique Quebec (Quebec) G1P 4S3 Phone: 418.781.0333 ext.: 3408 Fax Number: 418-781-0024 Contact Person: Marc Chaunet, Regulatory Affairs and Quality System Director Email: marc.chaunet@opsens.com Date Prepared: June 17, 2020 #### 2. DEVICE Name of Device: OptoMonitor 3 Common or Usual Name: Pressure Monitor Classification name: Transducer, pressure, catheter tip (870.2870) Regulatory Class: II Product Code: DXO #### PREDICATE DEVICE 3. OptoMonitor System cleared via K192340 (cleared on 12/12/2019). This predicate has not been subject to a design-related recall. No reference devices were used in this submission. #### 4. DEVICE DESCRIPTION The proposed OptoMonitor 3 is a new version of the OptoMonitor System. This device and its components are considered accessories to Opsens OptoWire™ pressure guidewires and are intended for use with legally marketed pressure guidewires. The proposed OptoMonitor 3 includes an Optical Unit (OU), a Display Unit (DU), a Handle Unit (HU) and accessories (cables, power supply, etc). These hardware components and device functionalities are equivalent to that of the previous generation OptoMonitor (K192340 (cleared on 12/12/2019). The device is a non-sterile, non-patient contact device. {4}------------------------------------------------ #### 5. INDICATIONS FOR USE The OptoMonitor 3, in conjunction with the OptoWire™ pressure guidewire, is indicated for use 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. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE 6. DEVICE The proposed OptoMonitor 3 is substantially equivalent to the OptoMonitor cleared via K192340 on 12/12/2019. The proposed OptoMonitor 3 is a new version of the predecessor OptoMonitor. Indications for Use for the OptoMonitor 3 are the same as the predicate device indications K192340 (cleared on 12/12/2019). The technological characteristics of the proposed OptoMonitor 3 are essentially the same as for the OptoMonitor. The main difference between the subject device and its predecessor resides in the following: OPTICAL UNIT - New casing - New CPU and PCBs. A new software was also validated for the OU. Although, algorithms used for . the FFR calculation remained unchanged from the predicate OptoMonitor. - Addition of possibility to receive aortic pressure signal (Pa) from a Cathlab Hemodynamic system - Addition of a low-level signal input (Aortic In) allowing to connect an aortic pressure ● transducer and pass-through to Cathlab Hemodynamic system - Handle unit redesigned and connector split to separate electrical and optical connections - Software modifications to support new hardware - Removal of printer ## DISPLAY UNIT - Use of commercially available all-in-one PC. . - . New software to support additional hardware options - Addition of possibility to connect to hospital DICOM system ● The changes have been evaluated through the Risk Management Process and no new questions of safety and effectiveness were identified. Existing questions of safety and effectiveness are valid for the proposed device. Any change raises a question concerning whether its performance can be expected to be equivalent with the predicate. Performance testing has confirmed equivalence. No new questions of safety and effectiveness were identified during the execution of Verification and Validation activities. Therefore, the proposed device, OptoMonitor 3, meets substantial equivalence requirements with regards to the legally marketed predicate OptoMonitor (K192340 cleared on 12/12/2019). For detailed comparison, refer to the Substantial Equivalence table on the following pages. {5}------------------------------------------------ | Substantial Equivalence Table | | | | | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | | Proposed Device | Predicate Device | Differences | | | Regulatory Information | Name | OptoMonitor 3 | OptoMonitor | N/A | | | 510(k)# | K193620 | K192340 | N/A | | | Predicates | K192340 | K173860<br>K142598<br>K111395<br>K041134 | N/A | | | Product Code | DXO | DXO | Same | | | Class | 2 | 2 | Same | | | Regulation Number | 870.2870 | 870.2870 | Same | | | Regulation Generic Name | Transducer, pressure, catheter tip | Transducer, pressure, catheter tip | Same | | Intended use | Regulation Intended Use | Accessory equipment for processing mechanical or electrical property changes in relation to changes in blood pressure. | Accessory equipment for processing mechanical or electrical property changes in relation to changes in blood pressure. | Same | | | Indications | 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. | 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. | Same | | | Prescription Use | Rx Only | Rx Only | Same | | | System Components | Sterile, disposable guidewire<br>Reusable signal processor / monitor<br>Embedded software<br>Connecting cables | Sterile, disposable guidewire<br>Reusable signal processor / monitor<br>Embedded software<br>Connecting cables | Same | | Technological Characteristics | System Capabilities | Measurement of intravascular blood<br>Pressure including FFR. | Measurement of intravascular blood<br>Pressure including FFR. | Same | | | Pressure Sensing & Signal Transmission Technology | Fiberoptic sensor & fiber bundle embedded in guidewire. Monitor Senses pressure from Fiberoptic sensor. | Fiberoptic sensor & fiber bundle embedded in guidewire. Monitor Senses pressure from Fiberoptic sensor. | Same | | | Operating Temperature (Monitor) | 15°C to 30°C | 15°C to 30°C | Same | | | Transport Temperature (Monitor) | -25°C to 60°C | -25°C to 60°C | Same | | | Operating Relative Humidity (Monitor) | 10% to 85% non-condensing | 10% to 85% non-condensing | Same | | | Storage Temperature (Monitor) | Room Temperature | Room Temperature | Same | | | Proposed Device | Predicate Device | Differences | | | Operating Pressure | 70 to 106 kPa | 70 to 106 kPa | Same | | | Pressure Range | -30 to 300 mmHg | -30 to 300 mmHg | Same | | | Pressure Accuracy | +/- 1 mmHg plus +/- 1% of<br>reading<br>(pressure range -30 to 50<br>mmHg) or +/- 3% of reading<br>(pressure range 50 to 300<br>mmHg) | +/- 1 mmHg plus +/- 1% of<br>reading<br>(pressure range -30 to 50<br>mmHg) or +/- 3% of reading<br>(pressure range 50 to 300<br>mmHg) | Same | | | Thermal Zero Shift | <0.3 mmHg/deg C | <0.3 mmHg/deg C | Same | | | Zero Drift | <1 mmHg/h | <1 mmHg/h | Same | | | Electrical Isolation | Class 2 (double isolation) | Class 2 (double isolation) | Same | | | User Interface | Touchscreen | Touchscreen | Same | | | Auto-zeroing | Yes | Yes | Same | | | Real Time Curves | Aortic instantaneous pressure,<br>aortic mean pressure, distal<br>instantaneous pressure, distal<br>mean pressure | Aortic instantaneous pressure,<br>aortic mean pressure, distal<br>instantaneous pressure, distal<br>mean pressure | Same | | | Real Time Numerical<br>Values | Mean aortic pressure, mean<br>distal pressure, mean Pd/mean<br>Pa; FFR, dPR | Mean aortic pressure, mean<br>distal pressure, mean Pd/mean<br>Pa; FFR, dPR | Same | | | Recording Values | Instantaneous Pa, Pd and<br>Pd/Pa; mean Pa; mean Pd;<br>mean Pd/mean Pa; FFR, dPR | Instantaneous Pa, Pd and<br>Pd/Pa; mean Pa; mean Pd;<br>mean Pd/mean Pa; FFR, dPR | Same | | | Display Monitor | LCD | LCD | Same | | | Aortic Input | Low Level (5μV/V/mmHg) | High Level (100 mmHg/V) | Low level attributed<br>to Aortic input for<br>OpM3 | | | Distal Input | OptoWire (optical) | OptoWire (optical) | Same | | | AUX Input | High Level (100 mmHg/V) | N/A | High level input<br>added to AUX In for<br>OpM3 | | | Distal pressure<br>output | Low Level (5μV/V/mmHg) | Low Level (5μV/V/mmHg) | Same | | | Hardware<br>components | Signal Conditioner Unit (SCU),<br>the Display Unit (DU), The<br>Handle Unit (HU) and<br>accessories (cables, power<br>supply, etc) | Signal Conditioner Unit (SCU),<br>the Display Unit (DU), The<br>Handle Unit (HU) and<br>accessories (cables, power<br>supply, etc) | Same | | | Connected devices | OptoWire™ | OptoWire™ | Same | | K 1 9 3 6 2 0 {6}------------------------------------------------ {7}------------------------------------------------ #### PERFORMANCE DATA 7. The following performance data were provided in support of the substantial equivalence determination. Electrical safety and electromagnetic compatibility (EMC) was assessed with respect to the software change and the system was found to comply with IEC 60601-1, and IEC 60601-1-2 standard for EMC. 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 "moderate" level of concern, could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities. No animal studies or clinical investigations are included with this submission. #### 8. CONCLUSIONS The results from these tests mentioned above demonstrate that the technological and performance characteristics of the proposed OptoMonitor 3 is comparable to the predicate device, support substantial equivalence of the device that is the subject of this 510(k). The results of the verification/validation tests and the risk analysis have demonstrated that the additional features incorporated in the OptoMonitor 3 device do not add any new questions of safety and efficacy and is therefore substantially equivalent to the predicate OptoMonitor System (K192340 cleared on 12/12/2019).