OptoMonitor II

K161263 · Opsens, Inc. · DXO · Sep 13, 2016 · Cardiovascular

Device Facts

• Record ID: K161263
• Device Name: OptoMonitor II
• Applicant: Opsens, Inc.
• Product Code: DXO · Cardiovascular
• Decision Date: Sep 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2870
• Device Class: Class 2

Intended Use

The OptoMonitor 2 is a system intended for use in all blood vessels, including coronary and peripheral vasculature, to measure intravascular pressure during angiography and/or interventional procedures. Pressure measurements are obtained to provide hemodynamic information, such as FFR, for the diagnosis and treatment of blood vessel diseases. Pressurements are also obtained to provide intra-catheter or intravascular pressure, such as within occlusion perfusion catheter, for the diagnosis and treatment within the vasculature.

Device Story

OptoMonitor II is a pressure monitoring system for use in coronary and peripheral vasculature during angiography/interventional procedures. System inputs include optical pressure signals from fiberoptic sensors (e.g., OptoWire or occlusion perfusion catheters). Device transforms optical signals into pressure readings via an optical unit, display unit, and handle unit. Two operational modes: FFR mode (calculates Pd/Pa and FFR) and Pressure mode (monitors intra-catheter/intravascular pressure). Device automatically detects mode via EEPROM upon connection. Output displayed on LCD for clinician use; provides real-time pressure curves and numerical values (mean aortic/distal pressure). Used in clinical settings by physicians to guide diagnosis and treatment of vascular disease. System includes safety features like auto-zeroing and pressure range limits. Hardware is identical to predicate; software update enables new pressure monitoring modality.

Clinical Evidence

No clinical investigations or animal studies were conducted. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and software verification/validation activities.

Technological Characteristics

System comprises reusable signal processor, display unit, handle unit, and cables. Sensing principle: fiberoptic pressure sensor. Connectivity: optical interface for catheters. Software: embedded, moderate level of concern. Pressure range: -30 to 300 mmHg (FFR/low pressure) and up to 20 atm (high pressure mode). Accuracy: +/- 1 mmHg or 1-3% of reading. Power: standard supply. Sterilization: N/A (non-patient contact device).

Indications for Use

Indicated for patients undergoing angiography or interventional procedures requiring intravascular pressure monitoring in coronary or peripheral vasculature for diagnosis and treatment of blood vessel diseases.

Regulatory Classification

Identification

A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.

Predicate Devices

• OptoMonitor System (K142598)

Reference Devices

• Occlusion Perfusion Catheter (K130525)
• Occlusion Perfusion Catheter (K154554)
• Occlusion Perfusion Catheter (K153488)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 13, 2016

Opsens, Inc. % Chris Henza Regulatory Consultant Ultra Lifescience Solutions Inc 146 N. Greenview Ave Mundelein, Illinois 60060

Re: K161263

Trade/Device Name: OptoMonitor II Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO, DQX Dated: August 9, 2016 Received: August 11, 2016

Dear Chris Henza:

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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mude Yellman
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K161263

Device Name OptoMonitor II

### Indications for Use (Describe)

The OptoMonitor 2 is a system intended for use in all blood vessels, including coronary and peripheral vasculature, to measure intravascular pressure during angiography and/or interventional procedures.

Pressure measurements are obtained to provide hemodynamic information, such as FFR, for the diagnosis and treatment of blood vessel diseases. Pressurements are also obtained to provide intra-catheter or intravascular pressure, such as within occlusion perfusion catheter, for the diagnosis and treatment within the vasculature.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 7 510(k) Summary Document

#### SUBMITTER 7.1

Address: Opsens, Inc.

750, Boulevard du Parc Technologique

Quebec (Quebec) G1P 4S3

Phone: [phone] ext. 3401

Fax Number: 418-781-0024

Contact Person: Vanessa Mootoosamy, Director of Quality Assurance

Email: [e-mail]

Date Prepared: May 2, 2016

#### DEVICE 7.2

Name of Device: OptoMonitor II

Common or Usual Name: Pressure Monitor

Classification name: transducer, pressure, catheter tip (870.2870)

Regulatory Class: II

Product Code: DXO

#### 7.3 PREDICATE DEVICE

OptoMonitor System cleared via K142598 (cleared on 06/12/2015). This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

#### DEVICE DESCRIPTION 7.4

The proposed OptoMonitor II is a new version of the OptoMonitor System that includes software modifications and new labeling to allow for the expanded indications of intravascular pressure monitoring during interventional procedures, such as with the occlusion perfusion catheter, for diagnosis and treatment within the vasculature. This device and its components are considered accessories to catheter pressure transducers and are intended for use with legally marketed catheters.

### Software Description

The OptoMonitor II is intended to measure pressure using specifically devoted optical pressure sensing devices. The OptoMonitor II comprises two modes of operation:

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1) FFR mode using an OptoWire (The FFR mode is exactly the same as the predicate device, there are no changes to FFR mode included in this submission.)

2) Pressure mode using an Optical Pressure Catheter (The Pressure mode is a new modality and the subject of this submission)

The OptoMonitor II automatically switches to the proper operational mode upon connecting the device.

This information is contained within the EEPROM contained in every device that connect to the OptoMonitor II.

Both modes are nearly the same with the following differences:

- The FFR mode includes the calculation and display of Pd/Pa and FFR values.
- The FFR mode includes the equalization of distal pressure against aortic pressure.
- The pressure mode includes atm (atmosphere) as pressure unit.
- . The pressure mode does not allow re-zeroing the distal pressure of more than 50 mmHg when in mmHg, and of more than 300mmHg when in atm unit.
- . The pressure is not output on the distal output interface when unit ATM (instead of mmHg).

### Hardware Description

The proposed OptoMonitor-II includes the Optical Unit (OU), the Display Unit (DU), The Handle Unit (HU) and accessories (cables, power supply, etc). These hardware components are exactly the same as the cleared device hardware (K142598 cleared on 06/12/2015), software and labeling (to indicate updated software) is updated with this submission.

OptoMonitor-II is compatible with the cleared Occlusion Perfusion Catheter(OPC) devices as described in the FDA submissions K130525, K154554 & K153488. The OPC catheters are legally marketed devices that are not altered by Opsens. All sizes of Occlusion Perfusion Catheters are compatible with the OptoMonitor II device since the catheters are all within the specified pressure range and the connectors are compliant to Optomonitor requirements.

The device is a non-sterile, non-patient contact device.

#### INDICATIONS FOR USE 7.5

The OptoMonitor 2 is a system intended for use in all blood vessels, including coronary and peripheral vasculature, to measure intravascular pressure during angiography and/or interventional procedures.

Pressure measurements are obtained to provide hemodynamic information, such as FFR, for the diagnosis and treatment of blood vessel diseases. Pressure measurements are also obtained to provide intra-catheter or intravascular pressure, such as within occlusion catheter, for the diagnosis and treatment within the vasculature.

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# 7.6 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The proposed OptoMonitor II is a new version of the monitoring system that includes software modifications and new labeling where necessary to allow for the expanded indications of intravascular pressure monitoring during interventional procedures, such as with the occlusion catheter, for diagnosis and treatment within the vasculature.

The technological characteristics of the new modality raise a question concerning whether its performance can be expected to be equivalent with the additional catheter as with the predicate catheter. Performance testing has confirmed equivalence. No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities.

The identified questions of safety and efficacy apply to both the new device and the predicate and so the new device does not raise different questions of safety and efficacy. Therefore, the proposed device, OptoMonitor-II, meets substantial equivalence requirements with regards to the legally marketed predicate OptoMonitor System (K142598 cleared on 06/12/2015).

#### 7.7 PERFORMANCE DATA

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.

The Risk Management Report for the OptoMonitor II was used to determine if there would be necessary updates for the additional modality "Pressure Mode" in relation to the safety measures applied in the existing design. Since the Pressure Mode is a software only update, hardware testing was not updated with this release. Validation testing confirms system functionality with the additional software modality.

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.

#### CONCLUSIONS 7.8

The results from these tests mentioned above demonstrate that the technological and performance characteristics of the proposed OptoMonitor II is comparable to the predicate device, support the safety and effectiveness of the device that is the subject of this 510(k), and ensure the subject device can perform in a manner equivalent to the predicate device with the same intended use.

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The results of the verification/validation tests and the risk analysis have demonstrated that the additional modality of "pressure Mode" does not add any new questions of safety and is therefore substantially equivalent to the predicate OptoMonitor System (K142598 cleared on 06/12/2015).

| Substantial Equivalence Table | | | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed Device | Predicate Device (Primary) | |
| Regulatory Information | Name | OptoMonitor-II | OptoMonitor |
| | 510(k)# | Pending | K142598 |
| | Predicates | K142598 | K111395<br>K041134 |
| | Product Code | DXO | DQX, DXO |
| | Class | 2 | 2 |
| | Regulation Number | 870.2870 | 870.1330, 870.2870 |
| | Regulation Generic Name | Transducer, pressure, catheter tip | Wire, guide, catheter; Transducer, pressure, catheter tip |
| 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. |
| | Indications | The OptoMonitor-II is a system intended for use in all blood vessels, including coronary and peripheral vasculature, to measure intravascular pressure during angiography and/or interventional procedures. Pressure measurements are obtained to provide hemodynamic information, such as FFR, for the diagnosis and treatment of blood vessel diseases. Pressure measurements are also obtained to provide intracatheter or intravascular pressure, such as within occlusion perfusion catheter, for the diagnosis and treatment within the vasculature. | 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. |
| | Prescription Use | Rx Only | Rx Only |
| Technological Characteristics | System Components | Reusable signal processor / monitor<br>Embedded software<br>Connecting cables | Sterile, disposable guidewire<br>Reusable signal processor / monitor<br>Embedded software<br>Connecting cables |
| | System Capabilities | Measurement of intravascular blood Pressure including FFR. | Measurement of intravascular blood pressure including FFR. |
| | Pressure Sensing & Signal Transmission Technology | Sensess pressure from Fiberoptic sensor. | Fiberoptic sensor & fiber bundle embedded in guidewire. Monitor Sensess pressure from Fiberoptic sensor. |
| | Operating Temperature (Monitor) | 15°C to 30°C | 15°C to 30°C |
| Substantial Equivalence Table | | Predicate Device<br>(Primary) | |
| Transport Temperature<br>(Monitor) | -25°C to 60°C | -25°C to 60°C | |
| Operating Relative<br>Humidity<br>(Monitor) | 10% to 85% non-condensing | 10% to 85% non-condensing | |
| Storage Temperature<br>(Monitor) | Room Temperature | Room Temperature | |
| Operating Pressure | 70 to 106 kPa | 70 to 106 kPa | |
| Pressure Range | -30 to 300 mmHg FFR and catheter low<br>pressure range.<br>Distal high pressure range between -1<br>(-760 mmHg) atm and 20 atm (152000<br>mmHg) in high pressure mode. | -30 to 300 mmHg | |
| Pressure Accuracy | +/- 1 mmHg plus +/- 1% of reading<br>(pressure range -30 to 50 mmHg) or +/-<br>3% of reading (pressure range 50 to<br>300 mmHg)<br>The high pressure range shall have an<br>accuracy of 4% of reading or 1% of the<br>full scale range whichever is greater. | +/- 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 | |
| Zero Drift | <1 mmHg/h | <1 mmHg/h | |
| Electrical Isolation | Class 2 (double isolation) | Class 2 (double isolation) | |
| User Interface | Touchscreen | Touchscreen | |
| Auto-zeroing | Yes | Yes | |
| Real Time Curves | Aortic instantaneous pressure, aortic<br>mean pressure, distal instantaneous<br>pressure, distal mean pressure | Aortic instantaneous pressure, aortic<br>mean pressure, distal instantaneous<br>pressure, distal mean pressure | |
| Real Time Numerical<br>Values | Mean aortic pressure, mean distal<br>pressure, mean Pd/mean Pa | Mean aortic pressure, mean distal<br>pressure, mean Pd/mean Pa | |
| Recording Values | Instantaneous Pa, Pd and Pd/Pa; mean<br>Pa; mean Pd; mean Pd/mean Pa | Instantaneous Pa, Pd and Pd/Pa; mean<br>Pa; mean Pd; mean Pd/mean Pa | |
| Display Monitor | LCD | LCD | |
| Aortic Input | High Level (100 mmHg/V) | High Level (100 mmHg/V) | |
| Distal pressure output | FFR mode remains unchanged. | Low level 5uV/mmHg | |
| Substantial Equivalence Table | | | |
| | Proposed Device | Predicate Device<br>(Primary) | |
| | Hardware components | Signal Conditioner Unit (SCU), the<br>Display Unit (DU), The Handle Unit (HU) and accessories (cables, power<br>supply, etc) | Signal Conditioner Unit (SCU), the<br>Display Unit (DU), The Handle Unit (HU) and accessories (cables, power supply,<br>etc) |
| | Connected devices | OptoWire<br>fOPC | OptoWire |

#### 7.9 Substantial Equivalence Table

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