OptoWire Deux

K152991 · Opsens · DQX · Feb 11, 2016 · Cardiovascular

Device Facts

• Record ID: K152991
• Device Name: OptoWire Deux
• Applicant: Opsens
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 11, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or other any interventional procedures. Blood pressurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.

Device Story

OptoWire Deux is a steerable, hybrid Nitinol/Stainless Steel pressure-sensing guidewire (0.014" diameter, 175 cm length). It features an optical pressure sensor located 3.5 cm proximal to the radio-opaque tip. Used in conjunction with the Opsens OptoMonitor system, the device measures intravascular blood pressure. The guidewire transmits pressure signals via an embedded fiber optic bundle to the monitor. Clinicians use the resulting hemodynamic data, including fractional flow reserve (FFR), to diagnose and treat blood vessel disease during angiography or interventional procedures. The device is supplied sterile, single-use, and pre-connected to a unique cable and torque device. It is operated by physicians in clinical settings.

Clinical Evidence

Bench testing only. Performance data included surface inspection, turn-to-failure, catheter compatibility, fatigue, torque strength, torquability, flexibility, pushability, tip load, coating durability, tensile strength, particulate testing (USP 788), and pressure accuracy. Biocompatibility testing was performed per ISO 10993-1:2009, including cytotoxicity, systemic toxicity, sensitization, hemocompatibility, intracutaneous toxicity, and pyrogenicity. All tests met acceptance criteria.

Technological Characteristics

Hybrid Nitinol/Stainless Steel guidewire; 0.014" OD; 175 cm length. Sensing: Fiber optic sensor with fiber bundle transmission. Coatings: PTFE (shaft), PET+ hydrophilic (intermediate). Sterilization: 100% ethylene oxide (EN ISO 11135-1:2007). Connectivity: Proprietary cable connection to OptoMonitor system. Pressure range: -30 to 300 mmHg. Accuracy: +/- 1 mmHg (+/- 1% of reading for -30 to 50 mmHg; +/- 3% for 50 to 300 mmHg).

Indications for Use

Indicated for patients undergoing diagnostic angiography or interventional procedures requiring blood pressure measurement in coronary or peripheral vessels to obtain hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• OptoWire and OptoMonitor System (K142598)

Submission Summary (Full Text)

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Public Health Service

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

February 11, 2016

Opsens Vanessa Mootoosamy Director Of Quality Assurance 2014, Cyrille Duquet Street, #125 Quebec, G1N 4N6 CA

Re: K152991

Trade/Device Name: OptoWire Deux pressure guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DXO Dated: January 7, 2016 Received: January 12, 2016

Dear Vanessa Mootoosamy:

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 (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 [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.

Mitchell Stein

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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |

## Indications for Use

510(k) Number (if known)

K152991

Device Name

OptoWire Deux pressure guidewire

### 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 pressurements 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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| Section 005 | 510(k) Summary | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General<br>Information: | Owner's Name:<br>Address: | Opsens, Inc.<br>2014 rue Cyrille Duquet, #125<br>Québec, QC G1N 4N6 Canada |
| | Contact Person:<br>Address:<br>Telephone:<br>Fax Number: | Vanessa Mootoosamy<br>Opsens Inc. Director, Quality Assurance<br>014 rue Cyrille Duquet, #125<br>Québec, QC G1N 4N6 Canada<br>418-682-9996 ext. 239<br>418-682-9939 |
| Subject Device: | Trade Name:<br>Common Name:<br>Product Code:<br>FDA Regulation:<br>Device Classification: | OptoWire Deux pressure guidewire<br>Catheter pressure guide wire<br>DQX / DXO<br>21 CFR 870.1330-Catheter Guide Wire<br>21 CFR 870.2870-Catheter Tip Pressure<br>Transducer<br>Class II |
| Predicate Device: | Trade Name:<br>Common Name:<br>Product Code:<br>FDA Regulation:<br>Device Classification:<br>Premarket Notification: | OptoWire and OptoMonitor System<br>Intravascular Pressure Monitoring System<br>DQX / DXO<br>21 CFR 870.1330 - Catheter Guide Wire<br>21 CFR 870.2870 - Catheter Tip Pressure<br>Transducer<br>Class II<br>K142598 |
| Indications for Use: | To measure pressure in blood vessels including both coronary and peripheral<br>vessels, during diagnostic angiography and/or other any interventional<br>procedures. Blood pressure measurements provide hemodynamic information,<br>such as fractional flow reserve, for the diagnosis and treatment of blood vessel<br>disease. | |
| Description of<br>device: | The OptoWire Deux is a hybrid Nitinol/Stainless Steel pressure sensing guidewire<br>that is a steerable guidewire with an optical pressure sensor mounted proximal to<br>the 3.5 cm long radio opaque tip. The OptoWire Deux is for use in combination<br>with Opsens' OptoMonitor system for blood pressure measurement. The<br>OptoWire Deux has a diameter of 0.014" (0.36 mm) and an effective length of<br>175 cm. The OptoWire Deux is supplied preconnected to the OptoWire cable<br>along with a torque device. The OptoWire cable is unique to each OptoWire and<br>it must be used conjunctionally with the OptoWire supplied in the same tray.<br>OptoWire Deux is supplied sterile, non-pyrogenic and is intended for single use<br>only. The changes described in this special 510k device modification only affect<br>the OptoWire. There are no change to the OptoMonitor device included in the | cleared systems K142598. |

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Page 2 of 5 There have been no change to the indications for use, warnings contraindications Labeling: or precautions in comparison to the device cleared in K142598. The mode of operation remain the same. A minor change related to schematic in device labeling was performed to identify and describe the new device design feature. Substantial The OptoWire Deux is substantially equivalent to the OptoWire One included in the OptoWire & OptoMonitor system (K142598).The OptoWire Deux pressure Equivalence: guide wire has the same technological characteristics and the same similarities to the predicate. A substantial equivalence summary table is provided at the end of this 510(k) Summary. The OptoWire Deux: ● have the same indication for use, ● use the same operating principle, ● incorporate the same basic design, are packaged and sterilized using the same materials and processes. ● Statement on These changes do not in any way alter the device indications for use, or the fundamental scientific technology upon which the device is based. Fundamental technology: Biocompatibility The OptoWire Deux new design has been tested in accordance with ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) to determine which tests are necessary to demonstrate biocompatibility of the patient-contacting materials present in the finished device. The OptoWire is characterized as an external communicating, direct-contact (circulating blood) device with limited (< 24 hours) patient contact. The following biocompatibility tests are recommended for such devices: ● Cytotoxicity ● Systemic Toxicity ● Sensitization Hemocompatibility ● Intracutaneous Toxicity Pyrogenicity ● ● Each of these tests were performed on finished, sterilized OptoWire Deux samples; the results of this testing are summarized in this special 510(k). All testing was performed in accordance with Good Laboratory Practices. The sample devices met the acceptance criteria. Performance Data The OptoWire Deux new design was subjected to the following test methods (bench test) to demonstrate that these devices comply with the performance data from the predicate device: Surface Inspection Turn-to-failure ● ● ● Catheter Compatibility Fatigue ● ● Torque Strength Torquability ● ● Flexibility (Support) ● Coating Pushability ● Tip Load ● Coating Durability Tip Flexibility Coating Damage ● ● Tensile Strength Particulates (USP788) . . Pressure accuracy

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October 7, 2015

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The OptoWire Deux, OptoWire Cable and Torque Device are sterile, single-use Sterilization, Packaging & devices provided in a unit package consisting of a protective guidewire hoop. Shelf Life thermoformed tray and lid, which are sealed in a medical-grade Tyvek - polyester pouch. Each pouch is placed in a shelf box. The devices are sterilized in this configuration using a 100% ethylene oxide sterilization process that has been successfully validated in accordance with EN ISO 11135-1:2007 (Sterilization of healthcare products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices). The device sterility assurance level (SAL) is 10-6. The device will be labeled as nonpyrogenic. There have been no changes in the packaging or sterilization method. The OptoWire Deux was validated by way of a Product Adoption, where sterility was verified at fractional, bioburden and EO residual tests were also performed. The OptoWire Deux has a shelf life of 1 year and 3 years shelf life testing is currently on-going. Conclusion The results from these tests mentioned above: demonstrate that the technological and performance characteristics of the ● subject OptoWire Deux pressure guide wire 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 identical intended use.
The results of the verification/validation tests and the risk analysis have demonstrated that the OptoWire Deux Guidewire is in accordance with product specifications that were previously cleared for the predicate device (OptoWire and OptoMonitor System, cleared in 510(k) K142598).

| Substantial Equivalence Table | | | |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | OptoWire Deux | OptoWire One as part of<br>OptoWire and OptoMonitor System<br>(Predicate Device K142598; Opsens,<br>Inc.) | |
| Device Common<br>Usual Name | Intravascular Pressure Guide Wire | Intravascular Pressure Guide Wire | |
| Device Class | Class II | Class II | |
| Product Code /<br>Regulation | DQX / 21 CFR 870.1330<br>DXO / 21 CFR 870.2870 | DQX / 21 CFR 870.1330<br>DXO / 21 CFR 870.2870 | |
| Regulation Name | Pressure Guide Wire<br>Catheter tip pressure transducer | Pressure Guide Wire<br>Catheter tip pressure transducer | |
| Prescription Use | Rx Only | Rx Only | |
| Indications for Use | The OptoWire Deux pressure<br>guidewire is indicated for use to<br>measure pressure in blood vessels<br>including both coronary and<br>peripheral vessels, during diagnostic<br>angiography and/or any<br>interventional procedures. Blood<br>pressure measurements provide<br>hemodynamic information, such as<br>fractional flow reserve, for the | The OptoWire One pressure guidewire<br>is indicated for use to measure pressure<br>in blood vessels including both<br>coronary and peripheral vessels, during<br>diagnostic angiography and/or any<br>interventional procedures. Blood<br>pressure measurements provide<br>hemodynamic information, such as<br>fractional flow reserve, for the<br>diagnosis and treatment of blood vessel<br>disease. | |
| | diagnosis and treatment of blood<br>vessel disease. | | |
| Device Description | The OptoWire Deux is a hybrid<br>Nitinol/Stainless Steel pressure<br>sensing guidewire that is a steerable<br>guidewire with an optical pressure<br>sensor mounted proximal to the 3.5<br>cm long radio opaque tip. The<br>OptoWire Deux is for use in<br>combination with Opsens'<br>OptoMonitor system for blood<br>pressure measurement. The<br>OptoWire Deux has a diameter of<br>0.014" (0.36 mm) and an effective<br>length of 175 cm. The OptoWire<br>Deux is supplied pre-connected to<br>the OptoWire cable along with a<br>torque device. The OptoWire cable is<br>unique to each OptoWire and it must<br>be used conjunctionally with the<br>OptoWire supplied in the same tray.<br>OptoWire Deux is supplied sterile,<br>non-pyrogenic and is intended for<br>single use only<br>The intermediate section comprises a<br>hydrophilic coating. | The OptoWire One is a hybrid<br>Nitinol/Stainless Steel pressure sensing<br>guidewire that is a steerable guidewire<br>with an optical pressure sensor mounted<br>proximal to the 3.5 cm long radio<br>opaque tip. The OptoWire One is for<br>use in combination with Opsens'<br>OptoMonitor system for blood pressure<br>measurement. The OptoWire One has a<br>diameter of 0.014" (0.36 mm) and an<br>effective length of 175 cm. The<br>OptoWire One is supplied pre-<br>connected to the OptoWire cable along<br> | |
| System Components | Sterile, disposable guidewire | Sterile, disposable guidewire | |
| System Capabilities | Measurement of intravascular blood<br>pressure and flow including FFR<br>(when used with OptoMonitor<br>system) | Measurement of intravascular blood<br>pressure and flow including FFR<br>(when used with OptoMonitor system) | |
| Pressure Sensing &<br>Signal Transmission<br>Technology | Fiber optic sensor & fiber bundle<br>embedded in guidewire | Fiber optic sensor & fiber bundle<br>embedded in guidewire | |
| Sterile, Single Use<br>Patient Contact<br>Component? | Yes | Yes | |
| Guidewire OD | 0.014" | 0.014" | |
| Guidewire Length | 175 cm | 175 cm | |
| Guidewire Shaft<br>Material | Stainless Steel; Nitinol | Stainless Steel; Nitinol | |
| Guidewire shaft<br>section Coating | Teflon (PTFE) | Teflon (PTFE) | |
| Guidewire<br>intermediate section<br>Coating | PET+ Hydrophilic coating | Silicone | |
| Guidewire tip section<br>Coating | Uncoated | Silicone | |
| Guidewire Tip<br>Configuration | Straight | Straight | |
| Guidewire Tip<br>Length | 3.5 cm | 3.5 cm | |
| Pressure Sensor<br>Location | 3.5 cm from distal tip | 3.5 cm from distal tip | |
| FFR Capability? | Yes | Yes | |
| Basis for FFR<br>Determination | Simultaneous acquisition of 2<br>pressure values: distal pressure from<br>sensor embedded in OptoWire; aortic<br>pressure from external pressure<br>transducer | Simultaneous acquisition of 2 pressure<br>values: distal pressure from sensor<br>embedded in OptoWire; aortic pressure<br>from external pressure transducer | |
| Pressure Range | -30 to 300 mmHg | -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<br>to 300 mmHg) | +/- 1 mmHg plus +/- 1% of reading<br>(pressure range -30 to 50 mmHg) or +/- 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 | |

(Statement of equivalence)

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