OptoWire III

K191907 · Opsens, Inc. · DQX · Jan 2, 2020 · Cardiovascular

Device Facts

• Record ID: K191907
• Device Name: OptoWire III
• Applicant: Opsens, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The OptoWire III pressure guidewire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic and/or any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.

Device Story

OptoWire III is a sterile, single-use pressure guidewire used to measure intravascular blood pressure and fractional flow reserve (FFR). It functions as a guidewire to direct catheters through blood vessels while simultaneously acting as a pressure transducer. The device incorporates a fiber-optic sensor and fiber bundle; it connects to the OptoMonitor system (cleared separately) via a Fiber Optic Interface Cable. The OptoMonitor processes optical signals from the wire to display pressure waveforms and FFR values. Used in clinical settings (e.g., cath lab) by physicians, the device provides real-time hemodynamic data to assist in diagnosing and treating blood vessel disease. Compared to the predicate OptoWire Deux, the OptoWire III features design modifications to improve robustness and manufacturability, including a reduced tip length, modified coil gap, and updated tube configuration. The device is intended to provide equivalent clinical performance to the predicate.

Clinical Evidence

No human clinical trials were conducted. Evidence consists of bench testing and an animal study. Bench testing included biocompatibility (ISO 10993-1), sterilization (ISO 11135-1), packaging (ISO 11607-1), and mechanical performance (tip flexibility, tensile strength, torquability, kink resistance). An animal study (porcine model) compared OptoWire III to OptoWire Deux, evaluating guidewire atraumaticity, trackability, steerability, pushability, and pressure waveform quality. The device demonstrated 'workhorse' performance and equivalence to the predicate in all evaluated parameters.

Technological Characteristics

0.014" diameter guidewire; 180 cm length. Materials: Stainless steel, Nitinol, PTFE coating, PET. Sensing: Fiber-optic sensor and fiber bundle. Connectivity: Wired connection to OptoMonitor system. Sterilization: Ethylene Oxide (EtO). Standards: ISO 11135-1, ISO 11607-1, ASTM F1980-07, ISO 10993-1, ISO 11070.

Indications for Use

Indicated for patients undergoing diagnostic angiography or interventional procedures requiring intravascular blood pressure measurement and hemodynamic assessment (e.g., FFR) in coronary or peripheral vessels.

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 Deux (K152991)

Submission Summary (Full Text)

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January 2, 2020

Opsens Inc. % Chris Henza Regulatory Consultant Ultra LifeScience Solutions Inc. 872 S. Milwaukee Ave #286 Libertyville, Illinois 60048

Re: K191907

Trade/Device Name: OptoWire III Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DXO Dated: November 28, 2019 Received: December 3, 2019

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. 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191907

Device Name OptoWire III

Indications for Use (Describe)

The OptoWire III pressure guidewire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic and/or 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) |
|-----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 5 510(K) Summary OptoWire III

#### 1. SUBMITTER

Address: Opsens, Inc.

750, Boulevard du Parc Technologique

Quebec (Quebec) G1P 4S3

Phone: [phone] ext 3408

Fax Number: 418-781-0024

Contact Person: Marc Chaunet, Requlatory Affairs and Quality System Director

Email: [e-mail]

Date Prepared: July 12, 2019

#### 2. DEVICE

Name of Device: OptoWire III

Common or Usual Name: Pressure Guidewire

Classification name: Wire, guide, catheter; Transducer, pressure, catheter tip

Regulatory Class: II

Product Code: DQX, DXO

#### PREDICATE DEVICE 3.

OptoWire Deux cleared via K152991 (cleared on 02/11/2016). This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

#### DEVICE DESCRIPTION 4.

The proposed OptoWire III is a new version of the OptoWire Deux that includes changes to strengthen the robustness of the product. Additional changes have been made to improve manufacturability. Changes include a reduction in tip length and coil gap, changes in the tube inner and outer configuration, and a minor material change in the PTFE coating.

The Opsens OptoWire III is used in conjunction with the Opsens OptoMonitor and Accessories, the "OptoMonitor System" consisting of an electronic signal processing and display units (OptoMonitor) that process signals received from the OptoWire to display intravascular blood pressure and hemodynamic information, such as fractional flow reserve (FFR) values, and various connection cables. The OptoMonitor is cleared in a separate 510(k), K142598.

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The OptoWire III consists of the following items:

- 1. OptoWire assembly (quidewire) including the pressure sensor sub-assembly
- 2. Fiber Optic Interface Cable (FOIC)
- Packaging including tray, Torque Device, pouch and box 3.
- 4. Labelling including labels and printed IFU

#### INDICATIONS FOR USE 5.

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 OptoWire III is substantially equivalent to the OptoWire Deux pressure quidewire cleared in K152991 on Feb 11, 2016.

The proposed OptoWire III is a new version of the pressure quidewire that includes design changes from OptoWire Deux to OptoWire III (also referred to as OptoWire San (OW San)) is to strengthen the robustness of the wire. Additional changes were simultaneously implemented to optimize the manufacturing process. The proposed device and the predicate device are considered catheter quide wires and pressure transducer tips which are coded as DQX & DXO.

Indications for Use for the OptoWire III are exactly the same as the predicate device indications (K152991 on Feb 11, 2016).

The technological characteristics of the proposed OptoWire III include a reduction in tip length and coil gap, changes in the tube inner and outer configuration, and a minor material change in the PTFE coating. 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, OptoWire III, meets substantial equivalence requirements with regards to the leqally marketed predicate OptoWire Deux (K152991 cleared on Feb 11, 2016).

For detailed comparison, refer to the Substantial Equivalence table on the following pages.

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| | Proposed Device | Predicate Device |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Information | Name<br>OptoWire III | Name<br>OptoWire Deux |
| | 510(k)#<br>Pending | 510(k)#<br>K152991 |
| | Predicates<br>K152991 | Predicates<br>K142598 |
| | Product Code<br>DQX, DXO | Product Code<br>DQX, DXO |
| | Class<br>2 | Class<br>2 |
| | Regulation Number<br>870.1330, 870.2870 | Regulation Number<br>870.1330, 870.2870 |
| | Regulation Generic Name<br>Wire, guide, catheter; Transducer, pressure, catheter tip | Regulation Generic Name<br>Wire, guide, catheter; Transducer, pressure, catheter tip |
| Intended use | Regulation Intended Use<br>Coiled wire fits inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.<br>Catheter tip transmits mechanical or electrical property changes in relation to changes in blood pressure to accessory equipment for processing. | Regulation Intended Use<br>Coiled wire fits inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.<br>Catheter tip transmits mechanical or electrical property changes in relation to changes in blood pressure to accessory equipment for processing. |
| | Indications<br>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 | Indications<br>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 |

| | | Proposed Device | Predicate Device |
|-------------------------------|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics | Prescription Use | Rx Only | Rx Only |
| | System Components | Sterile, disposable guidewire | Sterile, disposable guidewire |
| | System Capabilities | Measurement of intravascular blood<br>pressure and flow including FFR. (when<br>used with the OptoMonitor system) | Measurement of intravascular blood<br>pressure and flow including FFR. (when<br>used with the OptoMonitor system) |
| | Pressure Sensing & Signal<br>Transmission Technology | Fiberoptic sensor & fiber bundle<br>embedded in guidewire. | Fiberoptic sensor & fiber bundle<br>embedded in guidewire. |
| | Sterile, Single Use Patient<br>Contact Component? | Yes | Yes |
| | Guidewire OD | 0.014" | 0.014" |
| | Guidewire Length | 180 cm | 175 cm |
| | Guidewire Shaft Material | Stainless Steel, Nitinol | Nitinol |
| | Guidewire Shaft Design | Two tubes joined by a laser butt weld | Continuous outer tube supported by<br>safety wires |
| | Guidewire Shaft Coating | Teflon (PTFE) | Teflon (PTFE) |
| | Guidewire Intermediate<br>Section Coating | PET + Hydrophilic coating | PET + Hydrophilic coating |

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| | Proposed Device | Predicate Device |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Guidewire Tip section<br>Coating | Uncoated | Uncoated |
| Guidewire Tip<br>Configuration | Straight | Straight |
| Guidewire Tip Design | Coiled | Coiled |
| Guidewire Tip Length | 3.0 cm | 3.5 cm |
| Radiopaque Tip? | Yes | Yes |
| Pressure Sensor Location | 3.0 cm from distal tip | 3.5 cm from distal tip |
| Pressure Sensor Bonding | Stainless steel 304 ring, laser welded | Glass ring + adhesive |
| OptoWire Optical<br>Connector | Adhesive | Connector capillary ring + adhesive |
| FFR Capability | Yes | Yes |
| Basis for FFR<br>Determination | Simultaneous acquisition of 2 pressure<br>values: distal pressure from sensor<br>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 to<br>300 mmHg) | +/- 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 | <1mmHg/h | <1mmHg/h |

#### PERFORMANCE DATA 7.

# Risk Based Approach

The Risk Management Report was prepared to document the evaluations and decisions made as well as necessary safety measures in the design and the manufacturing of the OptoWire III. Many of the risks are mitigated by design, labels, sterilization, packaging, and shelf life, and biocompatibility.

Since the OptoWire III is the third generation of the OptoWire device, the risk management process has leveraged the activities of previous generation OptoWire Deux device risk management process activities. The risk Management Report addresses the differences between the predicate/proposed device and specifically consider the impact of these changes including their intent as an improvement.

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The risks related to all applicable hazards which were identified for the OptoWire III have been reduced to the acceptable level by mitiqation. The OptoWire III is shown to be at least as safe and effective as the predicate device and the inherent risks are believed to be overcome by the benefits of the device use as indicated. Therefore, all residual risks post-mitigation have been deemed acceptable for this design.

## Sterilization, Packaging, Shelf life Testing:

The following standards are utilized to show equivalence of Sterilization, Packaging, and Shelf life:

- . ISO 11135-1 (2014) Sterilization of health-care products - ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices. (Sterility)
- . ISO 11607-1 Packaging for terminally sterilized medical devices - part 1: requirements for materials, sterile barrier systems and packaging systems [including: amendment 1 (2014)]. (Sterility)
- . ASTM F1980-07 (Reapproved 2011), standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)

### Biocompatibility testing:

The biocompatibility evaluation was conducted in accordance with the FDA quidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (Attachment A) published June 16, 2016. This device is cateqorized in ISO 10993-1:2018 as "External communicating device – circulating blood" per section 5.2.3 c). The device will have limited exposure, a cumulative sum of single, multiple or repeated duration of contact up to 24 h. Testing completed on this device includes:

- Cytotoxicity
- Sensitization
- . Intracutaneous reactivity
- . Systemic toxicity (acute)
- . Hemocompatibility
- . Pyrogenicity (rabbit test)
- . SC5b-9 complement
- . Partial Tromboplastin Time

### Design Verification Pre-Conditioning:

The OptoWire III devices were exposed to EtO and Simulated Distribution prior to the execution of testing as pre-conditioning. Additionally, testing with the indicator "T1" was completed on devices subjected to accelerated aging the equivalent of 1 year ("TO" = no aqing).

### Design Verification:

Testing was conducted based on requirements of the latest FDA quidance document on quidewires: FDA Draft Guidance Coronary, Peripheral, and Neurovascular Guidewire, dated June 15, 2018. All Design Requirements were verified for the OptoWire III.

Design Specification Verification and ISO 11070 Compliance were completed by documentation check and therefore did not use any OptoWire III product.

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The Fiber Optic Interface Cable and Sensor are tested at a component level as some verification items are difficult or not possible to assess once the components are built into the OptoWire III.

The Design Check and Functional testing are performed on finished devices with pre-conditioning. Since the design check consists of physical measurements and inspections, the test is only completed on unaged products. The Functional testing is completed on both unaged (TO) and aged (T1) products.

Mechanical Performance testing are performed on finished devices with pre-conditioning as specified in the protocols. Certain tests that relate to improvements from the OptoWire Deux also include a comparison to the predicate device (without any pre-conditioning). These tests include: Mechanical tests for Tip Flexibility, Tensile Strength, Torquability, Catheter Compatibility, Kink Resistance test, Bending test, Coating Pushability. The Mechanical testing is completed on both unaged (T0) and aged (T1) products.

No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities.

### Animal studies:

Animal performance testing was completed to validate device functionality. The animal model was a porcine model (Sus scrofa – Hybrid farm pigs). A non-atherosclerotic swine model was chosen because the model has been used extensively for angiographic/pressure studies, resulting in a large volume of data on its vascular response and correlation to humans. The study included 1 female pig and one spare animal that was not used.

The performance of the Optwire III was compared to the Optowire Deux in the LCx, LAD and LAD side branches. The evaluation consisted of tests to confirm compatibility with coronary arteries by examining the following criteria:

- 1. Guidewire atraumaticity
- . Tip flexibility
- Guidewire flexibility
- 2. Trackability
- Steerability
- . Torquability

### Pushability

- 3. Catheter compatibility
- . Restriction
- . Support (deliverability)
- 4. Stent compatibility
- 5. Radiopacity and pressure waveform

Results were recorded as less than average, average, greater than average, and "workhorse". The OptoWire III obtained a 'workhorse' score for most of the parameters evaluated and demonstrated a similar performance as the control, OptoWire Deux, for the pressure waveform and radiopactity. It can be concluded based on the results that the OptoWire III is substantially equivalent to the control.

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#### CONCLUSIONS 8.

The results from these tests mentioned above demonstrate that the technological and performance characteristics of the proposed OptoWire III 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.

The results of the verification/validation tests and the risk analysis have demonstrated that the OptoWire III does not raise any new questions of safety and is therefore substantially equivalent to the predicate OptoWire Deux (K152991 on Feb 11, 2016).