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.

Device Description

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 OptoWire III consists of the following items:

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

AI/ML Overview

The provided text describes a 510(k) premarket notification for the OptoWire III. This document focuses on demonstrating substantial equivalence to a predicate device (OptoWire Deux) rather than proving the device meets acceptance criteria from a clinical study with specific performance metrics like sensitivity, specificity, or accuracy compared to a ground truth.

Therefore, much of the requested information regarding acceptance criteria for a diagnostic study, sample sizes for training/test sets, expert qualifications, and adjudication methods is not present in this regulatory submission. The document emphasizes engineering and bench testing to demonstrate that changes made to the OptoWire III do not raise new questions of safety or effectiveness compared to its predicate.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of specific acceptance criteria (e.g., target sensitivity, specificity) with corresponding reported device performance for a diagnostic task. Instead, it compares the technological characteristics and performance of the proposed device (OptoWire III) to its predicate device (OptoWire Deux) to demonstrate substantial equivalence.

The "Performance Data" section describes various design verification tests, biocompatibility tests, and animal studies to ensure the OptoWire III functions as intended and is safe. Key performance aspects like Pressure Accuracy and Thermal Zero Shift for the pressure sensor are explicitly stated and are identical to the predicate:

Acceptance Criteria (Predicate)	Reported Device Performance (Proposed Device)
+/- 1 mmHg plus +/-1% of reading (pressure range -30 to 50 mmHg) or +/- 3% of reading (pressure range 50 to 300 mmHg)	+/- 1 mmHg plus +/-1% of reading (pressure range -30 to 50 mmHg) or +/- 3% of reading (pressure range 50 to 300 mmHg)
<0.3 mmHg/deg C	<0.3 mmHg/deg C
<1mmHg/h	<1mmHg/h

Other performance characteristics evaluated in animal studies were assessed qualitatively against the predicate:

Performance Aspect	Reported Device Performance (OptoWire III vs. OptoWire Deux)
Guidewire atraumaticity	Obtained a 'workhorse' score for most parameters evaluated.
Tip flexibility	Obtained a 'workhorse' score for most parameters evaluated.
Guidewire flexibility	Obtained a 'workhorse' score for most parameters evaluated.
Trackability	Obtained a 'workhorse' score for most parameters evaluated.
Steerability	Obtained a 'workhorse' score for most parameters evaluated.
Torquability	Obtained a 'workhorse' score for most parameters evaluated.
Pushability	Obtained a 'workhorse' score for most parameters evaluated.
Catheter compatibility	Obtained a 'workhorse' score for most parameters evaluated.
Restriction	Obtained a 'workhorse' score for most parameters evaluated.
Support (deliverability)	Obtained a 'workhorse' score for most parameters evaluated.
Stent compatibility	Obtained a 'workhorse' score for most parameters evaluated.
Radiopacity and pressure waveform	Demonstrated similar performance as the control (OptoWire Deux).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions an animal study for performance testing:

Sample Size for Test Set: 1 female pig (Sus scrofa – Hybrid farm pigs), with one spare animal not used.
Data Provenance: The study was conducted on an animal model, not human data. The specific country of origin is not stated, but the submission is to the U.S. FDA. The study was conducted prospectively as part of the device verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable to this type of submission. Ground truth for diagnostic accuracy (e.g., FFR values from the device vs. a gold standard) is not explicitly established by independent expert review in this context. The animal study focused on functional performance and comparison to a known safe and effective predicate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The animal study described qualitative assessments of guidewire performance characteristics compared to a control device, not a diagnostic decision requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a pressure guidewire, not an AI-powered diagnostic tool for interpretation by human readers. Therefore, no MRMC study or AI assistance improvement analysis was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The OptoWire III is a physical medical device (guidewire with a sensor) that measures pressure. It is not an algorithm, and thus standalone algorithm performance is not relevant. Its functionality is linked to the OptoMonitor System.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the pressure measurement capability, the "ground truth" is typically the physical principles of pressure measurement and calibration against known pressure standards. The document states "Simultaneous acquisition of 2 pressure values: distal pressure from sensor embedded in OptoWire; aortic pressure from external pressure transducer" for FFR determination, implying a comparison against an external reference for aortic pressure, but not a separate "ground truth" derived from expert consensus or pathology in a diagnostic sense. For the animal study, the ground truth was the observable performance of the device in a living system, judged comparatively against the predicate.

8. The sample size for the training set

Not applicable. This is a medical device approval, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

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

{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,

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

{2}------------------------------------------------

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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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}------------------------------------------------

5 510(K) Summary OptoWire III

1. SUBMITTER

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, Requlatory Affairs and Quality System Director

Email: marc.chaunet@opsens.com

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.

{4}------------------------------------------------

The OptoWire III consists of the following items:

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

INDICATIONS FOR USE 5.

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.

{5}------------------------------------------------

	Proposed Device	Predicate Device
Regulatory Information	NameOptoWire III	NameOptoWire Deux
	510(k)#Pending	510(k)#K152991
	PredicatesK152991	PredicatesK142598
	Product CodeDQX, DXO	Product CodeDQX, DXO
	Class2	Class2
	Regulation Number870.1330, 870.2870	Regulation Number870.1330, 870.2870
	Regulation Generic NameWire, guide, catheter; Transducer, pressure, catheter tip	Regulation Generic NameWire, guide, catheter; Transducer, pressure, catheter tip
Intended use	Regulation Intended UseCoiled wire fits inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.Catheter tip transmits mechanical or electrical property changes in relation to changes in blood pressure to accessory equipment for processing.	Regulation Intended UseCoiled wire fits inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.Catheter tip transmits mechanical or electrical property changes in relation to changes in blood pressure to accessory equipment for processing.
	IndicationsTo 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	IndicationsTo 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 bloodpressure and flow including FFR. (whenused with the OptoMonitor system)	Measurement of intravascular bloodpressure and flow including FFR. (whenused with the OptoMonitor system)
	Pressure Sensing & SignalTransmission Technology	Fiberoptic sensor & fiber bundleembedded in guidewire.	Fiberoptic sensor & fiber bundleembedded in guidewire.
	Sterile, Single Use PatientContact 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 bysafety wires
	Guidewire Shaft Coating	Teflon (PTFE)	Teflon (PTFE)
	Guidewire IntermediateSection Coating	PET + Hydrophilic coating	PET + Hydrophilic coating

{6}------------------------------------------------

	Proposed Device	Predicate Device
Guidewire Tip sectionCoating	Uncoated	Uncoated
Guidewire TipConfiguration	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 OpticalConnector	Adhesive	Connector capillary ring + adhesive
FFR Capability	Yes	Yes
Basis for FFRDetermination	Simultaneous acquisition of 2 pressurevalues: distal pressure from sensorembedded in OptoWire; aorticpressure from external pressuretransducer	Simultaneous acquisition of 2 pressurevalues: distal pressure from sensorembedded in OptoWire; aortic pressurefrom external pressure transducer
Pressure Range	-30 to 300 mmHg	-30 to 300 mmHg
Pressure Accuracy	+/- 1 mmHg plus +/-1% of reading(pressure range -30 to 50 mmHg) or+/-3% of reading (pressure range 50 to300 mmHg)	+/- 1 mmHg plus +/-1% of reading(pressure range -30 to 50 mmHg) or +/-3% of reading (pressure range 50 to 300mmHg)
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.

{7}------------------------------------------------

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.

{8}------------------------------------------------

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
1. Trackability
Steerability
. Torquability

Pushability

1. Catheter compatibility
. Restriction
. Support (deliverability)
1. Stent compatibility
1. 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.

{9}------------------------------------------------

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).

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
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.(b)
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.