(121 days)
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.
The OptoWire Deux is a hybrid Nitinol/Stainless Steel pressure sensing guidewire that is a steerable guidewire with an optical pressure sensor mounted proximal to the 3.5 cm long radio opaque tip. The OptoWire Deux is for use in combination with Opsens' OptoMonitor system for blood pressure measurement. The OptoWire Deux has a diameter of 0.014" (0.36 mm) and an effective length of 175 cm. The OptoWire Deux is supplied preconnected to the OptoWire cable along with a torque device. The OptoWire cable is unique to each OptoWire and it must be used conjunctionally with the OptoWire supplied in the same tray. OptoWire Deux is supplied sterile, non-pyrogenic and is intended for single use only. The changes described in this special 510k device modification only affect the OptoWire. There are no change to the OptoMonitor device included in the cleared systems K142598.
The Opsens OptoWire Deux pressure guidewire is designed to measure blood pressure in coronary and peripheral vessels during diagnostic angiography and interventional procedures, providing hemodynamic information such as fractional flow reserve (FFR). The device is a hybrid Nitinol/Stainless Steel steerable guidewire with an optical pressure sensor.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (OptoWire One, K142598) through verification and validation tests rather than explicitly stating acceptance criteria and numerical performance for all aspects. However, some key performance specifications are listed and implicitly serve as acceptance criteria for functionality.
| Characteristic | Acceptance Criteria (from predicate device spec) | Reported Device Performance (OptoWire Deux) |
|---|---|---|
| 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 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) |
| Thermal Zero Shift | < 0.3 mmHg/deg C | < 0.3 mmHg/deg C |
| Zero Drift | < 1 mmHg/h | < 1 mmHg/h |
| Biocompatibility | Met acceptance criteria for various tests (see below) | Met acceptance criteria for all tested areas |
| Sterility | Sterility Assurance Level (SAL) of 10^-6 | Verified at fractional, bioburden, and EO residual tests |
| Shelf Life | 1 year (initial validation); 3 years (on-going testing) | 1 year (validated); 3 years (on-going) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific "test set" for a clinical study. Instead, it describes a series of bench tests and biocompatibility tests to demonstrate that the OptoWire Deux complies with the performance data from its predicate device.
- Bench Tests: "Each of these tests were performed on finished, sterilized OptoWire Deux samples." The exact number of samples for each specific bench test (e.g., Turn-to-failure, Fatigue, Torque Strength, etc.) is not specified in the provided text.
- Biocompatibility Tests: "Each of these tests were performed on finished, sterilized OptoWire Deux samples." The exact number of samples is not specified.
- Data Provenance: The device performance data is derived from bench testing and biocompatibility testing conducted by the manufacturer (Opsens, Inc. in Quebec, Canada) to support the substantial equivalence claim. This is a pre-clinical, prospective testing scenario rather than a clinical data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the document describes pre-clinical bench testing and biocompatibility assessments, not a study involving human interpretation or clinical ground truth. The "ground truth" for the engineering and material performance aspects would be defined by established standards, test methodologies, and specification limits, not expert consensus.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. Testing results are compared against predefined technical specifications and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:
This information is not applicable. The OptoWire Deux is a physical medical device (guidewire) used for pressure measurement, not an AI or imaging-based diagnostic tool that would typically involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable as the device is a physical guidewire, not a standalone algorithm.
7. The Type of Ground Truth Used:
For the performance and biocompatibility aspects, the "ground truth" is established by:
- Engineering Specifications: Defined parameters for guidewire dimensions, shaft material properties, coatings, and pressure sensing capabilities (e.g., pressure range, accuracy, thermal zero shift, zero drift).
- Standardized Test Methods: Adherence to recognized national and international standards for medical device testing (e.g., ISO 10993-1:2009 for biocompatibility, and various bench test methods for mechanical performance).
- Predicate Device Performance: The OptoWire One (K142598) serves as the benchmark, with the OptoWire Deux demonstrating comparable performance.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" in the context of this device's pre-market submission, as it is not an AI/machine learning device. The design, materials, and manufacturing processes are developed based on engineering principles and previous device experience.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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)
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| Section 005 | 510(k) Summary | |
|---|---|---|
| GeneralInformation: | Owner's Name:Address: | Opsens, Inc.2014 rue Cyrille Duquet, #125Québec, QC G1N 4N6 Canada |
| Contact Person:Address:Telephone:Fax Number: | Vanessa MootoosamyOpsens Inc. Director, Quality Assurance014 rue Cyrille Duquet, #125Québec, QC G1N 4N6 Canada418-682-9996 ext. 239418-682-9939 | |
| Subject Device: | Trade Name:Common Name:Product Code:FDA Regulation:Device Classification: | OptoWire Deux pressure guidewireCatheter pressure guide wireDQX / DXO21 CFR 870.1330-Catheter Guide Wire21 CFR 870.2870-Catheter Tip PressureTransducerClass II |
| Predicate Device: | Trade Name:Common Name:Product Code:FDA Regulation:Device Classification:Premarket Notification: | OptoWire and OptoMonitor SystemIntravascular Pressure Monitoring SystemDQX / DXO21 CFR 870.1330 - Catheter Guide Wire21 CFR 870.2870 - Catheter Tip PressureTransducerClass IIK142598 |
| Indications for Use: | To measure pressure in blood vessels including both coronary and peripheralvessels, during diagnostic angiography and/or other any interventionalprocedures. Blood pressure measurements provide hemodynamic information,such as fractional flow reserve, for the diagnosis and treatment of blood vesseldisease. | |
| Description ofdevice: | The OptoWire Deux is a hybrid Nitinol/Stainless Steel pressure sensing guidewirethat is a steerable guidewire with an optical pressure sensor mounted proximal tothe 3.5 cm long radio opaque tip. The OptoWire Deux is for use in combinationwith Opsens' OptoMonitor system for blood pressure measurement. TheOptoWire Deux has a diameter of 0.014" (0.36 mm) and an effective length of175 cm. The OptoWire Deux is supplied preconnected to the OptoWire cablealong with a torque device. The OptoWire cable is unique to each OptoWire andit must be used conjunctionally with the OptoWire supplied in the same tray.OptoWire Deux is supplied sterile, non-pyrogenic and is intended for single useonly. The changes described in this special 510k device modification only affectthe 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 ofOptoWire and OptoMonitor System(Predicate Device K142598; Opsens,Inc.) | ||
| Device CommonUsual Name | Intravascular Pressure Guide Wire | Intravascular Pressure Guide Wire | |
| Device Class | Class II | Class II | |
| Product Code /Regulation | DQX / 21 CFR 870.1330DXO / 21 CFR 870.2870 | DQX / 21 CFR 870.1330DXO / 21 CFR 870.2870 | |
| Regulation Name | Pressure Guide WireCatheter tip pressure transducer | Pressure Guide WireCatheter tip pressure transducer | |
| Prescription Use | Rx Only | Rx Only | |
| Indications for Use | The OptoWire Deux pressureguidewire is indicated for use tomeasure pressure in blood vesselsincluding both coronary andperipheral vessels, during diagnosticangiography and/or anyinterventional procedures. Bloodpressure measurements providehemodynamic information, such asfractional flow reserve, for the | The OptoWire One pressure guidewireis indicated for use to measure pressurein blood vessels including bothcoronary and peripheral vessels, duringdiagnostic angiography and/or anyinterventional procedures. Bloodpressure measurements providehemodynamic information, such asfractional flow reserve, for thediagnosis and treatment of blood vesseldisease. | |
| diagnosis and treatment of bloodvessel disease. | |||
| Device Description | The OptoWire Deux is a hybridNitinol/Stainless Steel pressuresensing guidewire that is a steerableguidewire with an optical pressuresensor mounted proximal to the 3.5cm long radio opaque tip. TheOptoWire Deux is for use incombination with Opsens'OptoMonitor system for bloodpressure measurement. TheOptoWire Deux has a diameter of0.014" (0.36 mm) and an effectivelength of 175 cm. The OptoWireDeux is supplied pre-connected tothe OptoWire cable along with atorque device. The OptoWire cable isunique to each OptoWire and it mustbe used conjunctionally with theOptoWire supplied in the same tray.OptoWire Deux is supplied sterile,non-pyrogenic and is intended forsingle use onlyThe intermediate section comprises ahydrophilic coating. | The OptoWire One is a hybridNitinol/Stainless Steel pressure sensingguidewire that is a steerable guidewirewith an optical pressure sensor mountedproximal to the 3.5 cm long radioopaque tip. The OptoWire One is foruse in combination with Opsens'OptoMonitor system for blood pressuremeasurement. The OptoWire One has adiameter of 0.014" (0.36 mm) and aneffective length of 175 cm. TheOptoWire One is supplied pre-connected to the OptoWire cable along | |
| System Components | Sterile, disposable guidewire | Sterile, disposable guidewire | |
| System Capabilities | Measurement of intravascular bloodpressure and flow including FFR(when used with OptoMonitorsystem) | Measurement of intravascular bloodpressure and flow including FFR(when used with OptoMonitor system) | |
| Pressure Sensing &Signal TransmissionTechnology | Fiber optic sensor & fiber bundleembedded in guidewire | Fiber optic sensor & fiber bundleembedded in guidewire | |
| Sterile, Single UsePatient ContactComponent? | Yes | Yes | |
| Guidewire OD | 0.014" | 0.014" | |
| Guidewire Length | 175 cm | 175 cm | |
| Guidewire ShaftMaterial | Stainless Steel; Nitinol | Stainless Steel; Nitinol | |
| Guidewire shaftsection Coating | Teflon (PTFE) | Teflon (PTFE) | |
| Guidewireintermediate sectionCoating | PET+ Hydrophilic coating | Silicone | |
| Guidewire tip sectionCoating | Uncoated | Silicone | |
| Guidewire TipConfiguration | Straight | Straight | |
| Guidewire TipLength | 3.5 cm | 3.5 cm | |
| Pressure SensorLocation | 3.5 cm from distal tip | 3.5 cm from distal tip | |
| FFR Capability? | Yes | Yes | |
| Basis for FFRDetermination | Simultaneous acquisition of 2pressure values: distal pressure fromsensor embedded 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 50to 300 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 | <1 mmHg/h | <1 mmHg/h |
(Statement of equivalence)
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§ 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.