(170 days)
No
The summary describes a pressure guidewire and its associated monitoring system, focusing on hardware changes and performance testing against a predicate device. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is used to measure pressure for diagnostic purposes and does not provide therapy.
Yes
The intended use explicitly states "To measure pressure in blood 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." This directly indicates its use for diagnosis.
No
The device description clearly outlines hardware components including a guidewire assembly with a pressure sensor, a fiber optic interface cable, and packaging. It is used in conjunction with an electronic signal processing and display unit (OptoMonitor).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems.
- Device Function: The OptoWire III is a guidewire with a pressure sensor that is inserted directly into blood vessels within the body to measure pressure. This is an in vivo measurement, not an in vitro examination of a specimen outside the body.
- Intended Use: The intended use is to measure pressure in blood vessels during procedures, providing hemodynamic information for diagnosis and treatment of blood vessel disease. This is a direct measurement within the patient.
Therefore, the OptoWire III is an invasive medical device used for in vivo measurements, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DQX, DXO
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 OptoMonitor is cleared in a separate 510(k), K142598.
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 3.
-
- Labelling including labels and printed IFU
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels including both coronary and peripheral vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Risks are mitigated by design, labels, sterilization, packaging, shelf life, and biocompatibility. The OptoWire III is shown to be at least as safe and effective as the predicate device.
Sterilization, Packaging, Shelf life Testing:
Standards utilized:
- 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:
Conducted in accordance with FDA guidance 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. Categorized as "External communicating device – circulating blood" per section 5.2.3 c). Limited exposure, up to 24 h. Testing included: Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity (acute), Hemocompatibility, Pyrogenicity (rabbit test), SC5b-9 complement, Partial Tromboplastin Time.
Design Verification Pre-Conditioning:
OptoWire III devices were exposed to EtO and Simulated Distribution prior to testing. Testing with indicator "T1" was completed on devices subjected to accelerated aging the equivalent of 1 year ("TO" = no aging).
Design Verification:
Testing conducted based on FDA Draft Guidance Coronary, Peripheral, and Neurovascular Guidewire, dated June 15, 2018. All Design Requirements were verified. Design Specification Verification and ISO 11070 Compliance were completed by documentation check. The Fiber Optic Interface Cable and Sensor are tested at a component level. Design Check (physical measurements and inspections) performed on unaged products. Functional testing completed on both unaged (TO) and aged (T1) products.
Mechanical Performance testing:
Performed on finished devices with pre-conditioning. Comparisons to the predicate device (OptoWire Deux, without pre-conditioning) for improvements. Tests included: Mechanical tests for Tip Flexibility, Tensile Strength, Torquability, Catheter Compatibility, Kink Resistance test, Bending test, Coating Pushability. Completed on both unaged (T0) and aged (T1) products. No new questions of safety and effectiveness were identified.
Animal studies:
Study type: Animal performance testing.
Animal model: porcine model (Sus scrofa – Hybrid farm pigs), non-atherosclerotic.
Sample size: 1 female pig and one spare animal (not used).
Comparison: Optwire III compared to Optowire Deux in LCx, LAD and LAD side branches.
Evaluation criteria:
-
- Guidewire atraumaticity, Tip flexibility, Guidewire flexibility
-
- Trackability, Steerability, Torquability, Pushability
-
- Catheter compatibility, Restriction, Support (deliverability)
-
- Stent compatibility
-
- Radiopacity and pressure waveform
Key results: Results recorded as less than average, average, greater than average, and "workhorse". The OptoWire III obtained a 'workhorse' score for most parameters and demonstrated similar performance as the control, OptoWire Deux, for pressure waveform and radiopacity. Concluded that OptoWire III is substantially equivalent to the control.
- Radiopacity and pressure waveform
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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) |
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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.
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.
4
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 3.
-
- 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 | |
| OptoWire III | Name | |
| OptoWire Deux | ||
| 510(k)# | ||
| Pending | 510(k)# | |
| K152991 | ||
| Predicates | ||
| K152991 | Predicates | |
| K142598 | ||
| Product Code | ||
| DQX, DXO | Product Code | |
| DQX, DXO | ||
| Class | ||
| 2 | Class | |
| 2 | ||
| Regulation Number | ||
| 870.1330, 870.2870 | Regulation Number | |
| 870.1330, 870.2870 | ||
| Regulation Generic Name | ||
| Wire, guide, catheter; Transducer, pressure, catheter tip | Regulation Generic Name | |
| Wire, guide, catheter; Transducer, pressure, catheter tip | ||
| Intended use | Regulation Intended Use | |
| Coiled 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 Use | |
| Coiled 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. | ||
| Indications | ||
| 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 | |
| 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 | ||
| pressure and flow including FFR. (when | |||
| used with the OptoMonitor system) | Measurement of intravascular blood | ||
| pressure and flow including FFR. (when | |||
| used with the OptoMonitor system) | |||
| Pressure Sensing & Signal | |||
| Transmission Technology | Fiberoptic sensor & fiber bundle | ||
| embedded in guidewire. | Fiberoptic sensor & fiber bundle | ||
| embedded in guidewire. | |||
| Sterile, Single Use Patient | |||
| 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 | |
| safety wires | |||
| Guidewire Shaft Coating | Teflon (PTFE) | Teflon (PTFE) | |
| Guidewire Intermediate | |||
| Section Coating | PET + Hydrophilic coating | PET + Hydrophilic coating |
6
| Proposed Device | Predicate Device | |
|---|---|---|
| Guidewire Tip section | ||
| Coating | Uncoated | Uncoated |
| Guidewire Tip | ||
| 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 | ||
| Connector | Adhesive | Connector capillary ring + adhesive |
| FFR Capability | Yes | Yes |
| Basis for FFR | ||
| Determination | Simultaneous acquisition of 2 pressure | |
| values: distal pressure from sensor | ||
| embedded in OptoWire; aortic | ||
| pressure from external pressure | ||
| transducer | Simultaneous acquisition of 2 pressure | |
| values: distal pressure from sensor | ||
| embedded in OptoWire; aortic pressure | ||
| from 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 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 |