(270 days)
Not Found
No
The description focuses on pressure sensing and signal processing to display FFR values, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is used to measure pressure for diagnostic purposes and provide information for treatment, rather than directly treating the disease itself.
Yes
The "Intended Use / Indications for Use" states that the device is used for “diagnosis and treatment of blood vessel disease” and that it provides “hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.”
No
The device description explicitly lists hardware components including a pressure sensing guidewire (OptoWire), electronic signal processing and display units (OptoMonitor), and connection cables.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that the device measures pressure in blood vessels during procedures. This is an in vivo measurement, meaning it's performed within the living body.
- Intended Use: The intended use is to measure pressure in blood vessels for diagnostic and interventional procedures, not to analyze samples taken from the body.
Therefore, the OptoWire and OptoMonitor System is an in vivo diagnostic and interventional device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
DQX, DXO
Device Description
The OptoWire and OptoMonitor System includes a pressure sensing guidewire (OptoWire), electronic signal processing and display units (OptoMonitor) that process signals received from the OptoWire to display intravascular blood pressure and fractional flow reserve (FFR) values, and various connection cables. The OptoWire and OptoWire cable are sterile, single-use devices; the remaining system components are reusable.
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
Not Found
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)
Bench testing has been performed to confirm that the OptoWire and OptoMonitor System meets predetermined acceptance criteria and is substantially equivalent to the predicate devices. Testing included:
OptoWire - Mechanical/Functional Verification: Tip Testing, Wire Flexibility/Support, Tensile Test, Torque Tests, Turn to Failure, Fatigue Test, Coating Testing, Compatibility Test, Surface Inspection, Corrosion Test, Dimensional testing. Purpose: Functionality and Performance, Safety, Usability. All internal design criteria were successfully met. Subject device compared favorably to predicate devices tested.
OptoMonitor - SCU Hardware, DU Hardware, HCU Hardware, System: visual & design, specs & environment, single fault conditions, electrical performance. Age Testing, Transportation Testing, Cleaning. Purpose: Functionality and Performance, Reliability, Safety, Usability, Environmental. All internal design criteria were successfully met.
Animal studies have been performed to characterize the in-vivo performance of the OptoWire and OptoMonitor System, as compared to the predicate device and other currently marketed devices with the same indications for use. Animal testing included assessment of the system handling characteristics, compatibility with other devices, and pressure measurement capabilities.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2015
Opsens. Inc. % Pamela Papineau President Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K142598
Trade/Device Name: OptoWire and OptoMonitor System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DXO Dated: May 13, 2015 Received: May 14, 2015
Dear Pamela Papineau:
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. Isting 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
1
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 vours.
A. Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142598
Device Name OptoWire and OptoMonitor System
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 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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Section 5 – 510(k) Summary
General Information
| Owner's Name: | Opsens, Inc. |
|---|---|
| Address: | 2014 rue Cyrille Duquet, #125 |
| Quebec, QC G1N 4N6 Canada | |
| Telephone: | 418-682-9996 |
| Fax Number: | 418-682-9939 |
| Contact Person: | Pamela Papineau, RAC (US, EU, CAN) |
| Delphi Medical Device Consulting, Inc. | |
| Address: | 5 Whitcomb Avenue |
| Ayer, MA 01432 | |
| Telephone Number: | (978) 772-3552 |
| Fax Number: | (978) 796-5460 |
| Subject Device: | |
| Trade Name: | OptoWire and OptoMonitor System |
| Common Name: | Intravascular Pressure Monitoring System |
| Product Code: | DXQ / DXO |
| FDA Regulation: | 21 CFR 870.1330 - Catheter Guide Wire |
| 21 CFR 870.2870 – Catheter Tip Pressure Transducer | |
| Device Classification: | Class II |
| Predicate Devices: | |
| Product Name: | PrimeWire Prestige Plus Pressure Guide Wire (Volcano Corp.) |
| Common Name: | Pressure Guide Wire |
| Product Code: | DQX |
| FDA Regulation: | 21 CFR 870.1330 – Catheter Guide Wire |
| Device Classification: | Class II |
| Premarket Notification: | K111395 |
| Product Name: | ComboMap Pressure and Flow System (Volcano Corp.) |
ComboMap Pressure and Flow System (Volcano Corp.) Intravascular Pressure Monitoring System OBJ 21 CFR 870.1200 – Diagnostic Intravascular Catheter Class II K041134
Indications for Use:
Premarket Notification:
Common Name:
FDA Regulation: Device Classification:
Product Code:
To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or other any interventional procedures. Blood pressure
4
measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.
Device Description:
The OptoWire and OptoMonitor System includes a pressure sensing guidewire (OptoWire), electronic signal processing and display units (OptoMonitor) that process signals received from the OptoWire to display intravascular blood pressure and fractional flow reserve (FFR) values, and various connection cables. The OptoWire and OptoWire cable are sterile, single-use devices; the remaining system components are reusable.
Substantial Equivalence:
The OptoWire and OptoMonitor System is substantially equivalent to the Volcano Corp. PrimeWire Prestige Plus Pressure Sensing Guidewire (K111395) and the Volcano Corp. ComboMap Pressure and Flow System (K041134). Substantial equivalence is based on indications for use, technological characteristics, device materials, performance characteristics; physical and functional test results, and conformity with standards. A substantial equivalence summary table is provided at the end of this 510(k) Summary.
Biocompatibility Testing:
Testing has been performed on the OptoWire device in accordance with the ISO 10993 family of standards to confirm that all patient-contacting materials are biocompatible. This testing included cytotoxicity, intracutaneous toxicity, acute systemic toxicity, sensitization, hemocompatibility and pyrogenicity.
Sterilization, Packaging and Shelf Llife:
The OptoWire is sterilized to a 106 SAL using an ethylene oxide process that has been validated in accordance with ISO 11135-1. The remaining system components are non-sterile. Testing has been performed to confirm that all packaging (sterile barrier and outer packaging) meets predetermined acceptance criteria with respect to sterile package seal strength and seal integrity, and that the packaging adequately protects all system components throughout transportation and storage. The sterile product shelf life has been validated through package and product testing of unaged devices as well as devices that have been held at an elevated temperature to simulate the labelled shelf life. Samples will also be tested after real time aging.
Software:
The OptoMonitor contains software that has been developed, documented and validated in accordance with industry standards (IEC 62304 - Medical device software - Software life cycle processes) and FDA guidance (General Principles of Software Validation; Final Guidance for FDA and Industry). Complete software design, risk and validation documents have been provided in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Software validation has demonstrated that the system software operates in accordance with design specifications and the system operates as intended when used for its intended use.
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Electrical Safety and EMC Testing:
The OptoMonitor has been tested in accordance with IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) to demonstrate electrical safety; testing in accordance with IEC 60601-1-2 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests) has confirmed electromagnetic compatibility.
Performance Testing - Bench:
Bench testing has been performed to confirm that the OptoWire and OptoMonitor System meets predetermined acceptance criteria and is substantially equivalent to the predicate devices. The following is a summary of the performance (bench) testing presented in this 510(k):
| Component | Testing | Purpose | Met Acceptance
Criteria? | |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | |
| | OptoWire | | | |
| Mechanical /
Functional
Verification | • Tip Testing
• Wire
Flexibility/Support
• Tensile Test
• Torque Tests
• Turn to Failure
• Fatigue Test
• Coating Testing
• Compatibility Test
• Surface Inspection
• Corrosion Test
• Dimensional testing | • Sensor Sensitivity to
Bending
• Pressure and Sensor
Testing
• Optical Contrast
• Optical Sensor Testing
• Ambient Pressure
Range
• Signal Loss
• Connection/
Disconnection Testing
• Age testing | • Functionality
and
Performance
• Safety
• Usability | Yes. All internal
design criteria were
successfully met.
Subject device
compared favorably
to predicate devices
tested. |
| OptoMonitor | | | | |
| • SCU
Hardware
• DU
Hardware
• HCU
Hardware
• System | • visual & design
• specs & environment
• single fault conditions
• electrical performance | • Age Testing
• Transportation Testing
• Cleaning | • Functionality
and
Performance
• Reliability
• Safety
• Usability
• Environmental | Yes. All internal
design criteria were
successfully met. |
Performance Testing - Animal:
Animal studies have been performed to characterize the in-vivo performance of the OptoWire and OptoMonitor System, as compared to the predicate device and other currently marketed devices with the same indications for use. Animal testing included assessment of the system handling characteristics, compatibility with other devices, and pressure measurement capabilities.
Conclusion:
The OptoWire and OptoMonitor System has been demonstrated to be substantially equivalent to the predicate devices.
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| | OptoWire and OptoMonitor System
(current submission; Opsens, Inc.) | PrimeWire Prestige Plus
Pressure Guide Wire
(K111395; Volcano Corp.) | ComboMap Pressure and Flow System
(K041134; Volcano Corp.) |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common/Usual Name | Intravascular Pressure Guide Wire
and Monitoring System | Intravascular Pressure Guide Wire | Intravascular Pressure Monitoring System |
| Device Class | Class II | Class II | Class II |
| Product Code / Regulation | DQX / 21 CFR 870.1330
DXO / 21 CFR 870.2870 | DQX / 21 CFR 870.1330 | OBJ / 21 CFR 870.2870 |
| Regulation Name | Pressure Guide Wire
Diagnostic Intravascular Monitor | Pressure Guide Wire | Diagnostic Intravascular Monitor |
| Indications for Use | To measure pressure in blood vessels,
including both coronary and peripheral
vessels, during diagnostic angiography
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. | To measure pressure in blood vessels,
including both coronary and peripheral
vessels, during diagnostic angiography
and/or any interventional procedures.
Blood pressure measurements provide
hemodynamic information for the diagnosis
and treatment of blood vessel disease.
Intended for use with signal processing
system such as Volcano ComboMap. | A multi-mode system intended for use in
all blood vessels, including coronary and
peripheral arteries, to measure
intravascular blood pressure and/or blood
flow velocities during diagnostic
angiography and/or interventional
procedures.
Intended for use with pressure sensing
guidewire such as Volcano PrimeWire. |
| System Components | Sterile, disposable guidewire
Reusable signal processor / monitor
Embedded software
Connecting cables | Sterile, disposable guidewire | Reusable signal processor / monitor
Embedded software
Connecting cables |
| System Capabilities | Measurement of intravascular blood
pressure including FFR. | Measurement of intravascular blood
pressure and flow including FFR
(when used with pressure/flow system) | Measurement of intravascular blood
pressure and flow including FFR
(when used with pressure wire) |
| Prescription Use | Rx Only | Rx Only | Rx Only |
| Pressure Sensing & Signal
Transmission Technology | Fiberoptic sensor & fiber bundle embedded
in guidewire | Hard wired strain gauge embedded in
guidewire | Hard wired strain gauge embedded in
compatible guidewire |
| | OptoWire and OptoMonitor System
(current submission; Opsens, Inc.) | PrimeWire Prestige Plus
Pressure Guide Wire
(K111395; Volcano Corp.) | ComboMap Pressure and Flow System
(K041134; Volcano Corp.) |
| Sterile, Single Use Patient
Contact Component? | Yes – OptoWire | Yes – PrimeWire Prestige Plus | No – computer-controlled pressure and
flow monitoring instrument intended for
use with compatible pressure guidewire |
| FFR Capability? | Yes | Yes | Yes |
| FFR Viewing? | Yes | N/A | 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 PrimeWire; aortic pressure
from external pressure transducer | Simultaneous acquisition of 2 pressure
values: distal pressure from sensor
embedded in compatible guidewire; aortic
pressure from external pressure transducer |
| Operating Temperature
(Monitor) | 15°C to 30°C | N/A | 16°C to 32°C |
| Transport Temperature
(Monitor) | -25°C to 60°C | N/A | -20°C to 60°C |
| Operating Relative Humidity
(Monitor) | 10% to 85% non-condensing | N/A | 30% to 75% |
| Storage Temperature
(Monitor) | Room Temperature | N/A | -20°C to 60°C |
| Operating Pressure | 70 to 106 kPa | N/A | 50 to 106 kPa |
| Pressure Range | -30 to 300 mmHg | -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) | Unknown | +/- 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 |