(121 days)
No
The summary describes a pressure sensing guidewire and its associated monitor system. There is no mention of AI or ML in the device description, intended use, or performance studies. The changes described are related to the physical design of the guidewire.
No.
The device measures pressure for diagnostic purposes and does not directly provide therapy. It provides information for diagnosis and treatment decisions.
Yes
The device measures pressure in blood vessels to provide hemodynamic information, such as fractional flow reserve, for the diagnosis of blood vessel disease.
No
The device description explicitly states it is a "hybrid Nitinol/Stainless Steel pressure sensing guidewire" and describes physical components like a "steerable guidewire," "optical pressure sensor," and "OptoWire cable." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of the OptoWire Deux is to measure pressure within blood vessels during diagnostic angiography and interventional procedures. This is a direct measurement within the body, not an analysis of a sample taken from the body.
- The device description and intended use clearly indicate an invasive procedure. The device is a guidewire inserted into blood vessels.
- The measurements are hemodynamic. Hemodynamic measurements relate to the flow of blood within the circulatory system, which is an in-vivo process.
Therefore, the OptoWire Deux is an in-vivo diagnostic and interventional device, not an in-vitro diagnostic device.
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 pressurements 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 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 intermediate section comprises a hydrophilic coating.
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
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
Key Metrics
- Pressure Range: -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)
- Thermal Zero Shift:
§ 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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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
1
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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Page 1 of 5
| Section 005 | 510(k) Summary | |
|---|---|---|
| General | ||
| Information: | Owner's Name: | |
| Address: | Opsens, Inc. | |
| 2014 rue Cyrille Duquet, #125 | ||
| Québec, QC G1N 4N6 Canada | ||
| Contact Person: | ||
| Address: | ||
| Telephone: | ||
| Fax Number: | Vanessa Mootoosamy | |
| Opsens Inc. Director, Quality Assurance | ||
| 014 rue Cyrille Duquet, #125 | ||
| Québec, QC G1N 4N6 Canada | ||
| 418-682-9996 ext. 239 | ||
| 418-682-9939 | ||
| Subject Device: | Trade Name: | |
| Common Name: | ||
| Product Code: | ||
| FDA Regulation: | ||
| Device Classification: | OptoWire Deux pressure guidewire | |
| Catheter pressure guide wire | ||
| DQX / DXO | ||
| 21 CFR 870.1330-Catheter Guide Wire | ||
| 21 CFR 870.2870-Catheter Tip Pressure | ||
| Transducer | ||
| Class II | ||
| Predicate Device: | Trade Name: | |
| Common Name: | ||
| Product Code: | ||
| FDA Regulation: | ||
| Device Classification: | ||
| Premarket Notification: | OptoWire and OptoMonitor System | |
| Intravascular Pressure Monitoring System | ||
| DQX / DXO | ||
| 21 CFR 870.1330 - Catheter Guide Wire | ||
| 21 CFR 870.2870 - Catheter Tip Pressure | ||
| Transducer | ||
| Class II | ||
| K142598 | ||
| 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. | ||
| Description of | ||
| device: | 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. |
4
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 (