(55 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing that would typically indicate the presence of AI/ML in this type of device. The description focuses on pressure measurement and hardware components.
No
The device measures pressure and provides diagnostic information; it does not directly treat or alleviate a disease or condition.
Yes
The "Intended Use" clearly states that the device is used "during diagnostic angiography" and that "Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel desease." This directly indicates a diagnostic purpose.
No
The device description explicitly lists hardware components (Optical Unit, Display Unit, Handle Unit, cables, power supply) and mentions electrical safety and EMC testing, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "measure pressure in blood vessels... during diagnostic angiography and/ or any interventional procedures." This is a direct measurement of a physiological parameter within the body, not an analysis of a sample taken from the body.
- Device Description: The device is described as a "non-sterile, non-patient contact device" that is an accessory to pressure guidewires. It measures pressure in situ within the blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device measures a physical parameter directly within the body.
N/A
Intended Use / 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 desease.
The OptoMonitor 3, in conjunction with the OptoWire™ pressure guidewire, is indicated 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
DXO
Device Description
The proposed OptoMonitor 3 and its components are considered accessories to Opsens OptoWire™ pressure guidewires and are intended for use with legally marketed pressure guidewires.
The proposed OptoMonitor 3 includes an Optical Unit (OU), a Display Unit (DU), a Handle Unit (HU) and accessories (cables, power supply, etc).
The device is a non-sterile, non-patient contact device.
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
catheterization and related cardiovascular specialty laboratories
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)
Electrical safety and electromagnetic compatibility (EMC) tests were performed, and the system complied with relevant standards (IEC 60601-1, IEC60601-1-2:2007, IEC60601-1-2:2014). Wireless coexistence testing was successfully conducted per ANSI/IEEE C63.27:2017. No new safety or effectiveness concerns were identified. The results demonstrated that the technological and performance characteristics are comparable to the predicate device, supporting substantial equivalence.
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
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 24, 2020
Opsens Inc. Marc Chaunet Director, Regulatory Affairs and Quality System 750 boulevard Du Parc Technologique Quebec, QC G1P 4S3 Canada
Re: K202943
Trade/Device Name: OptoMonitor 3 Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO Dated: September 24, 2020 Received: September 30, 2020
Dear Marc Chaunet:
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,
LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, & Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202943
Device Name OptoMonitor 3
Indications for Use (Describe)
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 desease.
| 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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ഗ 510(k) Summary OptoMonitor 3
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, Regulatory Affairs and Quality System Director
Email: marc.chaunet@opsens.com
Date Prepared: November 20, 2020
2. DEVICE
Name of Device: OptoMonitor 3
Common or Usual Name: Pressure Monitor
Classification name: Transducer, pressure, catheter tip (870.2870)
Regulatory Class: II
Product Code: DXO
PREDICATE DEVICE 3.
OptoMonitor 3 System cleared via K193620 (cleared on 06/18/2020). This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
DEVICE DESCRIPTION 4.
The proposed OptoMonitor 3 and its components are considered accessories to Opsens OptoWire™ pressure guidewires and are intended for use with legally marketed pressure guidewires.
The proposed OptoMonitor 3 includes an Optical Unit (OU), a Display Unit (DU), a Handle Unit (HU) and accessories (cables, power supply, etc).
The device is a non-sterile, non-patient contact device.
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INDICATIONS FOR USE 5.
The OptoMonitor 3, in conjunction with the OptoWire™ pressure guidewire, is indicated 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE 6. DEVICE
The proposed OptoMonitor 3 is substantially equivalent to the OptoMonitor 3 cleared via K193620 on 06/18/2020.
Indications for Use for the OptoMonitor 3 remains unchanged from the cleared Indications for Use of the OptoMonitor 3 K193620 on 06/18/2020.
The technological characteristics of the proposed OptoMonitor 3 are essentially the same as for the OptoMonitor 3 cleared via K193620 on 06/18/2020. The main difference between the subject device and its predecessor resides in the following:
OPTICAL UNIT
-
Bluetooth communication between the Optical and Display units (cabled ethernet / serial offered ● as backup)
DISPLAY UNIT -
Bluetooth communication between the Optical and Display units (cabled ethernet / serial offered . as backup)
-
A new 10 inch DU option .
SOFTWARE
- DICOM network and terminology were updated for clarity
- Minor changes to user interface including optimization of button positions, dPR manual scale, . patient data entry, showing values as the cursor moves, and the option to view previous recordings.
These changes are validated in accordance with Opsens QMS including code review, unit testing, system testing, and regression testing. 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. While reviewing the device risk management file, no other security issues were found related to the addition of the wireless function.
Therefore, the proposed device, OptoMonitor 3, meets substantial equivalence requirements with regards to the legally marketed predicate OptoMonitor (K192340 cleared on 12/12/2019).
For detailed comparison, refer to the Substantial Equivalence table on the following pages.
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K202943
| Characteristics | OptoMonitor 3
(K202943) | OptoMonitor 3
(K193620) | Differences |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Intended Use | To be used for pressure
measurements 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. | To be used for pressure
measurements 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. | Same |
| General Indication
for use | The OptoMonitor 3 is a
diagnostic computer intended
for use in catheterization and
related cardiovascular specialty
laboratories to compute and
display various physiological
parameters based on the
output from a measuring
device. | The OptoMonitor 3 is a
diagnostic computer
intended for use in
catheterization and related
cardiovascular specialty
laboratories to compute
and display various
physiological parameters
based on the output from a
measuring device. | Same |
| FFR Capability | Yes | Yes | Same |
| Basis for FFR
Determination | Ratio of whole heartbeats of Pd
and Pa | Ratio of whole heartbeats
of Pd and Pa | Same |
| Operating
Temperature | 15°C to 30°C | 15°C to 30°C | Same |
| Operating Relative
Humidity | 10% to 85% non-condensing | 10% to 85% non-
condensing | Same |
| Operating Pressure | 70 to 106 kPa | 70 to 106 kPa | Same |
| Pressure Range | -30 to 300 mmHg | -30 to 300 mmHg | Same |
| 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) | Same |
| Zero Drift |