(268 days)
No
The description focuses on mathematical calculations and comparisons to expert annotations and existing software, with no mention of AI or ML algorithms.
No
The device is intended to measure cardiovascular blood pressure and provide hemodynamic information for diagnosis and treatment, which are diagnostic functions, not therapeutic.
Yes
The device is intended to measure cardiovascular blood pressure and provide hemodynamic information for the diagnosis and treatment of blood vessels, which are diagnostic purposes.
No
The device description states it includes the "display of ARi/TIARi adjunctive hemodynamic indicators when compared to the approved OptoMonitor 3". The predicate device (K213854) is also named "OptoMonitor 3". The description and performance studies refer to "pressure recordings" and "pressure tracings", implying the device processes data from a pressure sensor or transducer, which is a hardware component. The summary does not explicitly state the device is software-only and the context strongly suggests interaction with hardware for data acquisition.
Based on the provided information, the OptoMonitor 3 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "measure cardiovascular blood pressure... during interventional procedures." This involves direct measurement of physiological parameters within the body, not the examination of specimens derived from the human body (like blood, urine, or tissue) outside of the body.
- Device Description: The description focuses on the display of hemodynamic indicators derived from blood pressure measurements.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health. The OptoMonitor 3 is a device used in vivo (within the living body) to monitor physiological parameters during a medical procedure.
N/A
Intended Use / Indications for Use
The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.
Product codes
DXO
Device Description
The proposed OptoMonitor 3 includes the display of ARi/TIARi adjunctive hemodynamic indicators when compared to the approved OptoMonitor 3 with a fully integrated TAVI software update cleared via K213854.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart chambers, coronary vessels and peripheral vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
interventional procedures
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
A retrospective analysis was conducted with the objective to compare ARi and TIARi calculation of OpM3 TAVI algorithm and Microsoft Excel based on the mathematical expressions given in the literature by Sinning et al. and Bugan and Kumar et al.. The analysis data set utilized clinically derived data recorded with the OptoMonitor from existing pre and post market data sources. A total of 30 pressure recordings from 10 unique patients, for a total of 150 beats, was analyzed.
Summary of Performance Studies
A retrospective analysis was conducted with the objective to compare ARi and TIARi calculation of OpM3 TAVI algorithm and Microsoft Excel based on the mathematical expressions given in the literature by Sinning et al. and Bugan and Kumar et al.. The analysis data set utilized clinically derived data recorded with the OptoMonitor from existing pre and post market data sources. A total of 30 pressure recordings from 10 unique patients, for a total of 150 beats, was analyzed. The results of the analysis showed that manual calculation of regurgitation indices using mathematical formulas given in the literature yields statistically equivalent results to the indices displayed by OpM3 TAVI. The correlation coefficients and the graphs with the estimated line from the Deming regression, as well as the Bland-Altman plots, indicate high levels of agreement for each of the four indices. For additional exploration, the Pearson correlations were found to be higher than 0.99 for all four indices.
A clinical study, an annotation study, was retrospectively conducted on 420 waveforms in 29 patients in order to compare the values annotated by expert clinicians, a commercially available hemodynamic software and the outputs of OpM3. The experts panel annotated the systolic Ao, diastolic LV, diastolic Ao, and LVEDP pressures on the pressure tracings. A statistical analysis included least mean square analysis and Bland-Altman. The study found the following Levels of Agreement (LoA) between the values identified by the OptoMonitor 3 and by the experts panel for each of the annotation:
Systolic LV: Upper LoA 0.22, Lower LoA -0.26
Systolic Ao: Upper LoA 0.15, Lower LoA -0.17
Diastolic Ao: Upper LoA 0.23, Lower LoA -0.11
Diastolic Lv: Upper LoA 4.02, Lower LoA -3.45
LVEDP: Upper LoA 4.77, Lower LoA -2.42
Key Metrics
Retrospective Analysis: Pearson correlations were found to be higher than 0.99 for all four indices.
Clinical Study (Levels of Agreement from Bland-Altman analysis):
Systolic LV: Upper LoA 0.22, Lower LoA -0.26
Systolic Ao: Upper LoA 0.15, Lower LoA -0.17
Diastolic Ao: Upper LoA 0.23, Lower LoA -0.11
Diastolic Lv: Upper LoA 4.02, Lower LoA -3.45
LVEDP: Upper LoA 4.77, Lower LoA -2.42
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).
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February 12, 2025
Opsens Inc. Marc Chaunet Regulatory Affairs Director 750, Boulevard du Parc Technologique Quebec, QC G1P 4S3 Canada
Re: K241418
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: January 10, 2025 Received: January 13, 2025
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
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assistance/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,
for
Robert T. Kazmierski -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241418
Device Name OptoMonitor 3
Indications for Use (Describe)
The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.
| 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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510(k) Summary OptoMonitor 3
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, Senior Regulatory Affairs Manager
Email: marc.chaunet@opsens.com
Date Prepared: January 10th, 2025
DEVICE
Name of Device: OptoMonitor 3
Regulation Number: 21 CFR 870.2870
Regulation Name: Catheter Tip Pressure Transducer
Regulatory Class: II
Product Code: DXO
PREDICATE DEVICE
The proposed OptoMonitor 3 is substantially equivalent to the Opsens existing OptoMonitor 3 cleared in K213854 on 09/14/2022 [Predicate].
The predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION
The proposed OptoMonitor 3 includes the display of ARi/TIARi adjunctive hemodynamic indicators when compared to the approved OptoMonitor 3 with a fully integrated TAVI software update cleared via K213854.
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INDICATIONS FOR US
The Indications for Use of the subject device OptoMonitor 3 remains unchanged from that of the current device cleared via K213854.
OptoMonitor 3: The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures.
Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during transcatheter aortic valve procedures.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The proposed OptoMonitor 3 with display of ARi/TIARi adjunctive hemodynamic indicators is substantially equivalent to the approved OptoMonitor 3 cleared via K213854. The indications for use remain unchanged from the currently marketed OptoMonitor 3 indications.
The technological characteristics related to the proposed device are the same. No new questions of safety and effectiveness were identified during the execution of Verification and Validation activities.
Therefore, the proposed device, OptoMonitor 3 meet substantial equivalence requirements with regards to the legally marketed predicate.
For detailed comparison, refer to the Substantial Equivalence table on the following pages.
| Table 1: OptoMonitor 3 with display of ARi/TIARi adjunctive hemodynamic indicators | |
|---|---|
| OptoMonitor 3 with display of ARi/TIARi adjunctive hemodynamic indicators | |||
|---|---|---|---|
| OptoMonitor 3 (with ARi/TIARi) | OptoMonitor 3 (Predicate) | ||
| Regulatory | |||
| Information | Device Name | OptoMonitor 3 | OptoMonitor 3 |
| 510(k)# | K241418 | K213854 | |
| Product Code | DXO | DXO | |
| Class | 2 | 2 | |
| Regulation Number | 870.2870 | 870.2870 | |
| Regulation Generic Name | transducer, pressure, catheter tip | transducer, pressure, catheter tip | |
| Indications for Use | The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. | ||
| Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during transcatheter aortic valve procedures. | The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. | ||
| Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during transcatheter aortic valve procedures. | |||
| Intended use | Prescription Use | Rx Only | Rx Only |
| Tech | |||
| nology | System Components / device materials | Reusable signal processor / monitor | |
| Embedded software | Reusable signal processor / monitor | ||
| Embedded software | |||
| OptoMonitor 3 with display of ARI/TIARi adjunctive hemodynamic indicators | |||
| OptoMonitor 3 (with ARI/TIARI) | OptoMonitor 3 | ||
| (Predicate) | |||
| System Capabilities | Connecting cables | ||
| Measurement of intravascular blood | |||
| pressure including FFR and measurement | |||
| inside left ventricle | Connecting cables | ||
| Measurement of intravascular blood | |||
| pressure including FFR and measurement | |||
| inside left ventricle | |||
| Pressure Sensing & Signal | |||
| Transmission Technology | Fiberoptic sensor & fiber bundle | ||
| embedded in guidewire. Monitor Senses | |||
| pressure from Fiberoptic sensor. | Fiberoptic sensor & fiber bundle | ||
| embedded in guidewire. Monitor Senses | |||
| pressure from Fiberoptic sensor. | |||
| Operating Temperature | |||
| (Monitor) | 15°C to 30°C | 15°C to 30°C | |
| Transport Temperature | |||
| (Monitor) | -25°C to 60°C | -25°C to 60°C | |
| Operating Relative | |||
| Humidity | |||
| (Monitor) | 10% to 85% non-condensing | 10% to 85% non-condensing | |
| Storage Temperature | |||
| (Monitor) | Room Temperature | Room Temperature | |
| Operating Pressure | 70 to 106 kPa | 70 to 106 kPa | |
| 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 |