(175 days)
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 proposed OptoMonitor 3 is a new version of the OptoMonitor System. This device 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). These hardware components and device functionalities are equivalent to that of the previous generation OptoMonitor (K192340 (cleared on 12/12/2019).
The device is a non-sterile, non-patient contact device.
The provided text describes a 510(k) premarket notification for the OptoMonitor 3 device, which is an updated version of the OptoMonitor System. The submission aims to establish substantial equivalence to a predicate device (K192340).
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison table between the proposed OptoMonitor 3 and its predicate device, OptoMonitor (K192340), rather than explicitly listing acceptance criteria with reported performance for a new study. However, the "Technological Characteristics" section of the table effectively serves as a list of performance parameters with implied acceptance criteria being "Same" as the predicate device.
| Performance Parameter | Acceptance Criteria (Implied: Same as Predicate) | Reported Device Performance (OptoMonitor 3) |
|---|---|---|
| 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 | <0.3 mmHg/deg C | <0.3 mmHg/deg C |
| Zero Drift | <1 mmHg/h | <1 mmHg/h |
2. Sample Size for Test Set and Data Provenance
The document states: "No animal studies or clinical investigations are included with this submission." and "Results from these tests mentioned above demonstrate that the technological and performance characteristics of the proposed OptoMonitor 3 is comparable to the predicate device". This implies that the substantial equivalence determination for performance was primarily based on bench testing and verification/validation activities of the device's hardware and software changes, rather than a clinical trial with a "test set" of patients.
Therefore:
- Sample Size for Test Set: Not applicable in the context of a clinical test set. Performance was evaluated through technical testing.
- Data Provenance: Not applicable for clinical data. The data provenance would be internal laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical studies or human-in-the-loop evaluations were performed as part of this submission, there were no experts used to establish ground truth for a clinical test set. The validation focused on engineering and software verification.
4. Adjudication Method for the Test Set
Not applicable, as there was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or cited in this submission. The device is a pressure monitoring system, not an imaging interpretation or diagnostic aid that typically requires such studies.
6. Standalone (Algorithm Only) Performance Study
The document focuses on the entire OptoMonitor 3 system. While it mentions that "algorithms used for the FFR calculation remained unchanged from the predicate OptoMonitor," it does not detail a standalone performance study solely on the FFR algorithm. The performance data presented (pressure range, accuracy, etc.) relates to the entire device's ability to measure pressure.
7. Type of Ground Truth Used
For the engineering and software verification/validation, the ground truth would be established by:
- Reference standards and calibrated instruments: For pressure measurements, the device's output would be compared against known, highly accurate reference pressure sources.
- Pre-defined specifications and requirements: The software and hardware performance were validated against their design specifications.
8. Sample Size for the Training Set
Not applicable. This device is a measurement instrument, not an AI/ML model that undergoes a training phase with a "training set" of data in the typical sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/ML model.
Summary of Device Changes and Performance Rationale:
The OptoMonitor 3 is an updated version of the predicate OptoMonitor. The key changes are related to:
- Optical Unit: New casing, CPU, PCBs, validated software (algorithms for FFR calculation unchanged), addition of capability to receive aortic pressure signal from Cathlab Hemodynamic system, addition of low-level signal input, redesigned handle unit.
- Display Unit: Use of commercially available all-in-one PC, new software to support additional hardware options, addition of possibility to connect to hospital DICOM system.
- Aortic Input: Change from High Level (100 mmHg/V) to Low Level (5μV/V/mmHg) for the aortic input.
- AUX Input: Addition of a High Level (100 mmHg/V) AUX input, which was not present on the predicate.
The manufacturer argues substantial equivalence because:
- Indications for Use are the same.
- Technological characteristics are "essentially the same."
- The "Substantial Equivalence Table" shows identical specifications for crucial performance parameters like pressure range, accuracy, thermal zero shift, and zero drift.
- Software verification and validation testing were conducted.
- Electrical safety and EMC testing confirmed compliance with relevant standards.
- Risk Management processes evaluated the changes, and "no new questions of safety and effectiveness were identified."
- The algorithms for FFR calculation remained unchanged.
Therefore, the study supporting the device's acceptance criteria primarily involved bench testing and verification/validation activities against established engineering specifications and comparison to the predicate device's performance characteristics, without the need for animal or clinical studies.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 18, 2020
Opsens Inc. Marc Chaunet Director, Regulatory Affairs and Quality System 750 boulevard Du Parc Technologique Quebec, G1P 4S3 Ca
Re: K193620
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: May 18, 2020 Received: May 18, 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
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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 and 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)
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
SUBMITTER 1.
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: June 17, 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 System cleared via K192340 (cleared on 12/12/2019). This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
4. DEVICE DESCRIPTION
The proposed OptoMonitor 3 is a new version of the OptoMonitor System. This device 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). These hardware components and device functionalities are equivalent to that of the previous generation OptoMonitor (K192340 (cleared on 12/12/2019).
The device is a non-sterile, non-patient contact device.
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5. INDICATIONS FOR USE
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 cleared via K192340 on 12/12/2019.
The proposed OptoMonitor 3 is a new version of the predecessor OptoMonitor.
Indications for Use for the OptoMonitor 3 are the same as the predicate device indications K192340 (cleared on 12/12/2019).
The technological characteristics of the proposed OptoMonitor 3 are essentially the same as for the OptoMonitor. The main difference between the subject device and its predecessor resides in the following:
OPTICAL UNIT
- New casing
- New CPU and PCBs. A new software was also validated for the OU. Although, algorithms used for . the FFR calculation remained unchanged from the predicate OptoMonitor.
- Addition of possibility to receive aortic pressure signal (Pa) from a Cathlab Hemodynamic system
- Addition of a low-level signal input (Aortic In) allowing to connect an aortic pressure ● transducer and pass-through to Cathlab Hemodynamic system
- Handle unit redesigned and connector split to separate electrical and optical connections
- Software modifications to support new hardware
- Removal of printer
DISPLAY UNIT
- Use of commercially available all-in-one PC. .
- . New software to support additional hardware options
- Addition of possibility to connect to hospital DICOM system ●
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, 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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| Substantial Equivalence Table | ||||
|---|---|---|---|---|
| Proposed Device | Predicate Device | Differences | ||
| Regulatory Information | Name | OptoMonitor 3 | OptoMonitor | N/A |
| 510(k)# | K193620 | K192340 | N/A | |
| Predicates | K192340 | K173860K142598K111395K041134 | N/A | |
| Product Code | DXO | DXO | Same | |
| Class | 2 | 2 | Same | |
| Regulation Number | 870.2870 | 870.2870 | Same | |
| Regulation Generic Name | Transducer, pressure, catheter tip | Transducer, pressure, catheter tip | Same | |
| Intended use | Regulation Intended Use | Accessory equipment for processing mechanical or electrical property changes in relation to changes in blood pressure. | Accessory equipment for processing mechanical or electrical property changes in relation to changes in blood pressure. | Same |
| 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 treatment of blood vessel disease. | 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. | Same | |
| Prescription Use | Rx Only | Rx Only | Same | |
| System Components | Sterile, disposable guidewireReusable signal processor / monitorEmbedded softwareConnecting cables | Sterile, disposable guidewireReusable signal processor / monitorEmbedded softwareConnecting cables | Same | |
| Technological Characteristics | System Capabilities | Measurement of intravascular bloodPressure including FFR. | Measurement of intravascular bloodPressure including FFR. | Same |
| 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. | Same | |
| Operating Temperature (Monitor) | 15°C to 30°C | 15°C to 30°C | Same | |
| Transport Temperature (Monitor) | -25°C to 60°C | -25°C to 60°C | Same | |
| Operating Relative Humidity (Monitor) | 10% to 85% non-condensing | 10% to 85% non-condensing | Same | |
| Storage Temperature (Monitor) | Room Temperature | Room Temperature | Same | |
| Proposed Device | Predicate Device | Differences | ||
| 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% ofreading(pressure range -30 to 50mmHg) or +/- 3% of reading(pressure range 50 to 300mmHg) | +/- 1 mmHg plus +/- 1% ofreading(pressure range -30 to 50mmHg) or +/- 3% of reading(pressure range 50 to 300mmHg) | Same | |
| Thermal Zero Shift | <0.3 mmHg/deg C | <0.3 mmHg/deg C | Same | |
| Zero Drift | <1 mmHg/h | <1 mmHg/h | Same | |
| Electrical Isolation | Class 2 (double isolation) | Class 2 (double isolation) | Same | |
| User Interface | Touchscreen | Touchscreen | Same | |
| Auto-zeroing | Yes | Yes | Same | |
| Real Time Curves | Aortic instantaneous pressure,aortic mean pressure, distalinstantaneous pressure, distalmean pressure | Aortic instantaneous pressure,aortic mean pressure, distalinstantaneous pressure, distalmean pressure | Same | |
| Real Time NumericalValues | Mean aortic pressure, meandistal pressure, mean Pd/meanPa; FFR, dPR | Mean aortic pressure, meandistal pressure, mean Pd/meanPa; FFR, dPR | Same | |
| Recording Values | Instantaneous Pa, Pd andPd/Pa; mean Pa; mean Pd;mean Pd/mean Pa; FFR, dPR | Instantaneous Pa, Pd andPd/Pa; mean Pa; mean Pd;mean Pd/mean Pa; FFR, dPR | Same | |
| Display Monitor | LCD | LCD | Same | |
| Aortic Input | Low Level (5μV/V/mmHg) | High Level (100 mmHg/V) | Low level attributedto Aortic input forOpM3 | |
| Distal Input | OptoWire (optical) | OptoWire (optical) | Same | |
| AUX Input | High Level (100 mmHg/V) | N/A | High level inputadded to AUX In forOpM3 | |
| Distal pressureoutput | Low Level (5μV/V/mmHg) | Low Level (5μV/V/mmHg) | Same | |
| Hardwarecomponents | Signal Conditioner Unit (SCU),the Display Unit (DU), TheHandle Unit (HU) andaccessories (cables, powersupply, etc) | Signal Conditioner Unit (SCU),the Display Unit (DU), TheHandle Unit (HU) andaccessories (cables, powersupply, etc) | Same | |
| Connected devices | OptoWire™ | OptoWire™ | Same |
K 1 9 3 6 2 0
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PERFORMANCE DATA 7.
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety and electromagnetic compatibility (EMC) was assessed with respect to the software change and the system was found to comply with IEC 60601-1, and IEC 60601-1-2 standard for EMC.
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities.
No animal studies or clinical investigations are included with this submission.
8. CONCLUSIONS
The results from these tests mentioned above demonstrate that the technological and performance characteristics of the proposed OptoMonitor 3 is comparable to the predicate device, support substantial equivalence of the device that is the subject of this 510(k).
The results of the verification/validation tests and the risk analysis have demonstrated that the additional features incorporated in the OptoMonitor 3 device do not add any new questions of safety and efficacy and is therefore substantially equivalent to the predicate OptoMonitor System (K192340 cleared on 12/12/2019).
§ 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).