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.

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.

AI/ML Overview

The provided text describes the 510(k) submission for the OptoMonitor 3 device, which is a pressure monitor used with OptoWire™ pressure guidewires to measure pressure in blood vessels. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (OptoMonitor 3 cleared via K193620).

Crucially, this document does not describe a study involving an AI/Machine Learning algorithm for diagnostic purposes, nor does it present acceptance criteria and performance data in the context of an AI-based system. Instead, it concerns a medical device that measures physiological pressure. The "performance data" section specifically refers to electrical safety, electromagnetic compatibility (EMC), and wireless coexistence testing, not diagnostic accuracy or efficacy.

Therefore, many of the requested points related to AI/ML (e.g., ground truth, expert consensus, MRMC study, training data) are not applicable to the content of this document.

However, I can extract the relevant information regarding acceptance criteria and performance testing for this specific device.

Device Type: Medical Device - Catheter Tip Pressure Transducer (OptoMonitor 3)
Intended Use: To measure pressure in blood vessels (coronary and peripheral) during diagnostic angiography and/or interventional procedures, providing hemodynamic information such as fractional flow reserve for diagnosis and treatment of blood vessel disease.

Here's an attempt to answer the prompt based only on the provided text, recognizing that it's for a traditional medical device, not an AI product:

Acceptance Criteria and Device Performance Study for OptoMonitor 3

The OptoMonitor 3 is a pressure monitoring device, and the provided document is a 510(k) submission seeking substantial equivalence to a predicate device. The "study" described here is primarily a series of verification and validation (V&V) tests to confirm that changes in the new device version do not introduce new questions of safety and effectiveness, and that its performance remains comparable to the predicate. It is not a clinical study assessing diagnostic accuracy in the way an AI algorithm would be evaluated.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal "acceptance criteria" table with numerical targets in the same format as for an AI/ML diagnostic. Instead, it focuses on demonstrating that the performance characteristics of the new OptoMonitor 3 are "essentially the same" or "equivalent" to the predicate OptoMonitor 3 (K193620). The changes are primarily related to communication methods (Bluetooth) and display unit options, along with minor software updates. The "performance data" section details compliance with various electrical safety, EMC, and wireless coexistence standards.

The table below summarizes the key performance characteristics compared to the predicate, implying that the acceptance criterion is "same" or "equivalent performance" to the legally marketed and cleared predicate device.

Characteristic	Predicate Device (K193620) Performance	Subject Device (K202943) Performance	Differences (and Implied Acceptance: "Same/Equivalent")
Intended Use	To measure pressure in blood vessels... for diagnosis and treatment of blood vessel disease.	To measure pressure in blood vessels... for diagnosis and treatment of blood vessel disease.	Same
General Indication for Use	Diagnostic computer... to compute and display various physiological parameters.	Diagnostic computer... to compute and display various physiological parameters.	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 (-30 to 50 mmHg) or +/- 3% of reading (50 to 300 mmHg)	+/- 1 mmHg plus +/- 1% of reading (-30 to 50 mmHg) or +/- 3% of reading (50 to 300 mmHg)	Same
Zero Drift	<1 mmHg/h	<1 mmHg/h	Same
Electrical Isolation	Class 1	Class 1	Same
User Interface	Bedside: Touch screen; Control room: None	Bedside: Touch screen; Control room: Yes	Same, except for the addition of a control room.
Auto-zeroing	Yes	Yes	Same
Real Time Curves	Aortic instantaneous/mean pressure, distal instantaneous/mean pressure.	Aortic instantaneous/mean pressure, distal instantaneous/mean pressure.	Same
Real Time Numerical Values	Mean aortic pressure, mean distal pressure, FFR, dPR	Mean aortic pressure, mean distal pressure, FFR, dPR	Same
Minimum Pd/Pa Cursor	Yes	Yes	Same
Recording Values	Instantaneous Pa, Pd and Pd/Pa; mean Pa; mean Pd	Instantaneous Pa, Pd and Pd/Pa; mean Pa; mean Pd	Same
Display Monitor	LCD	LCD	Same
Display Unit Size	15 inch	15 inch, 10 inch	Equivalent. Refer to Section 18 for test data.
Bluetooth Communication	Cabled ethernet / serial between Optical and Display units	Bluetooth communication between Optical and Display units (cabled ethernet/serial backup)	Equivalent. Refer to Section 17 for test data.
Aortic Input	Low Level (5µV/V/mmHg)	Low Level (5µV/V/mmHg)	Same
Distal Input	OptoWire (optical)	OptoWire (optical)	Same
AUX Input	High Level (100 mmHg/V)	High Level (100 mmHg/V)	Same
Distal Output	Low Level (5µV/V/mmHg)	Low Level (5µV/V/mmHg)	Same
Pressure Guidewire	Opsens OptoWire™	Opsens OptoWire™	Same

Performance Data provided to support substantial equivalence (Verification & Validation (V&V))

Electrical safety and electromagnetic compatibility (EMC) testing:
- Compliance with IEC 60601-1:2012 (Consolidated text - edition 3.1)
- Compliance with IEC60601-1-2:2007 (third edition)
- Compliance with IEC60601-1-2:2014 (fourth edition)
Wireless coexistence testing:
- Successfully tested per ANSI/IEEE C63.27:2017 in accordance with the FDA guidance (2013) Radio Frequency Wireless Technology in Medical Devices.
Risk Management Process: Evaluated changes, and "no new questions of safety and effectiveness were identified."
Verification and Validation activities: "No new questions of safety and effectiveness were identified during the execution of Verification and Validation activities."
Software Validation: Changes are validated in accordance with Opsens QMS, including code review, unit testing, system testing, and regression testing.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable in the context of clinical data for diagnostic accuracy. The testing described is primarily laboratory-based V&V testing (e.g., electrical safety, EMC, wireless coexistence), not a patient-based test set size.
Data Provenance: Not applicable. The "study" is a technical V&V assessment of the device hardware and software, not a collection of patient data.
Retrospective/Prospective: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not a study requiring expert-established ground truth for diagnostic purposes. The "ground truth" for the V&V tests are the established standards for electrical safety, EMC, and wireless communication, and the specifications of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI-assisted device, therefore an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI algorithm. Its performance is inherent in its measurement capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the AI/clinical ground truth sense. The "ground truth" for this device's performance relies on:
- Engineering specifications and standards: Compliance with IEC 60601-1, IEC 60601-1-2, ANSI/IEEE C63.27, etc., which define acceptable performance for medical electrical equipment.
- Predicate device performance: The previously cleared OptoMonitor 3 (K193620) serves as the benchmark for "equivalent" performance characteristics.

8. The sample size for the training set:

Not applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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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

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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, & 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 pressuremeasurements in blood vesselsincluding both coronary andperipheral vessels, duringdiagnostic angiography and/orother any interventionalprocedures.Blood pressure measurementsprovide hemodynamicinformation, such as fractionalflow reserve, for the diagnosisand treatment of blood vesseldisease.	To be used for pressuremeasurements in bloodvessels including bothcoronary and peripheralvessels, during diagnosticangiography and/or otherany interventionalprocedures.Blood pressuremeasurements providehemodynamic information,such as fractional flowreserve, for the diagnosisand treatment of bloodvessel disease.	Same
General Indicationfor use	The OptoMonitor 3 is adiagnostic computer intendedfor use in catheterization andrelated cardiovascular specialtylaboratories to compute anddisplay various physiologicalparameters based on theoutput from a measuringdevice.	The OptoMonitor 3 is adiagnostic computerintended for use incatheterization and relatedcardiovascular specialtylaboratories to computeand display variousphysiological parametersbased on the output from ameasuring device.	Same
FFR Capability	Yes	Yes	Same
Basis for FFRDetermination	Ratio of whole heartbeats of Pdand Pa	Ratio of whole heartbeatsof Pd and Pa	Same
OperatingTemperature	15°C to 30°C	15°C to 30°C	Same
Operating RelativeHumidity	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% ofreading (pressure range -30 to50 mmHg) or +/- 3% of reading(pressure range 50 to 300mmHg)	+/- 1 mmHg plus +/- 1% ofreading (pressure range -30to 50 mmHg) or +/- 3% ofreading (pressure range 50to 300 mmHg)	Same
Zero Drift	<1 mmHg/h	<1 mmHg/h	Same
Electrical Isolation	Class 1	Class 1	Same
User Interface	Bedside: Touch screenControl room: Yes	Bedside: Touch screenControl room: None	Same, except forthe addition of acontrol room.
Auto-zeroing	Yes	Yes	Same
Real Time Curves	Aortic instantaneous pressure,aortic mean pressure, distalinstantaneous pressure, distalmean pressure	Aortic instantaneouspressure, aortic meanpressure, distalinstantaneous pressure,distal mean pressure	Same
Characteristics	OptoMonitor 3(K202943)	OptoMonitor 3(K193620)	Differences
Real Time NumericalValues	Mean aortic pressure, meandistal pressure, FFR, dPR	Mean aortic pressure,mean distal pressure, FFR,dPR	Same
Minimum Pd/PaCursor (Detection ofFFR Locus)	Yes	Yes	Same
Recording Values	Instantaneous Pa, Pd andPd/Pa; mean Pa; mean Pd	Instantaneous Pa, Pd andPd/Pa; mean Pa; mean Pd	Same
Display Monitor	LCD	LCD	Same
Display Unit size	15 inch10 inch	15 inch	Equivalent. Refer toSection 18 for testdata.
Bluetooth	Bluetooth communicationbetween the Optical andDisplay units (cabled ethernet /serial offered as backup)	Cabled ethernet / serialcommunication betweenthe Optical and Displayunits	Equivalent. Refer toSection 17 for testdata.
Aortic Input	Low Level (5μV/V/mmHg)	Low Level (5μV/V/mmHg)	Same
Distal Input	OptoWire (optical)	OptoWire (optical)	Same
AUX Input	High Level (100 mmHg/V)	High Level (100 mmHg/V)	Same
Distal Output	Low Level (5μV/V/mmHg)	Low Level (5μV/V/mmHg)	Same
Pressure Guidewire	Opsens OptoWire™	Opsens OptoWire™	Same

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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) were assessed with respect to the software change and the system was found to comply with Electrical Safety and Electromagnetic Compatibility standards:

. IEC 60601-1:2012 (Consolidated text - edition 3.1) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
. IEC60601-1-2:2007 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (third edition)
. IEC60601-1-2:2014 Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests (fourth edition)

Wireless coexistence testing of the system was successfully tested per ANSI/IEEE C63.27:2017 in accordance with the FDA guidance (2013) Radio Frequency Wireless Technology in Medical Devices.

No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities.

Additionally, the following standards were applied during the development and testing of the OptoMonitor 3:

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. EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes.
. EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
. IEC 62304:2006 Medical device software life cycle processesIEC60601-2-34 :2011 Medical Electrical Equipment – Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment.
IEC 60601-1-6:2010 + A1 :2013 Medical Electrical Equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability.
IEC 61000-3-2: 2018 Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤16 A per phase)
IEC 61000-3-3:2013 +AMD1:2017 Electromagnetic compatibility (EMC) - Part 3-3: Limits -Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16 A per phase and not subject to conditional connection
. IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
. IEC 61000-4-3:2006 +AMD1:2010 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
. IEC 61000-4-4:2012 Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
IEC 61000-4-5:2014 +AMD1:2017 Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test
. IEC 61000-4-6:2013 Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields
IEC 61000-4-8:2009 Electromagnetic compatibility (EMC) – Part 4-8: Testing and measurement techniques – Power frequency magnetic field immunity test
IEC 61000-4-11 :2004+ AMD1:2017 Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests
IEC CISPR 11:2015 +AMD1:2016+AMD2:2019 CSV (Consolidated version)Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
IPC-A-610D Acceptability of Electronic Assemblies
. ETSI EN 301 489-17 V2.2.1 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for Broadband Data Transmission Systems; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU
ETSI EN 300 328 V2.2.1 Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU
. Systems Using Digital Modulation FCC 15.247
. RSS-247Digital Transmission Systems (DTSs), Frequency Hopping Systems (FHSs) and License-Exempt Local Area Network (LE-LAN) Devices

No animal studies or clinical investigations are included with this submission.

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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 and 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 3 System (K193620 cleared on 06/18/2020).

Regulation Number and Section

§ 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).