The OPUSWAVE System with DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

Device Description

The OPUSWAVE Dual Sensor Imaging System consists of a wheeled console with monitor, keyboard, mouse, a software graphical user interface and a Motor Drive Unit (MDU) protected by an MDU cover. The MDU is connected to a DualView Catheter capable of imaging both, Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS) modalities, either simultaneously or asynchronously, without removing the catheter from the imaging site. The system allows image data to be exported and stored on external media (USB, DVD), and for integration with Cath Lab imaging technologies (angio, ECG).
The sterile operator (physician) is able to control image acquisition by manually positioning the imaging sensor as well as performing pullback (automatically or manually) for defined regions of interest. The system provides analysis tools such as area and linear measurements.

AI/ML Overview

The provided FDA 510(k) Clearance Letter for the OPUSWAVE Dual Sensor Imaging System focuses on establishing substantial equivalence to predicate devices, primarily through engineering and regulatory compliance testing. While it mentions various verification and validation activities, it does not contain the detailed clinical study data typically found when a device’s performance against specific acceptance criteria is being proven, especially for AI-enabled devices requiring human reader studies or detailed standalone performance metrics.

Based on the information given, here's an analysis of what can be extracted or inferred, and what cannot be answered:

Acceptance Criteria and Study for OPUSWAVE Dual Sensor Imaging System

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating equivalence to predicate devices for imaging capabilities (OCT and IVUS modalities), safety (electrical safety, EMC, laser output, acoustic output), and software functionality. There are no specific quantitative performance metrics or acceptance criteria reported similar to what would be found for an algorithm that provides diagnostic outputs (e.g., sensitivity, specificity, accuracy).

However, based on the provided text, we can infer the "acceptance criteria" were met through various tests that showed compliance with standards and equivalence to predicates.

Acceptance Criteria Category (Inferred)	Reported Device Performance (Inferred/Directly Stated)
Electrical Safety	Complies with IEC 60601-1 standard.
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2 standard.
Software Functionality	Software verification and validation testing successfully completed; fulfillment documentation provided as recommended by FDA guidance ("Enhanced" level, implying potential for serious injury/death from failure).
Design Verification	Performs pursuant to defined design input requirements.
Design Validation (Simulated Use)	Meets user needs and intended use.
Acoustic Output (IVUS)	Does not exceed Track 3 limits (equivalent to predicate 1 meeting 60601-2-37 requirements).
Laser Output (OCT)	Class 1 Laser Output per 60825-1 (equivalent to predicate 2 being Class 1M).
Image Quality/Clinical Equivalence	Demonstrated substantial equivalence to predicate devices through animal testing. No quantitative imaging performance metrics (e.g., resolution, penetration depth, signal-to-noise ratio) are explicitly provided as acceptance criteria or results beyond "real-time grayscale image".

2. Sample Size for the Test Set and Data Provenance:

Test Set Sample Size: Not specified. The document mentions "animal testing" and "simulated use testing" for design validation. For software, general "verification and validation testing" is mentioned, but specific test set sizes (e.g., number of test cases, images, patients) are not provided.
Data Provenance:
- Animal Study: Animal data. Details on geographic origin or whether it was retrospective/prospective are not provided.
- Simulated Use Testing: Implies a controlled environment, likely within the manufacturer's facility, but specifics are not given.
- Software V&V: Internal testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not Applicable / Not Provided: The document does not describe the establishment of a "ground truth" in the clinical sense (e.g., for diagnostic accuracy) as it's not a device focusing on automated interpretation or diagnosis. The studies mentioned (animal, simulated use, software V&V) would have their own internal verification against design specifications or a recognized standard, but not a human expert-adjudicated ground truth as would be typical for AI/CADx devices.

4. Adjudication Method for the Test Set:

Not Applicable / Not Provided: As there's no mention of expert-established ground truth for a diagnostic test set, there's no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

No: The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the OPUSWAVE Dual Sensor Imaging System to the predicate devices and is not included as part of this premarket notification." Therefore, an MRMC study demonstrating human reader improvement with AI assistance was not conducted or reported. This device is an imaging system, not an AI interpretation tool.

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

Not Applicable (in the classic AI sense): This device is an imaging system, not an AI algorithm designed to provide standalone diagnostic outputs. Its "performance" would be related to image quality, system functionality, and safety parameters. While the system's software underwent "verification and validation testing," this is to ensure the software itself functions correctly and safely within the imaging system, not to assess its diagnostic accuracy as a standalone algorithm.

7. The Type of Ground Truth Used:

Design Specifications, Regulatory Standards, and Animal Models:
- For electrical safety and EMC: Compliance with IEC 60601-1 and IEC 60601-1-2.
- For software: Compliance with FDA Software Guidance ("Enhanced" level), suggesting verification against defined requirements.
- For design: Compliance with "defined design input requirements."
- For clinical equivalence/imaging capabilities: Demonstrated equivalence in "animal testing," implying that normal anatomy and pathology in animal models served as a reference.

8. The Sample Size for the Training Set:

Not Applicable / Not Provided: This device is not described as an AI/machine learning device that requires a "training set" in the context of model development. The verification and validation activities are for the entire system, not for training a specific algorithm.

9. How the Ground Truth for the Training Set was Established:

Not Applicable / Not Provided: As there is no mention of a training set for an AI algorithm, there is no ground truth establishment process described for one.

Summary of Device and Evidence Focus:

The OPUSWAVE Dual Sensor Imaging System is an intravascular imaging system (OCT and IVUS). The 510(k) clearance relied on demonstrating substantial equivalence to existing predicate devices, rather than proving novel clinical efficacy or superior diagnostic accuracy through large-scale human clinical trials or AI performance evaluations. The "studies" primarily referenced are engineering verification and validation testing, animal studies for equivalence, and compliance with recognized safety and software standards. The document does not suggest that the device incorporates AI in a way that requires AI-specific performance criteria (e.g., sensitivity, specificity, MRMC studies) for its clearance.

Summary

FDA 510(k) Clearance Letter - OPUSWAVE Dual Sensor Imaging System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 2, 2025

Terumo Cardiovascular Systems THI Plant
Rahul Reddy Chinkeri
Senior Regulatory Affairs Specialist
6190 Jackson Rd
Ann Arbor, Michigan 48103

Re: K250684
Trade/Device Name: OPUSWAVE Dual Sensor Imaging System
Regulation Number: 21 CFR 892.1560
Regulation Name: Ultrasonic Pulsed Echo Imaging System
Regulatory Class: Class II
Product Code: NQQ, IYO
Dated: March 6, 2025
Received: June 3, 2025

Dear Rahul Reddy Chinkeri:

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.

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"

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K250684 - Rahul Reddy Chinkeri
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(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 (QS) 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K250684 - Rahul Reddy Chinkeri
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-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,

Aneesh S. Deoras -S

Aneesh Deoras
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

Page 4

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.	K250684
Please provide the device trade name(s).

OPUSWAVE Dual Sensor Imaging System

Please provide your Indications for Use below.

The OPUSWAVE System with DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures

Please select the types of uses (select one or both, as applicable).	☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

OPUSWAVE Dual Sensor Imaging System
Page 13 of 45

Page 5

OPUSWAVE Dual Sensor Imaging System 510(k) Summary

Terumo Cardiovascular Systems THI Plant
OPUSWAVE Dual Sensor Imaging System
510(k) Summary Traditional 510(k)
Page 1 of 4

OPUSWAVE Dual Sensor Imaging System 510(k) Summary

This section is prepared in accordance with 21 CFR Part 807.92

I. General Information

Submitters Name and Address: Terumo Cardiovascular Systems THI Plant
6190 Jackson Road
Ann Arbor, MI 48103

Name of the Contact Person: Rahul Reddy Chinkeri, Senior RA Specialist
Phone Number: Tel: +1 734-822-1877
Email: rahul.chinkeri@terumomedical.com
Establishment Registration: 3005228872
Date Prepared: 28 February 2025

II. Device Information

Trade Name: OPUSWAVE Dual Sensor Imaging System
Common/Generic Name: Optical Coherence Tomography (OCT) Imaging System / Ultrasonic pulsed echo imaging system
Classification Name: Ultrasonic pulsed echo imaging system
Device Class: Class II
Classification Panel: Radiology/Cardiology Panel
Regulation Number: 21 CFR 892.1560
Product Code(s): NQQ / IYO

III. Predicate Device

Predicate Device#1, iLab Ultrasound Imaging System cleared under K152316.
Predicate Device#2, Ilumien Optis cleared under K141453.

IV. Device Description

K250684

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OPUSWAVE Dual Sensor Imaging System
510(k) Summary Traditional 510(k)
Page 2 of 4

The sterile operator (physician) is able to control image acquisition by manually positioning the imaging sensor as well as performing pullback (automatically or manually) for defined regions of interest. The system provides analysis tools such as area and linear measurements.

V. Indications for Use

The OPUSWAVE System with DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

VI. Comparison of Intended Use / Indications to the Predicate Device

The subject and the predicate devices have the same intended use as the devices are intended to provide intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

VII. Comparison of Technological Characteristics

Attribute	Proposed Device #1OPUSWAVE Dual Sensor Imaging System	Predicate Device #1iLab Ultrasound Imaging System	Predicate Device #2Ilumien Optis	Discussion
Manufacturer	Terumo	Boston Scientific	Abbott	-
Trade Name	OPUSWAVE Dual Sensor Imaging System	iLab Ultrasound Imaging System	Ilumien Optis	-
Common Name	Optical Coherence Tomography (OCT) Imaging System / Ultrasonic pulsed echo imaging system	Ultrasonic pulsed echo imaging system	Optical Coherence Tomography (OCT) Imaging System	Equivalent
Regulation Number	21 CFR 892.1560	21 CFR 892.1560	21 CFR 892.1560	Equivalent
Regulation Name	Ultrasonic pulsed echo imaging system	Ultrasonic pulsed echo imaging system	Ultrasonic pulsed echo imaging system	Equivalent
Regulation Class	II	II	II	Equivalent
510(k) Clearance Number	Subject of this submission	K152316	K141453	-
Product Code	NQQ / IYO	IYO	NQQ	Equivalent
Form factor	Cart-based Console	Cart-based Console	Cart-based Console	Equivalent
Catheter Mechanical Drive	Motor Drive Unit (MDU)	Motor Drive Unit (MDU)	Drive-motor and Optical Controller (DOC)	Equivalent
User Interface	PC-based system with Keyboard and Mouse	PC-based system with Touchpad and Mouse	PC-based system with Keyboard and Mouse	Equivalent
Software Interface	Custom GUI	Custom GUI	Custom GUI	Equivalent

K250684

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Terumo Cardiovascular Systems THI Plant
OPUSWAVE Dual Sensor Imaging System
510(k) Summary Traditional 510(k)
Page 3 of 4

Attribute	Proposed Device #1OPUSWAVE Dual Sensor Imaging System	Predicate Device #1iLab Ultrasound Imaging System	Predicate Device #2Ilumien Optis	Discussion
Image Output	Real-time grayscale image	Real-time grayscale image	Real-time grayscale image	Equivalent
File archive	Network, USB, Optical, Hard drive	Network, Optical, Hard drive	Network, USB, Optical, Hard drive	Equivalent
IVUS Imaging Mode	B Mode	B Mode	Not applicable	Equivalent to predicate 1
IVUS center frequency	40MHz	40MHz	Not applicable	Equivalent to predicate 1
Acoustic Output	Does not exceed Track 3 limits	Does not exceed Track 1 limits.	Not applicable	Equivalent to predicate 1: Dual Sensor will meet 60601-2-37 req.
OCT laser wavelength	1300 nm	Not applicable	1305 nm	Equivalent to predicate 2
Scanning Laser Source Output	Class 1 Laser Output per 60825-1	Not applicable	Class 1M Laser Output per 60825-1	Equivalent to predicate 2
Coronary flush required (OCT imaging only)	Yes; Saline or Contrast or Saline/Contrast mixture	Not required	Yes	Equivalent – coronary flush is required for OCT imaging modes
Pullback Trigger	Automatic or Manual	Automatic or Manual	Automatic or Manual	Equivalent

Table 1: Comparison of Technological Characteristics between the OPUSWAVE Dual Sensor Imaging System (Subject Device), Lab Ultrasound Imaging System (Predicate Device#1) and Ilumien Optis (Predicate Device#2)

VIII. Performance Data

The following performance data were provided in support of the substantial equivalence determination:

Electrical Safety and Electromagnetic Compatibility (EMC)

Evaluation for electrical safety and EMC testing was conducted on the OPUSWAVE Dual Sensor Imaging System. The OPUSWAVE Dual Sensor Imaging System complies with the IEC 60601-1 standard for electrical safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing was completed successfully. The fulfillment documentation is 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 documentation level required for OPUSWAVE Dual Sensor Imaging System is considered as "Enhanced" level since a failure of the software to perform the functions correctly could result in serious injury or death.

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Terumo Cardiovascular Systems THI Plant
OPUSWAVE Dual Sensor Imaging System
510(k) Summary Traditional 510(k)
Page 4 of 4

Design Verification and Validation Testing

Design verification testing was conducted and demonstrates that OPUSWAVE Dual Sensor Imaging System performs pursuant to the defined design input requirements for the subject device. Design validation, including simulated use testing, was conducted and demonstrates that the OPUSWAVE Dual Sensor Imaging System meets user needs and intended use.

Animal Study

Animal testing was performed and demonstrated the substantial equivalence of the OPUSWAVE Dual Sensor Imaging System to the predicate devices and is included as part of this premarket notification.

Clinical Studies

Clinical testing was not required to demonstrate the substantial equivalence of the OPUSWAVE Dual Sensor Imaging System to the predicate devices and is not included as part of this premarket notification.

IX. Conclusion

The information provided above supports that the OPUSWAVE Dual Sensor Imaging System is substantially equivalent to the predicate devices with respect to the intended use and technological characteristics. Verification and validation testing supports that the hardware and software difference do not raise any new issues of safety and effectiveness. Therefore, it is concluded that the OPUSWAVE Dual Sensor Imaging System is substantially equivalent to the predicate device.

K250684

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.