OPUSWAVE Dual Sensor Imaging System

K250684 · Terumo Cardiovascular Systems Thi Plant · NQQ · Jul 2, 2025 · Radiology

Device Facts

• Record ID: K250684
• Device Name: OPUSWAVE Dual Sensor Imaging System
• Applicant: Terumo Cardiovascular Systems Thi Plant
• Product Code: NQQ · Radiology
• Decision Date: Jul 2, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended 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

Device Story

OPUSWAVE Dual Sensor Imaging System provides intravascular imaging of coronary arteries using a DualView Catheter capable of simultaneous or asynchronous Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS) modalities. System consists of a wheeled console with monitor, keyboard, mouse, and Motor Drive Unit (MDU). Physician operates system in a clinical setting (e.g., Cath Lab), manually positioning the sensor and controlling pullback (automatic or manual) to acquire image data. System integrates with existing Cath Lab technologies (angio, ECG) and provides real-time grayscale imaging with analysis tools for area and linear measurements. Data can be stored on external media. By providing high-resolution dual-modality imaging, the device assists physicians in visualizing coronary anatomy, potentially improving procedural guidance and clinical decision-making during interventional procedures.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing (electrical safety, EMC, software verification/validation) and animal study.

Technological Characteristics

Cart-based console; MDU-driven catheter; IVUS (40MHz, B-mode); OCT (1300nm laser, Class 1 per IEC 60825-1). Connectivity: Network, USB, Optical, Hard drive. Software: Custom GUI. Sterilization: Not specified. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (acoustic output).

Indications for Use

Indicated for patients who are candidates for transluminal interventional procedures requiring intravascular imaging of coronary arteries.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• iLab Ultrasound Imaging System (K152316)
• Ilumien Optis (K141453)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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"

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

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K250684 - Rahul Reddy Chinkeri
Page 2

(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 ([e-mail]) or phone [phone] 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

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OPUSWAVE Dual Sensor Imaging System
Page 13 of 45

| 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) | ? |

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

# 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: [phone] |
| Email: | [e-mail] |
| 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

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).

K250684
TERUMO

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

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 #1
OPUSWAVE Dual Sensor Imaging System | Predicate Device #1
iLab Ultrasound Imaging System | Predicate Device #2
Ilumien 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
TERUMO

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

| Attribute | Proposed Device #1
OPUSWAVE Dual Sensor Imaging System | Predicate Device #1
iLab Ultrasound Imaging System | Predicate Device #2
Ilumien 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.

K250684
TERUMO

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

## 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
TERUMO