DualView Catheter

K250751 · Terumo Corporation · DQO · Jul 17, 2025 · Cardiovascular

Device Facts

• Record ID: K250751
• Device Name: DualView Catheter
• Applicant: Terumo Corporation
• Product Code: DQO · Cardiovascular
• Decision Date: Jul 17, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

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

DualView Catheter is a rapid exchange (RX) diagnostic intravascular catheter used for coronary artery imaging. It features an imaging core with a lens and transducer that rotates within a catheter sheath to capture 360° images via simultaneous near-infrared light and ultrasound. The device is used with a 0.014" guidewire and connects to the OPUSWAVE system. During operation, the imaging core is pulled back within the sheath to obtain long-axis images. Radiopaque markers assist in positioning. The device is intended for use by clinicians in interventional settings to visualize coronary anatomy, aiding in the assessment of vessel pathology and guiding interventional procedures. It benefits patients by providing high-resolution, dual-modality imaging to support clinical decision-making during coronary interventions.

Clinical Evidence

No clinical data included. Evidence consists of bench-level design verification and validation testing, electrical safety/EMC testing, and animal studies (swine model) evaluating tissue injury, thrombus formation, and handling performance.

Technological Characteristics

Rapid exchange (RX) catheter; 2.6 Fr imaging window, 3.0 Fr shaft; 137 cm effective length. Imaging: 1300 nm near-infrared light and 40 MHz ultrasound. Hydrophilic coating. Radiopaque markers for positioning. Sterilization: Ethylene oxide (ISO 11135). Biocompatibility: ISO 10993-1 (Externally communicating, circulating blood, limited contact). Transducer IPX7 rated (IEC 60529).

Indications for Use

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

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Optis Integrated System, Dragonfly Optis Imaging Catheter (K141769)
• Opticross 40 MHz Coronary Imaging Catheter (K123621)

Reference Devices

• OPUSWAVE (K250684)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

June 17, 2025

Terumo Corporation
% Patrick McDonald
Senior Regulatory Affairs Specialist
Terumo Medical Corporation
265 Davidson Avenue, Suite 320
Somerset, New Jersey 08873

Re: K250751
Trade/Device Name: DualView Catheter
Regulation Number: 21 CFR 870.1200
Regulation Name: Diagnostic Intravascular Catheter
Regulatory Class: Class II
Product Code: DQO, OBJ
Dated: June 17, 2025
Received: June 17, 2025

Dear Patrick McDonald:

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.

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

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K250751 - Patrick McDonald
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (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.

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-

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K250751 - Patrick McDonald
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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K250751

Device Name
DualView Catheter

Indications for Use (Describe)
DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”

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Terumo Corporation
Traditional 510(k) –DualView Catheter
510(k) Summary
K250751

# 510(k) SUMMARY

## A. SUBMITTER INFORMATION (807.92(a)(1))

Prepared by: Patrick McDonald
Senior Regulatory Affairs Specialist

Terumo Medical Corporation
Tel: [phone]
Fax: [phone]

Prepared For: Owner/Operator
Terumo Corporation
44-1, 2-Chome, Hatagaya
Shibuya-Ku, Tokyo
Japan 151-0072
Owner/Operator Number: 8010026

Manufacturer and Sterilization Facility (Applicant)
Ashitaka Factory of Terumo Corporation
150, Maimaigi-cho,
Fujinomiya, Shizuoka 418-0015, Japan
Registration Number: 9681834

Contact Person: Patrick McDonald
Senior Regulatory Affairs Specialist
Terumo Medical Corporation
265 Davidson Avenue, Suite 320
Tel [phone]
Fax [phone]
Email: [e-mail]

Date prepared: 17JUL2025

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Terumo Corporation
Traditional 510(k) –DualView Catheter
510(k) Summary
K250751

## B. DEVICE NAME (807.92(a)(2))

Proprietary Name: DualView Catheter
Common Name: Diagnostic Catheter
Classification Name: Diagnostic Intravascular Catheter
Classification Panel: Cardiovascular
Regulation: 21 CFR 870.1200
Classification Product Codes: DQO
Subsequent Product Code: OBJ
Classification: Class II

## C. PREDICATE DEVICE (807.92(a)(3))

The legally marketed devices to which substantial equivalence is claimed are:

Primary Predicate K141769 Optis Integrated System, Dragonfly Optis Imaging Catheter
Secondary Predicate K123621 Opticross 40 MHz Coronary Imaging Catheter

## D. REASON FOR 510(k) SUBMISSION

This traditional 510(k) for DualView Catheter is being submitted as this is a new medical device for the US market.

## E. DEVICE DESCRIPTION (807.92(a)(4))

The DualView Catheter is a catheter consisting of two assemblies: the catheter sheath and the imaging core (consisting of lens and transducer). During imaging, the imaging core rotates inside the catheter sheath to obtain a 360° image of the surface layer of the vessel wall by irradiating with near-infrared light and ultrasound. By pulling back the imaging core inside the catheter sheath, an image in the long axis direction can be obtained.

This is a rapid exchange (RX) design (short monorail) catheter, which is used with a 0.014" (0.36 mm) guidewire. The catheter is 2.6 Fr (0.86 mm) in the imaging

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Terumo Corporation
Traditional 510(k) –DualView Catheter
510(k) Summary
K250751

window section and 3.0 Fr (1.01 mm) in the shaft section with an effective length of 137 cm. The catheter has a 100 cm hydrophilic coating starting from the distal end, which becomes highly lubricious when wet. The catheter has a telescoping section, and the telescoping length is 155 mm. When connected to the OPUSWAVE, the imaging core can be pulled back 150 mm in the catheter sheath. There are two radiopaque markers. The distal radiopaque marker is located 7 mm from the distal end of the catheter sheath, and the sensor radiopaque marker is located where the near-infrared light and ultrasound are emitted. Those markers allow a user to confirm the positional relationship between the distal end of the catheter and the sensor position (imaging point). There are two depth markers, one at 90 cm and the other at 100 cm from the distal end of the catheter sheath, which serves as a guide for insertion.

The transducer has an IPX7 ingress rating in accordance with IEC 60529.

The catheter is stored in the holder tube and is secured to the catheter holder. The catheter comes with the Motor Drive Unit (MDU) Cover and accessories. The MDU Cover consists of an adapter and a plastic cover sheet to maintain the sterility of the catheter and clean field. The catheter accessories consist of a connection tube with a three-way stopcock, a priming syringe, and a reservoir syringe for priming the catheter lumen with heparinized saline solution.

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Terumo Corporation
Traditional 510(k) –DualView Catheter
510(k) Summary
K250751

## F. INDICATIONS FOR USE (807.92(a)(5))

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

## G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))

DualView Catheter, the subject of this Traditional 510(k), is substantially equivalent in its Intended Use, Indications for Use, and Technological Characteristics to the predicates, Optis Integrated System, Dragonfly Optis Imaging Catheter (K141769) manufactured by LightLab Imaging Inc and Opticross 40 MHz Coronary Imaging Catheter (K123621) manufactured by Boston Scientific Corporation.

The comparison of the technological characteristics is summarized in Table 1.

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Terumo Corporation

Traditional
510(k) - DualView Catheter

510(k) Summary

K250751

Table 1: Summary of Comparative Information

| Device Characteristics | Subject Device: DualView Catheter | Primary Predicate Device: Optis Integrated System, Dragonfly Optis Imaging Catheter (K141769) | Secondary Predicate Device: Opticross 40 MHz Coronary Imaging Catheter (K123621) |
| --- | --- | --- | --- |
| Manufacturer | Ashitaka Factory of Terumo Corporation | LightLab Imaging Inc | Boston Scientific Corporation |
| Intended Use | DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. | Same | Same |
| Indications for Use | DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. | The OPTIS Integrated System with C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTIS Integrated | This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. |

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Terumo Corporation
Traditional 510(k) – DualView Catheter
510(k) Summary
K250751

| | | System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated. | |
| --- | --- | --- | --- |
| **Imaging Energy** | Optical Coherence Tomography/ Ultrasound | Optical Coherence Tomography | Ultrasound |
| **Optical Wavelength** | 1300 nm | 1305 nm | Not applicable |
| **Ultrasound Frequency** | 40 MHz | Not applicable | 40 MHz |
| **Effective Length** | 1370 mm | 1350 mm | 1350 mm |
| **Catheter O.D.** | Imaging window: 2.6 Fr (0.86 mm)
Proximal shaft: 3.0 Fr (1.01 mm) | Imaging window: 2.7 Fr
Proximal shaft: 3.2 Fr | Imaging window: 2.6 Fr
Proximal shaft: 3.0 Fr (1.00 mm) |
| **Maximum guidewire O.D.** | 0.014” (0.36mm) | 0.014” (0.356mm) | 0.014” (0.36mm) |
| **Package** | Individual package on which the product label and the peel-off labels are attached 1 unit per package. | Individual package on which the product label and the peel-off labels are attached 1 unit per package. | Individual package on which the product label and the peel-off labels are attached 1 unit per package. |
| **Operation Principle** | Manual | Manual | Manual |

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Terumo Corporation
Traditional 510(k) – DualView Catheter
510(k) Summary
K250751

| Sterilization | Ethylene oxide | Ethylene Oxide | Irradiation |
| --- | --- | --- | --- |
| Shelf life | 36 Months | 24 Months | 12 Months |

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Terumo Corporation
Traditional 510(k) – DualView Catheter
510(k) Summary
K250751

# H. NON CLINICAL TESTS (807.92(b)(1))

## Performance Testing

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

| Test Item |
| --- |
| Radio-detectability |
| Appearance of Catheter |
| Corrosion Resistance |
| Tensile Strength |
| Freedom from leakage |
| Small bore connector |
| Sliding resistance (Imaging window) |
| Particle count |
| Slidability of Guidewire |
| Bending strength |
| Dimensions |
| Imaging quality |
| Pullback/forward durability |
| Coating Integrity |
| Stent crossability |
| Simulated use – Human factor usability engineering |

System level Design verification and validation testing were performed on the OPUSWAVE (K250684) with the DualView Catheter to demonstrate that the product specifications met the predefined requirements and it is safe and effective for its intended use. The result of this testing concludes that the DualView Catheter is safe and effective for its intended use.

## Software Verification and Validation Testing

Software verification and validation testing were conducted per IEC 62304 Standard and 'Enhanced' level of documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Content of Premarket Submissions for Device Software Functions," with OPUSWAVE (K250684)

## Electrical Safety and Electromagnetic Compatibility (EMC) and Collateral Standards

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Terumo Corporation
Traditional 510(k) – DualView Catheter
510(k) Summary
K250751

Electrical safety and EMC testing was conducted for the OPUSWAVE. The system is in compliance with IEC 60601-1 and collateral standards, IEC 60601-2-18, IEC 60601-1-2, IEC 60825, and IEC 60601-2-37.

## Animal Study

A safety animal study, in swine model, evaluated the tissue injury level and thrombus formation of coronary arteries that were exposed to simultaneous near-infrared light and ultrasound energy application. It was concluded that there were no issues related to tissue damage and thrombus formation in coronary arteries caused by simultaneous application or near infrared light and ultrasound.

A performance animal study, in swine model, successfully assessed key performance and handling criteria compared to predicate devices and concluded that the system performed as intended.

## Biocompatibility

In accordance with ISO 10993-1, DualView Catheter is classified as: Externally Communicating Device, Circulating Blood, Limited Contact (<24 hours). The finished device’s patient contacting parts were tested in accordance with the tests recommended in the FDA Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.” Screening tests were performed on accelerated aged devices to show that the biocompatibility is maintained throughout the shelf life of the product. Results of the testing demonstrate that the device is biocompatible throughout the shelf-life of the product.

## Sterilization

The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014/Amd 1:2018, Sterilization of Health Care Products – Ethylene Oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of $10^{-6}$.

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Terumo Corporation
Traditional 510(k) – DualView Catheter
510(k) Summary
K250751

I. CLINICAL TESTS (807.92(b)(2))

This 510(k) does not include data from clinical tests.

J. CONCLUSION (807.92(b)(3))

In summary, DualView Catheter, subject of this 510(k), is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the predicates, Optis Integrated System, Dragonfly Optis Imaging Catheter (K141769) manufactured by LightLab Imaging Inc and Opticross 40 MHz Coronary Imaging Catheter (K123621) manufactured by Boston Scientific Corporation.

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