SpectraWAVE Imaging System

K221257 · Spectrawave, Inc. · NQQ · Feb 28, 2023 · Radiology

Device Facts

• Record ID: K221257
• Device Name: SpectraWAVE Imaging System
• Applicant: Spectrawave, Inc.
• Product Code: NQQ · Radiology
• Decision Date: Feb 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The SpectraWAVE Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The SpectraWAVE Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter. The SpectraWAVE Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure. The NIRS capability of the SpectraWAVE Imaging System is intended for the detection of lipid core containing plaques of interest. The NIRS capability of the SpectraWAVE Imaging System is intended for the assessment of coronary artery lipid core burden. The NIRS capability of the SpectraWAVE Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

Device Story

SpectraWAVE Imaging System is an intravascular imaging device combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) to assess coronary artery structure and composition. The system comprises a mobile console, proprietary software, a Catheter Interface Unit (CIU), and a sterile, single-use 2.5 French dual-modality imaging catheter. The catheter features a rotating fiber optic core that delivers infrared light to tissue and collects reflections. Used in cardiac catheterization labs by physicians and healthcare professionals. The system processes reflected optical signals to construct real-time cross-sectional and longitudinal images, calculates vessel dimensions (cross-sectional area, diameter), and identifies lipid-core-containing plaques. Output is displayed on high-resolution touch-screen monitors for physician evaluation. The device aids in assessing coronary artery lipid core burden and identifying patients/plaques at increased risk of major adverse cardiac events, supporting clinical decision-making during interventional procedures.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, animal testing (GLP porcine coronary artery model), and summative usability testing. Bench testing confirmed performance specifications, biocompatibility (ISO 10993-1), and electrical safety (IEC 60601 series). Animal study evaluated acute performance and vascular injury. Usability testing confirmed safe and effective operation per ANSI/AAMI/IEC 62366-1.

Technological Characteristics

Dual-modality intravascular imaging system (OCT and NIRS). Components: mobile console, CIU, 2.5 Fr single-use catheter. Sensing: swept-source semiconductor laser, rotating fiber optic core. Connectivity: touch-screen interface, native data storage. Standards: IEC 62304 (software), ISO 10993-1 (biocompatibility), IEC 60601-1/1-2/1-6/62366-1/60825-1 (safety/EMC). Sterilization: validated to SAL 10^-6.

Indications for Use

Indicated for patients who are candidates for transluminal interventional procedures requiring coronary artery imaging. Catheter use restricted to vessels 2.0-5.2 mm in diameter. Contraindicated for target vessels with previous bypass procedures.

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

• Dragonfly OpStar Imaging Catheter (K192019)
• Makoto Intravascular Imaging System, Dualpro IVUS+NIRS Imaging Catheter (K183599)

Submission Summary (Full Text)

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February 28, 2023

SpectraWAVE, Inc. Farzad Parsaie VP, Quality Assurance & Regulatory Affairs 12 Oak Park Drive Bedford, Massachusetts 01730

Re: K221257

Trade/Device Name: SpectraWAVE Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: NQQ, ORD, OGZ, IYO Dated: February 24, 2023 Received: February 24, 2023

Dear Farzad Parsaie:

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

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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 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 (QS) 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 medical devices and radiation-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 ([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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# Indications for Use

510(k) Number (if known) K221257

Device Name

SpectraWAVE Imaging System

Indications for Use (Describe)

The Spectra WAVE Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The SpectraWAVE Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.

The SpectraWAVE Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.

The NIRS capability of the SpectraWAVE Imaging System is intended for the detection of lipid core containing plaques of interest.

The NIRS capability of the SpectraWAVE Imaging System is intended for the assessment of coronary artery lipid core burden.

The NIRS capability of the SpectraWAVE Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

Type of Use (Select one or both, as applicable)

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## Traditional 510(k) Summary

- 1. Basic Information-Submitter:

| 510(k) Owner: | SpectraWAVE, Inc. |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 12 Oak Park Drive<br>Bedford, MA 01730<br>[phone] (main number) |
| Official Contact: | Farzad Parsaie<br>VP, Quality Assurance & Regulatory Affairs<br>[phone] (main number)<br>[e-mail] |
| Date Summary Prepared: | 28 February 2023 |
| 2. Device Name: | |
| Trade Name:<br>Model Number:<br>Common Name:<br>Classification Name:<br>Regulation Numbers: | SpectraWAVE Imaging System<br>System: 931; Catheter: 951<br>Optical Coherence Tomography Imaging System<br>Ultrasonic pulsed echo imaging system<br>Diagnostic intravascular catheter<br>21 CFR 892.1560, 21 CFR 870.1200 |
| Product Code:<br>Classification: | NQQ, ORD, OGZ, IYO<br>Class II |

- 3. Predicate Devices:
2

- K192019 Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version . E.5.1
- . K183599 Infraredx, Inc. Makoto Intravascular Imaging System™, Dualpro™ IVUS+NIRS Imaging Catheter- secondary predicate
- Device Description: 4.

The SpectraWAVE Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system.

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The SpectraWAVE Imaging System consists of the following components:

- Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface.
- Software: A proprietary application software that orchestrates the control, . acquisition, processing, and display of the OCT-NIRS data.
- . Catheter Interface Unit (CIU): A tethered CIU that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console.
- . Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.
- 5. Indications for Use Statement:

The SpectraWAVE Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The SpectraWAVE Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.

The SpectraWAVE Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.

The NIRS capability of the SpectraWAVE Imaging System is intended for the detection of lipid core containing plaques of interest.

The NIRS capability of the SpectraWAVE Imaging System is intended for the assessment of coronary artery lipid core burden.

The NIRS capability of the SpectraWAVE Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

- 6. Technological Characteristics:
The SpectraWAVE Imaging System is utilizing a primary and secondary predicate device as the product combines features of two predicate devices with the same intended use into a single new device. As shown in Tables 1 and 2 below, the SpectraWAVE Imaging System is substantially equivalent to the respective features of the two predicate devices because it has the same intended use, and the technological characteristics are similar and substantially equivalent to the cited predicates.

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| Table 1: Primary Predicate Device Comparison | | | |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion of<br>Equivalence &<br>Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging System<br>Dragonfly OpStar™ Imaging Catheter | |
| 510(k) Number | This submission | K192019 | NA |
| Product Code | NQQ - System, imaging, optical coherence<br>tomography<br>ORD - Optical Coherence Tomography,<br>Intravascular Catheter | NQQ - System, imaging, optical coherence<br>tomography<br>DQO - Catheter, Intravascular, Diagnostic | Same for NQQ code<br>Substantially<br>equivalent for ORD<br>vs DQO codes.<br>While the predicates<br>used DQO as an<br>additional code, the<br>ORD code is more<br>exact for both the<br>proposed and<br>predicate devices. |
| Intended Use | The SpectraWAVE Imaging System and the<br>SpectraWAVE Imaging Catheter are intended<br>for the imaging of coronary arteries. | The OPTIS Imaging System with Dragonfly<br>OpStar Imaging Catheter is intended for the<br>imaging of coronary arteries. | Same |
| Intended<br>Users | Physicians and healthcare professionals | Physicians and healthcare professionals | Same |
| Operational<br>Environment | Cardiac catheterization laboratory | Cardiac catheterization laboratory | Same |
| Indications<br>For Use | The SpectraWAVE Imaging System is intended<br>for the imaging of coronary arteries and is<br>indicated in patients who are candidates for<br>transluminal interventional procedures. | The Dragonfly OpStar™ imaging catheter with<br>OCT imaging system is intended for the<br>imaging of coronary arteries and is indicated in<br>patients who are candidates for transluminal<br>interventional procedures. The Dragonfly<br>OpStar Imaging Catheter is intended for use in | Substantially<br>equivalent for the<br>OCT portion of the<br>device.<br>The scan range of<br>the SpectraWAVE |
| Table 1: Primary Predicate Device Comparison | | | |
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion of<br>Equivalence &<br>Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging System<br>Dragonfly OpStar™ Imaging Catheter | |
| | The SpectraWAVE Imaging Catheter is<br>intended for use in vessels 2.0 to 5.2 mm in<br>diameter.<br><br>The SpectraWAVE Imaging Catheter is not<br>intended for use in a target vessel which has<br>undergone a previous bypass procedure.<br><br>The NIRS capability of the SpectraWAVE<br>Imaging System is intended for the detection of<br>lipid core containing plaques of interest.<br><br>The NIRS capability of the SpectraWAVE<br>Imaging System is intended for the<br>assessment of coronary artery lipid core<br>burden.<br><br>The NIRS capability of the SpectraWAVE<br>Imaging System is intended for the<br>identification of patients and plaques at<br>increased risk of major adverse cardiac events. | vessels 2.0 to 3.5 mm in diameter. The<br>Dragonfly OpStar Imaging Catheter is not<br>intended for use in the left main coronary artery<br>or in a target vessel which has undergone a<br>previous bypass procedure.<br><br>The AptiVue™ E-series software is intended<br>for use only with compatible OPTIS™ imaging<br>systems. The OPTIS imaging system with a<br>compatible Dragonfly™ imaging catheter is<br>intended for the imaging of coronary arteries<br>and is indicated in patients who are candidates<br>for transluminal interventional procedures. The<br>compatible Dragonfly™ imaging catheters are<br>intended for use in vessels 2.0 to 3.5 mm in<br>diameter. The compatible Dragonfly™ imaging<br>catheters are not intended for use in the left<br>main coronary artery or in a target vessel<br>which has undergone a previous bypass<br>procedure.<br><br>The OPTIS imaging system is intended for use<br>in the catheterization and related<br>cardiovascular specialty laboratories and will<br>further compute and display various<br>physiological parameters based on the output<br>from one or more electrodes, transducers, or<br>measuring devices. The physician may use the<br>acquired physiological parameters, along with | Imaging System<br>allows imaging of<br>vessels up to 5.2mm<br>in diameter, which<br>covers the expected<br>range of left main<br>coronary arteries. |
| Table 1: Primary Predicate Device Comparison | | | |
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion of<br>Equivalence &<br>Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging System<br>Dragonfly OpStar™ Imaging Catheter | |
| System<br>Components | Imaging System reusable electrical mechanical<br>unit<br>Intravascular imaging catheter<br>Disposable accessories | Imaging System reusable electrical mechanical<br>unit<br>Intravascular imaging catheter<br>Disposable accessories | Substantially<br>Equivalent |
| Primary<br>Functions | Delivers energy (infrared light) to the tissue.<br>Measures the depth and pattern of reflections<br>from the tissue from the return near infrared<br>light to create high resolution, real time images.<br>Stores images for evaluation and review. | Delivers energy (infrared light) to the tissue.<br>Measures the depth and pattern of reflections<br>from the tissue from the return near infrared<br>light to create high resolution, real time images.<br>Stores images for evaluation and review. | Same |
| Image<br>Creation,<br>Display and<br>Storage | Process reflected optical signals to construct<br>images.<br>Display images.<br>Store images. | Process reflected optical signals to construct<br>images.<br>Display images.<br>Store images. | Same |
| Measure<br>Vessel Cross<br>Sectional Area | Calculate and report vessel cross sectional<br>area | Calculate and report vessel cross sectional<br>area | Same |
| Measure<br>Vessel Linear<br>Dimensions | Calculate and display vessel diameter at user<br>specified locations within the displayed image | Calculate and display vessel diameter at user<br>specified locations within the displayed image | Same |
| Calculate<br>Vessel<br>Physical<br>Parameters | Calculate and display mathematical<br>comparisons of image data such as %<br>reduction from average, length of narrowing. | Calculate and display mathematical<br>comparisons of image data such as %<br>reduction from average, length of narrowing. | Same |
| Table 1: Primary Predicate Device Comparison | | | |
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion of<br>Equivalence &<br>Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging System<br>Dragonfly OpStar™ Imaging Catheter | |
| Procedural<br>Steps | System set-up, patient data entry, catheter<br>preparation insertion of catheter into the artery<br>under fluoroscopic guidance, proper<br>positioning of the catheter distal to the target<br>vessel, image acquisition and evaluation of the<br>acquired images. | System set-up, patient data entry, catheter<br>preparation and flushing, insertion of catheter<br>into the artery under fluoroscopic guidance,<br>proper positioning of the catheter distal to the<br>target vessel, image acquisition and evaluation<br>of the acquired images. | Substantially<br>Equivalent |
| Use of Results | Physicians evaluate the images in combination<br>with other tests and evaluations to assess the<br>patient's coronary arteries. | Physicians evaluate the images in combination<br>with other tests and evaluations to assess the<br>patient's coronary arteries. | Same |
| Imaging Catheter | | | |
| Primary<br>Functions | To position the catheter into the vessel to be<br>imaged.<br>To deliver near infrared light to tissues.<br>To collect reflections. | To position the catheter into the vessel to be<br>imaged.<br>To deliver near infrared light to tissues.<br>To collect reflections. | Same |
| Design<br>Features | Rapid exchange, mono-rail tip design with two<br>sub-assemblies (catheter sheath and imaging<br>core). | Rapid exchange, mono-rail tip design with two<br>sub-assemblies (catheter sheath and imaging<br>core).…