HyperVue™ Imaging System

K230691 · Spectrawave, Inc. · NQQ · Jun 7, 2023 · Radiology

Device Facts

• Record ID: K230691
• Device Name: HyperVue™ Imaging System
• Applicant: Spectrawave, Inc.
• Product Code: NQQ · Radiology
• Decision Date: Jun 7, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

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

Device Story

HyperVue™ Imaging System is an intravascular imaging device combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) to assess coronary artery vessel composition and structure. System comprises a mobile console, proprietary application software, a tethered Catheter Interface Unit (CIU), and a sterile, single-use 2.5 French dual-modality imaging catheter. During procedures in the cardiac catheterization laboratory, physicians insert the catheter into the artery under fluoroscopic guidance. The fiber optic imaging core delivers infrared light to tissue; the system measures reflected light to construct high-resolution, real-time images. Software processes signals to calculate vessel cross-sectional area, diameter, and percent stenosis. Output is displayed on console monitors for physician evaluation alongside other clinical tests. Device aids in identifying lipid core-containing plaques and assessing lipid core burden to inform clinical decision-making regarding interventional procedures.

Clinical Evidence

No clinical testing provided. Evidence consists of bench testing, software verification/validation per IEC 62304, and summative human factors engineering (HFE) usability testing per ANSI/AAMI/IEC 62366-1.

Technological Characteristics

Dual-modality OCT and NIRS imaging system. Components: mobile console, CIU, and 2.5 French fiber-optic imaging catheter. Connectivity: Windows Enterprise IoT-based platform. Software: proprietary application for data acquisition, processing, and display. Features include automated measurement tools (border contours, cross-sectional area, percent stenosis). Sterilization: single-use sterile catheter. Standards: IEC 62304 (software), ANSI/AAMI/IEC 62366-1 (usability).

Indications for Use

Indicated for patients who are candidates for transluminal interventional procedures requiring coronary artery imaging. Starlight™ Imaging Catheter for vessels 2.0-5.2 mm diameter; contraindicated for 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

• SpectraWAVE Imaging System and Catheter (K221257)

Submission Summary (Full Text)

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June 7, 2023

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

Re: K230691

Trade/Device Name: HyperVue™ 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: March 13, 2023 Received: March 13, 2023

Dear Farzad Parsaie:

We have reviewed vour 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 (DICE(@fda.hhs.gov) 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K230691

Device Name

HyperVue™ Imaging System

### Indications for Use (Describe)

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

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

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

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

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

The NIRS capability of the HyperVue 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) | |
|--------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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# Traditional 510(k) Summary

#### 1. Submitter Name & Address:

| 510(k) Owner: | SpectraWAVE, Inc. |
|-------------------|------------------------------------------------------------------------------------------------------------|
| Address: | 12 Oak Park Drive<br>Bedford, MA 01730<br>[phone] |
| Official Contact: | Farzad Parsaie<br>VP, Quality Assurance & Regulatory Affairs<br>[phone]<br>[e-mail] |
| Date Prepared: | 6/5/2023 |

## 2. Device Name:

| Trade Name: | HyperVue™ Imaging System |
|----------------------|------------------------------------------------------------------------------------|
| Model Number: | System: 931 |
| Common Name: | Optical Coherence Tomography Imaging System |
| Classification Name: | System, Imaging, Optical Coherence Tomography<br>Diagnostic intravascular catheter |
| Regulation Numbers: | 21 CFR 892.1560, 21 CFR 870.1200 |
| Product Code: | NQQ, ORD, OGZ, IYO |
| Classification: | Class II |

#### 3. Predicate Device:

- . K221257, SpectraWAVE Imaging System and Catheter
#### Device Description: 4.

The HyperVue™ 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.

The HyperVue™ Imaging System consists of the following components:

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

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

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

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

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

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

#### 6. Technological Characteristics:

Three of the four system components in the HyperVue™ Imaging System - Console, CIU and Imaging Catheter - are the same as the predicate device. The subject of this application is for the Software module which contains updates with similar technological characteristics and substantially equivalent performance to the cited predicate. Table 1 below provides a comparative summary (predicate vs proposed device) for the relevant system characteristics/features.

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| Predicate Device Comparison | | | |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer<br>& Model | PREDICATE DEVICE<br>SpectraWAVE, Inc.<br>SpectraWAVE Imaging System (K221257) | PROPOSED DEVICE<br>SpectraWAVE, Inc.<br>HyperVue™ Imaging System | Discussion of<br>Equivalence &<br>Differences |
| Product Code | NQQ - System, imaging, optical coherence<br>tomography<br>ORD - Optical Coherence Tomography,<br>Intravascular Catheter<br>OGZ - Catheter, Intravascular, Plaque<br>Morphology Evaluation<br>IYO - System, Imaging, Pulsed Echo,<br>Ultrasonic | NQQ - System, imaging, optical coherence<br>tomography<br>ORD - Optical Coherence Tomography,<br>Intravascular Catheter<br>OGZ - Catheter, Intravascular, Plaque<br>Morphology Evaluation<br>IYO - System, Imaging, Pulsed Echo,<br>Ultrasonic | Same |
| Intended Use | The SpectraWAVE Imaging System and the<br>SpectraWAVE Imaging Catheter are intended<br>for the imaging of coronary arteries. | The HyperVue™ Imaging System and the<br>Starlight™ Imaging Catheter are intended for<br>the imaging of coronary arteries. | Same<br>Added tradenames<br>only |
| 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.<br>The SpectraWAVE Imaging Catheter is<br>intended for use in vessels 2.0 to 5.2 mm in<br>diameter.<br>The SpectraWAVE Imaging Catheter is not<br>intended for use in a target vessel which has<br>undergone a previous bypass procedure. | The HyperVue™ 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.<br>The Starlight™ Imaging Catheter is intended<br>for use in vessels 2.0 to 5.2 mm in diameter.<br>The Starlight Imaging Catheter is not intended<br>for use in a target vessel which has undergone<br>a previous bypass procedure.<br>The NIRS capability of the HyperVue Imaging<br>System is intended for the detection of lipid<br>core containing plaques of interest. | Same<br>Added tradenames<br>only |
| Predicate Device Comparison | | | |
| Manufacturer<br>& Model | PREDICATE DEVICE<br>SpectraWAVE, Inc.<br>SpectraWAVE Imaging System (K221257) | PROPOSED DEVICE<br>SpectraWAVE, Inc.<br>HyperVue™ Imaging System | Discussion of<br>Equivalence &<br>Differences |
| | The NIRS capability of the SpectraWAVE<br>Imaging System is intended for the detection of<br>lipid core containing plaques of interest.<br>The NIRS capability of the SpectraWAVE<br>Imaging System is intended for the<br>assessment of coronary artery lipid core<br>burden.<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. | The NIRS capability of the HyperVue Imaging<br>System is intended for the assessment of<br>coronary artery lipid core burden.<br>The NIRS capability of the HyperVue Imaging<br>System is intended for the identification of<br>patients and plaques at increased risk of major<br>adverse cardiac events. | |
| 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<br>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<br>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 |
| Predicate Device Comparison | | | |
| Manufacturer<br>& Model | PREDICATE DEVICE<br>SpectraWAVE, Inc.<br>SpectraWAVE Imaging System (K221257) | PROPOSED DEVICE<br>SpectraWAVE, Inc.<br>HyperVue™ Imaging System | Discussion of<br>Equivalence &<br>Differences |
| 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 |
| 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 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. | Same |
| 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 |
| Operating<br>System (OS) | Windows-based (Windows Professional<br>Desktop) | Windows-based (Windows Enterprise IoT)<br>Windows Enterprise IoT OS provides<br>configurability for deploying a single-<br>purpose dedicated system. | Substantially<br>equivalent<br>There is no<br>difference in the<br>fundamental<br>performance and<br>intended use of the<br>software due to<br>change to OS |
| User<br>Convenience<br>Features | Computer-aided measurement tools, such as<br>border contours, computation of cross-<br>sectional area, and percent stenosis.<br>Display of live angiography imagery on the<br>SpectraWAVE Imaging System display<br>monitors. | Computer-aided measurement tools, such as<br>border contours, computation of cross-<br>sectional area, and percent stenosis.<br>Display of live angiography imagery on the<br>HyperVue™ Imaging System display monitors. | Substantially<br>equivalent<br>The additional<br>features are minor<br>changes compared<br>to the predicate and<br>were added to the |
| Predicate Device Comparison | | | |
| Manufacturer<br>& Model | PREDICATE DEVICE | PROPOSED DEVICE | Discussion of<br>Equivalence &<br>Differences |
| | SpectraWAVE, Inc.<br>SpectraWAVE Imaging System (K221257) | SpectraWAVE, Inc.<br>HyperVue™ Imaging System | proposed device to<br>provide user-<br>selectable and<br>optional user<br>convenience<br>features.<br>No changes were<br>made to the<br>intended use or<br>indications of use of<br>the device. |
| | | The following updates have been added<br>compared to the predicate device:<br>• Addition of new user-selectable and<br>optional image overlays on the displayed<br>viewports (Angiography & OCT-NIRS) to<br>highlight OCT/NIRS-derived features.<br>• Update to User Interface (UI) look-and-feel<br>and clinical workflow | |

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#### 7. Performance Testing:

#### 7.1 Summary of Performance Testing:

Design verification and validation (V&V) of the HyperVue™ Imaging System with the updated software were performed in compliance with external standards and internal design control procedures. V&V testing comprised of system/software verification and summative usability testing to confirm device performance.

#### 7.2 Sterilization and Shelf Life:

No change from K221257. Sterilization and shelf life are not impacted since this 510(k) submission covers only a software update for the HyperVue™ Imaging System.

#### 7.3 Biocompatibility:

No change from K221257. Biocompatibility is not impacted since this 510(k) submission covers only a software update for the HyperVue™ Imaging System.

#### 7.4 Software:

HyperVue™ Imaging System and Application Software were developed and tested in compliance with IEC 62304. Software verification and validation were conducted to FDA requlations, standards, and quidance document requirements. The results of this testing conclude the software has met these requirements.

#### 7.5 EMC/Basic Electrical Safety:

No change from K221257. This 510(k) submission covers only a software update package for the HyperVue™ Imaging System. EMC & Basic Electrical Safety are not impacted by this software update.

#### 7.6 Bench testing:

In addition to the software verification testing described above, benchtop testing of the entire device was conducted to evaluate certain system-level features, such as measurements, that require both hardware and software to evaluate. The results of this testing conclude the system has met these requirements.

#### 7.7 Animal Testing:

Not applicable. No animal testing was necessary to demonstrate equivalence.

#### 7.8 Human Factors Engineering (HFE) Usability Study:

Usability evaluation was conducted to establish that the updated software for the HyperVue™ Imaging System meets the needs of the intended users to perform OCT-NIRS imaging safely and effectively according to ANSI/AAMI/IEC 62366-1.

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The updated software for the HyperVue™ Imaging System has been found to be safe and effective for the intended users, uses, and use environments.

#### 7.9 Clinical Testing:

No clinical testing is provided in this pre-market notification.

#### 8. Conclusion and Statement of Equivalence:

Modifications to the software of the device presented in this 510(k) submission do not raise new questions of safety or effectiveness. As demonstrated by risk management activities, software verification, and HFE usability study testing, the proposed HyperVue™ Imaging System does not raise new questions of safety or effectiveness and is therefore considered substantially equivalent to the predicate device.