(82 days)
The HyperVue™ Imaging System - Integrated with compatible HyperVue™ Software and Starlight™ Imaging Catheter 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 - Integrated is intended for the detection of lipid core containing plaques of interest.
The NIRS capability of the HyperVue Imaging System - Integrated is intended for the assessment of coronary artery lipid core burden.
The NIRS capability of the HyperVue Imaging System - Integrated is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
The HyperVue Imaging System – Integrated is a stationary, capital equipment platform intended for intravascular optical imaging of coronary arteries. HyperVue Imaging System – Integrated with the HyperVue Software and the Starlight Imaging Catheter is used as 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).
N/A
FDA 510(k) Clearance Letter - HyperVue™ Imaging System - Integrated
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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
December 15, 2025
SpectraWAVE, Inc.
Ankit Shah
Senior Regulatory Affairs Manager
12 Oak Park Drive
Bedford, Massachusetts 01730
Re: K253101
Trade/Device Name: HyperVue™ Imaging System - Integrated
Regulation Number: 21 CFR 892.1560
Regulation Name: Ultrasonic pulsed echo imaging system
Regulatory Class: Class II
Product Code: NQQ, IYO
Dated: September 23, 2025
Received: September 24, 2025
Dear Ankit Shah:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K253101 - Ankit Shah 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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K253101 - Ankit Shah Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh S. Deoras -S
Aneesh Deoras
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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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. | K253101 |
|---|---|
| Please provide the device trade name(s). | |
| HyperVue™ Imaging System - Integrated |
Please provide your Indications for Use below.
The HyperVue™ Imaging System - Integrated with compatible HyperVue™ Software and Starlight™ Imaging Catheter 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 - Integrated is intended for the detection of lipid core containing plaques of interest.
The NIRS capability of the HyperVue Imaging System - Integrated is intended for the assessment of coronary artery lipid core burden.
The NIRS capability of the HyperVue Imaging System - Integrated is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
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)
HyperVue Imaging System - Integrated
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510(k) Summary
K253101 Premarket Notification HyperVue™ Imaging System – Integrated 1
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. Submitter Name & Address:
510(k) Owner: SpectraWAVE, Inc.
Address: 12 Oak Park Drive
Bedford, MA 01730
(781) 701-8148
Official Contact: Ankit K. Shah
Senior Manager Regulatory Affairs
(323) 401 6480
ashah@spectrawave.com
Date Prepared: 9/23/2025
510(k) Number: K253101
2. Device Name:
| Trade Name | HyperVue™ Imaging System - Integrated |
|---|---|
| Common Name | Optical Coherence Tomography Imaging System |
| Classification Name | System, Imaging, Optical Coherence Tomography |
| Regulation Number | 21 CFR 892.1560 |
| Product Code | NQQ, IYO |
| Classification | Class II |
3. Predicate Device:
- Predicate Device: K221257, HyperVue Imaging System
- Recall Status: The predicate device (K221257) has not been subject to a design-related recall.
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K253101 Premarket Notification HyperVue™ Imaging System – Integrated 2
4. Device Description:
The HyperVue Imaging System – Integrated is a stationary, capital equipment platform intended for intravascular optical imaging of coronary arteries. HyperVue Imaging System – Integrated with the HyperVue Software and the Starlight Imaging Catheter is used as 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).
Indications for Use Statement:
The HyperVue™ Imaging System – Integrated with compatible HyperVue™ Software and Starlight™ Imaging Catheter 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 - Integrated is intended for the detection of lipid core containing plaques of interest.
The NIRS capability of the HyperVue Imaging System - Integrated is intended for the assessment of coronary artery lipid core burden.
The NIRS capability of the HyperVue Imaging System - Integrated is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
5. Technological Characteristics:
The HyperVue Imaging System - Integrated has the same intended use, indications for use, functionality, and operating principle as the predicate device. Differences in the form factor and mobility configuration do not raise new questions of safety and effectiveness.
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K253101 Premarket Notification HyperVue™ Imaging System – Integrated 3
| PREDICATE DEVICE | SUBJECT DEVICE | Discussion of Equivalence & Differences | |
|---|---|---|---|
| SpectraWAVE, Inc. HyperVue Imaging System (K221257) | SpectraWAVE, Inc. HyperVue Imaging System – Integrated (K253101) | ||
| Product Code | NQQ – System, imaging, optical coherence tomography ORD – Optical Coherence Tomography, Intravascular Catheter OGZ – Catheter, Intravascular, Plaque Morphology Evaluation IYO – System, Imaging, Pulsed Echo, Ultrasonic | NQQ – System, imaging, optical coherence tomography IYO – System, Imaging, Pulsed Echo, Ultrasonic | Same |
| Intended Use | The HyperVue™ Imaging System and the SpectraWAVE Starlight™ Imaging Catheter are intended for the imaging of coronary arteries. | The HyperVue® Imaging System – Integrated is used with HyperVue® Software and the Starlight® Imaging Catheter intended for the imaging of coronary arteries. | Same Only added tradenames for the HyperVue Software and Starlight Imaging Catheter |
| Intended Users | Physicians and healthcare professionals | Physicians and healthcare professionals | Same |
| Operational Environment | Cardiac catheterization laboratory | Cardiac catheterization laboratory | Same |
| Primary Components | Console, Controller, Software and Catheter | Console and Controller | Different HyperVue Software (K251198) and Starlight Imaging Catheter (K243016) now have their independent clearances |
| Indications For Use | The HyperVue™ Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for | The HyperVue™ Imaging System – Integrated with compatible HyperVue™ Software and Starlight™ Imaging Catheter is intended for the imaging of coronary | Same |
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K253101 Premarket Notification HyperVue™ Imaging System – Integrated 4
| PREDICATE DEVICE | SUBJECT DEVICE | Discussion of Equivalence & Differences | |
|---|---|---|---|
| SpectraWAVE, Inc. HyperVue Imaging System (K221257) | SpectraWAVE, Inc. HyperVue Imaging System – Integrated (K253101) | ||
| 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. | 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 - Integrated is intended for the detection of lipid core containing plaques of interest. The NIRS capability of the HyperVue Imaging System - Integrated is intended for the assessment of coronary artery lipid core burden. The NIRS capability of the HyperVue Imaging System - Integrated is intended for the identification of patients and plaques at increased risk of major adverse cardiac events. | ||
| Primary Functions | Provide rotational and linear moment to the Starlight Imaging Catheter for initiating pullback Delivers energy (infrared light) to the tissue. | Provide rotational and linear motion to the Starlight Imaging Catheter for initiating pullback | Same |
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K253101 Premarket Notification HyperVue™ Imaging System – Integrated 5
| PREDICATE DEVICE | SUBJECT DEVICE | Discussion of Equivalence & Differences | |
|---|---|---|---|
| SpectraWAVE, Inc. HyperVue Imaging System (K221257) | SpectraWAVE, Inc. HyperVue Imaging System – Integrated (K253101) | ||
| 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. | 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 - Integrated is intended for the detection of lipid core containing plaques of interest. The NIRS capability of the HyperVue Imaging System - Integrated is intended for the assessment of coronary artery lipid core burden. The NIRS capability of the HyperVue Imaging System - Integrated is intended for the identification of patients and plaques at increased risk of major adverse cardiac events. | ||
| Primary Functions | Provide rotational and linear moment to the Starlight Imaging Catheter for initiating pullback Delivers energy (infrared light) to the tissue. | Provide rotational and linear motion to the Starlight Imaging Catheter for initiating pullback Delivers energy (infrared light) to the tissue through the Starlight Imaging Catheter. Measures the depth and pattern of reflections from the tissue from the return near-infrared light to create high-resolution, real-time images. Stores images for evaluation and review. | Same |
| Image Creation, Display and Storage | Process reflected optical signals to construct images. Display images. Store images. | Process reflected optical signals to construct images. Display images. Store images. | Same |
| Measure Vessel Linear Dimensions | Calculate and display vessel diameter at user specified locations within the displayed image | Calculate and display vessel diameter at user specified locations within the displayed image | Same |
| Calculate Vessel Physical Parameters | Calculate and display mathematical comparisons of image data such as % reduction from average, length of narrowing, cross-sectional area. | Calculate and display mathematical comparisons of image data such as % reduction from average, length of narrowing, cross-sectional area. | Same (Same HyperVue Software – K251198 for subject and predicate device) |
| Use of Results | Physicians evaluate the images in combination with other tests and evaluations to assess the patient's coronary arteries. | Physicians evaluate the images in combination with other tests and evaluations to assess the patient's coronary arteries. | Same |
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K253101 Premarket Notification HyperVue™ Imaging System – Integrated 6
| PREDICATE DEVICE | SUBJECT DEVICE | Discussion of Equivalence & Differences | |
|---|---|---|---|
| SpectraWAVE, Inc. HyperVue Imaging System (K221257) | SpectraWAVE, Inc. HyperVue Imaging System – Integrated (K253101) | ||
| Measures the depth and pattern of reflections from the tissue from the return near-infrared light to create high-resolution, real-time images. Stores images for evaluation and review. | Delivers energy (infrared light) to the tissue through the Starlight Imaging Catheter. Measures the depth and pattern of reflections from the tissue from the return near-infrared light to create high-resolution, real-time images. Stores images for evaluation and review. | ||
| Image Creation, Display and Storage | Process reflected optical signals to construct images. Display images. Store images. | Process reflected optical signals to construct images. Display images. Store images. | Same |
| Measure Vessel Linear Dimensions | Calculate and display vessel diameter at user specified locations within the displayed image | Calculate and display vessel diameter at user specified locations within the displayed image | Same |
| Calculate Vessel Physical Parameters | Calculate and display mathematical comparisons of image data such as % reduction from average, length of narrowing, cross-sectional area. | Calculate and display mathematical comparisons of image data such as % reduction from average, length of narrowing, cross-sectional area. | Same (Same HyperVue Software – K251198 for subject and predicate device) |
| Use of Results | Physicians evaluate the images in combination with other tests and evaluations to assess the patient's coronary arteries. | Physicians evaluate the images in combination with other tests and evaluations to assess the patient's coronary arteries. | Same |
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K253101 Premarket Notification HyperVue™ Imaging System – Integrated 7
| PREDICATE DEVICE | SUBJECT DEVICE | Discussion of Equivalence & Differences | |
|---|---|---|---|
| SpectraWAVE, Inc. HyperVue Imaging System (K221257) | SpectraWAVE, Inc. HyperVue Imaging System – Integrated (K253101) | ||
| Operating System (OS) | Windows-based (Windows Enterprise IoT) | Windows-based (Windows Enterprise IoT) | Same (Same HyperVue Software – K251198 for subject and predicate device) |
| User Convenience Features | Computer-aided measurement tools, such as border contours, computation of cross-sectional area, user-selectable image overlays, and percent stenosis. Display of live angiography imagery on the HyperVue Imaging System display monitors. | Computer-aided measurement tools, such as border contours, computation of cross-sectional area, user-selectable image overlays, and percent stenosis. Display of live angiography imagery on the display monitors. | Same (Same HyperVue Software – K251198 for subject and predicate device) |
| Energy Source | Near infrared light | Near infrared light | Same |
| Operating Conditions | 15 - 30°C 5 – 80% RH, non-condensing | 15 - 30°C 5 – 80% RH, non-condensing | Same |
| Sterile Barrier Interface | Controller encapsulated in single use disposable bag | Controller encapsulated in single use disposable bag | Same |
| Configuration | Mobile cart with braking system | Fixed and installed in a catheterization lab | Different (Does not introduce concerns about safety and effectiveness) |
| Catheter Connection | Single Connection | Single Connection | Same |
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K253101 Premarket Notification HyperVue™ Imaging System – Integrated 8
| PREDICATE DEVICE | SUBJECT DEVICE | Discussion of Equivalence & Differences | |
|---|---|---|---|
| SpectraWAVE, Inc. HyperVue Imaging System (K221257) | SpectraWAVE, Inc. HyperVue Imaging System – Integrated (K253101) | ||
| Linear Motion | 60mm/s and 120mm/s | 60mm/s and 120mm/s | Same |
| Rotational Motion | 12000 rpm | 12000 rpm | Same |
| Monitors | High resolution touch-screen monitors | High resolution touch-screen monitors | Same |
6. Performance Data:
6.1 Non-Clinical Testing:
Design verification and validation of the HyperVue Imaging System - Integrated were performed in compliance with external standards and internal design control procedures comprised of EMC/Electrical Safety, Bench Testing, and summative usability testing to confirm device performance. The testing is conducted to demonstrate safety and effectiveness and ensure that the subject device performs as intended.
EMC/Electrical Safety:
The HyperVue Imaging System - Integrated has been tested and is in compliance with general safety requirements, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, and IEC 60825-1.
Performance – Bench Testing:
HyperVue Imaging System - Integrated was tested in accordance with an established test plan that fully evaluated all functions performed by the subject device. Design verification and validation testing is performed at a unit, integration, system level verifying the use of the subject device with HyperVue Software and Starlight Imaging Catheter (K243016).
Summative Evaluation:
Usability evaluation was conducted to establish that the HyperVue Imaging System – Integrated meets the needs of the intended users to perform its intended use safely and effectively according to ANSI/AAMI/IEC 62366-1.
The HyperVue Imaging System - Integrated has been found to be safe and effective for the intended users, uses, and use environments.
7. Conclusion and Statement of Equivalence:
The information presented in this 510(k) submission demonstrates that the HyperVue Imaging System - Integrated is as safe and as effective, and performs as well as or better than the predicate device, and is therefore considered substantially equivalent to the predicate device.
N/A