The SpectraWAVE X1-FFR Software is a standalone medical device which is used in the catheterization lab as an angiography image assessment tool for assessing Fractional Flow Reserve using non-invasive quantitative and functional analysis of coronary vasculature.

The SpectraWAVE X1-FFR software comprises image processing and computational algorithms to perform functional coronary angiography, providing longitudinal estimations of coronary pressure drop and Fractional Flow Reserve (FFR) during angiogram and percutaneous coronary intervention (PCI) procedures.
The SpectraWAVE X1-FFR Software is a procedural aid intended to be used to support diagnosis by clinicians.

AI-derived algorithms are deployed on the device to support vessel segmentation and contouring. Analytical (non-AI) models are used for generating FFR values.

The SpectraWAVE X1-FFR Software:

provides measurements of localized coronary pressure drops over the length of a coronary vessel, including the right and left coronary tree.
provides dimensions of the coronary vessels and the amount of stenosis in coronary vessels;
enables physiology assessment in a non-invasive manner, without the need for adenosine and without the need for additional radiation and contrast administration.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) clearance letter for the SpectraWAVE X1-FFR Software, extracting the requested information about acceptance criteria and the supporting study:

SpectraWAVE X1-FFR Software: Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" for the X1-FFR's performance, but it does report on a key performance metric: the relationship between X1-FFR and invasive hyperemic pressure wire measurements.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Bias between X1-FFR and invasive hyperemic pressure wire	A bias close to 0, indicating accuracy.	0.00
Agreement between X1-FFR and invasive hyperemic pressure wire	Narrow 95% limits of agreement, indicating precision and consistency.	[-0.12, 0.12]

Note: The phrase "All testing passed the acceptance criteria" is mentioned, suggesting that internal acceptance criteria were defined and met, but these specific criteria are not detailed in the public 510(k) summary. The reported Bland-Altman analysis results serve as a key demonstration of performance.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 306 vessels from 285 patients.
Data Provenance: The study was a "retrospective clinical analysis." The country of origin is not specified in the provided document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, the ground truth itself is defined by "invasive hyperemic pressure wire" measurements, which are considered the gold standard for FFR assessment and are performed by trained medical professionals (cardiologists).

4. Adjudication Method for the Test Set

The adjudication method for the test set is not explicitly described. Since the ground truth "invasive hyperemic pressure wire" is a direct physiological measurement, rather than a subjective interpretation, a formal adjudication of ground truth for the FFR values themselves is less common than for image-based diagnoses.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size on how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance of the X1-FFR software against a gold standard.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The "retrospective clinical analysis" assessed the X1-FFR software's performance "relative to invasive hyperemic pressure wire." This implies the algorithm-only performance was evaluated without human-in-the-loop assistance for the FFR calculation itself. The software is described as a "procedural aid intended to be used to support diagnosis by clinicians," but the reported performance study specifically evaluates the software's calculation directly against the ground truth.

7. Type of Ground Truth Used

The ground truth used was invasive hyperemic pressure wire measurements. This is considered the current clinical gold standard (outcome/physiological measurement) for Fractional Flow Reserve (FFR).

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set. It only describes the "retrospective clinical analysis" which served as the performance validation (test set).

9. How the Ground Truth for the Training Set Was Established

The document does not specify how the ground truth for the training set was established, as the training set details are not provided.

Summary

FDA 510(k) Clearance Letter - SpectraWAVE X1-FFR Software

Page 1

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

Doc ID # 04017.08.00

October 17, 2025

SpectraWAVE, Inc.
℅ Ankit Shah
Senior Manager Regulatory Affairs
12 Oak Park Drive
BEDFORD, MA 01730

Re: K251355
Trade/Device Name: X1-FFR
Regulation Number: 21 CFR 892.1600
Regulation Name: Angiographic X-Ray System
Regulatory Class: Class II
Product Code: QHA, LLZ
Dated: September 15, 2025
Received: September 16, 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.

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K251355 - Ankit Shah
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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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K251355 - Ankit Shah
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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,

Lu Jiang

Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiologic Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

510(k) Number (if known)
K251355

Device Name
X1-FFR

Indications for Use (Describe)

The SpectraWAVE X1-FFR Software features segmentation of coronary vessels, and measurement and reporting tools to facilitate the following use:

Calculate the dimensions of coronary vessels;
Quantify stenosis in coronary vessels;
Quantify pressure drop in coronary vessels;

The SpectraWAVE X1-FFR Software is intended to be used by or under the supervision of a cardiologist.

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:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"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."

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

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Premarket Notification, SpectraWAVE X1-FFR Software

K251355

510(k) Summary

Traditional 510(k) Summary

1. Basic Information-Submitter:

510(k) Owner: SpectraWAVE, Inc.

Address: 12 Oak Park Drive
Bedford, MA 01730
(781) 701-8148 (main number)

Official Contact: Ankit Shah
Senior Manager, Regulatory Affairs
(323) 401-6480
ashah@spectrawave.com

Date Summary Prepared: 10/17/2025

2. Device Name:

Trade Name: X1-FFR
Common Name: X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Classification Name: Angiographic x-ray system
Regulation Numbers: 21 CFR 892.1600
Product Code: QHA, LLZ
Classification: Class II

3. Predicate Devices:

K180019 Pie Medical Imaging CAAS Workstation

4. Device Description:

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The SpectraWAVE X1-FFR Software is a procedural aid intended to be used to support diagnosis by clinicians.

AI-derived algorithms are deployed on the device to support vessel segmentation and contouring. Analytical (non-AI) models are used for generating FFR values.

The SpectraWAVE X1-FFR Software:

provides measurements of localized coronary pressure drops over the length of a coronary vessel, including the right and left coronary tree.
provides dimensions of the coronary vessels and the amount of stenosis in coronary vessels;
enables physiology assessment in a non-invasive manner, without the need for adenosine and without the need for additional radiation and contrast administration.

5. Indications for Use Statement:

The SpectraWAVE X1-FFR Software features segmentation of coronary vessels, and measurement and reporting tools to facilitate the following use:

Calculate the dimensions of coronary vessels;
Quantify stenosis in coronary vessels;
Quantify pressure drop in coronary vessels;

The SpectraWAVE X1-FFR Software is intended to be used by or under the supervision of a cardiologist.

6. Comparison of Technological Characteristics:

A comparison of the technological characteristics of the subject and the predicate device is provided in the table below.

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SUBJECT DEVICE	PREDICATE DEVICE	Comparison
SpectraWAVE X1-FFR	Pie Medical CAAS Workstation (K180019)
Company	Company
SpectraWAVE12 Oak Park DriveBedford, MA 01730, USA	Pie Medical Imaging BVPhilipsweg 1, 6227 AJMaastricht, The Netherlands
Intended Use	Intended Use	Comparison
The SpectraWAVE X1-FFR Software is a software product intended to be used by or under the supervision of a cardiologist in order to aid in reading, co-registering, and interpreting cardiovascular X-ray images to support in diagnoses and for assistance during the intervention of cardiovascular conditions.	CAAS Workstation is a modular software product intended to be used by or under supervision of a cardiologist or radiologist in order to aid in reading, co-registering and interpreting cardiovascular X-Ray images to support diagnoses and for assistance during intervention of cardiovascular conditions.	Identical
Indications for Use	Indications for Use	Comparison
The SpectraWAVE X1-FFR Software features segmentation of coronary vessels, and measurement and reporting tools to facilitate the following use:• Calculate the dimensions of coronary vessels;• Quantify stenosis in coronary vessels;• Quantify pressure drop in coronary vessels;The SpectraWAVE X1-FFR Software is intended to be used by or under the supervision of a cardiologist.	CAAS Workstation features segmentation of cardiovascular structures, 3D reconstruction of vessel segments and catheter path based on multiple angiographic images, measurement and reporting tools to facilitate the following use:• Calculate the dimensions of cardiovascular structures;• Quantify stenosis in coronary and peripheral vessels;• Quantify the motion of the left and right ventricular wall;• Perform density measurements;• Determine C-arm position for optimal imaging of cardiovascular structures;• Enhance stent visualization and measure stent dimensions;	The subject device indications are identical to a subset of the indications cleared for the predicate device.Indications for the subject device focus on the assessment of coronary vessels.

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SUBJECT DEVICE	PREDICATE DEVICE	Comparison
SpectraWAVE X1-FFR	Pie Medical CAAS Workstation (K180019)
	• Quantify pressure drop in coronary vessels;• Co-registration of angiographic X-Ray images with IVUS and OCT images.CAAS Workstation is intended to be used by or under supervision of a cardiologist or radiologist.
Regulation Number	Regulation Number	Comparison
21 CFR 892.1600	21 CFR 892.1600	Identical
FDA Product Code	FDA Product Code	Comparison
QHA, LLZ	QHA, LLZ	Identical
Data Input	Data Input	Comparison
X-ray angiography in Display format (vendor independent)	X-ray angiography in DICOM format (vendor independent);• IVUS and OCT data in DICOM format (vendor independent);• IVUS data as video stream	The subject device data input type is similar to a subset of the data inputs cleared for the predicate device.The subject device uses X-Ray angiography in display format and does not accept other image types.
Image Display	Image Display	Comparison
• 2D X-Ray Image	• 2D X-ray image;• 3D reconstruction based on 2 X-ray images;• 2D intravascular image;• Longitudinal intravascular reconstruction	The subject device's image display outputs are identical to a subset of the image display outputs cleared for the predicate device.

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SUBJECT DEVICE	PREDICATE DEVICE	Comparison
SpectraWAVE X1-FFR	Pie Medical CAAS Workstation (K180019)
		The subject device displays 2D X-Ray Images and does not display 3D reconstruction or intravascular formats.
Image Assessment	Image Assessment	Comparison
• Automatic calibration;• Vessel dimensions (diameters, lengths);• Automatic and manual stenosis assessment;• Pressure drop calculation in coronary vessel	• Manual and automatic calibration;• Basic length, diameter, density and angle measurements;• Vessels and ventricle dimensions (diameters, areas, volumes);• Automatic and manual stenosis assessment;• Left and right ventricular wall motion;• Left ventricular myocardium dimensions;• Enhanced stent visualization;• Stent dimensions;• Pressure drop calculation in coronary vessels;• Providing common frame of reference for IVUS and OCT data with X-ray angiographic data	The subject device's image assessment capabilities are identical to a subset of the image assessment capabilities cleared for the predicate device.The subject device's image assessment focuses on the analysis of coronary vessels.

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7. Performance Testing:

7.1 Summary of Performance Testing:

Design verification and validation of the SpectraWAVE X1-FFR Software were performed in compliance with external standards and internal design control procedures comprised of software development, bench testing (software and algorithm), and summative usability testing to confirm device performance.

7.2 Software:

SpectraWAVE X1-FFR Software was developed and tested in compliance with IEC 62304. Software verification and validation were conducted in accordance with applicable FDA regulations, standards, and guidance document requirements. The results of this testing conclude the software has met these requirements.

7.3 Performance Data:

SpectraWAVE performed a series of tests to demonstrate that the X1-FFR Software meets its performance specifications. Comprehensive verification and validation activities were successfully completed, raising no safety or effectiveness concerns. All testing passed the acceptance criteria.

X1-FFR performance relative to invasive hyperemic pressure wire was assessed in a retrospective clinical analysis of 306 vessels from 285 patients. The mean age of the patients included in the study was 66 years old, and 73% were male. Of the 306 vessels analyzed, 65% were LAD, 17% were RCA, and 17% were LCX. The average FFR across the population was 0.82. A Bland-Altman analysis assessing the relationship between X1-FFR and invasive hyperemic pressure wire evaluation across the entire dataset demonstrated a bias of 0.00 with 95% limits of agreement of [-0.12, 0.12].

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7.4 Cybersecurity

SpectraWAVE X1-FFR Software's cybersecurity and interoperability risks have been appropriately mitigated to provide reasonable assurance of the safety and effectiveness of the device.

7.5 Summative Usability Testing:

Usability evaluation was conducted to establish that the SpectraWAVE X1-FFR Software meets the needs of the intended users to perform assessment of blood flow through the coronary artery, safely and effectively according to ANSI/AAMI/IEC 62366-1.

The SpectraWAVE X1-FFR Software has been found to be safe and effective for the intended users, indications for use, and use environments.

8. Conclusion and Statement of Equivalence:

The information presented in this 510(k) submission demonstrates that the SpectraWAVE X1-FFR Software is as safe and effective as the predicate device and is therefore considered substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.