The Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The Vis-Rx Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure.

Device Description

The Gentuity® Imaging System provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system utilizes fiber-optic technology to deliver near-infrared light and receive light reflected from coronary tissue to produce images. The Gentuity Imaging System consists of the Gentuity Imaging Console, Vis-Rx® Micro-Imaging Catheter, and optional Gentuity Review Station. The console houses the Optical Engine, Computer and application software, and Probe Interface Module (PIM). The Vis-Rx catheter is a sterile, single-use catheter with an external sheath and an optical imaging core. The Gentuity Review Station is an optional stand-alone computer for analysis and review.

AI/ML Overview

This document, K192922, is a 510(k) Premarket Notification for the Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter. It establishes substantial equivalence to a predicate device, rather than providing a detailed clinical study demonstrating the device's meeting of specific acceptance criteria.

While the document references "performance testing" and "design verification and validation," it does not present a formal clinical study with a predefined test set, ground truth establishment, or specific acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) typical of AI/CADe submissions. Instead, the performance testing focuses on engineering specifications, physical properties of the catheter, and a comparison of image quality with a predicate device.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be directly extracted from this 510(k) summary. The document focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than establishing de novo performance thresholds.

However, based on the provided text, here's an attempt to address the points where information is available or can be inferred:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for diagnostic accuracy or clinical performance metrics in the way a de novo device with AI might. Instead, performance testing focused on engineering specifications, physical characteristics, and image quality comparison to a predicate device.

Category	Acceptance Criteria (Implied/Inferred)	Reported Device Performance
General Safety	Compliance with relevant electrical safety (IEC 60601 series), laser safety (IEC 60825-1, 21 CFR 1040.10, 1040.11), and software standards (IEC 62304, DICOM).	"The Gentuity® Imaging System has been tested and is in compliance with general safety requirements...The results of this testing conclude the software has met these requirements."
Bench Testing	System meets its performance specifications (scan range, axial resolution, optical sensitivity, A-line rate, dynamic range, frame rate, pullback rate and range, FORJ characteristics; catheter: visual/dimensional, tensile strength, leakage, corrosion, torque, particulates, coating, lubricity/friction, flexibility/kink). Bench testing successfully demonstrates the product meets specifications and raises no new safety/effectiveness issues.	"Comprehensive verification and validation activities were successfully completed, raising no new issues of safety or effectiveness. All testing passed the acceptance criteria." Specific metrics are not provided in the summary but were presumably documented in the submission.
Biocompatibility	Compliance with ISO 10993-1 for cytotoxicity, sensitization, intracuraneous reactivity, acute systemic toxicity, material mediated pyrogenicity, hemolysis, complement SC5b-9 and C3a, in vivo thrombogenicity.	"The Vis-Rx was subjected to a series of biocompatibility tests in accordance with FDA guidance, using International Standard ISO 10993-1." (Implied: Passed, as it concluded substantial equivalence).
Sterilization	Achieve a Sterility Assurance Level (SAL) of $10^{-6}$ according to international sterilization standards.	"Sterilization and sterilization were performed to ensure a SAL of 106, according to international sterilization standards." (Assuming "106" in the text means $10^{-6}$).
Packaging & Shelf Life	Packaging integrity (visual inspection, bubble leak, seal strength) maintained after sterilization, environmental conditioning, and simulated shipping/distribution.	"Testing was conducted after sterilization, environmental conditioning including aging, and simulated shipping and distribution." (Implied: Passed, as it concluded substantial equivalence).
System Performance (Console, SW, PIM, Catheter)	Successful performance in simulated use (tortuous path model), automatic flush detection, lumen segmentation, NURD (Non-Uniform Rotational Distortion), image brightness, lateral resolution, measurement accuracy. (Implied: Acceptable performance for intended use).	Described as tested. (Implied: Passed, as it concluded substantial equivalence).
Animal Testing (Safety)	Histomorphology findings similar between Gentuity System and predicate, and clinical usability (catheter handling, ease of use, radiopacity) similar to predicate.	"The Gentuity System performed as intended and the histomorphology findings were similar between the two treatment groups... Clinical usability assessment... was also performed and found to be similar to the predicate."
Third-Party Image Quality Assessment	Image quality attributes (image contrast, axial resolution, tissue depth penetration) and image artifacts (seam-line, NURD, saturation) were scored, with the two systems (Gentuity vs. predicate) demonstrating substantially equivalent imaging quality.	"The results of this test conclude that the two systems provide substantially equivalent imaging quality."
Usability	Meets the needs of intended users to perform OCT imaging safely and effectively according to ANSI/AAMI/IEC 62366-1:2015.	"Usability evaluation was conducted to establish that the Gentuity Imaging System meets the needs of the intended users to perform OCT imaging safely and effectively... The results... conclude the Gentuity Imaging System... is substantially equivalent to the... predicate device."

2. Sample size used for the test set and the data provenance

Test Set (Image Quality Assessment): While an exact number of images/cases is not specified for the "Third-Party Image Quality Assessment," it involved "cross-sectional images extracted from pullbacks with Vis-Rx and with the predicate device." The data provenance for this assessment is not specified (e.g., country of origin, retrospective/prospective), but the context of "animal studies" suggests it was likely derived from the animal testing conducted.
Animal Testing: Two animal studies were conducted. No specific number of animals or cases is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For the "Third-Party Image Quality Assessment," "Two independent end user reviewers viewed cross-sectional images." Their specific qualifications (e.g., number of years of experience, specific specialty like cardiology/interventional radiology) are not stated beyond being "end user reviewers."
There's no mention of ground truth established by experts for algorithmic performance in terms of diagnostic accuracy, as this is not an AI/CADe device being assessed for diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is described for the image quality assessment. The document simply states "Each cross-sectional image was scored by each reviewer." It does not mention how disagreements were resolved or if a consensus mechanism was employed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No a multi-reader multi-case (MRMC) comparative effectiveness study of human readers with vs. without AI assistance was reported. This device is an imaging system, not an AI/CADe device intended to assist human interpretation in that manner. The "Third-Party Image Quality Assessment" was a comparison of image quality between two devices, not an evaluation of human reader performance with or without AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable, as the device is an imaging system, not a standalone AI diagnostic algorithm. The software features mentioned (automatic lumen detection, lumen measurements, etc.) are image processing features within the system, not standalone diagnostic algorithms evaluated for their own performance metrics against ground truth.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the Third-Party Image Quality Assessment, the "ground truth" was essentially the subjective scores given by the two independent reviewers based on predefined attributes and artifacts. This is not a clinical ground truth like pathology or outcomes.
For the Animal Testing (Safety), histomorphology findings (presumably from pathology of animal tissues) were used as the basis for comparison of safety and bio-response between the Gentuity system and the predicate. This could be considered a form of ground truth for safety evaluation.
For Lumen Segmentation and Measurement Accuracy (under "System: Console, SW, PIM, Catheter"), the ground truth would likely be established through phantom studies or calibrated measurements where the true dimensions are known. This is a technical ground truth, not a clinical one.

8. The sample size for the training set

The document does not detail any "training set" for an AI algorithm in the context of diagnostic performance. The software development and testing were performed in compliance with IEC 62304, which focuses on software lifecycle processes and safety, not on statistical performance of machine learning models.

9. How the ground truth for the training set was established

As no training set for an AI algorithm (in the diagnostic sense) is described, this question is not applicable based on the provided document. The "ground truth" for verifying the system's various engineering functions would typically be established through calibrated instruments, known reference standards, or direct physical measurements during bench testing.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

February 20, 2020

Gentuity, LLC % Diane Horwitz Regulatory Consultant Mandell Horwitz Consultants LLC 5 Lake Como Ct. Greenville, South Carolina 29609

Re: K192922

Trade/Device Name: Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NQQ, DQO Dated: January 22, 2020 Received: January 22, 2020

Dear Diane Horwitz:

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 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

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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 (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark Fellman 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) K192922

Device Name

Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter

Indications for Use (Describe)

The Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is intended for intravascular imaging and is indicated for use in coronary arteries who are candidates for transluminal interventional procedures. The Vis-Rx Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure.

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)

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Image /page/3/Picture/1 description: The image shows the logo for Gentuity. The logo features the word "GENTUITY" in a simple, sans-serif font, with the letters in a light gray color. To the left of the word, there is a graphic of concentric, curved lines in a light teal color, resembling a fingerprint or a stylized "G".

510(k) SUMMARY

1. GENERAL INFORMATION

1.1 Submitter and 510(k) Owner

Gentuity, LLC 142 North Road, Suite G Sudbury, MA 01776

1.2 Official Correspondent

Diane Horwitz, Ph.D., RAC 5 Lake Como Ct. Greenville, SC 29609 Telephone: 703.307.2921 Email: dmh@mandellhorwitzconsulting.com

1.3 Date of Preparation

February 19, 2020

NAME OF THE DEVICE 2.

2.1.1 Trade/Proprietary Name

Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter

2.1.2 Common/Usual Name

Optical Coherence Tomography Imaging System Optical Coherence Tomography Intravascular Catheter

2.1.3 Classification Information

Classification Name:	Optical Coherence Tomography Imaging System
Classification Regulation:	21 CFR 892.1560
Class:	II
Product Code:	NQQ
Panel:	Cardiovascular
Reference Device:
Classification Name:	Optical Coherence Tomography Intravascular Cathete
Classification Regulation:	21 CFR 870.1200
Class:	II
Product Code:	ORD
Panel:	Cardiovascular

3. PREDICATE DEVICES

ILUMIEN OPTIS™ Mobile System, Lightlab Imaging, Inc., K152120 (Primary Predicate) DragonflyTM OPTISTM Imaging Catheter, Lightlab Imaging, Inc., K141453

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Image /page/4/Picture/1 description: The image shows the logo for Gentuity. The logo consists of the word "GENTUITY" in a sans-serif font. To the left of the word is a graphic of concentric circles that resemble a fingerprint. The word "GENTUITY" is in gray, and the concentric circles are in a light teal color.

4. DESCRIPTION OF THE DEVICE

The Gentuity Imaging System consists of the following components:

1. The Gentuity Imaging Console: A mobile system that houses the Optical Engine, the Computer and application software, and the Probe Interface Module (PIM). It also includes two monitors, keyboard, mouse, and cord storage as well as external interfaces to the system. The PIM provides the interconnection between the Gentuity Imaging Console and the Vis-Rx® Catheter.
1. Vis-Rx® Micro-Imaging Catheter: The Vis-Rx catheter is a sterile, single-use catheter that consists of an external sheath and an optical imaging core. The external sheath facilitates placement of the device into the coronary artery, and houses the optical imaging core. An optical fiber and lens assembly rotates inside the optical imaging core. The optical fiber and lens deliver near-infrared light to the tissue and receive reflected light. The Vis-Rx catheter is a rapid exchange design, compatible with an 0.014" guidewire. The catheter attaches to the PIM, which is mounted outside the sterile field on the table bed rail. A sterile 3 ml purge syringe is provided with the Vis-Rx catheter.
1. Optional Gentuity Review Station: The Gentuity Review Station (GRS) is an optional stand-alone computer with the Gentuity application software that provides analysis and review capabilities similar to what may be performed on the Gentuity Console. The GRS allows physicians to review images for research, presentation and publication preparation outside the catheterization lab without the Gentuity Console.

5. INDICATION FOR USE

INTENDED USE COMPARED TO THE PREDICATES 6.

The intended use for the Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is the same as the predicate device. The statement is similar with changes to the scan range and imaging of the left main coronary artery. The devices share the same target patient population, the same users and conditions of use. Both devices are prescription only.

The increased scan range of the Gentuity System allows imaging of vessels up to 6 mm in diameter, which covers the expected diameter range of left main coronary arteries. This change does not introduce new issues of safety or effectiveness and was validated using bench and GLP animal testing.

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Image /page/5/Picture/1 description: The image shows the logo for Gentuity. The logo consists of the word "GENTUITY" in a sans-serif font, with the letters in a light gray color. To the left of the word is a graphic of concentric arcs in a light teal color, resembling a fingerprint or a stylized eye. The arcs are not complete circles, but rather broken lines that create a sense of movement or scanning.

Table 1. Intended Use / Indications for Use Comparison for the
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter Versus the Predicate
Subject DeviceGentuity® Imaging System with	Primary PredicateILUMIEN OPTISTM Mobile System,K152120	Secondary PredicateDragonflyTM OPTISTM ImagingCatheter, K141453
Vis-Rx® Imaging Catheter
21 CFR 892.1560	21 CFR 892.1560	21 CFR 870.1200
21 CFR 870.1200
System Imaging Optical CoherenceTomography (OCT), DiagnosticIntravascular Catheter	System Imaging Optical CoherenceTomography (OCT)	Diagnostic Intravascular Catheter
Procode: NQQ, DQO	NQQ	DQO
The Gentuity® HF-OCT ImagingSystem with Vis-Rx® Micro-Imaging Catheter is intended forintravascular imaging and isindicated for use in coronary arteriesin patients who are candidates fortransluminal interventionalprocedures. The Vis-Rx Micro-Imaging Catheter is intended for usein vessels 1.3 to 6.0 mm in diameter.The Vis-Rx Micro-Imaging Catheteris not intended for use in a targetvessel that has undergone a previousbypass procedure.	The OPTISTM Mobile System withDragonflyTM DUO or DragonflyTMOPTISTM Imaging Catheter is intendedfor the imaging of coronary arteries andis indicated in patients who arecandidates for transluminalinterventional procedures.The DragonflyTM DUO or DragonflyTMOPTISTM Imaging Catheter is intendedfor use in vessels 2.0 to 3.5 mm indiameter.The DragonflyTM DUO or DragonflyTMOPTISTM Imaging Catheter is notintended for use in the left maincoronary artery or in a target vesselwhich has undergone a previous bypassprocedure.The OPTISTM Mobile System willfurther acquire radio frequency signaloutputs from both a distal intracoronarypressure transducer and a proximalaortic pressure transducer to determinethe physiological parameter, FractionalFlow Reserve (FFR). The physicianmay use the FFR parameter, along withknowledge of patient history, medicalexpertise and clinical judgment todetermine if therapeutic intervention isindicated.	The ILUMIEN OPTIS with C7Dragonfly, Dragonfly DUO, orDragonfly OPTIS Imaging Catheter isintended for the imaging of coronaryarteries and is indicated in patientswho are candidates for transluminalinterventional procedures.The C7 Dragonfly, Dragonfly DUO,or Dragonfly OPTIS ImagingCatheter is intended for use in vessels2.0 to 3.5 mm in diameter.The C7 Dragonfly, Dragonfly DUO,or Dragonfly OPTIS ImagingCatheter is not intended for use in theleft main coronary artery or in a targetvessel which has undergone aprevious bypass procedure.The ILUMIEN OPTIS will furtheracquire radio frequency signaloutputs from both a distalintracoronary pressure transducer anda proximal aortic pressure transducerto determine the physiologicalparameter, Fractional Flow Reserve(FFR). The physician may use theFFR parameter, along withknowledge of patient history, medicalexpertise and clinical judgment todetermine if therapeutic interventionis indicated

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Image /page/6/Picture/1 description: The image shows the logo for Gentuity. The logo consists of the word "GENTUITY" in a simple, sans-serif font. To the left of the word is a graphic of concentric arcs, resembling a fingerprint or a stylized representation of data waves. The color palette is muted, with the text in a gray tone and the arcs in a teal color.

7. TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATES

A comparison of the technological features between the Gentuity® Imaging System and the predicate is shown in Table 2 below for the Gentuity Imaging Console and in Table 3 for the Vis-Rx® Imaging Catheter.

TechnologicalCharacteristic	Subject DeviceGentuity Imaging Console	PredicateOPTIST™ Mobile System,(K152120)	Same or DifferentSignificance
Mode ofOperation	Computer controlled swept-source(rapidly tunable laser) transmittingnear infrared light delivered throughan Imaging Core housed within anExternal Catheter Sheath. Imageacquisition (imaging core rotationand pullback) driven by system-catheter interconnection (PIM) andsynchronized with contrast injection.Returned reflected light is processedby the system hardware and softwareto construct an OCT image.	Computer controlled swept-source(rapidly tunable laser) transmittingnear infrared light delivered throughan Imaging Core housed within anExternal Catheter Sheath. Imageacquisition (imaging core rotation andpullback) driven by system-catheterinterconnection (DOC) andsynchronized with contrast injection.Returned reflected light is processedby the system hardware and softwareto construct an OCT image*	Same
SystemComponents	A swept-source engine	A swept-source engine	Same
	A host computer with embeddedapplication software	A host computer with embeddedapplication software	Same
	Interconnection between system andcatheter (PIM)	Interconnection between system andcatheter (DOC)	Same
	A mobile console with monitors,keyboard and mouse housing theoptical engine and host computer,and connected to the PIM via anelectro-optical umbilical cord.	A mobile console with monitors,keyboard and mouse, housing theoptical engine and host computer, andconnected to the DOC via an electro-optical umbilical cord.	Same
OpticalParameters	Swept-sourceCenter Wavelength: 1310 nm(nominal)Class 1	Swept-sourceCenter Wavelength: 1305 nm(nominal)Class 1M	Similar; no opticalsafety precautionsrequired
	Aiming beam - Visible laser diodeWavelength: 650 nm (nominal)Class 1	Aiming beam – Visible laser diodeWavelength: 670 nm (nominal)Class 1M	Similar; no opticalsafety precautionsrequired
Image Display	Cross SectionL-modeProfile display3DAngio view	Cross SectionL-modeProfile display3DAngio coregistration	Same
Software Features	Automatic lumen detectionAutomatic lumen measurementsUser generated length, areameasurementsText annotationsZoom	Automatic lumen detectionAutomatic lumen measurementsUser generated length, areameasurementsText annotationsZoom	Same

Table 2. Technology Comparison for Gentuity Imaging Console Versus the OPTIS Predicate

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Image /page/7/Picture/1 description: The image shows the logo for Gentuity. The logo consists of the word "GENTUITY" in a sans-serif font, with the letters in a gray color. To the left of the word is a graphic of concentric circles in a light blue color. The circles are not complete, but rather are made up of short, curved lines.

	Subject DeviceVis-Rx® Imaging Catheter	Predicate DeviceDragonfly OPTIS(K141453)	Same or DifferentSignificance
Catheter BodyExternal Sheath	1.8 Fr diameter	2.7 Fr diameter	Similar
Insertable Length	145 cm insertable length	135 cm insertable length	Similar
Tip	Minirail tip	Minirail tip	Same
Guide CatheterCompatibility	6 Fr	6 Fr	Same
Guidewire	0.014" guidewire compatible	0.014" guidewire compatible	Same
Connector	Connector Hub with optical andpullback connections	Connector Hub with optical andpullback connections	Same
RadiopaqueMarkers	Three markers	Three markers	Same
Purge	Saline purge of catheter lumen	Contrast purge of catheter lumen	Similar, using less contrastthan the subject device.
RFID	Located in catheter connector andPIM	Located in catheter connectorand DOC	Same
Sterile and SingleUse	Yes	Yes	Same

Table 3. Technology Comparison for the Vis-Rx® Imaging Catheter Versus the Dragonfly Predicate

7.1 Similarities and Differences in Technology Comparison

The Gentuity console and Vis-Rx® catheter are equivalent to the OPTIS Mobile System and Dragonfly OPTIS Imaging Catheter in terms of hardware, firmware components and operational use.

Console:

Components of both are housed in a mobile cart and include a PIM which provides the interconnection between the Imaging System and the optical imaging catheters that emit nearinfrared light to produce high-resolution real-time images. Both the Gentuity console and the predicate device employ a graphical user interface (GUI) and software control to obtain and display Optical Coherence Tomography (OCT) images. Both systems provide angiographic inputs and outputs allowing shared display of OCT and angiographic images.

The Gentuity console represents an incremental improvement to the predicate device in terms of performance through the scanning laser, PIM design and technological characteristics. The improvements include the following: an increase in A-line rate, frame rate, image scan-range, pullback speed, and pullback length.

Ergonomic changes include a touch screen monitor enhancing input and display control for the non-sterile operator and bed rail mounting of the PIM supporting its placement outside of the sterile field and eliminating the need for bagging.

Catheter:

The Vis-Rx® catheter is equivalent to the predicate device in terms of functional design and operational use. They both are comprised of a rapid exchange catheter sheath and an internal imaging core comprising the rotating fiber optic and lens which emits near infrared light to the tissue and receives reflected light. Like the predicate, catheters are connected to the Console via the

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Image /page/8/Picture/1 description: The image shows the logo for Gentuity. The logo features the word "GENTUITY" in a simple, sans-serif font, with the letters in a muted gray color. To the left of the word, there is a stylized graphic resembling a fingerprint or a series of concentric arcs in a light teal color. The overall design is clean and modern.

PIM which controls lens rotation and pullback. Both catheters are purged prior to use. In both the Vis-Rx and the predicate device emitted and returned reflected light are combined and processed by imaging system software to construct an OCT image.

The Vis-Rx catheter represents an incremental improvement to the predicate device in terms of performance without change to operational characteristics and fundamental technology. The improvements include the following: Smaller crossing profile (1.8 Fr); higher speed imaging (250 frames/second), and longer pullback (≤100 mm).

PERFORMANCE TESTING 8.

The Gentuity® Imaging System has been tested and is in compliance with general safety requirements, IEC 60825-1:2nd Ed. 2007, IEC 60601-1-2 Ed.3 IEC 60601-1-2:2014, IEC 60601-1-6: 2010+ A1:2013, IEC 60601-2-18:2009; Laser Safety EC 60825-1:2014 21 CFR, Subchapter J, parts 1040.10 and 1040.11

In addition to the electrical safety testing performed. Gentuity Imaging System and Gentuity Review Station software has been developed and tested in compliance with IEC 62304: 2006 and DICOM Standard: 2015b. Software verification and validation was conducted to FDA regulations, standards and guidance document requirements. The results of this testing conclude the software has met these requirements.

Design verification and validation of the Gentuity Imaging System was performed in compliance with internal design control procedures comprised of bench testing, animal testing, third-party image quality assessment and summative usability testing to confirm device performance.

8.1 Bench testing: Gentuity performed a series of bench tests to demonstrate its system meets its performance specifications using finished, sterilized and preconditioned product. Comprehensive verification and validation activities were successfully completed, raising no new issues of safety or effectiveness. All testing passed the acceptance criteria.

Performance testing was conducted against known standards or the product specification and evaluated the following:

Console, software and PIM

. Scan range
. Axial resolution
. Optical Sensitivity
A-line rate .
. Dynamic range
. Frame rate
. Pullback rate and range
. Fiber Optic Rotary Joint (FORJ) Insertion loss
. FORJ Rotational uniformity
. FORJ Return loss.

Catheter:

Visual & Dimensional Inspection .
. Tensile Strength

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Image /page/9/Picture/1 description: The image shows the logo for Gentuity. The logo consists of the word "GENTUITY" in a simple, sans-serif font, with each letter rendered in a light gray color. To the left of the word, there is a stylized graphic that resembles a fingerprint or a series of concentric arcs. The arcs are rendered in a light teal color, and they are broken up into short, dashed lines, giving the impression of a modern, tech-oriented design.

Leakage ●
. Corrosion
Torque .
. Particulates
Coating characterization .
Lubricity/Friction
Flexibility and Kink

Biological Safety Testing

The Vis-Rx was subjected to a series of biocompatibility tests in accordance with FDA guidance, using International Standard ISO 10993-1.

. Cvtotoxicitv
. Sensitization
. Intracutaneous Reactivity
. Acute Systemic Toxicity
. Material Mediated Pyrogenicity
Hemolysis (Direct and Indirect)
Complement SC5b-9 and C3a .
. In Vivo Thrombogenicity

Sterilization

Sterilization and sterilization were performed to ensure a SAL of 106, according to international sterilization standards.

Packaging Validation and Shelf Life

Visual Inspection, Bubble Leak and Seal Strength testing was used to evaluate integrity of the packaging configuration. Testing was conducted after sterilization, environmental conditioning including aging, and simulated shipping and distribution.

System: Console, SW, PIM, Catheter

. Simulated Use in tortuous path model
. Automatic Flush Detection
. Lumen Segmentation
. NURD (Non-Uniform Rotational Distortion)
. Image Brightness
. Lateral Resolution
Measurement Accuracy

8.2 Animal Testing: Gentuity conducted two animal studies to evaluate the safety and effectiveness of its system compared to the predicate system.

Safety: The Gentuity System performed as intended and the histomorphology findings were similar between the two treatment groups (Gentuity System versus predicate system). Clinical usability assessment evaluating catheter handling, ease of use and radiopacity was also performed and found to be similar to the predicate.
Third-Party Image Quality Assessment: Two independent end user reviewers viewed cross-sectional images extracted from pullbacks with Vis-Rx and with the predicate device. Each cross-sectional image was scored by each reviewer on 3 image quality attributes (image contrast, axial resolution and tissue depth penetration) and 3 image artifacts (seam-

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Image /page/10/Picture/1 description: The image shows the logo for Gentuity. The logo consists of the word "GENTUITY" in a simple, sans-serif font, with the letters in a light gray color. To the left of the word is a graphic element composed of several concentric, curved lines in a light teal color, resembling a fingerprint or a stylized sound wave.

line (heart-beat motion artifacts), NURD (rotational motion artifacts) and saturation (strong reflection artifacts). The results of this test conclude that the two systems provide substantially equivalent imaging quality.

8.3 Summative Usability Testing: Usability evaluation was conducted to establish that the Gentuity Imaging System meets the needs of the intended users to perform OCT imaging safely and effectively according to ANSI/AAMI/IEC 62366-1:2015.

The results of the performance testing conclude the Gentuity Imaging System with the Vis-Rx Catheter is substantially equivalent to the ILUMIEN OPTIS with Dragonfly OPTIS Imaging Catheter predicate device.

CONCLUSIONS 9.

The information presented in this 510(k) submission demonstrates that the Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
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.(b)
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.