(127 days)
Not Found
No
The summary describes standard image processing techniques for OCT data and does not mention AI, ML, or related concepts.
No
The device is an imaging system designed for intravascular imaging of coronary arteries, providing diagnostic information for interventional procedures, rather than directly treating a condition.
Yes
The device is an imaging system (OCT) that produces images of coronary arteries, which are then used by physicians for analysis and review (diagnosis) in patients undergoing interventional cardiac procedures.
No
The device description explicitly states the system consists of a console, catheter, and optional review station, all of which are hardware components. While software is mentioned for image processing, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intravascular imaging" in coronary arteries. This is a procedure performed within the body to visualize structures, not a test performed on a sample taken from the body.
- Device Description: The device is a system that uses fiber-optic technology to capture images from within the coronary arteries. This is an imaging system, not a device designed to analyze biological samples.
- Mechanism: The system works by emitting and receiving light reflected from tissue to create images. This is a physical imaging process, not a chemical, biological, or immunological test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on the analysis of such samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is an imaging system used for visualization during interventional procedures.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NQQ, DQO
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 following components:
-
- 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.
-
- 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.
-
- 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.
Mentions image processing
Returned reflected light is processed by the system hardware and software to construct an OCT image.
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Leakage
- Corrosion
- Torque
- Particulates
- Coating characterization
- Lubricity/Friction
- Flexibility and Kink
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-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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ILUMIEN OPTIS™ Mobile System, Lightlab Imaging, Inc., K152120, DragonflyTM OPTISTM Imaging Catheter, Lightlab Imaging, Inc., K141453
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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 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 following components:
-
- 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.
-
- 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.
-
- 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
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.
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 Device | ||
| Gentuity® Imaging System with | Primary Predicate | |
| ILUMIEN OPTISTM Mobile System, | ||
| K152120 | Secondary Predicate | |
| DragonflyTM OPTISTM Imaging | ||
| Catheter, K141453 | ||
| Vis-Rx® Imaging Catheter | ||
| 21 CFR 892.1560 | 21 CFR 892.1560 | 21 CFR 870.1200 |
| 21 CFR 870.1200 | ||
| System Imaging Optical Coherence | ||
| Tomography (OCT), Diagnostic | ||
| Intravascular Catheter | System Imaging Optical Coherence | |
| Tomography (OCT) | Diagnostic Intravascular Catheter | |
| Procode: NQQ, DQO | NQQ | DQO |
| 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. | The OPTISTM Mobile System with | |
| DragonflyTM DUO or DragonflyTM | ||
| OPTISTM Imaging Catheter is intended | ||
| for the imaging of coronary arteries and | ||
| is indicated in patients who are | ||
| candidates for transluminal | ||
| interventional procedures. |
The DragonflyTM DUO or DragonflyTM
OPTISTM Imaging Catheter is intended
for use in vessels 2.0 to 3.5 mm in
diameter.
The DragonflyTM DUO or DragonflyTM
OPTISTM Imaging Catheter is not
intended for use in the left main
coronary artery or in a target vessel
which has undergone a previous bypass
procedure.
The OPTISTM Mobile System will
further acquire radio frequency signal
outputs from both a distal intracoronary
pressure transducer and a proximal
aortic pressure transducer to determine
the physiological parameter, Fractional
Flow Reserve (FFR). The physician
may use the FFR parameter, along with
knowledge of patient history, medical
expertise and clinical judgment to
determine if therapeutic intervention is
indicated. | The ILUMIEN OPTIS with C7
Dragonfly, Dragonfly DUO, or
Dragonfly OPTIS Imaging Catheter is
intended for the imaging of coronary
arteries and is indicated in patients
who are candidates for transluminal
interventional procedures.
The C7 Dragonfly, Dragonfly DUO,
or Dragonfly OPTIS Imaging
Catheter is intended for use in vessels
2.0 to 3.5 mm in diameter.
The C7 Dragonfly, Dragonfly DUO,
or Dragonfly OPTIS Imaging
Catheter is not intended for use in the
left main coronary artery or in a target
vessel which has undergone a
previous bypass procedure.
The ILUMIEN OPTIS will further
acquire radio frequency signal
outputs from both a distal
intracoronary pressure transducer and
a proximal aortic pressure transducer
to determine the physiological
parameter, Fractional Flow Reserve
(FFR). The physician may use the
FFR parameter, along with
knowledge of patient history, medical
expertise and clinical judgment to
determine if therapeutic intervention
is 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.
| Technological
Characteristic | Subject Device
Gentuity Imaging Console | Predicate
OPTIST™ Mobile System,
(K152120) | Same or Different
Significance |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Mode of
Operation | Computer controlled swept-source
(rapidly tunable laser) transmitting
near infrared light delivered through
an Imaging Core housed within an
External Catheter Sheath. Image
acquisition (imaging core rotation
and pullback) driven by system-
catheter interconnection (PIM) and
synchronized with contrast injection.
Returned reflected light is processed
by the system hardware and software
to construct an OCT image. | Computer controlled swept-source
(rapidly tunable laser) transmitting
near infrared light delivered through
an Imaging Core housed within an
External Catheter Sheath. Image
acquisition (imaging core rotation and
pullback) driven by system-catheter
interconnection (DOC) and
synchronized with contrast injection.
Returned reflected light is processed
by the system hardware and software
to construct an OCT image* | Same |
| System
Components | A swept-source engine | A swept-source engine | Same |
| | A host computer with embedded
application software | A host computer with embedded
application software | Same |
| | Interconnection between system and
catheter (PIM) | Interconnection between system and
catheter (DOC) | Same |
| | A mobile console with monitors,
keyboard and mouse housing the
optical engine and host computer,
and connected to the PIM via an
electro-optical umbilical cord. | A mobile console with monitors,
keyboard and mouse, housing the
optical engine and host computer, and
connected to the DOC via an electro-
optical umbilical cord. | Same |
| Optical
Parameters | Swept-source
Center Wavelength: 1310 nm
(nominal)
Class 1 | Swept-source
Center Wavelength: 1305 nm
(nominal)
Class 1M | Similar; no optical
safety precautions
required |
| | Aiming beam - Visible laser diode
Wavelength: 650 nm (nominal)
Class 1 | Aiming beam – Visible laser diode
Wavelength: 670 nm (nominal)
Class 1M | Similar; no optical
safety precautions
required |
| Image Display | Cross Section
L-mode
Profile display
3D
Angio view | Cross Section
L-mode
Profile display
3D
Angio coregistration | Same |
| Software Features | Automatic lumen detection
Automatic lumen measurements
User generated length, area
measurements
Text annotations
Zoom | Automatic lumen detection
Automatic lumen measurements
User generated length, area
measurements
Text annotations
Zoom | 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 Device
Vis-Rx® Imaging Catheter | Predicate Device
Dragonfly OPTIS
(K141453) | Same or Different
Significance |
|----------------------------------|--------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------|
| Catheter Body
External 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 Catheter
Compatibility | 6 Fr | 6 Fr | Same |
| Guidewire | 0.014" guidewire compatible | 0.014" guidewire compatible | Same |
| Connector | Connector Hub with optical and
pullback connections | Connector Hub with optical and
pullback connections | Same |
| Radiopaque
Markers | Three markers | Three markers | Same |
| Purge | Saline purge of catheter lumen | Contrast purge of catheter lumen | Similar, using less contrast
than the subject device. |
| RFID | Located in catheter connector and
PIM | Located in catheter connector
and DOC | Same |
| Sterile and Single
Use | 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.