(155 days)
Yes
The summary explicitly mentions the use of "AI to identify B-Mode with Stent & Guide Catheter" and describes the use of HF-OCT images as "Al training and test data sets."
No.
The device is intended for intravascular imaging to produce high-resolution, real-time images of coronary arteries; it does not perform any therapeutic function.
Yes.
The device is intended for "intravascular imaging" and "provides images of the coronary arteries," which are used to assess the condition of the arteries in patients candidates for "transluminal interventional procedures." This imaging provides information about the patient's medical condition, which is a diagnostic function.
No
The device description explicitly states that the system consists of a console, a catheter, and an optional review station, indicating the presence of hardware components beyond just software.
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 directly on the patient's body, not on a sample of biological material outside the body.
- Device Description: The device uses fiber-optic technology to image coronary tissue in vivo.
- Input Imaging Modality: Optical Coherence Tomography (OCT) is an imaging technique performed on the patient, not on a sample.
- Anatomical Site: The device is used in coronary arteries, which are within the patient's body.
IVD devices are designed to perform tests on samples of biological material (like blood, urine, tissue) to provide information about a person's health. This device is used for direct visualization within the body.
No
The letter does not explicitly state that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
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 artents 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
DQO, NQQ
Device Description
The Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (herein 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 high resolution, real-time 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 System 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 softvare 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
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
Coronary arteries, vessels 1.3 to 6.0 mm in diameter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Catheterization laboratory, physicians.
Description of the training set, sample size, data source, and annotation protocol
HF-OCT images used as the Al training and test data sets included clinical data acquired with the Gentuity HF-OCT Imaging System and Vis-Rx catheters. The study population was based on the 510(k) cleared Gentuity device indications for use statement and its product labeling. The intent-to-treat population included participants that were already scheduled for a visit to the catheterization laboratory and were candidates for transluminal interventional procedures.
Training Sample Size: 20 participants.
Age Range (N) (%): 40 (2) (10%).
Description of the test set, sample size, data source, and annotation protocol
HF-OCT images used as the Al training and test data sets included clinical data acquired with the Gentuity HF-OCT Imaging System and Vis-Rx catheters. The study population was based on the 510(k) cleared Gentuity device indications for use statement and its product labeling. The intent-to-treat population included participants that were already scheduled for a visit to the catheterization laboratory and were candidates for transluminal interventional procedures.
Test Sample Size: Not explicitly stated, though a table of demographics for "Test" data is provided. Assuming the sum of N values in the test set. Test Sample Size: (1+17+7) = 25 for age, (15+10) = 25 for sex, (3+20+2)=25 for BMI.
Age Range (N) (%): 40 (2) (8%).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification testing has been conducted to confirm that the device modifications meet its product specifications and that these modifications do not raise any new issues of safety and effectiveness. Additionally, design validation against the user needs was conducted using the new features of the user interface. 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 and that the software is determined to be safe and effective and is substantially equivalent to the predicate Gentuity HF-OCT Imaging System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
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August 8, 2023
Gentuity, LLC Padmini Gagnon Regulatory Affairs Manager 142 North Road, Suite G Sudbury, Massachusetts 01776
Re: K230620
Trade/Device Name: Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO, NQQ Dated: March 31, 2023 Received: April 3, 2023
Dear Padmini Gagnon:
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230620
Device Name
The 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 artents 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/0 description: The image shows the logo for Gentuity. The logo features the word "GENTUITY" in a sans-serif font, with the letters in a muted gray color. To the left of the word is a graphic of concentric arcs in a teal color, resembling a fingerprint or sound waves. The overall design is clean and modern.
510(k) SUMMARY
GENERAL INFORMATION 1.
1.1 Submitter and 510(k) Owner
Gentuity, LLC 142 North Road, Suite G Sudbury, MA 01776
1.2 Official Correspondent
Padmini Gagnon Gentuity, LLC 142 North Road, Suite G Sudbury, MA 01776 Email: pgagnon@gentuity.com Phone (508) 425-1560
1.3 Date of Preparation
June 28, 2023
2. NAME OF THE DEVICE
2.1 Trade/Proprietary Name
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
2.2 Common/Usual Name
Optical Coherence Tomography Imaging System Optical Coherence Tomography Intravascular Catheter
510(k) number - K230620 2.3
2.4 Classification Information
| Classification Name: | Optical Coherence Tomography Imaging System |
|---|---|
| Classification Regulation: | 21 CFR 892.1560 |
| Class: | II |
| Product Code: | NQQ |
| Panel: | Cardiovascular |
| Classification Name: | Diagnostic Intravascular Catheter |
| Classification Regulation: | 21 CFR 870.1200 |
| Class: | II |
| Product Code: | DQO |
| Panel: | Cardiovascular |
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Image /page/4/Picture/0 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 is a graphic of concentric arcs in a teal color, resembling a fingerprint or a stylized eye. The overall design is clean and modern.
3. PREDICATE DEVICE
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter, K192922
4. REFERENCE DEVICE
Abbott Medical's "OPTIS™ Mobile Next Imaging System, OPTIS™ Integrated Next Imaging System with Ultreon™ Software 1.0". This OCT device has been cleared under K210458 and shares the same intended use as the Gentuity device as well as similar software features.
5. DESCRIPTION OF THE DEVICE
The Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (herein 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 high resolution, real-time 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 System 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
Image /page/5/Picture/0 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 of concentric circles or arcs in a teal color, resembling a fingerprint or a target. The overall design is clean and modern.
INDICATIONS FOR USE 6.
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.
7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
A comparison of the technological features between the proposed modified Gentuity device, which includes software modifications and new device features, and its predicate device is shown in Table 1 below.
| Description | Gentuity Imaging System
(K192922) | Gentuity Imaging System
(Subject
Device)
K230620 |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. Reflected light is collected,
returned, and processed by the system
hardware and software to construct an OCT
image. | Same |
| Intended Use | Intravascular image in the coronary arteries | Same |
| Description | Gentuity Imaging System
(K192922) | Gentuity
Imaging System
(Subject
Device)
K230620 |
| 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. | Same |
| Classification | 21 CFR 892.1560
NQQ
System, Imaging OCT | Same |
| Optical Engine | Swept-source laser | Same |
| Computer | A host computer with embedded application
software | Same |
| Interconnection
between system
and catheter | Probe Interface Module (PIM) | Same |
| Console | 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. | Same |
| System Optical Specifications | | |
| Swept-source laser | Class 1 | Same |
| Center wavelength | 1310 nm (nominal) | Same |
| Aiming beam laser | Class 1 | Same |
| Wavelength | 650 nm (nominal) | Same |
| Pullback Parameters | | |
| Pullback Range | Variable up to 100 mm | Same |
| Pullback Rate | Variable up to 100 mm/sec | Same |
| General Scan Parameters | | |
| Scan Range | 7.6 mm (in contrast) | 8.93 mm (in
contrast) |
| Axial Resolution | Less than 20 µm in tissue | Same |
| Optical Sensitivity | ≥ 90 dB | Same |
| A-line rate | 200 kHz | Same |
| Description | Gentuity Imaging System
(K192922) | Gentuity
Imaging System
(Subject
Device)
K230620 |
| Frame Rate | 250 frames per second (Hz) | Same |
| Image Display | Cross Section
L-mode
Lumen profile display
3D
Angio sync | Same |
| Software Features | Automatic lumen detection
Automatic lumen measurements
Automatic MLA identification
User generated length, area measurements
Text annotations
Zoom | Same |
| Software Features
(Stent Expansion
Visualization Tool) | Not available | Stent Expansion
View Mode
Longitudinal
Zoom & Zoom
Indicator
AI to identify B-
Mode with
Stent & Guide
Catheter
Training Mode
Image Display
Speed
Optimization
Angle
measurement
tool |
Table 1. Comparison Table
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Image /page/6/Picture/0 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 circles in a light teal color. The circles are not complete, but rather are made up of short, dashed lines.
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Image /page/7/Picture/0 description: The image shows the logo for Gentuity. The logo consists of the word "GENTUITY" in a light gray sans-serif font. To the left of the word is a graphic of concentric arcs in a light teal color, resembling a fingerprint or a stylized representation of data waves. The overall design is clean and modern.
Similarities and Differences in Technology Comparison 7.1
The modified software and its features are substantially equivalent to the Gentuity Imaging System in terms of product intended use, design, mode of action, materials of construction, operational and technological features, hardware, firmware components, clinical use, and target population.
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Image /page/8/Picture/0 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, curved lines that resemble a fingerprint or a stylized eye. The word "GENTUITY" is in gray, while the curved lines are in a light teal color.
Both the proposed device software and the predicate Gentuity Imaging System software perform OCT Imaging acquisition using OCT software. The Gentuity console employs a graphical user interface (GUI) and software control to obtain and display Optical Coherence Tomography (OCT) images. The Gentuity System provides angiographic inputs and outputs allowing shared display of OCT and angiographic images. Components are housed in a mobile cart and include a PIM which provides the interconnection between the "Gentuity System" and the "Vis-Rx Catheter" that emit near-infrared light to produce high-resolution real-time images. These features remain the same and are unaffected by the addition of the new software features.
The device modifications represent an incremental improvement to the predicate device in terms of adding the new software features:
- Stent Expansion View Mode
- Longitudinal Zoom & Zoom Indicator
- Al to identify B-Mode with Stent & Guide Catheter
- Training Mode
- Image Display Speed Optimization
- . Angle measurement tool
8. PERFORMANCE TESTING
The modified software has been developed and tested in compliance with IEC 62304: 2015. Software verification and validation activities as well as design validation were performed to evaluate the proposed device software modifications.
Software Verification testing has been conducted to confirm that the device modifications meet its product specifications and that these modifications do not raise any new issues of safety and effectiveness. Additionally, design validation against the user needs was conducted using the new features of the user interface. 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 and that the software is determined to be safe and effective and is substantially equivalent to the predicate Gentuity HF-OCT Imaging System.
HF-OCT images used as the Al training and test data sets included clinical data acquired with the Gentuity HF-OCT Imaging System and Vis-Rx catheters. The study population was based on the 510(k) cleared Gentuity device indications for use statement and its product labeling. The intent-to-treat population included participants that were already scheduled for a visit to the catheterization laboratory and were candidates for transluminal interventional procedures.
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Image /page/9/Picture/0 description: The image shows the logo for Gentuity. The logo consists of a circular design on the left, made up of concentric lines in a light teal color, resembling a fingerprint or a ripple effect. To the right of the circular design is the word "GENTUITY" in a simple, sans-serif font, with each letter in a muted gray color. The overall design is clean and modern.
| Training | Test | ||||
|---|---|---|---|---|---|
| Age | Age | ||||
| Range | (N) | (%) | Range | (N) | (%) |
| 40 | 2 | 10 | >40 | 2 | 8 |
Patient population included the following:
9. CONCLUSIONS
The information presented in these 510(k) submissions demonstrates that the modified subject device software and its features are substantially equivalent to the predicate device Gentuity HF-OCT Imaging System software.