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

K230620 · Gentuity, LLC · DQO · Aug 8, 2023 · Cardiovascular

Device Facts

• Record ID: K230620
• Device Name: Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
• Applicant: Gentuity, LLC
• Product Code: DQO · Cardiovascular
• Decision Date: Aug 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: AI/ML

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Stent expansion visualization	—	—	—	Training: 20 patients (Age 26-100, 75% Male, 85% BMI 25-40). Test: 25 patients (Age 26-100, 60% Male, 80% BMI 25-40).	—	—	—

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.

Device Story

System uses fiber-optic technology to deliver near-infrared light into coronary arteries via Vis-Rx Micro-Imaging Catheter; receives reflected light to produce high-resolution, real-time OCT images. Operated by clinicians in catheterization labs. Console houses optical engine, computer, and PIM; optional Review Station allows off-lab analysis. New software features include AI-based identification of B-mode images with stent and guide catheter, Stent Expansion View Mode, longitudinal zoom, and angle measurement tools. Output assists physicians in visualizing coronary anatomy and stent placement during interventional procedures, potentially improving procedural outcomes.

Clinical Evidence

Bench testing and software verification/validation performed per IEC 62304:2015. AI algorithm training and testing utilized clinical datasets acquired with the predicate system. Study population included patients scheduled for catheterization lab visits who were candidates for transluminal interventional procedures. No new clinical prospective trials were required; substantial equivalence supported by software verification and design validation against user needs.

Technological Characteristics

Swept-source OCT imaging system; 1310 nm center wavelength; 200 kHz A-line rate; 250 Hz frame rate. Components: mobile console, PIM, and single-use Vis-Rx catheter (rapid exchange, 0.014" guidewire compatible). Connectivity: electro-optical umbilical. Software: includes AI-based B-mode identification, stent expansion visualization, and measurement tools. Class 1 laser system.

Indications for Use

Indicated for intravascular imaging of coronary arteries in patients undergoing transluminal interventional procedures. Compatible with vessels 1.3 to 6.0 mm in diameter. Contraindicated for use in target vessels with previous bypass procedures.

Regulatory Classification

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.

Predicate Devices

• Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (K192922)

Reference Devices

• Abbott Medical's OPTIS™ Mobile Next Imaging System, OPTIS™ Integrated Next Imaging System with Ultreon™ Software 1.0 (K210458)

Submission Summary (Full Text)

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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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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 ([e-mail]) or phone [phone] 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)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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: [e-mail] Phone [phone]

#### 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:

- 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 System and the Vis-Rx Catheter.
- 2. 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.
- 3. 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.

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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<br>(K192922) | Gentuity Imaging System<br>(Subject<br>Device)<br>K230620 |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mode of Operation | Computer controlled swept-source (rapidly<br>tunable laser) transmitting near-infrared light<br>delivered through an Imaging Core housed<br>within an External Catheter Sheath. Image<br>acquisition (imaging core rotation and<br>pullback) driven by system-catheter<br>interconnection (PIM) and synchronized with<br>contrast injection. Reflected light is collected,<br>returned, and processed by the system<br>hardware and software to construct an OCT<br>image. | Same |
| Intended Use | Intravascular image in the coronary arteries | Same |
| Description | Gentuity Imaging System<br>(K192922) | Gentuity<br>Imaging System<br>(Subject<br>Device)<br>K230620 |
| Indications for use | The Gentuity® HF-OCT Imaging System with<br>Vis-Rx® Micro-Imaging Catheter is intended<br>for intravascular imaging and is indicated for<br>use in coronary arteries in patients who are<br>candidates for transluminal interventional<br>procedures. The Vis-Rx Micro-Imaging<br>Catheter is intended for use in vessels 1.3 to<br>6.0 mm in diameter. The Vis-Rx Micro-Imaging<br>Catheter is not intended for use in a target<br>vessel that has undergone a previous bypass<br>procedure. | Same |
| Classification | 21 CFR 892.1560<br>NQQ<br>System, Imaging OCT | Same |
| Optical Engine | Swept-source laser | Same |
| Computer | A host computer with embedded application<br>software | Same |
| Interconnection<br>between system<br>and catheter | Probe Interface Module (PIM) | Same |
| Console | A mobile console with monitors, keyboard and<br>mouse, housing the optical engine and host<br>computer, and connected to the PIM via an<br>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<br>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<br>(K192922) | Gentuity<br>Imaging System<br>(Subject<br>Device)<br>K230620 |
| Frame Rate | 250 frames per second (Hz) | Same |
| Image Display | Cross Section<br>L-mode<br>Lumen profile display<br>3D<br>Angio sync | Same |
| Software Features | Automatic lumen detection<br>Automatic lumen measurements<br>Automatic MLA identification<br>User generated length, area measurements<br>Text annotations<br>Zoom | Same |
| Software Features<br>(Stent Expansion<br>Visualization Tool) | Not available | Stent Expansion<br>View Mode<br>Longitudinal<br>Zoom & Zoom<br>Indicator<br>AI to identify B-<br>Mode with<br>Stent & Guide<br>Catheter<br>Training Mode<br>Image Display<br>Speed<br>Optimization<br>Angle<br>measurement<br>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) | (%) |
| <25 | 0 | 0 | <25 | 0 | 0 |
| 26-50 | 3 | 15 | 26-50 | 1 | 4 |
| 51-75 | 12 | 60 | 51-75 | 17 | 68 |
| 76-100 | 5 | 25 | 76-100 | 7 | 28 |
| Sex | | | Sex | | |
| | (N) | (%) | | (N) | (%) |
| Male | 15 | 75 | Male | 15 | 60 |
| Female | 5 | 25 | Female | 10 | 40 |
| BMI | | | BMI | | |
| Range | (N) | (%) | Range | (N) | (%) |
| <25 | 1 | 5 | <25 | 3 | 12 |
| 25-40 | 17 | 85 | 25-40 | 20 | 80 |
| >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.