(127 days)
Not Found
No
The summary describes a standard OCT imaging system and catheter. There is no mention of AI, ML, or advanced image processing that would suggest the use of such technologies. The performance studies focus on biocompatibility, sterilization, and animal studies, not algorithmic performance metrics.
No
Explanation: The device is an imaging system designed for visualization and diagnosis, not for treating or curing a medical condition. Its purpose is to provide images of coronary arteries.
Yes
The "Intended Use / Indications for Use" section states that the system is "intended for intravascular imaging" and "provides images of the coronary arteries". Imaging is a diagnostic function, as it provides information used to identify or analyze a medical condition.
No
The device description clearly outlines multiple hardware components, including an imaging console, a catheter, and an optional review station, in addition to the 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 during transluminal interventional procedures. This involves directly imaging the inside of blood vessels within the body.
- Device Description: The device is a system that uses fiber-optic technology to capture images from within the coronary arteries. It consists of an imaging console and a catheter that is inserted into the body.
- Nature of the Data: The device produces real-time images of the coronary tissue. This is in-vivo imaging, not the analysis of samples taken from the body (which is the hallmark of IVD).
IVD devices are designed to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health. This device operates in vivo (inside the body) to visualize structures directly.
N/A
Intended Use / Indications for Use
The Gentuity® HF-OCT Imaging System with Vis-Rx® Prime 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 Prime Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Prime Micro-Imaging Catheter is also intended for use prior to or following transluminal interventional procedures. The Vis-Rx Prime Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure.
Product codes
NQQ, DQO
Device Description
The Gentuity® HF-OCT 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 HF-OCT 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® Prime Micro-Imaging Catheter.
-
- Vis-Rx Prime Micro-Imaging Catheter: The Vis-Rx Prime Micro-Imaging 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 Prime Micro-Imaging 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 Prime Micro-Imaging Catheter.
-
- Optional Gentuity Review Station: The Gentuity Review Station (GRS) is an optional standalone 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
Yes
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)
Performance testing to support the review of the 510(k) Premarket Notification included bench and animal testing. The following performance data supported substantial equivalence.
Biocompatibility
The biocompatibility evaluation for the Gentuity® HF-OCT Imaging System with Vis-Rx® Prime Catheter was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Pyrogen Testing
- Hemocompatibility - Hemolysis
- Hemocompatibility – Partial Thromboplastin Time (PTT)
- Hemolysis - Complement Activation
- Thrombogenicity
The Vis-Rx Prime Micro-Imaging Catheter is considered an External Communicating Device: Circulating Blood,
§ 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
January 31, 2025
Gentuity, LLC Edwin Rule Director, Global Regulatory Affairs 142 North Road Suite G Sudbury, Massachusetts 01776
Re: K242966
Trade/Device Name: Gentuity® HF-OCT Imaging System with Vis-Rx Prime® 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 3, 2025 Received: January 3, 2025
Dear Edwin Rule:
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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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).
2
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
3
Indications for Use
510(k) Number (if known) K242966
Device Name
Gentuity® HF-OCT Imaging System with Vis-Rx® Prime Micro-Imaging Catheter
Indications for Use (Describe)
The Gentuity® HF-OCT Imaging System with Vis-Rx® Prime 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 Prime Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Prime Micro-Imaging Catheter is also intended for use prior to or following transluminal interventional procedures. The Vis-Rx Prime 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/4/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 arcs in a light teal color, resembling a fingerprint or a stylized eye. The overall design is clean and modern.
510(k) SUMMARY
GENERAL INFORMATION 1.
Submitter and 510(k) Owner 1.1
Gentuity, LLC 142 North Road Suite G Sudbury, MA 01776
1.2 Official Correspondent
Edwin Rule 142 North Road Suite G Sudbury, MA 01776 erule@gentuity.com
1.3 Date of Preparation
September 20, 2024
2. NAME OF THE DEVICE
2.1 Trade/Proprietary Name
Gentuity® HF-OCT Imaging System with Vis-Rx® Prime Micro-Imaging Catheter
2.2 Common/Usual Name
Optical Coherence Tomography Imaging System Optical Coherence Tomography Intravascular Catheter
2.3 510(k) Number
2.4 Classification Information
| Classification Name: | Ultrasonic Pulsed Echo Imaging System |
|---|---|
| Classification Regulation: | 21 CFR 892.1560 |
| Class: | II |
| Product Code: | NQQ |
| Panel: | General Surgical |
| Classification Name: | Diagnostic Intravascular Catheter |
| Classification Regulation: | 21 CFR 870.1200 |
| Class: | II |
| Product Code: | DQO |
| Panel: | Cardiovascular |
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Image /page/5/Picture/0 description: The image shows the logo for Gentuity. The logo consists of a series of concentric arcs on the left side, resembling a fingerprint or a stylized water ripple effect. To the right of the arcs is the word "GENTUITY" in a simple, sans-serif font. The color scheme is muted, with the arcs in a light teal and the text in a gray color.
3. PREDICATE DEVICE
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter (K242239).
4. DESCRIPTION OF THE DEVICE
The Gentuity® HF-OCT 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 HF-OCT 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® Prime Micro-Imaging Catheter.
-
- Vis-Rx Prime Micro-Imaging Catheter: The Vis-Rx Prime Micro-Imaging 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 Prime Micro-Imaging 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 Prime Micro-Imaging Catheter.
-
- Optional Gentuity Review Station: The Gentuity Review Station (GRS) is an optional standalone 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.
INDICATIONS FOR USE 5.
The Gentuity® HF-OCT Imaging System with Vis-Rx® Prime 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 Prime Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Prime Micro-Imaging Catheter is also intended for use prior to or following transluminal interventional procedures. The Vis-Rx Prime Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure.
TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE 6.
There have been no changes to the Intended Use or to the Indications for Use of the device. The Vis-Rx Prime Micro-Imaging Catheter design seeks to accomplish the following:
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Image /page/6/Picture/0 description: The image shows the logo for Gentuity. The logo consists of a series of concentric, teal-colored arcs on the left, resembling a fingerprint or sound wave pattern. To the right of the arcs is the word "GENTUITY" in a simple, sans-serif font, with the letters rendered in a muted gray color. The overall design is clean and modern.
- Materials changes (catheter)
- Minor design changes (catheter)
- Change packaging from a tray with a sealed lid inside a sealed pouch to a clamshell tray in a sealed pouch (catheter)
- Sterilization method change from e-beam to gamma irradiation (catheter)
- · Resolve software anomalies (console)
7. PERFORMANCE TESTING
Performance testing to support the review of the 510(k) Premarket Notification included bench and animal testing. The following performance data supported substantial equivalence.
Biocompatibility
The biocompatibility evaluation for the Gentuity® HF-OCT Imaging System with Vis-Rx® Prime Catheter was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- । Sensitization
- -Irritation
- -Systemic toxicity
- -Pyrogen Testing
- -Hemocompatibility - Hemolysis
- -Hemocompatibility – Partial Thromboplastin Time (PTT)
- -Hemolysis - Complement Activation
- -Thrombogenicity
The Vis-Rx Prime Micro-Imaging Catheter is considered an External Communicating Device: Circulating Blood,