(17 days)
Not Found
No
The summary describes a standard OCT imaging system and catheter, focusing on the hardware and basic software for image acquisition and review. There is no mention of AI, ML, or advanced image processing that would typically indicate the use of such technologies.
No
The device is described as an "Imaging System" intended for "intravascular imaging" and to "produce high resolution, real-time images" of coronary arteries. Its purpose is diagnostic, providing visual information, rather than directly treating a disease or condition. It is used in patients who are "candidates for transluminal procedures" or "prior to or following transluminal interventional procedures," suggesting it aids in planning or assessing interventions, but is not an intervention itself.
Yes
The device is described as an "Imaging System" that provides "real-time images" of coronary arteries, which are then used to "review images" and perform "analysis." Furthermore, its "Intended Use / Indications for Use" states it is "intended for intravascular imaging" and for use "prior to or following transluminal interventional procedures," indicating its role in providing information to guide medical decisions.
No
The device description clearly lists hardware components such as the Gentuity Imaging Console (housing the Optical Engine, Computer, and PIM), the Vis-Rx Micro-Imaging Catheter (a physical catheter with an optical fiber and lens assembly), and the optional Gentuity Review Station (a standalone computer). While software is mentioned, it is part of a larger system that includes significant hardware.
Based on the provided information, the Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body. The purpose is to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- The Gentuity system is used for in vivo imaging. It directly images the coronary arteries inside the patient's body using optical coherence tomography (OCT).
- The intended use and device description clearly state that it is for intravascular imaging in coronary arteries. This is a direct imaging procedure performed within the patient.
Therefore, the Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter falls under the category of imaging devices used for diagnostic purposes within the body, not IVD devices.
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 also intended for use prior to or following transluminal interventional procedures. The Vis-Rx 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® 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 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 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)
No additional non-clinical and clinical performance testing was required to support review of this 510(k) Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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August 16, 2024
Gentuity, LLC Sharon Timberlake Vice President Clinical, Quality and Regulatory Affairs 142 North Road, Suite G Sudbury, Massachusetts 01776
Re: K242239
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: July 29, 2024 Received: July 30, 2024
Dear Sharon Timberlake:
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 (the 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.
1
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" (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 QS 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.
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).
Sincerely,
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
2
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) K242239
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 in patients who are candidates for transluminal 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 also intended for use prior to or following transluminal interventional procedures. 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/4/Picture/0 description: The image shows the logo for Gentuity. The logo consists of a stylized fingerprint graphic to the left of the word "GENTUITY". The fingerprint graphic is made up of several concentric arcs in a light blue color. The word "GENTUITY" is written in a simple, sans-serif font in a gray color.
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
Sharon Timberlake 142 North Road Suite G Sudbury, MA 01776 stimberlake@gentuity.com
1.3 Date of Preparation
August 15, 2024
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
2.3 510(k) Number
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: | Optical Coherence Tomography Intravascular Catheter |
| Classification Regulation: | 21 CFR 870.1200 |
| Class: | II |
| Product Code: | DQO |
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Image /page/5/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 water ripple. The color scheme is muted, with the text in a light gray and the graphic in a teal color.
3. PREDICATE DEVICE
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter (K230620).
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 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 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 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® 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 also intended for use prior to or following transluminal interventional procedures. The Vis-Rx Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure.
6. TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE
There have been no changes to the technological characteristics, sterilization method, device packaging, device materials and components of the proposed device being reviewed under
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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 arcs in a light teal color, resembling a fingerprint or a stylized eye. The logo has a clean and modern design.
this 510(k) Premarket Notification. As a result, the proposed device is identical to the predicate device.
7. PERFORMANCE TESTING
No additional non-clinical and clinical performance testing was required to support review of this 510(k) Premarket Notification.
8. CONCLUSIONS
The information presented in this 510(k) Premarket Notification demonstrates the Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter is substantially equivalent to the predicate device.