(26 days)
Not Found
No
The document describes standard image and signal processing techniques for IVUS and pressure data, with no mention of AI or ML.
No.
The device is used for diagnostic purposes such as qualitative evaluation of vascular morphology, measuring intravascular blood pressure, and providing images of vessel lumen and wall structures, not for treating or curing a disease.
Yes
The intended use and indications for use explicitly state that the device is for "qualitative evaluation of vascular morphology," "diagnostic angiography," and that the iFR Modality has a "diagnostic cut-point" to guide revascularization decisions. These all point to the device being used for diagnosis.
No
The device description explicitly mentions interfacing with hardware components like IVUS imaging catheters, pressure wires, and a Patient Interface Module (PIM). It also describes the use of a transducer to emit and receive sound waves, which is a hardware function. Furthermore, the summary mentions "New image signal processing hardware and software," indicating the presence of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The IntraSight System operates by using Intravascular Ultrasound (IVUS) and pressure measurements within the blood vessels. It directly interacts with the patient's internal anatomy.
- Intended Use: The intended use describes the evaluation of vascular morphology and blood pressure in vivo (within the living body), not on samples taken from the body.
- Device Description: The description details how the system uses a transducer and pressure wires inserted into the vessels to acquire data.
Therefore, the IntraSight System is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IntraSight System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.
The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.
Rotational 45MHz feature is intended for the qualitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the Spinvision (PIMr) withdraws the imaging core within the protective sheath for a maximum of 15 cm.
The FFR Modality is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravasular blood pressure during diagnostic angiography and/or interventional procedures.
The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision making the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.
Product codes (comma separated list FDA assigned to the subject device)
IYO, DSA, DSK
Device Description
The IntraSight System provides qualitative and quantitative evaluation of vascular morphology in the coronary arteries and peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The IntraSight System interfaces with Volcano Intravascular Ultrasound (IVUS) Imaging Catheters and pressure wires. When operating in the IVUS mode, the IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures and produce a 360° cross-sectional, tomographic image. When operating in the pressure mode, the system acquires intraluminal data from a pressure guide wire while simultaneously taking aortic pressure data from the established catheterization lab equipment. Catheters and guide wires are connected to the system via the Patient Interface Module (PIM).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intravascular Ultrasound (IVUS)
Anatomical Site
coronary arteries and vessels of the peripheral vasculature; all blood vessels, including coronary and peripheral 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 completed for a determination of substantial equivalence included the following:
- Master Safety Testing (EMC and Electrical Safety)
- Environmental Testing
- Design Verification
- Software Verification and Validation
- Packaging Validation
- Simulated Use / Usability Validation
- Image Validation
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.
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
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 11, 2019
Volcano Corporation Kimberly Simon Regulatory Affairs Specialist 3721 Valley Centre Drive. Suite 500 San Diego, California 92130
Re: K190078
Trade/Device Name: IntraSight System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, DSA, DSK Dated: January 15, 2019 Received: January 16, 2019
Dear Kimberly Simon:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Munk Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190078
Device Name
IntraSight System
Indications for Use (Describe)
The IntraSight System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.
The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.
Rotational 45MHz feature is intended for the qualitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the Spinvision (PIMr) withdraws the imaging core within the protective sheath for a maximum of 15 cm.
The FFR Modality is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravasular blood pressure during diagnostic angiography and/or interventional procedures.
The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision making the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
| SPONSOR: | Volcano Corporation
3721 Valley Centre Drive, Suite 500
San Diego, CA 92130 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Kimberly Simon
Regulatory Affairs Specialist
Philips Volcano
3721 Valley Centre Drive, Suite 500
San Diego, CA 92130
Tel: (858) 720-4113 |
| DATE PREPARED: | January 15, 2019 |
| DEVICE: | IntraSight |
| TRADE NAME: | IntraSight |
| COMMON NAME: | System, Imaging, Pulsed Echo, Ultrasonic |
| CLASSIFICATION: | 21 CFR Part 892.1560
IYO: Ultrasonic Pulsed Echo Imaging System
21 CFR Part 870.2900
DSA: Patient Transducer and Electrical Cable
21 CFR Part 870.1110
DSK: 870.1110 Blood Pressure Computer |
| PREDICATE DEVICE: | Volcano s5i/CORE and CORE Mobile Precision Guided
Therapy Systems (K173860) |
| DEVICE DESCRIPTION: | The IntraSight System provides qualitative and quantitative
evaluation of vascular morphology in the coronary arteries
and peripheral vasculature. It is also indicated as an
adjunct to conventional angiographic procedures to provide
an image of vessel lumen and wall structures. The
IntraSight System interfaces with Volcano Intravascular
Ultrasound (IVUS) Imaging Catheters and pressure wires.
When operating in the IVUS mode, the IVUS catheter uses
a transducer near the distal tip to emit and receive high
frequency sound waves. The system is then able to analyze
the signal that is received by the transducer to differentiate
between vessel structures and produce a 360° cross-
sectional, tomographic image. When operating in the
pressure mode, the system acquires intraluminal data from |
4
a pressure guide wire while simultaneously taking aortic pressure data from the established catheterization lab equipment. Catheters and guide wires are connected to the system via the Patient Interface Module (PIM).
INTENDED USE:
The IntraSight system is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.
The pressure feature is intended for use in all blood vessels. including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.
Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the Spinvision (PIMr) withdraws the imaging core within the protective sheath for a maximum of 15 cm.
The FFR Modality is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.
The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cutpoint of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision making by indicating the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.
5
COMPARISON OF CHARACTERISTICS:
The IntraSight System is a modification to the currently marketed CORE Integrated System. The IntraSight System is a modification to the currently marketed CORE System cleared of K173860. The modifications to the CORE System include:
- Reduced functional capability removal of the VH ● IVUS modality
- New image signal processing hardware and . software, as the current image signal processing hardware is going end-of-life
- Updated software platform (Endeavour App . Engine) to provide an improved User Interface
- . Updated secondary user interface (bedside controller) to provide an improved ease of use
- . Update to the FM-PIM in order to provide an adaptor for compatibility to the Verrata pressure wires, changes to PIM firmware, and fluid ingress protection
None of these modifications effect or alter the fundamental scientific technologies of the currently marketed device.
PERFORMANCE DATA:
Performance testing completed for a determination of substantial equivalence included the following:
- Master Safety Testing (EMC and Electrical Safety) ●
- Environmental Testing
- Design Verification
- Software Verification and Validation ●
- Packaging Validation
- Simulated Use / Usability Validation
- Image Validation ●