(29 days)
Not Found
No
The summary describes standard medical imaging and pressure measurement technologies without mentioning AI or ML.
No
The device is described for qualitative evaluation and imaging of vascular morphology, blood flow, and intravascular pressure measurement, not for treatment or therapy.
Yes
The device is explicitly indicated for "qualitative evaluation of vascular morphology," "qualitative blood flow information," and "to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures," and the iFR modality reliably guides revascularization decisions, all of which are diagnostic functions.
No
The device description explicitly states that the system interfaces with hardware components (Volcano Intravascular Ultrasound (IVUS) Imaging Catheters and pressure wires) and connects to them via a Patient Interface Module (PIM). It also describes the function of the IVUS catheter's transducer. This indicates it is a hardware-based system with associated software, not a software-only device.
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 ultrasound and pressure measurements within the patient's blood vessels. It directly interacts with the patient's anatomy to provide imaging and physiological data.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The system is used in vivo (within the living body).
The device is a medical imaging and physiological monitoring system used during procedures, not a diagnostic test performed on samples outside the body.
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 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 the wall structures. The Pullback feature of 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 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 the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.
Product codes
IYO, DSK, DSA
Device Description
The IntraSight Mobile 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 Mobile 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 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic Pulsed Echo Imaging System
Anatomical Site
coronary arteries and vessels of the peripheral vasculature.
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:
- EMC and Electrical Safety Testing
- Environmental Testing
- Design Verification
- Software Verification and Validation
- Packaging Validation
- Simulated Use / Usability Validation
- Image Validation
All device acceptance criteria were met. Results of testing show that the proposed IntraSight Mobile System meets its intended use.
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.
IntraSight K190078
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
§ 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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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: a symbol on the left and the text on the right. The symbol on the left is a stylized image of a bird or eagle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 19, 2021
Volcano Corporation Linda Schulz Sr. Regulatory Affairs Specialist 3721 Valley Centre Dr Ste 500 San Diego, California 92130
Re: K203719
Trade/Device Name: IntraSight Mobile Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, DSK, DSA Dated: December 18, 2020 Received: December 21, 2020
Dear Linda Schulz:
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,
Mark Fellman 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)
K203719
Device Name
IntraSight Mobile
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 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 the wall structures. The Pullback feature of 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 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 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) |
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Image /page/3/Picture/1 description: The image shows the logo for Volcano Corporation. The logo consists of a gray square with a white mountain inside, followed by the word "VOLCANO" in large, blue letters. Below the word "VOLCANO" is the phrase "PRECISION GUIDED THERAPY" in smaller, black letters.
510(k) SUMMARY December 18, 2020
| SPONSOR: | Volcano Corporation
3721 Valley Centre Drive, Suite
500 San Diego, CA 92130 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Linda Schulz
Sr. Regulatory Affairs Specialist
Volcano Corporation
3721 Valley Centre Drive, Suite
500 San Diego, CA 92130
Tel: (858) 720-4113 |
| DATE PREPARED: | December 18, 2020 |
| DEVICE: | IntraSight Mobile |
| TRADE NAME: | IntraSight Mobile |
| 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: | IntraSight K190078 |
DEVICE DESCRIPTION:
The IntraSight Mobile 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 Mobile 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
4
Image /page/4/Picture/1 description: The image shows the logo for Volcano Corporation. The logo consists of a gray square with a white mountain inside, followed by the word "VOLCANO" in blue, block letters. Below the word "VOLCANO" is the phrase "PRECISION GUIDED THERAPY" in smaller, black letters.
360° cross-sectional, tomographic image. When operating in the pressure mode, the system acquires intraluminal data from 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 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 by indicating the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.
SUBSTANTIAL EQUIVALENCE:
The IntraSight Mobile System is a modification to the currently marketed IntraSight System cleared under K190078. The purpose of the modification is to provide the cath lab integrated system functionality on a light-weight mobile cart. The functionality of the system remains the same and is now available in a mobile version with a touch screen on the panel PC. For additional protection of the secondary controller, a rugged housing has been added that can be attached to the cart or to the bedside.
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Image /page/5/Picture/1 description: The image shows the logo for Volcano Corporation. The logo consists of a gray square with a blue triangle inside, followed by the word "VOLCANO" in blue, and the words "PRECISION GUIDED THERAPY" in black below. The logo is simple and modern, and the colors are clean and professional.
None of the modifications effect or alter the fundamental scientific technologies of the currently marketed device.
The proposed IntraSight Mobile System has the following similarities to the currently marketed IntraSight System:
- same intended use and operating principle ●
- have the same Indications for Use ●
- incorporates the same basic design for image acquisition, measurements, and archiving
- incorporates the same basic materials ●
- uses the same Patient Interface Modules, and the same compatible catheters and pressure wires
- uses the same software platform and user interface
- is designed and manufactured to the same electrical and physical safety standards
PERFORMANCE DATA:
Performance testing completed for a determination of substantial equivalence included the following:
- EMC and Electrical Safety Testing ●
- Environmental Testing
- Design Verification
- Software Verification and Validation
- Packaging Validation ●
- Simulated Use / Usability Validation ●
- Image Validation
CONCLUSION:
All device acceptance criteria were met. Results of testing show that the proposed IntraSight Mobile System meets its intended use. The differences between the subject device and predicate device do not raise new questions of safety and/or effectiveness. Therefore, the proposed IntraSight Mobile System is substantially equivalent to the predicate IntraSight System.