(29 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on hardware configurations and existing imaging/pressure modes.
No
The device is used for diagnostic purposes (evaluating vascular morphology, providing images of vessel lumen and wall structures, measuring intravascular blood pressure) and not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used for "qualitative and quantitative evaluation of vascular morphology" and provides "an image of vessel lumen and wall structures," in addition to measuring "intravascular blood pressure during diagnostic angiography." These functions are inherently diagnostic, as they provide information about a patient's condition to help determine a diagnosis.
No
The device description explicitly mentions hardware components like a tower or portable model, an integrated model with a CPU, cables, a connection box, and accessories and bedside peripherals. It also describes operating modes related to hardware functionalities (IVUS imaging and FFR pressure mode).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The Volcano s5™ Imaging and Pressure System is used for in vivo (within the living body) evaluation of vascular morphology and pressure. It uses intravascular ultrasound and pressure measurements directly within the blood vessels.
- Lack of Specimen Analysis: The device does not collect or analyze specimens taken from the body. It interacts directly with the internal structures of the body.
Therefore, the intended use and device description clearly indicate that this is an in vivo diagnostic and imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Volcano s5™ Imaging and Pressure 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. VH® IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to sem-iautomatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.
The pressure feature is intended for use in all blood vessels, including coronary and perioheral 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 orovide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.
Product codes (comma separated list FDA assigned to the subject device)
IYO, DSK, DSA
Device Description
The Volcano s5 and CORE Series Precision Guided Therapy Systems are currently available in 2 configurations: (1) a tower or a portable model, (2) an integrated model. The Volcano s5i® and CORE™ Precision Guided Therapy Systems are the integrated configurations that are integrated in the catheterization (cath) laboratory, meaning that the CPU is located outside the cath lab and the controls and accessories are cabled in a trench under the floor into the cath lab for use on the patient. Some models of this configuration have the cables from the trench consolidated through the Connection Box located in the cath lab which then distributes connections to all the s5i/CORE accessories and bedside peripherals.
The Volcano s5™ and CORE™ Mobile tower systems are the tower/portable (rollaround or mobile) versions of the integrated systems can be rolled into the cath lab itself and the accessories and bedside peripherals directly connect to the system. There are two (2) operating modes available on both the integrated as well as the tower models of the Volcano Precision Guided Therapy Systems, namely: (1) the Intravascular Ultrasound (IVUS) imaging mode and (2) the Fractional Flow Reserve (FFR) pressure mode.
As an accessory to the currently cleared s5 Series/CORE Systems , the Volcano LoMap is intended to allow the systems to interface with physiology monitors/hemodynamic monitoring equipment and aortic transducers for pressure level amplification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Coronary arteries, peripheral vasculature, all blood vessels
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)
Non-clinical Testing: Applicable testing was performed as required by the Quality System to evaluate the modification to the Volcano s5 Series/CORE Systems. The following tests were conducted: Reliability HALT, Electrical Safety, Electromagnetic Compatibility, Software Tests. The test results were found to be acceptable by the respective test plans and protocols. Biocompatibility testing was not required as the proposed accessory does not come in contact with the patient or any fluid path.
Clinical Testing: No human or animal clinical testing was performed for this premarket notification.
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
§ 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.
0
NOV 1 5 2013
510(k) SUMMARY
The 510(k) Summary is submitted as reguired by section 807.92(a)
| SPONSER: | Volcano Corporation
3721 Valley Centre Dr., Suite 500
San Diego, CA 92130 | |
|------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| CONTACT/
SUBMITTER: | Elaine Alan
Sr. Regulatory Affairs Specialist
Volcano Corporation
1 Fortune Dr.
Billerica, MA 01821 | Phone: 978-439-3357
Fax:
eMail: ealan@volcanocorp.com |
| | DATE SUBMITTED: September 30, 2013 | |
| DEVICE: | Volcano s5™/s5i® CORE and CORE Mobile Series Precision Guided
Therapy Systems | |
| Trade Name: | Volcano s5™/s5i® CORE and CORE Mobile Series Precision Guided
Therapy Systems | |
| Common Name: | Ultrasonic pulsed echo imaging system | |
Classification and Product Codes:
| CFR Number | Class | Product Code |
|---|---|---|
| 892.1560 Ultrasonic pulsed echo imaging system | II | IYO |
| 870.1110 Blood Pressure Computer | II | DSK |
| 870.2900 Patient Transducer and Electrical Cable | II | DSA |
PREDICATE DEVICE: K123898, Volcano s5™s5i® Intravascular Ultrasound Imaging System
DEVICE DESCRIPTION
The Volcano s5 and CORE Series Precision Guided Therapy Systems are currently available in 2 configurations: (1) a tower or a portable model, (2) an integrated model. The Volcano s5i® and CORE™ Precision Guided Therapy Systems are the integrated configurations that are integrated in the catheterization (cath) laboratory, meaning that the CPU is located outside the cath lab and the controls and accessories are cabled in a trench under the floor into the cath lab for use on the patient. Some models of this configuration have the cables from the trench consolidated through the Connection Box
1
located in the cath lab which then distributes connections to all the s5i/CORE accessories and bedside peripherals.
The Volcano s5™ and CORE™ Mobile tower systems are the tower/portable (rollaround or mobile) versions of the integrated systems can be rolled into the cath lab itself and the accessories and bedside peripherals directly connect to the system. There are two (2) operating modes available on both the integrated as well as the tower models of the Volcano Precision Guided Therapy Systems, namely: (1) the Intravascular Ultrasound (IVUS) imaging mode and (2) the Fractional Flow Reserve (FFR) pressure mode.
As an accessory to the currently cleared s5 Series/CORE Systems , the Volcano LoMap is intended to allow the systems to interface with physiology monitors/hemodynamic monitoring equipment and aortic transducers for pressure level amplification.
INDICATIONS FOR USE
The Volcano s5™ Imaging and Pressure 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. VH® IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.
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
2
provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The proposed device is identical to the currently marketed device except for the addition of a new optional accessory, the Volcano LoMap. The Volcano LoMap acts as an interface between Volcano s5 Series/CORE Systems and hemodynamic systems in the catheterization laboratory. The technological characteristics, fundamental scientific technology, and indications for use remain unchanged.
PERFORMANCE DATA: Non-clinical Testing
Applicable testing was performed as require by the Quality System to evaluate the modification to the Volcano s5 Series/CORE Systems. The following tests were conducted:
- . Reliability HALT
- Electrical Safety .
- Electromagnetic Compatibility ♥
- Software Tests .
The test results were found to be acceptable by the respective test plans and protocols.
Biocompatibility testing was not required as the proposed accessory does not come in contact with the patient or any fluid path.
PERFORMANCE DATA: Clinical Testing
No human or animal clinical testing was performed for this premarket notification.
Conclusion
Completion of these tests concluded that the proposed Volcano s5 Series/CORE Systems are substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 15, 2013
Volcano Corporation Elaine Alan 1 Fortune Dr Billerica, MA 01821 US
Re: K 133142
Trade/Device Name: Volcano LoMap. Volcano LoMap Option Kit For Mobile System. Volcano LoMap Option for Integrated System, Volcano $5 Precision Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO Dated: September 30, 2013 Received: October 17, 2013
Dear Elaine Alan:
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. 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 (2) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda,gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K133142 510(k) Number (if known):
Device Name: Volcano s5&/s5(@ CORE and CORE Mobile Series Precision Guided Therapy Systems
Indications for Use:
The Volcano s5™ Imaging and Pressure 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. VH® IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to sem-iautomatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.
The pressure feature is intended for use in all blood vessels, including coronary and perioheral 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 orovide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Digitally signed by
Owen P. Faris -S
Date: 2013.11.15
11:13:58 -05'00'
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