(196 days)
Not Found
No
The summary describes a standard intravascular ultrasound (IVUS) catheter that generates real-time images based on ultrasonic echoes. There is no mention of AI or ML being used for image processing, analysis, or any other function. The performance testing focuses on physical and signal processing characteristics, not algorithmic performance.
No
The device is described as an imaging tool for evaluation of vascular morphology, not for treatment.
Yes
Explanation: The device is described as an "IVUS Catheter" designed to "evaluate vascular morphology" and provide a "cross-sectional image" of blood vessels. This process of imaging and assessing the structure and condition of vessels falls under the definition of diagnosis, as it aims to identify or characterize a medical condition.
No
The device description clearly details a physical catheter with an ultrasound transducer array, which is a hardware component. The software mentioned is for processing the echoes to generate images, but it is part of a system that includes significant hardware.
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 Visions® PV .018 Digital IVUS Catheter is an imaging device that uses ultrasound to visualize the internal structure of blood vessels in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "evaluation of vascular morphology in blood vessels" and provides "a cross-sectional image of such vessels." This is a diagnostic imaging function, not an in vitro diagnostic test.
Therefore, this device falls under the category of medical imaging devices used for diagnostic purposes within the body, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Visions® PV .018 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.
The Visions® PV .018 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Product codes
OBJ, ITX
Device Description
The Visions® PV .018 Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array located near the distal tip of the catheter. The array radiates acoustic energy into the surrounding tissue and detects the subsequent ultrasonic echoes. The information from the echoes is used to generate real-time images of the coronary or peripheral vessels.
The Visions® PV .018 catheter utilizes an internal lumen that allows the catheters to track over a 0.018" (0.46 mm) guide wire. The guide wire exits from the guide wire lumen approximately 31 cm proximal to the catheter tip. The PV .018 catheters are introduced either percutaneously or via surgical cut down into the vascular system.
The Visions® PV .018 catheter may only be used with Volcano imaging systems, such as the Volcano s5™, Volcano s5i™, Volcano CORE Mobile, and Volcano CORE imaging systems. The catheter will not operate if connected to any other imaging system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Coronary and 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
Non-clinical device testing was conducted to confirm the performance of the modified device. Bench testing was conducted against product specification and evaluated the following:
- Shelf Life
- Floppy Tip Tensile Testing
- ESL Tensile Testing
- Signal Processing
All bench testing was successfully completed and met the pre-determined acceptance criteria. The successful completion of performance testing concluded that the modified Visions® PV .018 catheter is substantially equivalent to the currently marketed Visions F/X (Model 82700) catheter.
Biocompatibility testing was conducted on the device and the following tests were successfully completed:
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Systemic Toxicity
- Pyrogenicity
- ASTM Hemolysis
- Partial Thromboplastin Time
- In vivo Thromboresistance
- C3a Complement Activation
- SC5-b Complement Activation
- Bacterial Endotoxins (LAL)
- LEAP Latex Elisa for Antigenic Protein
- Platelet and Leukocyte Counts
- Chemical Characterization
The successful completion of performance testing and biocompatibility testing concluded that the modified Visions® PV .018 catheter is substantially equivalent to the currently marketed Visions F/X (Model 82700) catheter.
Key Metrics
Not Found
Predicate Device(s)
Visions F/X Model 82700 (K944004)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of three curved lines that form the shape of a head and body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 4, 2015
Volcano Corporation Mary Stanners Regulatory Affairs Specialist 3721 Valley Centre Drive, Suite 500 San Diego CA 92130
Re: K150442
Trade/Device Name: Volcano Visions PV .018 Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: May 22, 2015 Received: May 26, 2015
Dear Mary Stanners:
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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 Industry and Consumer Education 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.
Sincerely yours,
Mitchell Stein
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) K150442
Device Name
Visions ® PV.018 Digital IVUS Catheter
Indications for Use (Describe)
The Visions® PV .018 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.
The Visions® PV .018 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
| 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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Volcano Corpora 3721 Valley Centre Drive San Diego, California 92130 www.volcanocorp.com
510(K) SUMMARY
| SPONSOR: | Volcano Corporation
3721 Valley Centre Drive, Suite 500
San Diego, CA 92130 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Mary Stanners
Regulatory Affairs Specialist
Volcano Corporation
3721 Valley Centre Drive
San Diego, California 92130
Tel: (858) 764-1296 |
| DATE OF SUBMISSION: | August 31, 2015 |
| DEVICE: | Volcano Visions® PV .018 Digital IVUS Catheter |
| Trade Name: | Volcano Visions® PV .018 Digital IVUS Catheter |
| Common Name: | Diagnostic Intravascular Catheter |
Classification and Product Codes:
| CFR Number | Class | Product Code |
|---|---|---|
| 21 CFR 870.1200 Diagnostic | ||
| Intravascular Catheter | II | OBJ |
| 21 CFR 892.1570 Diagnostic | ||
| Ultrasound Transducer | II | ITX |
PANEL:
Cardiovascular
PREDICATE DEVICE: Visions F/X Model 82700 (K944004)
DEVICE DESCRIPTION:
The Visions® PV .018 Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array located near the distal tip of the catheter. The array radiates acoustic energy into the
4
surrounding tissue and detects the subsequent ultrasonic echoes. The information from the echoes is used to generate real-time images of the coronary or peripheral vessels.
The Visions® PV .018 catheter utilizes an internal lumen that allows the catheters to track over a 0.018" (0.46 mm) guide wire. The guide wire exits from the guide wire lumen approximately 31 cm proximal to the catheter tip. The PV .018 catheters are introduced either percutaneously or via surgical cut down into the vascular system.
The Visions® PV .018 catheter may only be used with Volcano imaging systems, such as the Volcano s5™, Volcano s5i™, Volcano CORE Mobile, and Volcano CORE imaging systems. The catheter will not operate if connected to any other imaging system.
INDICATIONS FOR USE:
The Visions® PV .018 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a crosssectional image of such vessels. This device is not currently indicated for use in cerebral vessels.
The Visions® PV .018 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
COMPARISON OF TECHNOLOGICAL CHARACTERISICS:
The modifications made to the Visions® PV .018 Digital IVUS Catheter (changes in catheter material, catheter scanner assembly and catheter connector assembly) do not affect the intended use of the device or technologies included as part of the device and they do not alter the fundamental scientific technologies. The indications for use are identical to those of the currently marketed predicate device (Visions F/X Model 82700; cleared under K944004). The modified catheter is substantially equivalently to currently marketed predicate device.
PERFORMANCE DATA:
Non-clinical device testing was conducted to confirm the performance of the modified device. Bench testing was conducted against product specification and evaluated the following:
- Shelf Life
- Floppy Tip Tensile Testing ●
- . ESL Tensile Testing
- . Signal Processing
All bench testing was successfully completed and met the pre-determined acceptance criteria. The successful completion of performance testing concluded that the modified Visions® PV .018 catheter is substantially equivalent to the currently marketed Visions F/X (Model 82700) catheter.
Biocompatibility testing was conducted on the device and the following tests were successfully completed:
5
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- . Systemic Toxicity
- Pyrogenicity
- ASTM Hemolysis
- Partial Thromboplastin Time
- In vivo Thromboresistance
- . C3a Complement Activation
- SC5-b Complement Activation
- Bacterial Endotoxins (LAL)
- LEAP Latex Elisa for Antigenic Protein
- Platelet and Leukocyte Counts •
- Chemical Characterization .
The successful completion of performance testing and biocompatibility testing concluded that the modified Visions® PV .018 catheter is substantially equivalent to the currently marketed Visions F/X (Model 82700) catheter.