(66 days)
Not Found
No
The description focuses on the hardware (transducer, catheter) and basic image generation from ultrasound echoes. There is no mention of AI, ML, or advanced image processing beyond real-time image generation. The performance study is a literature search, not a study of algorithmic performance.
No
The device is described as an imaging catheter designed for evaluating vascular morphology and providing cross-sectional images, making it a diagnostic tool rather than a therapeutic one.
Yes
The device is described as providing "cross-sectional image of such vessels" and "an image of the vessel lumen and wall structures and dimensional measurements from the image" for "evaluation of vascular morphology," which falls under the definition of diagnostic imaging.
No
The device description clearly states it is an "intravascular imaging catheter with a digital ultrasound transducer at the distal end," indicating it is a physical hardware 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. They are used outside of the body.
- Device Function: The Visions® PV .035 Digital IVUS Catheter is an intravascular imaging catheter. It is inserted into the blood vessels of the peripheral vasculature to provide real-time images of the vessel lumen and wall structures.
- Method of Use: The device directly interacts with the patient's internal anatomy (blood vessels) and does not analyze samples taken from the body.
Therefore, the Visions® PV .035 Digital IVUS Catheter is a medical device used for imaging within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Visions® PV .035 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the 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 .035 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 and dimensional measurements from the image.
Product codes
OBJ
Device Description
The Visions® PV .035 Digital IVUS Catheter is an over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels.
The Visions® PV .035 Digital IVUS Catheter is introduced percutaneously or via surgical cutdown into the vascular system, and is designed to track over 0.035"-0.038" (0.89-0.97mm) guide wires.
The catheter body has markers 1 cm apart along the working length. There are 25 radiopaque (RO) markers on the distal end of the catheter, starting 1 cm from the imaging plane, with the 25th RO marker overlapping the distal-most wide inked marker. Inked markers (non-radiopaque) continue along the shaft, spaced 1 cm apart, middle-to-middle, with wider marks indicating 5 cm intervals.
A lubricious hydrophilic coating is applied externally to a distal portion of the catheter. The Visions® PV .035 Digital IVUS Catheter, catalog number 88901, may only be used with the In-Vision Imaging System, Volcano s5" Series and CORE " Series of Systems. This 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
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)
A literature search was carried out to support minor modifications to the contraindication sections for the Visions® PV.035 Digital IVUS Catheter. The results of this search supported modifications to the contraindication section.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Visions® PV .035 Digital IVUS Catheter, K121273
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/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is horizontally oriented and appears to be part of a document or heading. The words are capitalized, with each word separated by a space.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 31, 2015
Volcano Corporation Neeta Sharma Director, Regulatory Affairs 3721 Valley Centre Dr Ste 500 San Diego, CA 92130
Re: K153094
Trade/Device Name: Visions PV .035 Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: December 11, 2015 Received: December 14, 2015
Dear Neeta Sharma:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
Sincerelv vours.
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) K153094
Device Name Visions® PV .035 Digital IVUS catheter
Indications for Use (Describe)
The Visions® PV .035 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the 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 .035 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 and dimensional measurements from the image.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
| SPONSOR: | Volcano Corporation
3721 Valley Center Drive
San Diego, CA 92130 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Neeta Sharma
Director, Regulatory Affairs
Volcano Corporation
3721 Valley Center Drive
San Diego, CA 92130
Tel: (858) 720-4187
Fax: (858) 720-0335 |
| DATE PREPARED: | October 23, 2015 |
| DEVICE: | Volcano Visions® PV .035 Digital IVUS Catheter |
| TRADE NAME: | Visions® PV .035 Digital IVUS Catheter |
| COMMON NAME: | Diagnostic Intravascular Catheter |
| CLASSIFICATION: | 21 CFR 870.1200
OBJ: Diagnostic Intravascular Catheter
Class II Device |
| PREDICATE DEVICE: | Visions® PV .035 Digital IVUS Catheter, K121273 |
| DEVICE DESCRIPTION: | The Visions® PV .035 Digital IVUS Catheter is an over-
the-wire intravascular imaging catheter with a digital
ultrasound transducer at the distal end. The transducer
utilizes a 64-element cylindrical array that radiates acoustic
energy into the surrounding tissue and detects the
subsequent echoes. The information from the echoes is used
to generate real-time images of the peripheral vessels. |
| | The Visions® PV .035 Digital IVUS Catheter is introduced
percutaneously or via surgical cutdown into the vascular
system, and is designed to track over 0.035"-0.038" (0.89-
0.97mm) guide wires. |
| | The catheter body has markers 1 cm apart along the
working length. There are 25 radiopaque (RO) markers on
the distal end of the catheter, starting 1 cm from the
imaging plane, with the 25th RO marker overlapping the
distal-most wide inked marker. Inked markers (non- |
4
radiopaque) continue along the shaft, spaced 1 cm apart, middle-to-middle, with wider marks indicating 5 cm intervals.
A lubricious hydrophilic coating is applied externally to a distal portion of the catheter. The Visions® PV .035 Digital IVUS Catheter, catalog number 88901, may only be used with the In-Vision Imaging System, Volcano s5" Series and CORE " Series of Systems. This catheter will not operate if connected to any other imaging system.
INDICATIONS FOR USE:
The Visions® PV.035 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. This device is not currently indicated for use in cerebral vessels.
The Visions® PV .035 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 and dimensional measurements from the image.
COMPARISON OF CHARACTERISTICS:
Volcano Corporation made minor revisions to the instructions for use for the Visions® PV.035 Digital IVUS Catheter. These edits include revisions to contraindication section and other editorial changes to improve and streamline the overall IFU. There is no change to the current device design, specifications, indications, and/or any other characteristics.
PERFORMANCE DATA:
A literature search was carried out to support minor modifications to the contraindication sections for the Visions® PV.035 Digital IVUS Catheter. The results of this search supported modifications to the contraindication section.