(29 days)
Not Found
No
The summary describes a standard ultrasound imaging catheter and system. There is no mention of AI, ML, or advanced image processing techniques that would suggest the use of such technologies. The focus is on the hardware (transducer array, catheter design) and basic real-time image generation.
No.
The device is described as an imaging catheter for evaluating vascular morphology, generating real-time images, and providing images of the vessel lumen and wall structures, which are diagnostic functions, not therapeutic.
Yes
Explanation: The device is used to "evaluate vascular morphology" and provides "cross-sectional images" of blood vessels, which are diagnostic activities. It aids in imaging the "vessel lumen and wall structures" to help understand the state of the vasculature.
No
The device description clearly details a physical catheter with an ultrasound transducer array, guide wire lumen, and radiopaque markers. It is a hardware device that interfaces with specific imaging systems and software.
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 Eagle Eye® Platinum ST catheter is an imaging device that is inserted directly into blood vessels (in vivo) to visualize their structure. 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" by providing "a cross-sectional image." This is a diagnostic imaging procedure, not an in vitro test.
Therefore, the Eagle Eye® Platinum ST catheter falls under the category of medical devices used for diagnostic imaging, but not specifically as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Eagle Eye® Platinum ST catheters are 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 Eagle Eye Platinum ST ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Product codes (comma separated list FDA assigned to the subject device)
OBJ, ITX
Device Description
The Eagle Eye Platinum ST Catheter incorporates a cylindrical ultrasound transducer array. The array 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 coronary and peripheral vessels.
The Eagle Eye Platinum ST Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The catheter is introduced percutaneously or via surgical cutdown into the vascular system.
Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge, starting 10 mm from the proximal edge of the portion of the scanner marker tube normally visible under fluoroscopy.
The Eagle Eye Platinum ST Catheter may only be used with the In-Vision Imaging System, Volcano s5 or Volcano s5i Imaging System. These systems use Volcano VH IVUS system software v1.2 or higher. This catheter will not operate if connected to any other imaging system.
Mentions image processing
Yes
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Applicable testing was performed in accordance with the Design Verification Plan including a Risk Analysis addressing the impact of enhancements to the device and components. The test results indicate the Eagle Eye Platinum ST Catheter is comparable to the predicate device.
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
§ 870.1200 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
II
ITX
Volcano Corporation March 5, 2012
APR - 5 2012 Eagle Eye Platinum ST Catheter Special 510(k)
510 (K) Summary
| Date Prepared: | February 29, 2012 | |
|---|---|---|
| Submitted by: | Volcano Corporation | |
| 3661 Valley Centre Dr. | ||
| Suite 200 | ||
| San Diego, CA 92130 | ||
| Contact person: | Marilyn Pourazar | |
| Senior Director of Regulatory Affairs | ||
| Phone number: | (858) 720-4116 | |
| Facsimile number: | (858) 720-0612 | |
| Device Name: | Eagle Eye Platinum ST Catheter | |
| Classification Name: | Class Product Code | |
| 21 CFR 870.1200 Diagnostic Intravascular Catheter | II | OBJ |
Predicate Device: Eagle Eye Platinum Digital IVUS Catheter
21 CFR 892.1570 Diagnostic Ultrasound Transducer
The Volcano Eagle Eye Platinum ST Catheter is substantially equivalent to the following:
| 510(k) Number | Product Name | Clearance Date |
|---|---|---|
| K092596 | Eagle Eye Platinum Digital IVUS Catheter | December 10, |
| 2009 |
Device Description:
The Eagle Eye Platinum ST Catheter incorporates a cylindrical ultrasound transducer array. The array 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 coronary and peripheral vessels.
1
K120 697
Volcano Corporation March 5, 2012
Eagle Eye Platinum ST Cathete Special 510(k)
The Eagle Eye Platinum ST Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The catheter is introduced percutaneously or via surgical cutdown into the vascular system.
Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge, starting 10 mm from the proximal edge of the portion of the scanner marker tube normally visible under fluoroscopy.
The Eagle Eye Platinum ST Catheter may only be used with the In-Vision Imaging System, Volcano s5 or Volcano s5i Imaging System. These systems use Volcano VH IVUS system software v1.2 or higher. This catheter will not operate if connected to any other imaging system.
Intended Use:
The Eagle Eye Platinum ST 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.
Device Technological Characteristics and Comparison to Predicate Device: The Volcano Corporation Eagle Eye Platinum ST Catheter is substantially equivalent to the predicate device, Eagle Eye Platinum Digital IVUS Catheter.
The Eagle Eye Platinum ST catheter uses the same fundamental scientific technology and has the same intended use as that of the predicate device.
Performance Data:
Applicable testing was performed in accordance with the Design Verification Plan including a Risk Analysis addressing the impact of enhancements to the device and components. The test results indicate the Eagle Eye Platinum ST Catheter is comparable to the predicate device.
22
2
Volcano Corporation March 5, 2012
Eagle Eye Platinum ST Catheter Special 510(k)
Conclusion:
The Volcano Eagle Eye Platinum ST Catheter has the same performance specifications, fundamental scientific technology and intended use as that of the predicate device, Eagle Eye Platinum Digital IVUS Catheter. The design enhancements to the device do not raise any new questions regarding safety or efficacy. The performance data and a declaration of conformity with design controls support a determination of continuing substantial equivalence of the modified device to the predicate device. ·
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains an image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written around the edge of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Volcano Corporation c/o Ms. Marilyn Pourazar Senior Director, Regulatory Affairs 3661 Valley Centre Dr. Suite 200 San Diego, CA 92130
APR - 5 2012
Re: K120697
Trade/Device Name: Eagle Eye Platinum Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: OBJ, ITX Dated: March 5, 2012 Received: March 7, 2012
Dear Ms. Pourazar:
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.
4
Page 2-Ms. Pourazar
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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
Bram D. Zuckerman, M.D. Director / Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Eagle Eye Platinum ST Catheter Special 510(k)
Volcano Corporation March 5, 2012
510(k) Number (if known): K120697
Device Name: Eagle Eye Platinum ST Catheter
Indications for Use:
The Eagle Eye® Platinum ST catheters are 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 Eagle Eye Platinum ST ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
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 IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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