(245 days)
Not Found
No
The document describes a standard intravascular ultrasound (IVUS) catheter and its associated imaging systems. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the hardware (transducer array, catheter design) and basic image generation from ultrasound echoes.
No
Explanation: The device is described as being for "evaluation of vascular morphology" and provides "cross-sectional image" as an "adjunct to conventional angiographic procedures." It is an imaging device used for diagnosis and assessment, not for treating any condition.
Yes
The device generates real-time images of coronary or peripheral vessels to evaluate vascular morphology, which is a diagnostic function.
No
The device description clearly details physical hardware components, specifically the IVUS catheters with ultrasound transducers, and mentions bench testing and biocompatibility testing related to these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "evaluation of vascular morphology in blood vessels... by providing a cross-sectional image of such vessels." This describes a device used in vivo (within the body) to visualize structures, not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue samples.
- Device Description: The description details a catheter with an ultrasound transducer array that is introduced into the vascular system. This is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or performing tests on samples outside the body, which are hallmarks of IVD devices.
Therefore, the Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line is an in vivo imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line, including the Eagle Eye Platinum catheter, Eagle Eye Platinum ST catheter and the PV.014P catheter, 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. These devices are not currently indicated for use in the cerebral vessels.
The Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line is 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 EEP line of digital IVUS catheters consists of the following products:
- Eagle Eye Platinum Catheter, Part # 809746001, Model 85900P ●
- Eagle Eye Platinum Short Tip Catheter, Part # 400-0200.141, Model 85900PST
- Visions PV .014 Platinum, Part # 400-0200.233, Model 85910P
The EEP line of catheters 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.
All of the EEP line of catheters utilizes an internal lumen that allows the catheters to track over a 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 EEP line catheters are introduced either percutaneously or via surgical cut down into the vascular system.
The EEP line of catheters may be used with the In-Vision Imaging System, Volcano s5™, Volcano s5i™, Volcano CORE Mobile, and Volcano CORE imaging systems. The catheters are designed to work with 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
Blood vessels of the coronary and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 device testing was conducted to confirm the performance of the modified device. Bench testing was conducted against known standards or product specification and evaluated the following:
- Friction Force
- Coating Adhesion
- . Particulate Generation
All bench testing was successfully completed.
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 ●
- . Genotoxicity
The successful completion of performance testing and biocompatibility testing concluded that the modified Eagle Eye Platinum catheters are substantially equivalent to the currently marketed Eagle Eye Platinum catheters.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Volcano Corporation Elaine Alan Senior Regulatory Affairs Specialist 1 Fortune Drive Billerica, Massachusetts 01821
Re: K143701
Trade/Device Name: Eagle Eye Platinum (EEP) Digital IVUS Catheter Line Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: June 23, 2015 Received: July 16, 2015
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 (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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.
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,
Arthell Stein
forBram 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) K143701
Device Name
Eagle Eye Platinum (EEP) Digital IVUS Catheter Line
Indications for Use (Describe)
The Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line, including the Eagle Eye Platinum catheter, Eagle Eye Platinum ST catheter and the PV.014P catheter, 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. These devices are not currently indicated for use in the cerebral vessels.
The Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line is 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Volcano. The logo consists of a gray square with a white triangle inside, and the word "VOLCANO" in large, bold, blue letters. The triangle inside the square is pointing downwards. The word "VOLCANO" is to the right of the square.
Volcano Corporation 1 Fortune Drive Billerica, MA 01821 Main: +1 978-262-0049 Fax : +1 978-262-0035 www.volcanocorp.com
510(K) SUMMARY
| SPONSOR: | Volcano Corporation
3721 Valley Centre Drive, Suite 500
San Diego, CA 92130 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Elaine Alan
Senior Regulatory Affairs Specialist
Volcano Corporation
1 Fortune Drive
Billerica, MA 01821
Tel: (858) 764-1281 |
| DATE OF SUBMISSION: | December 21, 2014 |
| DEVICE: | Eagle Eye Platinum (EEP) Digital IVUS Catheter Line |
| Trade Name: | Eagle Eye Platinum (EEP) Digital IVUS Catheter Line |
| 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 |
PREDICATE DEVICE:
Eagle Eye Platinum (EEP) Digital IVUS Catheter (K092596) Eagle Eye Platinum Short Tip (EEP-ST) Catheter (K120697)
4
DEVICE DESCRIPTION:
The EEP line of digital IVUS catheters consists of the following products:
- Eagle Eye Platinum Catheter, Part # 809746001, Model 85900P ●
- Eagle Eye Platinum Short Tip Catheter, Part # 400-0200.141, Model 85900PST
- Visions PV .014 Platinum, Part # 400-0200.233, Model 85910P
The EEP line of catheters 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.
All of the EEP line of catheters utilizes an internal lumen that allows the catheters to track over a 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 EEP line catheters are introduced either percutaneously or via surgical cut down into the vascular system.
The EEP line of catheters may be used with the In-Vision Imaging System, Volcano s5™, Volcano s5i™, Volcano CORE Mobile, and Volcano CORE imaging systems. The catheters are designed to work with Volcano VH IVUS system software v1.2 or higher. This catheter will not operate if connected to any other imaging system.
INDICATIONS FOR USE:
The Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line, including the Eagle Eye Platinum catheter, Eagle Eye Platinum ST catheter and the PV.014P catheter, 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. These devices are not currently indicated for use in the cerebral vessels.
The Eagle Eye® Platinum (EEP) Digital IVUS Catheter Line 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 modification made to the EEP line of catheters (change in hydrophilic coating) does not affect the intended use of the device or technologies included as part of the device product line and it does not alter the fundamental scientific technologies. The indications for use are identical to those of the currently marketed devices (EEP; K092596 and EEP-ST K120697). The modified catheters are substantially equivalently to currently marketed predicate devices.
5
PERFORMANCE DATA:
Non-clinical device testing was conducted to confirm the performance of the modified device. Bench testing was conducted against known standards or product specification and evaluated the following:
- Friction Force
- Coating Adhesion
- . Particulate Generation
All bench testing was successfully completed.
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 ●
- . Genotoxicity
The successful completion of performance testing and biocompatibility testing concluded that the modified Eagle Eye Platinum catheters are substantially equivalent to the currently marketed Eagle Eye Platinum catheters.