(108 days)
Eagle Eye Platinum Digital IVUS catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature to provide an image of such vessels. This device is not currently indicated for use in cerebral vessels. The Eagle Eye Platinum Digital IVUS catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Eagle Eye® Platinum Digital IVUS Catheters incorporate a cylindrical ultrasound transducer array used to radiate 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 and peripheral vessels. The Eagle Eye" Platinum catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 rnm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The Eagle Eye Platinum catheter is introduced percutaneously or via surgical cut down into the vascular system. Two types of markers are used along the shaft length: Three radio-opaque markers applied along the length of the distal inner-shaft to aide in positioning the catheter in the vascular anatomy during an angiographic procedure. A pair of brachial and femoral (one each) shaft markers located on the outer proximal shaft aid in gauging the IVUS transducer position relative to the guiding catheter tip when introducing the EEP catheter through the guiding catheter. A hub fitting is attached to the proximal end of the catheter via an integrated strain relief and provides a channel for the ultrasound scanner leads to interface electrically with the patient interface module (PIM) connector of the imaging system. The Eagle Eye Platinum eatheters may only be used with the Volcano In-Vision imaging System, Volcano st, or Volcano s5i Imaging Systems. The catheters are designed to work with Volcano VH IVUS system software v 1.2 or higher. This catheter will not operate if connected to any other imaging system.
The provided text does not include information about specific acceptance criteria or a study proving the device meets those criteria. The document is an "Abbreviated 510(k) Summary" for the Eagle Eye® Platinum Digital IVUS Catheter, which primarily focuses on establishing substantial equivalence to a predicate device.
Here's a breakdown of why the requested information is not present in the provided text:
- No Acceptance Criteria or Performance Data: The document states "Device Design Requirements: Biocompatibility, shelf life, sterilization, package integrity, and design verification testing will be performed to prove that the materials and manufacturing processes selected for the catheter body of the Eagle Eye® Platinum catheter do not pose a significant safety risk to the patient." However, it does not provide specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for any performance aspect of the device itself (beyond general safety requirements). There is also no table of reported device performance.
- No Clinical Study Details: The document explicitly states, "The Eagle Eye® Platinum atheter is a redesign of the catheter body elements of the Eagle Eye Gold only and does not change the ultrasound signal or signal processing used for the predicate device." This indicates that the substantial equivalence argument relies on the design changes being limited to the catheter body, implying that the core imaging performance (ultrasound signal and processing) is unchanged from the predicate. Therefore, detailed clinical performance studies (such as those involving test sets, ground truth, experts, MRMC, or standalone performance) are not detailed because they are not the primary basis for this type of 510(k) submission.
Summary based on the provided text:
| Question | Answer (based on provided text) |
|---|---|
| 1. Table of Acceptance Criteria and Reported Device Performance | The document states general design requirements such as "Biocompatibility, shelf life, sterilization, package integrity, and design verification testing will be performed to prove that the materials and manufacturing processes selected for the catheter body... do not pose a significant safety risk." However, it does not provide specific numerical acceptance criteria or reported device performance metrics for diagnostic accuracy, sensitivity, specificity, or other imaging performance attributes. |
| 2. Sample size and data provenance for test set | Not applicable. The document is a 510(k) summary relying on substantial equivalence, and it does not describe a clinical performance study with a test set for diagnostic efficacy of the imaging component. The changes described are to the catheter body, not the ultrasound signal or signal processing. |
| 3. Number of experts and qualifications for ground truth (test set) | Not applicable. No clinical performance study on diagnostic accuracy is described. |
| 4. Adjudication method for test set | Not applicable. No clinical performance study on diagnostic accuracy is described. |
| 5. MRMC comparative effectiveness study and effect size | Not applicable. No MRMC study is described. The submission focuses on substantial equivalence based on limited changes to the catheter body. |
| 6. Standalone (algorithm only) performance study | Not applicable. This device is an imaging catheter and is not an AI/algorithm-only device. The core imaging performance is asserted to be unchanged from the predicate device based on the limited design modifications. |
| 7. Type of ground truth used | Not applicable. No clinical performance study on diagnostic accuracy requiring ground truth is described. The device provides "an image of the vessel lumen and wall structures," but the document doesn't detail a study validating the accuracy of these images against a ground truth. |
| 8. Sample size for the training set | Not applicable. This document is for a medical device (intravascular catheter), not an AI algorithm requiring a training set in the conventional sense. The submission relies on the established performance of the predicate device's imaging system. |
| 9. How ground truth for the training set was established | Not applicable. Please see point 8. |
This document is a regulatory submission focused on demonstrating substantial equivalence of a modified device (Eagle Eye® Platinum) to a previously cleared device (Eagle Eye Gold). The modifications are specifically to the catheter body and blood-contacting materials, not to the core imaging technology or signal processing. Therefore, the detailed performance data and clinical study information usually associated with new diagnostic devices or AI algorithms are not part of this specific submission summary.
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Volcano Corporation August 14, 2009
Eagle Eye® Platinum Digital IVUS Catheter
Abbreviated 510(k)
Abbreviated 510(k)
Section 5: 510(k) Summary Submitter Name: Volcano Corporation Address: 2870 Kilgore Road Rancho Cordova, CA 95670 Contact: Donovan Mav Regulatory Affairs Engineer DEC 1 0 2009 Phone: (916) 231-4558 Fax: (916) 638-2647 E-mail: dmay@volcanocorp.com Date Prepared: August 14, 2009 Eagle Eye® Platinum Digital IVUS Catheter Device Trade Name: Device Common Name: Intravascular IVUS Imaging Catheter Classification Name: Diagnostic Intravascular Catheter, 870.1200 Diagnostic Ultrasound Transducer, 892.1570 Classification Code: OBJ: Catheter, Ultrasound, Intravascular ITX: Transducer, Ultrasonic, Diagnostic Eagle Eye® Gold IVUS Imaging Catheter, 510(k) Number K073473, Predicate Device: Classification Code: OBJ, Regulation Number 870.1200
Device Description:
Eagle Eye® Platinum Digital IVUS Catheters incorporate a cylindrical ultrasound transducer array used to radiate 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 and peripheral vessels.
The Eagle Eye" Platinum catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 rnm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The Eagle Eye Platinum catheter is introduced percutaneously or via surgical cut down into the vascular system.
Two types of markers are used along the shaft length:
- Three radio-opaque markers applied along the length of the distal inner-shaft to aide in positioning the 1. catheter in the vascular anatomy during an angiographic procedure.
- A pair of brachial and femoral (one each) shaft markers located on the outer proximal shaft aid in gauging 2. the IVUS transducer position relative to the guiding catheter tip when introducing the EEP catheter through the guiding catheter.
A hub fitting is attached to the proximal end of the catheter via an integrated strain relief and provides a channel for the ultrasound scanner leads to interface electrically with the patient interface module (PIM) connector of the imaging system.
The Eagle Eye Platinum eatheters may only be used with the Volcano In-Vision imaging System, Volcano st, or Volcano s5i Imaging Systems. The catheters are designed to work with Volcano VH IVUS system software v 1.2 or higher. This catheter will not operate if connected to any other imaging system. 034
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Volcano Corporation August 14, 2009
Eagle Eye® Platinum Digital IVUS Catheter Abbreviated 510(k)
Intended Use: . Eagle Eye . Platinum Digital.IVUS catheters are designed for use-in the evaluation of vascularmorphology in blood vessels of the coronary and perioderal varies were areas-sections in vasuality such vessels. This device is not currently indicated for use in cerebral vessels. The Eagle Eye PPatinum Digital IVUS catheters are designed for as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Intended Users: Eagle Eye® Platinum Digital IVUS catheters are designed and intended for single use by interventional cardiologists and cardiac catheterization lab staff.
Device Design Requirements: Biocompatibility, shelf life, sterilization, package integrity, and design verification testing will be performed to prove that the materials and manifacturing processes selected for the cather body of the Eagle Eye® Platinum catheter do not pose a significant safety risk to the patient.
Substantial Equivalence Discussion: The Eagle Eye® Platinum Digital IVUS Catheter uses the same fundamental scientific technologies and has the same intended use as that of the predicate device the Fagle Eye Gold IVUS Imaging Catheter. The Eagle Eye Platinum atheter is a redesign of the catheter body elements of the Eagle Eye Gold only and does not change the ultrasound signal or signal processing used for the predicate device. The ultrasound scanner of the Eagle Eye" Platinum is identical to that of the Eagle Eye Gold however the blood contacting materials not included in the ultrasound scanner and the catherer body manufacturing processes have been changed and updated to represent current state of the art materials and methods.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Volcano Corporation C/O Donovan May, Regulatory Affairs Engineer 2870 Kilgore Rd. Rancho Cordova, CA 95670
DEC 1 0 2009
Re: K092596
Trade/Device Name: Eagle Eye Platinum Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: November 11, 2009 Received: November 13, 2009
Dear Mr. May:
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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Mr. Donovan May
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/CDRH/CDRHOffices/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
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Volcano Corporation August 14, 2009
Eagle Eye® Platinum Digital IVUS Catheter Abbreviated 510(k)
Section 4: Indications for Use
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
510(k) Number (if known): K092596
.
Device Name: Eagle Eye® Platinum Digital IVUS Catheter
Indications for USe: Eagle vascular morphology in blood vessels of the coronary and period for use in the evaluation of
inage of such vessels This device is the coronary and perioheral vasculation of image of such vessels. This device is not currently indicated for use in cerebral vessels.
Platinum Dicital IVUS cathers are docience for use in cerebral vessels. The Eagle Platinum Digital WUS cather contently nucated for use in cerebral vessels. The Eagle Eye"
Platinum Digital IVUS catheters are designed for use as an adjunct to conventional a provide an image of the vessel lumen and wall structures.
| Prescription Use | YES (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use | NO (21 CFR 801 Subpart C) |
|---|---|---|---|---|
| ------------------ | ---------------------------------------- | -------- | ---------------------- | ---------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | ||
|---|---|---|
| Division of Cardiovascular Devices | Page 1 of 1 | |
| 510(k) Number | KP92596 | 033 |
§ 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).