(151 days)
No
The document describes a physical ultrasound catheter and its compatibility with existing ultrasound consoles. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is used to visualize cardiac structures, blood flow, and other devices within the heart, which is a diagnostic function, not a therapeutic one.
No
The device is marketed as a visualization tool ("to visualize cardiac structures, blood flow and other devices within the heart") and the "Summary of Performance Studies" explicitly states "the use of the images is limited to visualization with no direct or indirect diagnostic use."
No
The device description explicitly details a physical catheter with a transducer, shaft, and handle, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The ViewFlex Xtra ICE Catheter is an in vivo device. It is inserted directly into the heart within the patient's body to visualize structures and devices.
The description clearly states it's an "intracardiac ultrasound catheter" inserted "via intravascular access" to "visualize cardiac structures, blood flow and other devices within the heart." This is the definition of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
Product codes
OBJ
Device Description
The ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The ViewFlex Xtra is a sterile, single use, temporary, intracardiac ultrasound catheter indicated for use in adult and adolescent pediatric patients. The ViewFlex catheter shaft is a 9 French catheter constructed with radiopaque tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anterior-to-posterior deflection. The handle of the device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II, ViewMate Z and Philips CX50 ultrasound consoles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
heart
Indicated Patient Age Range
adult and adolescent pediatric patients
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)
There have been no device changes and no changes to the visualization location. This submission is to expand the current indications for use to include visualizing other devices within the heart. Demonstration of the ability of the ViewFlex Xtra ICE catheter to image devices in the heart was provided by referencing image quality testing and data for the cleared ViewFlex Xtra ICE catheter (K121381) and images collected during the use of the predicates for visualizing other devices within the heart. The Instructions for Use was updated to include examples of types of devices which could be imaged using the ViewFlex Xtra ICE catheter and that the use of the images is limited to visualization with no direct or indirect diagnostic use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
t ﺑﺎ
Premarket Notification 510(k)
Image /page/0/Picture/4 description: The image contains the logo for St. Jude Medical. The logo consists of a grid of black squares on the left, followed by the text "ST. JUDE MEDICAL" in a serif font. The text is right-aligned with the grid of squares.
510(K) SUMMARY
1. Administrative Information
Name: Irvine Biomedical, Inc. a St. Jude Medical Company Address: 2375 Morse Avenue Irvine, CA 92614 949-769-5053 Phone: Fax: 877-482-7739 Contact Person: Jennifer Correa Regulatory Affairs Specialist II Date: December 18, 2013
2. Device Information
Trade Name of Device: ViewFlex Xtra ICE Catheter Common Name: ICE Catheter Regulation Name: 870.1200, Diagnostic Intravascular Catheter Product Codes: OBJ
3. Predicate Device Information
-
- ViewFlex Xtra ICE Catheter (Irvine Biomedical, Inc. a St. Jude Medical Company) - K121381 cleared June 7, 2012
-
- AcuNav Diagnostic Ultrasound Catheter (Siemens Medical Solutions USA, Inc.) - K071234 cleared June 29, 2007
1
Premarket Notification 510(k)
Image /page/1/Figure/3 description: The image shows the logo for St. Jude Medical. The logo consists of a grid of squares on the left and the text "ST. JUDE MEDICAL" on the right. The text is in a bold, sans-serif font.
Device Description 4.
The ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The ViewFlex Xtra is a sterile, single use, temporary, intracardiac ultrasound catheter indicated for use in adult and adolescent pediatric patients. The ViewFlex catheter shaft is a 9 French catheter constructed with radiopaque tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anterior-to-posterior deflection. The handle of the device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II, ViewMate Z and Philips CX50 ultrasound consoles.
ડાં Intended Use
The ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures; blood flow and other devices within the heart.
Technological Characteristics 6.
The design, technological characteristics and materials of the proposed ViewFlex Xtra ICE Catheter are identical to the predicate, cleared ViewFlex Xtra ICE Catheter. There have been no device changes.
7. Summary of Non-clinical Testing
There have been no device changes and no changes to the visualization location. This submission is to expand the current indications for use to include visualizing other devices within the heart. Demonstration of the ability of the ViewFlex Xtra ICE catheter to image devices in the heart was provided by referencing image quality testing and data for the cleared ViewFlex Xtra ICE catheter (K121381) and images collected during the use of the predicates for visualizing other devices within the heart. The Instructions for Use was updated to include examples of types of devices which could be imaged using the ViewFlex Xtra ICE catheter and that the use of the images is limited to visualization with no direct or indirect diagnostic use.
2
ST. Jude Medical
Premarket Notification 510(k)
Substantial Equivalence Conclusion 8.
The proposed ViewFlex Xtra ICE Catheter in this submission is substantially equivalent to previously cleared St. Jude Medical's ViewFlex Xtra ICE Catheter (K121381, June 7, 2012) and Siemen's AcuNav Diagnostic Ultrasound Catheter (K071234, June 29, 2007). Differences between the devices do not raise issues of safety or effectiveness.
3
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
May 19, 2014
Irvine Biomedical, Inc. A St. Jude Medical Company Jennifer Correa 2375 Morse Avenue Irvine, CA 92614 US
Re: K133853
Trade/Device Name: VIEWFLEX XTRA ICE CATHETER Regulation Number: 21 CFR 870.1200 Regulation Name: Ice Catheter / Regulatory Class: Class II Product Code: OBJ Dated: April 11, 2014 Received: April 14, 2014
Dear Jennifer Correa:
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
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.lda.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/Reportal?roblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/4/Picture/7 description: The image shows a logo with the letters FDA in a stylized font. The letters are interconnected and have a textured appearance. A signature or handwritten text is overlaid on top of the logo, obscuring some of the letters. The overall design appears to be a combination of typography and handwriting.
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
E MEDICAL
Premarket Notification 510(k)
Indications for Use
510(k) Number (if known): K133853
Device Name: ViewFlex Xtra ICE Catheter
Indications for Use:
The ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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