(30 days)
No
The description focuses on the physical characteristics and mechanical manipulation of the catheter and its connection to a standard ultrasound system. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is for visualization and diagnostic purposes, not for treating or curing a medical condition.
Yes
Explanation: The device is indicated for use "to visualize cardiac structures and blood flow within the heart," which is a diagnostic purpose achieved through intracardiac ultrasound imaging.
No
The device description clearly details a physical catheter with a transducer, steering mechanism, and tubing, 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 Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The ViewFlex™ Plus ICE Catheter is an intracardiac ultrasound catheter. Its purpose is to visualize structures and blood flow within the heart using ultrasound technology. It does not perform tests on samples taken from the body.
- Intended Use: The intended use clearly states "to visualize cardiac structures and blood flow within the heart." This is a diagnostic imaging function, not an in vitro diagnostic test.
Therefore, the ViewFlex™ Plus ICE Catheter is a diagnostic imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The ViewFlex™ Plus ICE Catheter, part of the ViewMate™ System, is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.
Product codes
74 DOO
Device Description
The ViewFlex Plus ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to accurately visualize cardiac structures and blood flow within the heart when connected to a ViewMate II (Philips HD11 XE, cleared under K062247) ultrasound system via the Patient Isolation Module (cleared under K073709). The catheter shaft is 9 French, 90 cm radio-opaque Pebax tubing that is shipped sterile. The catheter offers a bi-directional curve with a deflection angle of at least 120 degrees each direction that can easily be manipulated with one hand by turning the black knob left or right. The transducer is in the neutral/straight position when the white line of the knob is aligned with the center white line on the handle. To move the transducer away from the image, turn the handle to the left. The steering mechanism engages when the left arrow line is crossed. To move the transducer toward the structure of interest, turn the handle to the right. A 10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter consists of a 64-element linear phased array transducer with a multiple frequency range between 4.5 MHz, a viewing angle of up to 90 degrees, and a viewing depth of up to 21 cm with the ViewMate II.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
cardiac structures, 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)
Bench testing was performed to confirm that the changes met design requirements and did not affect the safe or effective use of the device. The following non-clinical bench tests were performed: catheter protection, catheter inspection, tip alignment, deflection angle, tip stability, tip responsiveness, one-handed operation, planarity, handle markings, tip position and shaft-tohandle tensile test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
510(k) Summary (K101239) N
Date Prepared: May 21, 2010
2.1 Establishment Address and Reqistration
St. Jude Medical Cooper Run Executive Park 575 Route 73 North, Building D West Berlin, NJ 08091-9293 Establishment Registration Number: 2248049
Submitter's Name/Contact Person 2.2
Loucinda Bjorklund St. Jude Medical One St. Jude Medical Drive St. Paul, MN 55117 USA
Device Classification 2.3
| Trade Name: | ViewFlex ™ Plus ICE Catheter |
|---|---|
| Common Name: | Catheter |
| Classification Name: | 892.1550, System, Imaging, Pulsed Doppler Ultrasonic; |
| 892.1570, Transducer, Ultrasonic | |
| 892.1560, System, Imaging, Pulsed Echo, Ultrasonic | |
| 892.1200, Diagnostic Intravascular Catheter |
Predicate Device 2.4
K073709 ViewFlex Plus ICE Catheter (St. Jude Medical)
2.5 Indications for Use
The ViewFlex Plus ICE Catheter, part of the ViewMate System, is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.
Device Description 2.6
The ViewFlex Plus ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to accurately visualize cardiac structures and blood flow within the heart when connected to a ViewMate II (Philips HD11 XE, cleared under K062247) ultrasound system via the Patient Isolation Module (cleared under K073709). The catheter shaft is 9 French, 90 cm radio-opaque Pebax tubing that is shipped sterile. The catheter offers a bi-directional curve with a deflection angle of at least 120 degrees each direction that can easily be manipulated with one hand by turning the black knob left or right. The transducer is in the neutral/straight position when the white line of the knob is aligned with the center white line on the handle. To move the transducer away from the image, turn the handle to the left. The steering mechanism engages
Page 1 of 2
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when the left arrow line is crossed. To move the transducer toward the structure of interest, turn the handle to the right. A 10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter consists of a 64-element linear phased array transducer with a multiple frequency range between 4.5 MHz, a viewing angle of up to 90 degrees, and a viewing depth of up to 21 cm with the ViewMate II.
Summary of Non-Clinical Testing 2.7
Bench testing was performed to confirm that the changes met design requirements and did not affect the safe or effective use of the device. The following non-clinical bench tests were performed: catheter protection, catheter inspection, tip alignment, deflection angle, tip stability, tip responsiveness, one-handed operation, planarity, handle markings, tip position and shaft-tohandle tensile test.
2.8 Summary of Design Control Activities
The development of the ViewFlex Plus ICE Catheter was performed in accordance with St. Jude Medical Quality System Requirements, and in compliance with the Quality System Regulation design controls requirements as described in 21 CFR 820.30.
2.9 Conclusion
The ViewFlex Plus ICE Catheter has the same indications for use and fundamental scientific technology as the predicate device. All technological characteristics of the ViewFlex Plus ICE Catheter are substantially equivalent to the predicate device.
Where operational and performance differences exist between the modified device and the predicate device, performance testing demonstrates that the differences do not adversely affect the safe or effective use of the device.
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle, with its wings forming a swooping shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
St. Jude Medical c/o Ms. Loucinda Bjorklund Senior Regulatory Affairs Specialist One St. Jude Medical Drive Saint Paul, MN 55117
JUN - 2 2010
Re: K101239
Trade/Device Name: ViewFlex Plus ICE Catheter Regulatory Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II (two) Product Code: 74 DOO Dated: April 30, 2010 Received: May 3, 2010
Dear Ms. Bjorklund:
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.
3
Page 2 - Ms. Loucinda Biorklund
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 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,
S. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special Premarket Notification 510(k) ViewFlex Plus Catheter St. Jude Medical
1 Indications for Use
510(k) Number (if known)
510(k) Number (if known): K101239
"Device Name:" ViewFlex "M Plus "CE Catheter,"part of the "ViewMate" " "System
Indications for Use:
The ViewFlex™ Plus ICE Catheter, part of the ViewMate™ System, is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K101239