(30 days)
None
No
The summary describes a standard ultrasound catheter and console without mentioning any AI/ML features for image processing, analysis, or other functions.
No
The device is described as an intracardiac ultrasound catheter used to visualize cardiac structures and blood flow. It is a diagnostic tool, not a therapeutic one that treats or prevents a disease.
No
An Intracardiac Echocardiography (ICE) catheter is used to visualize cardiac structures. While it provides diagnostic information, its primary function is imaging rather than direct diagnosis.
No
The device description clearly details a physical catheter with a transducer, shaft, and handle, indicating it is a hardware device, not software-only.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The ViewFlex™ Xtra ICE Catheter is an intracardiac ultrasound catheter. It is inserted directly into the heart to visualize structures and blood flow within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it is for "visualize cardiac structures and blood flow within the heart." This is a direct imaging function performed inside the patient.
Therefore, based on the provided information, the ViewFlex™ Xtra ICE Catheter is a medical device used for in vivo imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ViewFlex™ Xtra 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
IYO
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 and ViewMate Z 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)
The results of bench testing demonstrated that the device meets the established performance specifications. The results of biocompatibility testing demonstrated that the modified design meets specifications in accordance with ISO 10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ViewFlex Plus Catheter (K101239)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
・ .
.
| 510(k) Summary | |
|---|---|
| 510(k) Number | To be assigned |
| Submitter Information: | |
| Date Prepared: | May 04, 2012 |
| Submitter Name & | |
| Address: | Irvine Biomedical, Inc. |
| a St. Jude Medical Company | |
| 2375 Morse Avenue | |
| Irvine, CA 92614 | |
| Contact Person: | Loucinda Bjorklund |
| Sr. Regulatory Affairs Specialist | |
| Phone (651) 756-3230 | |
| Fax (952) 930-9481 | |
| LBjorklund@sjm.com | |
| Device Information: | |
| Trade Name: | ViewFlex™ Xtra ICE Catheter |
| Common Name: | ICE Catheter |
| Class | II |
| Classification Name: | 892.1550, System, Imaging, Pulsed Doppler Ultrasonic; ITX 892.1570, |
| Transducer, Ultrasonic; | |
| 892.1560, System, Imaging, Pulsed Echo, Ultrasonic | |
| 892.1200, Diagnostic Intravascular Catheter | |
| Predicate Device: | ViewFlex Plus Catheter (K101239) |
| 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 and ViewMate Z ultrasound consoles. | |
| Intended Use: | |
| (Indications for Use) | The ViewFlex Xtra 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. | |
| Comparison to Predicate | |
| Devices | The ViewFlex™ Xtra ICE Catheter has the same intended use and |
| fundamental scientific technology as the predicate device. The | |
| technological characteristics of the ViewFlex™ Xtra ICE Catheter are | |
| substantially equivalent to the predicate device including packaging, | |
| biocompatibility, sterilization, and labeling. Through biocompatibility and | |
| bench performance testing it was demonstrated that the design | |
| modifications do not adversely affect the safety and effectiveness. | |
| Summary on Non-Clinical | |
| Testing | The results of bench testing demonstrated that the device meets the |
| established performance specifications. The results of biocompatibility | |
| testing demonstrated that the modified design meets specifications in | |
| accordance with ISO 10993-1. | |
| Statement of Equivalence | The ViewFlex Xtra ICE Catheter has the same indications for use and |
| technological characteristics as the predicate device. Based on this and the | |
| data provided in this pre-market notification, the subject device and | |
| predicate device has been shown to be substantially equivalent. |
1
Image /page/1/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles three abstract shapes that could be interpreted as birds in flight or abstract human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 7 2012
Irvine Biomedical, Inc. St. Jude Medical Company c/o Mrs. Loucinda Bjorklund Sr. Regulatory Affairs Specialist 2375 Morse Avenue Irvine, CA 92614
K121381 Re:
KT21561
Trade/Device Name: ViewFlex™ Xtra ICE Catheter Regulatory Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II (two) Product Code: IYO Dated: May 4, 2012 Received: May 8, 2012
Dear Mrs. Bjorklund:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section J ro(x) promatic is substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encry manatiment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date at answasions of the Federal Food. Drug commerce prior to May 28, 1970, the encomence with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance the approval application (PMA).
and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, sabject to annual registration, listing of
general controls provisions of the Act include requirements for annual registrating and general controls provisions of the rict mercials and prohibitions against misbranding and devices, good manufacturing placece, iaoonag information related to contract liability. adulteration. Please note: CDRFI does not evaluate international and not misleading.
2
Page 2 - Mrs. Loucinda Bjorklund
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 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
3
K121381
INDICATIONS FOR USE
510(k) Number (if known): Device Name: ViewFlexTM Xtra ICE Catheter
Indications for Use:
The ViewFlex™ Xtra 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)
Over-The-Counter Use AND/OR (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)
Division Sign Off
vision Sign-Off) vision of Cardiovascular Devices
510(k) Number K121381
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