(68 days)
Not Applicable
No
The summary describes a standard intracardiac ultrasound catheter for visualization and does not mention any AI/ML capabilities or image processing beyond basic ultrasound functionality.
No
The device is described as an ultrasound catheter to visualize cardiac structures and blood flow, with no mention of exerting a therapeutic effect or actively treating a condition.
No
The device description explicitly states: "The use of these images is limited to visualization with no direct or indirect diagnostic use."
No
The device description clearly states it is a "temporary intracardiac ultrasound catheter" with a physical shaft, transducer, and deflection capabilities, which are hardware 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 that the device is used to "visualize cardiac structures, blood flow and other devices within the heart." It explicitly states that "The use of these images is limited to visualization with no direct or indirect diagnostic use."
- Device Description: The description reinforces that the device is a temporary intracardiac ultrasound catheter for visualization.
- Nature of IVDs: IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device operates within the body and uses ultrasound to create images, not to analyze biological samples.
Therefore, the ViewFlex™ Xtra ICE Catheter is an in vivo 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 ("ViewFlex™ Catheter") is a temporary intracardiac ultrasound catheter intended for use in patients to accurately visualize cardiac structures, blood flow and other devices within the heart when connected to a compatible intracardiac ultrasound console via the compatible ViewFlex™ Catheter Interface Module. Examples of the types of other devices that can be visualized include, and are not limited to, intracardiac catheters, septal occluders, delivery wires, delivery sheaths, sizing balloons and transseptal needles. The use of these images is limited to visualization with no direct or indirect diagnostic use. The ViewFlex™ Catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A 10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter tip has four-directional deflection allowing for Left-Right and Posterior-Anterior deflection, with an angle of at least 120 degrees in each direction. The ViewFlex™ Catheter is compatible with the ViewMate™ Z, ViewMate™, ViewMate™ Multi, and Philips CX50 ultrasound consoles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac structures (within the 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
Design verification activities were performed with their respective acceptance criteria to ensure that the use of the ViewFlex™ Xtra ICE Catheter in conjunction with the ViewMate™ Multi Ultrasound System does not affect the safety or effectiveness of the device. All testing performed met the established performance specifications.
Testing:
The ViewFlex™ XTRA ICE Catheter was tested in accordance with the following industry guidance documents and standards:
– BS EN 60601-2-37: 2008+A1:2015 - Medical electrical equipment: Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.BS EN 60601-1: 2006+A12:2014 (Edition 3.1) - Medical electrical equipment: General requirements for basic safety and essential performance.
– BS EN 60601-1-2:2015 (Edition 4.0) - Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests.
Types of Testing Performed:
– Design validation
– Design verification
Key Metrics
Not Found
Predicate Device(s)
ViewFlex™ Xtra ICE Catheter (K133853)
Reference Device(s)
Not Applicable
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 7, 2022
Irvine Biomedical, a St. Jude Medical Company Suzanne Pekarna Senior Specialist Regulatory Affairs 2375 Morse Ave Irvine. California 92614
Re: K223077
Trade/Device Name: ViewFlex™ Xtra ICE Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: September 29, 2022 Received: September 30, 2022
Dear Suzanne Pekarna:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223077
Device Name ViewFlex™ Xtra ICE Catheter
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Special 510(k) K223077 ViewFlex™ Xtra ICE Catheter Compatibility with ViewMate™ Multi Ultrasound System
Image /page/3/Picture/1 description: The image contains the Abbott logo. The logo consists of a blue stylized letter 'a' on the left and the word 'Abbott' in black on the right. The 'a' is a rounded square shape with a gap in the upper right corner. The word 'Abbott' is in a bold, sans-serif font.
| 510(k) Information | |
|---|---|
| 510(k) Number | K223077 |
| 510(k) Type | Special 510(k) |
| Date Prepared | 29 September 2022 |
| Submitter Information | |
| Manufacturer Name & | |
| Address | Irvine Biomedical, a St. Jude Medical Company1 |
| 2375 Morse Ave | |
| Irvine, CA 92614, USA | |
| Contact Person | Suzanne Pekarna |
| Senior Specialist Regulatory Affairs | |
| 651-756-4601 | |
| suzanne.pekarna@abbott.com | |
| Device Information: | |
| Trade Name | ViewFlex™ Xtra ICE Catheter |
| Common Name | ICE Catheter |
| Class | II |
| Classification Name | 870.1200, Diagnostic Intravascular Catheter |
| Product Code | OBJ |
| Subsequent Product Code | OBJ |
| Predicate Device | ViewFlex™ Xtra ICE Catheter (K133853) |
| Reference Device | Not Applicable |
| Device Description | The ViewFlex™ Xtra ICE Catheter ("ViewFlex™ Catheter") is a temporary |
| intracardiac ultrasound catheter intended for use in patients to accurately | |
| visualize cardiac structures, blood flow and other devices within the heart | |
| when connected to a compatible intracardiac ultrasound console via the | |
| compatible ViewFlex™ Catheter Interface Module. Examples of the types of | |
| other devices that can be visualized include, and are not limited to, | |
| intracardiac catheters, septal occluders, delivery wires, delivery sheaths, | |
| sizing balloons and transseptal needles. The use of these images is limited to | |
| visualization with no direct or indirect diagnostic use. The ViewFlex™ | |
| Catheter has a useable length of 90 cm, with a 9 French (F) shaft with an | |
| ultrasound transducer. A 10F introducer is recommended for use with this | |
| catheter for insertion into the femoral or jugular veins. The catheter tip has | |
| four-directional deflection allowing for Left-Right and Posterior-Anterior | |
| deflection, with an angle of at least 120 degrees in each direction. | |
| The ViewFlex™ Catheter is compatible with the ViewMate™ Z, | |
| ViewMate™, ViewMate™ Multi, and Philips CX50 ultrasound consoles. | |
| Indication 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. | |
| Patient Population | The patient population includes both adult and adolescent pediatric patients |
| with suspected or confirmed cardiac electrical or structural abnormalities who | |
| require visualization of cardiac structures, blood flow, or other devices within | |
| the heart. The testing performed supports safety and effectiveness in both | |
| (adult and adolescent pediatric) patient populations. | |
| Predicate Comparison | |
| Comparison | Both the subject and predicate devices have the same intended use, |
| indications for use and method of operation. There are no changes to the | |
| 510(k) Information | claims, clinical applications, patient populations, or performance |
| specifications. The current compatible consoles for the predicate device are | |
| the ViewMate Z (K101091), ViewMate (K192410), and Philips CX50 | |
| (K123754) Ultrasound consoles. The subject device is compatible with these | |
| consoles as well as the ViewMate™ Multi Ultrasound System (K222754, | |
| currently under review). The predicate device IFU does not list ViewMate™ | |
| Multi Ultrasound System as a compatible console. Each device is inspected | |
| and functionally tested prior to packaging, labeling and sterilizing. | |
| The differences between the subject ViewFlex™ Catheter and the predicate | |
| device does not raise any new questions of safety and effectiveness. | |
| Non-Clinical Testing | |
| Summary | Design verification activities were performed with their respective |
| acceptance criteria to ensure that the use of the ViewFlex™ Xtra ICE | |
| Catheter in conjunction with the ViewMate™ Multi Ultrasound System does | |
| not affect the safety or effectiveness of the device. All testing performed met | |
| the established performance specifications. | |
| Testing | |
| The ViewFlex™ XTRA ICE Catheter was tested in accordance with the | |
| following industry guidance documents and standards: | |
| – BS EN 60601-2-37: 2008+A1:2015 - Medical electrical equipment: Part | |
| 2-37: Particular requirements for the basic safety and essential | |
| performance of ultrasonic medical diagnostic and monitoring | |
| equipment.BS EN 60601-1: 2006+A12:2014 (Edition 3.1) - Medical | |
| electrical equipment: General requirements for basic safety and essential | |
| performance. | |
| – BS EN 60601-1-2:2015 (Edition 4.0) - Medical electrical equipment. | |
| General requirements for basic safety and essential performance. | |
| Collateral standard. Electromagnetic compatibility. Requirements and | |
| tests. | |
| Types of Testing Performed | |
| – Design validation | |
| – Design verification | |
| Risk Management | |
| There were no new or modified hazards identified as a result of the proposed | |
| modifications. Abbott has reviewed the applicable risk management | |
| documentation for the addition of the ViewMate™ Multi Ultrasound System | |
| and determined that the changes described in Section 3.1 of the Special | |
| 510(k) submission do not increase existing risks or create new risks to the | |
| user or patient, and that the residual risk remains acceptable following | |
| verification and validation activities. Updates to the risk analysis were | |
| limited to addition of the ViewMate™ Multi Ultrasound System and the | |
| addition of test reports related to the modifications. | |
| Statement of Equivalence | The technological characteristics for the subject device, and the indications |
| for use are the same as the predicate device. Based on this and the | |
| verification and validation data provided in this pre-market notification, the | |
| subject device and predicate device have been demonstrated to be | |
| substantially equivalent. |
1 Abbott Medical is a registered trade name for the Irvine Biomedical, Inc., a St Jude Medical Company.
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Special 510(k) K223077 ViewFlex™ Xtra ICE Catheter Compatibility with ViewMate™ Multi Ultrasound System
Image /page/4/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue stylized letter "a" on the left and the word "Abbott" in black on the right. The letter "a" is made up of three horizontal lines and a vertical line, forming a square shape with rounded corners.