(68 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study information for the ViewFlex™ Xtra ICE Catheter, based on the provided document:
This document is a 510(k) clearance letter and a summary of the special 510(k) submission for the ViewFlex™ Xtra ICE Catheter's compatibility with the ViewMate™ Multi Ultrasound System. It describes the testing performed to ensure the updated device (the ViewFlex™ Xtra ICE Catheter when used with the new ViewMate™ Multi Ultrasound System) does not raise new questions of safety or effectiveness compared to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "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."
While specific, granular acceptance criteria values are not explicitly listed in this summary, the general acceptance criteria are implicitly that the device, when used with the new console, performs safely and effectively within established performance specifications, and meets relevant industry standards.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Ensure safety and effectiveness when used with ViewMate™ Multi Ultrasound System | "All testing performed met the established performance specifications." |
| Compliance with BS EN 60601-2-37 (basic safety & essential performance of ultrasonic medical diagnostic and monitoring equipment) | No adverse findings reported; compliance affirmed implicitly by FDA clearance, and statement "All testing performed met the established performance specifications." |
| Compliance with BS EN 60601-1 (general requirements for basic safety and essential performance of medical electrical equipment) | No adverse findings reported; compliance affirmed implicitly by FDA clearance, and statement "All testing performed met the established performance specifications." |
| Compliance with BS EN 60601-1-2 (electromagnetic compatibility) | No adverse findings reported; compliance affirmed implicitly by FDA clearance, and statement "All testing performed met the established performance specifications." |
| No new or increased hazards identified as a result of modifications | "There were no new or modified hazards identified as a result of the proposed modifications. Abbott has reviewed the applicable risk management documentation... and determined that the changes... 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." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the test set in terms of number of patients, cases, or images. The testing described is primarily non-clinical design verification and validation testing rather than clinical performance testing with patient data.
The data provenance is for non-clinical testing (bench testing, performance evaluations) related to device compatibility and adherence to standards. It does not involve human patient data from a specific country, nor is it described as retrospective or prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to this submission. The ground truth for this type of special 510(k) submission for device compatibility is established through objective engineering and performance testing, comparing the device's output and safety metrics against predefined specifications and industry standards, rather than expert interpretation of clinical data to establish a "ground truth" diagnosis.
4. Adjudication Method for the Test Set:
This information is not applicable. Since the testing focuses on technical performance and compliance with standards, there is no need for expert adjudication in the traditional sense of resolving discrepancies in diagnostic interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the diagnostic performance of an AI-powered device or a new imaging modality and compare it to existing methods or human readers. The ViewFlex™ Xtra ICE Catheter is a diagnostic intravascular catheter, and this particular submission focuses on its compatibility with a new ultrasound console, not on comparing its diagnostic performance or an AI component to human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The ViewFlex™ Xtra ICE Catheter is a medical device (a catheter with an ultrasound transducer) that requires a human operator and an ultrasound console to function. It is not an AI algorithm or a standalone diagnostic tool in that sense. The device's performance is inherently tied to its use by a human and with supporting equipment.
7. The Type of Ground Truth Used:
The ground truth used for this type of non-clinical testing is based on established engineering specifications, industry standards, and validated test methods. For example, measuring a deflection angle would use a calibrated measurement system (engineering ground truth), or testing electrical safety complies with specific limits defined in the referenced standards (standard-based ground truth).
8. The Sample Size for the Training Set:
Not applicable. This submission is for a medical device (a catheter) and its compatibility with an ultrasound system. It does not involve machine learning or AI algorithms that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI algorithm in this submission.
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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
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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
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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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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 Company12375 Morse AveIrvine, CA 92614, USA |
| Contact Person | Suzanne PekarnaSenior Specialist Regulatory Affairs651-756-4601suzanne.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 temporaryintracardiac ultrasound catheter intended for use in patients to accuratelyvisualize cardiac structures, blood flow and other devices within the heartwhen connected to a compatible intracardiac ultrasound console via thecompatible ViewFlex™ Catheter Interface Module. Examples of the types ofother 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 tovisualization with no direct or indirect diagnostic use. The ViewFlex™Catheter has a useable length of 90 cm, with a 9 French (F) shaft with anultrasound transducer. A 10F introducer is recommended for use with thiscatheter for insertion into the femoral or jugular veins. The catheter tip hasfour-directional deflection allowing for Left-Right and Posterior-Anteriordeflection, 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 adolescentpediatric patients to visualize cardiac structures, blood flow and other deviceswithin the heart. |
| Patient Population | The patient population includes both adult and adolescent pediatric patientswith suspected or confirmed cardiac electrical or structural abnormalities whorequire visualization of cardiac structures, blood flow, or other devices withinthe 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 performancespecifications. The current compatible consoles for the predicate device arethe ViewMate Z (K101091), ViewMate (K192410), and Philips CX50(K123754) Ultrasound consoles. The subject device is compatible with theseconsoles 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 inspectedand functionally tested prior to packaging, labeling and sterilizing.The differences between the subject ViewFlex™ Catheter and the predicatedevice does not raise any new questions of safety and effectiveness. |
| Non-Clinical TestingSummary | Design verification activities were performed with their respectiveacceptance criteria to ensure that the use of the ViewFlex™ Xtra ICECatheter in conjunction with the ViewMate™ Multi Ultrasound System doesnot affect the safety or effectiveness of the device. All testing performed metthe established performance specifications. |
| TestingThe ViewFlex™ XTRA ICE Catheter was tested in accordance with thefollowing industry guidance documents and standards:– BS EN 60601-2-37: 2008+A1:2015 - Medical electrical equipment: Part2-37: Particular requirements for the basic safety and essentialperformance of ultrasonic medical diagnostic and monitoringequipment.BS EN 60601-1: 2006+A12:2014 (Edition 3.1) - Medicalelectrical equipment: General requirements for basic safety and essentialperformance.– 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 andtests. | |
| Types of Testing Performed– Design validation– Design verification | |
| Risk ManagementThere were no new or modified hazards identified as a result of the proposedmodifications. Abbott has reviewed the applicable risk managementdocumentation for the addition of the ViewMate™ Multi Ultrasound Systemand determined that the changes described in Section 3.1 of the Special510(k) submission do not increase existing risks or create new risks to theuser or patient, and that the residual risk remains acceptable followingverification and validation activities. Updates to the risk analysis werelimited to addition of the ViewMate™ Multi Ultrasound System and theaddition of test reports related to the modifications. | |
| Statement of Equivalence | The technological characteristics for the subject device, and the indicationsfor use are the same as the predicate device. Based on this and theverification and validation data provided in this pre-market notification, thesubject device and predicate device have been demonstrated to besubstantially 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
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§ 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).