(30 days)
The ViewFlex™ Eco Reprocessed 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™ Eco Reprocessed ICE 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™ Eco Reprocessed ICE 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™ Eco Reprocessed ICE Catheter is compatible with the ViewMate™ Z, ViewMate™, ViewMate™ Multi, and Philips CX50 ultrasound consoles.
The provided text does not contain information about an AI/ML-driven device or study results proving a device meets acceptance criteria regarding AI/ML performance. The document is a 510(k) premarket notification for a medical device (ViewFlex™ Eco Reprocessed ICE Catheter) that appears to be entirely hardware-based, with no mention of AI or machine learning components.
Therefore, I cannot provide the requested information about acceptance criteria and study results for an AI/ML device based on this document. The document primarily focuses on verifying the safety and effectiveness of a reprocessed catheter and its compatibility with an additional ultrasound console, through non-clinical testing (design validation and verification) and risk management.
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May 3, 2023
Quynh Phuong Le Regulatory Affairs Manager Abbott Medical 14901 Deveau Place Minnetonka, Minnesota 55345
Re: K230934
Trade/Device Name: ViewFlex™ Eco Reprocessed ICE Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWO. OBJ Dated: March 31, 2023 Received: April 3, 2023
Dear Ouynh Le:
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 medical devices and radiation-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) K230934
Device Name ViewFlex™ Eco Reprocessed ICE Catheter
Indications for Use (Describe)
The ViewFlex™ Eco Reprocessed 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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Image /page/3/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.
| 510(k) Number | K230934 |
|---|---|
| 510(k) Type | Special 510(k) |
| Date Prepared | 03 April 2023 |
| Manufacturer Name & Address | Abbott Medical14901 DeVeau PlaceMinnetonka, MN 55345-2126, USA |
| Contact Person | Quynh Phuong LeRegulatory Affairs Manager949-769-5058 or 949-469-9779quynphuong.le@abbott.com |
| Trade Name | ViewFlex™ Eco Reprocessed ICE Catheter |
| Common Name | ICE Catheter |
| Class | II |
| Classification Name | 870.1200, Diagnostic Intravascular Catheter |
| Product Code | OWQ |
| Subsequent Product Code | OBJ |
| Predicate Device | ViewFlex™ Xtra Reprocessed ICE Catheter (K222217) |
| Reference Device | ViewFlex™ Xtra ICE Catheter (K223077) |
| Device Description | The ViewFlex™ Eco Reprocessed ICE Catheter is a temporaryintracardiac ultrasound catheter intended for use in patients toaccurately visualize cardiac structures, blood flow and other deviceswithin the heart when connected to a compatible intracardiac ultrasoundconsole 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, deliverywires, delivery sheaths, sizing balloons and transseptal needles. The useof these images is limited to visualization with no direct or indirectdiagnostic use. The ViewFlex™ Eco Reprocessed ICE Catheter has auseable length of 90 cm, with a 9 French (F) shaft with an ultrasoundtransducer. A 10F introducer is recommended for use with this catheterfor insertion into the femoral or jugular veins. The catheter tip hasfour-directional deflection allowing for Left-Right and Posterior-Anterior deflection, with an angle of at least 120 degrees in eachdirection.The ViewFlex™ Eco Reprocessed ICE Catheter is compatible with theViewMate™ Z, ViewMate™, ViewMate™ Multi, and Philips CX50ultrasound consoles. |
| Indications For Use | The ViewFlex™ Eco Reprocessed ICE Catheter is indicated for use inadult 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 pediatricpatients with suspected or confirmed cardiac electrical or structuralabnormalities who require visualization of cardiac structures, bloodflow, or other devices within the heart. The testing performed supportssafety and effectiveness in both (adult and adolescent pediatric) patientpopulations. |
| Comparison | The subject, predicate and reference devices have the same intendeduse, indications for use and method of operation. There are no changesto the claims, clinical applications, patient populations, or performancespecifications. The current compatible consoles for the predicate device |
| are the ViewMate™ Z, ViewMate™, and Philips CX50 ultrasound | |
| consoles. The subject device has added an additional compatibleconsole, ViewMate™ Multi Ultrasound System which is compatiblewith the reference device cleared under K223077. | |
| The difference between the subject device ViewFlex™ EcoReprocessed ICE Catheter and the predicate device does not raise any | |
| new questions of safety or efficacy. | |
| Non-Clinical Testing Summary | Design verification activities were performed with their respectiveacceptance criteria to ensure that the use of the ViewFlex™ EcoReprocessed ICE Catheter in conjunction with the ViewMate™ MultiUltrasound System does not affect the safety or effectiveness of thedevice. All testing performed met the established performancespecifications. |
| TestingThe ViewFlex™ Eco Reprocessed ICE Catheter was developed andtested in accordance with the following industry guidance documentsand standards:- BS EN 60601-2-37: 2008+A1:2015 - Medical electricalequipment: Part 2-37: Particular requirements for the basic safetyand essential performance of ultrasonic medical diagnostic andmonitoring equipment.BS EN 60601-1: 2006+A12:2014 (Edition3.1) - Medical electrical equipment: General requirements forbasic safety and essential performance.- BS EN 60601-1-2:2015 (Edition 4.0) - Medical electricalequipment. General requirements for basic safety and essentialperformance. Collateral standard. Electromagnetic compatibility.Requirements and tests. | |
| Types of Testing Performed- Design validation- Design verification | |
| Risk ManagementAbbott has reviewed the applicable risk management files, and therewere no new or modified hazards identified as result of the proposedmodifications. | |
| Conclusion | The technological characteristics for the subject device, and theindications for use are the same as the predicate device. Based on thisand the data provided in this pre-market notification, the subjectdevice and predicate device have been demonstrated to besubstantially equivalent. |
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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).