(147 days)
The ViewFlex™ Xtra 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™ Xtra 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™ Xtra 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™ Xtra Reprocessed ICE Catheter is compatible with the ViewMate™ Z, ViewMate™ and Philips CX50 ultrasound consoles. The ViewFlex™ Xtra Reprocessed Reprocess Catheter has been reprocessed by Abbott one (1) time. Each catheter includes marking on the proximal handle and connector that identify the catheter status. Device is taken out of service after reaching the maximum number of reprocessing cycles. Abbott restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Please specify which information from the document is necessary to fulfill the request. The document is about the FDA 510(k) clearance for a reprocessed medical device, the "ViewFlex™ Xtra Reprocessed ICE Catheter." It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.
However, the document does not contain the kind of information typically associated with complex AI/ML device studies that require:
- A table of acceptance criteria and reported device performance for an AI/ML algorithm.
- Sample sizes for test sets, data provenance, ground truth establishment by experts, or adjudication methods for AI/ML performance.
- Details on multi-reader multi-case (MRMC) studies or effect sizes of human reader improvement with AI assistance.
- Stand-alone (algorithm-only) performance metrics.
- Training set details for AI/ML models.
The study described in this document focuses on the reprocessing of a medical device and its continued safety and effectiveness after being reprocessed once. The "functional and safety testing" mentioned refers to engineering and manufacturing performance verification (e.g., cleaning validation, biocompatibility, sterilization, design validation/verification, packaging verification) to ensure the reprocessed device performs comparably to the new device and meets established specifications. It's not a study about an AI/ML algorithm's performance in a diagnostic context.
Therefore, I cannot provide the requested information (1-9) as it pertains to an AI/ML device study, because the provided document does not describe such a study.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 19, 2022
Abbott Medical Quynh Phuong Le Regulatory Affairs Project Manager 14901 Deveau Place Minnetonka, Minnesota 55345
Re: K222217
Trade/Device Name: ViewFlexTM Xtra Reprocessed ICE Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWO. OBJ Dated: December 13, 2022 Received: December 14, 2022
Dear Ouynh Phuong 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
{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 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
{2}------------------------------------------------
K22217 - Quynh Phuong Le
The following device is included in the scope of this 510(k) submission:
| Description | ReferenceModelNumber(Predicate) | ReprocessedModelNumber(Subject) | UsableLength | French Size | System Compatibility |
|---|---|---|---|---|---|
| ViewFlex™ XtraReprocessed ICECatheter | D087031 | D087031-R | 90cm | 9F | ViewMate™ ZViewMate™Philips CX 50 |
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K222217
Device Name ViewFlex™ Xtra Reprocessed ICE Catheter
Indications for Use (Describe)
The ViewFlex™ Xtra 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Type | Traditional 510(k) |
|---|---|
| Date Prepared | 22 July 2022 |
| Manufacturer Name &Address | Abbott Medical14901 De Veau PlaceMinnetonka, MN 55345-2126, USA |
| Contact Person | Quynh Phuong LeRegulatory Affairs Project Manager949-769-5058 or 949-469-9779quynphuong.le@abbott.com |
| Trade Name | ViewFlex™ Xtra 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 ICE Catheter (K133853) |
| Device Description | The ViewFlex™ Xtra Reprocessed ICE Catheter is a temporary intracardiacultrasound catheter intended for use in patients to accurately visualize cardiacstructures, blood flow and other devices within the heart when connected to acompatible intracardiac ultrasound console via the compatible ViewFlex™Catheter Interface Module. Examples of the types of other devices that can bevisualized include, and are not limited to, intracardiac catheters, septal occluders,delivery wires, delivery sheaths, sizing balloons and transseptal needles. The useof these images is limited to visualization with no direct or indirect diagnostic use.The ViewFlex™ Xtra Reprocessed ICE Catheter has a useable length of 90 cm,with a 9 French (F) shaft with an ultrasound transducer. A 10F introducer isrecommended for use with this catheter for insertion into the femoral or jugularveins. The catheter tip has four-directional deflection allowing for Left-Right andPosterior-Anterior deflection, with an angle of at least 120 degrees in eachdirection.The ViewFlex™ Xtra Reprocessed ICE Catheter is compatible with theViewMate™ Z, ViewMate™ and Philips CX50 ultrasound consoles.The ViewFlex™ Xtra Reprocessed Reprocess Catheter has been reprocessed byAbbott one (1) time. Each catheter includes marking on the proximal handle andconnector that identify the catheter status. Device is taken out of service afterreaching the maximum number of reprocessing cycles. Abbott restricts itsreprocessing to exclude devices previously reprocessed by other reprocessors. |
| Model Number | D087031-R |
| Indication For Use | The ViewFlex™ Xtra Reprocessed ICE Catheter is indicated for use in adult andadolescent pediatric patients to visualize cardiac structures, blood flow and otherdevices within the heart |
| Comparison | Both the subject and predicate devices have the same intended use, indicationsfor use and method of operation. There are no changes to the claims, clinicalapplications, patient populations, or performance specifications. The subjectdevice is reprocessed 1 time (1X) after clinical use of the predicate device.Abbott's reprocessing includes removal of visible soil and decontamination.Each device is inspected and functionally tested prior to packaging, labeling andsterilizing.The differences between the ViewFlex™ Xtra Reprocessed ICE Catheter and thepredicate device does not raise any new questions of safety and effectiveness. |
| Functional and SafetyTesting | Design verification activities were performed with their respective acceptancecriteria to ensure that the 1X reprocessing from the clinically used ViewFlex™Xtra ICE Catheter does not affect the safety or effectiveness of the device. Alltesting performed met the established performance specifications. |
| Testing | |
| The ViewFlex™ Xtra Reprocessed ICE Catheter was developed and tested inaccordance with the following industry guidance documents and standards: | |
| -- Guidance for Industry and FDA staff: Medical Device User Fee andModernization Act of 2002, Validation Data in Premarket NotificationSubmissions (510(k)s) for Reprocessed Single-Use Medical Devices | |
| - EN ISO 14971:2019 Medical Devices – Application of Risk Management toMedical Devices | |
| Types of Testing Performed | |
| - Cleaning Validation | |
| - Biocompatibility | |
| - Sterilization | |
| - Design validation | |
| - Design verification | |
| - Packaging verification | |
| Conclusion | The technological characteristics for the subject device, and the indications foruse are the same as the predicate device. Based on this and the data provided inthis pre-market notification, the subject device and predicate device have beendemonstrated to be substantially equivalent. |
{5}------------------------------------------------
The following device is included in the scope of this 510(k) submission:
| Description | ReferenceModelNumber(Predicate) | ReprocessedModelNumber(Subject) | UsableLength | French Size | System Compatibility |
|---|---|---|---|---|---|
| ViewFlex™ XtraReprocessed ICECatheter | D087031 | D087031-R | 90cm | 9F | ViewMate™ ZViewMate™Philips CX 50 |
§ 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).