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.

Device Description

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 ViewFlex™ Eco Reprocessed ICE Catheter is reprocessed by Abbott no more than two (2) times. Each catheter includes marking on the proximal handle and connector that identify the catheter status. The 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary for the ViewFlex™ Eco Reprocessed ICE Catheter:

Summary of Acceptance Criteria and Device Performance:

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Met established performance specifications.
Design Validation	Met established performance specifications.
Design Verification	Met established performance specifications.
Cleaning Validation	Met established performance specifications.
Risk Management	No new or modified hazards identified as a result of the proposed modification (additional reprocessing cycle).

Study Information:

Table of Acceptance Criteria and Reported Device Performance: This information is provided in the table above. The document states that all testing performed met the established performance specifications for each category.
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample size for the test set used in the non-clinical performance evaluation. It only mentions that "Design verification activities were performed with their respective acceptance criteria."
- Data Provenance: Not specified, but generally, non-clinical tests like these are conducted in a laboratory setting by the manufacturer (Abbott Medical, USA).
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This device is a medical catheter and the tests described are primarily engineering and biocompatibility evaluations, not diagnostic image interpretation studies requiring expert clinicians to establish ground truth.
Adjudication Method for the Test Set:
- Not applicable. The tests are objective measurements against predefined engineering and material specifications, not subjective interpretations requiring adjudication.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. The document explicitly states: "No clinical investigations have been performed for the subject or predicate devices. Clinical data is not required for the demonstration of substantial equivalent based on the risk assessment in Section 10 and verification in Section 12 and validation in Section 13 summarized in this 510(k)." Therefore, no MRMC study was conducted.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This is a physical medical device (catheter), not an AI algorithm. Its performance is evaluated through engineering, material, and reprocessing verification and validation, not standalone algorithmic performance.
The Type of Ground Truth Used:
- The "ground truth" for the non-clinical studies (biocompatibility, design validation/verification, cleaning validation) would be defined by established engineering specifications, material standards, and regulatory guidance documents. For example, for biocompatibility, it would be adherence to ISO 10993 standards and a lack of adverse biological responses. For cleaning validation, it would be a verifiable reduction in contaminants below a specified threshold.
The Sample Size for the Training Set:
- Not applicable. As this is not an AI/algorithm-based device, there is no "training set" in the context of machine learning. The "development" and "testing" referred to are related to engineering design and physical performance testing.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI algorithm.

Summary

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June 30, 2023

Abbott Medical Quynh Phuong Le Regulatory Affairs Manager 14901 Deveau Place Minnetonka, Minnesota 55345

Re: K231588

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: OWQ, OBJ Dated: May 31, 2023 Received: June 1, 2023

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 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

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801 and Part 809 ); medical device reporting (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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K231588 - Quynh Phuong Le

The following device is included in the scope of this 510(k) submission:

Description	ReferenceModelNumber(Predicate)	ReprocessedModelNumber(Subject)	UsableLength	FrenchSize	SystemCompatibility
ViewFlex™ EcoReprocessed ICECatheter	D087031-R	D087031-R	90cm	9F	ViewMate™ZViewMate™ViewMate™MultiPhilips CX 50

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Indications for Use

510(k) Number (if known) K231588

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)

Commercial Use of a Pesticide for Producing an Agricultural Commodity
For Hire Structural Pest Control

|× | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.

510(k) Number	K231588
510(k) Type	Special 510(k)
Date Prepared	31 May 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™ Eco Reprocessed ICE Catheter (K230934)
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 otherdevices within the heart when connected to a compatibleintracardiac ultrasound console via the compatible ViewFlex™Catheter Interface Module. Examples of the types of other devicesthat can be visualized include, and are not limited to, intracardiaccatheters, septal occluders, delivery wires, delivery sheaths, sizingballoons and transseptal needles. The use of these images is limitedto visualization with no direct or indirect diagnostic use. TheViewFlex™ Eco Reprocessed ICE Catheter has a useable lengthof 90 cm, with a 9 French (F) shaft with an ultrasound transducer.A 10F introducer is recommended for use with this catheter forinsertion 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 compatiblewith the ViewMate™ Z, ViewMate™, ViewMate™ Multi andPhilips CX50 ultrasound consoles.The ViewFlex™ Eco Reprocessed ICE Catheter is reprocessed byAbbott no more than two (2) times. Each catheter includes markingon the proximal handle and connector that identify the catheterstatus. The device is taken out of service after reaching themaximum number of reprocessing cycles. Abbott restricts itsreprocessing to exclude devices previously reprocessed by otherreprocessors.
Indications for Use	The ViewFlex™ Eco Reprocessed ICE Catheter is indicated foruse in adult and adolescent pediatric patients to visualize cardiacstructures, blood flow and other devices within the heart.
Comparison	The subject and predicate devices have the same intended use,indications for use and method of operation. There are nochanges to the claims, clinical applications, patient populations,or performance specifications. The subject device has added anadditional reprocessing cycle after clinical use of the predicatedevice cleared under K230934.The differences between the subject device, ViewFlex™ EcoReprocessed ICE Catheter (2X), and the predicate device,ViewFlex™ Eco Reprocessed ICE Catheter (1X), does not raiseany 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 subject device doesnot affect the safety or effectiveness of the device. All testingperformed met the established performance specifications.TestingThe ViewFlex™ Eco Reprocessed ICE Catheter was developedand tested in accordance with the following industry guidancedocuments and standards:- Guidance for Industry and FDA staff: Medical DeviceUser Fee and Modernization Act of 2002, Validation Datain Premarket Notification Submissions (510(k)s) forReprocessed Single-Use Medical Devices- EN ISO 14971:2019 Medical Devices – Application ofRisk Management to Medical DevicesTypes of Testing Performed- Biocompatibility- Design validation- Design verification- Cleaning ValidationRisk ManagementAbbott has reviewed the applicable risk management files, andthere were no new or modified hazards identified as result of theproposed modification.
Clinical Testing	No clinical investigations have been performed for the subject orpredicate devices. Clinical data is not required for thedemonstration of substantial equivalent based on the riskassessment in Section 10 and verification in Section 12 andvalidation in Section 13 summarized in this 510(k).
Conclusion	The technological characteristics for the subject device, and theindications for use are the same as the predicate device. Based onthis and the data provided in this pre-market notification, thesubject device and predicate device have been demonstrated to besubstantially equivalent.

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The following device is included in the scope of this 510(k) submission:

Description	ReferenceModelNumber(Predicate)	ReprocessedModelNumber(Subject)	UsableLength	FrenchSize	SystemCompatibility
ViewFlex™ EcoReprocessed ICECatheter	D087031-R	D087031-R	90cm	9F	ViewMate™ ZViewMate™ViewMate™MultiPhilips CX 50

Regulation Number and Section

§ 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).