(30 days)
No
The summary describes a standard ultrasound catheter for visualization and does not mention any AI/ML capabilities or image processing beyond basic ultrasound functionality.
No.
The device is used for visualization purposes only, and its use is limited to "no direct or indirect diagnostic use." It does not provide therapy or treatment.
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 is a physical catheter with an ultrasound transducer, designed for insertion into the heart, and connects to external hardware (ultrasound consoles). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "visualize cardiac structures, blood flow and other devices within the heart." This is a direct visualization tool used in vivo (within the living body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description clearly states it's an "intracardiac ultrasound catheter" used to "accurately visualize cardiac structures, blood flow and other devices within the heart." It emphasizes that the use of these images is "limited to visualization with no direct or indirect diagnostic use."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are typically used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a medical imaging tool used directly on the patient for visualization purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
OWO, OBJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
cardiac structures, 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™ Eco Reprocessed 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™ Eco Reprocessed ICE Catheter was developed and 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 Reprocessed ICE Catheter (K222217)
Reference Device(s)
ViewFlex™ Xtra ICE Catheter (K223077)
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).
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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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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
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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 Medical |
| 14901 DeVeau Place | |
| Minnetonka, MN 55345-2126, USA | |
| Contact Person | Quynh Phuong Le |
| Regulatory Affairs Manager | |
| 949-769-5058 or 949-469-9779 | |
| quynphuong.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 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. | |
| Indications For Use | 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. | |
| 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. | |
| Comparison | The subject, predicate and reference devices have the same intended |
| use, indications for use and method of operation. There are no changes | |
| to the claims, clinical applications, patient populations, or performance | |
| specifications. 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 compatible | |
| console, ViewMate™ Multi Ultrasound System which is compatible | |
| with the reference device cleared under K223077. | |
| The difference between the subject device ViewFlex™ Eco | |
| Reprocessed 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 respective |
| acceptance criteria to ensure that the use of the ViewFlex™ Eco | |
| Reprocessed 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™ Eco Reprocessed ICE Catheter was developed and | |
| 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
Abbott has reviewed the applicable risk management files, and there
were no new or modified hazards identified as result of the proposed
modifications. |
| Conclusion | The technological characteristics for the subject device, and the
indications for use are the same as the predicate device. Based on this
and the data provided in this pre-market notification, the subject
device and predicate device have been demonstrated to be
substantially equivalent. |
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