(29 days)
Not Found
No
The summary describes a reprocessed intracardiac ultrasound catheter and its compatibility with existing ultrasound consoles. There is no mention of AI, ML, or any advanced image processing beyond basic ultrasound visualization. The performance studies focus on reprocessing validation and standard device testing, not algorithmic performance.
No.
The device is used to visualize cardiac structures for diagnostic purposes, not to treat a medical condition.
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 description clearly states it is a "temporary intracardiac ultrasound catheter" with a physical shaft, ultrasound transducer, and deflection capabilities. It is a hardware device that connects to an ultrasound console.
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 body) during a medical procedure.
- Device Description: The description confirms it's an "intracardiac ultrasound catheter" used to "accurately visualize cardiac structures, blood flow and other devices within the heart." It explicitly states that "The use of these images is limited to visualization with no direct or indirect diagnostic use."
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any tests on samples.
The device is an in vivo diagnostic imaging device, specifically an ultrasound catheter used for visualization within the heart.
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 (comma separated list FDA assigned to the subject device)
OWQ, 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
cardiac structures, within the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification activities were performed with their respective acceptance criteria to ensure that the use of the subject device 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: Guidance for Industry and FDA staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices, EN ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices.
Types of Testing Performed: Biocompatibility, Design validation, Design verification, Cleaning Validation.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ViewFlex™ Eco Reprocessed ICE Catheter (K230934)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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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
1
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
2
K231588 - Quynh Phuong Le
The following device is included in the scope of this 510(k) submission:
| Description | Reference
Model
Number
(Predicate) | Reprocessed
Model
Number
(Subject) | Usable
Length | French
Size | System
Compatibility |
|----------------------------------------------|---------------------------------------------|---------------------------------------------|------------------|----------------|----------------------------------------------------------------|
| ViewFlex™ Eco
Reprocessed ICE
Catheter | D087031-R | D087031-R | 90cm | 9F | ViewMate™Z
ViewMate™
ViewMate™
Multi
Philips CX 50 |
3
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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4
Image /page/4/Picture/0 description: The image shows the Abbott logo. The logo consists of a blue square with a stylized "a" inside, followed by the word "Abbott" in black, bold font. The logo is simple and modern, and the colors are clean and professional.
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 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™ Eco Reprocessed ICE Catheter (K230934) |
| 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. | |
| 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. | |
| Comparison | The subject and predicate 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 subject device has added an | |
| additional reprocessing cycle after clinical use of the predicate | |
| device cleared under K230934. | |
| The differences between the subject device, ViewFlex™ Eco | |
| Reprocessed ICE Catheter (2X), and the predicate device, | |
| ViewFlex™ Eco Reprocessed ICE Catheter (1X), does not raise | |
| any new questions of safety and effectiveness. | |
| Non-Clinical Testing | |
| Summary | Design verification activities were performed with their respective |
| acceptance criteria to ensure that the use of the subject device 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:
- Guidance for Industry and FDA staff: Medical Device
User Fee and Modernization Act of 2002, Validation Data
in Premarket Notification Submissions (510(k)s) for
Reprocessed Single-Use Medical Devices - EN ISO 14971:2019 Medical Devices – Application of
Risk Management to Medical Devices
Types of Testing Performed
- Biocompatibility
- Design validation
- Design verification
- Cleaning Validation
Risk Management
Abbott has reviewed the applicable risk management files, and
there were no new or modified hazards identified as result of the
proposed modification. |
| Clinical Testing | 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). |
| 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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6
Image /page/6/Picture/0 description: The image contains the logo for Abbott, a healthcare company. The logo consists of a stylized blue symbol on the left, resembling a rounded square with a missing corner. To the right of the symbol is the word "Abbott" in bold, black font. The overall design is clean and corporate, reflecting the company's professional image.
The following device is included in the scope of this 510(k) submission:
| Description | Reference
Model
Number
(Predicate) | Reprocessed
Model
Number
(Subject) | Usable
Length | French
Size | System
Compatibility |
|----------------------------------------------|---------------------------------------------|---------------------------------------------|------------------|----------------|-----------------------------------------------------------------|
| ViewFlex™ Eco
Reprocessed ICE
Catheter | D087031-R | D087031-R | 90cm | 9F | ViewMate™ Z
ViewMate™
ViewMate™
Multi
Philips CX 50 |