(146 days)
Not Found
No
The summary describes a reprocessed ultrasound catheter for visualization. There is no mention of AI/ML in the intended use, device description, or performance studies. The focus is on the physical characteristics and reprocessing validation of the device.
No.
The device's intended use is to visualize cardiac structures and blood flow, which is a diagnostic function, not a therapeutic one.
No
Explanation: 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 explicitly states it is a "temporary intracardiac ultrasound catheter" with a physical shaft, ultrasound transducer, and deflection capabilities, indicating it is a hardware device.
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 visualization tool, not a device that performs tests on biological samples to diagnose a condition.
- Device Description: The description explicitly states, "The use of these images is limited to visualization with no direct or indirect diagnostic use." This directly contradicts the purpose of an IVD.
- Lack of Diagnostic Claims: There are no claims or descriptions related to diagnosing diseases, conditions, or states of health based on the information provided by the device.
- Performance Studies: The performance studies focus on the safety and effectiveness of the device for visualization and mechanical/electrical performance, not on diagnostic accuracy metrics like sensitivity, specificity, etc., which are typical for IVDs.
IVDs are designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device operates in vivo (inside the body) and is used for visualization, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Reprocessed ViewFlex Xtra 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)
OWO
Device Description
The Reprocessed ViewFlex Xtra ICE 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
cardiac structures, blood flow and other devices 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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Diagnostic Ultrasound Catheters. This included the following:
- Biocompatibility .
- Cleaning Validation .
- Sterilization Validation ●
- Functional testing .
- . Visual Inspection
- . Dimensional Verification
- . Ultrasound Transducer Testing
- . Simulated Use
- Mechanical Characteristics ■
- Electrical Safety Testing .
- · Dielectric and Current Leakage
- . Packaging Validation
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.
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
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 logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
March 6, 2018
Innovative Health, LLC. Amy Stoklas-Oakes Director. Ouality and Regulatory 1435 North Hayden Road Suite 100 Scottsdale, Arizona 85257
Re: K173262
Trade/Device Name: Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter (See enclosed list for model numbers) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWO Dated: February 1, 2018 Received: February 5, 2018
Dear Amy Stoklas-Oakes:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
M & Hillelemen
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
The item numbers in the scope of this submission are as follows:
| REF Item
Number | Catalog
ltem
Number | Description | Sheath
Usable
Length
(cm) | French
Size | System
Compatibility |
|--------------------|---------------------------|-----------------------------------------------------|------------------------------------|----------------|-----------------------------------------------------------------------------------------|
| D087031 | 100046963 | ViewFlex Xtra ICE Diagnostic
Ultrasound Catheter | 90 | 9F | St. Jude Medical
ViewMate.
ViewMate II,
ViewMate Z
Console/Phillips
CX50 |
Table 1: Devices in Scope
3
Indications for Use
510(k) Number (if known)
K173262
Device Name
Reprocessed ViewFlex Xtra ICE Diagnostic Ultrasound Catheter
Indications for Use (Describe)
The Reprocessed ViewFlex Xtra 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
SECTION 5: 510(k) SUMMARY
As required by 21 CFR 807.92(c)
Submitter's Name and Address:
Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257
Contact Name and Information:
Amy Stoklas-Oakes Director. Quality and Requlatory Innovative Health, LLC. (480) 525-5972 (office) (888) 965-7705 (fax) astoklas-oakes@innovative-health.com
Date prepared:
October 10, 2017
Device Information:
Trade/Proprietary Name:
Common Name: Classification Name: Classification Number: Product Code:
Reprocessed ViewFlex Xtra ICE Diagnostic Ultrasound Catheters ICE Catheter Reprocessed Intravascular Ultrasound Catheter Class II, 21 CFR 870.1200 owq
Predicate Device:
| 510(k) Number | 510(k) Title | Manufacturer |
|---|---|---|
| K133853 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, Inc. a |
| St. Jude Medical Company |
Device Description:
The Reprocessed ViewFlex Xtra ICE 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 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.
5
| REF Item Number | Catalog/Reorder Item Number | Description | Sheath Usable Length (cm) | French Size | System Compatibility |
|---|---|---|---|---|---|
| D087031 | 100046963 | ViewFlex Xtra ICE Diagnostic Ultrasound Catheter | 90 | 9F | St. Jude Medical ViewMate, ViewMate II, ViewMate Z Console/Phillips CX50 |
The item numbers in scope of this submission are as follows:
Table 5.1: Device Scope
Indications for Use:
The Reprocessed ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Diagnostic Ultrasound Catheters are identical to the predicate devices. There are no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of the Diagnostic Ultrasound Catheter includes removal of visible soil and decontamination. Each device is inspected and function tested prior to packaging and labeling.
Functional and Safety Testing:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Diagnostic Ultrasound Catheters. This included the followina:
- Biocompatibility .
- Cleaning Validation .
- Sterilization Validation ●
- Functional testing .
- . Visual Inspection
- . Dimensional Verification
- . Ultrasound Transducer Testing
- . Simulated Use
- Mechanical Characteristics ■
- Electrical Safety Testing .
- · Dielectric and Current Leakage
- . Packaging Validation
The Reprocessed Diagnostic Ultrasound Catheters are reprocessed no more than one (1) time. Each device is marked and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Conclusion:
Innovative Health concludes that the Reprocessed Diagnostic Ultrasound Catheter is as safe and effective as the predicate devices described herein.