(120 days)
Not Found
No
The summary describes a reprocessed ultrasound catheter for visualization and does not mention any AI/ML capabilities or image processing beyond basic ultrasound. The performance studies focus on reprocessing validation and basic device functionality.
No.
The device is intended for visualization of cardiac structures, blood flow, and other devices within the heart, which is a diagnostic purpose, not a therapeutic one.
No
Explanation: The "Device Description" section 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 for use within the body, not for testing samples outside the body (in vitro).
- Device Description: The description reinforces that it's an "intracardiac ultrasound catheter" used for visualization within the heart.
- Explicit Statement: 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, which is to provide diagnostic information.
IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health, such as diagnosing a disease or condition. This device operates within the body for visualization purposes.
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
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
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
- Packaging Performance Validation
- Electrical Safety Testing
- Dielectric and Current Leakage
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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 acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
November 20, 2020
Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 435 North Hayden Road Suite 100 Scottsdale, Arizona 85257
Re: K202042
Trade/Device Name: Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWO Dated: October 19, 2020 Received: October 20, 2020
Dear Amanda Babcock:
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 probibitions 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); 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-devices/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 (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,
Mark Fellman Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
| 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:
3
Indications for Use
510(k) Number (if known)
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.
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:
Amanda Babcock Regulatory Affairs Manager Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com
Date prepared:
November 19, 2020
Device Information:
Trade/Proprietary Name:
Common Name: Classification Name: Classification Number: Product Code:
Reprocessed ViewFlex Xtra ICE Diagnostic Ultrasound Catheter ICE Catheter Reprocessed Intravascular Ultrasound Catheter Class II, 21 CFR 870.1200 owq
Predicate Device:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K173262 | Reprocessed ViewFlex Xtra ICE Diagnostic | |
| Ultrasound Catheter | Innovative Health, LLC. | |
| 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
The item numbers in scope of this submission are as follows:
| 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 |
Table 5.1: Device Scope
This 510(k) adds a second reprocessing cycle to the same device cleared under K173262 and minor changes to the reprocessing and sterilization release method.
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 following:
- Biocompatibility ●
- Cleaning Validation ●
- Sterilization Validation
- Functional testing ●
- . Visual Inspection
- . Dimensional Verification
- . Ultrasound Transducer Testing
- Simulated Use .
- I Mechanical Characteristics
- Packaging Performance Validation ●
- Electrical Safety Testing
- . Dielectric and Current Leakage
The Reprocessed Diagnostic Ultrasound Catheters are reprocessed no more than two (2) times. 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.
6
Predicate Comparison:
A comparison of the device and reprocessing methods with the predicates are provided in the table below:
| K202042 | K173262 | K133853 | |
|---|---|---|---|
| Device: | Identical | Identical | Identical |
| Reprocessing Cycles: | 2 | 1 | 0 |
| Reprocessing Method: | Change to processing | ||
| parameters to | |||
| accommodate increase | |||
| in batch size. | |||
| Packaging configuration | |||
| change. | Cleared/validated | ||
| process | N/A | ||
| Sterilization: | Change to release | ||
| method. No change to | |||
| the sterilization method | |||
| or SAL. | Cleared/validated | ||
| process | N/A | ||
| Routine Monitoring: | Change to frequency | ||
| and adjustment of limits. | Cleared process | N/A |
Conclusion:
Innovative Health concludes that the Reprocessed Diagnostic Ultrasound Catheter is as safe and effective as the predicate devices described herein.