(260 days)
Not Found
No
The summary describes a reprocessed ultrasound catheter and its functional and performance testing, with no mention of AI or ML capabilities.
No.
The device is used to visualize cardiac structures and blood flow, not to treat a disease or 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 is a physical catheter with an ultrasound transducer, designed for insertion into the body. 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 body) during a medical procedure.
- Device Description: The description reinforces its use as an intracardiac ultrasound catheter for visualization within the heart.
- Lack of Diagnostic Use: Crucially, the description explicitly states: "The use of these images is limited to visualization with no direct or indirect diagnostic use." IVDs are specifically intended for use in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
This device is a medical device used for imaging during a procedure, not an IVD used for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
The reprocessed ViewFlex™ Xtra ICE catheter is 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
Device Description
The Reprocessed ViewFlex™ Xtra 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 Reprocessed ViewFlex™ Xtra ICE catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A10F 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
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)
Specific non-clinical tests performed included: cleaning validation, sterilization verification, ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F2096), and shelf-life validation (ASTM 1980-07). In addition, validation of functional performance (bench testing) was performed through simulated use, visual inspection, and fatigue testing.
Testing performed:
• Electrical Leakage
• Torsional Strength
• Flexation Fatigue
• Fluid Integrity
• Joint Bond Strength
• Deflection Fatigue
• Stiffness
• Tip Buckling
• Transducer Sensitivity
• Ultrasound console compatibility
• Acoustic Output
• Thermistor Functionality
Performance testing shows the reprocessed ViewFlex™ Xtra ICE catheter to perform as originally intended.
In addition, the device was tested for biocompatibility per ISO 10993-1 for external communicating device, short duration contact with circulating blood (
§ 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 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 14, 2019
Sterilmed, Inc. Jan Flegeau Associate Director, Regulatory Affairs 5010 Cheshire Pkwy N. Suite 2 Plymouth, Minnesota 55446
Re: K190478
Trade/Device Name: Reprocessed ViewFlex™ Xtra ICE Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWQ Dated: October 9, 2019 Received: October 10, 2019
Dear Jan Flegeau:
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); 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,
Nicole Gillette Assistant Director (Acting) 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
The following device model is included in the scope of this 510(k) submission:
Model Number | Description | Useable Length | French Size |
---|---|---|---|
D087031 | Reprocessed | ||
ViewFlex™ Xtra ICE | |||
Catheter | 90 cm | 9F |
3
Indications for Use
510(k) Number (if known) K190478
Device Name Reprocessed ViewFlex™ Xtra ICE catheter
Indications for Use (Describe)
The reprocessed ViewFlex™ Xtra ICE catheter is 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
Date Prepared: | November 14, 2019 |
---|---|
Submitter and | |
Manufacturer: | Sterilmed, Inc. |
5010 Cheshire Parkway N, Suite 2 | |
Plymouth, MN 55446 | |
www.sterilmed.com | |
Manufacturing | |
Facility Address: | 11400 73rd Avenue |
North Maple Grove | |
MN 55369 | |
Official | |
Correspondent: | Jan Flégeau |
Associate Director, Regulatory Affairs | |
Sterilmed, Inc. | |
Tel: 786-575-5903 | |
Email: jflegeau@its.jnj.com | |
Trade Name: | Reprocessed ViewFlex™ Xtra ICE catheter |
Regulation Name: | Diagnostic Intravascular Catheter |
Device Classification: | Class II |
Product Code | OWQ |
Predicate Device: | ViewFlex™ Xtra ICE Catheter (K133853) |
Device Description: | The Reprocessed ViewFlex™ Xtra 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 Reprocessed ViewFlex™ Xtra ICE catheter has a useable | |
length of 90 cm, with a 9 French (F) shaft with an ultrasound | |
transducer. A10F 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 reprocessed ViewFlex™ Xtra ICE catheter is compatible
with the ultrasound consoles listed in the table below. See table
below for specifics on each ultrasound console. | |||
---|---|---|---|
Compatible Ultrasound | |||
Console* | ViewMate™ II | ViewMate™ Z | |
or ViewMate™ | Philips | ||
CX50a | |||
Compatible ViewFlex™ | |||
Catheter Interface Module | 100038191 | H701374 | |
100043720 | H701375 | ||
H700296 | |||
Maximum Viewing Depth | |||
*All consoles are not available in all countries. | 18 cm | 18 cm | 18 cm |
Model Number | RD087031 | ||
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 Reprocessed ViewFlex™ Xtra ICE catheter has the same | ||
technological and performance characteristics as the predicate | |||
device (K133853). The catheter is connected to a compatible | |||
ultrasound console via the appropriate Catheter Interface | |||
Module (CIM). Clinically, these devices are most often inserted | |||
into a vein and advanced into the heart. A small incision is | |||
made in the skin, usually in the groin or neck area, then a needle | |||
and introducer sheath are used to puncture the vein. The | |||
catheter is inserted and manipulated through the sheath into the | |||
vein until appropriately positioned. The ultrasound transducer | |||
on the tip of the catheter is then used to visualize cardiac | |||
structures, blood flow and other devices within the heart. | |||
Functional and Safety | |||
Testing: | Representative samples of reprocessed devices were tested to | ||
demonstrate appropriate functional characteristics. Process | |||
validation testing was performed to validate the cleaning and | |||
sterilization procedures as well as device packaging. In | |||
addition, the manufacturing process includes visual and | |||
validated functional testing of all products produced. The | |||
reprocessed ViewFlex™ Xtra ICE catheter is marked and | |||
tracked through the reprocessing cycle. After the device has | |||
been reprocessed one (1) time, it is rejected from further | |||
reprocessing. | |||
Summary of | |||
Non-Clinical Tests | |||
Conducted: | Specific non-clinical tests performed included: cleaning | ||
validation, sterilization verification, ethylene oxide residual | |||
testing (ISO 10993-7), packaging validation (ASTM D4169, | |||
ASTM F88, ASTM F2096), and shelf-life validation (ASTM | |||
1980-07). In addition, validation of functional performance | |||
(bench testing) was performed through simulated use, visual | |||
inspection, and fatigue testing. |
6
| | Testing performed:
• Electrical Leakage
• Torsional Strength
• Flexation Fatigue
• Fluid Integrity
• Joint Bond Strength
• Deflection Fatigue
• Stiffness
• Tip Buckling
• Transducer Sensitivity
• Ultrasound console compatibility
• Acoustic Output
• Thermistor Functionality
Performance testing shows the reprocessed ViewFlex™ Xtra ICE catheter to perform as originally intended.
In addition, the device was tested for biocompatibility per ISO 10993-1 for external communicating device, short duration contact with circulating blood (