(116 days)
Not Found
No
The description focuses on the physical design and function of a microcatheter for delivering devices and agents, with no mention of AI or ML.
Yes.
The device is intended for the "infusion of diagnostic ... or therapeutic agents into the neuro, peripheral and coronary vasculature." Devices that deliver therapeutic agents are considered therapeutic devices.
No.
The device itself is a microcatheter intended for the introduction of other devices or agents, including diagnostic agents like contrast media, but it is not a diagnostic device that performs the diagnosis itself. Its purpose is delivery, not diagnosis.
No
The device description clearly details a physical catheter with various material properties, dimensions, and accessories, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the introduction of non-liquid interventional devices and infusion of diagnostic or therapeutic agents into the vasculature. This is an invasive procedure performed directly on the patient's body.
- Device Description: The description details a catheter designed to be inserted into veins or arteries and navigated to a treatment site. This is a medical device used for direct intervention within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on samples outside the body.
The device is a medical device used for delivering other substances or devices within the patient's circulatory system, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The VIA™ Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media), or therapeutic agents into the neuro, peripheral and coronary vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY, KRA
Device Description
The VIA™ Microcatheter and VIA™ PLUS Microcatheter are designed to be introduced over a stcerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with manipulation while in the vasculature. Throughout the procedure the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Interventional devices and infusion of diagnostic and therapeutic agents can be delivered through the lumen of the catheter to the treatment site.
The VIA™ Microcatheter is a sterile single lumen device with a single distal tip marker designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as an intraluminal flow diverter.
The VIA™ and VIA™ PLUS Microcatheter are available in effective lengths of 154 cm and 133 cm and inner diameters of 0.27 inches and 0.33 inches, respectively. For commercialization purposes the 0.027 inch diameter will be named the VIA™ Microcatheter and the 0.033 inch diameter will be named the VIA™ PLUS Microcatheter.
The VIA™ Microcatheter is presented in a tyvek pouch and is sterile, single-use only and nonpvrogenic.
Accessories: Each VIA™ Microcatheter is provided with a shaping mandrel to facilitate distal tip shaping.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic techniques
Anatomical Site
neuro, peripheral and coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Device performance testing confirms that the VIA™ Microcatheter can be used according to its intended use. The VIA™ Microcatheter has been verified and validated according to Sequent Medical's procedures for product design and development. Performance testing included:
- Bench Testing
- Sterilization Validation
- Packaging and Shelf Life Testing
- Biocompatibility and Chemical Testing
- Simulated Use Testing in Animals
This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate device (s) for its intended use in the introduction of non-liquid interventional devices, infusion of diagnostic and therapeutic agents into the neuro, coronary, and peripheral vasculature.
Nonclinical tests included:
- Physical characteristics unique to the VIA Microcatheter, such as visual and dimensional tolerances, kink resistance, and catheter tip shape retention
- Safety features such as burst pressure, tensile force, and coating adhesion
- Functional characteristics such as navigation and track force in a worst-case model that incorporates two 360 degree loops, as well as interventional device retraction and catheter flow rate.
Bench tests performed, methodology/purpose, applicable international standard/Sequent Test Method (TM), result, and conclusion are detailed in a table:
- Visual and Dimensional: Met performance specifications per standard and test method. Complete conformance to standard.
- Kink Resistance: Met performance specifications per standard and test method. Conformance to standard with deviations: Kink diameter determined based on mechanical kink (drop in compressive force) instead of 50% reduction in water flow, deemed appropriate as Via is primarily used to deliver non-liquid devices.
- Tip Buckling: Met performance specifications per test method. Complete conformance to Sequent TM.
- Tracking Force: Met performance specifications per test method. Complete conformance to Sequent TM.
- Steam Shaping and Shape Retention: Met performance specifications per test method. Complete conformance to Sequent TM.
- Shaft Tensile: Met performance specifications per standard and test method. Complete conformance to standard.
- Hub-Shaft Tensile: Met performance specifications per standard and test method. Complete conformance to standard.
- Burst: Met performance specifications per standard and test method. Complete conformance to standard.
- Coating Friction and Coating Integrity: Met performance specifications per standard and test method. Complete conformance to supplier test methods. In line with FDA guidance document on coating integrity.
- Coating Adherence/Particulate: Met performance specifications per standard and test method. Complete conformance to Sequent TM. In line with FDA guidance documents on particulate testing.
- Hub Performance: Met performance specifications per standard and test method. Conformance to standard with deviations: Used an alternative ISO 594-2:1998 fitting for Separation Force and Unscrewing Torque, which was measured to have a minor diameter greater than called for, deemed worst case and acceptable. Only short term stress cracking inspected; long term testing not applicable due to short duration of RHV or syringes connection during device delivery.
Nonclinical testing demonstrated that the VIA™ and VIA™ PLUS Microcatheter can perform as intended, and demonstrated substantial equivalence to the predicate devices.
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.
Marksman Catheter (K091559), Excelsior XT-27 Microcatheter (K113778), VIA™ Microcatheter (K123477)
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
DEC 2 0 2013
Section 5.
510(K) Summary
5. 510(K) SUMMARY
K13265Z
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).
| DATE PREPARED | 11/15/2013 |
|---|---|
| APPLICANT | Sequent Medical, Inc. |
| 11A Columbia | |
| Aliso Viejo, CA 92656 | |
| Tel: (949) 830-9600 | |
| Fax: (949) 830-9658 | |
| OFFICIAL | |
| CORRESPONDENT | Melanie Parravi |
| 11A Columbia | |
| Aliso Viejo. CA 92656 | |
| melaniep@sequentmedical.com | |
| Tel: (949) 830-9600 x 130 | |
| Fax: (949) 830-9568 | |
| TRADE NAME | VIATM Microcatheter |
| COMMON NAME | Continuous Flush catheter |
| DEVICE | |
| CLASSIFICATION | Class II, 21 CFR §870.1210 |
| PRODUCT CODES | DQY: Percutaneous Catheter |
| KRA: Continuous Flush Catheter | |
| PREDICATE | |
| DEVICES | Marksman Catheter (K091559) |
| Excelsior XT-27 Microcatheter (K113778) | |
| PRIOR SUBMISSION | There has been a prior submission for the subject device |
| and approval was obtained under K123477 for | |
| peripheral and coronary indications | |
| PURPOSE OF | |
| SUBMISSION | The purpose of this submission is to gain marketing |
| clearance for an expansion of the Indications for Use to | |
| include use of the VIATM and VIATM PLUS | |
| Microcatheters in the neuro vasculature. The submission | |
| also requests clearance to extend the shelf life from 6 | |
| months to 1 year. |
SUBSTANTIALLY EQUIVALENT TO:
The VIATM Microcatheter is substantially equivalent to the previously cleared Marksman™ Catheter (K091559), Excelsior XT-27 Microcatheter (K113778) and VIA™ Microcatheter (K123477).
1
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The VIA™ Microcatheter and VIA™ PLUS Microcatheter are designed to be introduced over a stcerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with manipulation while in the vasculature. Throughout the procedure the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Interventional devices and infusion of diagnostic and therapeutic agents can be delivered through the lumen of the catheter to the treatment site.
The VIA™ Microcatheter is a sterile single lumen device with a single distal tip marker designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as an intraluminal flow diverter.
The VIA™ and VIA™ PLUS Microcatheter are available in effective lengths of 154 cm and 133 cm and inner diameters of 0.27 inches and 0.33 inches, respectively. For commercialization purposes the 0.027 inch diameter will be named the VIA™ Microcatheter and the 0.033 inch diameter will be named the VIA™ PLUS Microcatheter.
The VIA™ Microcatheter is presented in a tyvek pouch and is sterile, single-use only and nonpvrogenic.
Accessories: Each VIA™ Microcatheter is provided with a shaping mandrel to facilitate distal tip shaping.
INDICATIONS FOR USE:
The VIA™ Microcatheter is intended for the introduction of non-liguid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media), or therapeutic agents into the neuro, peripheral and coronary vasculature.
TECHNICAL CHARACTERISTICS:
The VIA™ Microcatheter incorporates variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over a selectively-placed guidewire. The inner lumen incorporates a PTFE liner to facilitate movement of devices through the catheter's lumen to the intended destination in the vasculature. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The tip of the catheter can be steam-shaped by physician for proper adjustment to the anatomy prior to use.
2
PERFORMANCE DATA:
Device performance testing confirms that the VIA™ Microcatheter can be used according to its intended use. The VIA™ Microcatheter has been verified and validated according to Sequent Medical's procedures for product design and development. Performance testing included:
- Bench Testing .
- . Sterilization Validation
- Packaging and Shelf Life Testing .
- Biocompatibility and Chemical Testing .
- . Simulated Use Testing in Animals
This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate device (s) for its intended use in the introduction of non-liquid interventional devices, infusion of diagnostic and therapeutic agents into the neuro, coronary, and peripheral vasculature.
The information provided by Sequent Medical in this 510(k) application was found to be substantially equivalent to all the predicate devices, including the Marksman™ Catheter (K091559), the Excelsior XT-27 Microcatheter (K113778) and the VIA™ Microcatheter (K123477)
NONCLINICAL TESTS DISCUSSION:
The nonclinical tests included:
- Physical characteristics unique to the VIA Microcatheter, such as visual and dimensional . tolerances, kink resistance, and catheter tip shape retention
- Safety features such as burst pressure, tensile force, and coating adhesion .
- . Functional characteristics such as navigation and track force in a worst-case model that incorporates two 360 degree loops, as well as interventional device retraction and catheter flow rate.
The following table lists the bench tests performed, the methodology/purpose of the test, the associated international standard (if applicable), and final results.
3
SECTION 5.
510(K) Summar
| Test | Methodology | Applicable International Standard and/or Sequent Test Method (TM) | Result | Conclusion |
|---|---|---|---|---|
| Visual and Dimensional | Tests conformance to specified microcatheter dimensions and visual criteria. | ISO 10555-1:2009 | Met performance specifications per standard and test method | Complete conformance to standard |
| Kink Resistance | Measures diameter at which microcatheter shaft sections and junctions will kink. | BS EN 13868:2002 | Met performance specifications per standard and test method | Conformance to standard with the following deviations: |
Kink diameter determined based on mechanical kink (drop in compressive force) instead of 50% reduction in water flow. This method is appropriate as the Via is primarily used to deliver non-liquid devices. |
| Tip Buckling | Tests force required for tip to buckle. | Internal test method | Met performance specifications per test method | Complete conformance to Sequent TM |
| Tracking Force | Tests force required to advance an interventional device through the microcatheter lumen. | Internal test method | Met performance specifications per test method | Complete conformance to Sequent TM |
| Steam Shaping and Shape Retention | Tests that microcatheter can be steam shaped to a clinically relevant angle and can maintain a minimum % of the initial angle after simulated use. | Internal test method | Met performance specifications per test method | Complete conformance to Sequent TM |
| Shaft Tensile | Measures the ultimate tensile strength of all Pebax and Vestamid junctions along the length of the catheter shaft. | ISO 10555-1:2009 | Met performance specifications per standard and test method | Complete conformance to standard |
| Hub-Shaft Tensile | Measures the ultimate tensile strength of the hub to shaft junction | ISO 10555-1:2009 | Met performance specifications per standard and test method | Complete conformance to standard |
| Test | Methodology | Applicable
International
Standard and/or
Sequent Test
Method (TM) | Result | Conclusion |
| Burst | Measures peak pressure
before microcatheter
burst/liquid leakage. | ISO 10555-1:2009 | Met performance
specifications per
standard and test
method | Complete conformance to standard |
| Coating Friction
and Coating
Integrity | Measures the average peak
coating friction/lubricity. | Harland Medical
Systems Coating
Friction and Dye
Test Methods | Met performance
specifications per
standard and test
method | Complete conformance to supplier test methods |
| | Coating integrity uses dye to
test that coating remains
adhered to catheter after
simulated use. | FDA Guidance
Document, Class II
Special Controls
for PTCA Catheters
(section 12) (Issued
2010) | Met performance
specifications per
standard and test
method | In line with FDA guidance document on coating integrity |
| Coating
Adherence/
Particulate | Measures particulate
generated from the
hydrophilic coating on
exterior of microcatheter, as
well as particulate generated
from advancing an
interventional device
through the inner lumen of
the microcatheter. | Internal test method
FDA Guidance
Document, Non-
Clinical
Engineering Tests
for Intravascular
Stents and
Associated
Delivery Systems
(section 12) (Issued
2010)
FDA Guidance
Document, Class II
Special Controls | Met performance
specifications per
standard and test
method | Complete conformance to Sequent TM
In line with FDA guidance documents on particulate
testing |
| Test | Methodology | Applicable
International
Standard and/or
Sequent Test
Method (TM) | Result | Conclusion |
| Hub Performance | Tests hub liquid and air
leakage, as well as that the
hub can withstand adequate
forces. Tests that the hub
meets general requirements
for conical fittings. | for PTCA Catheters
(section 13) (Issued
2010)
ISO 594-1:1986
ISO 594-2:1998
Internal test method | Met performance
specifications per
standard and test
method | Conformance to standard with the following deviations:
Used an alternative ISO 594-2:1998 fitting to test hubs
for Separation Force and Unscrewing Torque. The fitting
used was measured to have a minor diameter greater than
called for in the standard. This was deemed as worst case
for these tests, therefore acceptable to use.
Only short term stress cracking was inspected for on
hubs. ISO 594-2:1998 calls for inspection after 48 hours.
Intended use of Via microcatheter only requires RHV or
syringes to be connected for short durations during
delivery of implant, therefore long term testing is not
applicable. |
Page 4 of 7
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4
SECTION 5.
510(K) Summary
Page 5 of 7
:
5
Section 5.
510(K) Summar
Page 6 of 7
.
6
Nonclinical testing demonstrated that the VIA™ and VIA™ PLUS Microcatheter can perform as intended, and demonstrated substantial equivalence to the predicate devices: Marksman™ Catheter (K091559), Excelsior XT-27 Microcatheter (K113778) and VIA™ Microcatheter (K123477).
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
A technological comparison, bench testing, and simulated use testing demonstrate the substantial equivalence of the VIA™ Microcatheter to the predicate devices.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
Sequent Medical, Inc. Ms. Melanie Parravi, Vice President Quality Assurance and Regulatory Compliance 11A Columbia Aliso Viejo, CA 92656
Re: K132652
Trade/Device Name: VIA and VIA PLUS Microcatheters Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA, DQY Dated: September 23, 2013 Received: September 24, 2013
Dear Ms. Parravi:
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
8
Page 2 – Ms. Melanie Parravi
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
Carlos L. Peña, Ph.D. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K132652
Device Name: VIA and VIA PLUS Microcatheter
Indications For Use:
The VIA™ Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media), or therapeutic agents into the neuro, peripheral and coronary vasculature.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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