(157 days)
Not Found
No
The description focuses on the physical characteristics and mechanical function of a microcatheter, with no mention of AI or ML capabilities.
No
The device is described as a microcatheter intended for the introduction of non-liquid interventional devices (like coils/stents) and diagnostic agents (like contrast media) into the vasculature, which serves as a delivery tool rather than directly providing therapy.
No
The device is a microcatheter intended for the introduction of non-liquid interventional devices and infusion of diagnostic agents. While it facilitates the infusion of diagnostic agents, the device itself is not performing diagnosis; it's a delivery tool.
No
The device description clearly details a physical microcatheter with specific dimensions, materials (PTFE liner, hydrophilic coating), and accessories (shaping mandrels). It also mentions bench testing, sterilization validation, packaging, shelf life, biocompatibility, and simulated use testing in animals, all of which are associated with a physical medical device, not software.
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 agents into the neuro, peripheral and coronary vasculature. This is an in-vivo application, meaning it's used within a living organism.
- Device Description: The description details a physical catheter designed for navigating blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be inserted into the body for therapeutic or diagnostic delivery purposes as described here.
N/A
Intended Use / Indications for Use
The VIA™ 17 Microcatheter is intended for the introduction of non-liquid interventional devices (such as coils/ stents) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral and coronary vasculature.
Product codes
DQY, KRA
Device Description
The VIA™ 17 Microcatheter is a sterile single lumen device 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 coils/stents.
The VIA™ 17 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.0175 inches.
The VIA™ 17 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic.
Accessories: Each VIA™ 17 Microcatheter is provided with shaping mandrels to facilitate distal tip shaping.
In intravascular procedures, the device assists the physician in:
- Accessing the targeted vasculature to facilitate the delivery of interventional devices, such as coils and stents, and infusion of diagnostic agents such as contrast.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro, peripheral and coronary vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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)
Device performance testing confirms that the VIA™ 17 Microcatheter can be used according to its intended use. The VIA™ 17 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 Assessment
- Biocompatibility Assessment
- Simulated Use Testing in Animals
This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate device, for its intended use in the introduction of interventional devices and infusion of diagnostic agents into the vasculature.
The nonclinical tests included:
- Physical characteristics unique to the VIA™ 17 Microcatheter, such as visual and dimensional tolerances, kink resistance, and catheter tip shape retention.
- Safety features such as burst pressure, tensile force and coating adherence.
- Functional characteristics such as navigation and track force. Interventional device retraction and catheter flow rate.
Kink Resistance: All units passed acceptance criteria. Acceptance criteria based on measured Headway 17 kink resistance. Substantially equivalent to predicate.
Tip Buckling: All units passed acceptance criteria. Acceptance criteria based on measured Headway 17 tip buckling. Substantially equivalent to predicate.
Tracking Force: All units passed acceptance criteria. Acceptance criteria identical to VIA 21 and VIA 27/33. Substantially equivalent to predicate.
Steam Shaping and Shape Retention: All units passed acceptance criteria. Acceptance criteria based on measured Headway 17 shape retention. Substantially equivalent to predicate.
Microcatheter Tensile Strength: All units passed acceptance criteria per ISO10555-1:2014. Substantially equivalent to predicate.
Catheter Leakage and Static Burst: All units passed acceptance criteria. Acceptance criteria identical to VIA 21 and VIA 27/33. Substantially equivalent to predicate.
Retraction: All units passed acceptance criteria. Acceptance criteria identical to VIA 21 and VIA 27/33. Substantially equivalent to predicate.
Coating Friction and Coating Integrity: All units passed acceptance criteria. Acceptance criteria identical to VIA 21 and VIA27/33. Substantially equivalent to predicate.
Coating Adherence/Particulate: All units passed acceptance criteria per USP24 . Acceptance criteria identical to VIA 21 and VIA27/33. Substantially equivalent to predicate.
Flow Rate: All units passed acceptance criteria per ISO10555-1:2014. Flow rate was determined and documented in the instructions for use. Substantially equivalent to predicate.
Hub Performance: Test results adopted from VIA 27/VIA33 (K132652). All units passed acceptance criteria per ISO594-1:1986 and ISO 594-2:1998. Substantially equivalent to predicate.
Visual and Dimensional: All units passed acceptance criteria. Substantially equivalent to predicate.
Catheter Torque to Failure: Characterization only. Results comparable to VIA 21. Substantially equivalent to predicate.
Biocompatibility and chemical testing was adopted from the testing performed on the VIA (VIA 27) Microcatheter:
Materials Mediated Rabbit Pyrogen Test: Non-pyrogenic - Pass
ISO Guinea Pig Maximization Sensitization: Non-sensitization response - Pass
ISO Acute Systemic Injection Test: Non Toxic - Pass
ISO Intracutaneous Reactivity Test: Non-irritant - Pass
Four Hour Thromboresistance Evaluation in Dogs: Thromboresistance characteristics of test group similar to control - Pass
ASTM Hemolysis Assay Direct Contact and Extract: Non-hemolytic under direct and extract test conditions - Pass
Complement Activation with Comparison Article: Results of test group comparable to control group - Pass
Partial Thromboplastin Time with Comparison Article: Results of test group comparable to control group -both non-activators of the intrinsic coagulation pathway - Pass
Platelet and Leukocyte Counts with Comparison Article: Results of test group comparable to control group - Pass
ISO MEM Elution Assay with L-929 Mouse Fibroblast: Non-toxic - Pass
Colorant Analysis Testing: Elemental results meet requirements of 21 CFR 74.3045 - Pass
Use in a clinical setting was conducted in animals to show that no new risks were identified and that the safety and effectiveness profile is similar to well-established comparison market-approved devices. Bench Testing was performed in models representing the higher risk neurovascular anatomy which is the worst case representation of the cardiac and peripheral vascular anatomies.
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.
VIA™ 21 Microcatheter (K150894), VIA™ and VIA™ PLUS Microcatheters (K132652), Headway 17 Advanced Microcatheter (K101542)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 18, 2017
Sequent Medical, Inc. Bethany Barrett Regulatory/Clinical Project Manager 11A Columbia Aliso Viejo, California 92656
Re: K162565
Trade/Device Name: VIA™ 17 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: January 26, 2017 Received: February 1, 2017
Dear Ms. Barrett:
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 (reporting of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
Carlos L. Pena-S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K162565
Device Name VIA™ 17 Microcatheter
Indications for Use (Describe)
The VIA™ 17 Microcatheter is intended for the introduction of non-liquid interventional devices (such as coils/ stents) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral and coronary vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CER 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."
3
510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).
| DATE PREPARED | 2/17/2017 |
|---|---|
| APPLICANT | Sequent Medical, Inc. |
| 11A Columbia | |
| Aliso Viejo, CA 92656 | |
| Tel: (949) 830-9600 | |
| Fax: (949) 830-9658 | |
| OFFICIAL | |
| CORRESPONDENT | Bethany Barrett |
| 11A Columbia | |
| Aliso Viejo, CA 92656 | |
| bethanyb@sequentmedical.com | |
| Tel: (949) 830-9600 x 113 | |
| Fax: (949) 830-9568 | |
| TRADE NAME | VIA™ 17 Microcatheter |
| COMMON NAME | Percutaneous Catheter, Continuous Flush Catheter |
| DEVICE | |
| CLASSIFICATION | Class II, 21 CFR §870.1250, §870.1210 |
| PRODUCT CODES | DQY: Percutaneous Catheter |
| KRA: Continuous Flush Catheter | |
| PREDICATE | |
| DEVICES | VIA™ 21 Microcatheter (K150894) |
| VIA™ and VIA™ PLUS Microcatheters (K132652) | |
| Headway 17 Advanced Microcatheter (K101542) |
SUBSTANTIALLY EQUIVALENT TO:
The VIA™ 17 Microcatheter is substantially equivalent to the previously cleared VIA 21 Microcatheter (K150894), VIA (VIA 27) and VIA PLUS (VIA 33) Microcatheters (K132652), and Headway 17 Advanced Microcatheter (K101542).
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The VIA™ 17 Microcatheter is a sterile single lumen device 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
4
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 coils/stents.
The VIATM 17 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.0175 inches.
The VIA™ 17 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic.
Accessories: Each VIA™ 17 Microcatheter is provided with shaping mandrels to facilitate distal tip shaping.
In intravascular procedures, the device assists the physician in:
- Accessing the targeted vasculature to facilitate the delivery of interventional devices, such as coils and stents, and infusion of diagnostic agents such as contrast.
INDICATIONS FOR USE:
The VIA™ 17 Microcatheter is intended for the introduction of non-liquid interventional devices (such as coils/stents) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral and coronary vasculature.
TECHNICAL CHARACTERISTICS:
The VIA™ 17 Microcatheter incorporates variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. 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.
PERFORMANCE DATA:
Device performance testing confirms that the VIA™ 17 Microcatheter can be used according to its intended use. The VIA™ 17 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 Assessment
- Biocompatibility Assessment
- Simulated Use Testing in Animals ●
5
This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate device, for its intended use in the introduction of interventional devices and infusion of diagnostic agents into the vasculature.
The information provided by Sequent Medical in this 510(k) application was found to be substantially equivalent to the predicate devices, the VIA 21 Microcatheter (K150894), VIA (VIA 27) and VIA PLUS (VIA 33) Microcatheters (K132652), and the Headway 17 Advanced Microcatheter (K101542).
NONCLINICAL TESTS DISCUSSION:
The nonclinical tests included:
- Physical characteristics unique to the VIA™ 17 Microcatheter, such as visual and ● dimensional tolerances, kink resistance, and catheter tip shape retention.
- Safety features such as burst pressure, tensile force and coating adherence.
- Functional characteristics such as navigation and track force. Interventional ● device retraction and catheter flow rate.
- The full list of non-clinical tests are listed in Table 1 below: ●
| Test | Test Method Summary | Result |
|---|---|---|
| Kink Resistance | This method measures the diameter at which the VIA shaft sections | |
| and junctions will kink. Each catheter section is inserted into an | ||
| automated test fixture and kinked. The kink diameter is then | ||
| calculated based on shaft displacement at peak force. | All units passed | |
| acceptance criteria. | ||
| Acceptance criteria | ||
| based on measured | ||
| Headway 17 kink | ||
| resistance. | ||
| Substantially | ||
| equivalent to | ||
| predicate. | ||
| Tip Buckling | This method measures the catheter tip buckling force by pushing the | |
| catheter tip into a load cell until it buckles. The peak force is | ||
| measured and recorded. | All units passed | |
| acceptance criteria. | ||
| Acceptance criteria | ||
| based on measured | ||
| Headway 17 tip | ||
| buckling. Substantially | ||
| equivalent to | ||
| predicate. | ||
| Tracking Force | This method tests the force required to pass interventional devices | |
| through the VIA catheter. Each VIA is inserted into a tracking | ||
| fixture and the hard model tortuosity fixture. The interventional | ||
| device is pushed through the tortuosity fixture and VIA catheter. The | ||
| peak force required to push the device through the VIA is recorded. | All units passed | |
| acceptance criteria. | ||
| Acceptance criteria | ||
| identical to VIA 21 | ||
| and VIA 27/33. | ||
| Substantially | ||
| equivalent to | ||
| predicate. | ||
| Test | Test Method Summary | Result |
| Steam Shaping | ||
| and Shape | ||
| Retention | This method measures the ability of the VIA to be steam shaped | |
| using a shaping mandrel and the ability of the VIA to hold the shape | ||
| during use. The VIA is shaped per the VIA IFU shaping instructions. | ||
| The tip angle is measured and must fall within the documented | ||
| specification. The VIA is then subjected to simulated use through a | ||
| guide catheter in 37° water. After guidewire insertion for a specified | ||
| time, the tip angle is measured again and shape retention is evaluated | ||
| per the specification. | All units passed | |
| acceptance criteria. | ||
| Acceptance criteria | ||
| based on measured | ||
| Headway 17 shape | ||
| retention. | ||
| Substantially | ||
| equivalent to | ||
| predicate. | ||
| Microcatheter | ||
| Tensile Strength | This method tests the tensile strength of the microcatheter shaft | |
| sections (each joint/transition tested individually). This method | ||
| aligns with the method described in ISO 10555-1:2014. | All units passed | |
| acceptance criteria per | ||
| ISO10555-1:2014. | ||
| Substantially | ||
| equivalent to | ||
| predicate. | ||
| Catheter | ||
| Leakage and | ||
| Static Burst | This method measures the leakage and static burst pressure of the | |
| VIA. This method aligns with the method described in ISO 10555- | ||
| 1:2014. | All units passed | |
| acceptance criteria. | ||
| Acceptance criteria | ||
| identical to VIA 21 | ||
| and VIA 27/33. | ||
| Substantially | ||
| equivalent to | ||
| predicate. | ||
| Retraction | This method measures the distance that the VIA catheter pulls back | |
| during interventional device recapture. This test is performed in a | ||
| simulated use model. The guide catheter and VIA Microcatheter are | ||
| inserted into the fixture. A worst case interventional device is | ||
| deployed through the VIA and recaptured. The displacement of the | ||
| catheter in the fixture is measured and recorded. | All units passed | |
| acceptance criteria. | ||
| Acceptance criteria | ||
| identical to VIA 21 | ||
| and VIA 27/33. | ||
| Substantially | ||
| equivalent to | ||
| predicate. | ||
| Coating Friction | ||
| and Coating | ||
| Integrity | Measures the catheter coating friction/lubricity over multiple friction | |
| test cycles using an automated friction tester. | ||
| Coating integrity uses dye to test that coating remains adhered to | ||
| catheter after simulated use through a tortuous model. | All units passed | |
| acceptance criteria. | ||
| Acceptance criteria | ||
| identical to VIA 21 | ||
| and VIA27/33. | ||
| Substantially | ||
| equivalent to | ||
| predicate. | ||
| Coating | ||
| Adherence/ | ||
| Particulate | This method measures the particulate generated during simulated | |
| navigation and adjunct device delivery. The VIA is cycled through | ||
| the tracking fixture and the hard model tortuosity fixture. A worst | ||
| case interventional device is then cycled through the inner diameter | ||
| (ID) of the VIA while inside the tortuosity fixture. Both the ID of the | ||
| fixture and the ID of the VIA are flushed with particulate free water | ||
| and the collected fluid is tested for particulate using the light | ||
| obscuration method. | All units passed | |
| acceptance criteria per | ||
| USP24 . | ||
| Acceptance criteria | ||
| identical to VIA 21 | ||
| and VIA27/33. | ||
| Substantially | ||
| equivalent to | ||
| predicate. | ||
| Flow Rate | This method measures the flow rate through the VIA by pushing | |
| fluid through the catheter at a constant rate while pressure is being | ||
| monitored. | All units passed | |
| acceptance criteria per | ||
| ISO10555-1:2014. | ||
| Flow rate was | ||
| Test | Test Method Summary | Result |
| determined and | ||
| documented in the | ||
| instructions for use. | ||
| Substantially | ||
| equivalent to | ||
| predicate. | ||
| Hub | ||
| Performance | This method 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. Methods used are per ISO594- | ||
| 1:1986 and ISO 594-2:1998. | Test results adopted | |
| from VIA 27/VIA33 | ||
| (K132652). All units | ||
| passed acceptance | ||
| criteria per ISO594- | ||
| 1:1986 and ISO 594- | ||
| 2:1998. Substantially | ||
| equivalent to | ||
| predicate. | ||
| Visual and | ||
| Dimensional | This method measures inner diameter, outer diameter, catheter | |
| length, coated length, tip length, distance between marker bands, and | ||
| unbraided length. | All units passed | |
| acceptance criteria. | ||
| Substantially | ||
| equivalent to | ||
| predicate. | ||
| Catheter Torque | ||
| to Failure | This method measures how many complete rotations the catheter can | |
| withstand before breaking. The catheter is inserted through a | ||
| tortuous model inside a heated water bath. The distal end of the | ||
| catheter is secured in place and the proximal end is rotated until | ||
| failure. This test is performed in both clockwise and | ||
| counterclockwise directions. | Characterization only. | |
| Results comparable to | ||
| VIA 21. Substantially | ||
| equivalent to | ||
| predicate. |
Table 1. Non-Clinical Tests
6
7
Nonclinical testing demonstrated that the VIA™ 17 Microcatheter can perform as intended, and demonstrated substantial equivalence to the predicate devices: VIA 21 Microcatheter (K150894), VIA (VIA 27) and VIA PLUS (VIA 33) Microcatheters (K132652), and Headway 17 Advanced Microcatheter (K101542).
BIOCOMPATIBILITY AND CHEMICAL TESTING:
Biocompatibility and chemical testing was adopted from the testing performed on the VIA (VIA 27) Microcatheter. The full list of biocompatibility and chemical testing that was adopted can be found in Table 2 below:
Table 2. Biocompatibility and Chemical Testing
| Test | Applicable International
Standard | Result |
|----------------------------------------------|--------------------------------------|--------------------------------------|
| Materials Mediated Rabbit
Pyrogen Test | ISO10993-11:2006 | Non-pyrogenic - Pass |
| ISO Guinea Pig Maximization
Sensitization | ASTM F720-81 (2002) | Non-sensitization response -
Pass |
8
| Test | Applicable International
Standard | Result |
|----------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| ISO Acute Systemic Injection
Test | ISO10993-11:2006 | Non Toxic - Pass |
| ISO Intracutaneous Reactivity
Test | ISO10993-10:2010 | Non-irritant - Pass |
| Four Hour Thromboresistance
Evaluation in Dogs | ISO10993-4:2002 (2006) | Thromboresistance
characteristics of test group
similar to control - Pass |
| ASTM Hemolysis Assay Direct
Contact and Extract | ISO10993-4:2002 (2006)
ASTM F619-03
ASTM F756-08 | Non-hemolytic under direct and
extract test conditions - Pass |
| Complement Activation with
Comparison Article | ISO10993-4:2002 (2006) | Results of test group comparable
to control group - Pass |
| Partial Thromboplastin Time
with Comparison Article | ISO10993-4:2002 (2006)
ASTM F2382-04 | Results of test group comparable
to control group -both non-
activators of the intrinsic
coagulation pathway - Pass |
| Platelet and Leukocyte Counts
with Comparison Article | ISO10993-4:2002 (2006) | Results of test group comparable
to control group - Pass |
| ISO MEM Elution Assay with
L-929 Mouse Fibroblast | ISO10993-5:2009 | Non-toxic - Pass |
| Chemical Testing | | |
| Test | Applicable International
Standard | Result |
| Colorant Analysis Testing | 21 CFR 74.3045 (2012) | Elemental results meet
requirements of 21 CFR
74.3045 - Pass |
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
A technological comparison, as well as bench and simulated use testing demonstrate the substantial equivalence of the VIA™ 17 Microcatheter to the predicate devices. Table 3 below shows a summary of the VIA™ 17 technological characteristics as compared to the predicate devices.
9
Table 3. Substantial Equivalence Summary – Technological Characteristics
| Element | SUBJECT DEVICE
- VIATM 17
MICROCATHETER | VIATM 21
MICROCATHETER
(K150894) | VIATM (VIA 27) AND
VIATM PLUS (VIA 33)
MICROCATHETER
(K132652) | HEADWAY 17
ADVANCED
MICROCATHETER
(K101542) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Differences in Technological Characteristics | | | | |
| The subject and predicate devices are substantially equivalent with respect to design characteristics. The slight variations in
flexibility as well as differences in ID and OD are what differentiate these catheters. Each manufacturer optimizes these design
variations towards a more specific application (e.g. infusion of diagnostic and therapeutic agents) or for the introduction of specific
devices such as embolic agents, coils and stents. Devices are composed of similar materials, all of which have extensive clinical
history of safe use in medical devices | | | | |
| Design Features -
Equivalent ? | | | | |
| Materials | PTFE, Pebax, Vestamid,
Stainless Steel wire,
Polypropylene
Yes | PTFE, Pebax, Vestamid,
Stainless Steel wire,
Polypropylene
Yes | PTFE, Pebax, Vestamid,
Stainless Steel wire,
Polypropylene
Yes | PTFE, Pebax, Stainless
Steel wire, Nylon
Santoprene
Yes |
| Tip Shape | Straight tip configuration
and the physician has the
option to steam shape the
tip using the Shaping
Mandrel prior to use to
ensure proper adjustment
to the anatomy.
Yes | Straight tip
configuration and the
physician has the option
to steam shape the tip
using the Shaping
Mandrel prior to use to
ensure proper
adjustment to the
anatomy.
Yes | Straight tip configuration
and the physician has the
option to steam shape the
tip using the Shaping
Mandrel prior to use to
ensure proper adjustment
to the anatomy.
Yes | Straight tip
configuration and the
physician has the
option to steam shape
the tip prior to use to
ensure proper
adjustment to the
anatomy.
Yes |
| Element | SUBJECT DEVICE - VIATM 17
MICROCATHETER | VIATM 21
MICROCATHETER
(K150894) | VIATM (VIA 27) AND
VIATM PLUS (VIA 33)
MICROCATHETER
(K132652) | HEADWAY 17
ADVANCED
MICROCATHETER
(K101542) |
| Effective
Lengths | Via 17: 154 cm
Yes | Via 21: 154 cm
Yes | Via 27: 154 cm
Via 33: 133 cm
Yes | 150 cm
Yes |
| Proximal/Distal
OD | Via 17: Proximal
2.5F/Distal 2.2F
Yes | Via 21: Proximal
2.8F/Distal 2.5F
Yes | Via 27: Proximal
3.2F/Distal 3.0F
Via 33: Proximal 3.8
F/Distal 3.4F
Yes | Proximal OD: 2.4F
Distal OD: 1.7F
Yes |
| ID | Via 17: 0.0175 inch/1.3F
Yes | Via 21: 0.021 inch/1.6F
Yes | Via 27: 0.027 inch/2.1F
Via 33: 0.033 inch/2.5F
Yes | ID: 0.017 inch
Yes |
| Hydrophilic
Coating Length | Via 17: 100 cm
Yes | Via 21: 100 cm
Yes | Via 27: 100 cm
Via 33: 100 cm
Yes | 102 cm (measured)
Yes |
| Tip Length | 1mm
Yes | 1mm
Yes | 1mm
Yes | 0.64 mm (measured)
Yes |
| Distal Tip
Length | Via 17: 10cm
Yes | Via 21: 5cm
Yes | Via 27:10cm
Via 33: 5 cm
Yes | 11cm
Yes |
| Element | SUBJECT DEVICE - VIATM 17
MICROCATHETER | VIA TM 21
MICROCATHETER
(K150894) | VIATM (VIA 27) AND
VIA™ PLUS (VIA 33)
MICROCATHETER
(K132652) | HEADWAY 17
ADVANCED
MICROCATHETER
(K101542) |
| Tip Markers | 2 markers, 90%Pt-10%Ir
Yes | 1 marker, 90%Pt-10%Ir
Yes | 1 marker, 90%Pt-10%Ir
Yes | 2 markers, confirmed
to be radiopaque
Yes |
| Coating | Polyvinylpyrrolidone
Yes | Polyvinylpyrrolidone
Yes | Polyvinylpyrrolidone
Yes | Confirmed to be
lubricious
Yes |
| Method of
supply | Sterile, single-use, non-
pyrogenic
Yes | Sterile, single-use, non-
pyrogenic
Yes | Sterile, single-use, non-
pyrogenic
Yes | Sterile, single-use, non-
pyrogenic
Yes |
| Packaging | Primary package: Coiled
Hoop within a single
pouch
Secondary Package:
Chipboard unit carton
Yes | Primary package: Coiled
Hoop within a single
pouch
Secondary Package:
Chipboard unit carton
Yes | Primary package: Coiled
Hoop within a single
pouch
Secondary Package:
Chipboard unit carton
Yes | Primary package:
Coiled Hoop within a
single pouch
Secondary Package:
Chipboard unit carton
Yes |
| Sterilization | Ethylene Oxide
Sterilization
Yes | Ethylene Oxide
Sterilization
Yes | Ethylene Oxide
Sterilization
Yes | Ethylene Oxide
Sterilization
Yes |
| Element | SUBJECT DEVICE - VIATM 17
MICROCATHETER | VIATM 21
MICROCATHETER
(K150894) | VIATM (VIA 27) AND
VIATM PLUS (VIA 33)
MICROCATHETER
(K132652) | HEADWAY 17
ADVANCED
MICROCATHETER
(K101542) |
| Indication for Use - Equivalent ? | | | | |
| The Subject and
the comparison
devices maintain
similar indications | The VIA 17 Microcatheter
is intended for the
introduction of non-liquid
interventional devices
(such as coils/stents) and
infusion of diagnostic
agents (such as contrast
media) into the neuro,
peripheral, and coronary
vasculature.
Yes | The VIA Catheter is
intended for the
introduction of non-
liquid interventional
devices (such as
stents/flow diverters)
and infusion of
diagnostic (such as
contrast media) or non-
liquid therapeutic agents
into the neuro,
peripheral, and coronary
vasculature.
Yes | The VIA Catheter 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.
Yes | The Headway 21
Microcatheter is
intended to for general
intravascular use,
including the
peripheral, coronary
and neuro vasculature
for the infusion of
diagnostic agents, such
as contrast media, and
therapeutic agents, such
as occlusion coils.
Yes |
| Summary Statement of Substantial Equivalence | | | | |
| Use in a clinical setting was conducted in animals to show that no new risks were identified and that the safety and effectiveness
profile is similar to well-established comparison market-approved devices. Bench Testing was performed in models representing
the higher risk neurovascular anatomy which is the worst case representation of the cardiac and peripheral vascular anatomies. The | | | | |
10
11
12
the higher risk neurovascular anatomy, which is the worst case representation of the earther and peripheral vascular anato
VIA™ 17 Microcatheter has equivalent performance ch