(139 days)
No
The summary describes a physical microcatheter used for delivering devices and agents, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is described as a microcatheter intended for the introduction of interventional devices and infusion of diagnostic agents. It is an access tool rather than a device that directly provides therapy or treatment.
No
The device is a microcatheter intended for the introduction of interventional devices and infusion of diagnostic agents. It is a delivery tool, not a device that itself diagnoses a condition.
No
The device description clearly describes a physical catheter with a lumen, radiopaque marker bands, and a luer adapter, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The VIA® Microcatheter is an invasive device used to introduce other interventional devices and diagnostic agents directly into the vasculature of the human body. It is used in vivo (within the living organism), not in vitro (outside the living organism).
- Intended Use: The intended use clearly describes the introduction of devices and agents into the neuro, peripheral, and coronary vasculature. This is a procedural function, not a diagnostic test performed on a specimen.
Therefore, the VIA® Microcatheter falls under the category of an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
VIA 21, 27, 33 - The VIA® Microcatheter is intended for the introduction of interventional devices (such as the WEB device/stents/flow diverters) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral, and coronary vasculature.
VIA 17, 17 Preshaped 45°, 17 Preshaped 90° - The VIA® Microcatheter is intended for the introduction of interventional devices (such as coils/stents) and infusion of diagnostic agents (such as contrast media) 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 is a single lumen catheter designed to be introduced over a steerable 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 radiopaque marker bands using fluoroscopic techniques (VIA17 Microcatheter has 2 radiopaque marker bands. VIA 21, 27 and 33 Microcatheters have one radiopaque tip marker band). Diagnostic and interventional devices can be delivered through the lumen of the catheter to the treatment site. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories.
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)
Biocompatibility testing:
- Cytotoxicity: Non-cytotoxic
- Sensitization: Non-sensitizing
- Irritation/Intracutaneous Toxicity: Non-irritant
- Acute Systemic Toxicity: Systemically non-toxic
- Material-Mediated Pyrogenicity: Non-pyrogenic
- Hemocompatibility (ASTM Hemolysis Assay – Direct Contact and Indirect Contact): Non-hemolytic
- Hemocompatibility (Partial Thromboplastin Time (PTT) with Sponsor-Supplied Comparison Article): No adverse effect on Unactivated Partial Thromboplastin Time of human plasma.
- Hemocompatibility (ISO Complement Activation C3a and SC5b-9 Assay with Sponsor-Supplied Comparison Article): C3a and SC5b-9 complement proteins were considered to be non-activated as compared to the comparison article.
- Hemocompatibility (Platelet and Leukocyte Counts with Sponsor-Supplied Comparison Article): Platelet count for the test article exposed blood are not statistically significantly different as compared to reference control or comparison article.
- Hemocompatibility (Thromboresistance Evaluation): Non-thrombogenic
- Genotoxicity (ISO Bacterial Mutagenicity Test - Ames Assay): Non-mutagenic
- Genotoxicity (ISO In Vitro Mouse Lymphoma with Extended Treatment): Non-mutagenic and non-clastogenic
Bench testing:
- Visual and Dimensional Inspection: Pass
- Hub ISO 80369-7: Pass
- WEB Retraction: Pass
- Kink Resistance: Pass
- Tensile: Pass
- Tip Buckling: Pass
- Steam Shaping / Shape Retention: Pass
- Catheter Leakage and Static Burst: Pass
- Coating Friction & Durability: Pass
- Coating Particulate: Pass
- Coating Integrity: For characterization only.
- Catheter Torque Strength: For characterization only.
- Tracking Force: Pass
- Flow Rate: For characterization only.
- Dead Space: For characterization only.
Animal Study: No animal study was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K101542, K110813, K110741, K121785
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).
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Image /page/0/Picture/0 description: The image contains 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 with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
December 24, 2019
MicroVention, Inc. Sapna Singh Associate Director, Regulatory Affairs 35 Enterprise Aliso Viejo, California 92656
Re: K192135
Trade/Device Name: VIA® Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: November 22, 2019 Received: November 25, 2019
Dear Sapna Singh:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (OS) 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 mediation-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,
Xiaolin Zheng, Ph.D., M.S. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192135
Device Name VIA® Microcatheter
Indications for Use (Describe)
VIA 21, 27, 33 - The VIA® Microcatheter is intended for the introduction of interventional devices (such as the WEB device/stents/flow diverters) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral, and coronary vasculature.
VIA 17, 17 Preshaped 45°, 17 Preshaped 90° - The VIA® Microcatheter is intended for the introduction of 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
I. SUBMITTER
MicroVention Inc. 35 Enterprise, Aliso Viejo, CA 92656 Phone: 714-247-8162 Fax: 714-439-1044 Contact Person: Sapna Singh Date Prepared: November 22, 2019
II. DEVICE
| Name of Device | VIA® Microcatheter |
|---|---|
| Common Name | Catheter, Percutaneous |
| Classification Name | Percutaneous Catheter (21 CFR 870.1250) |
| Continuous Flush Catheter (21 CFR 870.1210) | |
| Regulatory Class | Class II |
| Classification Product Code | DQY |
| Subsequent Product Code | KRA |
III. PREDICATE DEVICE
VIA® Microcatheter (K150894, K132652, K162565) manufactured by Sequent Medical Inc. (SMI).
IV. REFERENCE DEVICE
Headway Microcatheter (K101542, K110813) manufactured by MicroVention Inc. (MVI) Scepter C Balloon Catheter (K110741, K121785) manufactured by MicroVention Inc. (MVI)
V. DEVICE DESCRIPTON
The VIA® Microcatheter is a single lumen catheter designed to be introduced over a steerable 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 radiopaque marker bands using fluoroscopic techniques (VIA17 Microcatheter has 2 radiopaque marker bands. VIA 21, 27 and 33 Microcatheters have one radiopaque tip marker band). Diagnostic and interventional devices can be delivered through the
4
lumen of the catheter to the treatment site. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories.
VI. INDICATION FOR USE
VIA 21, 27, 33 - The VIA® Microcatheter is intended for the introduction of interventional devices (such as the WEB device/stents/flow diverters) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral, and coronary vasculature.
VIA 17, 17 Preshaped 45°, 17 Preshaped 90° - The VIA® Microcatheter is intended for the introduction of interventional devices (such as coils/stents) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral, and coronary vasculature.
| Headway Microcatheter | SMI VIA Microcatheter | MVI VIA
Microcatheter | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|
| Reference Device | Predicate Device | Subject Device | | |
| Headway 17 Advanced
(K101542) Headway 27
(K110813) | VIA17 (K162565) VIA21
(K150894) VIA27 & 33
(K132652) | | | |
| Intended Use The Headway Microcatheter
is intended 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. | VIA21, 27, 33: The VIA
Catheter is intended for
the introduction of
nonliquid 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. | VIA 21, 27, 33 - The
VIA® Microcatheter is
intended for the
introduction of
interventional devices
(such as the WEB
device/stents/flow
diverters) and infusion of
diagnostic agents (such
as contrast media) into
the neuro, peripheral, and
coronary vasculature. | | |
| | The VIA 17 Microcatheter
is intended for the
introduction of non-liquid
interventional devices
(such as coils/stents) and
infusion of diagnostic agents | VIA 17, 17 Preshaped
45°, 17 Preshaped 90° -
The VIA® Microcatheter
is intended for the
introduction of
interventional devices
(such as coils/stents) and | | |
| | infusion of diagnostic
agents (such as contrast
media) neuro, peripheral,
and coronary vasculature. | (such as coils/stents)
and infusion of
diagnostic agents (such
as contrast media) into
the neuro, peripheral,
and coronary
vasculature. | | |
| Device
Classification | Class II DQY
21 CFR 870.1250
21 CFR 870.1210 | Class II DQY, KRA
21 CFR 870.1250
21 CFR 870.1210 | Class II DQY, KRA
21 CFR 870.1250
21 CFR 870.1210 | |
| Catheter
Body | Outer layer of Pebax and
Grilamid; inner layer PTFE.
Between outer and inner
layer is stainless steel coil. | Outer layer of Pebax and
Vestamid; inner layer
PTFE. Between outer and
inner layer is stainless
steel braid and coil. | Same as SMI VIA
Microcatheters | |
| Marker | Platinum/Iridium | Platinum/Iridium | Same as SMI VIA
Microcatheters | |
| Hub | Nylon | Polypropylene | Same as SMI VIA
Microcatheters | |
| Strain Relief | Pebax | Polyolefin | Same as SMI VIA
Microcatheters | |
| Introducer | Pebax | Pebax | Same as Headway
Microcatheters | |
| Shaping
Mandrel | Stainless steel | Stainless steel | Same as Headway
Microcatheters | |
| Catheter size
(OD Distal) | Headway 17 Advanced:
0.022"
Headway 27: 0.034" | VIA17: 2.2F (0.029")
VIA21: 2.5F (0.033")
VIA27: 3.0F (0.039")
VIA33: 3.4F (0.045") | Same as SMI VIA
Microcatheters | |
| ID | | | | |
| | Headway 17 Advanced:
0.017"
Headway 27: 0.027" | VIA17: 0.0175"
VIA21: 0.021"
VIA27: 0.027"
VIA33: 0.033" | Same as SMI VIA
Microcatheters | |
| | | OD Proximal Headway 17 Advanced:
0.031"
Headway 21: 0.040" | VIA17: 0.032"
VIA21: 0.036"
VIA27: 0.042"
VIA33: 0.050" | Same as SMI VIA
Microcatheters |
| | | Effective
Length | 150 cm | VIA17: 154 cm
VIA21: 154 cm
VIA27: 154 cm
VIA33: 133 cm |
| Coating | | Hydronic Acid (Hydrophilic
Coating) - 100cm | Polyvinylpyrrolidone
(Hydrophilic Coating) -
100 cm | Same as Headway
Microcatheters – 100 cm |
| Tip
Configuration | Headway 17 Advanced:
Straight & Preshaped
Headway 21: Straight | Straight | VIA17: Straight &
Preshaped
VIA21, 27, 33: Straight | |
| Guidewire
Compatibility | Headway 17 Advanced:
0.014" OD or smaller
Headway 21: 0.018" OD or
smaller | VIA17: 0.014" OD or
smaller
VIA21, 27, 33: 0.018" OD
or smaller | Same as SMI VIA
Microcatheters | |
| Accessories | Introducer sheath and shaping
mandrel | Shaping mandrel | Same as Headway
Microcatheters | |
| Method of
Supply | Sterile and single use | Sterile and single use | Same as SMI VIA &
Headway Microcatheters | |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same as SMI VIA &
Headway Microcatheters | |
| Packaging
Configuration | Catheter placed into a HDPE dispenser coil. Introducers sheath and shaping mandrel placed on a polyethylene packaging card that is attached to the dispenser coil. Dispenser coil is inserted into a Tyvek® pouch. Pouch and IFU placed in bleached sulfate carton box. | Catheter placed into a HDPE dispenser coil. Shaping mandrel placed on a polyethylene packaging card that is attached to the dispenser coil. Dispenser coil is inserted into a Tyvek® pouch. Pouch and IFU placed in bleached sulfate carton box. | Same as Headway
Microcatheters | |
VII. TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE
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PERFORMANCE DATA VIII.
Biocompatibility testing
Biocompatibility evaluation for the VIA® Microcatheter was conducted in accordance with "Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The microcatheter is considered a limited (. | Pass |
| Coating Integrity | Coating integrity uses dye to test that coating remains
adhered to catheter after simulated use through a
tortuous model. | For
characterization
only. |
| Catheter Torque
Strength | The method measures how many complete rotations the
catheter can withstand before breaking. | For
characterization
only. |
| Tracking Force | The method tests the force required to pass
interventional devices through the VIA catheter. | Pass |
| Flow Rate | The method measures the flow rate through the VIA by
pushing fluid through the catheter at a constant rate
while pressure is being monitored. | For
characterization
only. |
| Dead Space | The non-hydrated VIA is attached to a syringe pump
and slowly filled with controlled amounts of distilled
water. Once water is observed to be exiting the raised
tip of the catheter, the volume of liquid dispensed is
recorded. | For
characterization
only |
Animal Study
No animal study was conducted.
CONCLUSION IX.
The VIA® Microcatheter is substantially equivalent to the identified predicate regarding performance, intended use, design, materials, principle of operation and overall technological characteristics. The nonclinical data supports the substantial equivalence of the subject device and the verification and validation testing demonstrate that the subject device should perform as intended when used as instructed in the instructions for use.