(157 days)
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.
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 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.
The provided text describes the 510(k) summary for the VIA™ 17 Microcatheter, focusing on its substantial equivalence to previously cleared predicate devices rather than a standalone clinical study to prove the device meets acceptance criteria in the traditional sense of AI/ML performance.
The document details rigorous nonclinical tests (bench testing, sterilization validation, packaging and shelf-life assessment, biocompatibility assessment, and simulated use testing in animals) to demonstrate this substantial equivalence. It does not describe an AI/ML device, nor does it present "accuracy," "sensitivity," or "specificity" metrics typically used for such devices.
Therefore, many of the requested categories for AI/ML device studies (such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance metrics of an AI algorithm) are not applicable to this submission.
However, I can extract information related to the acceptance criteria and the results of the nonclinical tests performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Kink Resistance | Based on measured Headway 17 kink resistance. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Tip Buckling | Based on measured Headway 17 tip buckling. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Tracking Force | Identical to VIA 21 and VIA 27/33. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Steam Shaping and Shape Retention | Based on measured Headway 17 shape retention. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Microcatheter Tensile Strength | Per ISO 10555-1:2014. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Catheter Leakage and Static Burst | Identical to VIA 21 and VIA 27/33. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Retraction | Identical to VIA 21 and VIA 27/33. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Coating Friction and Coating Integrity | Identical to VIA 21 and VIA 27/33. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Coating Adherence/Particulate | Per USP 24 <788>. Identical to VIA 21 and VIA 27/33. | All units passed acceptance criteria. Substantially equivalent to predicate. |
| Flow Rate | Per ISO 10555-1:2014. | All units passed acceptance criteria. Flow rate was determined and documented in the instructions for use. Substantially equivalent to predicate. |
| Hub Performance | Per ISO 594-1:1986 and ISO 594-2:1998. | Test results adopted from VIA 27/VIA33 (K132652). All units passed acceptance criteria. Substantially equivalent to predicate. |
| Visual and Dimensional | Not explicitly stated as "acceptance criteria" but implied via "All units passed acceptance criteria." | 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 (various tests like Pyrogen, Sensitization, Systemic Injection, Intracutaneous Reactivity, Thromboresistance, Hemolysis, Complement Activation, Partial Thromboplastin Time, Platelet and Leukocyte Counts, MEM Elution Assay) | Applicable International Standards (e.g., ISO 10993-11:2006, ASTM F720-81 (2002), ISO 10993-10:2010, ISO 10993-4:2002 (2006), ASTM F619-03, ASTM F756-08, ASTM F2382-04, ISO 10993-5:2009). | All units passed acceptance criteria (e.g., Non-pyrogenic, Non-sensitization, Non-toxic, Non-irritant, Thromboresistance similar to control, Non-hemolytic, Comparable to control, Non-activators of coagulation pathway, Comparable to control). Pass. |
| Chemical Testing (Colorant Analysis) | 21 CFR 74.3045 (2012) | Elemental results meet requirements of 21 CFR 74.3045. Pass. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical bench test. It generally states "All units passed acceptance criteria" for each test, implying a sufficient number of units were tested to demonstrate compliance.
- Data Provenance: The tests are "bench testing," "simulated use testing in animals," "sterilization validation," "packaging and shelf-life assessment," and "biocompatibility assessment." This indicates lab-based, animal-based, and compliance-based testing rather than human clinical data. The country of origin for the data is not specified, but the applicant (Sequent Medical, Inc.) is based in Aliso Viejo, California, USA, suggesting the studies were conducted under US regulatory standards. The data is prospective for these tests, as they are performed specifically to evaluate the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable as the studies are non-clinical, bench, and animal tests. "Ground truth" in this context refers to the defined physical, mechanical, chemical, and biological properties measured and compared against established standards or predicate device performance, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable for non-clinical, bench testing, and animal studies.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable. The device is a microcatheter, not an AI/ML diagnostic tool that would involve human readers interpreting medical cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is based on:
- Defined physical and mechanical properties: Measured values (e.g., kink diameter, buckling force, tensile strength, flow rate, dimensions).
- Compliance with international standards: (e.g., ISO 10555-1:2014, ISO 594-1:1986, ISO 594-2:1998, USP 24 <788>).
- Comparison to predicate device performance: The performance of the VIA™ 17 Microcatheter was specifically compared to established performance characteristics of the VIA™ 21 Microcatheter (K150894), VIA™ and VIA™ PLUS Microcatheters (K132652), and Headway 17 Advanced Microcatheter (K101542).
- Biological responses: For biocompatibility, "ground truth" is typically defined by the absence of adverse biological reactions as per ISO 10993 series and other relevant standards.
- Simulated use in animals: This provides physiological "ground truth" for how the device performs in a living system without causing new risks.
8. The sample size for the training set
- This is not applicable as the device is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- This is not applicable as the device is not an AI/ML algorithm.
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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.
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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
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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) |
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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 ColumbiaAliso Viejo, CA 92656Tel: (949) 830-9600Fax: (949) 830-9658 |
| OFFICIALCORRESPONDENT | Bethany Barrett11A ColumbiaAliso Viejo, CA 92656bethanyb@sequentmedical.comTel: (949) 830-9600 x 113Fax: (949) 830-9568 |
| TRADE NAME | VIA™ 17 Microcatheter |
| COMMON NAME | Percutaneous Catheter, Continuous Flush Catheter |
| DEVICECLASSIFICATION | Class II, 21 CFR §870.1250, §870.1210 |
| PRODUCT CODES | DQY: Percutaneous CatheterKRA: Continuous Flush Catheter |
| PREDICATEDEVICES | 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
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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 ●
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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 sectionsand junctions will kink. Each catheter section is inserted into anautomated test fixture and kinked. The kink diameter is thencalculated based on shaft displacement at peak force. | All units passedacceptance criteria.Acceptance criteriabased on measuredHeadway 17 kinkresistance.Substantiallyequivalent topredicate. |
| Tip Buckling | This method measures the catheter tip buckling force by pushing thecatheter tip into a load cell until it buckles. The peak force ismeasured and recorded. | All units passedacceptance criteria.Acceptance criteriabased on measuredHeadway 17 tipbuckling. Substantiallyequivalent topredicate. |
| Tracking Force | This method tests the force required to pass interventional devicesthrough the VIA catheter. Each VIA is inserted into a trackingfixture and the hard model tortuosity fixture. The interventionaldevice is pushed through the tortuosity fixture and VIA catheter. Thepeak force required to push the device through the VIA is recorded. | All units passedacceptance criteria.Acceptance criteriaidentical to VIA 21and VIA 27/33.Substantiallyequivalent topredicate. |
| Test | Test Method Summary | Result |
| Steam Shapingand ShapeRetention | This method measures the ability of the VIA to be steam shapedusing a shaping mandrel and the ability of the VIA to hold the shapeduring use. The VIA is shaped per the VIA IFU shaping instructions.The tip angle is measured and must fall within the documentedspecification. The VIA is then subjected to simulated use through aguide catheter in 37° water. After guidewire insertion for a specifiedtime, the tip angle is measured again and shape retention is evaluatedper the specification. | All units passedacceptance criteria.Acceptance criteriabased on measuredHeadway 17 shaperetention.Substantiallyequivalent topredicate. |
| MicrocatheterTensile Strength | This method tests the tensile strength of the microcatheter shaftsections (each joint/transition tested individually). This methodaligns with the method described in ISO 10555-1:2014. | All units passedacceptance criteria perISO10555-1:2014.Substantiallyequivalent topredicate. |
| CatheterLeakage andStatic Burst | This method measures the leakage and static burst pressure of theVIA. This method aligns with the method described in ISO 10555-1:2014. | All units passedacceptance criteria.Acceptance criteriaidentical to VIA 21and VIA 27/33.Substantiallyequivalent topredicate. |
| Retraction | This method measures the distance that the VIA catheter pulls backduring interventional device recapture. This test is performed in asimulated use model. The guide catheter and VIA Microcatheter areinserted into the fixture. A worst case interventional device isdeployed through the VIA and recaptured. The displacement of thecatheter in the fixture is measured and recorded. | All units passedacceptance criteria.Acceptance criteriaidentical to VIA 21and VIA 27/33.Substantiallyequivalent topredicate. |
| Coating Frictionand CoatingIntegrity | Measures the catheter coating friction/lubricity over multiple frictiontest cycles using an automated friction tester.Coating integrity uses dye to test that coating remains adhered tocatheter after simulated use through a tortuous model. | All units passedacceptance criteria.Acceptance criteriaidentical to VIA 21and VIA27/33.Substantiallyequivalent topredicate. |
| CoatingAdherence/Particulate | This method measures the particulate generated during simulatednavigation and adjunct device delivery. The VIA is cycled throughthe tracking fixture and the hard model tortuosity fixture. A worstcase interventional device is then cycled through the inner diameter(ID) of the VIA while inside the tortuosity fixture. Both the ID of thefixture and the ID of the VIA are flushed with particulate free waterand the collected fluid is tested for particulate using the lightobscuration method. | All units passedacceptance criteria perUSP24 <788>.Acceptance criteriaidentical to VIA 21and VIA27/33.Substantiallyequivalent topredicate. |
| Flow Rate | This method measures the flow rate through the VIA by pushingfluid through the catheter at a constant rate while pressure is beingmonitored. | All units passedacceptance criteria perISO10555-1:2014.Flow rate was |
| Test | Test Method Summary | Result |
| determined anddocumented in theinstructions for use.Substantiallyequivalent topredicate. | ||
| HubPerformance | This method tests hub liquid and air leakage, as well as that the hubcan withstand adequate forces. Tests that the hub meets generalrequirements for conical fittings. Methods used are per ISO594-1:1986 and ISO 594-2:1998. | Test results adoptedfrom VIA 27/VIA33(K132652). All unitspassed acceptancecriteria per ISO594-1:1986 and ISO 594-2:1998. Substantiallyequivalent topredicate. |
| Visual andDimensional | This method measures inner diameter, outer diameter, catheterlength, coated length, tip length, distance between marker bands, andunbraided length. | All units passedacceptance criteria.Substantiallyequivalent topredicate. |
| Catheter Torqueto Failure | This method measures how many complete rotations the catheter canwithstand before breaking. The catheter is inserted through atortuous model inside a heated water bath. The distal end of thecatheter is secured in place and the proximal end is rotated untilfailure. This test is performed in both clockwise andcounterclockwise directions. | Characterization only.Results comparable toVIA 21. Substantiallyequivalent topredicate. |
Table 1. Non-Clinical Tests
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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 InternationalStandard | Result |
|---|---|---|
| Materials Mediated RabbitPyrogen Test | ISO10993-11:2006 | Non-pyrogenic - Pass |
| ISO Guinea Pig MaximizationSensitization | ASTM F720-81 (2002) | Non-sensitization response -Pass |
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| Test | Applicable InternationalStandard | Result |
|---|---|---|
| ISO Acute Systemic InjectionTest | ISO10993-11:2006 | Non Toxic - Pass |
| ISO Intracutaneous ReactivityTest | ISO10993-10:2010 | Non-irritant - Pass |
| Four Hour ThromboresistanceEvaluation in Dogs | ISO10993-4:2002 (2006) | Thromboresistancecharacteristics of test groupsimilar to control - Pass |
| ASTM Hemolysis Assay DirectContact and Extract | ISO10993-4:2002 (2006)ASTM F619-03ASTM F756-08 | Non-hemolytic under direct andextract test conditions - Pass |
| Complement Activation withComparison Article | ISO10993-4:2002 (2006) | Results of test group comparableto control group - Pass |
| Partial Thromboplastin Timewith Comparison Article | ISO10993-4:2002 (2006)ASTM F2382-04 | Results of test group comparableto control group -both non-activators of the intrinsiccoagulation pathway - Pass |
| Platelet and Leukocyte Countswith Comparison Article | ISO10993-4:2002 (2006) | Results of test group comparableto control group - Pass |
| ISO MEM Elution Assay withL-929 Mouse Fibroblast | ISO10993-5:2009 | Non-toxic - Pass |
| Chemical Testing | ||
| Test | Applicable InternationalStandard | Result |
| Colorant Analysis Testing | 21 CFR 74.3045 (2012) | Elemental results meetrequirements of 21 CFR74.3045 - 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.
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Table 3. Substantial Equivalence Summary – Technological Characteristics
| Element | SUBJECT DEVICE- VIATM 17MICROCATHETER | VIATM 21MICROCATHETER(K150894) | VIATM (VIA 27) ANDVIATM PLUS (VIA 33)MICROCATHETER(K132652) | HEADWAY 17ADVANCEDMICROCATHETER(K101542) |
|---|---|---|---|---|
| Summary of Differences in Technological Characteristics | ||||
| The subject and predicate devices are substantially equivalent with respect to design characteristics. The slight variations inflexibility as well as differences in ID and OD are what differentiate these catheters. Each manufacturer optimizes these designvariations towards a more specific application (e.g. infusion of diagnostic and therapeutic agents) or for the introduction of specificdevices such as embolic agents, coils and stents. Devices are composed of similar materials, all of which have extensive clinicalhistory of safe use in medical devices | ||||
| Design Features -Equivalent ? | ||||
| Materials | PTFE, Pebax, Vestamid,Stainless Steel wire,PolypropyleneYes | PTFE, Pebax, Vestamid,Stainless Steel wire,PolypropyleneYes | PTFE, Pebax, Vestamid,Stainless Steel wire,PolypropyleneYes | PTFE, Pebax, StainlessSteel wire, NylonSantopreneYes |
| Tip Shape | Straight tip configurationand the physician has theoption to steam shape thetip using the ShapingMandrel prior to use toensure proper adjustmentto the anatomy.Yes | Straight tipconfiguration and thephysician has the optionto steam shape the tipusing the ShapingMandrel prior to use toensure properadjustment to theanatomy.Yes | Straight tip configurationand the physician has theoption to steam shape thetip using the ShapingMandrel prior to use toensure proper adjustmentto the anatomy.Yes | Straight tipconfiguration and thephysician has theoption to steam shapethe tip prior to use toensure properadjustment to theanatomy.Yes |
| Element | SUBJECT DEVICE- VIATM 17MICROCATHETER | VIATM 21MICROCATHETER(K150894) | VIATM (VIA 27) ANDVIATM PLUS (VIA 33)MICROCATHETER(K132652) | HEADWAY 17ADVANCEDMICROCATHETER(K101542) |
| EffectiveLengths | Via 17: 154 cmYes | Via 21: 154 cmYes | Via 27: 154 cmVia 33: 133 cmYes | 150 cmYes |
| Proximal/DistalOD | Via 17: Proximal2.5F/Distal 2.2FYes | Via 21: Proximal2.8F/Distal 2.5FYes | Via 27: Proximal3.2F/Distal 3.0FVia 33: Proximal 3.8F/Distal 3.4FYes | Proximal OD: 2.4FDistal OD: 1.7FYes |
| ID | Via 17: 0.0175 inch/1.3FYes | Via 21: 0.021 inch/1.6FYes | Via 27: 0.027 inch/2.1FVia 33: 0.033 inch/2.5FYes | ID: 0.017 inchYes |
| HydrophilicCoating Length | Via 17: 100 cmYes | Via 21: 100 cmYes | Via 27: 100 cmVia 33: 100 cmYes | 102 cm (measured)Yes |
| Tip Length | 1mmYes | 1mmYes | 1mmYes | 0.64 mm (measured)Yes |
| Distal TipLength | Via 17: 10cmYes | Via 21: 5cmYes | Via 27:10cmVia 33: 5 cmYes | 11cmYes |
| Element | SUBJECT DEVICE- VIATM 17MICROCATHETER | VIA TM 21MICROCATHETER(K150894) | VIATM (VIA 27) ANDVIA™ PLUS (VIA 33)MICROCATHETER(K132652) | HEADWAY 17ADVANCEDMICROCATHETER(K101542) |
| Tip Markers | 2 markers, 90%Pt-10%IrYes | 1 marker, 90%Pt-10%IrYes | 1 marker, 90%Pt-10%IrYes | 2 markers, confirmedto be radiopaqueYes |
| Coating | PolyvinylpyrrolidoneYes | PolyvinylpyrrolidoneYes | PolyvinylpyrrolidoneYes | Confirmed to belubriciousYes |
| Method ofsupply | Sterile, single-use, non-pyrogenicYes | Sterile, single-use, non-pyrogenicYes | Sterile, single-use, non-pyrogenicYes | Sterile, single-use, non-pyrogenicYes |
| Packaging | Primary package: CoiledHoop within a singlepouchSecondary Package:Chipboard unit cartonYes | Primary package: CoiledHoop within a singlepouchSecondary Package:Chipboard unit cartonYes | Primary package: CoiledHoop within a singlepouchSecondary Package:Chipboard unit cartonYes | Primary package:Coiled Hoop within asingle pouchSecondary Package:Chipboard unit cartonYes |
| Sterilization | Ethylene OxideSterilizationYes | Ethylene OxideSterilizationYes | Ethylene OxideSterilizationYes | Ethylene OxideSterilizationYes |
| Element | SUBJECT DEVICE- VIATM 17MICROCATHETER | VIATM 21MICROCATHETER(K150894) | VIATM (VIA 27) ANDVIATM PLUS (VIA 33)MICROCATHETER(K132652) | HEADWAY 17ADVANCEDMICROCATHETER(K101542) |
| Indication for Use- Equivalent ? | ||||
| The Subject andthe comparisondevices maintainsimilar indications | The VIA 17 Microcatheteris intended for theintroduction of non-liquidinterventional devices(such as coils/stents) andinfusion of diagnosticagents (such as contrastmedia) into the neuro,peripheral, and coronaryvasculature.Yes | The VIA Catheter isintended for theintroduction of non-liquid interventionaldevices (such asstents/flow diverters)and infusion ofdiagnostic (such ascontrast media) or non-liquid therapeutic agentsinto the neuro,peripheral, and coronaryvasculature.Yes | The VIA Catheter isintended for theintroduction of non-liquidinterventional devices(such as stents/flowdiverters) and infusion ofdiagnostic (such ascontrast media) ortherapeutic agents into theneuro, peripheral, andcoronary vasculature.Yes | The Headway 21Microcatheter isintended to for generalintravascular use,including theperipheral, coronaryand neuro vasculaturefor the infusion ofdiagnostic agents, suchas contrast media, andtherapeutic agents, suchas 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 effectivenessprofile is similar to well-established comparison market-approved devices. Bench Testing was performed in models representingthe higher risk neurovascular anatomy which is the worst case representation of the cardiac and peripheral vascular anatomies. The |
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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
§ 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).