(148 days)
The VIA™ 21 Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or non-liquid therapeutic agents into the neuro, peripheral, and coronary vasculature.
The VIA™ 21 Microcatheter is 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 physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Diagnostic, therapeutic and interventional devices can be delivered through the lumen of the catheter to the treatment site.
The VIATM 21 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 an intraluminal flow diverter.
The VIA™ 21 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.021 inches.
The VIA™ 21 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic.
Accessories: Each VIA™ 21 Microcatheter is provided with a shaping mandrel 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 intraluminal flow diverters, infusion of diagnostic agents such as contrast and infusion of therapeutic agents.
The provided document describes the VIA™ 21 Microcatheter and its non-clinical performance data to demonstrate substantial equivalence to predicate devices, rather than a study proving a device meets specific acceptance criteria for an AI/ML algorithm.
Therefore, many of the requested categories for AI/ML performance evaluation are not applicable to this document. The document focuses on the physical and functional characteristics of a medical device (a microcatheter).
However, I can extract the acceptance criteria and performance data for the device itself based on the provided text.
Here's the information derived from the document, with "N/A" for sections not relevant to this type of device and study:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criterion (Test) | Methodology | Reported Device Performance (Result & Conclusion) |
|---|---|---|
| Visual and Dimensional | Tests conformance to specified microcatheter dimensions and visual criteria. (ISO 10555-1:2013, TM036) | Met performance specifications per DTM003. Complete conformance to standard. |
| Kink Resistance | Measures diameter at which microcatheter shaft sections and junctions will kink. (BS EN 13868:2002, TM035) | Met performance specifications per DTM003. Conformance to standard with the following deviations: Kink diameter determined based on mechanical kink (drop in compressive force) instead of 50% reduction in water flow. This method is appropriate as the Via 21 is primarily used to deliver non-liquid devices. |
| Tip Buckling | Tests force required for tip to buckle. (TM034) | Met performance specifications per DTM003. Complete conformance to Sequent TM. |
| Tracking Force | Tests force required to advance an interventional device through the microcatheter lumen. (TM032) | Met performance specifications per DTM003. Complete conformance to Sequent TM. |
| Steam Shaping and Shape Retention | Tests that microcatheter can be steam shaped to a clinically relevant angle and can maintain a minimum % of the initial angle after simulated use. (TM038) | Met performance specifications per DTM003. Complete conformance to Sequent TM. |
| Shaft Tensile | Measures the ultimate tensile strength of all Pebax and Vestamid junctions along the length of the catheter shaft. (ISO 10555-1:2013, TM031) | Met performance specifications per DTM003. Complete conformance to standard. |
| Hub-Shaft Tensile | Measures the ultimate tensile strength of the hub to shaft junction. (ISO 10555-1:2013, TM031) | Met performance specifications per DTM003. Complete conformance to standard. |
| Burst | Measures peak pressure before microcatheter burst/liquid leakage. (ISO 10555-1:2013, TM037) | Met performance specifications per DTM003. Complete conformance to standard. |
| Coating Friction and Coating Integrity | Measures the average peak coating friction/lubricity. Coating integrity uses dye to test that coating remains adhered to catheter after simulated use. (Harland Medical Systems Coating Friction and Dye Test Methods, FDA Guidance Document, Class II Special Controls for PTCA Catheters (section 12) (Issued 2010)) | Met performance specifications per DTM003. Complete conformance to Harland test methods. In line with FDA guidance document on coating integrity. |
| Coating Adherence/Particulate | Measures particulate generated from the hydrophilic coating on exterior of microcatheter, as well as particulate generated from advancing an interventional device through the inner lumen of the microcatheter. (TM042, FDA Guidance Documents) | Met performance specifications per DTM003. Complete conformance to Sequent TM. In line with FDA guidance documents on particulate testing. |
| Flow Rate | Measures flow rates through the microcatheter at defined injection rates using saline and contrast. (ISO 10555-1:2013) | Met performance specifications per DTM003. Complete conformance to standard. |
| Hub Performance | Tests hub liquid and air leakage, as well as that the hub can withstand adequate forces. Tests that the hub meets general requirements for conical fittings. (ISO 594-1:1986, ISO 594-2:1998, TM043) | Test results adopted from VIA 27/VIA33 (K132652). Conformance to standard with the following deviations: Used an alternative ISO 594-2:1998 fitting to test hubs for Separation Force and Unscrewing Torque. The fitting used was measured to have a minor diameter greater than called for in the standard. This was deemed as worst case for these tests, therefore acceptable to use. Only short term stress cracking was inspected for on hubs. ISO 594-2:1998 calls for inspection after 48 hours. Intended use of Via 21 microcatheter only requires RHV or syringes to be connected for short durations during delivery of implant, therefore long term testing is not applicable. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state sample sizes for each bench test, but refers to "Simulated Use Testing in Animals" with results summarized as "no new risks were identified and that the safety and effectiveness profile is similar to well-established comparison market-approved devices." This suggests animal testing was performed. The provenance is likely prospective as part of the device development and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical device, and the testing involves engineering and materials science principles, not expert interpretation of outputs like in an AI/ML system.
4. Adjudication method for the test set
N/A. Not applicable to engineering bench testing.
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
N/A. This is a physical medical device, not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for most of these tests relies on established engineering standards (ISO, ASTM, BS EN) and internal Sequent Test Methods (TM), which define acceptable physical, mechanical, and functional properties of catheters. For the biocompatibility testing, accepted biological endpoints (e.g., non-pyrogenic, non-toxic, non-hemolytic) serve as the ground truth.
8. The sample size for the training set
N/A. This is a physical medical device. There is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
N/A. This is a physical medical device.
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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 features the department's name encircling a stylized symbol. The symbol consists of a triple-profile silhouette of a human head, with flowing lines suggesting movement or progress. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2015
Sequent Medical, Inc Ms. Bethany Barrett Regulatory/Clinical Project Manager 11A Columbia Aliso Viejo, California 92656
Re: K150894
Trade/Device Name: VIA™ 21 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: July 27, 2015 Received: July 29, 2015
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
{1}------------------------------------------------
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of 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 yours,
Carlos L. Pena - SD/A
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) K150894
Device Name VIA™ 21 Microcatheter
Indications for Use (Describe)
The VIA™ 21 Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or non-liquid therapeutic agents into the neuro, peripheral, and coronary vasculature.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 | 4/1/2015 |
|---|---|
| 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™ 21 Microcatheter |
| COMMON NAME | Continuous Flush Catheter |
| DEVICECLASSIFICATION | Class II, 21 CFR §870.1250, 21 CFR §870.1210 |
| PRODUCT CODES | DQY: Percutaneous CatheterKRA: Continuous Flush Catheter |
| PREDICATEDEVICES | VIA™ (VIA 27) and VIA™ PLUS (VIA 33)Microcatheters (K132652)Headway 21 Microcatheter (K093160)Orion Microcatheter (K113289) |
| PRIOR SUBMISSION | This is an original submission. There has been no priorsubmission for the subject device. |
SUBSTANTIALLY EQUIVALENT TO:
The VIA™ 21 Microcatheter is substantially equivalent to the previously cleared VIATM (VIA 27) and VIA™ PLUS (VIA 33) Microcatheters (K132652), Headway 21 Microcatheter (K093160) and Orion Microcatheter (K113289).
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The VIA™ 21 Microcatheter is 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
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manipulation while in the vasculature. Throughout the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Diagnostic, therapeutic and interventional devices can be delivered through the lumen of the catheter to the treatment site.
The VIATM 21 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 an intraluminal flow diverter.
The VIA™ 21 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.021 inches.
The VIA™ 21 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic.
Accessories: Each VIA™ 21 Microcatheter is provided with a shaping mandrel 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 intraluminal flow diverters, infusion of diagnostic agents such as contrast and infusion of therapeutic agents.
INDICATIONS FOR USE:
The VIA™ 21 Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or non-liquid therapeutic agents into the neuro, peripheral and coronary vasculature.
TECHNICAL CHARACTERISTICS:
The VIA™ 21 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.
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PERFORMANCE DATA:
Device performance testing confirms that the VIA™ 21 Microcatheter can be used according to its intended use. The VIA™ 21 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, infusion of diagnostic and non-liquid therapeutic 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. VIA™ (VIA 27) and VIATM PLUS (VIA 33) Microcatheters (K132652), Headway 21 Microcatheter (K093160) and Orion Microcatheter (K113289).
NONCLINICAL TESTS DISCUSSION:
The nonclinical tests included:
- Physical characteristics unique to the VIA™ 21 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 | Methodology | ApplicableInternationalStandard and/orSequent TestMethod (TM) | Result | Conclusion |
|---|---|---|---|---|
| Visual and Dimensional | Tests conformance tospecified microcatheterdimensions and visualcriteria. | ISO 10555-1:2013TM036 | Met performancespecificationsper DTM003 | Completeconformance tostandard |
| Test | Methodology | ApplicableInternationalStandard and/orSequent TestMethod (TM) | Result | Conclusion |
| Kink Resistance | Measures diameter atwhich microcathetershaft sections andjunctions will kink. | BS EN 13868:2002TM035 | Met performancespecificationsper DTM003 | Conformance tostandard with thefollowingdeviations:Kink diameter |
| determined basedon mechanical kink(drop incompressive force)instead of 50%reduction in water | ||||
| flow. This methodis appropriate asthe Via 21 isprimarily used todeliver non-liquiddevices. | ||||
| Tip Buckling | Tests force required fortip to buckle. | TM034 | Met performancespecificationsper DTM003 | Completeconformance toSequent TM |
| Tracking Force | Tests force required toadvance aninterventional devicethrough themicrocatheter lumen. | TM032 | Met performancespecificationsper DTM003 | Completeconformance toSequent TM |
| Steam Shaping andShape Retention | Tests that microcathetercan be steam shaped to aclinically relevant angleand can maintain aminimum % of the initialangle after simulateduse. | TM038 | Met performancespecificationsper DTM003 | Completeconformance toSequent TM |
| Shaft Tensile | Measures the ultimatetensile strength of allPebax and Vestamidjunctions along thelength of the cathetershaft. | ISO 10555-1:2013TM031 | Met performancespecificationsper DTM003 | Completeconformance tostandard |
| Hub-Shaft Tensile | Measures the ultimatetensile strength of thehub to shaft junction. | ISO 10555-1:2013TM031 | Met performancespecificationsper DTM003 | Completeconformance tostandard |
| Burst | Measures peak pressurebefore microcatheterburst/liquid leakage. | ISO 10555-1:2013TM037 | Met performancespecificationsper DTM003 | Completeconformance tostandard |
| Test | Methodology | ApplicableInternationalStandard and/orSequent TestMethod (TM) | Result | Conclusion |
| Coating Friction andCoating Integrity | Measures the averagepeak coatingfriction/lubricity.Coating integrity usesdye to test that coatingremains adhered tocatheter after simulateduse. | Harland MedicalSystems CoatingFriction and DyeTest MethodsFDA GuidanceDocument, Class IISpecial Controls forPTCA Catheters(section 12) (Issued2010) | Met performancespecificationsper DTM003 | Completeconformance toHarland testmethodsIn line with FDAguidance documenton coating integrity |
| CoatingAdherence/Particulate | Measures particulategenerated from thehydrophilic coating onexterior ofmicrocatheter, as well asparticulate generatedfrom advancing aninterventional devicethrough the inner lumenof the microcatheter. | TM042FDA GuidanceDocument, Non-Clinical EngineeringTests forIntravascular Stentsand AssociatedDelivery Systems(section 12) (Issued2010)FDA GuidanceDocument, Class IISpecial Controls forPTCA Catheters(section 13) (Issued2010) | Met performancespecificationsper DTM003 | Completeconformance toSequent TMIn line with FDAguidancedocuments onparticulate testing |
| Flow Rate | Measures flow ratesthrough themicrocatheter at definedinjection rates usingsaline and contrast. | ISO 10555-1:2013 | Met performancespecificationsper DTM003 | Completeconformance tostandard |
| Hub Performance | Tests hub liquid and airleakage, as well as thatthe hub can withstandadequate forces. Teststhat the hub meetsgeneral requirements forconical fittings. | ISO 594-1:1986ISO 594-2:1998TM043 | Test resultsadopted fromVIA 27/VIA33(K132652) | Conformance tostandard with thefollowingdeviations:Used an alternativeISO 594-2:1998fitting to test hubsfor SeparationForce andUnscrewingTorque. The fittingused was measuredto have a minordiameter greaterthan called for in |
| the standard. Thiswas deemed asworst case for thesetests, thereforeacceptable to use.Only short termstress cracking wasinspected for onhubs. ISO 594-2:1998 calls forinspection after 48hours. Intended useof Via 21microcatheter onlyrequires RHV orsyringes to beconnected for shortdurations duringdelivery of implant,therefore long termtesting is notapplicable. |
Table 1. Non-Clinical Tests
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510(K) SUMMARY
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510(K) SUMMARY
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Nonclinical testing demonstrated that the VIA™ 21 Microcatheter can perform as intended, and demonstrated substantial equivalence to the predicate devices: VIA™ (VIA 27) and VIA™ PLUS (VIA 33) Microcatheters (K132652), Headway 21 Microcatheter (K093160) and Orion Microcatheter (K113289).
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:
| Biocompatibility 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 |
| 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 |
Table 2. Biocompatibility and Chemical Testing
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| 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 Time withComparison 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 with L-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 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™ 21 Microcatheter to the predicate devices. Table 3 below shows a summary of the VIA™ 21 technological characteristics as compared to the predicate devices.
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Table 3. Substantial Equivalence Summary - Technological Characteristics
| Element | SUBJECT DEVICE- VIA™ 21MICROCATHETER(K150894) | VIA™ (VIA 27)AND VIA™ PLUS(VIA 33)MICROCATHETER(K132652) | HEADWAY 21MICROCATHETER(K093160) | ORION ™MICROCATHETERCATHETER (K113289)AND CE0297) |
|---|---|---|---|---|
| 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,Stainless Steel wire,Nylon SantopreneYes | PTFE, Pebax, StainlessSteel hypotube, Nitinolbraid reinforcement,polypropyleneYes |
| 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 tip configurationand the physician has theoption to steam shape the tipusing the Shaping Mandrelprior to use to ensure properadjustment to the anatomy.Yes | Straight tipconfiguration and thephysician has theoption to steam shapethe tip prior to use toensure properadjustment to theanatomy.Yes | Straight tipconfiguration and thephysician has theoption to steam shapethe tip prior to use toensure properadjustment to theanatomy.Yes |
| Element | SUBJECT DEVICE- VIATM 21MICROCATHETER(K150894) | VIATM (VIA 27)AND VIATM PLUS(VIA 33)MICROCATHETER(K132652) | HEADWAY 21MICROCATHETER(K093160) | ORION TMMICROCATHETERCATHETER (K113289)AND CE0297) |
| EffectiveLengths | Via 21: 154 cmYes | Via 27: 154 cmVia 33: 133 cmYes | 150 cmYes | 150 cmYes |
| Proximal/DistalOD | Via 21: Proximal2.8F/Distal 2.5FYes | Via 27: Proximal3.2F/Distal 3.0FVia 33: Proximal 3.8F/Distal 3.4FYes | Proximal OD: 2.5FDistal OD: 2.0FYes | Proximal OD: 2.4FDistal OD: 2.6FYes |
| ID | Via 21: 0.021 inch/ 1.6FYes | Via 27: 0.027 inch/ 2.1FVia 33: 0.033 inch/2.5FYes | ID: 0.021 inchYes | ID: 0.021 inchYes |
| HydrophilicCoating Length | Via 21: 100 cmYes | Via 27: 100 cmVia 33: 100 cmYes | 100cm (measured)Yes | 85 cm (measured)Yes |
| Tip Length | 1 mmYes | 1 mmYes | 0.66 mm (measured)Yes | 0.70 mm (measured)Yes |
| Element | SUBJECT DEVICE- VIATM 21MICROCATHETER(K150894) | VIA™ (VIA 27)AND VIA™ PLUS(VIA 33)MICROCATHETER(K132652) | HEADWAY 21MICROCATHETER(K093160) | ORION TMMICROCATHETERCATHETER (K113289)AND CE0297) |
| Distal TipLength | Via 21: 5cmYes | Via 27:10cmVia 33: 5 cmYes | 15cm (measured)Yes | 13.5 cm (measured)Yes |
| Tip Markers | 1 marker, 90%Pt-10%IrYes | 1 marker, 90%Pt-10%IrYes | 2 markers, confirmedto be radiopaqueYes | 2 markers, confirmedto be radiopaqueYes |
| Coating | PolyvinylpyrrolidoneYes | PolyvinylpyrrolidoneYes | Confirmed to belubriciousYes | 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 single pouchSecondary Package:Chipboard unit cartonYes | Primary package:Coiled Hoop within asingle pouchSecondary Package:Chipboard unit cartonYes | Primary package:Coiled Hoop within asingle pouchSecondary Package:Chipboard unit cartonYes |
| Sterilization | Ethylene OxideSterilization | Ethylene Oxide SterilizationYes | Ethylene OxideSterilization | Ethylene Oxidesterilization |
| Element | SUBJECT DEVICE- VIATM 21MICROCATHETER(K150894) | VIATM (VIA 27)AND VIATM PLUS(VIA 33)MICROCATHETER(K132652) | HEADWAY 21MICROCATHETER(K093160) | ORION TMMICROCATHETERCATHETER (K113289)AND CE0297) |
| Yes | Yes | Yes | Yes | |
| Indication for Use- Equivalent ? | ||||
| The Subject andthe comparisondevices maintainsimilar indications | The VIA 21 Microcatheteris intended for theintroduction of non-liquidinterventional devices(such as stents/flowdiverters) and infusion ofdiagnostic (such ascontrast media) or non-liquid therapeutic agentsinto the neuro, peripheral,and coronary vasculature.Yes | The VIA Catheter isintended for the introductionof non-liquid interventionaldevices (such as stents/flowdiverters) and infusion ofdiagnostic (such as contrastmedia) or therapeutic agentsinto the neuro, peripheral,and coronary vasculature.Yes | The Headway 21Microcatheter(K093160) is intendedto for generalintravascular use,including theperipheral, coronaryand neuro vasculaturefor the infusion ofdiagnostic agents,such as contrastmedia, and therapeuticagents, such asocclusion coils.Yes | The OrionTM Catheter(K113289 andCE0297) is intendedfor the controlledselective infusion ofphysician-specifiedtherapeutics agents orcontrast media into thevasculature of theperipheral and neuroanatomy.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. TheViaTM 21 Microcatheter has equivalent performance characteristics to the comparison devices. |
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§ 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).