The pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is intended for use in the neuro vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in peripheral or coronary arteries.

Device Description

The pORTAL Steerable Hydrophilic Guidewire is a disposable medical device designed for single use only. It is designed to selectively introduce and position catheters and other interventional devices within target vessels. In order to achieve this purpose, the guidewire must be capable of being steered through blood vessels. This necessitates pushing and torqueing capability within the product. The design of the distal section of the guides steerability, while maintaining the flexibility necessary to negotiate the tortuous path of the blood vessel network. Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessels. Two accessories are provided within the package. These are a Torquer device and an introducer Needle. Both can be used to aid in the use of the device.

The pORTAL EXT Extension Wire is intended to interface with pORTAL Steerable Hydrophilic Guidewire. It is provided sterile and is sold separately in its own packaging configuration. The 115cm extension wire provides a facility to extend the overall length of the pORTAL quidewire to 315cm (see table 1 for dimensional specifications). This enable length to be extended during use to aid with over-the wire exchange. This facilitates introduction and positioning of catheters and other interventional devices within the target anatomy, while the guidewire retains its working position at the location of intervention. The stiffness of the extension wire is comparable to the proximal, unground section of the pORTAL Guidewire.

AI/ML Overview

This is a 510(k) summary for a medical device (guidewire and extension wire), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details (sample size, provenance, expert adjudication, MRMC study, standalone performance, ground truth, training set), which are relevant for AI/ML device evaluations, are not applicable here.

Instead, the document details engineering bench testing and biocompatibility testing to demonstrate substantial equivalence to predicate devices. Here's what can be extracted from the provided text, formatted to address as many of your points as possible given the non-AI context:

1. A table of acceptance criteria and the reported device performance

The document provides a series of tables (Table 4, 5, 6, 7, 8, 9, 10, 11) detailing biocompatibility, performance, sterility, packaging integrity, and shelf-life testing. The "Results" column in these tables can be interpreted as the device performance relative to an implicit or explicit acceptance criterion. The acceptance criteria themselves are explicitly stated (e.g., "within specification," "meets acceptance criteria," "no evidence of damage").

Here is a summary table, combining some of the provided information, focusing on the guidewire as an example:

Acceptance Criterion (Test)	Reported Device Performance (Guidewire)
Biocompatibility
Chemical Characterization (NVR)	Low amounts of residue detected.
Chemical Characterization (FTIR)	Matches cellulose acetate ester, polyurethane, phenolic antioxidant.
Chemical Characterization (Trace Metals)	Contained trace amounts, most significant was tungsten.
Chemical Characterization (GC/MS)	No semi-volatile compounds detected > 1.0 ppm.
Chemical Characterization (LC/MS)	Indicated presence of antioxidant Irganox 1010.
Cytotoxicity	No evidence of cell lysis or toxicity (grade 0).
Sensitization	No evidence of delayed dermal contact sensitization.
Intracutaneous Reactivity/Irritation	Overall mean score difference from control was 0.0.
Acute Systemic Toxicity	No mortality or evidence of systemic toxicity.
Hemocompatibility (Hemolysis)	Hemolytic index 0.0% (direct contact) and 0.3% (extract), both non-hemolytic.
Hemocompatibility (Thromboresistance)	Minimal to slight thrombus formation, appeared equivalent to control.
Acute Systemic Toxicity (Pyrogenicity)	Total rise of rabbit temperatures within acceptable USP limits, nonpyrogenic.
Performance - Bench
Dimensional	Dimensional results meet acceptance criteria.
Tip Tensile Strength	Tensile strength meets specification.
Catheter Compatibility	Performed acceptably, compatible with tested microcatheters.
Coating Adherence/Integrity	No coating rubbed off during or after testing.
Tip Stiffness (Gram Weight)	Equivalent or less than predicate, within specification.
Tip Shape Retention	Better than or equivalent to predicate, within specification.
Lubricity and Durability	Better than or equivalent to predicate, meets acceptance criteria.
PTFE Coating Adherence (Saline Soak & Wipe Test)	All devices passed.
PTFE Coating Mandrel Adhesion (Saline Soak & Wrap Test)	All devices passed.
PTFE Adhesion / Durability (Eraser Test)	All devices passed.
Radiopacity	Comparable to predicate device, meets specification.
Torque Strength (Combined Load/Turns to Failure)	Demonstrated within specification.
ISO Flex Resistance Test (Bending Durability)	Comparable to predicate device.
Corrosion Resistance	Meets acceptance criteria, no evidence of corrosion.
FDA Tip Flexibility	Comparable or less atraumatic than predicate, peak load within specification.
Kink Resistance / Flexibility	Equivalent or better than predicate device.
Particle Residue	All parts & calculated tolerance interval below max specification.
Torque Response	Equivalent to predicate device, fresh and fatigued devices within specifications.
Packaging Inspection (Shelf Life)	Packaging did not incur any damage or defects.
Sterility
Residual Study (EtO, ECH)	All test articles passed acceptance criteria.
LAL Testing (Endotoxin)	All test articles passed acceptance criteria.
Product Bioburden Testing	All test articles passed bioburden acceptance criteria.
Packaging Integrity
Visual Inspection	All samples passed visual inspection.
Seal Integrity: Dye Penetration	All samples passed.
Pouch Peel Test	All samples passed.
Seal Tensile Strength	All samples within specifications.
Sterilization (Residuals)	All samples passed.
Seal integrity: Bubble leak test	All samples passed.
Cytotoxicity	All samples within cytotoxicity specifications.
Physiochemical	All samples within physiochemical specifications.
Age Testing (Visual Inspection)	All samples met age testing criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for each bench test conducted. It typically refers to "All devices," "All samples," or plural forms like "guidewires tested." Medical device bench testing often uses a representative sample per test, but the exact number isn't quantified here.

Data provenance (country of origin, retrospective/prospective) is not applicable or stated for this type of non-clinical, bench testing. The tests are conducted in a controlled laboratory environment.

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 device is not an AI/ML diagnostic tool requiring expert interpretation for ground truth. The "ground truth" for these tests is established by objective physical measurements and standardized test methods (e.g., ISO, ASTM standards, USP limits for pyrogenicity).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically associated with human interpretation of data, such as in clinical trials or AI/ML evaluations. Bench testing results are typically objectively measured and compared against predefined specifications.

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

Not applicable. MRMC studies are designed to evaluate the performance of AI-assisted human readers in diagnostic tasks. This device is a physical guidewire and extension wire, not an AI/ML product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This 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" in this context is defined by:

Standardized Test Methods: Adherence to recognized national and international standards (e.g., AAMI/ANSI/ISO 10993-1:2009 for biocompatibility, ISO 11070 for guidewires, ASTM F1929, ASTM F88, ASTM F2096 for packaging, USP for pyrogenicity).
Engineering Specifications: Internal design specifications that the device must meet (referred to by phrases like "meets specification," "within acceptable limits").
Predicate Device Comparison: Performance often compared to that of the already-marketed predicate devices to demonstrate "equivalent" or "better" performance.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of medical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 9, 2019

phenox Limited % Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K191687

Trade/Device Name: pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: September 9, 2019 Received: September 10, 2019

Dear Mark Job:

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.

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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 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 (QS) 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 (Acting) 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) K191687

Device Name

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire

Indications for Use (Describe)

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 (21 CFR 807.92)

I. SUBMITTER

phenox Limited, Ballybrit Business Park, Galway, Ireland

Contact Person: Garv Brogan Director of Regulatory Affairs, Phone: +353 91 740103

Date Prepared: May 31st, 2019

II. DEVICE

Name of Device: pORTAL® Steerable Hydrophilic Guidewire and pORTAL®EXT Extension Wire

Common or Usual Name: Catheter Guidewire

Classification: Class II, 21 CFR 870.1330, Catheter Guide wire

Product Code: MOF

III. PREDICATE DEVICE(S)

Traxcess 14EX Guidewire and Traxcess Docking Wire, K093397, Cleared Dec 2009. Transend EX Guidewire, K934122, cleared October 1993.

IV. DEVICE DESCRIPTION

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Part #	Content ofPackage	Description on label	TotalLength	OuterDiameter	Length ofHydrophilic Coating
PORT-14-200-1	1	pORTALSteerable HydrophilicGuidewire	205 cm	0.014"(0.36mm)	35.5 cm(nominal)
PORT-14-200-5	5	pORTALSteerable HydrophilicGuidewire	205 cm	0.014"(0.36mm)	35.5 cm(nominal)
PORT-14-115-1-EX	1	pORTALEXT Extension Wire	115 cm	0.014"(0.36mm)	N/A
PORT-14-115-5-EX	5	pORTALEXT Extension Wire	115 cm	0.014"(0.36mm)	N/A

Table 1: Product details of the pORTAL components

V. INDICATIONS FOR USE

IV. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

Parameter	Predicate Device(Transend EX)	Predicate Device(Traxcess 14EX)	Subject Device	Assessment ofdifferences
Model	Transend EX Guidewire	Traxcess 14EX Guidewireand Docking wire	pORTAL Guidewire andExtension System	Equivalent
510(k) number	K934122	K093397	K191687	Equivalent
ProductClassification	21 CFR 870.1330,Class II	21 CFR 870.1330,Class II	21 CFR 870.1330,Class II	Equivalent
Device Design	Steerable hydrophilicguidewire	Steerable hydrophilicguidewire and dockingwire	Steerable hydrophilicguidewire and extensionsystem	Equivalent
Indications forUse	The Transend EXguidewire is intendedfor general intravascularuse, includingneurovascular andperipheral vasculatures.The guidewire can betorqued to facilitate theselective placement ofdiagnostic ortherapeutic catheters.The device is notintended for use incoronary arteries. Thetorque device (pin vase)is included with theguidewire to facilitate	The Traxcess Guidewireand Docking Wire isintended for generalintravascular use,including the neuro andperipheral vasculature.The wire can be steeredto facilitate the selectiveplacement of diagnosticor therapeutic catheters.This device is notintended for use incoronary arteries.	The pORTAL SteerableHydrophilic Guidewire andpORTAL EXT Extension Wire isintended for use in the neurovasculature. The wire can besteered to facilitate theselective placement ofdiagnostic or therapeuticcatheters.This device is not intendedfor use in peripheral orcoronary arteries.	The Indications for Usestatement is similar to thepredicates with theexception that thetreatment indication isreduced to only includeneuro as opposed to ageneral intravascular useincluding peripheral. Thistightening of theindication statement doesnot raise any additionalquestions on safety andeffectiveness.
Mode of Action	The guidewire can besteered to facilitate theselective placement ofdiagnostic ortherapeutic catheters.	The guidewire can besteered to facilitate theselective placement ofdiagnostic or therapeuticcatheters.	The guidewire can besteered to facilitate theselective placement ofdiagnostic or therapeuticcatheters.	Equivalent

Table 2: Comparison of pORTAL technological characteristics with predicate device

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Parameter	Predicate Device(Transend EX)	Predicate Device(Traxcess 14EX)	Subject Device	Assessment ofdifferences
Device Sizes	Two lengths 182cm and205cm guidewire	200cm guidewire115cm docking wire	205cm guidewire115cm extension wire	The guidewire deviceshave similar overalllengths. Traxcess maybe extended using adocking wire, resultingin comparable lengthto the pORTALExtension wire. Theseminor differences inlengths do not raiseany additionalquestions on safetyand effectiveness.
Use	Single Use Device	Single Use Device	Single Use Device	Equivalent
Sterilization	EO Sterilization	EO Sterilization	EO Sterilization	Equivalent
Method of supply	Stored with a dispensercoil, Tyvek Pouch andshipping carton	Stored with a dispenser coil,Tyvek Pouch and shippingcarton	Stored with a dispenser coil,Tyvek Pouch and shippingcarton	Equivalent
Intended ClinicalEnvironment	Sterile operating theatre	Sterile operating theatre	Sterile operating theatre	Equivalent
Biocompatible	Yes	Yes	Yes	Equivalent

V. COMPARISON OF MATERIALS USED WITH THE PREDICATE DEVICES

Parameter	Predicate Device(Transend EX)	Predicate Device(Traxcess 14EX)	Subject Device	Assessment ofdifferences
WireMaterial	Guidewire:Scitanium (proprietary alloy)core wire	Guidewire:Stainless-steel core withNitinol tapered wireDocking Wire:Stainless-steel core withNitinol tube on distal end	Guidewire:35NLT Cobalt Chrome alloyExtension Wire:Stainless Steel core wire witha Nitinol tube on the distal end	While there are differences inmaterials, pORTAL usessimilar materials which arecommonly used in medicaldevices. DV testing on thepORTAL confirmed it willperform as intended and thedifference in materials do notraise questions of safety andeffectiveness
Coating	Distal:Hydrophilic coating "ICE"Proximal: PTFE	Distal: Hydrophilic coatingProximal: PTFE	Distal: Hydrophilic coatingProximal: PTFE	The function of each devicecoating is equivalent. Whilsthaving different materials,each of the device coatingsfunctions are used equivalentand incorporated in thedevice to increase thelubricity of the guidewires.The difference in materials donot raise questions of safetyand effectiveness
TipMaterial	Tapered ribbon Scitanium(proprietary alloy)	Platinum / Nitinol coil	Platinum/Tungsten coil	The function of each device tipis equivalent. The difference inmaterials do not raisequestions of safety andeffectiveness

Table 3: Comparison of pORTAL materials with predicate device

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VI. BIOCOMPATIBILITY

Biocompatibility testing for the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire was conducted to conform with the FDA consensus standard, recognition number 2-156, AAMI/ANSI/ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, along with the FDA Blue Book Memorandum# G95. Table 4 and 5 below summarizes the biocompatibility testing performed on the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire.

Test	Test Description	Result Summary	Conclusion
ChemicalCharacterization	Exhaustive Extraction inPurified Water (PW), 50%IsopropylAlcohol (IPA), and Hexane (Hex) forTotal Non-Volatile Residue (NVR)	The exaggerated extractions of the Phenox/LRM0.014" Neurovascular Guidewire yielded low(<0.24mg) amounts of residue from the PWextraction vehicle; the EtOH and Hex extractionvehicles yielded a slightly higher amount of NVRthan the PW.	Acceptable
	Fourier Transform Infrared (FTIR)Spectroscopy of residues obtainedfrom the test article extracts	Purified Water: Most closely matches celluloseacetate ester EtOH: Most closely matchespolyurethane Hexane: Most closely matchesphenolic antioxidant	Acceptable
	Determination of TraceMetals/Elements Using InductivelyCoupled Plasma (ICP) Spectroscopy(PW extract only)	The PW extract of the PORTAL Guidewire containedtrace amounts of metallics. The most significantamount of a metal detected was tungsten which waspresent at a level of 6.13 x $10^4$ mg/device.	Acceptable
	Gas Chromatography with MassSpectrometry (GC/MS) for detectionof volatile and semi-volatile organiccompounds from the test articleextracts	No semi-volatile compounds were detected in thePW, EtOH And Hex extracts of the pORTALGuidewire at a level greater than 1.0 ppm, thedetection limit of the method.	Acceptable
	Ultra-performance LiquidChromatography with MassSpectrometry (LC/MS) for detection ofnon-volatile compounds from the testarticle extracts	The LC/MS analyses of the EtOH and Hex extractsof the pORTAL Guidewire indicated the presence ofthe antioxidant Irganox 1010	Acceptable
Cytotoxicity	Cytotoxicity Study Using the ISOElution Method	The test article extract showed no evidence ofcausing cell lysis or toxicity and was a grade 0. Thetest article extract met the requirements of the testsince the grade was less than a grade 2 (mildreactivity).	Pass
Sensitization	ISO Guinea Pig MaximisationSensitisation Test	The test article extracts showed no evidence ofcausing delayed dermal contact sensitization in theguinea pig. The test article was not considered asensitizer in the guinea pig maximization test.	Pass
IntracutaneousReactivity/irritation	ISO Intracutaneous Study in Rabbits	The test article met the requirements of the testsince the difference between each test articleextract overall mean score and correspondingcontrol extract overall mean score was 0.0 and 0.0for the SC and SO test article extracts, respectively.	Pass
Acute SystemicToxicity	ISO Systemic Toxicity Study in Mice	There was no mortality or evidence of systemictoxicity from the extracts injected into mice. Eachtest article extract met the requirements of the study.	Pass
pORTAL Steerable Hydrophilic Guidewire
Test	Test Description	Result Summary	Conclusion
Hemocompatibility	ASTM Hemolysis Study	The hemolytic index for the test article in directcontact with blood was 0.0% and the hemolyticindex for the test article extract was 0.3%. Both thetest article in direct contact with blood and the testarticle extract were non-hemolytic.	Pass
Hemocompatibility	In Vivo ThromboresistanceStudy in Dogs Jugular Vein	Under the conditions of the study, minimal to slightthrombus formation was noted with the test articleand control article. The test and control articleappeared equivalent in this exaggerated model withneither demonstrating thromboresistance.Consequently, these results should be consideredwith respect to clinical use when assessing clinicalrelevance.	Pass
Acute SystemicToxicity(Material MediatedPyrogenicity)	USP Rabbit Pyrogen Study, MaterialMediated	The total rise of rabbit temperatures during the 3-hour observation period was within acceptableUSP limits. The test article was judged asnonpyrogenic.	Pass

Table 4: Biocompatibility Summary for pORTAL Guidewire

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Table 5: Biocompatibility Summary for pORTAL EXT Extension Wire

pORTAL EXT Extension Wire
Test	Test Description	Result Summary	Conclusion
ChemicalCharacterization	Exhaustive Extraction in PurifiedWater (PW), 50% Isopropyl Alcohol,and Hexane for Total Non-VolatileResidue	The exaggerated extractions of the pORTALExtension Wire yielded low (0.04 mg) amounts ofresidue from the PW extraction vehicle; the EtOH(0.071) and Hex (0.026) extraction vehicles yieldeda slightly higher and lower amounts of NVRrespectively than the PW.	Acceptable
	Fourier Transform Infrared Spec. ofresidues obtained from the test articleextracts	Purified Water: No major bands of interest wereobserved. EtOH: Most closely matches tracehydrocarbons, Hexane: Most closely matches tracehydrocarbons	Acceptable
	Determination of Trace MetalElements Using Inductively CoupledPlasma Spec.	The PW extract of the pORTAL Extension Wirecontained trace amounts of metallics. The mostsignificant amount of a metal detected wasaluminium which was present at a level of 5.06 x 10mg/device.	Acceptable
	Gas Chromatography with Mass Spec.for detection of volatile & semi-volatileorganic compounds from the testarticle extracts	No semi-volatile compounds were detected in thePW, EtOH And Hex extracts of the pORTALExtension Wire at a level greater than 1.0 ppm, thedetection limit of the method.	Acceptable
	Ultra-PerformanceLiquid Chromatography with MassSpec. for detection of non-volatilecompounds from the test articleextracts	The LC/MS data indicate the presence of numerousincompletely identified compounds in the PW, EtOH,and Hex extracts of the pORTAL Extension Wire.Analysis of the types of compounds detectedindicates that many of the chemical speciesdetected are structurally related.	Acceptable
Cytotoxicity	Cytotoxicity StudyUsing the ISOElution Method	The test article extract showed no evidence ofcausing cell lysis or toxicity and was a grade 0. Thetest article extract met the requirements of the testsince the grade was less than a grade 2 (mildreactivity).	Pass
Hemocompatibility	ASTM Hemolysis Study	The hemolytic index for the test article in directcontact with blood was 0.3% and the hemolyticindex for the test article extract was 0.6%. Both thetest article in direct contact with blood and the testarticle extract were non-hemolytic.	Pass

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VII. NON-CLINICAL PERFORMANCE DATA

The following non-clinical performance tests were executed to provide support for the substantial equivalence determination. These are summarized below.

Performance Testing - Bench

A full suite of performance testing on the bench was carried out on the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire. This testing included, Tensile Strength, Torque Strength, Tip Flexibility, Coating Adherence/Integrity & Catheter Compatibility under simulated conditions. The results of this testing demonstrated compliance to all the design attributes as well as demonstrating an acceptable performance outcome. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate substantial equivalence to the cited predicates.

pORTAL Steerable Hydrophilic Guidewire
Test	Test Method Summary	Results
Dimensional	The overall guidewire length, polymer jacket lengthand overall guidewire diameter were measured.	Dimensional results meet acceptancecriteria.
Tip Tensile Strength	The distal section of the wire was pulled until itfailed.	Results show the tensile strength meetsspecification.
Catheter Compatibility	The guidewire was tested with relevant interfacingdevices such as over the wire micro catheters undersimulated use.	The guidewires tested performedacceptably and were shown to becompatible with tested microcatheters.
Coating Adherence/Integrity	The guidewire was tracked multiple times through acatheter in a simulated anatomy. The coatings wereinspected for signs of damage or degradation.	No coating was rubbed off during or aftertesting of guidewire in any of themicrocatheters.
Tip Stiffness (Gram Weight)	The distal tip of the guidewire was compressed. Thepeak load was electronically recorded and reported.	Device stiffness is equivalent or lessthan predicate device. Device tipstiffness is within specification.
Tip Shape Retention	A J-Shape was formed on the distal end of the wire,then recorded using an image measuring system.	The guidewire distal tip retention isbetter than or equivalent to predicatedevice. Tip shape retention is withinspecification.
Lubricity and Durability Test	The guidewire, within a microcatheter was trackedmultiple times through a 3-Dimensional NeuroSilicone anatomy block. Resulting lubricity wasmeasured.	Lubricity and durability of the guidewireis better than or equivalent to thepredicate device. The device meetsacceptance criteria on both lubricity anddurability.
PTFE Coating Adherence (SalineSoak & Wipe Test)	The entire length was pulled through a fixed clamp.The wire was inspected for PTFE degradation ordamage.	All devices passed saline soak & wipetest.
PTFE Coating Mandrel AdhesionTest (Saline Soak & Wrap Test)	The wire was wrapped around a mandrel of a fixeddiameter (as defined in ISO11070 standard). Thewrapped PTFE coated wire was inspected under amicroscope for any signs of flaking, cracking ordelamination.	All devices passed saline soak & wraptest.
PTFE Adhesion / DurabilityTesting (Eraser Test)	The wire was placed in a fixture and subject to anumber of cycles underweight. The wire wasremoved and inspected for failure.	All devices passed eraser test.
Radiopacity	The radiopaque distal end of the guidewire wasimaged using standard fluoroscopy equipment. Animage was taken and reviewed to ensure visibility	Device radiopacity was seen to becomparable to predicate device. Devicemeets specification.
Torque Strength (CombinedLoad/Turns to Failure)	The guidewire was loaded into the guide catheterwithin a simulated neurovascular anatomy. Force isapplied and the specimen is rotated to failure.	Device torqueability was demonstratedwithin specification.
ISO Flex Resistance Test(Bending Durability)	Test method defined in ISO 11070 Annex G. Thetest region of the wire was wrapped aroundmandrels in opposing directions a number of times.The wire was removed and examined.	Flex resistance was comparable topredicate device.

Table 6: DV Summary for pORTAL Guidewire

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pORTAL Steerable Hydrophilic Guidewire
Test	Test Method Summary	Results
Corrosion Resistance	Test method defined in ISO 11070 Annex B. Theproducts were placed in a beaker of salt water atroom temp for 5 hours, and then placed in boilingdistilled water for 30 minutes, followed by 48 hoursat 37°C. The products were removed, and examinedfor evidence of corrosion.	Device meets acceptance criteria, noevidence of corrosion on device.
FDA Tip Flexibility	This test measures the load required to deflect thedistal tip of the guidewire to angles of 45° and 90. Aforce curve was generated for each specimen at thespecified deflection points and were electronicallycollected.	Tip stiffness properties were shown tobe comparable or less atraumatic thanpredicate device. Peak load was withinspecification.
Kink Resistance / Flexibility	The tip of each device was wrapped aroundmandrels, until kinking occurs.	Kink resistance was equivalent or betterthan predicate device.
Particle Residue	Following simulated use, particulates generated arecollected, and counted by size for each wire.	All parts & calculated tolerance intervalare below max specification for ≥10μmparticles/device and ≥25um particles/device and compared to a predicatedevice control.
Torque Response	The test measured the reaction of the distal end ofthe guidewire when the wire was placed within asimulated anatomy.	Equivalent torque response whencompared to predicate device. Bothfresh and fatigued devices are withinspecifications.

Table 7: DV Summary for pORTAL EXT Extension Wire

pORTAL EXT Extension Wire
Test	Test Method Summary	Results
Catheter Compatibility Test	The guidewire was tested with relevant interfacingdevices under simulated use.	The extension systems performedacceptably and were shown to becompatible with tested microcatheters.
PTFE Coating Mandrel AdhesionTest (Saline Soak & Wrap Test)	The wire was wrapped around a mandrel of a fixeddiameter (as defined in ISO11070 standard). Thewrapped PTFE coated wire was inspected under amicroscope for any signs of flaking, cracking ordelamination.	No damage was observed post soak &wrap test. All devices passed.
PTFE Coating Adherence (SalineSoak & Wipe Test)	The entire length was pulled through a fixedclamp. The wire was inspected for PTFEdegradation or damage.	No damage was observed post soak &wipe test. All devices passed.
PTFE Adhesion / Durability Testing(Eraser Test)	The wire was placed in a fixture and subject to anumber of cycles underweight. The wire wasremoved and inspected for failure.	No damage was observed post erasertest. All devices passed.
Dimensional Measurements	The overall length and maximum diameter of theextension wire were measured.	All dimensional measurements werewithin specifications.
Pull Test (Glue Joint Strength)	The joint strength of the extension wire ismeasured using a calibrated force tester	Joint strength measurements werewithin specifications.
Pull Test (Strength of Union)	The peak force to separate the guidewire from theextension wire is measured using a calibratedforce tester	Strength of union measurements werecomparable to predicate device andwithin specifications.
Hypotube Joint Flex Test	This test involves flex testing the integrity of theconnecting joint between the extension wire andthe guidewire. A force curve is generated for eachspecimen, and the peak load is electronicallycalculated and put into a report.	Results have shown comparable jointflex properties between the subjectdevice & predicate device. Device meetsspecification.
Particulate Residue Test	Following simulated use, particulates generatedare collected, and counted by size for each wire.	All parts & calculated tolerance intervalare below max specification for ≥10µmparticles/device and ≥25µm particles/device and compared to a predicatedevice control.

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pORTAL Guidewire and Extension System
Test	Test Method Summary	Results
Residual Study for guidewire after1x sterilisation	Wires were sterilized, then tested for EtO and ECH residual levels.	All test articles passed acceptance criteria.
LAL Testing	LAL enhancement and inhibition validation was performed followed by endotoxin testing.	All test articles passed acceptance criteria for endotoxin limits.
Product Bioburden Testing	Bioburden validation followed by bioburden testing was carried out on each test article.	All test articles passed bioburden acceptance criteria.

Table 8: Sterility Summary for pORTAL Guidewire and EXT Extension Wire

Table 9: Packaging Integrity Summary for pORTAL Guidewire and EXT Extension Wire ORTAL Guidewir od Evto nsion Syste

000 TAL Gülüsmile allu Excelsion SVSCHI
Test	Test Method Summary	Results
Visual Inspection	All samples are visually inspected for any damageor defects.	All samples passed visual inspection.
Seal Integrity: Dye Penetration	Packaging is exposed to a dye solution and isobserved and inspected for leakage. As per ASTMF1929.	All samples passed dye penetrationtesting.
Pouch Peel Test	The force required to separate the two sealedmaterials is recorded.	All samples passed pouch peel testing.
Seal Tensile Strength	The maximum tensile force required to separatethe seals is recorded. Test Method as per ASTMF88.	All samples were within seal tensilestrength specifications.
Sterilisation	Completed products were sterilized, then tested forEtO and ECH residual levels.	All samples passed sterilisation tests.
Seal integrity: Bubble leak test	Packaging is pressurized and submerged underwater while visually inspecting for streams ofescaping bubbles. As per ASTM F2096.	All samples passed the bubble leak test.
Cytotoxicity	ISO MEM elution -L929 fibroblast cultures - ISO10993-5	All samples were within cytotoxicityspecifications.
Physiochemical	The methods for these tests are outlined in TheUnited States Pharmacopeia Convention <661>	All samples were within physiochemicalspecifications.
Age Testing	All samples are visually inspected for any damageor defects.	All samples met age testing criteria.

Table 10: Shelf Life Testing Summary for pORTAL Guidewire for 2 years and 3 months

pORTAL Steerable Hydrophilic Guidewire
Test	Test Method Summary	Results
Dimensional	The overall guidewire length, polymer jacket lengthand overall guidewire diameter were measured.	Dimensional results meet acceptancecriteria.
Tip Tensile Strength	The distal section of the wire was pulled until itfailed.	Results show the tensile strength meetsspecification.
Catheter Compatibility	The guidewire was tested with relevant interfacingdevices such as over the wire micro catheters undersimulated use.	The guidewires tested performedacceptably and were shown to becompatible with tested microcatheters.
Coating Adherence/Integrity	The guidewire was tracked multiple times through acatheter in a simulated anatomy. The coatings wereinspected for signs of damage or degradation.	No coating was rubbed off during or aftertesting of guidewire in any of themicrocatheters.
Tip Stiffness (Gram Weight)	The distal tip of the guidewire was compressed. Thepeak load was electronically recorded and reported.	Device stiffness is equivalent or lessthan predicate device. Device tipstiffness is within specification.
Tip Shape Retention	A J-Shape was formed on the distal end of the wire,then recorded using an image measuring system.	The guidewire distal tip retention isbetter than or equivalent to predicatedevice. Tip shape retention is withinspecification.
Lubricity and Durability Test	The guidewire, within a microcatheter was trackedmultiple times through a 3-Dimensional NeuroSilicone anatomy block. Resulting lubricity wasmeasured.	Lubricity and durability of the guidewireis better than or equivalent to thepredicate device. The device meetsacceptance criteria on both lubricity anddurability.
PTFE Coating Adherence (SalineSoak & Wipe Test)	The entire length was pulled through a fixed clamp.The wire was inspected for PTFE degradation ordamage.	All devices passed saline soak & wipetest.

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pORTAL Steerable Hydrophilic Guidewire
Test	Test Method Summary	Results
PTFE Coating Mandrel AdhesionTest (Saline Soak & Wrap Test)	The wire was wrapped around a mandrel of a fixeddiameter (as defined in ISO11070 standard). Thewrapped PTFE coated wire was inspected under amicroscope for any signs of flaking, cracking ordelamination.	All devices passed saline soak & wraptest.
PTFE Adhesion / DurabilityTesting (Eraser Test)	The wire was placed in a fixture and subject to anumber of cycles underweight. The wire wasremoved and inspected for failure.	All devices passed eraser test.
Radiopacity	The radiopaque distal end of the guidewire wasimaged using standard fluoroscopy equipment. Animage was taken and reviewed to ensure visibility	Device radiopacity was seen to becomparable to predicate device. Devicemeets specification.
Torque Strength (CombinedLoad/Turns to Failure)	The guidewire was loaded into the guide catheterwithin a simulated neurovascular anatomy. Force isapplied and the specimen is rotated to failure.	Device torqueability was demonstratedwithin specification.
ISO Flex Resistance Test(Bending Durability)	Test method defined in ISO 11070 Annex G. Thetest region of the wire was wrapped aroundmandrels in opposing directions a number of times.The wire was removed and examined.	Flex resistance was comparable topredicate device.
Corrosion Resistance	Test method defined in ISO 11070 Annex B. Theproducts were placed in a beaker of salt water atroom temp for 5 hours, and then placed in boilingdistilled water for 30 minutes, followed by 48 hoursat 37°C. The products were removed, and examinedfor evidence of corrosion.	Device meets acceptance criteria, noevidence of corrosion on device.
FDA Tip Flexibility	This test measures the load required to deflect thedistal tip of the guidewire to angles of 45° and 90. Aforce curve was generated for each specimen at thespecified deflection points and were electronicallycollected.	Tip stiffness properties were shown tobe comparable or less atraumatic thanpredicate device. Peak load was withinspecification.
Kink Resistance / Flexibility	The tip of each device was wrapped aroundmandrels, until kinking occurs.	Kink resistance was equivalent or betterthan predicate device.
Particle Residue	Following simulated use, particulates generated arecollected, and counted by size for each wire. T	All parts & calculated tolerance intervalare below max specification for ≥10µmparticles/device and ≥25µmparticles/device.
Torque Response	The test measured the reaction of the distal end ofthe guidewire when the wire was placed within asimulated anatomy.	Equivalent torque response whencompared to predicate device. Bothfresh and fatigued devices are withinspecifications.
Packaging Inspection	The packaging should not incur any damage ordefects that may have a detrimental impact on theuse or performance of the product.	The packaging did not incur any damageor defects that may have a detrimentalimpact on the use or performance of theproduct.

Table 11: Shelf Life Testing Summary for pORTAL Extension Wire 5 years

pORTAL EXT Extension Wire

Test	Test Method Summary	Results
Catheter Compatibility Test	The guidewire was tested with relevant interfacingdevices under simulated use.	The extension systems performedacceptably and were shown to becompatible with tested microcatheters.
PTFE Coating Mandrel AdhesionTest (Saline Soak & Wrap Test)	The wire was wrapped around a mandrel of a fixeddiameter (as defined in ISO11070 standard). Thewrapped PTFE coated wire was inspected under amicroscope for any signs of flaking, cracking ordelamination.	No damage was observed post soak &wrap test. All devices passed.
PTFE Coating Adherence (SalineSoak & Wipe Test)	The entire length was pulled through a fixedclamp. The wire was inspected for PTFEdegradation or damage.	No damage was observed post soak &wipe test. All devices passed.
PTFE Adhesion / Durability Testing(Eraser Test)	The wire was placed in a fixture and subject to anumber of cycles underweight. The wire wasremoved and inspected for failure.	No damage was observed post erasertest. All devices passed.

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pORTAL EXT Extension Wire
Test	Test Method Summary	Results
Dimensional Measurements	The overall length and maximum diameter of theextension wire were measured.	All dimensional measurements werewithin specifications.
Joint Strength / Tensile Test	The joint strength of the extension wire ismeasured using a calibrated force tester	Joint strength measurements werewithin specifications.
Strength of Union	The peak force to separate the guidewire from theextension wire is measured using a calibratedforce tester	Strength of union measurements werecomparable to predicate device andwithin specifications.
Joint Flex Test	This test involves flex testing the integrity of theconnecting joint between the extension wire andthe guidewire. A force curve is generated for eachspecimen, and the peak load is electronicallycalculated and put into a report.	Results have shown comparable jointflex properties between the subjectdevice & predicate device. Device meetsspecification.
Particulate Residue Test	Following simulated use, particulates generatedare collected, and counted by size for each wire.	All parts & calculated tolerance intervalare below max specification for ≥10μmparticles/device and ≥25µmparticles/device.
Packaging Inspection	The packaging should not incur any damage ordefects that may have a detrimental impact on theuse or performance of the product.	The packaging did not incur any damageor defects that may have a detrimentalimpact on the use or performance of theproduct.

VIII. CONCLUSIONS

The pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire has an intended use and technological characteristics equivalent to the predicate devices. The subject device demonstrates product performance through successful bench testing. The pORTAL Guidewire device demonstrates it is safe for use for 2 years 3 months and the pORTAL Extension Wire is safe for 5 years. All packaging tests support the claimed shelf life. Device use is identical to the predicate devices and performance of the new device is comparable.

Taking this information into account, it is concluded that the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is substantially equivalent to the predicate devices, the Traxcess 14EX Guidewire and Traxcess Docking Wire (K093397) and Transend EX Guidewire (K934122).

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.