The SelectFlex Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Device Description

The subject SelectFlex Neurovascular Access System Family is a line extension to expand the previously cleared device (K211893) by offering a new SelectFlex III 064 Neurovascular Access Catheter with a diameter of 6F, a 6F dilator, an introducer sheath, and a 4.5F Access Tool that can be used with the catheter to access the desired anatomy. The 4.5F Access Tool is an accessory provided with the SelectFlex III 064 Neurovascular Access Catheter and is packaged in the same sterile pouch with the SelectFlex III 064 Neurovascular Access Catheter and accessories as part of the SelectFlex Neurovascular Access System Family.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (SelectFlex Neurovascular Access System Family) and does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/human-in-the-loop diagnostic system. Instead, it describes nonclinical performance testing (bench testing) and biocompatibility testing conducted to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested items (e.g., sample sized for the test set in an AI study, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I can extract the acceptance criteria (goals) and reported performance (results) from the nonclinical performance data section.

Here's the information based on the provided text:

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

For the SelectFlex Neurovascular Access System Family (including the SelectFlex III 064 Neurovascular Access Catheter, 6F Dilator, and 4.5F Access Tool where applicable):

Test Name	Acceptance Criteria (Goal)	Reported Device Performance (Result)
Visual Surface Requirements	To demonstrate that the device meets the visual surface requirements.	Pass: All samples met the predetermined acceptance criteria.
Dimensional Verification	To demonstrate that the device meets the dimensional requirements.	Pass: All samples met the predetermined acceptance criteria.
Liquid Leakage Under Pressure	To demonstrate that the device passes the liquid leakage under pressure test.	Pass: All samples met the predetermined acceptance criteria.
Hub Aspiration Air Leakage	To demonstrate that the device passes the hub aspiration air leakage test.	Pass: All samples met the predetermined acceptance criteria.
Simulated Use/Usability	To demonstrate that the device passes testing specified in the simulated use test protocol. Simulated use testing includes usability assessment with multiple physicians.	Pass: All samples met the predetermined acceptance criteria.
Flex Fatigue	To demonstrate that the device passes the flex fatigue test.	Pass: All samples met the predetermined acceptance criteria.
Inflation Fatigue	To demonstrate that the device passes the inflation fatigue test.	Pass: All samples met the predetermined acceptance criteria.
Burst Volume	To demonstrate that the device passes the burst volume test – tested to 2x the inflation volume.	Pass: All samples met the predetermined acceptance criteria.
Torque Test	To demonstrate the device's ability to rotate 720 degrees (2 full revolutions) at the proximal end.	Pass: All samples met the predetermined acceptance criteria.
Tip Deflection	To demonstrate that the tip deflection is comparable to the predicate device.	Pass: All samples met the predetermined acceptance criteria.
Device Removal in Support and Tracking Modes	To demonstrate that the forces in both support and tracking modes are comparable to the predicate device.	Pass: All samples met the predetermined acceptance criteria.
Peak Tensile Testing	To demonstrate that the device passes the peak tensile strength testing including all bonds and joints.	Pass: All samples met the predetermined acceptance criteria.
Flow Rate	To demonstrate that the flow rate is comparable to the predicate device.	Pass: All samples met the predetermined acceptance criteria.
Corrosion Resistance	To demonstrate that the device has no visual evidence of corrosion.	Pass: All samples met the predetermined acceptance criteria.
Radiopacity	To demonstrate that the marker band is positioned at the distal tip of the catheter and is clearly visible under typical fluoroscopic imaging conditions.	Pass: All samples met the predetermined acceptance criteria.
Particulates, Coating Integrity, Lubricity, Durability	To demonstrate the quantity and size of particles generated during simulated use are comparable to the predicate and reference devices.	Pass: All samples met the predetermined acceptance criteria.
Static Burst	To demonstrate that the device passes static burst as specified in the test protocol.	Pass: All samples met the predetermined acceptance criteria.
Shelf Life	To demonstrate that the device performance is maintained over the proposed shelf-life (6 months).	Pass: All samples met the predetermined acceptance criteria.

Biocompatibility Testing:

Test Name	Acceptance Criteria (Goal)	Reported Device Performance (Result)	Conclusion
Cytotoxicity	Absence of reactivity	No reactivity was observed with the test article at 24 and 48 hours.	Non-cytotoxic
Sensitization	No evidence of sensitization	The test article extracts showed no evidence of delayed dermal contact sensitization in the guinea pig maximization test.	Non-sensitizing
Intracutaneous Reactivity	No irritation	The scores from test article extracts were 0 from the saline extract and 0 from the sesame seed oil extract.	Non-irritant
Acute Systemic Toxicity	No abnormal clinical signs/toxicity	No abnormal clinical signs indicative of toxicity were observed for 72 hours. All animals were alive at the end of 72 hours and body weight changes were within acceptable parameters.	Non-toxic
Material Mediated Pyrogenicity	No significant temperature rise	No rabbit temperature rise ≥ 0.5 °C.	Non-pyrogenic
Hemolysis - Direct Contact and Extract Method	Non-hemolytic	Blank corrected hemolytic index: 0.15, 0.13.	Non-hemolytic
Complement Activation	Results within acceptable range	Results within acceptable range as compared to the controls.	Not a Sc5b-9 complement activator
Thrombogenicity	No adverse effects/thrombus	No adverse effects or clinical signs during test period and no thrombus score ≥ 2 for either test or control device.	Non-thrombogenic

2. Sample sized used for the test set and the data provenance
The document does not specify sample sizes for each particular test, only stating "All samples" or providing a conclusion based on the samples tested. The data provenance is "bench testing" and "biocompatibility testing," which are laboratory-based tests of the device itself, not clinical data or data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device performance and biocompatibility study, not an AI diagnostic study relying on expert ground truth. However, for "Simulated Use/Usability," it states "usability assessment with multiple physicians," but specific numbers or qualifications are not provided.

4. Adjudication method for the test set
Not applicable.

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. No AI component is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. No AI component is mentioned.

7. The type of ground truth used
For nonclinical performance, the "ground truth" is defined by established engineering and material science standards (e.g., ISO 10555-1, FDA guidance documents, ASTM D4332, AAMI TIR42, ISO 10993 series for biocompatibility). The device's physical properties and interactions are measured against these objective criteria.

8. The sample size for the training set
Not applicable. There is no AI training set as this is a device performance study.

9. How the ground truth for the training set was established
Not applicable. There is no AI training set.

Summary

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June 22, 2023

Image /page/0/Picture/1 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Q'Apel Medical, Inc. Kim Ky Manager, Regulatory Affairs 4245 Technology Drive Fremont, California 94538

Re: K230322

Trade/Device Name: SelectFlex Neurovascular Access System Family Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: May 23, 2023 Received: May 23, 2023

Dear Kim Ky:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 medical devices and radiation-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,

Naira Muradyan -S

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K230322

Device Name SelectFlex Neurovascular Access System Family

Indications for Use (Describe)

The SelectFlex Neurovascular Access System Family is introduction of interventional devices into the peripheral and neurovasculature.

Type of Use (Select one or both, as applicable)

X | Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY As required by 21 CFR 807.92

Applicant:

Submitter's Name:Address:	Q'Apel Medical Inc.4245 Technology DriveFremont, CA 94538	Feature	Subject DeviceSelectFlexNeurovascularAccess SystemFamily	Predicate DeviceBenchmarkIntracranialAccess System	Reference DeviceSelectFlexNeurovascularAccess SystemFamily	Comparison
Telephone:Fax:	510-738-6255510-738-6256	Device Name	SelectFlexNeurovascularAccess SystemFamily	BenchmarkIntracranialAccess System	SelectFlexNeurovascularAccess SystemFamily	N/A
Contact Person:Title:Telephone:	Kim KyManager, Regulatory Affairs510-828-4757	510(k) Number	K230322	K212838	K211893	N/A
Date Prepared:	June 21, 2023	Classification	Class II	Class II	Class II	Same
Device Trade name:	SelectFlex Neurovascular Access System Family	Product Codes	QJP, DQY	QJP, DQY	QJP, DQY	Same
Classification:	Class II	Regulation Number	870.1250	870.1250	870.1250	Same
Product Codes:	QJP, DQY	Indications for Use	The SelectFlexNeurovascularAccess SystemFamily is indicatedfor the introductionof interventionaldevices into theperipheral andneurovasculature.	The BenchmarkIntracranial AccessSystem is indicatedfor the introductionof interventionaldevices into theperipheral, coronary,and neurovasculature.	The SelectFlexNeurovascularAccess SystemFamily is indicatedfor the introductionof interventionaldevices into theperipheral andneurovasculature.	Same
Regulation Number:	21 CFR 870.1250	Materials	Commonly usedmedical-gradeplastics, stainlesssteel, nitinol.	Commonly usedmedical gradeplastics and stainlesssteel.	Commonly usedmedical-gradeplastics, stainlesssteel, nitinol.	Similar, thedifferences do notraise newquestionsregarding safetyand effectiveness.
Classification Name:	Catheter, Percutaneous, Neurovasculature	Outer Diameter (OD)	6F catheter: 0.083 in	0.081 – 0.083 in	7F catheter: 0.095 in	Similar, thedifference doesnot raise newquestionsregarding safetyand effectiveness.
Predicate Device:	Benchmark Intracranial Access System (K212838)	Inner Diameter (ID)	6F catheter: 0.064 in Min	0.070 in Min	7F catheter: 0.072 in Min	Similar, thedifference doesnot raise newquestionsregardingsafety andeffectiveness.
Reference Device:	SelectFlex Neurovascular Access System Family (K211893)	Effective length	95 and 105 cm	95 and 105 cm	95, 105, and 115 cm	Same
Tip Shape	Straight	Straight & Multi-Purpose	Straight	Same asreference device
Injection Port	Yes	Yes	Yes	Same
Radiopaque	Yes	Yes	Yes	Same

Indications for Use:

The SelectFlex Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Device Description:

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Comparison of Technological Characteristics with the Predicate and Reference Devices

The subject expanded SelectFlex Neurovascular Access System Family incorporates similar design, packaging, fundamental technology, manufacturing processes, sterilization process, and intended use as the predicate device (K212838) and reference device (K211893).

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Device Comparison Table
Feature	Subject Device	Predicate Device	Reference Device	Comparison
Device Name	SelectFlexNeurovascularAccess SystemFamily	BenchmarkIntracranialAccess System	SelectFlexNeurovascularAccess SystemFamily	N/A
Coating length	30 cm	10 cm	11.5 and 30 cm	Same asreferencedevice
ShaftReinforcement	Stainless steelreinforced shaft	Stainless steelreinforced shaft	Stainless steelreinforced shaft	Same
VariableStiffnessMechanism	Variabledurometercatheter shaftconstruction todeliver a flexibledistal tip andtransition to astiffer proximalsection; tentransitionsegmentsbetween thedistal tip andproximal shaft.&Two user-selectable variablestiffness modes ofthe distal 10 cm byapplication of fluidinto the distalscaffold chamberof the catheterwall. Fluidpressure enablesthe more flexibletracking mode;fluid withdrawalswitches to a lessflexible and moresupportive mode.	Variable durometercatheter shaftconstruction.	Variable durometercatheter shaftconstruction todeliver a flexibledistal tip andtransition to astiffer proximalsection; tentransitionsegments betweenthe distal tip andproximal shaft.&Two user-selectablevariable stiffnessmodes of thedistal 10 cm byapplicationof fluid into thedistal scaffoldchamber of thecatheter wall.Fluid pressureenables themore flexibletracking mode;fluid withdrawalswitches to a lessflexible andmore supportivemode.	Same asreference device
7F IntroducerSheath	N/A	7F IntroducerSheath	Same asreferencedevice
3 cc syringe	N/A	3 cc syringe	Same asreference device
Luer ActivatedValve	N/A	Luer ActivatedValve	Same asreference device
Device Comparison Table
Feature	Subject Device	Predicate Device	Reference Device	Comparison
Device Name	SelectFlexNeurovascularAccess SystemFamilyDilator	BenchmarkIntracranialAccess System	SelectFlexNeurovascularAccess SystemFamilyDilator	N/A
	EffectiveLength:105 and 115 cmID: 0.039 ± 0.001inOD: 0.060 ±0.001 inTip-TaperDistance: 0.394inTip-Tapered OD:0.14 cmMaterial:Hub: CS 00542,Winged ArmadilloDilator HubShaft: Pebax 7233Shaft Colorant:1.25% Max FosterMediBatch SlateGreyUMBXXX031616C1	N/A	Effective Length:105, 115, 125 cmID: 0.039 ± 0.001 inOD: 0.068 ± 0.001inTip-Taper Distance:0.591 inTip-Tapered OD:0.14 cmMaterial:Hub: CS 00542,Winged ArmadilloDilator HubShaft: Pebax 7233Shaft Colorant:1.25% Max FosterMediBatch SlateGreyUMBXXX031616C1	Similar toreference device
	4.5F Access Tool	5F Select Catheter	N/A	Similar topredicate device
	EffectiveLength:130 and 140cmID: 0.038 inMinOD: 4.5F (0.061 inMax)Tip Shape:SimmonsMaterial:Commonly usedmedical gradeplastics &stainless steel	Effective Length:123 and 131.5 cmID: 0.043 in MinOD: 5F (0.069 inMax)Tip Shapes:Berenstein, H1, andSimmonsMaterial: Commonlyused medical gradeplastics & stainlesssteel
GuidewireCompatibility	0.035 - 0.038 in	0.035 - 0.038 in	0.035 - 0.038 in	Same
How Supplied	Sterile, single-use	Sterile, single-use	Sterile, single-use	Same
Sterilizationmethod	Ethylene oxide(EtO)	EtO	EtO	Same
Device Comparison Table
Feature	Subject Device	Predicate Device	Reference Device	Comparison
Device Name	SelectFlexNeurovascularAccess SystemFamily	BenchmarkIntracranialAccess System	SelectFlexNeurovascularAccess SystemFamily	N/A
SterilityAssuranceLevel	$10^{-6}$	$10^{-6}$	$10^{-6}$	Same
Shelf-Life	6 months	36 months	36 months	A 6-monthshelf life wasValidated forthe subjectdevice.

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Nonclinical Performance Data:

The following nonclinical performance testing was conducted to support the determination of substantial equivalence.

Performance Testing Summary:

Bench testing was performed to evaluate the physical integrity, functionality, and performance of the SelectFlex Neurovascular Access System Family:

Test Name	Goal	ReferenceStandard or Guidance	Result
Visual SurfaceRequirements(SelectFlex III 064NeurovascularAccess Catheter, 6FDilator, 4.5F AccessTool)	To demonstrate thatthe device meets thevisual surfacerequirements.	ISO 10555-1 2013:Intravascular catheters- Sterile and single-use catheters - Part1: General requirements	PassAll samples met thepredeterminedacceptance criteria.
DimensionalVerification(SelectFlex III 064NeurovascularAccess Catheter, 6FDilator, 4.5F AccessTool)	To demonstrate thatthe device meets thedimensionalrequirements.	ISO 10555-1 2013:Intravascular catheters- Sterile and single-use catheters - Part1: General requirements	PassAll samples met thepredeterminedacceptance criteria.
Liquid LeakageUnder Pressure(SelectFlex III 064NeurovascularAccess Catheter)	To demonstrate thatthe device passes theliquid leakage underpressure test.	ISO 10555-1 2013,Section 4.7.1, Annex C	PassAll samples met thepredeterminedacceptance criteria.
Hub Aspiration AirLeakage(SelectFlex III 064Neurovascular AccessCatheter)	To demonstrate thatthe device passes thehub aspiration airleakage test.	ISO 10555-1 2013,Section 4.7.2, Annex D	PassAll samples met thepredeterminedacceptance criteria.
SimulatedUse/Usability(SelectFlex III 064NeurovascularAccess Catheter, 6FDilator, 4.5F AccessTool)	To demonstrate thatthe device passestesting specified in thesimulated use testprotocol.Simulated use testingincludes usabilityassessment withmultiple physicians.	FDA guidance:"Coronary, Peripheral,and NeurovascularGuidewires -Performance Tests andRecommended Labeling"	PassAll samples met thepredeterminedacceptance criteria.
Flex Fatigue(SelectFlex III 064NeurovascularAccess Catheter, 6FDilator, 4.5F AccessTool)	To demonstrate thatthe device passes theflex fatigue test.	FDA guidance:"Coronary, Peripheral,and NeurovascularGuidewires -Performance Tests andRecommended Labeling"	PassAll samples met thepredeterminedacceptance criteria.
Inflation Fatigue	To demonstrate that	ISO 10555-1 2013,	Pass
Test Name	Goal	ReferenceStandard or Guidance	Result
(SelectFlex III 064Neurovascular AccessCatheter)	the device passes theinflation fatigue test.	Section 4.7.1 – 20inflation cycles	All samples met thepredeterminedacceptance criteria.
Burst Volume(SelectFlex III 064Neurovascular AccessCatheter)	To demonstrate thatthe device passes theburst volume test –tested to 2x theinflation volume.	ISO 10555-1 2013:Intravascular catheters- Sterile and single-use catheters - Part1: General requirements	PassAll samples met thepredeterminedacceptance criteria.
Torque Test(SelectFlex III 064Neurovascular AccessCatheter, 4.5F AccessTool)	To demonstrate thedevice's ability torotate 720 degrees (2full revolutions) at theproximal end.	ISO 10555-1 2013:Intravascular catheters- Sterile and single-use catheters - Part1: General requirements	PassAll samples met thepredeterminedacceptance criteria.
Tip Deflection(SelectFlex III 064Neurovascular AccessCatheter)	To demonstrate thatthe tip deflection iscomparable to thepredicate device.	FDA Guidance:"Coronary, Peripheral,and NeurovascularGuidewires –Performance Tests andRecommended Labeling"	PassAll samples met thepredeterminedacceptance criteria.
Device Removal inSupport and TrackingModes(SelectFlex III 064Neurovascular AccessCatheter)	To demonstrate thatthe forces in bothsupport and trackingmodes arecomparable to thepredicate device.	FDA Guidance:"Coronary, Peripheral,and NeurovascularGuidewires –Performance Tests andRecommended Labeling"	PassAll samples met thepredeterminedacceptance criteria.
Peak TensileTesting(SelectFlex III 064NeurovascularAccess Catheter, 6FDilator, 4.5F AccessTool)	To demonstrate thatthe device passes thepeak tensile strengthtesting including allbonds and joints.	ISO 10555-1 2013,Section 4.6, Annex B	PassAll samples met thepredeterminedacceptance criteria.
Flow Rate(SelectFlex III 064Neurovascular AccessCatheter)	To demonstrate thatthe flow rate iscomparable to thepredicate device.	ISO 10555-1 2013:Intravascular catheters- Sterile and single-use catheters - Part1: General requirements	PassAll samples met thepredeterminedacceptance criteria.
CorrosionResistance(SelectFlex III 064NeurovascularAccess Catheter,4.5F Access Tool)	To demonstrate thatthe device has novisual evidence ofcorrosion.	ISO 10555-1 2013,Section 4.5, Annex A	PassAll samples met thepredeterminedacceptance criteria.
Radiopacity(SelectFlex III 064NeurovascularAccess Catheter,4.5F Access Tool)	To demonstrate thatthe marker band ispositioned at the distaltip of the catheter andis clearly visible undertypical fluoroscopicimaging conditions.	ISO 10555-1 2013:Intravascular catheters- Sterile and single-use catheters - Part1: General requirements	PassAll samples met thepredeterminedacceptance criteria.
Test Name	Goal	ReferenceStandard or Guidance	Result
Particulates, CoatingIntegrity, Lubricity,Durability(SelectFlex III 064Neurovascular AccessCatheter)	To demonstrate thequantity and size ofparticles generatedduring simulated useare comparable to thepredicate andreference devices.	1. AAMI TIR42:10Evaluation ofparticulates associatedwith vascular medicaldevices2. IntravascularCatheters, Wires, andDelivery Systems withLubricious Coatings -LabelingConsiderations, issuedon October 10, 2019.	PassAll samples met thepredeterminedacceptance criteria.
Static Burst(SelectFlex III 064NeurovascularAccess Catheter,4.5F Access Tool)	To demonstrate thatthe device passesstatic burst asspecified in the testprotocol.	ISO 10555-1 2013:Intravascular catheters- Sterile and single-use catheters - Part1: General requirements	PassAll samples met thepredeterminedacceptance criteria.
Shelf Life(SelectFlex III 064NeurovascularAccess Catheter, 6FDilator, 4.5F AccessTool)	To demonstrate thatthe deviceperformance ismaintained over theproposed shelf-life (6months).	ASTM D4332,Standard Practice forConditioning Containers,Packages, or PackagingComponents forTesting	PassAll samples met thepredeterminedacceptance criteria.

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The results of these tests provide reasonable assurance that the subject device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing.

Biocompatibility Testing:

The subject SelectFlex III 064 Neurovascular Access Catheter is categorized as limited exposure (< 24 hours), externally communicating device with circulating blood contact in accordance with ISO 10993-1. Q'Apel has conducted biocompatibility testing per ISO 10993-1 on the predicate device which supports the biocompatibility of the subject catheter.

Test Name	ReferenceStandard	Results	Conclusion
Cytotoxicity	ISO 10993-5	No reactivity was observedwith the test article at 24 and48 hours.	Non-cytotoxic
Sensitization	ISO10993-10	The test article extracts showedno evidence of delayed dermalcontact sensitization in the guineapig maximization test.	Non-sensitizing
IntracutaneousReactivity	ISO 10993-23	The scores from test articleextracts were 0 from the salineextract and 0 from the sesameseed oil extract.	Non-irritant

Additional biocompatibility testing was performed on the 4.5F Access Tool:

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Test Name	ReferenceStandard	Results	Conclusion
Acute SystemicToxicity	ISO 10993-11	No abnormal clinical signsindicative of toxicity wereobserved for 72 hours. Allanimals were alive at the endof 72 hours and body weightchanges were withinacceptable parameters.	Non-toxic
Material MediatedPyrogenicity	ISO 10993-11	No rabbit temperature rise ≥0.5 °C.	Non-pyrogenic
Hemolysis - DirectContact andExtract Method	ISO 10993-4	Blank corrected hemolyticindex: 0.15, 0.13.	Non-hemolytic
ComplementActivation	ISO 10993-4	Results within acceptablerange as compared to thecontrols.	Not a Sc5b-9 complementactivator
Thrombogenicity	ISO 10993-4	No adverse effects or clinicalsigns during test periodand no thrombus score ≥ 2 foreither test or control device.	Non-thrombogenic

Animal Study:

Animal testing was not deemed necessary to support the substantial equivalence of the SelectFlex Neurovascular Access System Family.

Clinical:

Clinical testing was not deemed necessary to support the substantial equivalence of the SelectFlex Neurovascular Access System Family.

Conclusion:

The SelectFlex Neurovascular Access System Family has the same intended use and indications for use as the predicate Benchmark Intracranial Access System (K212838). The technological characteristics of the subject device are similar to the predicate device. The differences in technological characteristics do not raise new questions of safety and effectiveness. The subject SelectFlex Neurovascular Access System Family is substantially equivalent to the predicate device, Benchmark Intracranial Access System.

Regulation Number and Section

§ 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).