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

Device Description

The SelectFlex Neurovascular Access System Family consists of sterile, single-use intravascular catheters used to facilitate access to target vasculature during interventional procedures. The system is composed of a SelectFlex Neurovascular Access Catheter, a 3cc Mode Control Syringe, a 7Fr Peel Away Introducer, Luer Activated Valve and a Dilator (only for versions with a Long Hydrophilic coating to ease dermal entry). The SelectFlex Neurovascular Access Catheter comes in usable lengths of 95, 105 or 115cm. The SelectFlex Neurovascular Access Catheter has variable stiffness along its length and has a dual mode stiffness mechanism on the distal portion of the catheter that is activated by the user allowing the device to transition between tracking and support modes. The distal end of the SelectFlex Neurovascular Access Catheter comes in two options of a short hydrophilic coating length of 11.5cm or a long hydrophilic coating length of 30cm.

AI/ML Overview

The provided FDA 510(k) summary for the SelectFlex Neurovascular Access System Family describes non-clinical performance data (bench testing) to demonstrate substantial equivalence to a predicate device, rather than a study involving human subjects or AI performance metrics. Therefore, many of the requested elements pertaining to AI studies, ground truth establishment, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document.

Here's the information that can be extracted and a clear indication where the requested information is not available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Test Description	Acceptance Criteria (Implied)	Reported Device Performance
Visual Surface Requirements (catheter and dilator)	All samples meet pre-determined acceptance criteria	PASS (All samples met the pre-determined acceptance criteria)
Dimensional Verification (catheter and dilator)	All samples meet pre-determined acceptance criteria	PASS (All samples met the pre-determined acceptance criteria)
Simulated Use/Usability	All samples meet pre-determined acceptance criteria	PASS (All samples met the pre-determined acceptance criteria)
Flexion Fatigue	All samples meet pre-determined acceptance criteria	PASS (All samples met the pre-determined acceptance criteria)
Inflation Fatigue	All samples meet pre-determined acceptance criteria	PASS (All samples met the pre-determined acceptance criteria)
Burst Volume	All samples meet pre-determined acceptance criteria	PASS (All samples met the pre-determined acceptance criteria)
ISO 80369-7: Small Bore Connectors for Hypodermic Applications	All samples meet pre-determined acceptance criteria	PASS (All samples met the pre-determined acceptance criteria)
Particulate Count	All samples meet pre-determined acceptance criteria	PASS (All samples met the pre-determined acceptance criteria)
Peak Tensile Testing (catheter and dilator)	All samples meet pre-determined acceptance criteria	PASS (All samples met the pre-determined acceptance criteria)

Note: The document states "All samples met the pre-determined acceptance criteria" for each test, implying that the acceptance criteria were defined prior to testing, but the specific quantitative or qualitative criteria for each test (e.g., maximum allowable particulate count, specific tensile strength values, specific pass/fail conditions for visual inspection) are not explicitly detailed in this summary.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size for each bench test beyond "All samples." It states "Simulated use testing includes a usability assessment with multiple physicians" but does not give a number for the physicians or the number of simulated cases.

Data Provenance: The data is from non-clinical bench testing and simulated use conditions, not from human clinical data or retrospective/prospective studies on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI performance study requiring ground truth established by experts. For the "Simulated Use/Usability" test, it mentions "multiple physicians," but their specific number or qualifications are not provided as they are assessing usability, not establishing ground truth on patient data.

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

Not applicable. This is not an AI performance study requiring adjudication of expert readings.

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

No MRMC comparative effectiveness study was done. This document describes the substantial equivalence of a physical medical device (catheter system) based on bench testing, not an AI software.

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

Not applicable. This document does not describe an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For the non-clinical bench tests, "ground truth" would be objective measurements against engineering specifications and industry standards (e.g., ISO 10555-1: 2013, ISO 80369-7) rather than clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This document does not describe an AI system that requires a training set.

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

Not applicable. This document does not describe an AI system.

Summary

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August 5, 2021

Q'Apel Medical Inc % Michele Lucey President Lakeshore Medical Device Consulting LLC 128 Blve Hill Landing Newbury, New Hampshire 03255

Re: K211893

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: July 6, 2021 Received: July 7, 2021

Dear Michele Lucey:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K211893

Device Name

SelectFlex Neurovascular Access System Family

Indications for Use (Describe)

The SelectFlex Neurovascular Access System Family is indicated for the 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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SPECIAL 510(k) SUMMARY As required by 21 CFR 807.92

Submitter Information:

Submitter's Name:	Q'Apel Medical Inc
Address:	46708 Lakeview Blvd
	Fremont CA 94538
Telephone:	510-738-6255
Fax:	510 738 6256
Contact Person:	Michele Lucey
Telephone:	603-748-1374
Date Prepared:	August 4, 2021
Device Trade Name:	SelectFlex Neurovascular Access System Family
Classification:	Class II
Product Code(s):	QJP, DQY
Regulation Number(s):	870.1250
Classification Name	Percutaneous Catheter
Predicate Devices:	SelectFlex 072 Neurovascular Access System K191664-
Indications for Use:

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

Device Description

Comparison of Technological Characteristics

The SelectFlex Neurovascular Access System Family incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those contained in the SelectFlex 072 Neurovascular Access System (K191664). The following table provides a comparison of the subject device to the predicate device:

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Comparison Table to Demonstrate Substantial Equivalence
	Subject Device	Predicate Device
Feature	SelectFlexNeurovascularAccess SystemFamily	SelectFlex 072NeurovascularAccess System	Comparison
RegulatoryClearance/ApprovalReference	Pending	K191664	NA
FDA Classification	Class II	Class II	Same
Product Code(s)	QJP, DQY	DQY	Same
Regulation Number	870.1250	870.1250	Same
Material	Commonly usedmedical gradeplastics, stainlesssteel, nitinol	Commonly usedmedical gradeplastics, stainlesssteel, nitinol	Similar, difference doesnot raise new questionsregarding safety andefficacy
Outer Diameter	.095-in	.095-in	Same
Inner dimension	.072-in	.072-in	Same
Fr Designation	7 Fr	7 Fr	Same
Effective length	95, 105, and 115cm	105cm	Similar, additionallengths are consistentwith catheters of thistype, this differencedoes not raise newquestions regardingsafety of effectiveness
Tip Shape	Straight	Straight	Same
Injection Port	Yes	Yes	Same
Radiopaque	Distal Tip has aradiopaque markerband, stainless steelreinforcement andnitinol scaffold in thecatheter shaft rendersthe shaft visible onfluoroscopy	Distal Tip has aradiopaque markerband, stainless steelreinforcement andnitinol scaffold inthe catheter shaftrenders the shaftvisible onfluoroscopy	Same
Comparison Table to Demonstrate Substantial Equivalence
	Subject Device	Predicate Device
Feature	SelectFlexNeurovascularAccess SystemFamily	SelectFlex 072NeurovascularAccess System	Comparison
Coating	Hydrophilic Coating– Distal Portion11.5cm and 30cm	Hydrophilic Coating– Distal Portion11.5cm	Similar, difference doesnot raise new questionsregarding safety andeffectiveness
Reinforced Shaft	Stainless steelreinforced shaft	Stainless steelreinforced shaft	Same
Variable StiffnessMechanism	Variable durometercatheter shaftconstruction todeliver a flexibledistal tip andtransition to a stifferproximal section; tentransition segmentsbetween the distal tipand proximal shaft.&Two user-selectablevariable stiffnessmodes of the distal10cm by applicationof fluid into thedistal scaffoldchamber of thecatheter wall. Fluidpressure enables themore flexibletracking mode; fluidwithdrawal switchesto a less flexible andmore supportivemode.	Variable durometercatheter shaftconstruction todeliver a flexibledistal tip andtransition to a stifferproximal section;ten transitionsegments betweenthe distal tip andproximal shaft.&Two user-selectablevariable stiffnessmodes of the distal10cm by applicationof fluid into thedistal scaffoldchamber of thecatheter wall. Fluidpressure enables themore flexibletracking mode; fluidwithdrawal switchesto a less flexible andmore supportivemode.	Same
Comparison Table to Demonstrate Substantial Equivalence
Feature	Subject Device	Predicate Device	Comparison
Distal End SegmentLength	SelectFlexNeurovascularAccess SystemFamily	SelectFlex 072NeurovascularAccess System	Comparison
Distal End SegmentLength	17, 22, and 27cm	17cm	Similar, difference doesnot raise new questionsregarding safety andeffectiveness
Tip Stiffness	0.12 N (tracking andsupport mode)	0.12 N (tracking andsupport mode)	Same
AccessoriesSupplied	7 Fr IntroducerSheath3cc syringeLuer ActivatedValveDilator (onlyincluded withcatheters that have aLong HydrophilicCoating)	7 Fr IntroducerSheath3cc syringeHub Extension Line	Similar, difference doesnot raise new questionsregarding safety andeffectiveness
GuidewireCompatibility	0.035-0.038-in	0.035-0.038-in	Same
How Supplied	Sterile, single use	Sterile, single use	Same
SterilizationMethod	EtO	EtO	Same
Sterility AssuranceLevel	10-6	10-6	Same

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Substantial Equivalence:

This summary demonstrates that the SelectFlex Neurovascular Access System Family and the predicate device have the same intended use, similar technological characteristics, materials, and principles of operation. It can therefore be concluded that the SelectFlex Neurovascular Access System Family is substantially equivalent to the predicate device.

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Nonclinical Performance Data:

Determination of substantial equivalence is based on an assessment of non-clinical performance bench test data.

Bench Testing:

Bench testing was performed to evaluate physical integrity, functionality, and performance of the SelectFlex Neurovascular Access System Family. Performance data includes dimensional verification, delivery and removal under simulated use conditions, bond tensile strength, and compatibility with interface devices. A summary of all tests performed is provided in the following table:

Test Description	Test Method	Results
Visual SurfaceRequirements(catheter and dilator)	Visual inspection of cathetersurfaces	PASSAll samples met the pre-determined acceptancecriteria
Dimensional Verification(catheter and dilator)	Device dimensions were measured toconfirm conformance to the productspecification	PASSAll samples met the pre-determined acceptancecriteria
SimulatedUse/Usability	Device preparation, delivery, access, wasevaluated in a challenging neurovascularmodel.Simulated use testing includes a usabilityassessment with multiple physicians	PASSAll samples met the pre-determined acceptancecriteria
Flexion Fatigue	Tested per ISO 10555-1: 2013 forFlexural Fatigue	PASSAll samples met the pre-determined acceptancecriteria
Inflation Fatigue	Tested per ISO 10555-1: 2013 forInflation Fatigue - 20 inflation cycles	PASSAll samples met the pre-determined acceptancecriteria
Burst Volume	Tested per ISO 10555-1: 2013 for InflationFatigue - tested to 2x the inflation volume	PASSAll samples met the pre-determined acceptancecriteria
ISO 80369-7: Small BoreConnectors forHypodermic Applications	Tested per ISO 80369-7, dimensional,leakage by pressure decay, freedom from airleakage, positive pressure liquid leakage,sub-atmospheric pressure air leakage, stresscracking, resistance to separation from axialload, resistance to separation fromunscrewing, resistance to overriding	PASSAll samples met the pre-determined acceptancecriteria
Test Description	Test Method	Results
Particulate Count	Effluent tested per AAMI TIR42, USP788 using multiple insertion andwithdrawal cycles	PASSAll samples met the pre-determined acceptancecriteria
Peak Tensile Testing(catheter and dilator)	Tested per ISO 10555-1 for tensilestrength including all bonds/joints	PASSAll samples met the pre-determined acceptancecriteria

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The results of these tests provide reasonable assurance that the 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; therefore, this device is substantially equivalent to the predicate device.

Biocompatibility:

The subject device is primarily comprised of the same materials used in the predicate device. Where there are minor differences, biocompatibility has been demonstrated through company testing of other devices with the same tissue contact categorization. No additional biocompatibility testing was performed.

Conclusion:

Based on the indications for use, technological characteristics, and performance testing, the SelectFlex Neurovascular Access System Family has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the SelectFlex 072 Neurovascular Access System, K191664.

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).