SelectFlex Neurovascular Access System Family

K230322 · Q'Apel Medical, Inc. · QJP · Jun 22, 2023 · Cardiovascular

Device Facts

• Record ID: K230322
• Device Name: SelectFlex Neurovascular Access System Family
• Applicant: Q'Apel Medical, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: Jun 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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

Device Story

The SelectFlex Neurovascular Access System Family is a line extension of a previously cleared neurovascular access catheter system. It consists of a 6F SelectFlex III 064 Neurovascular Access Catheter, a 6F dilator, an introducer sheath, and a 4.5F Access Tool. The system is used by physicians in clinical settings to access peripheral and neurovascular anatomy for the delivery of interventional devices. The catheter features a variable stiffness mechanism; fluid pressure in a distal scaffold chamber allows the user to toggle between a flexible tracking mode and a more supportive mode. The device is radiopaque for fluoroscopic visualization. By providing a stable access platform, the system facilitates the navigation of interventional tools to target sites, potentially improving procedural outcomes in neurovascular interventions.

Clinical Evidence

No clinical data was required. Substantial equivalence is supported by extensive bench testing, including visual inspection, dimensional verification, liquid leakage, hub aspiration, simulated use, flex/inflation fatigue, burst volume, torque, tip deflection, tensile strength, flow rate, corrosion resistance, radiopacity, and particulate/coating integrity testing. Biocompatibility was established per ISO 10993-1.

Technological Characteristics

Materials include medical-grade plastics, stainless steel, and nitinol. Features a variable stiffness catheter shaft (variable durometer) with a fluid-actuated distal scaffold chamber. Dimensions: 6F catheter (0.083 in OD, 0.064 in ID). Sterilization via Ethylene Oxide (EtO). Single-use, sterile. No software or electronic components.

Indications for Use

Indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Regulatory Classification

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.

Predicate Devices

• Benchmark Intracranial Access System (K212838)

Reference Devices

• SelectFlex Neurovascular Access System Family (K211893)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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:<br>Address: | Q'Apel Medical Inc.<br>4245 Technology Drive<br>Fremont, CA 94538 | Feature | Subject Device<br>SelectFlex<br>Neurovascular<br>Access System<br>Family | Predicate Device<br>Benchmark<br>Intracranial<br>Access System | Reference Device<br>SelectFlex<br>Neurovascular<br>Access System<br>Family | Comparison |
|-----------------------------------------|-------------------------------------------------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Telephone:<br>Fax: | 510-738-6255<br>510-738-6256 | Device Name | SelectFlex<br>Neurovascular<br>Access System<br>Family | Benchmark<br>Intracranial<br>Access System | SelectFlex<br>Neurovascular<br>Access System<br>Family | N/A |
| Contact Person:<br>Title:<br>Telephone: | Kim Ky<br>Manager, Regulatory Affairs<br>510-828-4757 | 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 SelectFlex<br>Neurovascular<br>Access System<br>Family is indicated<br>for the introduction<br>of interventional<br>devices into the<br>peripheral and<br>neurovasculature. | The Benchmark<br>Intracranial Access<br>System is indicated<br>for the introduction<br>of interventional<br>devices into the<br>peripheral, coronary,<br>and neuro<br>vasculature. | The SelectFlex<br>Neurovascular<br>Access System<br>Family is indicated<br>for the introduction<br>of interventional<br>devices into the<br>peripheral and<br>neurovasculature. | Same |
| Regulation Number: | 21 CFR 870.1250 | Materials | Commonly used<br>medical-grade<br>plastics, stainless<br>steel, nitinol. | Commonly used<br>medical grade<br>plastics and stainless<br>steel. | Commonly used<br>medical-grade<br>plastics, stainless<br>steel, nitinol. | Similar, the<br>differences do not<br>raise new<br>questions<br>regarding safety<br>and 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, the<br>difference does<br>not raise new<br>questions<br>regarding safety<br>and 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, the<br>difference does<br>not raise new<br>questions<br>regarding<br>safety and<br>effectiveness. |
| 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 as<br>reference 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:

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.

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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 | SelectFlex<br>Neurovascular<br>Access System<br>Family | Benchmark<br>Intracranial<br>Access System | SelectFlex<br>Neurovascular<br>Access System<br>Family | N/A |
| Coating length | 30 cm | 10 cm | 11.5 and 30 cm | Same as<br>reference<br>device |
| Shaft<br>Reinforcement | Stainless steel<br>reinforced shaft | Stainless steel<br>reinforced shaft | Stainless steel<br>reinforced shaft | Same |
| Variable<br>Stiffness<br>Mechanism | Variable<br>durometer<br>catheter shaft<br>construction to<br>deliver a flexible<br>distal tip and<br>transition to a<br>stiffer proximal<br>section; ten<br>transition<br>segments<br>between the<br>distal tip and<br>proximal shaft.<br>&<br>Two user-<br>selectable variable<br>stiffness modes of<br>the distal 10 cm by<br>application of fluid<br>into the distal<br>scaffold chamber<br>of the catheter<br>wall. Fluid<br>pressure enables<br>the more flexible<br>tracking mode;<br>fluid withdrawal<br>switches to a less<br>flexible and more<br>supportive mode. | Variable durometer<br>catheter shaft<br>construction. | Variable durometer<br>catheter shaft<br>construction to<br>deliver a flexible<br>distal tip and<br>transition to a<br>stiffer proximal<br>section; ten<br>transition<br>segments between<br>the distal tip and<br>proximal shaft.<br>&<br>Two user-<br>selectable<br>variable stiffness<br>modes of the<br>distal 10 cm by<br>application<br>of fluid into the<br>distal scaffold<br>chamber of the<br>catheter wall.<br>Fluid pressure<br>enables the<br>more flexible<br>tracking mode;<br>fluid withdrawal<br>switches to a less<br>flexible and<br>more supportive<br>mode. | Same as<br>reference device |
| 7F Introducer<br>Sheath | N/A | 7F Introducer<br>Sheath | Same as<br>reference<br>device | |
| 3 cc syringe | N/A | 3 cc syringe | Same as<br>reference device | |
| Luer Activated<br>Valve | N/A | Luer Activated<br>Valve | Same as<br>reference device | |
| Device Comparison Table | | | | |
| Feature | Subject Device | Predicate Device | Reference Device | Comparison |
| Device Name | SelectFlex<br>Neurovascular<br>Access System<br>Family<br>Dilator | Benchmark<br>Intracranial<br>Access System | SelectFlex<br>Neurovascular<br>Access System<br>Family<br>Dilator | N/A |
| | Effective<br>Length:<br>105 and 115 cm<br>ID: 0.039 ± 0.001<br>in<br>OD: 0.060 ±<br>0.001 in<br>Tip-Taper<br>Distance: 0.394<br>in<br>Tip-Tapered OD:<br>0.14 cm<br><br>Material:<br>Hub: CS 00542,<br>Winged Armadillo<br>Dilator Hub<br>Shaft: Pebax 7233<br>Shaft Colorant:<br>1.25% Max Foster<br>MediBatch Slate<br>Grey<br>UMBXXX031616C<br>1 | N/A | Effective Length:<br>105, 115, 125 cm<br>ID: 0.039 ± 0.001 in<br>OD: 0.068 ± 0.001<br>in<br>Tip-Taper Distance:<br>0.591 in<br>Tip-Tapered OD:<br>0.14 cm<br><br>Material:<br>Hub: CS 00542,<br>Winged Armadillo<br>Dilator Hub<br>Shaft: Pebax 7233<br>Shaft Colorant:<br>1.25% Max Foster<br>MediBatch Slate<br>Grey<br>UMBXXX031616<br>C1 | Similar to<br>reference device |
| | 4.5F Access Tool | 5F Select Catheter | N/A | Similar to<br>predicate device |
| | Effective<br>Length:<br>130 and 140<br>cm<br>ID: 0.038 in<br>Min<br>OD: 4.5F (0.061 in<br>Max)<br>Tip Shape:<br>Simmons<br><br>Material:<br>Commonly used<br>medical grade<br>plastics &<br>stainless steel | Effective Length:<br>123 and 131.5 cm<br>ID: 0.043 in Min<br>OD: 5F (0.069 in<br>Max)<br>Tip Shapes:<br>Berenstein, H1, and<br>Simmons<br><br>Material: Commonly<br>used medical grade<br>plastics & stainless<br>steel | | |
| Guidewire<br>Compatibility | 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 |
| Sterilization<br>method | Ethylene oxide<br>(EtO) | EtO | EtO | Same |
| Device Comparison Table | | | | |
| Feature | Subject Device | Predicate Device | Reference Device | Comparison |
| Device Name | SelectFlex<br>Neurovascular<br>Access System<br>Family | Benchmark<br>Intracranial<br>Access System | SelectFlex<br>Neurovascular<br>Access System<br>Family | N/A |
| Sterility<br>Assurance<br>Level | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | Same |
| Shelf-Life | 6 months | 36 months | 36 months | A 6-month<br>shelf life was<br>Validated for<br>the subject<br>device. |

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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 | Reference<br>Standard or Guidance | Result |
|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Visual Surface<br>Requirements<br>(SelectFlex III 064<br>Neurovascular<br>Access Catheter, 6F<br>Dilator, 4.5F Access<br>Tool) | To demonstrate that<br>the device meets the<br>visual surface<br>requirements. | ISO 10555-1 2013:<br>Intravascular catheters<br>- Sterile and single-<br>use catheters - Part<br>1: General requirements | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Dimensional<br>Verification<br>(SelectFlex III 064<br>Neurovascular<br>Access Catheter, 6F<br>Dilator, 4.5F Access<br>Tool) | To demonstrate that<br>the device meets the<br>dimensional<br>requirements. | ISO 10555-1 2013:<br>Intravascular catheters<br>- Sterile and single-<br>use catheters - Part<br>1: General requirements | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Liquid Leakage<br>Under Pressure<br>(SelectFlex III 064<br>Neurovascular<br>Access Catheter) | To demonstrate that<br>the device passes the<br>liquid leakage under<br>pressure test. | ISO 10555-1 2013,<br>Section 4.7.1, Annex C | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Hub Aspiration Air<br>Leakage<br>(SelectFlex III 064<br>Neurovascular Access<br>Catheter) | To demonstrate that<br>the device passes the<br>hub aspiration air<br>leakage test. | ISO 10555-1 2013,<br>Section 4.7.2, Annex D | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Simulated<br>Use/Usability<br>(SelectFlex III 064<br>Neurovascular<br>Access Catheter, 6F<br>Dilator, 4.5F Access<br>Tool) | To demonstrate that<br>the device passes<br>testing specified in the<br>simulated use test<br>protocol.<br>Simulated use testing<br>includes usability<br>assessment with<br>multiple physicians. | FDA guidance:<br>"Coronary, Peripheral,<br>and Neurovascular<br>Guidewires -<br>Performance Tests and<br>Recommended Labeling" | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Flex Fatigue<br>(SelectFlex III 064<br>Neurovascular<br>Access Catheter, 6F<br>Dilator, 4.5F Access<br>Tool) | To demonstrate that<br>the device passes the<br>flex fatigue test. | FDA guidance:<br>"Coronary, Peripheral,<br>and Neurovascular<br>Guidewires -<br>Performance Tests and<br>Recommended Labeling" | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Inflation Fatigue | To demonstrate that | ISO 10555-1 2013, | Pass |
| Test Name | Goal | Reference<br>Standard or Guidance | Result |
| (SelectFlex III 064<br>Neurovascular Access<br>Catheter) | the device passes the<br>inflation fatigue test. | Section 4.7.1 – 20<br>inflation cycles | All samples met the<br>predetermined<br>acceptance criteria. |
| Burst Volume<br>(SelectFlex III 064<br>Neurovascular Access<br>Catheter) | To demonstrate that<br>the device passes the<br>burst volume test –<br>tested to 2x the<br>inflation volume. | ISO 10555-1 2013:<br>Intravascular catheters<br>- Sterile and single-<br>use catheters - Part<br>1: General requirements | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Torque Test<br>(SelectFlex III 064<br>Neurovascular Access<br>Catheter, 4.5F Access<br>Tool) | To demonstrate the<br>device's ability to<br>rotate 720 degrees (2<br>full revolutions) at the<br>proximal end. | ISO 10555-1 2013:<br>Intravascular catheters<br>- Sterile and single-<br>use catheters - Part<br>1: General requirements | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Tip Deflection<br>(SelectFlex III 064<br>Neurovascular Access<br>Catheter) | To demonstrate that<br>the tip deflection is<br>comparable to the<br>predicate device. | FDA Guidance:<br>"Coronary, Peripheral,<br>and Neurovascular<br>Guidewires –<br>Performance Tests and<br>Recommended Labeling" | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Device Removal in<br>Support and Tracking<br>Modes<br>(SelectFlex III 064<br>Neurovascular Access<br>Catheter) | To demonstrate that<br>the forces in both<br>support and tracking<br>modes are<br>comparable to the<br>predicate device. | FDA Guidance:<br>"Coronary, Peripheral,<br>and Neurovascular<br>Guidewires –<br>Performance Tests and<br>Recommended Labeling" | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Peak Tensile<br>Testing<br>(SelectFlex III 064<br>Neurovascular<br>Access Catheter, 6F<br>Dilator, 4.5F Access<br>Tool) | To demonstrate that<br>the device passes the<br>peak tensile strength<br>testing including all<br>bonds and joints. | ISO 10555-1 2013,<br>Section 4.6, Annex B | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Flow Rate<br>(SelectFlex III 064<br>Neurovascular Access<br>Catheter) | To demonstrate that<br>the flow rate is<br>comparable to the<br>predicate device. | ISO 10555-1 2013:<br>Intravascular catheters<br>- Sterile and single-<br>use catheters - Part<br>1: General requirements | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Corrosion<br>Resistance<br>(SelectFlex III 064<br>Neurovascular<br>Access Catheter,<br>4.5F Access Tool) | To demonstrate that<br>the device has no<br>visual evidence of<br>corrosion. | ISO 10555-1 2013,<br>Section 4.5, Annex A | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Radiopacity<br>(SelectFlex III 064<br>Neurovascular<br>Access Catheter,<br>4.5F Access Tool) | To demonstrate that<br>the marker band is<br>positioned at the distal<br>tip of the catheter and<br>is clearly visible under<br>typical fluoroscopic<br>imaging conditions. | ISO 10555-1 2013:<br>Intravascular catheters<br>- Sterile and single-<br>use catheters - Part<br>1: General requirements | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Test Name | Goal | Reference<br>Standard or Guidance | Result |
| Particulates, Coating<br>Integrity, Lubricity,<br>Durability<br>(SelectFlex III 064<br>Neurovascular Access<br>Catheter) | To demonstrate the<br>quantity and size of<br>particles generated<br>during simulated use<br>are comparable to the<br>predicate and<br>reference devices. | 1. AAMI TIR42:10<br>Evaluation of<br>particulates associated<br>with vascular medical<br>devices<br>2. Intravascular<br>Catheters, Wires, and<br>Delivery Systems with<br>Lubricious Coatings -<br>Labeling<br>Considerations, issued<br>on October 10, 2019. | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Static Burst<br>(SelectFlex III 064<br>Neurovascular<br>Access Catheter,<br>4.5F Access Tool) | To demonstrate that<br>the device passes<br>static burst as<br>specified in the test<br>protocol. | ISO 10555-1 2013:<br>Intravascular catheters<br>- Sterile and single-<br>use catheters - Part<br>1: General requirements | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Shelf Life<br>(SelectFlex III 064<br>Neurovascular<br>Access Catheter, 6F<br>Dilator, 4.5F Access<br>Tool) | To demonstrate that<br>the device<br>performance is<br>maintained over the<br>proposed shelf-life (6<br>months). | ASTM D4332,<br>Standard Practice for<br>Conditioning Containers,<br>Packages, or Packaging<br>Components for<br>Testing | Pass<br>All samples met the<br>predetermined<br>acceptance 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 | Reference<br>Standard | Results | Conclusion |
|------------------------------|-----------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Cytotoxicity | ISO 10993-5 | No reactivity was observed<br>with the test article at 24 and<br>48 hours. | Non-cytotoxic |
| Sensitization | ISO10993-10 | The test article extracts showed<br>no evidence of delayed dermal<br>contact sensitization in the guinea<br>pig maximization test. | Non-sensitizing |
| Intracutaneous<br>Reactivity | ISO 10993-23 | The scores from test article<br>extracts were 0 from the saline<br>extract and 0 from the sesame<br>seed oil extract. | Non-irritant |

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

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| Test Name | Reference<br>Standard | Results | Conclusion |
|-----------------------------------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Acute Systemic<br>Toxicity | ISO 10993-11 | No abnormal clinical signs<br>indicative of toxicity were<br>observed for 72 hours. All<br>animals were alive at the end<br>of 72 hours and body weight<br>changes were within<br>acceptable parameters. | Non-toxic |
| Material Mediated<br>Pyrogenicity | ISO 10993-11 | No rabbit temperature rise ≥<br>0.5 °C. | Non-pyrogenic |
| Hemolysis - Direct<br>Contact and<br>Extract Method | ISO 10993-4 | Blank corrected hemolytic<br>index: 0.15, 0.13. | Non-hemolytic |
| Complement<br>Activation | ISO 10993-4 | Results within acceptable<br>range as compared to the<br>controls. | Not a Sc5b-9 complement<br>activator |
| Thrombogenicity | ISO 10993-4 | No adverse effects or clinical<br>signs during test period<br>and no thrombus score ≥ 2 for<br>either 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.